#ID ; Name ; CAS ; Year ; Status ; KNApSAcK_Id-NPAtlas_Id ; Indications ; NDA_Numbers 1 ; SULFAPYRIDINE ; 144-83-2 ; 1939 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 000159 (pdf 159.pdf not found) INN (SULFAPYRIDINE) SULFAPYRIDINE (LILLY) APPROVAL= AP YEAR= 1939 DISCONTINUED , 2 ; TRIPTORELIN ; 57773-63-4 ; 2000 ; ; ; CLASS ANTINEOPLASTIC -- SYNTHETIC ANALOG OF GONADATROPIN RELEASING HORMONE (GNRH) -- PALLIATIVE TREATMENT OF ADVANCED PROSTATE CANCER -- STIMULATES THE RELEASE OF LUTEINIZING HORMONE , ; NDA 020715 (label 20715.pdf) INN (TRIPTORELIN PAMOATE) TRELSTAR (VERITY) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 021288 (label 21288.pdf) INN (TRIPTORELIN PAMOATE) TRELSTAR (VERITY) APPROVAL= AP YEAR= 2001 , NDA 022437 (label 22437.pdf) INN (TRIPTORELIN PAMOATE) TRELSTAR (VERITY) APPROVAL= AP YEAR= 2010 , NDA 208956 (label 208956.pdf) INN (TRIPTORELIN PAMOATE) TRIPTODUR KIT (AZURITY) APPROVAL= AP YEAR= 2017 , 3 ; HISTAMINE ; 51-45-6 ; 1939 ; DISCONTINUED ; NATURAL MOLECULE C00001414 ; CLASS DIAGNOSTIC AID -- HISTAMINE RECEPTOR AGONIST -- ACUTE MYELOID LEUKAEMIA (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 000734 (pdf 734.pdf not found) INN (HISTAMINE PHOSPHATE) HISTAMINE PHOSPHATE (LILLY) APPROVAL= AP YEAR= 1939 DISCONTINUED , 4 ; BUTABARBITAL ; 125-40-6 ; 1939 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- BARBITURATES -- SEDATIVES -- GABA MODULATOR , ; NDA 000793 (label 793.pdf) INN (BUTABARBITAL SODIUM) BUTISOL SODIUM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1939 DISCONTINUED , NDA 083325 (pdf 83325.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083337 (pdf 83337.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083484 (pdf 83484.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083524 (pdf 83524.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (MARSHALL PHARMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083606 (pdf 83606.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083858 (pdf 83858.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (MARSHALL PHARMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083896 (pdf 83896.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083897 (pdf 83897.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083898 (pdf 83898.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084040 (pdf 84040.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084272 (pdf 84272.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084292 (pdf 84292.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084719 (pdf 84719.pdf not found) INN (BUTABARBITAL SODIUM) SARISOL NO. 1 (HALSEY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084723 (pdf 84723.pdf not found) INN (BUTABARBITAL SODIUM) SARISOL (HALSEY) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085380 (pdf 85380.pdf not found) INN (BUTABARBITAL SODIUM) BUTISOL SODIUM (MEDA PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085381 (pdf 85381.pdf not found) INN (BUTABARBITAL SODIUM) BUTICAPS (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085383 (pdf 85383.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WOCKHARDT) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085418 (pdf 85418.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (HIKMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085432 (pdf 85432.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (HIKMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085550 (pdf 85550.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL (BUNDY) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085764 (pdf 85764.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085772 (pdf 85772.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085849 (pdf 85849.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085866 (pdf 85866.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085873 (pdf 85873.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARB (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085880 (pdf 85880.pdf not found) INN (BUTABARBITAL SODIUM) BUTALAN (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085881 (pdf 85881.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085934 (pdf 85934.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085938 (pdf 85938.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088631 (pdf 88631.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088632 (pdf 88632.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , 5 ; DESOXYCORTICOSTERONE ACETATE ; 56-47-3 ; 1939 ; DISCONTINUED ; ; CLASS HORMONES -- ADRENOCORTICAL STEROID -- PRECURSOR OF ALDOSTERONE -- SUBSTRATE OF ALDOSTERONE SYNTHASE (CYTOCHROME P450 CYP11B2) , ; NDA 001104 (pdf 1104.pdf not found) INN (DESOXYCORTICOSTERONE ACETATE) DOCA (ORGANON USA INC) APPROVAL= AP YEAR= 1939 DISCONTINUED , NDA 005151 (pdf 5151.pdf not found) INN (DESOXYCORTICOSTERONE ACETATE) PERCORTEN (NOVARTIS) APPROVAL= AP YEAR= 1942 DISCONTINUED , 6 ; DESOXYCORTICOSTERONE PIVALATE ; 808-48-0 ; 0 ; DISCONTINUED ; ; CLASS HORMONES -- ANTI-ADDISON AGENTS -- ADRENOCORTICAL STEROID -- PRECURSOR OF ALDOSTERONE -- SUBSTRATE OF ALDOSTERONE SYNTHASE (CYTOCHROME P450 CYP11B2) , ; NDA 008822 (pdf 8822.pdf not found) INN (DESOXYCORTICOSTERONE PIVALATE) PERCORTEN (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 7 ; GUANIDINE ; 113-00-8 ; 1939 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- PARASYMPATHOMIMETICS -- ANTIHYPERTENSIVE -- FOUND IN URINE AS A NORMAL PRODUCT OF PROTEIN METABOLISM , ; NDA 001546 (pdf 1546.pdf not found) INN (GUANIDINE HYDROCHLORIDE) GUANIDINE HYDROCHLORIDE (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1939 DISCONTINUED , 8 ; MENADIONE ; 58-27-5 ; 0 ; DISCONTINUED ; ; CLASS BLOOD -- ANTIFIBRINOLYTIC AGENTS -- DIETARY SUPPLEMENT -- MICRONUTRIENT -- VITAMIN K3 , ; NDA 002139 (pdf 2139.pdf not found) INN (MENADIONE) MENADIONE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 9 ; THEOPHYLLINE ; 58-55-9 ; 1940 ; ; NATURAL MOLECULE C00001510 ; CLASS RESPIRATORY SYSTEM -- SMOOTH MUSCLE RELAXANT -- CARDIOTONIC -- BRONCHODILATOR AGENTS -- PHOSPHODIESTERASE INHIBITORS -- VASODILATOR AGENTS -- AMINOPHYLLINE IS THEOPHYLLINE WITH 1,2-ETHANEDIAMINE (2:1) , ; NDA 002386 (pdf 2386.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLIN (GD SEARLE LLC) APPROVAL= AP YEAR= 1940 DISCONTINUED , NDA 018232 (pdf 18232.pdf not found) INN (AMINOPHYLLINE) SOMOPHYLLIN (FISONS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018924 (pdf 18924.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 081142 (pdf 81142.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 084530 (pdf 84530.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VALE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084531 (pdf 84531.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VALE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084533 (pdf 84533.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PAL PAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084540 (pdf 84540.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084552 (pdf 84552.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084563 (pdf 84563.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084568 (pdf 84568.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084574 (pdf 84574.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084575 (pdf 84575.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084576 (pdf 84576.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084577 (pdf 84577.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084588 (pdf 84588.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084632 (pdf 84632.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084674 (pdf 84674.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (HALSEY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084699 (pdf 84699.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085003 (pdf 85003.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085261 (pdf 85261.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ANI PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085262 (pdf 85262.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED OBSOLETE , NDA 085284 (pdf 85284.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (KV PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085289 (pdf 85289.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (KV PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085333 (pdf 85333.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085409 (pdf 85409.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VINTAGE PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085410 (pdf 85410.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VINTAGE PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085498 (pdf 85498.pdf not found) INN (AMINOPHYLLINE) TRUPHYLLINE (COSETTE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085564 (pdf 85564.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085567 (pdf 85567.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086466 (pdf 86466.pdf not found) INN (AMINOPHYLLINE) SOMOPHYLLIN (FISONS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086606 (pdf 86606.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (KING PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086760 (pdf 86760.pdf not found) INN (AMINOPHYLLINE) PHYLLOCONTIN (PHARM RES ASSOC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087045 (pdf 87045.pdf not found) INN (AMINOPHYLLINE) SOMOPHYLLIN-DF (FISONS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087200 (pdf 87200.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087209 (pdf 87209.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (INTL MEDICATION) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087239 (pdf 87239.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ELKINS SINN) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087240 (pdf 87240.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (LUITPOLD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087242 (pdf 87242.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 087243 (pdf 87243.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLIN (GD SEARLE LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087250 (pdf 87250.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087387 (pdf 87387.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PHARMA SERVE NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087392 (pdf 87392.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (PHARMA SERVE NY) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087431 (pdf 87431.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (LYPHOMED) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087500 (pdf 87500.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087501 (pdf 87501.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087522 (pdf 87522.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087523 (pdf 87523.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087600 (pdf 87600.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (AM REGENT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087601 (pdf 87601.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (HOSPIRA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087621 (pdf 87621.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLIN (GD SEARLE LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087727 (pdf 87727.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE DYE FREE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087867 (pdf 87867.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087868 (pdf 87868.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087886 (pdf 87886.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088126 (pdf 88126.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088147 (pdf 88147.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% (HOSPIRA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088156 (pdf 88156.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088182 (pdf 88182.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088183 (pdf 88183.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088297 (pdf 88297.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088298 (pdf 88298.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088314 (pdf 88314.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088319 (pdf 88319.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088407 (pdf 88407.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088429 (pdf 88429.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088749 (pdf 88749.pdf not found) INN (AMINOPHYLLINE) AMINOPHYLLINE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006333 (pdf 6333.pdf not found) INN (THEOPHYLLINE SODIUM GLYCINATE) SYNOPHYLATE (CENT PHARMS) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008869 (pdf 8869.pdf not found) INN (PROCAINE MERETHOXYLLINE THEOPHYLLINE) DICURIN PROCAINE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018649 (label 18649.pdf) INN (THEOPHYLLINE) THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 019083 (pdf 19083.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019211 (label 19211.pdf) INN (THEOPHYLLINE) THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019212 (pdf 19212.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019826 (label 19826.pdf) INN (THEOPHYLLINE) THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 040034 (pdf 40034.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (INWOOD LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040052 (pdf 40052.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (INWOOD LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040086 (pdf 40086.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (RHODES PHARMS) APPROVAL= AP YEAR= 1996 , NDA 040539 (pdf 40539.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040543 (pdf 40543.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040546 (pdf 40546.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040548 (pdf 40548.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040560 (pdf 40560.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2006 , NDA 040595 (pdf 40595.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 081034 (pdf 81034.pdf not found) INN (THEOPHYLLINE) THEO-24 (AUXILIUM PHARMS INC) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 081236 (pdf 81236.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1992 , NDA 083921 (pdf 83921.pdf not found) INN (THEOPHYLLINE) ELIXOPHYLLIN (FOREST LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 084559 (pdf 84559.pdf not found) INN (THEOPHYLLINE) THEOLIXIR (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084578 (pdf 84578.pdf not found) INN (THEOPHYLLINE) LANOPHYLLIN (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084726 (pdf 84726.pdf not found) INN (THEOPHYLLINE) THEOPHYL-225 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 084731 (pdf 84731.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (SCHERER RP) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 084739 (pdf 84739.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084875 (pdf 84875.pdf not found) INN (MERSALYL SODIUM THEOPHYLLINE) MERSALYL-THEOPHYLLINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085075 (pdf 85075.pdf not found) INN (THEOPHYLLINE) AEROLATE SR (FLEMING PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085148 (pdf 85148.pdf not found) INN (THEOPHYLLINE SODIUM GLYCINATE) ASBRON (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085169 (pdf 85169.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HALSEY) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085186 (pdf 85186.pdf not found) INN (THEOPHYLLINE) ELIXOPHYLLIN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1979 , NDA 085187 (pdf 85187.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085202 (pdf 85202.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085203 (pdf 85203.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085204 (pdf 85204.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085205 (pdf 85205.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085206 (pdf 85206.pdf not found) INN (THEOPHYLLINE) SLO-PHYLLIN (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085263 (pdf 85263.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (KV PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085264 (pdf 85264.pdf not found) INN (THEOPHYLLINE) BRONKODYL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085328 (pdf 85328.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085353 (pdf 85353.pdf not found) INN (THEOPHYLLINE) THEOCLEAR-200 (CENT PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085502 (pdf 85502.pdf not found) INN (THEOPHYLLINE) ELIXICON (FOREST LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085545 (pdf 85545.pdf not found) INN (THEOPHYLLINE) ELIXOPHYLLIN (FOREST LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 085665 (pdf 85665.pdf not found) INN (THEOPHYLLINE) SUSTAIRE (ROERIG) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085863 (pdf 85863.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (PRECISION DOSE) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 085952 (pdf 85952.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (CHARTWELL RX) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085983 (pdf 85983.pdf not found) INN (THEOPHYLLINE) THEOBID (WHITBY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086001 (pdf 86001.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086107 (pdf 86107.pdf not found) INN (THEOPHYLLINE) THEOLAIR (3M) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086363 (pdf 86363.pdf not found) INN (THEOPHYLLINE) THEOLAIR-SR (3M) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 086399 (pdf 86399.pdf not found) INN (THEOPHYLLINE) THEOLAIR (MEDICIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086471 (pdf 86471.pdf not found) INN (THEOPHYLLINE) THEOPHYL-SR (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086480 (pdf 86480.pdf not found) INN (THEOPHYLLINE) THEOPHYL-SR (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086485 (pdf 86485.pdf not found) INN (THEOPHYLLINE) THEOPHYL-225 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086506 (pdf 86506.pdf not found) INN (THEOPHYLLINE) THEOPHYL (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086545 (pdf 86545.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 086569 (pdf 86569.pdf not found) INN (THEOPHYLLINE) THEOCLEAR L.A.-130 (SCHWARZ PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086720 (pdf 86720.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (PHARM ASSOC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086748 (pdf 86748.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (WOCKHARDT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086826 (pdf 86826.pdf not found) INN (THEOPHYLLINE) ELIXOPHYLLIN SR (FOREST LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 086998 (pdf 86998.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087010 (pdf 87010.pdf not found) INN (THEOPHYLLINE) THEOVENT (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087095 (pdf 87095.pdf not found) INN (THEOPHYLLINE) THEOCLEAR-80 (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087155 (pdf 87155.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-T (FISONS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087193 (pdf 87193.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-CRT (GRAHAM DM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087194 (pdf 87194.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-CRT (GRAHAM DM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087225 (pdf 87225.pdf not found) INN (THEOPHYLLINE) LABID (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087400 (pdf 87400.pdf not found) INN (THEOPHYLLINE) THEOCHRON (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 1983 , NDA 087449 (pdf 87449.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087462 (pdf 87462.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (SANDOZ) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087563 (pdf 87563.pdf not found) INN (THEOPHYLLINE) QUIBRON-T/SR (MONARCH PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087571 (pdf 87571.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (RHODES PHARMS) APPROVAL= AP YEAR= 1982 OBSOLETE , NDA 087679 (pdf 87679.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (CENCI) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087763 (pdf 87763.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-CRT (GRAHAM DM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 087854 (pdf 87854.pdf not found) INN (THEOPHYLLINE) THEOBID JR. (WHITBY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087892 (pdf 87892.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087893 (pdf 87893.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087894 (pdf 87894.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087910 (pdf 87910.pdf not found) INN (THEOPHYLLINE) THEOVENT (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087917 (pdf 87917.pdf not found) INN (THEOPHYLLINE) AQUAPHYLLIN (FERNDALE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087942 (pdf 87942.pdf not found) INN (THEOPHYLLINE) THEO-24 (ACTIENT PHARMS) APPROVAL= AP YEAR= 1983 OBSOLETE , NDA 087943 (pdf 87943.pdf not found) INN (THEOPHYLLINE) THEO-24 (ENDO OPERATIONS) APPROVAL= AP YEAR= 1983 , NDA 087944 (pdf 87944.pdf not found) INN (THEOPHYLLINE) THEO-24 (AUXILIUM PHARMS LLC) APPROVAL= AP YEAR= 1983 OBSOLETE , NDA 087995 (pdf 87995.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088015 (pdf 88015.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088016 (pdf 88016.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088022 (pdf 88022.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088253 (pdf 88253.pdf not found) INN (THEOPHYLLINE) T-PHYL (PHARM RES ASSOC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088255 (pdf 88255.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE-SR (SCHERER RP) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088269 (pdf 88269.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088303 (pdf 88303.pdf not found) INN (THEOPHYLLINE) ELIXOMIN (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088320 (pdf 88320.pdf not found) INN (THEOPHYLLINE) THEOCHRON (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 088321 (pdf 88321.pdf not found) INN (THEOPHYLLINE) THEOCHRON (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 088364 (pdf 88364.pdf not found) INN (THEOPHYLLINE) THEOLAIR-SR (3M) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088369 (pdf 88369.pdf not found) INN (THEOPHYLLINE) THEOLAIR-SR (3M) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088382 (pdf 88382.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-CRT (GRAHAM DM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 088383 (pdf 88383.pdf not found) INN (THEOPHYLLINE) SOMOPHYLLIN-CRT (GRAHAM DM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 088503 (pdf 88503.pdf not found) INN (THEOPHYLLINE) DURAPHYL (FOREST LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088504 (pdf 88504.pdf not found) INN (THEOPHYLLINE) DURAPHYL (FOREST LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088505 (pdf 88505.pdf not found) INN (THEOPHYLLINE) DURAPHYL (FOREST LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088654 (pdf 88654.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088656 (pdf 88656.pdf not found) INN (THEOPHYLLINE) QUIBRON-T (MONARCH PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088689 (pdf 88689.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (CENT PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088746 (pdf 88746.pdf not found) INN (THEOPHYLLINE) ACCURBRON (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089131 (pdf 89131.pdf not found) INN (THEOPHYLLINE) THEO-DUR (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089132 (pdf 89132.pdf not found) INN (THEOPHYLLINE) THEOLAIR-SR (3M) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089141 (pdf 89141.pdf not found) INN (THEOPHYLLINE) AEROLATE (FLEMING PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089223 (pdf 89223.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089539 (pdf 89539.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089540 (pdf 89540.pdf not found) INN (THEOPHYLLINE) SLO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089626 (pdf 89626.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (TARO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089763 (pdf 89763.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1990 , NDA 089807 (pdf 89807.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 089808 (pdf 89808.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 089822 (pdf 89822.pdf not found) INN (THEOPHYLLINE) UNI-DUR (SCHERING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089823 (pdf 89823.pdf not found) INN (THEOPHYLLINE) UNI-DUR (SCHERING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089932 (pdf 89932.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089976 (pdf 89976.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089977 (pdf 89977.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090355 (pdf 90355.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090430 (pdf 90430.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ALEMBIC) APPROVAL= AP YEAR= 2010 , NDA 091156 (pdf 91156.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 091586 (pdf 91586.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 206344 (pdf 206344.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (PHARM ASSOC) APPROVAL= AP YEAR= 2016 , NDA 212184 (pdf 212184.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 216961 (pdf 216961.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (TEVA PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 214113 (pdf 214113.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (RHODES PHARMS) APPROVAL= AP YEAR= 2023 , NDA 214950 (pdf 214950.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (LEADING) APPROVAL= AP YEAR= 2023 , NDA 216276 (pdf 216276.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 216300 (pdf 216300.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 214806 (pdf 214806.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (HARMAN FINOCHEM) APPROVAL= AP YEAR= 2023 , NDA 217422 (pdf 217422.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 218063 (pdf 218063.pdf not found) INN (THEOPHYLLINE) THEOPHYLLINE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 10 ; ERGOCALCIFEROL ; 50-14-6 ; 1941 ; ; ; CLASS METABOLISM -- VITAMIN D2 -- ANTIHYPOCALCEMIC AGENTS -- TREATMENT OF HYPOPARATHYROIDISM AND REFRACTORY RICKETS ALSO KNOWN AS VITAMIN D RESISTANT RICKETS,AND FAMILIAL HYPOPHOSPHATEMIA -- DIFFERENT METABOLIC FATES OF VITAMINS D2 AND D3 (PMID17023693) , ; NDA 003444 (pdf 3444.pdf not found) INN (ERGOCALCIFEROL) DRISDOL (SS PHARMA) APPROVAL= AP YEAR= 1941 , NDA 006071 (pdf 6071.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PHYTONADIONE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018933 (pdf 18933.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE VITAMIN A VITAMIN E) M.V.I.-12 LYOPHILIZED (TELIGENT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PANTOTHENIC ACID PHYTONADIONE PYRIDOXINE RIBOFLAVIN THIAMINE VITAMIN A PALMITATE VITAMIN E) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021625 (label 21625.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021643 (label 21643.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED , NDA 080704 (pdf 80704.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (BIONPHARMA) APPROVAL= AP YEAR= 1978 , NDA 080747 (pdf 80747.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (CHASE CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080825 (pdf 80825.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080884 (pdf 80884.pdf not found) INN (ERGOCALCIFEROL) DELTALIN (LILLY) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080951 (pdf 80951.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080956 (pdf 80956.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083102 (pdf 83102.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (WEST WARD) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084053 (pdf 84053.pdf not found) INN (ERGOCALCIFEROL) VITAMIN D (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040833 (pdf 40833.pdf not found) INN (ERGOCALCIFEROL) ERGOCALCIFEROL (CHARTWELL RX) APPROVAL= AP YEAR= 2009 , NDA 040865 (pdf 40865.pdf not found) INN (ERGOCALCIFEROL) ERGOCALCIFEROL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090455 (pdf 90455.pdf not found) INN (ERGOCALCIFEROL) ERGOCALCIFEROL (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091004 (pdf 91004.pdf not found) INN (ERGOCALCIFEROL) ERGOCALCIFEROL (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 204276 (pdf 204276.pdf not found) INN (ERGOCALCIFEROL) ERGOCALCIFEROL (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2018 , 11 ; ESTRONE ; 53-16-7 ; 1941 ; DISCONTINUED ; NATURAL MOLECULE C00003663 ; CLASS GENITO -- ANTI-MENOPAUSAL AGENTS -- ESTROGENS -- OSTEOPOROSIS PROPHYLACTIC , ; NDA 003977 (pdf 3977.pdf not found) INN (ESTRONE) THEELIN (PARKEDALE) APPROVAL= AP YEAR= 1941 DISCONTINUED , NDA 083397 (pdf 83397.pdf not found) INN (ESTRONE) ESTRONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083488 (pdf 83488.pdf not found) INN (ESTRONE) ESTROGENIC SUBSTANCE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085237 (pdf 85237.pdf not found) INN (ESTRONE) NATURAL ESTROGENIC SUBSTANCE-ESTRONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085239 (pdf 85239.pdf not found) INN (ESTRONE) ESTRONE (DR REDDYS) APPROVAL= AP YEAR= 1979 DISCONTINUED , 12 ; DIETHYLSTILBESTROL ; 56-53-1 ; 1973 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- CARCINOGENS -- ESTROGENS , ; NDA 004039 (pdf 4039.pdf not found) INN (DIETHYLSTILBESTROL) DIETHYLSTILBESTROL (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 004040 (pdf 4040.pdf not found) INN (DIETHYLSTILBESTROL) DIETHYLSTILBESTROL (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 004041 (pdf 4041.pdf not found) INN (DIETHYLSTILBESTROL) DIETHYLSTILBESTROL (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 004056 (pdf 4056.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 010010 (pdf 10010.pdf not found) INN (DIETHYLSTILBESTROL DIPHOSPHATE) STILPHOSTROL (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083002 (pdf 83002.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083003 (pdf 83003.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083004 (pdf 83004.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083005 (pdf 83005.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083006 (pdf 83006.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083007 (pdf 83007.pdf not found) INN (DIETHYLSTILBESTROL) STILBESTROL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , 13 ; SULFADIAZINE ; 68-35-9 ; 1941 ; ; ; CLASS ANTIINFECTIVES -- ANTIMALARIALS , ; NDA 004054 (pdf 4054.pdf not found) INN (SULFADIAZINE SODIUM) SULFADIAZINE SODIUM (LEDERLE) APPROVAL= AP YEAR= 1941 DISCONTINUED , NDA 004122 (pdf 4122.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (LILLY) APPROVAL= AP YEAR= 1941 DISCONTINUED , NDA 004125 (pdf 4125.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006317 (pdf 6317.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) NEOTRIZINE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006904 (pdf 6904.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TERFONYL (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006920 (pdf 6920.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFAS (LEDERLE) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 040091 (pdf 40091.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1994 , NDA 080013 (pdf 80013.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFOSE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080079 (pdf 80079.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFA-TRIPLE #2 (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080081 (pdf 80081.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080084 (pdf 80084.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080086 (pdf 80086.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080088 (pdf 80088.pdf not found) INN (SULFADIAZINE) SULFADIAZINE (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080094 (pdf 80094.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFOID (PAL PAK) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 080099 (pdf 80099.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080100 (pdf 80100.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080123 (pdf 80123.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) LANTRISUL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080280 (pdf 80280.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , 14 ; MEPERIDINE ; 57-42-1 ; 1942 ; ; ; CLASS NERVOUS SYSTEM -- ADJUVANTS IN ANESTHESIA -- ANALGESICS -- OPIOID -- NARCOTICS -- OPIATE AGONISTS -- ANTICHOLINERGIC , ; NDA 005010 (label 5010.pdf) INN (MEPERIDINE HYDROCHLORIDE) DEMEROL (VALIDUS PHARMS) APPROVAL= AP YEAR= 1942 NEWMOLECULARENTITY DISCONTINUED , NDA 011730 (label 11730.pdf) INN (MEPERIDINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) MEPERGAN (HIKMA) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 021171 (label 21171.pdf) INN (MEPERIDINE HYDROCHLORIDE) DEMEROL (HOSPIRA) APPROVAL= AP YEAR= 1942 , NDA 040110 (pdf 40110.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040163 (pdf 40163.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (SPECGX LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040186 (pdf 40186.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040191 (label 40191.pdf) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040305 (pdf 40305.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040318 (pdf 40318.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040331 (pdf 40331.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1999 , NDA 040352 (label 40352.pdf) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040446 (pdf 40446.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 073443 (pdf 73443.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073444 (pdf 73444.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073445 (pdf 73445.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 080364 (pdf 80364.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 080385 (pdf 80385.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080386 (pdf 80386.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080387 (pdf 80387.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080388 (pdf 80388.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080389 (pdf 80389.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080445 (pdf 80445.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1975 , NDA 080448 (pdf 80448.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 080454 (pdf 80454.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080455 (pdf 80455.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1972 , NDA 081002 (pdf 81002.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1993 , NDA 081309 (pdf 81309.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (INTL MEDICATION) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 085121 (pdf 85121.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) MEPERIDINE AND ATROPINE SULFATE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086332 (pdf 86332.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087847 (pdf 87847.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087848 (pdf 87848.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087853 (pdf 87853.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088279 (pdf 88279.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088280 (pdf 88280.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088281 (pdf 88281.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088282 (pdf 88282.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088432 (pdf 88432.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (ICU MEDICAL INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088639 (pdf 88639.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088640 (pdf 88640.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088744 (pdf 88744.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 089781 (pdf 89781.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089782 (pdf 89782.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089783 (pdf 89783.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089784 (pdf 89784.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089785 (pdf 89785.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089786 (pdf 89786.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089787 (pdf 89787.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089788 (pdf 89788.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040893 (pdf 40893.pdf not found) INN (MEPERIDINE HYDROCHLORIDE) MEPERIDINE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2009 , 15 ; HOMATROPINE METHYLBROMIDE ; 80-49-9 ; 1943 ; ; ; CLASS SENSORY -- ANTI-ULCER AGENTS -- ANTIMUSCARINICS -- ANTISPASMODICS -- ANTICHOLINERGIC , ; NDA 005213 (label 5213.pdf) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYCODAN (GENUS) APPROVAL= AP YEAR= 1943 NEWMOLECULARENTITY , NDA 040285 (pdf 40285.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040295 (pdf 40295.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040613 (pdf 40613.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (GENUS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 086308 (pdf 86308.pdf not found) INN (HOMATROPINE METHYLBROMIDE) HOMAPIN-10 (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086309 (pdf 86309.pdf not found) INN (HOMATROPINE METHYLBROMIDE) HOMAPIN-5 (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086310 (pdf 86310.pdf not found) INN (HOMATROPINE METHYLBROMIDE) EQUIPIN (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 088008 (pdf 88008.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1983 , NDA 088017 (pdf 88017.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 , NDA 088066 (pdf 88066.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROPANE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088508 (pdf 88508.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) TUSSIGON (KING PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 091528 (pdf 91528.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203535 (pdf 203535.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204765 (pdf 204765.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205731 (pdf 205731.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (PADAGIS US) APPROVAL= AP YEAR= 2017 , NDA 207176 (pdf 207176.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (AVANTHI INC) APPROVAL= AP YEAR= 2017 , NDA 207487 (pdf 207487.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 210663 (pdf 210663.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , 16 ; HYDROCODONE ; 125-29-1 ; 1943 ; ; ; CLASS RESPIRATORY SYSTEM -- ANALGESICS -- OPIOID -- ANTITUSSIVE , ; NDA 005213 (label 5213.pdf) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYCODAN (GENUS) APPROVAL= AP YEAR= 1943 NEWMOLECULARENTITY , NDA 019111 (label 19111.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) TUSSIONEX PENNKINETIC (UCB INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019410 (pdf 19410.pdf not found) INN (HYDROCODONE BITARTRATE) HYCOMINE (ENDO PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 019411 (pdf 19411.pdf not found) INN (HYDROCODONE BITARTRATE) HYCOMINE PEDIATRIC (ENDO PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 020716 (label 20716.pdf) INN (HYDROCODONE BITARTRATE IBUPROFEN) VICOPROFEN (ABBVIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040084 (pdf 40084.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040094 (pdf 40094.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040099 (label 40099.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCO (APIL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040100 (pdf 40100.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORTAB (UCB INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040117 (pdf 40117.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN HP (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040122 (pdf 40122.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040123 (pdf 40123.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040134 (pdf 40134.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (UCB INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040143 (pdf 40143.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040144 (pdf 40144.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040148 (label 40148.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCO (APIL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040149 (pdf 40149.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040155 (pdf 40155.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040157 (pdf 40157.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040182 (pdf 40182.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040201 (pdf 40201.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040210 (pdf 40210.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (UCB INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040236 (pdf 40236.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040240 (pdf 40240.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040248 (pdf 40248.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040280 (pdf 40280.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040281 (label 40281.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040285 (pdf 40285.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040288 (pdf 40288.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ZYDONE (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040295 (pdf 40295.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040307 (pdf 40307.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040308 (label 40308.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040309 (label 40309.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040355 (pdf 40355.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 , NDA 040356 (pdf 40356.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040358 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HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2003 , NDA 040464 (pdf 40464.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040468 (pdf 40468.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ANEXSIA (MALLINCKRODT) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040469 (pdf 40469.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040473 (pdf 40473.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040474 (pdf 40474.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040476 (pdf 40476.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040477 (pdf 40477.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040478 (pdf 40478.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040482 (pdf 40482.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2003 , NDA 040490 (pdf 40490.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040493 (pdf 40493.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040494 (pdf 40494.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040495 (pdf 40495.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040508 (pdf 40508.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040520 (pdf 40520.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040556 (pdf 40556.pdf not found) INN (HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN () APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040613 (pdf 40613.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (AKORN) APPROVAL= AP YEAR= 2008 , NDA 040655 (pdf 40655.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040656 (pdf 40656.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040658 (pdf 40658.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2006 , NDA 040729 (pdf 40729.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040736 (pdf 40736.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 040746 (pdf 40746.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 040748 (pdf 40748.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040754 (pdf 40754.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040757 (pdf 40757.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040769 (pdf 40769.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040813 (pdf 40813.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040822 (pdf 40822.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040824 (pdf 40824.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040825 (pdf 40825.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040826 (pdf 40826.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040834 (pdf 40834.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PHARM ASSOC) APPROVAL= AP YEAR= 2008 , NDA 075103 (pdf 75103.pdf not found) INN (HYDROCODONE BITARTRATE PHENYLPROPANOLAMINE HYDROCHLORIDE) CODAMINE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076023 (pdf 76023.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076604 (pdf 76604.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 , NDA 076642 (pdf 76642.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2004 , NDA 077273 (label 77273.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) TUSSICAPS (ECR PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077723 (pdf 77723.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077727 (pdf 77727.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 081051 (pdf 81051.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081067 (pdf 81067.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081068 (pdf 81068.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081069 (pdf 81069.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081070 (pdf 81070.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081079 (pdf 81079.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081080 (pdf 81080.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081083 (pdf 81083.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081223 (pdf 81223.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081226 (pdf 81226.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 085667 (pdf 85667.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN (ABBOTT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 086333 (pdf 86333.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) VICOPRIN (ABBOTT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087336 (pdf 87336.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORCET-HD (MALLINCKRODT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087677 (pdf 87677.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HY-PHEN (ASCHER) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087722 (pdf 87722.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORTAB (UCB INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087757 (pdf 87757.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) CO-GESIC (UCB INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087809 (pdf 87809.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) DURADYNE DHC (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087961 (pdf 87961.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) BANCAP HC (FOREST PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088008 (pdf 88008.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1983 , NDA 088017 (pdf 88017.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 , NDA 088058 (label 88058.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN (ABBVIE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088066 (pdf 88066.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROPANE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088508 (pdf 88508.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) TUSSIGON (KING PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088577 (pdf 88577.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088871 (pdf 88871.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCET (ABANA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088898 (pdf 88898.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ACETAMINOPHEN AND HYDROCODONE BITARTRATE (CENT PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088956 (pdf 88956.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089006 (pdf 89006.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089008 (pdf 89008.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089160 (pdf 89160.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ANEXSIA (MALLINCKRODT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089271 (pdf 89271.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089290 (pdf 89290.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089291 (pdf 89291.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089360 (pdf 89360.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) CO-GESIC (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089385 (pdf 89385.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) TYCOLET (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089420 (pdf 89420.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) AZDONE (SCHWARZ PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089554 (pdf 89554.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089557 (pdf 89557.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089689 (pdf 89689.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089696 (pdf 89696.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089697 (pdf 89697.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089698 (pdf 89698.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089699 (pdf 89699.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089725 (pdf 89725.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ANEXSIA 7.5/650 (MALLINCKRODT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089736 (label 89736.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN ES (ABBVIE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089831 (pdf 89831.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089883 (pdf 89883.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089907 (pdf 89907.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ALLAY (IVAX PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089971 (pdf 89971.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040881 (pdf 40881.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2010 , NDA 090118 (pdf 90118.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090265 (pdf 90265.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CARACO) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090380 (pdf 90380.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CARACO) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040846 (pdf 40846.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040849 (pdf 40849.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077454 (pdf 77454.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091632 (label 91632.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 022439 (label 22439.pdf) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) ZUTRIPRO (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022442 (label 22442.pdf) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) REZIRA (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090415 (pdf 90415.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091528 (pdf 91528.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 040894 (pdf 40894.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (GENUS) APPROVAL= AP YEAR= 2011 , NDA 200343 (pdf 200343.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (GENUS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091671 (pdf 91671.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX (NEOS THERAPS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201013 (pdf 201013.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 040838 (pdf 40838.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PHARM ASSOC) APPROVAL= AP YEAR= 2013 , NDA 091633 (pdf 91633.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202214 (pdf 202214.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (TRIS PHARMA INC) APPROVAL= AP YEAR= 2013 , NDA 202880 (label 202880.pdf) INN (HYDROCODONE BITARTRATE) ZOHYDRO ER (RECRO GAINESVILLE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204307 (label 204307.pdf) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) VITUZ (PERSION) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203838 (pdf 203838.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203839 (pdf 203839.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204627 (pdf 204627.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 204658 (pdf 204658.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205474 (label 205474.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) OBREDON (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 206627 (label 206627.pdf) INN (HYDROCODONE BITARTRATE) HYSINGLA ER (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2014 , NDA 022279 (label 22279.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYCOFENIX (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 022424 (label 22424.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) FLOWTUSS (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205657 (pdf 205657.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206438 (pdf 206438.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205658 (pdf 205658.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090468 (pdf 90468.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ZYFREL (CYPRESS PHARM INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202935 (pdf 202935.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 202991 (pdf 202991.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RHODES PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204575 (pdf 204575.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206470 (pdf 206470.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205001 (pdf 205001.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206142 (pdf 206142.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206245 (pdf 206245.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207137 (pdf 207137.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 203535 (pdf 203535.pdf not found) INN 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found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2017 , NDA 206869 (pdf 206869.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2017 , NDA 206891 (pdf 206891.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (ACELLA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206952 (pdf 206952.pdf not found) INN (HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2017 , NDA 206986 (pdf 206986.pdf not found) INN (HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE (ALVOGEN) APPROVAL= AP YEAR= 2020 , NDA 207171 (pdf 207171.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207172 (pdf 207172.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207176 (pdf 207176.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (AVANTHI INC) APPROVAL= AP YEAR= 2017 , NDA 207487 (pdf 207487.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 207975 (label 207975.pdf) INN (HYDROCODONE BITARTRATE) VANTRELA ER (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209036 (pdf 209036.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 209037 (pdf 209037.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 210211 (pdf 210211.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2017 , NDA 203863 (pdf 203863.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 207808 (pdf 207808.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RHODES PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208085 (label 208085.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) XTRELUS (ECI PHARMS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207509 (pdf 207509.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 207709 (pdf 207709.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 208540 (pdf 208540.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209924 (pdf 209924.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209958 (pdf 209958.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211487 (pdf 211487.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 206661 (pdf 206661.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211023 (pdf 211023.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 210663 (pdf 210663.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211690 (pdf 211690.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CEROVENE INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211729 (pdf 211729.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 205479 (pdf 205479.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ASPIRIN (LGM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 208269 (pdf 208269.pdf not found) INN (HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE (ALVOGEN) APPROVAL= AP YEAR= 2021 , NDA 201295 (pdf 201295.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214928 (pdf 214928.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PRINSTON INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , 17 ; ESTRADIOL ; 50-28-2 ; 1957 ; ; ; CLASS GENITO -- ANTI-MENOPAUSAL AGENTS -- ANTICHOLESTEREMIC AGENTS -- ESTROGENS , ; NDA 019081 (label 19081.pdf) INN (ESTRADIOL) ESTRADERM (NOVARTIS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 020323 (label 20323.pdf) INN (ESTRADIOL) VIVELLE (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020375 (label 20375.pdf) INN (ESTRADIOL) CLIMARA (BAYER HLTHCARE) APPROVAL= AP YEAR= 1994 , NDA 020417 (pdf 20417.pdf not found) INN (ESTRADIOL) FEMPATCH (PARKE DAVIS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020472 (label 20472.pdf) INN (ESTRADIOL) ESTRING (PFIZER) APPROVAL= AP YEAR= 1996 , NDA 020538 (label 20538.pdf) INN (ESTRADIOL) ESTRADIOL (SANDOZ) APPROVAL= AP YEAR= 1996 , NDA 020655 (label 20655.pdf) INN (ESTRADIOL) ALORA (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020847 (label 20847.pdf) INN (ESTRADIOL) ESCLIM (WOMEN FIRST HLTHCARE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020870 (label 20870.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) COMBIPATCH (NOVEN PHARMS INC) APPROVAL= AP YEAR= 1998 , NDA 020907 (label 20907.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (AMNEAL) APPROVAL= AP YEAR= 1998 , NDA 020908 (label 20908.pdf) INN (ESTRADIOL) VAGIFEM (NOVO NORDISK INC) APPROVAL= AP YEAR= 1999 , NDA 021040 (label 21040.pdf) INN (ESTRADIOL NORGESTIMATE) PREFEST (TEVA WOMENS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021048 (label 21048.pdf) INN (ESTRADIOL) ESTRADIOL (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021103 (label 21103.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (NOVO NORDISK) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 021166 (label 21166.pdf) INN (ESTRADIOL) ESTROGEL (ASCEND THERAPS US) APPROVAL= AP YEAR= 2004 , NDA 021167 (label 21167.pdf) INN (ESTRADIOL) VIVELLE (NOVARTIS) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 021258 (label 21258.pdf) INN (ESTRADIOL LEVONORGESTREL) CLIMARA PRO (BAYER HLTHCARE) APPROVAL= AP YEAR= 2003 , NDA 021310 (pdf 21310.pdf not found) INN (ESTRADIOL) ALORA (WATSON LABS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021355 (label 21355.pdf) INN (DROSPIRENONE ESTRADIOL) ANGELIQ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2005 , NDA 021371 (label 21371.pdf) INN (ESTRADIOL HEMIHYDRATE) ESTRASORB (EXELTIS USA INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021674 (label 21674.pdf) INN (ESTRADIOL) MENOSTAR (BAYER HLTHCARE) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021813 (label 21813.pdf) INN (ESTRADIOL) ELESTRIN (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2006 , NDA 021885 (label 21885.pdf) INN (ESTRADIOL LEVONORGESTREL) CLIMARA PRO (BERLEX LABS) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 022001 (label 22001.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (NOVO NORDISK INC) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 022014 (label 22014.pdf) INN (ESTRADIOL) EVAMIST (PADAGIS US) APPROVAL= AP YEAR= 2007 , NDA 022038 (label 22038.pdf) INN (ESTRADIOL) DIVIGEL (VERTICAL PHARMS) APPROVAL= AP YEAR= 2007 , NDA 040114 (pdf 40114.pdf not found) INN (ESTRADIOL) ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040138 (pdf 40138.pdf not found) INN (ESTRADIOL) ESTRADIOL (LANNETT CO INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040197 (pdf 40197.pdf not found) INN (ESTRADIOL) ESTRADIOL (BARR LABS INC) APPROVAL= AP YEAR= 1997 , NDA 040212 (pdf 40212.pdf not found) INN (ESTRADIOL) GYNODIOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040275 (label 40275.pdf) INN (ESTRADIOL) ESTRADIOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 , NDA 040297 (pdf 40297.pdf not found) INN (ESTRADIOL) ESTRADIOL (USL PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040312 (pdf 40312.pdf not found) INN (ESTRADIOL) INNOFEM (NOVO NORDISK INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040326 (label 40326.pdf) INN (ESTRADIOL) ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075182 (pdf 75182.pdf not found) INN (ESTRADIOL) ESTRADIOL (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2000 , NDA 075233 (pdf 75233.pdf not found) INN (ESTRADIOL) ESTRADIOL (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2000 , NDA 076812 (pdf 76812.pdf not found) INN (ESTRADIOL NORGESTIMATE) ESTRADIOL AND NORGESTIMATE (BARR) APPROVAL= AP YEAR= 2005 , NDA 078324 (pdf 78324.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (BRECKENRIDGE PHARM) APPROVAL= AP YEAR= 2008 , NDA 081295 (label 81295.pdf) INN (ESTRADIOL) ESTRACE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 084499 (label 84499.pdf) INN (ESTRADIOL) ESTRACE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084500 (label 84500.pdf) INN (ESTRADIOL) ESTRACE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 086069 (label 86069.pdf) INN (ESTRADIOL) ESTRACE (ALLERGAN) APPROVAL= AP YEAR= 1984 , NDA 010753 (pdf 10753.pdf not found) INN (POLYESTRADIOL PHOSPHATE) ESTRADURIN (WYETH AYERST) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 079193 (pdf 79193.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (BARR) APPROVAL= AP YEAR= 2010 , NDA 200747 (pdf 200747.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203752 (label 203752.pdf) INN (ESTRADIOL) MINIVELLE (NOVEN) APPROVAL= AP YEAR= 2012 , NDA 201675 (pdf 201675.pdf not found) INN (ESTRADIOL) ESTRADIOL (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2014 , NDA 205256 (pdf 205256.pdf not found) INN (ESTRADIOL) ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203339 (pdf 203339.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) AMABELZ (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 206388 (pdf 206388.pdf not found) INN (ESTRADIOL) ESTRADIOL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 207261 (pdf 207261.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 020167 (pdf 20167.pdf not found) INN (ESTRADIOL) ESTRADIOL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 208788 (pdf 208788.pdf not found) INN (ESTRADIOL) ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 208564 (label 208564.pdf) INN (ESTRADIOL) IMVEXXY (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209767 (pdf 209767.pdf not found) INN (ESTRADIOL) ESTRADIOL (ALVOGEN) APPROVAL= AP YEAR= 2018 , NDA 210194 (pdf 210194.pdf not found) INN (ESTRADIOL) ESTRADIOL (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2018 , NDA 210233 (pdf 210233.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (NAARI PTE LTD) APPROVAL= AP YEAR= 2018 , NDA 210488 (pdf 210488.pdf not found) INN (ESTRADIOL) ESTRADIOL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 206685 (label 206685.pdf) INN (ESTRADIOL) ESTRADIOL (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2018 , NDA 210132 (label 210132.pdf) INN (ESTRADIOL PROGESTERONE) BIJUVA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210264 (pdf 210264.pdf not found) INN (ESTRADIOL) ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 210612 (pdf 210612.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 211293 (pdf 211293.pdf not found) INN (ESTRADIOL) ESTRADIOL (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 211396 (pdf 211396.pdf not found) INN (ESTRADIOL) ESTRADIOL (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 213388 (label 213388.pdf) INN (ELAGOLIX SODIUM ESTRADIOL NORETHINDRONE ACETATE ELAGOLIX SODIUM) ORIAHNN COPACKAGED (ABBVIE) APPROVAL= AP YEAR= 2020 , NDA 214846 (label 214846.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE RELUGOLIX) MYFEMBREE (MYOVANT SCIENCES) APPROVAL= AP YEAR= 2021 , NDA 212313 (pdf 212313.pdf not found) INN (ESTRADIOL) ESTRADIOL (PRASCO) APPROVAL= AP YEAR= 2021 , NDA 214293 (pdf 214293.pdf not found) INN (ESTRADIOL PROGESTERONE) ESTRADIOL AND PROGESTERONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 206241 (pdf 206241.pdf not found) INN (ESTRADIOL) ESTRADIOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 211783 (pdf 211783.pdf not found) INN (ESTRADIOL) ESTRADIOL (CHEMO RESEARCH SL) APPROVAL= AP YEAR= 2022 , NDA 202985 (pdf 202985.pdf not found) INN (ESTRADIOL) ESTRADIOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204379 (pdf 204379.pdf not found) INN (ESTRADIOL) ESTRADIOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 214729 (pdf 214729.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ETYQA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216524 (pdf 216524.pdf not found) INN (ESTRADIOL) ESTRADIOL (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 , NDA 217334 (pdf 217334.pdf not found) INN (ESTRADIOL) ESTRADIOL (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217610 (pdf 217610.pdf not found) INN (ESTRADIOL) ESTRADIOL (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216160 (pdf 216160.pdf not found) INN (ESTRADIOL) ESTRADIOL (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2024 , 18 ; ETHINYL ESTRADIOL ; 57-63-6 ; 1943 ; ; ; CLASS GENITO -- ESTROGENS -- CONTRACEPTIVES , ; NDA 005292 (pdf 5292.pdf not found) INN (ETHINYL ESTRADIOL) ESTINYL (SCHERING) APPROVAL= AP YEAR= 1943 DISCONTINUED , NDA 005490 (pdf 5490.pdf not found) INN (ETHINYL ESTRADIOL) LYNORAL (ORGANON USA INC) APPROVAL= AP YEAR= 1944 DISCONTINUED , NDA 016649 (pdf 16649.pdf not found) INN (ETHINYL ESTRADIOL) FEMINONE (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016672 (pdf 16672.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) OVRAL (WYETH PHARMS) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016723 (pdf 16723.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 28 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016749 (pdf 16749.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 21 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016766 (pdf 16766.pdf not found) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE ACETATE) NORLESTRIN FE 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016806 (pdf 16806.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) OVRAL-28 (WYETH PHARMS) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016852 (pdf 16852.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 21 2.5/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016854 (pdf 16854.pdf not found) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE ACETATE) NORLESTRIN FE 2.5/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016927 (pdf 16927.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/50-21 (GD SEARLE LLC) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016936 (pdf 16936.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/50-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 017354 (label 17354.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN FE 1/20 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017355 (label 17355.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN FE 1.5/30 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017488 (pdf 17488.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) MODICON 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017489 (pdf 17489.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 1/35-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017565 (label 17565.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORINYL 1+35 21-DAY (ALLERGAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017566 (label 17566.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) BREVICON 21-DAY (ALLERGAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017576 (label 17576.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-50 (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017612 (label 17612.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LO/OVRAL (CADENCE HEALTH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017716 (pdf 17716.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-35 (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017735 (label 17735.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) MODICON 28 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017743 (label 17743.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) BREVICON 28-DAY (ALLERGAN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017802 (label 17802.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LO/OVRAL-28 (WYETH PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017875 (label 17875.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 21 1.5/30 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017876 (label 17876.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 21 1/20 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017919 (label 17919.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 1/35-28 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018127 (pdf 18127.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-35 (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018128 (pdf 18128.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-50 (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018160 (pdf 18160.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/35-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018168 (pdf 18168.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/35-21 (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018354 (pdf 18354.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 10/11-21 (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018668 (label 18668.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) NORDETTE-21 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018782 (label 18782.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) NORDETTE-28 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018926 (label 18926.pdf) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE) NORQUEST FE (PFIZER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 018977 (label 18977.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) TRI-NORINYL 21-DAY (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1984 , NDA 018985 (label 18985.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 7/7/7-21 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019004 (pdf 19004.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 7/14-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019190 (label 19190.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIPHASIL-28 (WYETH PHARMS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019192 (label 19192.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIPHASIL-21 (WYETH PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019653 (label 19653.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO CYCLEN-21 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019697 (label 19697.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020071 (label 20071.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGEN (ORGANON USA INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020130 (label 20130.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) ESTROSTEP 21 (APIL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020301 (label 20301.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) ORTHO-CEPT (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020683 (label 20683.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ALESSE (CADENCE HEALTH) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020713 (label 20713.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) MIRCETTE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020860 (pdf 20860.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVLITE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020946 (label 20946.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) PREVEN EMERGENCY CONTRACEPTIVE KIT (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021065 (label 21065.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FEMHRT (APIL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021090 (label 21090.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) CYCLESSA (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 2000 , NDA 021098 (label 21098.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YASMIN (BAYER HLTHCARE) APPROVAL= AP YEAR= 2001 , NDA 021102 (pdf 21102.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FEMHRT (WARNER CHILCOTT) APPROVAL= AP YEAR= 1999 NEWAPPLICATION , NDA 021180 (label 21180.pdf) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ORTHO EVRA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021187 (label 21187.pdf) INN (ETHINYL ESTRADIOL ETONOGESTREL) NUVARING (ORGANON USA ORGANON) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 021241 (label 21241.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN LO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021490 (label 21490.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) FEMCON FE (APIL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021544 (label 21544.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SEASONALE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2003 , NDA 021676 (label 21676.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2006 , NDA 021690 (label 21690.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 021840 (label 21840.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SEASONIQUE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2006 , NDA 021864 (label 21864.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LYBREL (WYETH PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021871 (label 21871.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 24 FE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021873 (label 21873.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 022045 (pdf 22045.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 070684 (pdf 70684.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070685 (pdf 70685.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070686 (pdf 70686.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070687 (pdf 70687.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1987 , NDA 071041 (pdf 71041.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 7/14 (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071042 (pdf 71042.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 7/14 (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071043 (pdf 71043.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 10/11 (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071044 (pdf 71044.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 10/11 (WATSON LABS TEVA) APPROVAL= AP YEAR= 1988 , NDA 071480 (pdf 71480.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHIN 1/35E-21 (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071481 (pdf 71481.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHIN 1/35E-28 (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071541 (pdf 71541.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) N.E.E. 1/35 21 (LPI) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071542 (pdf 71542.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) N.E.E. 1/35 28 (LPI) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071545 (pdf 71545.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORCEPT-E 1/35 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071546 (pdf 71546.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORCEPT-E 1/35 28 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072692 (pdf 72692.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 0.5/35-21 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072693 (pdf 72693.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 1/35-21 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072694 (pdf 72694.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GENCEPT 10/11-21 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072695 (pdf 72695.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 0.5/35-28 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072696 (pdf 72696.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 1/35-28 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072697 (pdf 72697.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GENCEPT 10/11-28 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072720 (pdf 72720.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/35E-21 (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072721 (pdf 72721.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/35E-28 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072722 (pdf 72722.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/50E-21 (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072723 (pdf 72723.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/50E-28 (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 073592 (pdf 73592.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVORA 0.15/30-21 (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073594 (pdf 73594.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVORA 0.15/30-28 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1993 , NDA 074538 (label 74538.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIVORA-21 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1997 , NDA 075256 (label 75256.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 , NDA 075288 (label 75288.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LOW-OGESTREL-21 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1999 , NDA 075406 (label 75406.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) OGESTREL 0.5/50-21 (WATSON LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075478 (pdf 75478.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 7/7/7 (BARR) APPROVAL= AP YEAR= 2002 , NDA 075548 (pdf 75548.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MICROGESTIN FE 1.5/30 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075647 (pdf 75647.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MICROGESTIN FE 1/20 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075796 (label 75796.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AVIANE-28 (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 075803 (label 75803.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LESSINA-21 (BARR) APPROVAL= AP YEAR= 2002 , NDA 075804 (pdf 75804.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) SPRINTEC (BARR) APPROVAL= AP YEAR= 2002 , NDA 075808 (pdf 75808.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-SPRINTEC (BARR) APPROVAL= AP YEAR= 2003 , NDA 075809 (pdf 75809.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ENPRESSE-21 (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 075840 (pdf 75840.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) CRYSELLE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 075862 (pdf 75862.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075863 (pdf 75863.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KARIVA (BARR) APPROVAL= AP YEAR= 2002 , NDA 075866 (pdf 75866.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) PORTIA-21 (BARR) APPROVAL= AP YEAR= 2002 , NDA 076064 (pdf 76064.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL FE 1.5/30 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076081 (pdf 76081.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL FE 1/20 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076105 (pdf 76105.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TRI-LEGEST FE (BARR) APPROVAL= AP YEAR= 2007 , NDA 076198 (pdf 76198.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BALZIVA-21 (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076221 (pdf 76221.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (BARR LABS INC) APPROVAL= AP YEAR= 2009 , NDA 076238 (pdf 76238.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BALZIVA-28 (BARR) APPROVAL= AP YEAR= 2004 , NDA 076334 (pdf 76334.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) PREVIFEM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2004 , NDA 076335 (pdf 76335.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-PREVIFEM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076380 (pdf 76380.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL 1/20 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076381 (pdf 76381.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL 1.5/30 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076405 (pdf 76405.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TRI-LEGEST 21 (BARR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076455 (pdf 76455.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VELIVET (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2004 , NDA 076625 (label 76625.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2004 , NDA 076626 (pdf 76626.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076627 (pdf 76627.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076783 (pdf 76783.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ARANELLE (BARR) APPROVAL= AP YEAR= 2004 , NDA 076785 (pdf 76785.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) KELNOR (BARR) APPROVAL= AP YEAR= 2005 , NDA 076915 (pdf 76915.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2005 , NDA 076916 (pdf 76916.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077075 (pdf 77075.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS FE 1.5/30 (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077077 (pdf 77077.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS FE 1/20 (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077101 (pdf 77101.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) QUASENSE (WATSON LABS) APPROVAL= AP YEAR= 2006 , NDA 077182 (pdf 77182.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2006 , NDA 077527 (pdf 77527.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077681 (label 77681.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2006 , NDA 022262 (label 22262.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LOSEASONIQUE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2008 , NDA 076393 (pdf 76393.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076629 (pdf 76629.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076784 (pdf 76784.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI LO SPRINTEC (BARR LABS INC) APPROVAL= AP YEAR= 2009 , NDA 078267 (pdf 78267.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078323 (pdf 78323.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 078379 (pdf 78379.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078515 (label 78515.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078965 (pdf 78965.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (BARR) APPROVAL= AP YEAR= 2010 , NDA 090081 (pdf 90081.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 , NDA 022501 (label 22501.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO LOESTRIN FE (APIL) APPROVAL= AP YEAR= 2010 , NDA 022532 (label 22532.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) BEYAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 076337 (pdf 76337.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 1/35 (ENDO OPERATIONS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076338 (pdf 76338.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 7/7/7 (ENDO OPERATIONS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078834 (pdf 78834.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 , NDA 078892 (pdf 78892.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 079064 (pdf 79064.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) INTROVALE (XIROMED) APPROVAL= AP YEAR= 2010 , NDA 079102 (pdf 79102.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ALTAVERA (XIROMED) APPROVAL= AP YEAR= 2010 , NDA 022573 (label 22573.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2010 , NDA 022574 (label 22574.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) SAFYRAL (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 090719 (pdf 90719.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONEST (NOVAST LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 076675 (pdf 76675.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) EMOQUETTE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077099 (pdf 77099.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ORSYTHIA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079218 (pdf 79218.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 079221 (pdf 79221.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) LORYNA (XIROMED) APPROVAL= AP YEAR= 2011 , NDA 090114 (pdf 90114.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) SYEDA (XIROMED) APPROVAL= AP YEAR= 2011 , NDA 090479 (pdf 90479.pdf not found) INN (NORGESTIMATE ETHINYL ESTRADIOL) NORGESTIMATE ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 090538 (pdf 90538.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BRIELLYN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 077502 (pdf 77502.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MYZILRA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 , NDA 078833 (pdf 78833.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 090946 (pdf 90946.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) DASETTA 7/7/7 (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090947 (pdf 90947.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PHILITH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090948 (pdf 90948.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) DASETTA 1/35 (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 091674 (pdf 91674.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 200407 (pdf 200407.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200494 (pdf 200494.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 091634 (pdf 91634.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ALYACEN 1/35 (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091636 (pdf 91636.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ALYACEN 7/7/7 (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 200538 (pdf 200538.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 078376 (pdf 78376.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GILDAGIA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 090523 (pdf 90523.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) MONO-LINYAH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 090524 (pdf 90524.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LINYAH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 090541 (pdf 90541.pdf not found) INN (NORGESTIMATE ETHINYL ESTRADIOL) TRI-LO-LINYAH (NOVAST LABS) APPROVAL= AP YEAR= 2022 , NDA 090721 (pdf 90721.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) FALMINA (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091105 (pdf 91105.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) ELINEST (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091204 (pdf 91204.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) WERA (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091346 (pdf 91346.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VIORELE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091408 (pdf 91408.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) KURVELO (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 091440 (pdf 91440.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 091452 (pdf 91452.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MARLISSA (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091663 (pdf 91663.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2012 , NDA 200541 (pdf 200541.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 201663 (pdf 201663.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 090793 (pdf 90793.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 090794 (pdf 90794.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 090938 (pdf 90938.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (BARR LABS INC) APPROVAL= AP YEAR= 2014 , NDA 091234 (pdf 91234.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091247 (pdf 91247.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) PIMTREA (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091425 (pdf 91425.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 091453 (pdf 91453.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN FE 1.5/30 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091454 (pdf 91454.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN FE 1/20 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091467 (pdf 91467.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) DAYSEE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 200245 (pdf 200245.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 201510 (pdf 201510.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PIRMELLA 7/7/7 (LUPIN LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201512 (pdf 201512.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PIRMELLA 1/35 (LUPIN LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201886 (pdf 201886.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) VYFEMLA (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 201887 (pdf 201887.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) ENSKYCE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 202296 (pdf 202296.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 202771 (pdf 202771.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 202772 (pdf 202772.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 202995 (pdf 202995.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 1/20 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 203006 (pdf 203006.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203667 (label 203667.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MINASTRIN 24 FE (APIL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204061 (label 204061.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) QUARTETTE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2013 , NDA 204426 (label 204426.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TAYTULLA (APIL) APPROVAL= AP YEAR= 2013 , NDA 204654 (label 204654.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO MINASTRIN FE (APIL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090293 (pdf 90293.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS 24 FE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 090716 (pdf 90716.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SETLAKIN (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 200910 (pdf 200910.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) XULANE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2014 , NDA 201095 (pdf 201095.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201108 (pdf 201108.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201661 (pdf 201661.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) NIKKI (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202015 (pdf 202015.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAELA (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 202247 (pdf 202247.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202742 (pdf 202742.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202996 (pdf 202996.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 1.5/30 (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 203113 (pdf 203113.pdf not found) INN (NORETHINDRONE ACETATE ETHINYL ESTRADIOL FERROUS FUMARATE) LO-BLISOVI FE (LUPIN LTD) APPROVAL= TA YEAR= 2014 , NDA 203371 (pdf 203371.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2014 , NDA 076681 (pdf 76681.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KIMIDESS (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 , NDA 091232 (pdf 91232.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LO-ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 200383 (pdf 200383.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2015 , NDA 200384 (pdf 200384.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2015 , NDA 200490 (pdf 200490.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 200492 (pdf 200492.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 200493 (pdf 200493.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 200897 (pdf 200897.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201088 (pdf 201088.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) VIENVA (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202085 (pdf 202085.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202086 (pdf 202086.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202131 (pdf 202131.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202741 (pdf 202741.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202770 (pdf 202770.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202791 (pdf 202791.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 202994 (pdf 202994.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 24 FE (NOVAST LABS) APPROVAL= AP YEAR= 2015 , NDA 203038 (pdf 203038.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203163 (pdf 203163.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ASHLYNA (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203164 (pdf 203164.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203593 (label 203593.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 203594 (label 203594.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 202016 (pdf 202016.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) MELAMISA (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 091398 (pdf 91398.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI 24 FE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 091690 (pdf 91690.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ETHINYL ESTRADIOL AND LEVONORGESTREL (NOVAST LABS) APPROVAL= TA YEAR= 2015 , NDA 200248 (pdf 200248.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 200486 (pdf 200486.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200488 (pdf 200488.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200489 (pdf 200489.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201584 (pdf 201584.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI FE 1/20 (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201585 (pdf 201585.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI FE 1.5/30 (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202132 (pdf 202132.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202226 (pdf 202226.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) BEKYREE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202507 (pdf 202507.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ELIFEMME (XIROMED) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202594 (pdf 202594.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202789 (pdf 202789.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) ISIBLOOM (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 203413 (pdf 203413.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 0.5/35 (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203448 (pdf 203448.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) KAITLIB FE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 203865 (pdf 203865.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203870 (pdf 203870.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203871 (pdf 203871.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203872 (pdf 203872.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204213 (pdf 204213.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FYAVOLV (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 204296 (pdf 204296.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 091332 (pdf 91332.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 201828 (pdf 201828.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) NORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 201896 (pdf 201896.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 201897 (pdf 201897.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203435 (pdf 203435.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LERIBANE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 203873 (pdf 203873.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204057 (pdf 204057.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK SPECLT) APPROVAL= AP YEAR= 2016 , NDA 204704 (pdf 204704.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 204848 (pdf 204848.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 205049 (label 205049.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205588 (pdf 205588.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 205943 (pdf 205943.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) FAYOSIM (LUPIN LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206287 (pdf 206287.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MIBELAS 24 FE (LUPIN) APPROVAL= AP YEAR= 2016 , NDA 206969 (pdf 206969.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207514 (pdf 207514.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208097 (pdf 208097.pdf not found) INN (NORETHINDRONE ACETATE ETHINYL ESTRADIOL ETHINYL ESTRADIOL FERROUS FUMARATE) NORETHINDRONE ACETATE ETHINYL ESTRADIOL ETHINYL ESTRADIOL FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 017948 (label 17948.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE FERROUS FUMARATE) NORMINEST FE (GD SEARLE LLC) APPROVAL= AP YEAR= 1978 , NDA 018206 (label 18206.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL FERROUS FUMARATE) LO/OVRAL FE (CADENCE HEALTH) APPROVAL= AP YEAR= 1979 , NDA 202689 (pdf 202689.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VOLNEA (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 204703 (pdf 204703.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 205441 (pdf 205441.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-MILI (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205449 (pdf 205449.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) MILI (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205630 (pdf 205630.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 205762 (pdf 205762.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LO-MILI (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205876 (pdf 205876.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (APOTEX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206120 (pdf 206120.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206866 (pdf 206866.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AYUNA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206886 (pdf 206886.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AFIRMELLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207054 (pdf 207054.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NYLIA 7/7/7 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207055 (pdf 207055.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYONANZ (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207056 (pdf 207056.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NYLIA 1/35 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207245 (pdf 207245.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2016 , NDA 207259 (pdf 207259.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208661 (pdf 208661.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO LARIN FE (NOVAST LABS LTD) APPROVAL= TA YEAR= 2016 , NDA 202875 (pdf 202875.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) NORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203291 (pdf 203291.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 206053 (pdf 206053.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 206201 (pdf 206201.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ETHINYL ESTRADIOL LEVONORGESTREL (MAYNE PHARMA INC) APPROVAL= TA YEAR= 2017 , NDA 206851 (pdf 206851.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SIMPESSE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206852 (pdf 206852.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LO SIMPESSE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206853 (pdf 206853.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) SIMLIYA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206864 (pdf 206864.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 207066 (pdf 207066.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 207081 (pdf 207081.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KALLIGA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207260 (pdf 207260.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207504 (pdf 207504.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 24 FE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207505 (pdf 207505.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA FE 1/20 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207506 (pdf 207506.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 1/20 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207535 (pdf 207535.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NEXESTA FE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207580 (pdf 207580.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA FE 1.5/30 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207581 (pdf 207581.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 1.5/30 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209170 (pdf 209170.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 203770 (pdf 203770.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) JAIMIESS (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 204847 (pdf 204847.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY 24 FE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205131 (pdf 205131.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 205948 (pdf 205948.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) TYDEMY (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 206597 (pdf 206597.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY FE 1/20 (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 209423 (pdf 209423.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210369 (pdf 210369.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 202970 (pdf 202970.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208612 (label 208612.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) BALCOLTRA (AVION PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208639 (pdf 208639.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (APOTEX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209407 (pdf 209407.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) ZUMANDIMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 209632 (pdf 209632.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) LO-ZUMANDIMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 205069 (pdf 205069.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 205947 (pdf 205947.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 206850 (pdf 206850.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ICLEVIA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207067 (pdf 207067.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2018 , NDA 209031 (pdf 209031.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY FE 1.5/30 (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 209297 (pdf 209297.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY 1.5/30 (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 209547 (pdf 209547.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) MALMOREDE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 209609 (pdf 209609.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 209627 (label 209627.pdf) INN (ETHINYL ESTRADIOL SEGESTERONE ACETATE) ANNOVERA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210017 (pdf 210017.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 202138 (pdf 202138.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) KEMEYA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 202817 (pdf 202817.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) CERINTA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 202988 (pdf 202988.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SYLEVIA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209548 (pdf 209548.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) LO-MALMOREDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 211944 (pdf 211944.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2019 , NDA 202318 (pdf 202318.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) KYRA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210830 (pdf 210830.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ELURYNG (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 202962 (pdf 202962.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) CHABELINA FE (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 204017 (label 204017.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TWIRLA (AGILE) APPROVAL= AP YEAR= 2020 , NDA 209405 (label 209405.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TYBLUME (EXELTIS USA INC) APPROVAL= AP YEAR= 2020 , NDA 210087 (pdf 210087.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FINZALA (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 , NDA 213034 (pdf 213034.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2020 , NDA 091692 (pdf 91692.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) DOLISHALE (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 207033 (pdf 207033.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2020 , NDA 207065 (pdf 207065.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2020 , NDA 212706 (pdf 212706.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MERZEE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213317 (pdf 213317.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GEMMILY (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 204305 (pdf 204305.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ETHINYL ESTRADIOL ETONOGESTREL (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 213950 (pdf 213950.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ETHINYL ESTRADIOL AND NORELGESTROMIN (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 214292 (pdf 214292.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 207577 (pdf 207577.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) VERARING (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213977 (pdf 213977.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ONSURA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 213901 (pdf 213901.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 207585 (pdf 207585.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) RHUZDAH (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211328 (pdf 211328.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) HALOETTE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 , NDA 213418 (pdf 213418.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 212298 (pdf 212298.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2023 , NDA 202980 (pdf 202980.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) TURQOZ (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 211157 (pdf 211157.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ENILLORING (XIROMED) APPROVAL= AP YEAR= 2023 , NDA 214594 (pdf 214594.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ETHINYL ESTRADIOL AND NORELGESTROMIN (ZYDUS NOVELTECH INC) APPROVAL= AP YEAR= 2023 , NDA 214640 (pdf 214640.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2023 , NDA 216558 (pdf 216558.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) OSHIH (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217087 (pdf 217087.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MINZOYA (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 19 ; ESTRADIOL VALERATE ; 979-32-8 ; 1954 ; ; ; CLASS GENITO -- ESTROGEN -- RAPIDLY HYDROLYZED IN ESTRADIOL , ; NDA 009402 (label 9402.pdf) INN (ESTRADIOL VALERATE) DELESTROGEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1954 , NDA 040628 (pdf 40628.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (FOSUN PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 083546 (pdf 83546.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083547 (pdf 83547.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (DR REDDYS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 083714 (pdf 83714.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (DR REDDYS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085860 (pdf 85860.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085865 (pdf 85865.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086423 (pdf 86423.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) DITATE-DS (SAVAGE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 090920 (pdf 90920.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (AM REGENT) APPROVAL= AP YEAR= 2010 , NDA 022252 (label 22252.pdf) INN (DIENOGEST ESTRADIOL VALERATE) NATAZIA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 202349 (pdf 202349.pdf not found) INN (DIENOGEST ESTRADIOL VALERATE) ESTRADIOL VALERATE AND DIENOGEST (WATSON LABS INC) APPROVAL= TA YEAR= 2017 , NDA 202999 (pdf 202999.pdf not found) INN (ESTRADIOL VALERATE ESTRADIOL VALERATE DIENOGEST) ESTRADIOL VALERATE ESTRADIOL VALERATE DIENOGEST (TEVA PHARMS USA) APPROVAL= TA YEAR= 2016 , NDA 203723 (pdf 203723.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 216656 (pdf 216656.pdf not found) INN (ESTRADIOL VALERATE) ESTRADIOL VALERATE (XIROMED) APPROVAL= AP YEAR= 2023 , 20 ; ESTRADIOL CYPIONATE ; 313-06-4 ; 1979 ; ; ; CLASS GENITO -- ESTROGEN -- RAPIDLY HYDROLYZED IN ESTRADIOL , ; NDA 017968 (pdf 17968.pdf not found) INN (ESTRADIOL CYPIONATE TESTOSTERONE CYPIONATE) DEPO-TESTADIOL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 020874 (label 20874.pdf) INN (ESTRADIOL CYPIONATE MEDROXYPROGESTERONE ACETATE) LUNELLE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 085470 (label 85470.pdf) INN (ESTRADIOL CYPIONATE) DEPO-ESTRADIOL (PFIZER) APPROVAL= AP YEAR= 1979 , NDA 085603 (pdf 85603.pdf not found) INN (ESTRADIOL CYPIONATE TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085620 (pdf 85620.pdf not found) INN (ESTRADIOL CYPIONATE) ESTRADIOL CYPIONATE (DR REDDYS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 089310 (pdf 89310.pdf not found) INN (ESTRADIOL CYPIONATE) ESTRADIOL CYPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 21 ; ESTRADIOL ACETATE ; 4245-41-4 ; 2003 ; ; ; CLASS GENITO -- ESTROGEN -- RAPIDLY HYDROLYZED IN ESTRADIOL , ; NDA 021367 (label 21367.pdf) INN (ESTRADIOL ACETATE) FEMRING (MILLICENT) APPROVAL= AP YEAR= 2003 , NDA 021633 (label 21633.pdf) INN (ESTRADIOL ACETATE) FEMTRACE (APIL) APPROVAL= AP YEAR= 2004 DISCONTINUED , 22 ; METHAMPHETAMINE ; 537-46-2 ; 1943 ; ; NATURAL MOLECULE C00042732 ; CLASS NERVOUS SYSTEM -- SYMPATHOMIMETIC AMINE -- PSYCHOSTIMULANTS -- TREATMENT OF ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY -- TREATMENT OF EXOGENOUS OBESITY -- LEADS TO THE FORMATION OF REACTIVE OXYGEN SPECIES IN THE BRAIN , ; NDA 005378 (label 5378.pdf) INN (METHAMPHETAMINE HYDROCHLORIDE) DESOXYN (AJENAT PHARMS) APPROVAL= AP YEAR= 1943 , NDA 040529 (pdf 40529.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPHETAMINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 083889 (pdf 83889.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPEX (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084931 (pdf 84931.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPHETAMINE HYDROCHLORIDE (REXAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 086359 (pdf 86359.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPHETAMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 091189 (pdf 91189.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPHETAMINE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 , NDA 203846 (pdf 203846.pdf not found) INN (METHAMPHETAMINE HYDROCHLORIDE) METHAMPHETAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2015 , 23 ; DICUMAROL ; 66-76-2 ; 1944 ; DISCONTINUED ; ; CLASS BLOOD -- ANTICOAGULANTS , ; NDA 005509 (pdf 5509.pdf not found) INN (DICUMAROL) DICUMAROL (LILLY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 005545 (pdf 5545.pdf not found) INN (DICUMAROL) DICUMAROL (ABBVIE) APPROVAL= AP YEAR= 1944 DISCONTINUED , 24 ; VITAMIN A ; 68-26-8 ; 1953 ; ; NATURAL MOLECULE C00031437 ; CLASS METABOLISM -- ANTI-ACNE AGENTS -- VITAMIN A -- ANTIXEROPHTHALMIC VITAMIN , ; NDA 008809 (label 8809.pdf) INN (VITAMIN A) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (VITAMIN E) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 021625 (label 21625.pdf) INN (VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (VITAMIN K) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 080952 (pdf 80952.pdf not found) INN (VITAMIN A) VITAMIN A (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080985 (pdf 80985.pdf not found) INN (VITAMIN A) VITAMIN A (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083080 (pdf 83080.pdf not found) INN (VITAMIN A) AQUASOL A (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083134 (pdf 83134.pdf not found) INN (VITAMIN A) VITAMIN A (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083351 (pdf 83351.pdf not found) INN (VITAMIN A) VITAMIN A (CHASE CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083973 (pdf 83973.pdf not found) INN (VITAMIN A) VITAMIN A (BANNER PHARMACAPS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (VITAMIN E) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018933 (pdf 18933.pdf not found) INN (VITAMIN E) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (VITAMIN E) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 021265 (label 21265.pdf) INN (VITAMIN K) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021646 (label 21646.pdf) INN (VITAMIN K) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , 25 ; TUBOCURARINE ; 57-95-4 ; 1945 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- ALKALOID -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- INTERFERES WITH NICOTINIC ACETYLCHOLINE RECEPTOR (ACHR) -- SKELETAL MUSCLE RELAXANTS , ; NDA 005657 (pdf 5657.pdf not found) INN (TUBOCURARINE CHLORIDE) TUBOCURARINE CHLORIDE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1945 NEWMOLECULARENTITY DISCONTINUED , NDA 006095 (pdf 6095.pdf not found) INN (TUBOCURARINE CHLORIDE) TUBOCURARINE CHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006325 (pdf 6325.pdf not found) INN (TUBOCURARINE CHLORIDE) TUBOCURARINE CHLORIDE (LILLY) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 089442 (pdf 89442.pdf not found) INN (TUBOCURARINE CHLORIDE) TUBOCURARINE CHLORIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 26 ; SULFABENZAMIDE ; 127-71-9 ; 1945 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 005794 (pdf 5794.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) SULTRIN (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1945 DISCONTINUED , NDA 086424 (pdf 86424.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087285 (pdf 87285.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PADAGIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087864 (pdf 87864.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087887 (pdf 87887.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRYSUL (SAVAGE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088462 (pdf 88462.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088463 (pdf 88463.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088607 (pdf 88607.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) GYNE-SULF (COSETTE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088821 (pdf 88821.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) VAGILIA (COSETTE) APPROVAL= AP YEAR= 1987 DISCONTINUED , 27 ; SULFACETAMIDE ; 144-80-9 ; 1945 ; ; ; CLASS SENSORY -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTIINFECTIVES -- COMPETES WITH PARA-AMINOBENZOIC ACID UTILIZATION , ; NDA 005794 (pdf 5794.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) SULTRIN (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1945 DISCONTINUED , NDA 005963 (pdf 5963.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULAMYD (SCHERING) APPROVAL= AP YEAR= 1946 DISCONTINUED , NDA 010210 (pdf 10210.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) METIMYD (SCHERING) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 012813 (label 12813.pdf) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) BLEPHAMIDE (ALLERGAN) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 018988 (pdf 18988.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) VASOCIDIN (NOVARTIS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019525 (label 19525.pdf) INN (FLUOROMETHOLONE SULFACETAMIDE SODIUM) FML-S (ALLERGAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019931 (label 19931.pdf) INN (SULFACETAMIDE SODIUM) KLARON (BAUSCH) APPROVAL= AP YEAR= 1996 , NDA 040066 (pdf 40066.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040215 (pdf 40215.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (AKORN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040216 (pdf 40216.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 073630 (pdf 73630.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074449 (pdf 74449.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 074511 (pdf 74511.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULSTER (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 077015 (pdf 77015.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 , NDA 080020 (pdf 80020.pdf not found) INN (SULFACETAMIDE SODIUM) ISOPTO CETAMIDE (ALCON) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080021 (pdf 80021.pdf not found) INN (SULFACETAMIDE SODIUM) CETAMIDE (ALCON) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080024 (pdf 80024.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACEL-15 (OPTOPICS) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080025 (pdf 80025.pdf not found) INN (SULFACETAMIDE SODIUM) SULF-10 (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080028 (pdf 80028.pdf not found) INN (SULFACETAMIDE SODIUM) BLEPH-10 (ALLERGAN) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080029 (pdf 80029.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (PADAGIS US) APPROVAL= AP YEAR= 1971 , NDA 080660 (pdf 80660.pdf not found) INN (SULFACETAMIDE SODIUM) OCUSULF-10 (MIZA PHARMS USA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083021 (pdf 83021.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULFACETAMIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084015 (pdf 84015.pdf not found) INN (SULFACETAMIDE SODIUM) BLEPH-10 (ALLERGAN) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084143 (pdf 84143.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULFACETAMIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084145 (pdf 84145.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULFACETAMIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084146 (pdf 84146.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULFACETAMIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084147 (pdf 84147.pdf not found) INN (SULFACETAMIDE SODIUM) SODIUM SULFACETAMIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 086424 (pdf 86424.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087285 (pdf 87285.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PADAGIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087547 (pdf 87547.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) ISOPTO CETAPRED (ALCON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087748 (pdf 87748.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) BLEPHAMIDE S.O.P. (ALLERGAN) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087771 (pdf 87771.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) CETAPRED (ALCON) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 087818 (pdf 87818.pdf not found) INN (SULFACETAMIDE SODIUM) SULTEN-10 (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087864 (pdf 87864.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087887 (pdf 87887.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRYSUL (SAVAGE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087949 (pdf 87949.pdf not found) INN (SULFACETAMIDE SODIUM) SULFAIR 10 (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088000 (pdf 88000.pdf not found) INN (SULFACETAMIDE SODIUM) SULFAIR 10 (PHARMAFAIR) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088007 (pdf 88007.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR (PHARMAFAIR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088032 (pdf 88032.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088059 (pdf 88059.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDAMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088089 (pdf 88089.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) SULPHRIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088186 (pdf 88186.pdf not found) INN (SULFACETAMIDE SODIUM) SULFAIR-15 (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088385 (pdf 88385.pdf not found) INN (SULFACETAMIDE SODIUM) SULFAIR FORTE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088462 (pdf 88462.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088463 (pdf 88463.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088607 (pdf 88607.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) GYNE-SULF (COSETTE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088791 (pdf 88791.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) VASOCIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088821 (pdf 88821.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) VAGILIA (COSETTE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088837 (pdf 88837.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR II (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088947 (pdf 88947.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089047 (pdf 89047.pdf not found) INN (SULFACETAMIDE SODIUM) SULF-15 (NOVARTIS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089068 (pdf 89068.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089560 (pdf 89560.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 078649 (pdf 78649.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (PADAGIS US) APPROVAL= AP YEAR= 2009 , NDA 078668 (pdf 78668.pdf not found) INN (SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM (TARO) APPROVAL= AP YEAR= 2009 , 28 ; SULFATHIAZOLE ; 72-14-0 ; 1945 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 005794 (pdf 5794.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) SULTRIN (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1945 DISCONTINUED , NDA 086424 (pdf 86424.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087285 (pdf 87285.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PADAGIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087864 (pdf 87864.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087887 (pdf 87887.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRYSUL (SAVAGE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088462 (pdf 88462.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088463 (pdf 88463.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) TRIPLE SULFA (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088607 (pdf 88607.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) GYNE-SULF (COSETTE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088821 (pdf 88821.pdf not found) INN (SULFABENZAMIDE SULFACETAMIDE SULFATHIAZOLE) VAGILIA (COSETTE) APPROVAL= AP YEAR= 1987 DISCONTINUED , 29 ; NITROFURAZONE ; 59-87-0 ; 1945 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- BROAD SPECTRUM ANTIBIOTIC , ; NDA 005795 (pdf 5795.pdf not found) INN (NITROFURAZONE) FURACIN (SHIRE) APPROVAL= AP YEAR= 1945 DISCONTINUED , NDA 017343 (pdf 17343.pdf not found) INN (NITROFURAZONE) ACTIN-N (SHERWOOD MEDCL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083789 (pdf 83789.pdf not found) INN (NITROFURAZONE) FURACIN (SHIRE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083791 (pdf 83791.pdf not found) INN (NITROFURAZONE) FURACIN (SHIRE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084393 (pdf 84393.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (LANNETT) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084968 (pdf 84968.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085130 (pdf 85130.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086077 (pdf 86077.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (AMBIX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086156 (pdf 86156.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (TARO) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086766 (pdf 86766.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (WENDT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087081 (pdf 87081.pdf not found) INN (NITROFURAZONE) NITROFURAZONE (WENDT) APPROVAL= AP YEAR= 1981 DISCONTINUED , 30 ; DIPHENHYDRAMINE ; 58-73-1 ; 1946 ; ; ; CLASS RESPIRATORY -- ANESTHETICS -- ANTI-ALLERGIC AGENTS -- ANTIDYSKINETICS -- ANTIHISTAMINE -- ANTIEMETICS -- ANTIPARKINSON AGENTS -- ANTIPRURITICS -- ANTITUSSIVES -- ETHANOLAMINE DERIVATIVES -- HISTAMINE H1 ANTAGONISTS -- HYPNOTICS AND SEDATIVES -- DIMENHYDRINATE IS A COMBINATION WITH CHLORO-THEOPHYLLINE , ; NDA 005845 (pdf 5845.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BENADRYL (MCNEIL CONS) APPROVAL= AP YEAR= 1946 NEWMOLECULARENTITY DISCONTINUED , NDA 006146 (pdf 6146.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BENADRYL (MCNEIL CONS) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006514 (pdf 6514.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BENYLIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009486 (pdf 9486.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BENADRYL PRESERVATIVE FREE (MCNEIL CONS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 019014 (pdf 19014.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BENYLIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021393 (label 21393.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) ADVIL PM (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2005 , NDA 021394 (label 21394.pdf) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) ADVIL PM (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2005 , NDA 040140 (pdf 40140.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040466 (pdf 40466.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (APP PHARMS) APPROVAL= AP YEAR= 2002 , NDA 040498 (pdf 40498.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2005 , NDA 070118 (pdf 70118.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHEN (MORTON GROVE) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 070205 (pdf 70205.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) HYDRAMINE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070497 (pdf 70497.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070524 (pdf 70524.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) VICKS FORMULA 44 (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071292 (pdf 71292.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) ANTITUSSIVE (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072416 (pdf 72416.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072646 (pdf 72646.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) SILPHEN (LANNETT CO INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073611 (pdf 73611.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (CUMBERLAND SWAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080519 (pdf 80519.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ALRA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080577 (pdf 80577.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080586 (pdf 80586.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080592 (pdf 80592.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080596 (pdf 80596.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080635 (pdf 80635.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080643 (pdf 80643.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080727 (pdf 80727.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080728 (pdf 80728.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080738 (pdf 80738.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080762 (pdf 80762.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080763 (pdf 80763.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) HYDRAMINE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080800 (pdf 80800.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080807 (pdf 80807.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080817 (pdf 80817.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1972 , NDA 080822 (pdf 80822.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 080832 (pdf 80832.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080845 (pdf 80845.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080868 (pdf 80868.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080873 (pdf 80873.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080939 (pdf 80939.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LANNETT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083027 (pdf 83027.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083061 (pdf 83061.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083063 (pdf 83063.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083087 (pdf 83087.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083088 (pdf 83088.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083183 (pdf 83183.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083237 (pdf 83237.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083275 (pdf 83275.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ANABOLIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083441 (pdf 83441.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 083533 (pdf 83533.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083567 (pdf 83567.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083634 (pdf 83634.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083674 (pdf 83674.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083797 (pdf 83797.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083953 (pdf 83953.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084094 (pdf 84094.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084506 (pdf 84506.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084524 (pdf 84524.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084640 (pdf 84640.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHEN (USL PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085083 (pdf 85083.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085138 (pdf 85138.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085150 (pdf 85150.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085156 (pdf 85156.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085287 (pdf 85287.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085621 (pdf 85621.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085701 (pdf 85701.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085874 (pdf 85874.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086543 (pdf 86543.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (NEWTRON PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086544 (pdf 86544.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (NEWTRON PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086586 (pdf 86586.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BELIX (HALSEY) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086874 (pdf 86874.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086875 (pdf 86875.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086937 (pdf 86937.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087066 (pdf 87066.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LYPHOMED) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087513 (pdf 87513.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1982 , NDA 087630 (pdf 87630.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087914 (pdf 87914.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087941 (pdf 87941.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087977 (pdf 87977.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LNK) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087978 (pdf 87978.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (LNK) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088034 (pdf 88034.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088304 (pdf 88304.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIBENIL (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088680 (pdf 88680.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088880 (pdf 88880.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089040 (pdf 89040.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089041 (pdf 89041.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089101 (pdf 89101.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089179 (pdf 89179.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) BELDIN (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089488 (pdf 89488.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089489 (pdf 89489.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 079113 (pdf 79113.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 090619 (pdf 90619.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090397 (pdf 90397.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2010 , NDA 040519 (pdf 40519.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (APP PHARMS) APPROVAL= AP YEAR= 2004 , NDA 080615 (pdf 80615.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 080715 (pdf 80715.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (ALRA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080841 (pdf 80841.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (HEATHER) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083531 (pdf 83531.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 084316 (pdf 84316.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WYETH AYERST) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084767 (pdf 84767.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085166 (pdf 85166.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085985 (pdf 85985.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 200888 (pdf 200888.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 , NDA 091526 (label 91526.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 205352 (label 205352.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) ALEVE PM (BAYER HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 205723 (pdf 205723.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 209726 (pdf 209726.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 207597 (pdf 207597.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (P AND L) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208499 (pdf 208499.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2019 , NDA 210676 (pdf 210676.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211830 (pdf 211830.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2019 , NDA 213663 (pdf 213663.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 216204 (pdf 216204.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 211404 (pdf 211404.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 2024 , NDA 218448 (pdf 218448.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE) DIPHENHYDRAMINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 31 ; SILODOSIN ; 160970-54-7 ; 2008 ; ; ; CLASS GENITO -- ALPHA-1 ADRENERGIC RECEPTOR ANTAGONIST -- PROSTATIC HYPERPLASIA , ; NDA 022206 (label 22206.pdf) INN (SILODOSIN) RAPAFLO (ALLERGAN) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 206541 (pdf 206541.pdf not found) INN (SILODOSIN) SILODOSIN (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 204726 (pdf 204726.pdf not found) INN (SILODOSIN) SILODOSIN (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 209745 (pdf 209745.pdf not found) INN (SILODOSIN) SILODOSIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210626 (pdf 210626.pdf not found) INN (SILODOSIN) SILODOSIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210687 (pdf 210687.pdf not found) INN (SILODOSIN) SILODOSIN (MSN) APPROVAL= AP YEAR= 2018 , NDA 211060 (pdf 211060.pdf not found) INN (SILODOSIN) SILODOSIN (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 211166 (pdf 211166.pdf not found) INN (SILODOSIN) SILODOSIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 211731 (pdf 211731.pdf not found) INN (SILODOSIN) SILODOSIN (ALEMBIC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 204793 (pdf 204793.pdf not found) INN (SILODOSIN) SILODOSIN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2020 , NDA 209029 (pdf 209029.pdf not found) INN (SILODOSIN) SILODOSIN (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 213230 (pdf 213230.pdf not found) INN (SILODOSIN) SILODOSIN (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 2022 , NDA 204816 (pdf 204816.pdf not found) INN (SILODOSIN) SILODOSIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , 32 ; TRIMETHADIONE ; 127-48-0 ; 1946 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANTS -- CONTROL OF PETIT MAL SEIZURES -- VOLTAGE DEPENDENT T-TYPE CALCIUM CHANNEL INHIBITOR , ; NDA 005856 (label 5856.pdf) INN (TRIMETHADIONE) TRIDIONE (ABBVIE) APPROVAL= AP YEAR= 1946 DISCONTINUED , 33 ; FOLIC ACID ; 59-30-3 ; 1946 ; ; ; CLASS BLOOD -- VITAMIN B9 -- DIETARY SUPPLEMENT , ; NDA 005897 (pdf 5897.pdf not found) INN (FOLIC ACID) FOLVITE (WYETH PHARMS INC) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006012 (pdf 6012.pdf not found) INN (FERROUS SULFATE FOLIC ACID) FOLVRON (LEDERLE) APPROVAL= AP YEAR= 1946 DISCONTINUED , NDA 006071 (pdf 6071.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006135 (pdf 6135.pdf not found) INN (FOLIC ACID) FOLIC ACID (LILLY) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (FOLIC ACID) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PHYTONADIONE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018933 (pdf 18933.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE VITAMIN A VITAMIN E) M.V.I.-12 LYOPHILIZED (TELIGENT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PANTOTHENIC ACID PHYTONADIONE PYRIDOXINE RIBOFLAVIN THIAMINE VITAMIN A PALMITATE VITAMIN E) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN K) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN THIAMINE TOCOPHEROL ACETATE VITAMIN A VITAMIN K) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (FOLIC ACID) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021643 (label 21643.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED , NDA 021646 (label 21646.pdf) INN (FOLIC ACID) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040514 (pdf 40514.pdf not found) INN (FOLIC ACID) FOLIC ACID (JUBILANT CADISTA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040582 (pdf 40582.pdf not found) INN (FOLIC ACID) FOLIC ACID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040625 (pdf 40625.pdf not found) INN (FOLIC ACID) FOLIC ACID (AMNEAL PHARM) APPROVAL= AP YEAR= 2005 , NDA 080600 (pdf 80600.pdf not found) INN (FOLIC ACID) FOLIC ACID (HIKMA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080680 (pdf 80680.pdf not found) INN (FOLIC ACID) FOLIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1971 , NDA 080686 (pdf 80686.pdf not found) INN (FOLIC ACID) FOLIC ACID (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080691 (pdf 80691.pdf not found) INN (FOLIC ACID) FOLIC ACID (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080755 (pdf 80755.pdf not found) INN (FOLIC ACID) FOLIC ACID (EVERYLIFE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080784 (pdf 80784.pdf not found) INN (FOLIC ACID) FOLIC ACID (PUREPAC PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080816 (pdf 80816.pdf not found) INN (FOLIC ACID) FOLIC ACID (LANNETT) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080903 (pdf 80903.pdf not found) INN (FOLIC ACID) FOLIC ACID (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 081066 (pdf 81066.pdf not found) INN (FOLIC ACID) FOLIC ACID (BEN VENUE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 083000 (pdf 83000.pdf not found) INN (FOLIC ACID) FOLIC ACID (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083133 (pdf 83133.pdf not found) INN (FOLIC ACID) FOLIC ACID (TABLICAPS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083141 (pdf 83141.pdf not found) INN (FOLIC ACID) FOLIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083526 (pdf 83526.pdf not found) INN (FOLIC ACID) FOLIC ACID (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083598 (pdf 83598.pdf not found) INN (FOLIC ACID) FOLIC ACID (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084158 (pdf 84158.pdf not found) INN (FOLIC ACID) FOLIC ACID (PHARMERAL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084472 (pdf 84472.pdf not found) INN (FOLIC ACID) FOLIC ACID (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084915 (pdf 84915.pdf not found) INN (FOLIC ACID) FOLIC ACID (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085061 (pdf 85061.pdf not found) INN (FOLIC ACID) FOLIC ACID (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085141 (pdf 85141.pdf not found) INN (FOLIC ACID) FOLIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 086296 (pdf 86296.pdf not found) INN (FOLIC ACID) FOLIC ACID (VINTAGE PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087438 (pdf 87438.pdf not found) INN (FOLIC ACID) FOLICET (MISSION PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087828 (pdf 87828.pdf not found) INN (FOLIC ACID) FOLIC ACID (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088199 (pdf 88199.pdf not found) INN (FOLIC ACID) FOLIC ACID (UDL) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088730 (pdf 88730.pdf not found) INN (FOLIC ACID) FOLIC ACID (VANGARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088949 (pdf 88949.pdf not found) INN (FOLIC ACID) FOLIC ACID (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089177 (pdf 89177.pdf not found) INN (FOLIC ACID) FOLIC ACID (BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089202 (pdf 89202.pdf not found) INN (FOLIC ACID) FOLIC ACID (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 040796 (pdf 40796.pdf not found) INN (FOLIC ACID) FOLIC ACID (LEADING) APPROVAL= AP YEAR= 2009 , NDA 090035 (pdf 90035.pdf not found) INN (FOLIC ACID) FOLIC ACID (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2009 , NDA 040756 (pdf 40756.pdf not found) INN (FOLIC ACID) FOLIC ACID (ENDO OPERATIONS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091145 (pdf 91145.pdf not found) INN (FOLIC ACID) FOLIC ACID (QINGDAO BAHEAL PHARM) APPROVAL= AP YEAR= 2013 , NDA 202437 (pdf 202437.pdf not found) INN (FOLIC ACID) FOLIC ACID (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 204418 (pdf 204418.pdf not found) INN (FOLIC ACID) FOLIC ACID (NUVO PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 211064 (pdf 211064.pdf not found) INN (FOLIC ACID) FOLIC ACID (ATHEM) APPROVAL= AP YEAR= 2019 , NDA 202522 (pdf 202522.pdf not found) INN (FOLIC ACID) FOLIC ACID (XGEN PHARMS) APPROVAL= AP YEAR= 2019 , 34 ; TRIPELENNAMINE ; 91-81-6 ; 1948 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTI-ALLERGIC AGENTS -- ETHYLENEDIAMINE DERIVATIVES -- HISTAMINE H1 ANTAGONISTS , ; NDA 005914 (pdf 5914.pdf not found) INN (TRIPELENNAMINE CITRATE) PBZ (NOVARTIS) APPROVAL= AP YEAR= 1948 NEWMOLECULARENTITY DISCONTINUED , NDA 010533 (pdf 10533.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) PBZ-SR (NOVARTIS) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 080713 (pdf 80713.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080744 (pdf 80744.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080785 (pdf 80785.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080790 (pdf 80790.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083037 (pdf 83037.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (ANABOLIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083149 (pdf 83149.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) PBZ (NOVARTIS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083557 (pdf 83557.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083625 (pdf 83625.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083626 (pdf 83626.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083989 (pdf 83989.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085188 (pdf 85188.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085412 (pdf 85412.pdf not found) INN (TRIPELENNAMINE HYDROCHLORIDE) TRIPELENNAMINE HYDROCHLORIDE (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , 35 ; HOMATROPINE METHYLBROMIDE ; 80-49-9 ; 1943 ; ; ; CLASS SENSORY -- ANTI-ULCER AGENTS -- ANTIMUSCARINICS -- ANTISPASMODICS -- ANTICHOLINERGIC , ; NDA 005213 (label 5213.pdf) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYCODAN (GENUS) APPROVAL= AP YEAR= 1943 NEWMOLECULARENTITY , NDA 040285 (pdf 40285.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040295 (pdf 40295.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040613 (pdf 40613.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (GENUS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 086308 (pdf 86308.pdf not found) INN (HOMATROPINE METHYLBROMIDE) HOMAPIN-10 (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086309 (pdf 86309.pdf not found) INN (HOMATROPINE METHYLBROMIDE) HOMAPIN-5 (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086310 (pdf 86310.pdf not found) INN (HOMATROPINE METHYLBROMIDE) EQUIPIN (MISSION PHARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 088008 (pdf 88008.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1983 , NDA 088017 (pdf 88017.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 , NDA 088066 (pdf 88066.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROPANE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088508 (pdf 88508.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) TUSSIGON (KING PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 091528 (pdf 91528.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203535 (pdf 203535.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204765 (pdf 204765.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205731 (pdf 205731.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (PADAGIS US) APPROVAL= AP YEAR= 2017 , NDA 207176 (pdf 207176.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE (AVANTHI INC) APPROVAL= AP YEAR= 2017 , NDA 207487 (pdf 207487.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 210663 (pdf 210663.pdf not found) INN (HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , 36 ; DIHYDROERGOTAMINE ; 511-12-6 ; 1946 ; ; ; CLASS NERVOUS SYSTEM -- VASOCONSTRICTOR -- ANTIMIGRAINE -- ANALGESICS NON-NARCOTIC -- 5-HYDROXYTRYPTAMINE 1 RECEPTOR AGONISTS -- SYMPATHOLYTICS , ; NDA 005929 (label 5929.pdf) INN (DIHYDROERGOTAMINE MESYLATE) D.H.E. 45 (BAUSCH) APPROVAL= AP YEAR= 1946 DISCONTINUED , NDA 018885 (pdf 18885.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE HEPARIN SODIUM LIDOCAINE HYDROCHLORIDE) EMBOLEX (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020148 (label 20148.pdf) INN (DIHYDROERGOTAMINE MESYLATE) MIGRANAL (BAUSCH) APPROVAL= AP YEAR= 1997 , NDA 040453 (pdf 40453.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 040475 (pdf 40475.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (PADAGIS US) APPROVAL= AP YEAR= 2003 , NDA 206621 (pdf 206621.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207264 (pdf 207264.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 211393 (pdf 211393.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 212046 (pdf 212046.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (PROVEPHARM SAS) APPROVAL= AP YEAR= 2020 , NDA 212907 (pdf 212907.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 213436 (label 213436.pdf) INN (DIHYDROERGOTAMINE MESYLATE) TRUDHESA (JN BIDCO) APPROVAL= AP YEAR= 2021 , NDA 214105 (pdf 214105.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (AMNEAL) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216881 (pdf 216881.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 215623 (pdf 215623.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE) DIHYDROERGOTAMINE MESYLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 37 ; DIMERCAPROL ; 59-52-9 ; 1946 ; ; ; CLASS VARIOUS -- CHELATING AGENT (AS, AU, HG ANTIDOTE) IN ACUTE POISONING , ; NDA 005939 (label 5939.pdf) INN (DIMERCAPROL) BAL (PROVEPHARM SAS) APPROVAL= AP YEAR= 1946 , 38 ; CHLOROQUINE ; 54-05-7 ; 1949 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS , ; NDA 006002 (label 6002.pdf) INN (CHLOROQUINE HYDROCHLORIDE) ARALEN HYDROCHLORIDE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 014860 (pdf 14860.pdf not found) INN (CHLOROQUINE PHOSPHATE PRIMAQUINE PHOSPHATE) ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 040516 (pdf 40516.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IMPAX LABS) APPROVAL= AP YEAR= 2003 , NDA 080880 (pdf 80880.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IMPAX LABS) APPROVAL= AP YEAR= 1974 , NDA 080886 (pdf 80886.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083082 (label 83082.pdf) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (HIKMA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 087228 (pdf 87228.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (MD PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087504 (pdf 87504.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087979 (pdf 87979.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088030 (pdf 88030.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 090249 (pdf 90249.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090610 (label 90610.pdf) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090612 (pdf 90612.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091621 (pdf 91621.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 214756 (pdf 214756.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (SUVEN PHARMS) APPROVAL= AP YEAR= 2021 , 39 ; MEPHENYTOIN ; 50-12-4 ; 1946 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- SODIUM CHANNEL BLOCKER , ; NDA 006008 (pdf 6008.pdf not found) INN (MEPHENYTOIN) MESANTOIN (NOVARTIS) APPROVAL= AP YEAR= 1946 DISCONTINUED , 40 ; METHYLERGONOVINE ; 113-42-8 ; 1946 ; ; ; CLASS VARIOUS -- OXYTOCIC -- ERGOT ALKALOID -- THE PREVENTION AND CONTROL OF POSTPARTUM HEMORRHAGE -- ALPHA-1 ADRENERGIC RECEPTOR PARTIAL AGONIST -- SEROTONERGIC (5-HT2) RECEPTOR PARTIAL AGONIST -- CONSTRICTION OF UTERINE VASCULAR SMOOTH MUSCLE (PMID24328019) , ; NDA 006035 (label 6035.pdf) INN (METHYLERGONOVINE MALEATE) METHERGINE (EDISON THERAPS LLC) APPROVAL= AP YEAR= 1946 , NDA 090193 (label 90193.pdf) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (AM REGENT) APPROVAL= AP YEAR= 2008 , NDA 040889 (pdf 40889.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2010 , NDA 091577 (pdf 91577.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 , NDA 210424 (pdf 210424.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 211483 (pdf 211483.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211455 (pdf 211455.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 212233 (pdf 212233.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (TULEX PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 211919 (pdf 211919.pdf not found) INN (METHYLERGONOVINE MALEATE) METHYLERGONOVINE MALEATE (RISING) APPROVAL= AP YEAR= 2021 , 41 ; SULFOXONE ; 144-76-3 ; 1974 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTI-BACTERIAL AGENTS -- ANTIBIOTIC -- TREATMENT OF PATIENT WITH LEPROSY , ; NDA 006044 (pdf 6044.pdf not found) INN (SULFOXONE SODIUM) DIASONE SODIUM (ABBVIE) APPROVAL= AP YEAR= 1974 DISCONTINUED , 42 ; ASCORBIC ACID ; 50-81-7 ; 1947 ; ; ; CLASS METABOLISM -- VITAMIN C -- ANTISCORBUTIC -- ANTIOXIDANTS -- FREE RADICAL SCAVENGERS , ; NDA 006071 (pdf 6071.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (ASCORBIC ACID) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PHYTONADIONE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018933 (pdf 18933.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE VITAMIN A VITAMIN E) M.V.I.-12 LYOPHILIZED (TELIGENT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PANTOTHENIC ACID PHYTONADIONE PYRIDOXINE RIBOFLAVIN THIAMINE VITAMIN A PALMITATE VITAMIN E) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN K) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN THIAMINE TOCOPHEROL ACETATE VITAMIN A VITAMIN K) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (ASCORBIC ACID) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021643 (label 21643.pdf) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E VITAMIN K) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED , NDA 021646 (label 21646.pdf) INN (ASCORBIC ACID) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 021881 (label 21881.pdf) INN (ASCORBIC ACID POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM ASCORBATE SODIUM CHLORIDE SODIUM SULFATE) MOVIPREP (SALIX PHARMS) APPROVAL= AP YEAR= 2006 , NDA 090145 (pdf 90145.pdf not found) INN (ASCORBIC ACID POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM ASCORBATE SODIUM CHLORIDE SODIUM SULFATE) PEG-3350 , SODIUM SULFATE , SODIUM CHLORIDE , POTASSIUM CHLORIDE , SODIUM ASCORBATE AND ASCORBIC ACID (NOVEL LABS INC) APPROVAL= AP YEAR= 2012 , NDA 209112 (label 209112.pdf) INN (ASCORBIC ACID) ASCOR (MCGUFF) APPROVAL= AP YEAR= 2017 , NDA 209381 (label 209381.pdf) INN (ASCORBIC ACID POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM ASCORBATE SODIUM CHLORIDE SODIUM SULFATE) PLENVU (SALIX) APPROVAL= AP YEAR= 2018 , 43 ; BIOTIN ; 58-85-5 ; 1947 ; ; NATURAL MOLECULE NPA013155 ; CLASS METABOLISM -- VITAMIN B7 , ; NDA 006071 (pdf 6071.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (BIOTIN) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A VITAMIN E) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (BIOTIN) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN DEXPANTHENOL ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE VITAMIN A VITAMIN E) M.V.I.-12 LYOPHILIZED (TELIGENT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (ASCORBIC ACID BIOTIN CYANOCOBALAMIN ERGOCALCIFEROL FOLIC ACID NIACINAMIDE PANTOTHENIC ACID PHYTONADIONE PYRIDOXINE RIBOFLAVIN THIAMINE VITAMIN A PALMITATE VITAMIN E) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN K) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN THIAMINE TOCOPHEROL ACETATE VITAMIN A VITAMIN K) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (BIOTIN) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (BIOTIN) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (BIOTIN) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021646 (label 21646.pdf) INN (BIOTIN) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , 44 ; MOMETASONE FUROATE ; 83919-23-7 ; 1987 ; ; ; CLASS METABOLISM -- ANTI-ALLERGIC AGENTS -- ANTI-INFLAMMATORY AGENTS , ; NDA 019543 (label 19543.pdf) INN (MOMETASONE FUROATE) ELOCON (ORGANON) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 019625 (label 19625.pdf) INN (MOMETASONE FUROATE) ELOCON (ORGANON) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019796 (label 19796.pdf) INN (MOMETASONE FUROATE) ELOCON (ORGANON) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 020762 (label 20762.pdf) INN (MOMETASONE FUROATE) NASONEX (ORGANON LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021067 (label 21067.pdf) INN (MOMETASONE FUROATE) ASMANEX TWISTHALER (ORGANON LLC) APPROVAL= AP YEAR= 2005 , NDA 075919 (pdf 75919.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 076067 (label 76067.pdf) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (PADAGIS US) APPROVAL= AP YEAR= 2002 , NDA 076171 (pdf 76171.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076481 (pdf 76481.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (ENCUBE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076499 (pdf 76499.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (ENCUBE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076591 (pdf 76591.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076624 (pdf 76624.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (TARO) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076679 (pdf 76679.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076788 (pdf 76788.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (TARO) APPROVAL= AP YEAR= 2006 , NDA 077061 (pdf 77061.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077180 (pdf 77180.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2005 , NDA 077401 (pdf 77401.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (COSETTE) APPROVAL= AP YEAR= 2006 , NDA 077447 (pdf 77447.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (COSETTE) APPROVAL= AP YEAR= 2006 , NDA 077678 (pdf 77678.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (COSETTE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078541 (pdf 78541.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 078571 (pdf 78571.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 022518 (label 22518.pdf) INN (FORMOTEROL FUMARATE MOMETASONE FUROATE) DULERA (ORGANON LLC) APPROVAL= AP YEAR= 2010 , NDA 090506 (pdf 90506.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 205641 (label 205641.pdf) INN (MOMETASONE FUROATE) ASMANEX HFA (ORGANON LLC) APPROVAL= AP YEAR= 2014 , NDA 091161 (pdf 91161.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (APOTEX) APPROVAL= AP YEAR= 2016 , NDA 207989 (pdf 207989.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209310 (label 209310.pdf) INN (MOMETASONE FUROATE) SINUVA (INTERSECT ENT INC) APPROVAL= AP YEAR= 2017 , NDA 207899 (pdf 207899.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (TORRENT) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211746 (label 211746.pdf) INN (MOMETASONE FUROATE OLOPATADINE HYDROCHLORIDE) RYALTRIS (GLENMARK SPECLT) APPROVAL= AP YEAR= 2022 , NDA 215712 (label 215712.pdf) INN (MOMETASONE FUROATE) NASONEX 24HR ALLERGY (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2022 , NDA 217460 (pdf 217460.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215878 (pdf 215878.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , NDA 217438 (pdf 217438.pdf not found) INN (MOMETASONE FUROATE) MOMETASONE FUROATE (APOTEX) APPROVAL= AP YEAR= 2024 , 45 ; NIACINAMIDE ; 98-92-0 ; 1947 ; ; NATURAL MOLECULE C00000209 ; CLASS METABOLISM -- VITAMIN B3-- ENZYME COFACTOR-- ANTI-PELLAGRA -- ANTIPRURITIC -- ANTIMICROBIAL -- PHOTO-PROTECTIVE -- SEBOSTATIC , ; NDA 006071 (pdf 6071.pdf not found) INN (NIACINAMIDE) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008378 (pdf 8378.pdf not found) INN (NIACINAMIDE PYRIDOXINE HYDROCHLORIDE TYROSINE) TPN (INTL MINERALS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (NIACINAMIDE) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (NIACINAMIDE) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (NIACINAMIDE) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (NIACINAMIDE) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (NIACINAMIDE) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (NIACINAMIDE) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (NIACINAMIDE) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (NIACINAMIDE) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (NIACINAMIDE) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (NIACINAMIDE) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (NIACINAMIDE) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021646 (label 21646.pdf) INN (NIACINAMIDE) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , 46 ; PYRIDOXINE ; 65-23-6 ; 1947 ; ; NATURAL MOLECULE C00001551 ; CLASS METABOLISM -- ANTI-INFLAMMATORY AGENTS -- VITAMIN B6 , ; NDA 006071 (pdf 6071.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008378 (pdf 8378.pdf not found) INN (NIACINAMIDE PYRIDOXINE HYDROCHLORIDE TYROSINE) TPN (INTL MINERALS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (PYRIDOXINE HYDROCHLORIDE) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 010598 (pdf 10598.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BENDECTIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (PYRIDOXINE HYDROCHLORIDE) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (PYRIDOXINE) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (PYRIDOXINE) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (PYRIDOXINE HYDROCHLORIDE) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (PYRIDOXINE) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (PYRIDOXINE HYDROCHLORIDE) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (PYRIDOXINE HYDROCHLORIDE) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (PYRIDOXINE HYDROCHLORIDE) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021646 (label 21646.pdf) INN (PYRIDOXINE) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 080572 (pdf 80572.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080581 (pdf 80581.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 080618 (pdf 80618.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1972 , NDA 080669 (pdf 80669.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (LUITPOLD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080761 (pdf 80761.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080854 (pdf 80854.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) HEXA-BETALIN (LILLY) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083760 (pdf 83760.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083771 (pdf 83771.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083772 (pdf 83772.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (DELL LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087967 (pdf 87967.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021876 (label 21876.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DICLEGIS (DUCHESNAY) APPROVAL= AP YEAR= 2013 , NDA 204879 (pdf 204879.pdf not found) INN (PYRIDOXINE HYDROCHLORIDE) PYRIDOXINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205811 (label 205811.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 209661 (label 209661.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BONJESTA (DUCHESNAY) APPROVAL= AP YEAR= 2016 , NDA 208518 (pdf 208518.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 207825 (pdf 207825.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212472 (pdf 212472.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217000 (pdf 217000.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , 47 ; THIAMINE ; 59-43-8 ; 1947 ; ; NATURAL MOLECULE C00000775 ; CLASS METABOLISM -- ANTI-INFLAMMATORY AGENTS -- VITAMIN B1 , ; NDA 006071 (pdf 6071.pdf not found) INN (THIAMINE HYDROCHLORIDE) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (THIAMINE HYDROCHLORIDE) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (THIAMINE HYDROCHLORIDE) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (THIAMINE HYDROCHLORIDE) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (THIAMINE HYDROCHLORIDE) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (THIAMINE) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (THIAMINE) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (THIAMINE HYDROCHLORIDE) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (THIAMINE) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (THIAMINE HYDROCHLORIDE) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (THIAMINE HYDROCHLORIDE) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (THIAMINE HYDROCHLORIDE) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021646 (label 21646.pdf) INN (THIAMINE) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040079 (pdf 40079.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 080509 (pdf 80509.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080553 (pdf 80553.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080556 (pdf 80556.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1972 , NDA 080571 (pdf 80571.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1974 , NDA 080575 (pdf 80575.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1975 , NDA 080667 (pdf 80667.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (LUITPOLD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080712 (pdf 80712.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080718 (pdf 80718.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080770 (pdf 80770.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080853 (pdf 80853.pdf not found) INN (THIAMINE HYDROCHLORIDE) BETALIN S (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083534 (pdf 83534.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083775 (pdf 83775.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (DELL LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 087968 (pdf 87968.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 091623 (pdf 91623.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2012 , NDA 206106 (pdf 206106.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208703 (pdf 208703.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215692 (pdf 215692.pdf not found) INN (THIAMINE HYDROCHLORIDE) THIAMINE HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2023 , 48 ; ALPHA-TOCOPHEROL ; 59-02-9 ; 1953 ; ; NATURAL MOLECULE C00007366 ; CLASS METABOLISM -- ANTIOXIDANTS -- VITAMINS -- PROTECTS AGAINST FREE RADICAL DAMAGE , ; NDA 006071 (pdf 6071.pdf not found) INN (VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (RIBOFLAVIN) M.V.I.-12 (HOSPIRA) APPROVAL= AP YEAR= 1953 , NDA 018439 (pdf 18439.pdf not found) INN (VITAMIN A) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (VITAMIN A) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (PHYTONADIONE) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (VITAMIN A) M.V.I.-12 LYOPHILIZED (ASTRAZENECA) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (PANTOTHENIC ACID) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021625 (label 21625.pdf) INN (VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (VITAMIN K) M.V.I. ADULT (PHARMACY BULK PACKAGE) (HOSPIRA) APPROVAL= AP YEAR= 2004 , 49 ; DIENESTROL ; 84-17-3 ; 1947 ; DISCONTINUED ; ; CLASS GENITO -- ESTROGENIC -- ESTROGEN DEFICIENCY -- TREATMENT OF ATROPHIC VAGINITIS AND KRAUROSIS VULVAE , ; NDA 006110 (pdf 6110.pdf not found) INN (DIENESTROL) DIENESTROL (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 083517 (pdf 83517.pdf not found) INN (DIENESTROL) DV (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083518 (pdf 83518.pdf not found) INN (DIENESTROL) DV (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084436 (pdf 84436.pdf not found) INN (DIENESTROL) ESTRAGUARD (SOLVAY) APPROVAL= AP YEAR= 1975 DISCONTINUED , 50 ; METHADONE ; 76-99-3 ; 1947 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC OPIOID -- ANTITUSSIVE AGENTS -- ANTITUSSIVES NARCOTICS -- OPIOID RECEPTOR AGONISTS -- TREATMENT OF OPIOID ADDICTION -- NMDA ANTAGONIST , ; NDA 006134 (label 6134.pdf) INN (METHADONE HYDROCHLORIDE) DOLOPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006383 (label 6383.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 017058 (label 17058.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973 , NDA 017108 (pdf 17108.pdf not found) INN (METHADONE HYDROCHLORIDE) WESTADONE (SANDOZ) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017116 (label 17116.pdf) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1973 , NDA 021624 (label 21624.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1947 , NDA 040050 (pdf 40050.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 040088 (pdf 40088.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 1994 , NDA 040180 (pdf 40180.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 040241 (pdf 40241.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 1998 , NDA 040517 (pdf 40517.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 074081 (pdf 74081.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074184 (pdf 74184.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1993 , NDA 075082 (pdf 75082.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM) APPROVAL= AP YEAR= 1998 , NDA 077142 (pdf 77142.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2005 , NDA 087393 (label 87393.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1981 , NDA 087997 (label 87997.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 088108 (pdf 88108.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 , NDA 088109 (pdf 88109.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 , NDA 089897 (label 89897.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1988 , NDA 090635 (pdf 90635.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2009 , NDA 090707 (label 90707.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090065 (pdf 90065.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , NDA 203502 (pdf 203502.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2015 , NDA 208306 (pdf 208306.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208305 (pdf 208305.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210484 (pdf 210484.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211228 (pdf 211228.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 207368 (pdf 207368.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 207537 (pdf 207537.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 204166 (pdf 204166.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 2020 , NDA 212093 (pdf 212093.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 , NDA 212094 (pdf 212094.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , 51 ; PROPYLTHIOURACIL ; 51-52-5 ; 1947 ; ; ; CLASS HORMONES -- TREATMENT OF HYPERTHYROIDISM -- INHIBITS THE SYNTHESIS OF THYROID HORMONES , ; NDA 006188 (label 6188.pdf) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (ENDO OPERATIONS) APPROVAL= AP YEAR= 1947 , NDA 006213 (pdf 6213.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (LILLY) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 080015 (pdf 80015.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080016 (pdf 80016.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080154 (pdf 80154.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (QUAGEN) APPROVAL= AP YEAR= 1971 , NDA 080159 (pdf 80159.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080172 (pdf 80172.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1973 , NDA 080215 (pdf 80215.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (ANI PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080285 (pdf 80285.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (ANABOLIC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080840 (pdf 80840.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080932 (pdf 80932.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083982 (pdf 83982.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084075 (pdf 84075.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084543 (pdf 84543.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (CHARTWELL RX) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085201 (pdf 85201.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 208867 (pdf 208867.pdf not found) INN (PROPYLTHIOURACIL) PROPYLTHIOURACIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , 52 ; DIBUCAINE ; 85-79-0 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- LOCAL ANESTHETIC , ; NDA 006203 (pdf 6203.pdf not found) INN (DIBUCAINE HYDROCHLORIDE) HEAVY SOLUTION NUPERCAINE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 53 ; HEXACHLOROPHENE ; 70-30-4 ; 1949 ; ; ; CLASS DERMATOLOGICALS -- ANTI-INFECTIVE -- DETERGENT -- USE AS A SURGICAL SCRUB -- BACTERIOSTATIC CLEANSING AGENT , ; NDA 006270 (pdf 6270.pdf not found) INN (HEXACHLOROPHENE) GAMOPHEN (ARBROOK) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 006882 (pdf 6882.pdf not found) INN (HEXACHLOROPHENE) PHISOHEX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 008402 (pdf 8402.pdf not found) INN (HEXACHLOROPHENE) PHISOHEX (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017405 (pdf 17405.pdf not found) INN (HEXACHLOROPHENE) SOY-DOME (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017411 (pdf 17411.pdf not found) INN (HEXACHLOROPHENE) HEXA-GERM (HUNTINGTON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017412 (pdf 17412.pdf not found) INN (HEXACHLOROPHENE) GERMA-MEDICA (HUNTINGTON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 017413 (pdf 17413.pdf not found) INN (HEXACHLOROPHENE) SCRUBTEAM SURGICAL SPONGEBRUSH (3M) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017421 (pdf 17421.pdf not found) INN (HEXACHLOROPHENE) DIAL (DIAL) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017423 (pdf 17423.pdf not found) INN (HEXACHLOROPHENE) SEPTISOL (VESTAL LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017424 (pdf 17424.pdf not found) INN (HEXACHLOROPHENE) SEPTISOL (VESTAL LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017433 (pdf 17433.pdf not found) INN (HEXACHLOROPHENE) PRE-OP (DAVIS AND GECK) APPROVAL= AP YEAR= 1978 , NDA 017446 (pdf 17446.pdf not found) INN (HEXACHLOROPHENE) PHISO-SCRUB (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017452 (pdf 17452.pdf not found) INN (HEXACHLOROPHENE) E-Z SCRUB (BECTON DICKINSON) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017460 (pdf 17460.pdf not found) INN (HEXACHLOROPHENE) SEPTI-SOFT (CALGON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018363 (pdf 18363.pdf not found) INN (HEXACHLOROPHENE) HEXASCRUB (PROF DSPLS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018375 (pdf 18375.pdf not found) INN (HEXACHLOROPHENE) TURGEX (XTTRIUM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019055 (pdf 19055.pdf not found) INN (HEXACHLOROPHENE) TURGEX (XTTRIUM) APPROVAL= - YEAR= 0 DISCONTINUED , 54 ; DIMERCAPROL ; 59-52-9 ; 1946 ; ; ; CLASS VARIOUS -- CHELATING AGENT (AS, AU, HG ANTIDOTE) IN ACUTE POISONING , ; NDA 005939 (label 5939.pdf) INN (DIMERCAPROL) BAL (PROVEPHARM SAS) APPROVAL= AP YEAR= 1946 , 55 ; SULFAMERAZINE ; 127-79-7 ; 1949 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 006317 (pdf 6317.pdf not found) INN (SULFAMERAZINE) SULFONAMIDES DUPLEX (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006904 (pdf 6904.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TERFONYL (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006920 (pdf 6920.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFAS (LEDERLE) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 080013 (pdf 80013.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFOSE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080079 (pdf 80079.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFA-TRIPLE #2 (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080086 (pdf 80086.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080094 (pdf 80094.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFOID (PAL PAK) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 080099 (pdf 80099.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080100 (pdf 80100.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080123 (pdf 80123.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) LANTRISUL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080280 (pdf 80280.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , 56 ; SULFAMETHAZINE ; 57-68-1 ; 1949 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 006317 (pdf 6317.pdf not found) INN (SULFAMETHAZINE) NEOTRIZINE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006904 (pdf 6904.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TERFONYL (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006920 (pdf 6920.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFAS (LEDERLE) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 080013 (pdf 80013.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFOSE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080079 (pdf 80079.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFA-TRIPLE #2 (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080086 (pdf 80086.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080094 (pdf 80094.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFOID (PAL PAK) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 080099 (pdf 80099.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080100 (pdf 80100.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) SULFALOID (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080123 (pdf 80123.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) LANTRISUL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080280 (pdf 80280.pdf not found) INN (SULFADIAZINE SULFAMERAZINE SULFAMETHAZINE) TRIPLE SULFA (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , 57 ; ISOPROTERENOL ; 7683-59-2 ; 1948 ; ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- NON SELECTIVE BETA ADRENERGIC RECEPTOR AGONIST -- SYMPATHOMIMETIC AMINE , ; NDA 006327 (pdf 6327.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006328 (pdf 6328.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 006905 (pdf 6905.pdf not found) INN (ISOPROTERENOL SULFATE) NORISODRINE (ABBVIE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 007245 (pdf 7245.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) AEROLONE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 010375 (pdf 10375.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (3M) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 010515 (label 10515.pdf) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (BAUSCH) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 011178 (pdf 11178.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 013296 (pdf 13296.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE PHENYLEPHRINE BITARTRATE) DUO-MEDIHALER (3M) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 016813 (pdf 16813.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) VAPO-ISO (FISONS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016814 (pdf 16814.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) NORISODRINE AEROTROL (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017366 (pdf 17366.pdf not found) INN (ACETYLCYSTEINE ISOPROTERENOL HYDROCHLORIDE) MUCOMYST W/ ISOPROTERENOL (MEAD JOHNSON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083283 (pdf 83283.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083346 (pdf 83346.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083431 (pdf 83431.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083486 (pdf 83486.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083724 (pdf 83724.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085540 (pdf 85540.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085904 (pdf 85904.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085994 (pdf 85994.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086764 (pdf 86764.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087935 (pdf 87935.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ARMOUR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087936 (pdf 87936.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ARMOUR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 206961 (pdf 206961.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (NEXUS) APPROVAL= AP YEAR= 2017 , NDA 210106 (pdf 210106.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 210322 (pdf 210322.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210576 (pdf 210576.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211738 (pdf 211738.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210845 (pdf 210845.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 211237 (pdf 211237.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMRING PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211864 (pdf 211864.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 212189 (pdf 212189.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 212573 (pdf 212573.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214775 (pdf 214775.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215542 (pdf 215542.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PENN LIFE) APPROVAL= AP YEAR= 2022 , NDA 211703 (pdf 211703.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215557 (pdf 215557.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , 58 ; ISOPROTERENOL ; 7683-59-2 ; 1948 ; ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- NON SELECTIVE BETA ADRENERGIC RECEPTOR AGONIST -- SYMPATHOMIMETIC AMINE , ; NDA 006327 (pdf 6327.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 006328 (pdf 6328.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 006905 (pdf 6905.pdf not found) INN (ISOPROTERENOL SULFATE) NORISODRINE (ABBVIE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 007245 (pdf 7245.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) AEROLONE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 010375 (pdf 10375.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (3M) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 010515 (label 10515.pdf) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (BAUSCH) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 011178 (pdf 11178.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISUPREL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 013296 (pdf 13296.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE PHENYLEPHRINE BITARTRATE) DUO-MEDIHALER (3M) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 016813 (pdf 16813.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) VAPO-ISO (FISONS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016814 (pdf 16814.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) NORISODRINE AEROTROL (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017366 (pdf 17366.pdf not found) INN (ACETYLCYSTEINE ISOPROTERENOL HYDROCHLORIDE) MUCOMYST W/ ISOPROTERENOL (MEAD JOHNSON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083283 (pdf 83283.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083346 (pdf 83346.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083431 (pdf 83431.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083486 (pdf 83486.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083724 (pdf 83724.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085540 (pdf 85540.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085904 (pdf 85904.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085994 (pdf 85994.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086764 (pdf 86764.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087935 (pdf 87935.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ARMOUR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087936 (pdf 87936.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ARMOUR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 206961 (pdf 206961.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (NEXUS) APPROVAL= AP YEAR= 2017 , NDA 210106 (pdf 210106.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 210322 (pdf 210322.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210576 (pdf 210576.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211738 (pdf 211738.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210845 (pdf 210845.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 211237 (pdf 211237.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AMRING PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211864 (pdf 211864.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 212189 (pdf 212189.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 212573 (pdf 212573.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214775 (pdf 214775.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215542 (pdf 215542.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (PENN LIFE) APPROVAL= AP YEAR= 2022 , NDA 211703 (pdf 211703.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215557 (pdf 215557.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE) ISOPROTERENOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , 59 ; TOLAZOLINE ; 59-98-3 ; 1948 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ADRENERGIC ALPHA ANTAGONISTS -- ANTIHYPERTENSIVE AGENTS , ; NDA 006403 (pdf 6403.pdf not found) INN (TOLAZOLINE HYDROCHLORIDE) PRISCOLINE (NOVARTIS) APPROVAL= AP YEAR= 1948 DISCONTINUED , 60 ; DOXYLAMINE ; 469-21-6 ; 1948 ; ; ; CLASS RESPIRATORY -- ANTIHISTAMINIC -- HYPNOTIC -- ANTI-ALLERGIC AGENTS -- ANTIEMETICS -- ANTITUSSIVE AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 006412 (pdf 6412.pdf not found) INN (DOXYLAMINE SUCCINATE) DECAPRYN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1948 NEWMOLECULARENTITY DISCONTINUED , NDA 010598 (pdf 10598.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BENDECTIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 018066 (label 18066.pdf) INN (DOXYLAMINE SUCCINATE) UNISOM (CHATTEM) APPROVAL= AP YEAR= 1978 , NDA 019440 (pdf 19440.pdf not found) INN (DOXYLAMINE SUCCINATE) UNISOM (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040167 (pdf 40167.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (PERRIGO) APPROVAL= AP YEAR= 1996 , NDA 040564 (pdf 40564.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (LNK) APPROVAL= AP YEAR= 2004 , NDA 070156 (pdf 70156.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXY-SLEEP-AID (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088603 (pdf 88603.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088900 (pdf 88900.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (COPLEY PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 021876 (label 21876.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DICLEGIS (DUCHESNAY) APPROVAL= AP YEAR= 2013 , NDA 205811 (label 205811.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 209661 (label 209661.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BONJESTA (DUCHESNAY) APPROVAL= AP YEAR= 2016 , NDA 208518 (pdf 208518.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (PAR PHARM INC) APPROVAL= AP YEAR= 2017 , NDA 207825 (pdf 207825.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212472 (pdf 212472.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217000 (pdf 217000.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , 61 ; AMODIAQUINE ; 86-42-0 ; 0 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS , ; NDA 006441 (pdf 6441.pdf not found) INN (AMODIAQUINE HYDROCHLORIDE) CAMOQUIN HYDROCHLORIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 62 ; DIETHYLCARBAMAZINE ; 90-89-1 ; 1950 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- FILARICIDES -- INTERFERES WITH CYCLOOXYGENASE AND LIPOXYGENASE PATHWAYS , ; NDA 006459 (pdf 6459.pdf not found) INN (DIETHYLCARBAMAZINE CITRATE) HETRAZAN (LEDERLE) APPROVAL= AP YEAR= 1950 DISCONTINUED , 63 ; LIDOCAINE ; 137-58-6 ; 1948 ; ; ; CLASS CARDIOVASCULAR -- ANESTHETIC (LOCAL) -- ANTIARRHYTHMIC , ; NDA 006488 (label 6488.pdf) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1948 , NDA 008048 (pdf 8048.pdf not found) INN (LIDOCAINE) XYLOCAINE (ASTRAZENECA) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008816 (label 8816.pdf) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 009470 (label 9470.pdf) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE VISCOUS (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 010417 (label 10417.pdf) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE 4% PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 010418 (pdf 10418.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE (ASTRAZENECA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 010496 (pdf 10496.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE 5% W/ GLUCOSE 7.5% (ASTRAZENECA) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 013077 (pdf 13077.pdf not found) INN (LIDOCAINE) XYLOCAINE (ASTRAZENECA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 013334 (pdf 13334.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE LIDOCAINE HYDROCHLORIDE) DECADRON W/ XYLOCAINE (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 014127 (pdf 14127.pdf not found) INN (LIDOCAINE) XYLOCAINE (ASTRAZENECA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 014394 (pdf 14394.pdf not found) INN (LIDOCAINE) XYLOCAINE (ASTRAZENECA) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 016297 (pdf 16297.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE 1.5% W/ DEXTROSE 7.5% (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016801 (pdf 16801.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 017508 (pdf 17508.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017549 (pdf 17549.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOPEN (MERIDIAN MEDCL TECHN) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017584 (pdf 17584.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1976 , NDA 017701 (pdf 17701.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017702 (pdf 17702.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 018388 (label 18388.pdf) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018461 (label 18461.pdf) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 , NDA 018543 (pdf 18543.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018885 (pdf 18885.pdf not found) INN (DIHYDROERGOTAMINE MESYLATE HEPARIN SODIUM LIDOCAINE HYDROCHLORIDE) EMBOLEX (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018954 (pdf 18954.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER (ABBOTT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018967 (pdf 18967.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019830 (label 19830.pdf) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1992 , NDA 019941 (label 19941.pdf) INN (LIDOCAINE PRILOCAINE) EMLA (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020530 (pdf 20530.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) IONTOCAINE (IOMED) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020575 (pdf 20575.pdf not found) INN (LIDOCAINE) DENTIPATCH (NOVEN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020612 (label 20612.pdf) INN (LIDOCAINE) LIDODERM (TEIKOKU PHARMA USA) APPROVAL= AP YEAR= 1999 , NDA 020962 (pdf 20962.pdf not found) INN (LIDOCAINE PRILOCAINE) EMLA (ASTRAZENECA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021380 (label 21380.pdf) INN (LIDOCAINE HYDROCHLORIDE) XYLOCAINE DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 021381 (label 21381.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) XYLOCAINE DENTAL WITH EPINEPHRINE (DENTSPLY PHARM) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 021451 (label 21451.pdf) INN (LIDOCAINE PRILOCAINE) ORAQIX (DENTSPLY PHARM) APPROVAL= AP YEAR= 2003 , NDA 021486 (label 21486.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EMPI) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021496 (label 21496.pdf) INN (BUPIVACAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE) DUOCAINE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021504 (label 21504.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOSITE TOPICAL SYSTEM KIT (VYTERIS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021623 (label 21623.pdf) INN (LIDOCAINE TETRACAINE) SYNERA (GALEN SPECIALTY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021717 (label 21717.pdf) INN (LIDOCAINE TETRACAINE) PLIAGLIS (TARO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 022114 (label 22114.pdf) INN (LIDOCAINE HYDROCHLORIDE) ZINGO (POWDER PHARMS) APPROVAL= AP YEAR= 2007 , NDA 040013 (pdf 40013.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040014 (pdf 40014.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040057 (pdf 40057.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EASTMAN KODAK) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 040078 (pdf 40078.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 , NDA 040302 (pdf 40302.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1998 , NDA 040433 (pdf 40433.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (SENTISS) APPROVAL= AP YEAR= 2003 , NDA 040708 (pdf 40708.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE VISCOUS (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 , NDA 040710 (pdf 40710.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2007 , NDA 050585 (label 50585.pdf) INN (CEFTRIAXONE SODIUM LIDOCAINE) ROCEPHIN KIT (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 060567 (pdf 60567.pdf not found) INN (LIDOCAINE HYDROCHLORIDE OXYTETRACYCLINE) TERRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 062499 (pdf 62499.pdf not found) INN (BACITRACIN ZINC LIDOCAINE NEOMYCIN SULFATE POLYMYXIN B SULFATE) LANABIOTIC (COMBE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 076290 (pdf 76290.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (HIKMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076320 (pdf 76320.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ENCUBE) APPROVAL= AP YEAR= 2003 , NDA 076453 (pdf 76453.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 078772 (pdf 78772.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080198 (pdf 80198.pdf not found) INN (LIDOCAINE) LIDOCAINE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1972 , NDA 080210 (pdf 80210.pdf not found) INN (LIDOCAINE) LIDOCAINE (BELMORA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080377 (pdf 80377.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080390 (pdf 80390.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (LYPHOMED) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 080404 (pdf 80404.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1971 OBSOLETE , NDA 080406 (pdf 80406.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080407 (pdf 80407.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1972 , NDA 080408 (pdf 80408.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1972 , NDA 080409 (pdf 80409.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LTA II KIT (HOSPIRA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080414 (pdf 80414.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (MILES) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080420 (pdf 80420.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080429 (pdf 80429.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) ANESTACON (BIONPHARMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080504 (pdf 80504.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (BELMORA LLC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080710 (pdf 80710.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080757 (pdf 80757.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080760 (pdf 80760.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080820 (pdf 80820.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080850 (pdf 80850.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 081318 (pdf 81318.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 083083 (pdf 83083.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083135 (pdf 83135.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (GD SEARLE LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083154 (pdf 83154.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (ABBOTT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083158 (pdf 83158.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1972 , NDA 083173 (pdf 83173.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1975 , NDA 083198 (pdf 83198.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083387 (pdf 83387.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083388 (pdf 83388.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083389 (pdf 83389.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083390 (pdf 83390.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083627 (pdf 83627.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083914 (pdf 83914.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% (HOSPIRA) APPROVAL= AP YEAR= 1974 , NDA 084048 (pdf 84048.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) OCTOCAINE (SEPTODONT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 084625 (pdf 84625.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084626 (pdf 84626.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084720 (pdf 84720.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE (CARLISLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084721 (pdf 84721.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) ALPHACAINE HYDROCHLORIDE (CARLISLE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084727 (pdf 84727.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCATON (PHARMATON) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084728 (pdf 84728.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCATON (PHARMATON) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084729 (pdf 84729.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCATON (PHARMATON) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084732 (pdf 84732.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE (CARLISLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084944 (pdf 84944.pdf not found) INN (LIDOCAINE) ALPHACAINE (CARLISLE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084946 (pdf 84946.pdf not found) INN (LIDOCAINE) ALPHACAINE (CARLISLE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084947 (pdf 84947.pdf not found) INN (LIDOCAINE) ALPHACAINE (CARLISLE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085037 (pdf 85037.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085131 (pdf 85131.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085463 (pdf 85463.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085995 (pdf 85995.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) PEDIATRIC LTA KIT (HOSPIRA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086283 (pdf 86283.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1979 , NDA 086364 (pdf 86364.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LARYNG-O-JET KIT (INTL MEDICATION) APPROVAL= AP YEAR= 1980 , NDA 086389 (pdf 86389.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE VISCOUS (INTL MEDICATION) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086402 (pdf 86402.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (INTL MEDICATION) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086578 (pdf 86578.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE VISCOUS (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086724 (pdf 86724.pdf not found) INN (LIDOCAINE) LIDOCAINE (TARO) APPROVAL= AP YEAR= 1981 , NDA 086761 (pdf 86761.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087872 (pdf 87872.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1982 , NDA 087881 (pdf 87881.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1982 , NDA 087931 (pdf 87931.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LARYNGOTRACHEAL ANESTHESIA KIT (KENDALL IL) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087980 (pdf 87980.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ABBOTT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088294 (pdf 88294.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088295 (pdf 88295.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088299 (pdf 88299.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088325 (pdf 88325.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088326 (pdf 88326.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088327 (pdf 88327.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088328 (pdf 88328.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088329 (pdf 88329.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 088330 (pdf 88330.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088331 (pdf 88331.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088367 (pdf 88367.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088368 (pdf 88368.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088389 (pdf 88389.pdf not found) INN (EPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE) LIGNOSPAN FORTE (DEPROCO) APPROVAL= AP YEAR= 1986 , NDA 088390 (pdf 88390.pdf not found) INN (EPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE) LIGNOSPAN STANDARD (DEPROCO) APPROVAL= AP YEAR= 1985 , NDA 088542 (pdf 88542.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LTA II KIT (HOSPIRA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088571 (pdf 88571.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1985 , NDA 088572 (pdf 88572.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) PEDIATRIC LTA KIT (ABBOTT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088586 (pdf 88586.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1985 , NDA 088802 (pdf 88802.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE VISCOUS (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 088803 (pdf 88803.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 089362 (pdf 89362.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ABBOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089635 (pdf 89635.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089644 (pdf 89644.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089645 (pdf 89645.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089646 (pdf 89646.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089649 (pdf 89649.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089650 (pdf 89650.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089651 (pdf 89651.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089688 (pdf 89688.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (PACO) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 022221 (label 22221.pdf) INN (LIDOCAINE HYDROCHLORIDE) AKTEN (THEA PHARMA) APPROVAL= AP YEAR= 2008 , NDA 090665 (pdf 90665.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091058 (pdf 91058.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091056 (pdf 91056.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040837 (pdf 40837.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 040911 (pdf 40911.pdf not found) INN (LIDOCAINE) LIDOCAINE (SEPTODONT INC) APPROVAL= AP YEAR= 2011 , NDA 200675 (pdf 200675.pdf not found) INN (LIDOCAINE) LIDOCAINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2012 , NDA 203040 (pdf 203040.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 203082 (pdf 203082.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 201094 (pdf 201094.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) GLYDO (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 202242 (pdf 202242.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204494 (pdf 204494.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2014 , NDA 091564 (pdf 91564.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202346 (pdf 202346.pdf not found) INN (LIDOCAINE) LIDOCAINE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2015 , NDA 206297 (pdf 206297.pdf not found) INN (LIDOCAINE) LIDOCAINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205318 (pdf 205318.pdf not found) INN (LIDOCAINE) LIDOCAINE (ENCUBE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206498 (pdf 206498.pdf not found) INN (LIDOCAINE) LIDOCAINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207810 (pdf 207810.pdf not found) INN (LIDOCAINE) LIDOCAINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207182 (pdf 207182.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208604 (pdf 208604.pdf not found) INN (LIDOCAINE) LIDOCAINE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208822 (pdf 208822.pdf not found) INN (LIDOCAINE) LIDOCAINE (VITRUVIAS THERAP) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207962 (label 207962.pdf) INN (LIDOCAINE) ZTLIDO (SCILEX PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208017 (pdf 208017.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (SPECTRA MDCL DEVICES) APPROVAL= AP YEAR= 2018 , NDA 210256 (pdf 210256.pdf not found) INN (LIDOCAINE) LIDOCAINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205887 (pdf 205887.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208474 (pdf 208474.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2018 , NDA 210958 (pdf 210958.pdf not found) INN (LIDOCAINE) LIDOCAINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211019 (pdf 211019.pdf not found) INN (LIDOCAINE) LIDOCAINE (COSETTE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211469 (pdf 211469.pdf not found) INN (LIDOCAINE) LIDOCAINE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 212486 (pdf 212486.pdf not found) INN (LIDOCAINE) LIDOCAINE (AILEX PHARMS LLC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209190 (pdf 209190.pdf not found) INN (LIDOCAINE) LIDOCAINE (IBSA) APPROVAL= AP YEAR= 2020 , NDA 211697 (pdf 211697.pdf not found) INN (LIDOCAINE) LIDOCAINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 212821 (pdf 212821.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (HUONS) APPROVAL= AP YEAR= 2020 , NDA 203265 (pdf 203265.pdf not found) INN (LIDOCAINE) LIDOCAINE (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206463 (pdf 206463.pdf not found) INN (LIDOCAINE) LIDOCAINE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 213253 (pdf 213253.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 205882 (pdf 205882.pdf not found) INN (LIDOCAINE) LIDOCAINE (NAL PHARM) APPROVAL= AP YEAR= 2021 , NDA 208660 (pdf 208660.pdf not found) INN (LIDOCAINE) LIDOCAINE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 212695 (pdf 212695.pdf not found) INN (LIDOCAINE) LIDOCAINE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 208475 (pdf 208475.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2021 , NDA 212482 (pdf 212482.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PADAGIS US) APPROVAL= AP YEAR= 2021 , NDA 214336 (pdf 214336.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2021 , NDA 214339 (pdf 214339.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2021 , NDA 213923 (pdf 213923.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 214269 (pdf 214269.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (SINTETICA US) APPROVAL= AP YEAR= 2022 , NDA 215132 (pdf 215132.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (AFAXYS) APPROVAL= AP YEAR= 2022 , NDA 216250 (pdf 216250.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214267 (pdf 214267.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (SINTETICA US) APPROVAL= AP YEAR= 2022 , NDA 216780 (pdf 216780.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 217692 (pdf 217692.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217693 (pdf 217693.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 218182 (pdf 218182.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2023 , NDA 217117 (pdf 217117.pdf not found) INN (LIDOCAINE) LIDOCAINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 218138 (pdf 218138.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE VISCOUS (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2024 , NDA 218411 (pdf 218411.pdf not found) INN (LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE (THE J MOLNER) APPROVAL= AP YEAR= 2024 , 64 ; EPINEPHRINE ; 51-43-4 ; 1948 ; ; NATURAL MOLECULE C00029643 ; CLASS METABOLISM -- ADRENERGIC AGONISTS -- BRONCHODILATOR AGENTS -- MYDRIATICS -- SYMPATHOMIMETICS -- VASOCONSTRICTOR AGENTS -- EMERGENCY TREATMENT OF SEVERE ALLERGIC REACTIONS , ; NDA 006488 (label 6488.pdf) INN (EPINEPHRINE) XYLOCAINE W/ EPINEPHRINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1948 , NDA 007942 (pdf 7942.pdf not found) INN (EPINEPHRINE) SUS-PHRINE SULFITE FREE (FOREST LABS) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 010374 (pdf 10374.pdf not found) INN (EPINEPHRINE BITARTRATE) MEDIHALER-EPI (3M) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 010418 (pdf 10418.pdf not found) INN (EPINEPHRINE) XYLOCAINE W/ EPINEPHRINE (ASTRAZENECA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 014763 (pdf 14763.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE (ASTRAZENECA) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 016126 (label 16126.pdf) INN (EPINEPHRINE BITARTRATE) BRONITIN MIST (WYETH CONS) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016803 (pdf 16803.pdf not found) INN (EPINEPHRINE) BRONKAID MIST (STERLING) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 016964 (label 16964.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) MARCAINE HYDROCHLORIDE W/ EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 017751 (pdf 17751.pdf not found) INN (EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDE) DURANEST (ASTRAZENECA) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 018304 (label 18304.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1981 , NDA 019430 (label 19430.pdf) INN (EPINEPHRINE) EPIPEN (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1987 , NDA 020530 (pdf 20530.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) IONTOCAINE (IOMED) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020800 (label 20800.pdf) INN (EPINEPHRINE) TWINJECT 0.3 (IMPAX) APPROVAL= AP YEAR= 2003 , NDA 020971 (label 20971.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2000 , NDA 021381 (label 21381.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) XYLOCAINE DENTAL WITH EPINEPHRINE (DENTSPLY PHARM) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 021383 (label 21383.pdf) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1965 , NDA 021384 (pdf 21384.pdf not found) INN (EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDE) DURANEST (DENTSPLY PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 021486 (label 21486.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EMPI) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021504 (label 21504.pdf) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOSITE TOPICAL SYSTEM KIT (VYTERIS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022010 (pdf 22010.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2006 , NDA 022046 (label 22046.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 040057 (pdf 40057.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (EASTMAN KODAK) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 070966 (pdf 70966.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 070967 (pdf 70967.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 070968 (pdf 70968.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 071165 (label 71165.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071166 (pdf 71166.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071167 (pdf 71167.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071168 (label 71168.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071169 (pdf 71169.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071170 (pdf 71170.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071171 (pdf 71171.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 077250 (pdf 77250.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) VIVACAINE (SEPTODONT) APPROVAL= AP YEAR= 2006 , NDA 078772 (pdf 78772.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080377 (pdf 80377.pdf not found) INN (EPINEPHRINE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080406 (pdf 80406.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080504 (pdf 80504.pdf not found) INN (EPINEPHRINE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (BELMORA LLC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080757 (pdf 80757.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080758 (pdf 80758.pdf not found) INN (EPINEPHRINE PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080759 (pdf 80759.pdf not found) INN (EPINEPHRINE PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080820 (pdf 80820.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083154 (pdf 83154.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (ABBOTT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083389 (pdf 83389.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083390 (pdf 83390.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (DELL LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084048 (pdf 84048.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) OCTOCAINE (SEPTODONT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 084720 (pdf 84720.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE (CARLISLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084728 (pdf 84728.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCATON (PHARMATON) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084729 (pdf 84729.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCATON (PHARMATON) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084732 (pdf 84732.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE (CARLISLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085463 (pdf 85463.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086402 (pdf 86402.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE (INTL MEDICATION) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087907 (pdf 87907.pdf not found) INN (EPINEPHRINE) EPINEPHRINE (ARMSTRONG PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088389 (pdf 88389.pdf not found) INN (EPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE) LIGNOSPAN FORTE (DEPROCO) APPROVAL= AP YEAR= 1986 , NDA 088390 (pdf 88390.pdf not found) INN (EPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE) LIGNOSPAN STANDARD (DEPROCO) APPROVAL= AP YEAR= 1985 , NDA 088571 (pdf 88571.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1985 , NDA 089635 (pdf 89635.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089644 (pdf 89644.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089645 (pdf 89645.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089646 (pdf 89646.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 089649 (pdf 89649.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089650 (pdf 89650.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089651 (pdf 89651.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 022466 (label 22466.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ORABLOC (PIERREL) APPROVAL= AP YEAR= 2010 , NDA 079138 (pdf 79138.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078959 (pdf 78959.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (SEPTODONT INC) APPROVAL= AP YEAR= 2011 , NDA 201739 (label 201739.pdf) INN (EPINEPHRINE) AUVI-Q (KALEO INC) APPROVAL= AP YEAR= 2012 , NDA 204200 (label 204200.pdf) INN (EPINEPHRINE) ADRENALIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 204640 (label 204640.pdf) INN (EPINEPHRINE) ADRENALIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 , NDA 205029 (label 205029.pdf) INN (EPINEPHRINE) EPINEPHRINE (BPI LABS) APPROVAL= AP YEAR= 2014 , NDA 201750 (pdf 201750.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN FORTE (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 201751 (label 201751.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207534 (label 207534.pdf) INN (EPINEPHRINE) SYMJEPI (ADAMIS PHARMS CORP) APPROVAL= AP YEAR= 2017 , NDA 209359 (label 209359.pdf) INN (EPINEPHRINE) EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 2019 , NDA 090589 (pdf 90589.pdf not found) INN (EPINEPHRINE) EPINEPHRINE AUTOINJECTOR (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 205920 (label 205920.pdf) INN (EPINEPHRINE) PRIMATENE MIST (ARMSTRONG PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207568 (pdf 207568.pdf not found) INN (EPINEPHRINE) EPINEPHRINE (AM REGENT) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211880 (pdf 211880.pdf not found) INN (EPINEPHRINE) EPINEPHRINE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2020 , NDA 208908 (pdf 208908.pdf not found) INN (EPINEPHRINE) EPINEPHRINE (HOSPIRA INC) APPROVAL= TA YEAR= 2021 , NDA 208475 (pdf 208475.pdf not found) INN (EPINEPHRINE LIDOCAINE HYDROCHLORIDE) LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2021 , NDA 211363 (label 211363.pdf) INN (EPINEPHRINE) EPINEPHRINE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2022 , NDA 215875 (label 215875.pdf) INN (EPINEPHRINE) ADRENALIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , 65 ; SULFISOXAZOLE ; 127-69-5 ; 1948 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- TREATMENT OF URINARY TRACT INFECTIONS -- SULFONAMIDES , ; NDA 006525 (pdf 6525.pdf not found) INN (SULFISOXAZOLE) GANTRISIN (ROCHE) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 006917 (pdf 6917.pdf not found) INN (SULFISOXAZOLE DIOLAMINE) GANTRISIN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 007757 (pdf 7757.pdf not found) INN (SULFISOXAZOLE DIOLAMINE) GANTRISIN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008414 (pdf 8414.pdf not found) INN (SULFISOXAZOLE DIOLAMINE) GANTRISIN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019358 (pdf 19358.pdf not found) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE) AZO GANTRISIN (ROCHE) APPROVAL= AP YEAR= 1990 NEWAPPLICATION DISCONTINUED , NDA 080036 (pdf 80036.pdf not found) INN (SULFISOXAZOLE) SOSOL (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080040 (pdf 80040.pdf not found) INN (SULFISOXAZOLE) SULSOXIN (SOLVAY) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080082 (pdf 80082.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080085 (pdf 80085.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080087 (pdf 80087.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080109 (pdf 80109.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080142 (pdf 80142.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (ANI PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080189 (pdf 80189.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080268 (pdf 80268.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080366 (pdf 80366.pdf not found) INN (SULFISOXAZOLE) SOXAZOLE (ALRA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080379 (pdf 80379.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (WEST WARD) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084031 (pdf 84031.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084148 (pdf 84148.pdf not found) INN (SULFISOXAZOLE DIOLAMINE) SULFISOXAZOLE DIOLAMINE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084385 (pdf 84385.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (PHARMERAL) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 084955 (pdf 84955.pdf not found) INN (SULFISOXAZOLE) SULFALAR (PARKE DAVIS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085534 (pdf 85534.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085628 (pdf 85628.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (RISING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087332 (pdf 87332.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (VITARINE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087649 (pdf 87649.pdf not found) INN (SULFISOXAZOLE) SULFISOXAZOLE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , 66 ; SULFISOXAZOLE ACETYL ; 80-74-0 ; 1953 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- TREATMENT OF URINARY TRACT INFECTIONS -- SULFONAMIDES , ; NDA 009182 (pdf 9182.pdf not found) INN (SULFISOXAZOLE ACETYL) GANTRISIN (ROCHE) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 050529 (pdf 50529.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) PEDIAZOLE (ROSS LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 050599 (pdf 50599.pdf not found) INN (ERYTHROMYCIN ESTOLATE SULFISOXAZOLE ACETYL) ILOSONE SULFA (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062758 (pdf 62758.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) ERYZOLE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062759 (pdf 62759.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , 67 ; SULFANILAMIDE ; 63-74-1 ; 1965 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- SULFONAMIDE ANCHORS ARE COORDINATED TO THE ACTIVE SITE METAL ION OF THE ZINC ENZYME CARBONIC ANHYDRASE (CA, EC 4.2.1.1) (PMID17251017) , ; NDA 006530 (label 6530.pdf) INN (SULFANILAMIDE) AVC (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 088718 (pdf 88718.pdf not found) INN (SULFANILAMIDE) SULFANILAMIDE (COSETTE) APPROVAL= AP YEAR= 1985 DISCONTINUED , 68 ; BETHANECHOL ; 590-63-6 ; 1948 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINERGIC -- MUSCARINIC AGONISTS -- PARASYMPATHOMIMETICS -- TREATMENT OF URINARY RETENTION , ; NDA 006536 (pdf 6536.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 040483 (pdf 40483.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040485 (pdf 40485.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040492 (pdf 40492.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040509 (pdf 40509.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040518 (pdf 40518.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040532 (pdf 40532.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040533 (pdf 40533.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040534 (pdf 40534.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040551 (pdf 40551.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040552 (pdf 40552.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040553 (pdf 40553.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040554 (pdf 40554.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040633 (pdf 40633.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040634 (pdf 40634.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040635 (pdf 40635.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040636 (pdf 40636.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040677 (pdf 40677.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040678 (pdf 40678.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040703 (pdf 40703.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT HOLDINGS INC) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040704 (pdf 40704.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040721 (pdf 40721.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040725 (pdf 40725.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040726 (pdf 40726.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040727 (pdf 40727.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040728 (pdf 40728.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 040739 (pdf 40739.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040740 (pdf 40740.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040741 (pdf 40741.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040855 (pdf 40855.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 2007 , NDA 084074 (pdf 84074.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084188 (pdf 84188.pdf not found) INN (BETHANECHOL CHLORIDE) MYOTONACHOL (GLENWOOD) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084353 (pdf 84353.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084378 (pdf 84378.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084379 (pdf 84379.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084383 (pdf 84383.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084384 (pdf 84384.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084402 (pdf 84402.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084408 (pdf 84408.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084441 (pdf 84441.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084689 (pdf 84689.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084702 (pdf 84702.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084712 (pdf 84712.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085228 (pdf 85228.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085229 (pdf 85229.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085230 (pdf 85230.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085839 (pdf 85839.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085841 (pdf 85841.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085842 (pdf 85842.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085882 (pdf 85882.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 086262 (pdf 86262.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 086263 (pdf 86263.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 087397 (pdf 87397.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087444 (pdf 87444.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088288 (pdf 88288.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088289 (pdf 88289.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088440 (pdf 88440.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088441 (pdf 88441.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089095 (pdf 89095.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089096 (pdf 89096.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089815 (pdf 89815.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040897 (pdf 40897.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091256 (pdf 91256.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , 69 ; CAFFEINE ; 58-08-2 ; 1948 ; ; NATURAL MOLECULE C00001492 NPA007904 ; CLASS NERVOUS SYSTEM -- STIMULANT , ; NDA 006620 (pdf 6620.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (NOVARTIS) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 009000 (label 9000.pdf) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (NOVARTIS) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 010996 (pdf 10996.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) DARVON COMPOUND (XANODYNE PHARM) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011483 (label 11483.pdf) INN (ASPIRIN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 013416 (label 13416.pdf) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) NORGESIC (BAUSCH) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 017534 (label 17534.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE) FIORINAL (ALLERGAN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 019429 (label 19429.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORINAL W/CODEINE (ALLERGAN) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020232 (label 20232.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORICET W/ CODEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1992 , NDA 020793 (label 20793.pdf) INN (CAFFEINE CITRATE) CAFCIT (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 020802 (label 20802.pdf) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) EXCEDRIN MIGRAINE RELIEF (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1998 , NDA 040085 (pdf 40085.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040109 (pdf 40109.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040261 (label 40261.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040267 (pdf 40267.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040316 (pdf 40316.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040336 (pdf 40336.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040387 (pdf 40387.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2003 , NDA 040390 (pdf 40390.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040394 (pdf 40394.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040496 (pdf 40496.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040510 (pdf 40510.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) ERGOTAMINE TARTRATE AND CAFFEINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040511 (pdf 40511.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 , NDA 040513 (pdf 40513.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040590 (pdf 40590.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) ERGOTAMINE TARTRATE AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2005 , NDA 040601 (pdf 40601.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040637 (pdf 40637.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WEST-WARD PHARM CORP) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040688 (pdf 40688.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WRASER PHARMS LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040701 (pdf 40701.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (BOCA PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 074359 (pdf 74359.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074654 (pdf 74654.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074817 (pdf 74817.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) INVAGESIC (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074911 (pdf 74911.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) PHRENILIN WITH CAFFEINE AND CODEINE (VALEANT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 074951 (pdf 74951.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STEVENS J) APPROVAL= AP YEAR= 1998 , NDA 074988 (pdf 74988.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (STEVENS J) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075141 (pdf 75141.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENGESIC (GALT PHARMS) APPROVAL= AP YEAR= 1998 , NDA 075231 (pdf 75231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075351 (pdf 75351.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075618 (pdf 75618.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075794 (pdf 75794.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (PERRIGO) APPROVAL= AP YEAR= 2001 , NDA 075929 (pdf 75929.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076528 (pdf 76528.pdf not found) INN (BUTALBITAL ACETAMINOPHEN CAFFEINE CODEINE PHOSPHATE) BUTALBITAL ACETAMINOPHEN CAFFEINE CODEINE (ABLE) APPROVAL= AP YEAR= 2003 , NDA 076560 (pdf 76560.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2004 , NDA 077233 (pdf 77233.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (EXELA PHARMA SCIENCE) APPROVAL= AP YEAR= 2006 , NDA 077304 (pdf 77304.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (EXELA PHARMA) APPROVAL= AP YEAR= 2006 , NDA 077906 (pdf 77906.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (AM REGENT) APPROVAL= AP YEAR= 2007 , NDA 077997 (pdf 77997.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 078002 (pdf 78002.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 078149 (pdf 78149.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2007 , NDA 080044 (pdf 80044.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (SANDOZ) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 083077 (pdf 83077.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083101 (pdf 83101.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND-65 (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084294 (pdf 84294.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084553 (pdf 84553.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) COMPOUND 65 (ALRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085441 (pdf 85441.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (IVAX PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085732 (pdf 85732.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086162 (pdf 86162.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086231 (pdf 86231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086237 (pdf 86237.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086398 (pdf 86398.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086557 (pdf 86557.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) MIGERGOT (COSETTE) APPROVAL= AP YEAR= 1983 , NDA 086562 (pdf 86562.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) WIGRAINE (ORGANON USA INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086710 (pdf 86710.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086986 (pdf 86986.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (LANNETT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086996 (pdf 86996.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 087048 (pdf 87048.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (PURACAP PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087628 (pdf 87628.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ANOQUAN (SHIRE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087629 (pdf 87629.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087804 (pdf 87804.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SPECGX LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088584 (pdf 88584.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) DHC PLUS (PHARM RES ASSOC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088616 (pdf 88616.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1984 , NDA 088743 (pdf 88743.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088758 (pdf 88758.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088765 (pdf 88765.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088825 (pdf 88825.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088972 (pdf 88972.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089007 (pdf 89007.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1986 , NDA 089023 (pdf 89023.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) TRIAD (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089025 (pdf 89025.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089067 (pdf 89067.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089102 (pdf 89102.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) FEMCET (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089115 (pdf 89115.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) MEDIGESIC PLUS (US CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089166 (pdf 89166.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC-A (LEITNER PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089175 (pdf 89175.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 1987 , NDA 089448 (pdf 89448.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089451 (pdf 89451.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089536 (pdf 89536.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089660 (pdf 89660.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089718 (pdf 89718.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040864 (pdf 40864.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2008 , NDA 040883 (pdf 40883.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIRROR PHARMS LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040885 (pdf 40885.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090064 (pdf 90064.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090077 (pdf 90077.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (SUN PHARM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090357 (pdf 90357.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 090827 (pdf 90827.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 091102 (pdf 91102.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 200243 (pdf 200243.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2012 , NDA 204785 (label 204785.pdf) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) TREZIX (KEY THERAP) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203335 (pdf 203335.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205013 (pdf 205013.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204195 (pdf 204195.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204209 (pdf 204209.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE AND DIHYDROCODEINE BITARTRATE (LARKEN LABS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207118 (pdf 207118.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 204984 (pdf 204984.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ALVOGEN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206615 (pdf 206615.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (KEY THERAP) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207400 (pdf 207400.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 204733 (pdf 204733.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 209587 (pdf 209587.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211106 (pdf 211106.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 210817 (pdf 210817.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2019 , NDA 212082 (pdf 212082.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 212083 (pdf 212083.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 213202 (pdf 213202.pdf not found) INN (CAFFEINE CITRATE) CAFFEINE CITRATE (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 204649 (pdf 204649.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 211543 (pdf 211543.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NESHER PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213046 (pdf 213046.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (TARO) APPROVAL= AP YEAR= 2020 , NDA 213321 (pdf 213321.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 203647 (pdf 203647.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 214039 (pdf 214039.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 205230 (pdf 205230.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214087 (pdf 214087.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215047 (pdf 215047.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NOVAST LABS) APPROVAL= AP YEAR= 2021 , NDA 211695 (pdf 211695.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215135 (pdf 215135.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215138 (pdf 215138.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 214287 (pdf 214287.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214288 (pdf 214288.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 216376 (pdf 216376.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , 70 ; ERGOTAMINE ; 113-15-5 ; 1948 ; ; NATURAL MOLECULE C00001724 ; CLASS NERVOUS SYSTEM -- ADRENERGIC ALPHA AGONISTS -- ANALGESICS -- SYMPATHOLYTICS -- VASOCONSTRICTOR AGENTS -- TO ABORT OR PREVENT VASCULAR HEADACHE , ; NDA 006620 (pdf 6620.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (NOVARTIS) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 009000 (label 9000.pdf) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (NOVARTIS) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 012102 (pdf 12102.pdf not found) INN (ERGOTAMINE TARTRATE) MEDIHALER ERGOTAMINE (3M) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 040510 (pdf 40510.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) ERGOTAMINE TARTRATE AND CAFFEINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040590 (pdf 40590.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) ERGOTAMINE TARTRATE AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2005 , NDA 084294 (pdf 84294.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) CAFERGOT (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 086557 (pdf 86557.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) MIGERGOT (COSETTE) APPROVAL= AP YEAR= 1983 , NDA 086562 (pdf 86562.pdf not found) INN (CAFFEINE ERGOTAMINE TARTRATE) WIGRAINE (ORGANON USA INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086750 (pdf 86750.pdf not found) INN (ERGOTAMINE TARTRATE) WIGRETTES (ORGANON USA INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087693 (pdf 87693.pdf not found) INN (ERGOTAMINE TARTRATE) ERGOMAR (PANGEA) APPROVAL= AP YEAR= 1985 , NDA 088337 (pdf 88337.pdf not found) INN (ERGOTAMINE TARTRATE) ERGOSTAT (WATSON LABS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , 71 ; METOCURINE ; 5152-30-7 ; 1949 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- LOCAL ANESTHETICS -- NEUROMUSCULAR NONDEPOLARIZING AGENTS , ; NDA 006632 (pdf 6632.pdf not found) INN (METOCURINE IODIDE) METUBINE IODIDE (LILLY) APPROVAL= AP YEAR= 1949 NEWMOLECULARENTITY DISCONTINUED , NDA 089443 (pdf 89443.pdf not found) INN (METOCURINE IODIDE) METOCURINE IODIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 72 ; MECHLORETHAMINE ; 51-75-2 ; 1949 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENTS -- TREATMENT OF HODGKIN'S DISEASE -- UNDERGOES RAPID CHEMICAL TRANSFORMATION -- THE DRUG IS NO LONGER PRESENT IN ACTIVE FORM A FEW MINUTES AFTER ADMINISTRATION , ; NDA 006695 (label 6695.pdf) INN (MECHLORETHAMINE HYDROCHLORIDE) MUSTARGEN (RECORDATI RARE) APPROVAL= AP YEAR= 1949 NEWMOLECULARENTITY DISCONTINUED , NDA 202317 (label 202317.pdf) INN (MECHLORETHAMINE HYDROCHLORIDE) VALCHLOR (HELSINN) APPROVAL= AP YEAR= 2013 , 73 ; METHOXAMINE ; 390-28-3 ; 1949 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- SELECTIVE ALPHA-1 ADRENORECEPTOR AGONIST -- VASOCONSTRICTOR -- SYMPATHOMIMETICS -- TREATMENT OF FAECAL INCONTINENCE , ; NDA 006772 (pdf 6772.pdf not found) INN (METHOXAMINE HYDROCHLORIDE) VASOXYL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1949 DISCONTINUED , 74 ; TRIHEXYPHENIDYL ; 144-11-6 ; 1949 ; ; ; CLASS NERVOUS SYSTEM -- ANTICHOLINERGIC -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- MUSCARINIC ANTAGONISTS , ; NDA 006773 (pdf 6773.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) ARTANE (LEDERLE) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 012947 (pdf 12947.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) ARTANE (LEDERLE) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 040177 (pdf 40177.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 , NDA 040184 (pdf 40184.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040251 (label 40251.pdf) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (MIKART) APPROVAL= AP YEAR= 1999 , NDA 040254 (label 40254.pdf) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1998 , NDA 040337 (pdf 40337.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 080381 (pdf 80381.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TREMIN (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084363 (pdf 84363.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 084364 (pdf 84364.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 085105 (pdf 85105.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085117 (pdf 85117.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085622 (pdf 85622.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088035 (pdf 88035.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 089514 (pdf 89514.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (PHARM VENTURES) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 091630 (pdf 91630.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2010 , 75 ; PARAMETHADIONE ; 115-67-3 ; 1949 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; NDA 006800 (pdf 6800.pdf not found) INN (PARAMETHADIONE) PARADIONE (ABBVIE) APPROVAL= AP YEAR= 1949 DISCONTINUED , 76 ; AMINOSALICYLIC ACID ; 65-49-6 ; 1950 ; ; ; CLASS ANTIINFECTIVES -- ANTITUBERCULOSIS -- ANTIBIOTIC -- ANTIBACTERIAL -- PRODUCTION OF A TOXIC INACTIVE METABOLITE , ; NDA 006811 (pdf 6811.pdf not found) INN (AMINOSALICYLIC ACID) PARASAL (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009052 (pdf 9052.pdf not found) INN (AMINOSALICYLIC ACID RESIN COMPLEX) REZIPAS (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074346 (pdf 74346.pdf not found) INN (AMINOSALICYLIC ACID) PASER (EUROCEPT PHARMS) APPROVAL= AP YEAR= 1994 , NDA 080059 (pdf 80059.pdf not found) INN (AMINOSALICYLATE SODIUM AMINOSALICYLIC ACID) NEOPASALATE (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 007320 (pdf 7320.pdf not found) INN (AMINOSALICYLATE SODIUM) TEEBACIN (CONSOLIDATED MIDLAND) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 009395 (pdf 9395.pdf not found) INN (POTASSIUM AMINOSALICYLATE) PASKALIUM (GLENWOOD) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 080097 (pdf 80097.pdf not found) INN (AMINOSALICYLATE SODIUM) SODIUM AMINOSALICYLATE (HEXCEL) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080098 (pdf 80098.pdf not found) INN (POTASSIUM AMINOSALICYLATE) POTASSIUM AMINOSALICYLATE (HEXCEL) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080138 (pdf 80138.pdf not found) INN (AMINOSALICYLATE SODIUM) SODIUM P.A.S. (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080947 (pdf 80947.pdf not found) INN (AMINOSALICYLATE SODIUM) P.A.S. SODIUM (CENTURY PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 77 ; CHLORPHENIRAMINE ; 132-22-9 ; 1949 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITIC AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 006921 (pdf 6921.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 007638 (pdf 7638.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 008794 (pdf 8794.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 008826 (pdf 8826.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012152 (pdf 12152.pdf not found) INN (CHLORPHENIRAMINE MALEATE) ORNADE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1959 DISCONTINUED OBSOLETE , NDA 017369 (pdf 17369.pdf not found) INN (CHLORPHENIRAMINE MALEATE) TELDRIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018050 (pdf 18050.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX PHENYLPROPANOLAMINE POLISTIREX) CORSYM (UCB INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018099 (pdf 18099.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CONTAC 12 HOUR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1980 DISCONTINUED OBSOLETE , NDA 018115 (pdf 18115.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) TRIAMINIC-12 (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018397 (pdf 18397.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) CHLOR-TRIMETON (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018556 (pdf 18556.pdf not found) INN (CHLORPHENIRAMINE MALEATE) DEMAZIN (SCHERING PLOUGH) APPROVAL= AP YEAR= 1984 DISCONTINUED OBSOLETE , NDA 018747 (pdf 18747.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) ISOCLOR (FISONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 018793 (pdf 18793.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) COLD CAPSULE IV (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018794 (pdf 18794.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) COLD CAPSULE V (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018809 (pdf 18809.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED OBSOLETE , NDA 018843 (pdf 18843.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018844 (pdf 18844.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018928 (pdf 18928.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) PENNTUSS (FISONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 018935 (pdf 18935.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) CODIMAL-L.A. 12 (SCHWARZ PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019111 (label 19111.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) TUSSIONEX PENNKINETIC (UCB INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019428 (pdf 19428.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019613 (pdf 19613.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CONTAC (NOVARTIS) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 019746 (pdf 19746.pdf not found) INN (CHLORPHENIRAMINE MALEATE) EFIDAC 24 CHLORPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 021369 (pdf 21369.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) CODEPREX (LANNETT CO INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021441 (label 21441.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL ALLERGY SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002 , NDA 021587 (label 21587.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL ALLERGY SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2004 , NDA 070797 (pdf 70797.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071455 (pdf 71455.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077273 (label 77273.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) TUSSICAPS (ECR PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 080626 (pdf 80626.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080696 (pdf 80696.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080700 (pdf 80700.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080779 (pdf 80779.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080786 (pdf 80786.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080791 (pdf 80791.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080797 (pdf 80797.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080809 (pdf 80809.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080821 (pdf 80821.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080846 (pdf 80846.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PHENETRON (LANNETT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080938 (pdf 80938.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080961 (pdf 80961.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083062 (pdf 83062.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (BELL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083078 (pdf 83078.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ANABOLIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083243 (pdf 83243.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083381 (pdf 83381.pdf not found) INN (CHLORPHENIRAMINE MALEATE) ANTAGONATE (BAYER PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083593 (pdf 83593.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083629 (pdf 83629.pdf not found) INN (CHLORPHENIRAMINE MALEATE) KLOROMIN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083733 (pdf 83733.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PYRIDAMAL 100 (BEL MAR) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 083753 (pdf 83753.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARMERAL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083787 (pdf 83787.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WEST WARD) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 085104 (pdf 85104.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARMAVITE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085139 (pdf 85139.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 085837 (pdf 85837.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086095 (pdf 86095.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086096 (pdf 86096.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086306 (pdf 86306.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086519 (pdf 86519.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (NEWTRON PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086941 (pdf 86941.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087164 (pdf 87164.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087520 (pdf 87520.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088359 (pdf 88359.pdf not found) INN (CHLORPHENIRAMINE MALEATE) DRIZE (ASCHER) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 088556 (pdf 88556.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PIONEER PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088681 (pdf 88681.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088940 (pdf 88940.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 040829 (pdf 40829.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (AVANTHI INC) APPROVAL= AP YEAR= 2009 , NDA 091632 (label 91632.pdf) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 022439 (label 22439.pdf) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) ZUTRIPRO (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022113 (label 22113.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL ALLERGY AND CONGESTION RELIEF (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2011 , NDA 091671 (pdf 91671.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX HYDROCODONE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX (NEOS THERAPS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204307 (label 204307.pdf) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) VITUZ (PERSION) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203838 (pdf 203838.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204627 (pdf 204627.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 205657 (pdf 205657.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206323 (label 206323.pdf) INN (CHLORPHENIRAMINE MALEATE CODEINE PHOSPHATE) TUXARIN ER (MAINPOINTE) APPROVAL= AP YEAR= 2015 , NDA 206438 (pdf 206438.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207768 (label 207768.pdf) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) TUZISTRA XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206660 (pdf 206660.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206891 (pdf 206891.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (ACELLA) APPROVAL= AP YEAR= 2017 DISCONTINUED , 78 ; PHENYL AMINOSALICYLATE ; 133-11-9 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL (TUBERCULOSTATIC) -- ANTIFUNGAL , ; NDA 011695 (pdf 11695.pdf not found) INN (PHENYL AMINOSALICYLATE) PHENY-PAS-TEBAMIN (PHARM RES ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , 79 ; DEXCHLORPHENIRAMINE ; 25523-97-1 ; 1950 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITIC AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 006921 (pdf 6921.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 007638 (pdf 7638.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= AP YEAR= 1950 , NDA 008794 (pdf 8794.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 008826 (pdf 8826.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 017369 (pdf 17369.pdf not found) INN (CHLORPHENIRAMINE MALEATE) TELDRIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 018397 (pdf 18397.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLOR-TRIMETON (SCHERING PLOUGH) APPROVAL= AP YEAR= 1981 , NDA 018747 (pdf 18747.pdf not found) INN (CHLORPHENIRAMINE MALEATE) ISOCLOR (FISONS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 018843 (pdf 18843.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 018844 (pdf 18844.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 018935 (pdf 18935.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CODIMAL-L.A. 12 (SCHWARZ PHARMA) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 019111 (label 19111.pdf) INN (CHLORPHENIRAMINE POLISTIREX) TUSSIONEX PENNKINETIC (UCB INC) APPROVAL= AP YEAR= 1987 , NDA 019428 (pdf 19428.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019746 (pdf 19746.pdf not found) INN (CHLORPHENIRAMINE MALEATE) EFIDAC 24 CHLORPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 021441 (label 21441.pdf) INN (CHLORPHENIRAMINE MALEATE) ADVIL ALLERGY SINUS (WYETH CONS) APPROVAL= AP YEAR= 2002 , NDA 021587 (label 21587.pdf) INN (CHLORPHENIRAMINE MALEATE) CHILDREN'S ADVIL ALLERGY SINUS (WYETH CONS) APPROVAL= AP YEAR= 2004 , NDA 070797 (pdf 70797.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071455 (pdf 71455.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 077273 (label 77273.pdf) INN (CHLORPHENIRAMINE POLISTIREX) TUSSICAPS (TYCO HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 080626 (pdf 80626.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ROXANE) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080696 (pdf 80696.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080700 (pdf 80700.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080779 (pdf 80779.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080786 (pdf 80786.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PVT FORM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080791 (pdf 80791.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080797 (pdf 80797.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ELKINS SINN) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080809 (pdf 80809.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (IMPAX LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080821 (pdf 80821.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (BEL MAR) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080846 (pdf 80846.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PHENETRON (LANNETT) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080938 (pdf 80938.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ELKINS SINN) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 080961 (pdf 80961.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (SANDOZ) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083062 (pdf 83062.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (BELL PHARMA) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083078 (pdf 83078.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (ANABOLIC) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083243 (pdf 83243.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PANRAY) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083381 (pdf 83381.pdf not found) INN (CHLORPHENIRAMINE MALEATE) ANTAGONATE (BAYER PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083593 (pdf 83593.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083629 (pdf 83629.pdf not found) INN (CHLORPHENIRAMINE MALEATE) KLOROMIN (HALSEY) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083733 (pdf 83733.pdf not found) INN (CHLORPHENIRAMINE MALEATE) PYRIDAMAL 100 (BEL MAR) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083753 (pdf 83753.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARMERAL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083787 (pdf 83787.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WEST WARD) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 085104 (pdf 85104.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARMAVITE) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 085139 (pdf 85139.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 085837 (pdf 85837.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (VITARINE) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 086095 (pdf 86095.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 086096 (pdf 86096.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086306 (pdf 86306.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PUREPAC PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 086519 (pdf 86519.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (NEWTRON PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 086941 (pdf 86941.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087164 (pdf 87164.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 087520 (pdf 87520.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PHARM ASSOC) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 088556 (pdf 88556.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (PIONEER PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 088681 (pdf 88681.pdf not found) INN (CHLOROHENIRAMINE MALEATE) CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088940 (pdf 88940.pdf not found) INN (CHLOROHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 086835 (pdf 86835.pdf not found) INN (DEXCHLORPHENIRAMINE MALEATE) POLARAMINE (SCHERING) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086837 (pdf 86837.pdf not found) INN (DEXCHLORPHENIRAMINE MALEATE) POLARAMINE (SCHERING) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088251 (pdf 88251.pdf not found) INN (DEXCHLORPHENIRAMINE MALEATE) DEXCHLORPHENIRAMINE MALEATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088682 (pdf 88682.pdf not found) INN (DEXCHLORPHENIRAMINE MALEATE) DEXCHLORPHENIRAMINE MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 040829 (pdf 40829.pdf not found) INN (CHLORPHENIRAMINE MALEATE) CHLORPHENIRAMINE MALEATE (AVANTHI INC) APPROVAL= AP YEAR= 2009 , NDA 091632 (label 91632.pdf) INN (CHLORPHENIRAMINE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 022439 (label 22439.pdf) INN (CHLORPHENIRAMINE) ZUTRIPRO (CYPRESS PHARM) APPROVAL= AP YEAR= 2011 , NDA 022113 (label 22113.pdf) INN (CHLORPHENIRAMINE MALEATE) ADVIL ALLERGY AND CONGESTION RELIEF (PFIZER CONS HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 091671 (pdf 91671.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX) HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX (NEOS THERAP INC) APPROVAL= AP YEAR= 2012 , NDA 204307 (label 204307.pdf) INN (CHLORPHENIRAMINE MALEATE) VITUZ (CYPRESS PHARM) APPROVAL= AP YEAR= 2013 , NDA 203838 (pdf 203838.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 , NDA 204627 (pdf 204627.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADDOCK LLC) APPROVAL= AP YEAR= 2014 , NDA 205657 (pdf 205657.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (COASTAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206323 (label 206323.pdf) INN (CHLORPHENIRAMINE MALEATE) CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (SPRIASO LLC) APPROVAL= AP YEAR= 2015 , NDA 206438 (pdf 206438.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 207768 (label 207768.pdf) INN (CHLORPHENIRAMINE POLISTIREX) TUZISTRA XR (VERNALIS R AND D LTD) APPROVAL= AP YEAR= 2015 , NDA 206660 (pdf 206660.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (BIO-PHARM INC) APPROVAL= AP YEAR= 2017 , NDA 206891 (pdf 206891.pdf not found) INN (CHLORPHENIRAMINE MALEATE) HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (ACELLA PHARMS LLC) APPROVAL= AP YEAR= 2017 , NDA 202520 (pdf 202520.pdf not found) INN (DEXCHLORPHENIRAMINE MALEATE) POLMON (CAPELLON PHARMS LLC) APPROVAL= AP YEAR= 2018 , 80 ; CROTAMITON ; 483-63-6 ; 1949 ; ; ; CLASS ANTIPARASITIC -- ANTIPRURITICS -- SCABICIDAL -- ERADICATION OF SCABIES -- SYMPTOMATIC TREATMENT OF PRURITIC SKIN , ; NDA 006927 (label 6927.pdf) INN (CROTAMITON) EURAX (JOURNEY) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 009112 (label 9112.pdf) INN (CROTAMITON) EURAX (JOURNEY) APPROVAL= AP YEAR= 1955 , NDA 087204 (pdf 87204.pdf not found) INN (CROTAMITON) CROTAN (LEGACY PHARMA) APPROVAL= AP YEAR= 1981 , 81 ; SULFASALAZINE ; 599-79-1 ; 1950 ; ; ; CLASS METABOLISM -- ANTIINFLAMMATORY -- TREATMENT OF MILD TO MODERATE ULCERATIVE COLITIS -- INTERFERENCE WITH TETRAHYDROBIOPTERIN METABOLISM (BINDS SEPIAPTERIN REDUCTASE (SPR)(PMID21499265)) , ; NDA 007073 (label 7073.pdf) INN (SULFASALAZINE) AZULFIDINE (PFIZER) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY , NDA 018605 (pdf 18605.pdf not found) INN (SULFASALAZINE) AZULFIDINE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 021243 (label 21243.pdf) INN (SULFASALAZINE) AZULFIDINE EN-TABS (PHARMACIA UPJOHN) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 040349 (pdf 40349.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2002 , NDA 075339 (pdf 75339.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2002 , NDA 080197 (pdf 80197.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (CHARTWELL) APPROVAL= AP YEAR= 1973 , NDA 083450 (pdf 83450.pdf not found) INN (SULFASALAZINE) S.A.S.-500 (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084964 (pdf 84964.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085828 (pdf 85828.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (WATSON LABS) APPROVAL= AP YEAR= 1977 , NDA 086184 (pdf 86184.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086983 (pdf 86983.pdf not found) INN (SULFASALAZINE) AZULFIDINE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1980 OBSOLETE , NDA 087197 (pdf 87197.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088052 (pdf 88052.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089339 (pdf 89339.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089590 (pdf 89590.pdf not found) INN (SULFASALAZINE) SULFASALAZINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 020465 (label 20465.pdf) INN (SULFASALAZINE) AZULFIDINE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1996 NEWAPPLICATION , 82 ; CORTISONE ACETATE ; 50-04-4 ; 1950 ; DISCONTINUED ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- REPLACEMENT THERAPY IN ADRENOCORTICAL DEFICIENCY STATES -- PSORIATIC -- ARTHRITIS RHEUMATOID ARTHRITIS -- RAPIDLY HYDROLYZED IN CORTISONE , ; NDA 007110 (pdf 7110.pdf not found) INN (CORTISONE ACETATE) CORTONE (MERCK) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY DISCONTINUED , NDA 007750 (pdf 7750.pdf not found) INN (CORTISONE ACETATE) CORTONE (MERCK) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 008126 (pdf 8126.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008284 (pdf 8284.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (PANRAY) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 009458 (pdf 9458.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (IMPAX LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 080333 (pdf 80333.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080341 (pdf 80341.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080493 (pdf 80493.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080630 (pdf 80630.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080694 (pdf 80694.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080731 (pdf 80731.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080776 (pdf 80776.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080836 (pdf 80836.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083147 (pdf 83147.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083471 (pdf 83471.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (BARR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083536 (pdf 83536.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084246 (pdf 84246.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (EVERYLIFE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085677 (pdf 85677.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085736 (pdf 85736.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085884 (pdf 85884.pdf not found) INN (CORTISONE ACETATE) CORTISONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , 83 ; PROCAINAMIDE ; 51-06-9 ; 1950 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC , ; NDA 007335 (pdf 7335.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PRONESTYL (APOTHECON) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY DISCONTINUED , NDA 017371 (pdf 17371.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PRONESTYL (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 020545 (pdf 20545.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCANBID (KING PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040111 (pdf 40111.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 083287 (pdf 83287.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083553 (pdf 83553.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAPAN (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083693 (pdf 83693.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083795 (pdf 83795.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084280 (pdf 84280.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084357 (pdf 84357.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084403 (pdf 84403.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084595 (pdf 84595.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084604 (pdf 84604.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084606 (pdf 84606.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084696 (pdf 84696.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085079 (pdf 85079.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085167 (pdf 85167.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085804 (pdf 85804.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086065 (pdf 86065.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN SR (PARKEDALE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 086468 (pdf 86468.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN SR (PARKE DAVIS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086942 (pdf 86942.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086943 (pdf 86943.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086952 (pdf 86952.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087020 (pdf 87020.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087021 (pdf 87021.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087079 (pdf 87079.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087080 (pdf 87080.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087361 (pdf 87361.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PRONESTYL-SR (APOTHECON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087502 (pdf 87502.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087510 (pdf 87510.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN SR (PARKEDALE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 087542 (pdf 87542.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087543 (pdf 87543.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087643 (pdf 87643.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087697 (pdf 87697.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087875 (pdf 87875.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088489 (pdf 88489.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAN SR (PARKEDALE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088530 (pdf 88530.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088531 (pdf 88531.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088532 (pdf 88532.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088533 (pdf 88533.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088534 (pdf 88534.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088535 (pdf 88535.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088636 (pdf 88636.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1984 , NDA 088637 (pdf 88637.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088824 (pdf 88824.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088830 (pdf 88830.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088958 (pdf 88958.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088959 (pdf 88959.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088974 (pdf 88974.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088989 (pdf 88989.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088990 (pdf 88990.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089026 (pdf 89026.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089027 (pdf 89027.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089029 (pdf 89029.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089030 (pdf 89030.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089042 (pdf 89042.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089069 (pdf 89069.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 089070 (pdf 89070.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 089219 (pdf 89219.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089220 (pdf 89220.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089221 (pdf 89221.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089256 (pdf 89256.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089257 (pdf 89257.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089284 (pdf 89284.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089369 (pdf 89369.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089370 (pdf 89370.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089371 (pdf 89371.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089415 (pdf 89415.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089416 (pdf 89416.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089438 (pdf 89438.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089520 (pdf 89520.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089528 (pdf 89528.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089529 (pdf 89529.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089537 (pdf 89537.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089840 (pdf 89840.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 206332 (pdf 206332.pdf not found) INN (PROCAINAMIDE HYDROCHLORIDE) PROCAINAMIDE HYDROCHLORIDE (NEXUS) APPROVAL= AP YEAR= 2017 , 84 ; ASPIRIN ; 50-78-2 ; 1950 ; ; ; CLASS NERVOUS SYSTEM -- ANTI-INFLAMMATORY AGENTS -- NSAID -- ANTICOAGULANTS -- CYCLOOXYGENASE INHIBITORS -- FIBRINOLYTIC AGENTS -- PLATELET AGGREGATION INHIBITORS -- SALICYLATES , ; NDA 007337 (label 7337.pdf) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) PERCODAN-DEMI (ENDO OPERATIONS) APPROVAL= AP YEAR= 1950 , NDA 010996 (pdf 10996.pdf not found) INN (ASPIRIN PROPOXYPHENE HYDROCHLORIDE) DARVON W/ ASA (XANODYNE PHARM) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011483 (label 11483.pdf) INN (ASPIRIN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011702 (label 11702.pdf) INN (ASPIRIN MEPROBAMATE) EQUAGESIC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012281 (pdf 12281.pdf not found) INN (ASPIRIN METHOCARBAMOL) ROBAXISAL (ROBINS AH) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012365 (label 12365.pdf) INN (ASPIRIN CARISOPRODOL) SOMA COMPOUND (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012366 (label 12366.pdf) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) SOMA COMPOUND W/ CODEINE (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 013416 (label 13416.pdf) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) NORGESIC (BAUSCH) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 016030 (pdf 16030.pdf not found) INN (ASPIRIN) 8-HOUR BAYER (BAYER) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 016829 (pdf 16829.pdf not found) INN (ASPIRIN PROPOXYPHENE NAPSYLATE) DARVON-N W/ ASA (AAIPHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 016863 (pdf 16863.pdf not found) INN (ASPIRIN PROPOXYPHENE NAPSYLATE) DARVON-N W/ ASA (AAIPHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 016891 (pdf 16891.pdf not found) INN (ASPIRIN PENTAZOCINE HYDROCHLORIDE) TALWIN COMPOUND (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017534 (label 17534.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE) FIORINAL (ALLERGAN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 019429 (label 19429.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORINAL W/CODEINE (ALLERGAN) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020802 (label 20802.pdf) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) EXCEDRIN MIGRAINE (GLAXOSMITHKLINE CONS) APPROVAL= AP YEAR= 1998 , NDA 020884 (label 20884.pdf) INN (ASPIRIN DIPYRIDAMOLE) AGGRENOX (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021317 (label 21317.pdf) INN (ASPIRIN) BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN (BAYER) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021387 (label 21387.pdf) INN (ASPIRIN PRAVASTATIN SODIUM) PRAVIGARD PAC COPACKAGED (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040116 (pdf 40116.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040118 (pdf 40118.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040252 (pdf 40252.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040255 (pdf 40255.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040260 (pdf 40260.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040283 (pdf 40283.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (OXFORD PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074359 (pdf 74359.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074654 (pdf 74654.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074817 (pdf 74817.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) INVAGESIC (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074951 (pdf 74951.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STEVENS J) APPROVAL= AP YEAR= 1998 , NDA 074988 (pdf 74988.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (STEVENS J) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075141 (pdf 75141.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENGESIC (GALT PHARMS) APPROVAL= AP YEAR= 1998 , NDA 075231 (pdf 75231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075351 (pdf 75351.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075794 (pdf 75794.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (PERRIGO) APPROVAL= AP YEAR= 2001 , NDA 078149 (pdf 78149.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2007 , NDA 080044 (pdf 80044.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (SANDOZ) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 081095 (pdf 81095.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081096 (pdf 81096.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081097 (pdf 81097.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081145 (pdf 81145.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (STEVENS J) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 083077 (pdf 83077.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083101 (pdf 83101.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND-65 (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084553 (pdf 84553.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) COMPOUND 65 (ALRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084978 (pdf 84978.pdf not found) INN (ASPIRIN MEPROBAMATE) MICRAININ (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085441 (pdf 85441.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (IVAX PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085638 (pdf 85638.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 4 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085639 (pdf 85639.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 3 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085640 (pdf 85640.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 2 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085732 (pdf 85732.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086162 (pdf 86162.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086231 (pdf 86231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086237 (pdf 86237.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086333 (pdf 86333.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) VICOPRIN (ABBOTT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086398 (pdf 86398.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086710 (pdf 86710.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086986 (pdf 86986.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (LANNETT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086996 (pdf 86996.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (LANNETT) APPROVAL= AP YEAR= 1981 , NDA 087048 (pdf 87048.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (PURACAP PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087211 (pdf 87211.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087464 (pdf 87464.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) CODOXY (HALSEY) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087742 (pdf 87742.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN HALF-STRENGTH (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087743 (pdf 87743.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) ROXIPRIN (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087794 (pdf 87794.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088305 (pdf 88305.pdf not found) INN (ASPIRIN BUTALBITAL) AXOTAL (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088740 (pdf 88740.pdf not found) INN (ASPIRIN MEPROBAMATE) Q-GESIC (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088809 (pdf 88809.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL COMPOUND (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088972 (pdf 88972.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089025 (pdf 89025.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089126 (pdf 89126.pdf not found) INN (ASPIRIN MEPROBAMATE) MEPROBAMATE AND ASPIRIN (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089127 (pdf 89127.pdf not found) INN (ASPIRIN MEPROBAMATE) MEPRO-ASPIRIN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089193 (pdf 89193.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089420 (pdf 89420.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) AZDONE (SCHWARZ PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089448 (pdf 89448.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089594 (pdf 89594.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089657 (pdf 89657.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040832 (pdf 40832.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (NOVAST LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040860 (pdf 40860.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (INGENUS PHARMS NJ) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078804 (pdf 78804.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (BARR) APPROVAL= AP YEAR= 2009 , NDA 090084 (pdf 90084.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091670 (pdf 91670.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203697 (label 203697.pdf) INN (ASPIRIN) VAZALORE (PLX PHARMA) APPROVAL= AP YEAR= 2013 , NDA 200671 (label 200671.pdf) INN (ASPIRIN) DURLAZA (HESP) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203335 (pdf 203335.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206392 (pdf 206392.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204195 (pdf 204195.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205103 (label 205103.pdf) INN (ASPIRIN OMEPRAZOLE) YOSPRALA (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206739 (pdf 206739.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (SANDOZ) APPROVAL= AP YEAR= 2017 , NDA 206964 (pdf 206964.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207944 (pdf 207944.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 206753 (pdf 206753.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208572 (pdf 208572.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (SUN PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209048 (pdf 209048.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 204552 (pdf 204552.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210318 (pdf 210318.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 , NDA 040910 (pdf 40910.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 205479 (pdf 205479.pdf not found) INN (ASPIRIN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ASPIRIN (LGM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214039 (pdf 214039.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 205230 (pdf 205230.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209929 (pdf 209929.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 211695 (pdf 211695.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 209791 (pdf 209791.pdf not found) INN (ASPIRIN OMEPRAZOLE) ASPIRIN OMEPRAZOLE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2023 , 85 ; OXYCODONE ; 76-42-6 ; 1950 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- ANTITUSSIVES -- NARCOTICS -- OPIATE AGONISTS , ; NDA 007337 (label 7337.pdf) INN (OXYCODONE TEREPHTHALATE) PERCODAN-DEMI (ENDO PHARMS) APPROVAL= AP YEAR= 1950 , NDA 020553 (label 20553.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCONTIN (PURDUE PHARMA LP) APPROVAL= AP YEAR= 1995 DISCONTINUED OBSOLETE , NDA 020932 (pdf 20932.pdf not found) INN (OXYCODONE HYDROCHLORIDE) ROXICODONE (ROXANE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021011 (label 21011.pdf) INN (OXYCODONE HYDROCHLORIDE) ROXICODONE (SPECGX LLC) APPROVAL= AP YEAR= 2000 , NDA 021378 (label 21378.pdf) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) COMBUNOX (FOREST LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040061 (pdf 40061.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXILOX (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040105 (pdf 40105.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040106 (pdf 40106.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040171 (pdf 40171.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040199 (label 40199.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040203 (pdf 40203.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040219 (pdf 40219.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040234 (pdf 40234.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040255 (pdf 40255.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040257 (label 40257.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040260 (pdf 40260.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040272 (pdf 40272.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040289 (pdf 40289.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040303 (label 40303.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040304 (pdf 40304.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040330 (label 40330.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (ENDO OPERATIONS) APPROVAL= AP YEAR= 1999 , NDA 040341 (label 40341.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040371 (pdf 40371.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040434 (label 40434.pdf) INN (OXYCODONE HYDROCHLORIDE) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2001 OBSOLETE , NDA 040535 (pdf 40535.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040545 (pdf 40545.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 040550 (pdf 40550.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040608 (pdf 40608.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2005 , NDA 040676 (pdf 40676.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040679 (pdf 40679.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040680 (pdf 40680.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040687 (pdf 40687.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040692 (pdf 40692.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040698 (pdf 40698.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040777 (pdf 40777.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2007 , NDA 040778 (pdf 40778.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 040789 (pdf 40789.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 075923 (pdf 75923.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ENDO PHARMS) APPROVAL= TA YEAR= 2002 OBSOLETE , NDA 076168 (label 76168.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (TEVA) APPROVAL= TA YEAR= 2003 , NDA 076318 (pdf 76318.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (IMPAX LABS) APPROVAL= TA YEAR= 2003 , NDA 076446 (pdf 76446.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= TA YEAR= 2003 , NDA 076610 (pdf 76610.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (TEVA) APPROVAL= TA YEAR= 2004 , NDA 076636 (pdf 76636.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076758 (pdf 76758.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 077290 (pdf 77290.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077712 (pdf 77712.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077822 (pdf 77822.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (MALLINCKRODT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078206 (pdf 78206.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078316 (pdf 78316.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (BARR LABS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078394 (pdf 78394.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078769 (pdf 78769.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 085106 (pdf 85106.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (ENDO OPERATIONS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085375 (pdf 85375.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) TYLOX (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085910 (pdf 85910.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE 2.5/APAP 500 (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085911 (pdf 85911.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE 5/APAP 500 (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087003 (pdf 87003.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET (HIKMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087406 (pdf 87406.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087463 (pdf 87463.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCET (SPECGX LLC) APPROVAL= AP YEAR= 1983 , NDA 087464 (pdf 87464.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) CODOXY (HALSEY) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087742 (pdf 87742.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN HALF-STRENGTH (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087743 (pdf 87743.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) ROXIPRIN (ROXANE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087794 (pdf 87794.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) OXYCODONE AND ASPIRIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088246 (pdf 88246.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) TYLOX-325 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088790 (pdf 88790.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) TYLOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089351 (pdf 89351.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089775 (pdf 89775.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET 5/500 (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089994 (pdf 89994.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (HALSEY) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 022272 (label 22272.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCONTIN (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2010 , NDA 090177 (pdf 90177.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090659 (pdf 90659.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090895 (pdf 90895.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 , NDA 091393 (pdf 91393.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (AVANTHI INC) APPROVAL= AP YEAR= 2009 , NDA 200534 (label 200534.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2010 , NDA 200535 (label 200535.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2010 , NDA 090084 (pdf 90084.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091313 (pdf 91313.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091490 (pdf 91490.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091670 (pdf 91670.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202080 (label 202080.pdf) INN (OXYCODONE HYDROCHLORIDE) OXAYDO (ZYLA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202116 (pdf 202116.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2011 , NDA 201194 (label 201194.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 040800 (pdf 40800.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202160 (pdf 202160.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 202537 (pdf 202537.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (VISTAPHARM) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202677 (pdf 202677.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2012 , NDA 203107 (pdf 203107.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090535 (pdf 90535.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090733 (pdf 90733.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090734 (pdf 90734.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201447 (pdf 201447.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 201972 (pdf 201972.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 203208 (pdf 203208.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204037 (pdf 204037.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 201278 (pdf 201278.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (RHODES PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203573 (pdf 203573.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203638 (pdf 203638.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203823 (pdf 203823.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204031 (label 204031.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) XARTEMIS XR (MALLINCKRODT INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204085 (pdf 204085.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204092 (pdf 204092.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205777 (label 205777.pdf) INN (NALOXONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE) TARGINIQ (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204603 (pdf 204603.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204979 (pdf 204979.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206456 (pdf 206456.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202662 (label 202662.pdf) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , NDA 202773 (pdf 202773.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (AVANTHI INC) APPROVAL= AP YEAR= 2015 , NDA 204752 (pdf 204752.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 208090 (label 208090.pdf) INN (OXYCODONE) XTAMPZA ER (COLLEGIUM PHARM INC) APPROVAL= AP YEAR= 2016 , NDA 205177 (pdf 205177.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207119 (pdf 207119.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2016 , NDA 207113 (pdf 207113.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ACETAMINOPHEN OXYCODONE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2016 , NDA 207511 (pdf 207511.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2016 , NDA 207574 (pdf 207574.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (CEROVENE INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207621 (label 207621.pdf) INN (NALTREXONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE) TROXYCA ER (PFIZER) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204021 (pdf 204021.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204407 (pdf 204407.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 207418 (pdf 207418.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207419 (pdf 207419.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208593 (pdf 208593.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 208795 (pdf 208795.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208817 (pdf 208817.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209777 (label 209777.pdf) INN (OXYCODONE HYDROCHLORIDE) ROXYBOND (PROTEGA PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203447 (pdf 203447.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206822 (pdf 206822.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2017 , NDA 207333 (pdf 207333.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209021 (pdf 209021.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209897 (pdf 209897.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2017 , NDA 210079 (pdf 210079.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NESHER PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207510 (pdf 207510.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210644 (pdf 210644.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 210758 (pdf 210758.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2018 , NDA 202142 (pdf 202142.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2018 , NDA 203864 (pdf 203864.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 209385 (pdf 209385.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211499 (pdf 211499.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 206914 (pdf 206914.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2019 , NDA 211748 (pdf 211748.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 211749 (pdf 211749.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 207834 (pdf 207834.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2019 , NDA 211708 (pdf 211708.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 040910 (pdf 40910.pdf not found) INN (ASPIRIN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ASPIRIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 205853 (pdf 205853.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212429 (pdf 212429.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213761 (pdf 213761.pdf not found) INN (OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 201448 (pdf 201448.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2021 , 86 ; SECOBARBITAL ; 76-73-3 ; 1950 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHESIA -- BARBITURATES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 007392 (pdf 7392.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (LILLY) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 083262 (pdf 83262.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083281 (pdf 83281.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084225 (pdf 84225.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084422 (pdf 84422.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (ANABOLIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084561 (pdf 84561.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084676 (pdf 84676.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084762 (pdf 84762.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084926 (pdf 84926.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085285 (pdf 85285.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (KV PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085477 (pdf 85477.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085792 (pdf 85792.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085798 (pdf 85798.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085867 (pdf 85867.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085869 (pdf 85869.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (IVAX PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085895 (pdf 85895.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (EVERYLIFE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085898 (pdf 85898.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085903 (pdf 85903.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085909 (pdf 85909.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086101 (pdf 86101.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086273 (pdf 86273.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086390 (pdf 86390.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086530 (pdf 86530.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 87 ; DICYCLOMINE ; 77-19-0 ; 1950 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTICHOLINERGIC -- ANTISPASMODIC -- ANTIMUSCARINICS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 007409 (label 7409.pdf) INN (DICYCLOMINE HYDROCHLORIDE) BENTYL (ALLERGAN) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY DISCONTINUED , NDA 007961 (label 7961.pdf) INN (DICYCLOMINE HYDROCHLORIDE) BENTYL (APTALIS PHARMA US) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008370 (label 8370.pdf) INN (DICYCLOMINE HYDROCHLORIDE) BENTYL (ABBVIE) APPROVAL= AP YEAR= 1952 , NDA 040161 (pdf 40161.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 1996 , NDA 040169 (pdf 40169.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 , NDA 040204 (pdf 40204.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1997 , NDA 040230 (label 40230.pdf) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1999 , NDA 040317 (pdf 40317.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1999 , NDA 040319 (pdf 40319.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1999 , NDA 040465 (pdf 40465.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 080614 (pdf 80614.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 083179 (pdf 83179.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084285 (pdf 84285.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1974 , NDA 084361 (pdf 84361.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084479 (pdf 84479.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084505 (pdf 84505.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084600 (pdf 84600.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085082 (pdf 85082.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 085223 (pdf 85223.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 088585 (pdf 88585.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089361 (pdf 89361.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 208353 (pdf 208353.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2017 , NDA 207084 (pdf 207084.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (RENEW PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207076 (pdf 207076.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210979 (pdf 210979.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 206468 (pdf 206468.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (NEXUS) APPROVAL= AP YEAR= 2019 , NDA 210257 (pdf 210257.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 210788 (pdf 210788.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212058 (pdf 212058.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (PRAXGEN PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212286 (pdf 212286.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 214721 (pdf 214721.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216736 (pdf 216736.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 216760 (pdf 216760.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2022 , NDA 217054 (pdf 217054.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216639 (pdf 216639.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2023 , NDA 216782 (pdf 216782.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217531 (pdf 217531.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 217916 (pdf 217916.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217566 (pdf 217566.pdf not found) INN (DICYCLOMINE HYDROCHLORIDE) DICYCLOMINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , 88 ; METHIMAZOLE ; 60-56-0 ; 1950 ; ; ; CLASS HORMONES -- TREATMENT OF HYPERTHYROIDISM -- INHIBITS THE SYNTHESIS OF THYROID HORMONES , ; NDA 007517 (label 7517.pdf) INN (METHIMAZOLE) TAPAZOLE (KING PHARMS) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY DISCONTINUED , NDA 040320 (label 40320.pdf) INN (METHIMAZOLE) TAPAZOLE (KING PHARMS LLC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040350 (label 40350.pdf) INN (METHIMAZOLE) METHIMAZOLE (MYLAN) APPROVAL= AP YEAR= 2000 , NDA 040411 (pdf 40411.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2001 , NDA 040547 (pdf 40547.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (QINGDAO BAHEAL PHARM) APPROVAL= AP YEAR= 2005 , NDA 040619 (pdf 40619.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (DISCOVERY THERAP) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040734 (pdf 40734.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2007 , NDA 040870 (pdf 40870.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 202068 (pdf 202068.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (RISING) APPROVAL= AP YEAR= 2012 , NDA 209827 (pdf 209827.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 218149 (pdf 218149.pdf not found) INN (METHIMAZOLE) METHIMAZOLE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , 89 ; QUINIDINE ; 56-54-2 ; 1950 ; ; NATURAL MOLECULE C00031117 ; CLASS CARDIOVASCULAR -- ADRENERGIC ALPHA-1 RECEPTOR ANTAGONISTS (PMID9570190)-- ANTIARRHYTHMIC AGENTS -- ANTIMALARIAL SCHIZONTICIDE -- P-GLYCOPROTEIN INHIBITOR -- SPECIFIC INHIBITOR OF CYP2D6 , ; NDA 007529 (pdf 7529.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (LILLY) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 011642 (label 11642.pdf) INN (QUINIDINE POLYGALACTURONATE) CARDIOQUIN (PHARM RES ASSOC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 012796 (label 12796.pdf) INN (QUINIDINE SULFATE) QUINIDEX (WYETH PHARMS INC) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 016647 (pdf 16647.pdf not found) INN (QUINIDINE GLUCONATE) QUINAGLUTE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 017917 (pdf 17917.pdf not found) INN (QUINIDINE GLUCONATE) DURAQUIN (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040045 (pdf 40045.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (COSETTE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081029 (pdf 81029.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081030 (pdf 81030.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081031 (pdf 81031.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 083288 (pdf 83288.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083347 (pdf 83347.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083393 (pdf 83393.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083439 (pdf 83439.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083576 (pdf 83576.pdf not found) INN (QUINIDINE SULFATE) QUINORA (KEY PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083583 (pdf 83583.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083622 (pdf 83622.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083640 (pdf 83640.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (CYCLE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083743 (pdf 83743.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083808 (pdf 83808.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083862 (pdf 83862.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083879 (pdf 83879.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083963 (pdf 83963.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (VINTAGE PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084003 (pdf 84003.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084177 (pdf 84177.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (BARR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084549 (pdf 84549.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084627 (pdf 84627.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (PHARMAVITE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084631 (pdf 84631.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084914 (pdf 84914.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084932 (pdf 84932.pdf not found) INN (QUINIDINE SULFATE) CIN-QUIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085038 (pdf 85038.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (LILLY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085068 (pdf 85068.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SCHERER LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085103 (pdf 85103.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (LILLY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085140 (pdf 85140.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085175 (pdf 85175.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (KING PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085222 (pdf 85222.pdf not found) INN (QUINIDINE SULFATE) QUINORA (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085276 (pdf 85276.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085296 (pdf 85296.pdf not found) INN (QUINIDINE SULFATE) CIN-QUIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085297 (pdf 85297.pdf not found) INN (QUINIDINE SULFATE) CIN-QUIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085298 (pdf 85298.pdf not found) INN (QUINIDINE SULFATE) CIN-QUIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085299 (pdf 85299.pdf not found) INN (QUINIDINE SULFATE) CIN-QUIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085322 (pdf 85322.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085444 (pdf 85444.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085583 (pdf 85583.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085584 (pdf 85584.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085632 (pdf 85632.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (CYCLE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085978 (pdf 85978.pdf not found) INN (QUINIDINE GLUCONATE) QUINACT (BAYER HLTHCARE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086099 (pdf 86099.pdf not found) INN (QUINIDINE GLUCONATE) QUINACT (BAYER HLTHCARE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086176 (pdf 86176.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087011 (pdf 87011.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087448 (pdf 87448.pdf not found) INN (QUINIDINE GLUCONATE) QUINATIME (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087785 (pdf 87785.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087810 (pdf 87810.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (ANI PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087837 (pdf 87837.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087909 (pdf 87909.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088072 (pdf 88072.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1983 , NDA 088081 (pdf 88081.pdf not found) INN (QUINIDINE GLUCONATE) QUINALAN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088431 (pdf 88431.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (CYCLE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088582 (pdf 88582.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088973 (pdf 88973.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089164 (pdf 89164.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089338 (label 89338.pdf) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 , NDA 089476 (pdf 89476.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089839 (pdf 89839.pdf not found) INN (QUINIDINE SULFATE) QUINIDINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089894 (pdf 89894.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 021879 (label 21879.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) NUEDEXTA (AVANIR PHARMS) APPROVAL= AP YEAR= 2010 , NDA 202993 (pdf 202993.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (PAR PHARM INC) APPROVAL= TA YEAR= 2015 , NDA 202934 (pdf 202934.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2017 , NDA 212589 (pdf 212589.pdf not found) INN (QUINIDINE GLUCONATE) QUINIDINE GLUCONATE (EYWA) APPROVAL= AP YEAR= 2021 , 90 ; THIAMYLAL ; 77-27-0 ; 1954 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 007600 (pdf 7600.pdf not found) INN (THIAMYLAL SODIUM) SURITAL (PARKEDALE) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , 91 ; THIAMYLAL ; 77-27-0 ; 1954 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 007600 (pdf 7600.pdf not found) INN (THIAMYLAL SODIUM) SURITAL (PARKEDALE) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , 92 ; PHENACEMIDE ; 63-98-9 ; 1951 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANTS , ; NDA 007707 (pdf 7707.pdf not found) INN (PHENACEMIDE) PHENURONE (ABBVIE) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , 93 ; DYPHYLLINE ; 479-18-5 ; 1951 ; DISCONTINUED ; NATURAL MOLECULE C00030143 ; CLASS RESPIRATORY -- BRONCHODILATOR AGENTS -- PHOSPHODIESTERASE INHIBITORS -- SMOOTH MUSCLE RELAXANTS -- VASODILATOR AGENTS , ; NDA 007794 (pdf 7794.pdf not found) INN (DYPHYLLINE) NEOTHYLLINE (TEVA) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , NDA 009088 (pdf 9088.pdf not found) INN (DYPHYLLINE) NEOTHYLLINE (TEVA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 084514 (pdf 84514.pdf not found) INN (DYPHYLLINE) DILOR (SAVAGE LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084566 (pdf 84566.pdf not found) INN (DYPHYLLINE) LUFYLLIN (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084751 (pdf 84751.pdf not found) INN (DYPHYLLINE) DILOR-400 (SAVAGE LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , 94 ; GALLAMINE ; 153-76-4 ; 0 ; DISCONTINUED ; ; CLASS METABOLISM -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS (ALLOSTERIC INTERACTION (PMID29056499)) -- SKELETAL MUSCLE RELAXANTS , ; NDA 007842 (pdf 7842.pdf not found) INN (GALLAMINE TRIETHIODIDE) FLAXEDIL (DAVIS AND GECK) APPROVAL= - YEAR= 0 DISCONTINUED , 95 ; DISULFIRAM ; 97-77-8 ; 1951 ; ; ; CLASS NERVOUS SYSTEM -- BLOCKS THE OXIDATION OF ALCOHOL AND PROMOTES UNPLEASANT SYMPTOMS -- TREATMENT OF CHRONIC ALCOHOL PATIENTS , ; NDA 007883 (pdf 7883.pdf not found) INN (DISULFIRAM) ANTABUSE (TEVA WOMENS) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , NDA 086889 (pdf 86889.pdf not found) INN (DISULFIRAM) DISULFIRAM (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086890 (pdf 86890.pdf not found) INN (DISULFIRAM) DISULFIRAM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087973 (pdf 87973.pdf not found) INN (DISULFIRAM) DISULFIRAM (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087974 (pdf 87974.pdf not found) INN (DISULFIRAM) DISULFIRAM (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088482 (pdf 88482.pdf not found) INN (DISULFIRAM) ANTABUSE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088483 (pdf 88483.pdf not found) INN (DISULFIRAM) ANTABUSE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088792 (pdf 88792.pdf not found) INN (DISULFIRAM) DISULFIRAM (STRIDES PHARMA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088793 (pdf 88793.pdf not found) INN (DISULFIRAM) DISULFIRAM (STRIDES PHARMA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 091619 (pdf 91619.pdf not found) INN (DISULFIRAM) DISULFIRAM (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2011 , NDA 091563 (pdf 91563.pdf not found) INN (DISULFIRAM) DISULFIRAM (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2012 , NDA 091681 (pdf 91681.pdf not found) INN (DISULFIRAM) DISULFIRAM (ALVOGEN) APPROVAL= AP YEAR= 2013 , NDA 202652 (pdf 202652.pdf not found) INN (DISULFIRAM) DISULFIRAM (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203916 (pdf 203916.pdf not found) INN (DISULFIRAM) DISULFIRAM (DASH PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 96 ; PROBENECID ; 57-66-9 ; 1951 ; ; ; CLASS METABOLISM -- URICOSURIC AGENT -- RENAL TUBULAR BLOCKING AGENT , ; NDA 007898 (pdf 7898.pdf not found) INN (PROBENECID) BENEMID (MERCK) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , NDA 012383 (pdf 12383.pdf not found) INN (COLCHICINE PROBENECID) COLBENEMID (MERCK) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040618 (pdf 40618.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (NOVAST LABS) APPROVAL= AP YEAR= 2008 , NDA 050457 (pdf 50457.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) POLYCILLIN-PRB (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050488 (pdf 50488.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PRINCIPEN W/ PROBENECID (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061741 (pdf 61741.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PROBAMPACIN (COSETTE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061898 (pdf 61898.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) POLYCILLIN-PRB (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062150 (pdf 62150.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PRINCIPEN W/ PROBENECID (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080966 (pdf 80966.pdf not found) INN (PROBENECID) PROBALAN (LANNETT) APPROVAL= AP YEAR= 1976 , NDA 083221 (pdf 83221.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID W/ COLCHICINE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083720 (pdf 83720.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083734 (pdf 83734.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (ANI PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083740 (pdf 83740.pdf not found) INN (PROBENECID) PROBENECID (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 084211 (pdf 84211.pdf not found) INN (PROBENECID) PROBENECID (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084279 (pdf 84279.pdf not found) INN (COLCHICINE PROBENECID) COL-PROBENECID (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 084321 (pdf 84321.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (BEECHAM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084442 (pdf 84442.pdf not found) INN (PROBENECID) PROBENECID (WATSON LABS TEVA) APPROVAL= AP YEAR= 1977 , NDA 085552 (pdf 85552.pdf not found) INN (COLCHICINE PROBENECID) PROBEN-C (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086130 (pdf 86130.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086150 (pdf 86150.pdf not found) INN (PROBENECID) PROBENECID (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086917 (pdf 86917.pdf not found) INN (PROBENECID) PROBENECID (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086954 (pdf 86954.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID W/ COLCHICINE (LEDERLE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 217020 (pdf 217020.pdf not found) INN (PROBENECID) PROBENECID (RISING) APPROVAL= AP YEAR= 2023 , NDA 217030 (pdf 217030.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (RISING) APPROVAL= AP YEAR= 2023 , 97 ; PROMETHAZINE ; 60-87-7 ; 1951 ; ; ; CLASS RESPIRATORY -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITICS -- HISTAMINE H1 ANTAGONISTS -- PHENOTHIAZINE DERIVATIVES -- SEDATIVES -- ANTIEMETIC , ; NDA 007935 (label 7935.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008306 (label 8306.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC W/ CODEINE (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008381 (label 8381.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE PLAIN (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008604 (pdf 8604.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC (ANI PHARMS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 008857 (pdf 8857.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (WYETH AYERST) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 010926 (label 10926.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (MYLAN) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011265 (label 11265.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011689 (label 11689.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (MYLAN) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 011730 (label 11730.pdf) INN (MEPERIDINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) MEPERGAN (HIKMA) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040026 (pdf 40026.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1998 , NDA 040027 (pdf 40027.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040151 (pdf 40151.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040372 (label 40372.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040428 (pdf 40428.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 2002 , NDA 040449 (pdf 40449.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040454 (pdf 40454.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040471 (pdf 40471.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040479 (pdf 40479.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040500 (pdf 40500.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003 , NDA 040504 (pdf 40504.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040515 (pdf 40515.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040524 (pdf 40524.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (BEDFORD LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040558 (pdf 40558.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040593 (pdf 40593.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040596 (pdf 40596.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 040603 (pdf 40603.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2006 , NDA 040622 (pdf 40622.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2006 , NDA 040643 (pdf 40643.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040649 (pdf 40649.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE DM (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040650 (pdf 40650.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE WITH CODEINE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 040654 (pdf 40654.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2006 , NDA 040660 (pdf 40660.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (GENUS) APPROVAL= AP YEAR= 2006 , NDA 040673 (pdf 40673.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2008 , NDA 040712 (pdf 40712.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006 , NDA 040713 (pdf 40713.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006 , NDA 040718 (pdf 40718.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2007 , NDA 040724 (pdf 40724.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 040737 (pdf 40737.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2008 , NDA 040791 (pdf 40791.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080629 (pdf 80629.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080949 (pdf 80949.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083176 (pdf 83176.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) REMSED (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083204 (pdf 83204.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083214 (pdf 83214.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083312 (pdf 83312.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973 , NDA 083401 (pdf 83401.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083403 (pdf 83403.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083426 (pdf 83426.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 , NDA 083532 (pdf 83532.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083603 (pdf 83603.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083604 (pdf 83604.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083613 (pdf 83613.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083658 (pdf 83658.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083711 (pdf 83711.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 , NDA 083712 (pdf 83712.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083838 (pdf 83838.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083955 (pdf 83955.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083997 (pdf 83997.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) ZIPAN-25 (ALTANA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084027 (pdf 84027.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084080 (pdf 84080.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084160 (pdf 84160.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084166 (pdf 84166.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084176 (pdf 84176.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 , NDA 084214 (pdf 84214.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084222 (pdf 84222.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084223 (pdf 84223.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084233 (pdf 84233.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084234 (pdf 84234.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 OBSOLETE , NDA 084539 (pdf 84539.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084554 (pdf 84554.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084555 (pdf 84555.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084557 (pdf 84557.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084591 (pdf 84591.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084772 (pdf 84772.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH FORTIS (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084901 (pdf 84901.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084902 (pdf 84902.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085146 (pdf 85146.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085385 (pdf 85385.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085388 (pdf 85388.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085664 (pdf 85664.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085684 (pdf 85684.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085953 (pdf 85953.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH PLAIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085986 (pdf 85986.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 086395 (pdf 86395.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087165 (pdf 87165.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHEGAN (COSETTE) APPROVAL= AP YEAR= 1987 , NDA 087518 (pdf 87518.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087953 (pdf 87953.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE PLAIN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1982 , NDA 087996 (pdf 87996.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) MYMETHAZINE FORTIS (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088739 (pdf 88739.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PHERAZINE W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088761 (pdf 88761.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC PLAIN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088762 (pdf 88762.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETH W/ DEXTROMETHORPHAN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088763 (pdf 88763.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088764 (label 88764.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC W/ CODEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088814 (pdf 88814.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088815 (pdf 88815.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088816 (pdf 88816.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088864 (pdf 88864.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ DEXTROMETHORPHAN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088868 (pdf 88868.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088870 (pdf 88870.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088875 (pdf 88875.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1984 , NDA 088896 (pdf 88896.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088897 (pdf 88897.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088913 (pdf 88913.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE DM (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089013 (pdf 89013.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089109 (pdf 89109.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089463 (pdf 89463.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089477 (pdf 89477.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089647 (pdf 89647.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040785 (pdf 40785.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040863 (pdf 40863.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040882 (pdf 40882.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 040891 (pdf 40891.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2009 , NDA 040902 (pdf 40902.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090180 (pdf 90180.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE CODEINE PHOSPHATE) PROMETHAZINE HYDROCHLORIDE CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2010 , NDA 091179 (pdf 91179.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2010 , NDA 090575 (pdf 90575.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091054 (pdf 91054.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091675 (pdf 91675.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 091687 (pdf 91687.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE) PROMETHAZINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 200386 (pdf 200386.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 200894 (pdf 200894.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 040674 (pdf 40674.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 040675 (pdf 40675.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 200963 (pdf 200963.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 209177 (pdf 209177.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 214238 (pdf 214238.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 213890 (pdf 213890.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 216446 (pdf 216446.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , 98 ; PHENYLEPHRINE ; 59-42-7 ; 1952 ; ; ; CLASS CARDIOVASCULAR -- SELECTIVE ADRENERGIC ALPHA-1 AGONISTS -- CARDIOTONIC AGENTS -- MYDRIATICS -- NASAL DECONGESTANTS -- SYMPATHOMIMETICS -- VASOCONSTRICTOR AGENTS , ; NDA 007953 (pdf 7953.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PYRILAMINE MALEATE) PREFRIN-A (ALLERGAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008306 (label 8306.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENERGAN VC W/ CODEINE (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008604 (pdf 8604.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC (ANI PHARMS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 013296 (pdf 13296.pdf not found) INN (ISOPROTERENOL HYDROCHLORIDE PHENYLEPHRINE BITARTRATE) DUO-MEDIHALER (3M) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 040654 (pdf 40654.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 040660 (pdf 40660.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 084300 (pdf 84300.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE) CYCLOMYDRIL (ALCON LABS INC) APPROVAL= AP YEAR= 1975 , NDA 088761 (pdf 88761.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC PLAIN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088764 (label 88764.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC W/ CODEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088815 (pdf 88815.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088816 (pdf 88816.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088868 (pdf 88868.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088870 (pdf 88870.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088896 (pdf 88896.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088897 (pdf 88897.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 040902 (pdf 40902.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 022565 (label 22565.pdf) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL CONGESTION RELIEF (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2010 , NDA 022113 (label 22113.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL ALLERGY AND CONGESTION RELIEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2011 , NDA 203826 (label 203826.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2012 , NDA 203510 (label 203510.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (PARAGON BIOTECK) APPROVAL= AP YEAR= 2013 , NDA 040674 (pdf 40674.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AKORN) APPROVAL= AP YEAR= 2014 , NDA 040675 (pdf 40675.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2014 , NDA 203200 (pdf 203200.pdf not found) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2014 , NDA 204300 (label 204300.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) VAZCULEP (EXELA PHARMA) APPROVAL= AP YEAR= 2014 , NDA 205388 (label 205388.pdf) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) OMIDRIA (RAYNER SURGICAL) APPROVAL= AP YEAR= 2014 , NDA 207926 (label 207926.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (ALCON) APPROVAL= AP YEAR= 2015 , NDA 200963 (pdf 200963.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 210333 (pdf 210333.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2018 , NDA 210334 (pdf 210334.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2018 , NDA 210025 (pdf 210025.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 , NDA 211078 (pdf 211078.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211079 (pdf 211079.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 208905 (pdf 208905.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2019 , NDA 210665 (pdf 210665.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 210666 (pdf 210666.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 210183 (pdf 210183.pdf not found) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 212909 (label 212909.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE) BIORPHEN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2019 , NDA 209967 (pdf 209967.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 211081 (pdf 211081.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (PROVEPHARM SAS) APPROVAL= AP YEAR= 2020 , NDA 211920 (pdf 211920.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213237 (pdf 213237.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213318 (pdf 213318.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2020 , NDA 210697 (pdf 210697.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 210696 (pdf 210696.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216859 (pdf 216859.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 217069 (pdf 217069.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 209968 (pdf 209968.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 215352 (label 215352.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE TROPICAMIDE) MYDCOMBI (EYENOVIA) APPROVAL= AP YEAR= 2023 , NDA 216496 (pdf 216496.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217521 (pdf 217521.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (BE PHARMS) APPROVAL= AP YEAR= 2023 , NDA 215183 (pdf 215183.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2024 , NDA 218110 (pdf 218110.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2024 , NDA 218412 (pdf 218412.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE (HAINAN POLY) APPROVAL= AP YEAR= 2024 , 99 ; HEXYLCAINE ; 532-77-4 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- LOCAL ANESTHETICS , ; NDA 008472 (pdf 8472.pdf not found) INN (HEXYLCAINE HYDROCHLORIDE) CYCLAINE (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , 100 ; PYRILAMINE ; 91-84-9 ; 1973 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- SEDATIVES , ; NDA 007953 (pdf 7953.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PYRILAMINE MALEATE) PREFRIN-A (ALLERGAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080808 (pdf 80808.pdf not found) INN (PYRILAMINE MALEATE) PYRILAMINE MALEATE (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 085231 (pdf 85231.pdf not found) INN (PYRILAMINE MALEATE) PYRILAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , 101 ; EDROPHONIUM ; 312-48-1 ; 1951 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDOTES -- ACETYLCHOLINESTERASE INHIBITOR -- REVERSAL AGENT OF NON DEPOLARIZING NEUROMUSCULAR RELAXANT , ; NDA 007959 (pdf 7959.pdf not found) INN (EDROPHONIUM CHLORIDE) TENSILON (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , NDA 019677 (label 19677.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019678 (label 19678.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 040043 (pdf 40043.pdf not found) INN (EDROPHONIUM CHLORIDE) EDROPHONIUM CHLORIDE PRESERVATIVE FREE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040044 (pdf 40044.pdf not found) INN (EDROPHONIUM CHLORIDE) EDROPHONIUM CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040131 (pdf 40131.pdf not found) INN (EDROPHONIUM CHLORIDE) EDROPHONIUM CHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 088873 (pdf 88873.pdf not found) INN (EDROPHONIUM CHLORIDE) ENLON (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089624 (pdf 89624.pdf not found) INN (EDROPHONIUM CHLORIDE) REVERSOL (ORGANON USA INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , 102 ; BROMODIPHENHYDRAMINE ; 1808-12-4 ; 1954 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIHISTAMINES -- HISTAMINE H1 RECEPTOR ANTAGONIST , ; NDA 007984 (pdf 7984.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE) AMBODRYL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009319 (pdf 9319.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) AMBENYL (FOREST LABS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 088343 (pdf 88343.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMANYL (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088626 (pdf 88626.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , 103 ; METHOTREXATE ; 59-05-2 ; 1953 ; ; ; CLASS ANTINEOPLASTIC -- FOLIC ACID ANTAGONISTS -- IMMUNOSUPPRESSIVE AGENTS -- NUCLEIC ACID SYNTHESIS INHIBITORS -- ANTIMETABOLITES -- TREATMENT OF SEVERE PSORIASIS AND ADULT RHEUMATOID ARTHRITIS -- ANTIMALARIALS , ; NDA 008085 (label 8085.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 011719 (label 11719.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1959 , NDA 040054 (label 40054.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 040233 (pdf 40233.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040263 (label 40263.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040265 (label 40265.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040266 (label 40266.pdf) INN (METHOTREXATE SODIUM) METHOTREXATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040385 (pdf 40385.pdf not found) INN (METHOTREXATE SODIUM) TREXALL (BARR) APPROVAL= AP YEAR= 2001 , NDA 040632 (pdf 40632.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2005 , NDA 040716 (pdf 40716.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 040767 (pdf 40767.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 040768 (pdf 40768.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 081099 (pdf 81099.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (BARR) APPROVAL= AP YEAR= 1990 , NDA 081235 (pdf 81235.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (MYLAN) APPROVAL= AP YEAR= 1992 , NDA 081242 (pdf 81242.pdf not found) INN (METHOTREXATE SODIUM) FOLEX PFS (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 086358 (pdf 86358.pdf not found) INN (METHOTREXATE SODIUM) MEXATE (BRISTOL) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087695 (pdf 87695.pdf not found) INN (METHOTREXATE SODIUM) FOLEX (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088648 (pdf 88648.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (NORBROOK) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088760 (pdf 88760.pdf not found) INN (METHOTREXATE SODIUM) MEXATE-AQ (BRISTOL MYERS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088935 (pdf 88935.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088936 (pdf 88936.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088937 (pdf 88937.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088954 (pdf 88954.pdf not found) INN (METHOTREXATE SODIUM) FOLEX (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089158 (pdf 89158.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (PHARMACHEMIE USA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089161 (pdf 89161.pdf not found) INN (METHOTREXATE SODIUM) ABITREXATE (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089180 (pdf 89180.pdf not found) INN (METHOTREXATE SODIUM) FOLEX PFS (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089263 (pdf 89263.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089293 (pdf 89293.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089294 (pdf 89294.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089295 (pdf 89295.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089296 (pdf 89296.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089308 (pdf 89308.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089309 (pdf 89309.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089322 (pdf 89322.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089323 (pdf 89323.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089340 (pdf 89340.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1986 , NDA 089341 (pdf 89341.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (HIKMA) APPROVAL= AP YEAR= 1986 , NDA 089342 (pdf 89342.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (HIKMA) APPROVAL= AP YEAR= 1986 , NDA 089343 (pdf 89343.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1986 , NDA 089354 (pdf 89354.pdf not found) INN (METHOTREXATE SODIUM) ABITREXATE (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089355 (pdf 89355.pdf not found) INN (METHOTREXATE SODIUM) ABITREXATE (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089356 (pdf 89356.pdf not found) INN (METHOTREXATE SODIUM) ABITREXATE (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089887 (pdf 89887.pdf not found) INN (METHOTREXATE SODIUM) MEXATE-AQ PRESERVED (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 040843 (pdf 40843.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (PHARMACHEMIE BV) APPROVAL= AP YEAR= 2010 , NDA 040850 (pdf 40850.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE () APPROVAL= AP YEAR= 2010 , NDA 040853 (pdf 40853.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE () APPROVAL= AP YEAR= 2010 , NDA 090029 (pdf 90029.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 090039 (pdf 90039.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 200171 (pdf 200171.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE PRESERVATIVE FREE () APPROVAL= AP YEAR= 2012 , NDA 201529 (pdf 201529.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201530 (pdf 201530.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (MYLAN) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204824 (label 204824.pdf) INN (METHOTREXATE) OTREXUP (OTTER PHARMS) APPROVAL= AP YEAR= 2013 , NDA 205776 (label 205776.pdf) INN (METHOTREXATE) RASUVO (MEDEXUS) APPROVAL= AP YEAR= 2014 , NDA 201749 (pdf 201749.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2015 , NDA 207812 (pdf 207812.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208400 (label 208400.pdf) INN (METHOTREXATE SODIUM) XATMEP (AZURITY) APPROVAL= AP YEAR= 2017 , NDA 210040 (pdf 210040.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203407 (pdf 203407.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM PRESERVATIVE FREE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 210737 (label 210737.pdf) INN (METHOTREXATE) REDITREX (NORDIC GRP) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210454 (pdf 210454.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213343 (pdf 213343.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214121 (label 214121.pdf) INN (METHOTREXATE) METHOTREXATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209787 (pdf 209787.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212479 (label 212479.pdf) INN (METHOTREXATE) JYLAMVO (SHORLA) APPROVAL= AP YEAR= 2022 , NDA 213362 (pdf 213362.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (DAITO) APPROVAL= AP YEAR= 2023 , NDA 216453 (pdf 216453.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ELITE LABS INC) APPROVAL= AP YEAR= 2024 , NDA 217552 (pdf 217552.pdf not found) INN (METHOTREXATE SODIUM) METHOTREXATE SODIUM (ALEMBIC) APPROVAL= AP YEAR= 2024 , 104 ; CHLOROTRIANISENE ; 569-57-3 ; 0 ; DISCONTINUED ; ; CLASS GENITO -- ANTINEOPLASTIC AGENTS -- ESTROGENIC , ; NDA 008102 (pdf 8102.pdf not found) INN (CHLOROTRIANISENE) TACE (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011444 (pdf 11444.pdf not found) INN (CHLOROTRIANISENE) TACE (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016235 (pdf 16235.pdf not found) INN (CHLOROTRIANISENE) TACE (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084652 (pdf 84652.pdf not found) INN (CHLOROTRIANISENE) CHLOROTRIANISENE (BANNER PHARMACAPS) APPROVAL= - YEAR= 0 DISCONTINUED , 105 ; LEUCOVORIN ; 58-05-9 ; 1952 ; ; ; CLASS VARIOUS -- ANTIANEMIC -- ANTIDOTE TO FOLIC ACID ANTAGONISTS -- ANTINEOPLASTIC ADJUNCTS -- RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA -- USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL -- RAPIDLY ABSORBED AND ENTERS THE GENERAL BODY POOL OF REDUCED FOLATES -- CONVERTED TO 5-METHYLTETRAHYDROFOLIC ACID (5-METHYL-THF) , ; NDA 008107 (pdf 8107.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HOSPIRA) APPROVAL= AP YEAR= 1952 NEWMOLECULARENTITY DISCONTINUED , NDA 018342 (pdf 18342.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018459 (pdf 18459.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 040056 (label 40056.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 040147 (pdf 40147.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040174 (pdf 40174.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040258 (pdf 40258.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040262 (label 40262.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040286 (pdf 40286.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040332 (pdf 40332.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040335 (label 40335.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 040338 (pdf 40338.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (AM REGENT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040347 (label 40347.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 070480 (pdf 70480.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ELKINS SINN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071104 (pdf 71104.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071198 (pdf 71198.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (BARR) APPROVAL= AP YEAR= 1987 , NDA 071199 (pdf 71199.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (BARR) APPROVAL= AP YEAR= 1987 , NDA 071598 (pdf 71598.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071600 (pdf 71600.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071962 (pdf 71962.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072733 (pdf 72733.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072734 (pdf 72734.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072735 (pdf 72735.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072736 (pdf 72736.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 073099 (pdf 73099.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 073101 (pdf 73101.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074544 (pdf 74544.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 , NDA 075327 (pdf 75327.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ANI PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 081224 (pdf 81224.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ELKINS SINN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081277 (pdf 81277.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 081278 (pdf 81278.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 087439 (pdf 87439.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088939 (pdf 88939.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089352 (pdf 89352.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089353 (pdf 89353.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089384 (label 89384.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 089465 (pdf 89465.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089496 (pdf 89496.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089503 (pdf 89503.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089504 (pdf 89504.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089628 (pdf 89628.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 089636 (pdf 89636.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089717 (label 89717.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1988 , NDA 089833 (pdf 89833.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089834 (pdf 89834.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089915 (pdf 89915.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 200753 (pdf 200753.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 200855 (pdf 200855.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 203800 (pdf 203800.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 209110 (pdf 209110.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207241 (pdf 207241.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 207226 (pdf 207226.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210917 (pdf 210917.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (NOVAST LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211132 (pdf 211132.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 213929 (pdf 213929.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (LEADING) APPROVAL= AP YEAR= 2020 , NDA 216590 (pdf 216590.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 217021 (pdf 217021.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HAINAN POLY) APPROVAL= AP YEAR= 2023 , 106 ; DIPHEMANIL ; 15394-62-4 ; 1976 ; DISCONTINUED ; ; CLASS METABOLISM -- TREATMENT OF DERMATOSES -- ANTICHOLINERGIC -- ANTIMUSCARINIC , ; NDA 008114 (pdf 8114.pdf not found) INN (DIPHEMANIL METHYLSULFATE) PRANTAL (SCHERING) APPROVAL= AP YEAR= 1976 DISCONTINUED , 107 ; MONOBENZONE ; 103-16-2 ; 1952 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- DEPIGMENTOR , ; NDA 008173 (label 8173.pdf) INN (MONOBENZONE) BENOQUIN (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1952 NEWMOLECULARENTITY DISCONTINUED , 108 ; HYDROCORTISONE ; 50-23-7 ; 1952 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- ADRENAL INSUFFICIENCY (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 008506 (pdf 8506.pdf not found) INN (HYDROCORTISONE) HYDROCORTONE (MERCK) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008697 (label 8697.pdf) INN (HYDROCORTISONE) CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1952 , NDA 009127 (pdf 9127.pdf not found) INN (HYDROCORTISONE) CORTRIL (PFIZER) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 009176 (pdf 9176.pdf not found) INN (HYDROCORTISONE) CORTRIL (PFIZER GLOBAL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 009585 (pdf 9585.pdf not found) INN (HYDROCORTISONE) CORT-DOME (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009659 (pdf 9659.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PANRAY) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 009796 (pdf 9796.pdf not found) INN (HYDROCORTISONE) CORTRIL (PFIPHARMECS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009864 (pdf 9864.pdf not found) INN (HYDROCORTISONE) CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009866 (label 9866.pdf) INN (HYDROCORTISONE SODIUM SUCCINATE) SOLU-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1955 , NDA 009895 (pdf 9895.pdf not found) INN (HYDROCORTISONE) CORT-DOME (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012052 (pdf 12052.pdf not found) INN (HYDROCORTISONE SODIUM PHOSPHATE) HYDROCORTONE (MERCK) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012770 (label 12770.pdf) INN (ACETIC ACID GLACIAL HYDROCORTISONE) VOSOL HC (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1961 , NDA 016199 (label 16199.pdf) INN (HYDROCORTISONE) CORTENEMA (ANI PHARMS) APPROVAL= AP YEAR= 1966 , NDA 020805 (label 20805.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE HYDROCORTISONE) CIPRO HC (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 040097 (pdf 40097.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) HYDROCORTISONE AND ACETIC ACID (BAUSCH AND LOMB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040168 (label 40168.pdf) INN (ACETIC ACID GLACIAL HYDROCORTISONE) HYDROCORTISONE AND ACETIC ACID (WOCKHARDT) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040247 (pdf 40247.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1999 , NDA 040310 (label 40310.pdf) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040351 (pdf 40351.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040417 (pdf 40417.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040503 (pdf 40503.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040609 (pdf 40609.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) HYDROCORTISONE AND ACETIC ACID (COSETTE) APPROVAL= AP YEAR= 2006 , NDA 040646 (pdf 40646.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (IMPAX LABS INC) APPROVAL= AP YEAR= 2007 , NDA 040666 (pdf 40666.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (HOSPIRA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040761 (pdf 40761.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 050168 (label 50168.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050169 (label 50169.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050237 (pdf 50237.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE) NEO-CORT-DOME (BAYER PHARMS) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050238 (pdf 50238.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE NEOMYCIN SULFATE) NEO-CORT-DOME (BAYER PHARMS) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 050272 (pdf 50272.pdf not found) INN (HYDROCORTISONE TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (LEDERLE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050416 (label 50416.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050479 (label 50479.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 060613 (label 60613.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CASPORYN HC (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1975 , NDA 060730 (pdf 60730.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOCORT (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061606 (pdf 61606.pdf not found) INN (HYDROCORTISONE POLYMYXIN B SULFATE) PYOCIDIN (FOREST LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061816 (pdf 61816.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOBIONE (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062302 (pdf 62302.pdf not found) INN (HYDROCORTISONE POLYMYXIN B SULFATE) OTOBIOTIC (SCHERING) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062381 (pdf 62381.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062389 (pdf 62389.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) ZINC BACITRACIN , NEOMYCIN SULFATE , POLYMYXIN B SULFATE & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062394 (pdf 62394.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062399 (pdf 62399.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTICAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062423 (pdf 62423.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1983 , NDA 062488 (pdf 62488.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1985 , NDA 062521 (pdf 62521.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOCORT (ACTAVIS LABS FL INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062617 (pdf 62617.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE , POLYMYXIN B SULFATE & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062623 (pdf 62623.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062822 (pdf 62822.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) PEDIOTIC (MONARCH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062874 (pdf 62874.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 064053 (pdf 64053.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064065 (pdf 64065.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTICAIR (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 , NDA 064068 (pdf 64068.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 065216 (pdf 65216.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (AMRING PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065219 (pdf 65219.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (AMRING PHARMS) APPROVAL= AP YEAR= 2006 , NDA 074171 (pdf 74171.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 075172 (pdf 75172.pdf not found) INN (HYDROCORTISONE) COLOCORT (CHARTWELL) APPROVAL= AP YEAR= 1999 , NDA 080344 (pdf 80344.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080355 (pdf 80355.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080395 (pdf 80395.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080400 (pdf 80400.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TEVA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080425 (pdf 80425.pdf not found) INN (HYDROCORTISONE) TEXACORT (MISSION PHARMA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080426 (pdf 80426.pdf not found) INN (HYDROCORTISONE) CETACORT (BAUSCH) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080438 (pdf 80438.pdf not found) INN (HYDROCORTISONE) HC #1 (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080442 (pdf 80442.pdf not found) INN (HYDROCORTISONE) NUTRACORT (BAUSCH) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080443 (pdf 80443.pdf not found) INN (HYDROCORTISONE) NUTRACORT (DOW PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080452 (pdf 80452.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080456 (pdf 80456.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (INGRAM PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080459 (pdf 80459.pdf not found) INN (HYDROCORTISONE) ELDECORT (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 080472 (pdf 80472.pdf not found) INN (HYDROCORTISONE) HYTONE (VALEANT INTL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080473 (pdf 80473.pdf not found) INN (HYDROCORTISONE) HYTONE (VALEANT INTL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080474 (pdf 80474.pdf not found) INN (HYDROCORTISONE) HYTONE (DERMIK LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080481 (pdf 80481.pdf not found) INN (HYDROCORTISONE) HC HYDROCORTISONE (C AND M PHARMA) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080482 (pdf 80482.pdf not found) INN (HYDROCORTISONE) HC HYDROCORTISONE (C AND M PHARMA) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080483 (pdf 80483.pdf not found) INN (HYDROCORTISONE) HI-COR (C AND M PHARMA) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080489 (pdf 80489.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ALTANA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 080496 (pdf 80496.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080568 (pdf 80568.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FERRANTE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080624 (pdf 80624.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080642 (pdf 80642.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080692 (pdf 80692.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1975 , NDA 080693 (pdf 80693.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1976 , NDA 080706 (pdf 80706.pdf not found) INN (HYDROCORTISONE) ALA-CORT (CROWN LABS) APPROVAL= AP YEAR= 1973 , NDA 080732 (pdf 80732.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080781 (pdf 80781.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080848 (pdf 80848.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 081203 (pdf 81203.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1993 , NDA 081271 (pdf 81271.pdf not found) INN (HYDROCORTISONE) TEXACORT (MISSION PHARMA) APPROVAL= AP YEAR= 1992 , NDA 083011 (pdf 83011.pdf not found) INN (HYDROCORTISONE) PROCTOCORT (MONARCH PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083140 (pdf 83140.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083201 (pdf 83201.pdf not found) INN (HYDROCORTISONE) ALA-CORT (CROWN LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083219 (pdf 83219.pdf not found) INN (HYDROCORTISONE) EPICORT (BLULINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083231 (pdf 83231.pdf not found) INN (HYDROCORTISONE) ALA-SCALP (LEGACY PHARMA) APPROVAL= AP YEAR= 1973 , NDA 083365 (pdf 83365.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083947 (pdf 83947.pdf not found) INN (HYDROCORTISONE UREA) CALMURID HC (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083999 (pdf 83999.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (BARR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084055 (pdf 84055.pdf not found) INN (HYDROCORTISONE) ELDECORT (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084059 (pdf 84059.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (G AND W LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084243 (pdf 84243.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084247 (pdf 84247.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084573 (pdf 84573.pdf not found) INN (HYDROCORTISONE) DERMACORT (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084698 (pdf 84698.pdf not found) INN (HYDROCORTISONE) NUTRACORT (HEALTHPOINT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084737 (pdf 84737.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084738 (pdf 84738.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084747 (pdf 84747.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084748 (pdf 84748.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084969 (pdf 84969.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084970 (pdf 84970.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085025 (pdf 85025.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PADAGIS US) APPROVAL= AP YEAR= 1982 , NDA 085026 (pdf 85026.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085027 (pdf 85027.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PADAGIS US) APPROVAL= AP YEAR= 1977 , NDA 085028 (pdf 85028.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085070 (pdf 85070.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085191 (pdf 85191.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085282 (pdf 85282.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (MERICON) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085492 (pdf 85492.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) ACETIC ACID W/ HYDROCORTISONE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085527 (pdf 85527.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (SYOSSET) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085662 (pdf 85662.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085663 (pdf 85663.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085733 (pdf 85733.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (IVAX PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085805 (pdf 85805.pdf not found) INN (HYDROCORTISONE) AEROSEB-HC (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085928 (pdf 85928.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (ABBOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085929 (pdf 85929.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085930 (pdf 85930.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085931 (pdf 85931.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085932 (pdf 85932.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085982 (pdf 85982.pdf not found) INN (HYDROCORTISONE) HYDRO-RX (X GEN PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086008 (pdf 86008.pdf not found) INN (HYDROCORTISONE UREA) ALPHADERM (BIOGLAN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086079 (pdf 86079.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (AMBIX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086080 (pdf 86080.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (AMBIX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086154 (pdf 86154.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086155 (pdf 86155.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086170 (pdf 86170.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (STIEFEL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086256 (pdf 86256.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086257 (pdf 86257.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1978 , NDA 086271 (pdf 86271.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (AMBIX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086272 (pdf 86272.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (AMBIX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086462 (pdf 86462.pdf not found) INN (HYDROCORTISONE) DERMACORT (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086535 (pdf 86535.pdf not found) INN (HYDROCORTISONE) ACTICORT (BAKER NORTON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086619 (pdf 86619.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086823 (pdf 86823.pdf not found) INN (HYDROCORTISONE) H-CORT (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086824 (pdf 86824.pdf not found) INN (HYDROCORTISONE) H-CORT (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086844 (pdf 86844.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) ORLEX HC (WARNER CHILCOTT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087136 (pdf 87136.pdf not found) INN (HYDROCORTISONE) FLEXICORT (WESTWOOD SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087143 (pdf 87143.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) ACETASOL HC (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087315 (pdf 87315.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087317 (pdf 87317.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087427 (pdf 87427.pdf not found) INN (HYDROCORTISONE) NOGENIC HC (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087457 (pdf 87457.pdf not found) INN (HYDROCORTISONE) SYNACORT (BAUSCH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087458 (pdf 87458.pdf not found) INN (HYDROCORTISONE) SYNACORT (BAUSCH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087459 (pdf 87459.pdf not found) INN (HYDROCORTISONE) SYNACORT (BAUSCH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087489 (pdf 87489.pdf not found) INN (HYDROCORTISONE) GLYCORT (HERAN) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087532 (pdf 87532.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087567 (pdf 87567.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087568 (pdf 87568.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087569 (pdf 87569.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087644 (pdf 87644.pdf not found) INN (HYDROCORTISONE) NUTRACORT (DOW PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087795 (pdf 87795.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 , NDA 087796 (pdf 87796.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087834 (pdf 87834.pdf not found) INN (HYDROCORTISONE) H-CORT (TORCH) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087838 (pdf 87838.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088027 (pdf 88027.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088029 (pdf 88029.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088039 (pdf 88039.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088041 (pdf 88041.pdf not found) INN (HYDROCORTISONE) BALNEOL-HC (SOLVAY) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088061 (pdf 88061.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088082 (pdf 88082.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PADDOCK LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088138 (pdf 88138.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE IN ABSORBASE (CMP PHARMA INC) APPROVAL= AP YEAR= 1985 , NDA 088214 (pdf 88214.pdf not found) INN (HYDROCORTISONE) PENECORT (ALLERGAN HERBERT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088215 (pdf 88215.pdf not found) INN (HYDROCORTISONE) PENECORT (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088216 (pdf 88216.pdf not found) INN (HYDROCORTISONE) PENECORT (ALLERGAN HERBERT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088217 (pdf 88217.pdf not found) INN (HYDROCORTISONE) PENECORT (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088250 (pdf 88250.pdf not found) INN (HYDROCORTISONE) ANUSOL HC (SALIX PHARMS) APPROVAL= AP YEAR= 1984 , NDA 088539 (pdf 88539.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088667 (pdf 88667.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088668 (pdf 88668.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088669 (pdf 88669.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088670 (pdf 88670.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088712 (pdf 88712.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) HYDROCORTISONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088759 (pdf 88759.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE) HYDROCORTISONE AND ACETIC ACID (TARO) APPROVAL= AP YEAR= 1985 , NDA 088799 (pdf 88799.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1984 , NDA 088842 (pdf 88842.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PHARMADERM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088845 (pdf 88845.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089024 (pdf 89024.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TARO) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089066 (pdf 89066.pdf not found) INN (HYDROCORTISONE) STIE-CORT (PADAGIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089074 (pdf 89074.pdf not found) INN (HYDROCORTISONE) STIE-CORT (PADAGIS US) APPROVAL= AP YEAR= 1985 , NDA 089273 (pdf 89273.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (TOPIDERM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089413 (pdf 89413.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089414 (pdf 89414.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1986 , NDA 089495 (pdf 89495.pdf not found) INN (HYDROCORTISONE) BETA-HC (BETA DERMAC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089577 (pdf 89577.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089578 (pdf 89578.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089579 (pdf 89579.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089580 (pdf 89580.pdf not found) INN (HYDROCORTISONE SODIUM SUCCINATE) A-HYDROCORT (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089581 (pdf 89581.pdf not found) INN (HYDROCORTISONE SODIUM PHOSPHATE) HYDROCORTISONE SODIUM PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089682 (pdf 89682.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1988 , NDA 089704 (pdf 89704.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (NASKA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089705 (pdf 89705.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (NASKA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089706 (pdf 89706.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (NASKA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089754 (pdf 89754.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 022436 (label 22436.pdf) INN (ACYCLOVIR HYDROCORTISONE) XERESE (BAUSCH) APPROVAL= AP YEAR= 2009 , NDA 040879 (pdf 40879.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (RISING) APPROVAL= AP YEAR= 2010 , NDA 065213 (pdf 65213.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 207029 (pdf 207029.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203804 (pdf 203804.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 203810 (pdf 203810.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213876 (label 213876.pdf) INN (HYDROCORTISONE) ALKINDI SPRINKLE (ETON) APPROVAL= AP YEAR= 2020 , NDA 214649 (pdf 214649.pdf not found) INN (HYDROCORTISONE) HYDROCORTISONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 109 ; HYDROCORTISONE ACETATE ; 50-03-3 ; 1951 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- RAPIDLY HYDROLYZED IN HYDROCORTISONE , ; NDA 080419 (pdf 80419.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086050 (pdf 86050.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 008228 (pdf 8228.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTONE (MERCK) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008917 (pdf 8917.pdf not found) INN (HYDROCORTISONE ACETATE) CORTEF ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 009018 (pdf 9018.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTONE (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009164 (pdf 9164.pdf not found) INN (HYDROCORTISONE ACETATE) CORTRIL (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009378 (pdf 9378.pdf not found) INN (HYDROCORTISONE ACETATE) CORTEF ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 009637 (pdf 9637.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 017351 (label 17351.pdf) INN (HYDROCORTISONE ACETATE) CORTIFOAM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1982 , NDA 040259 (pdf 40259.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (IMPERIUM) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040396 (pdf 40396.pdf not found) INN (HYDROCORTISONE ACETATE) MICORT-HC (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2001 , NDA 040398 (pdf 40398.pdf not found) INN (HYDROCORTISONE ACETATE) MICORT-HC (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 050201 (pdf 50201.pdf not found) INN (CHLORAMPHENICOL HYDROCORTISONE ACETATE POLYMYXIN B SULFATE) OPHTHOCORT (PARKEDALE) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 050202 (pdf 50202.pdf not found) INN (CHLORAMPHENICOL HYDROCORTISONE ACETATE) CHLOROMYCETIN HYDROCORTISONE (PARKEDALE) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 050218 (pdf 50218.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 050356 (label 50356.pdf) INN (COLISTIN SULFATE HYDROCORTISONE ACETATE NEOMYCIN SULFATE THONZONIUM BROMIDE) COLY-MYCIN S (ENDO OPERATIONS) APPROVAL= AP YEAR= 1962 , NDA 060188 (pdf 60188.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) COR-OTICIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 060610 (pdf 60610.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060612 (pdf 60612.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060731 (pdf 60731.pdf not found) INN (BACITRACIN HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060751 (pdf 60751.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 061016 (pdf 61016.pdf not found) INN (HYDROCORTISONE ACETATE OXYTETRACYCLINE HYDROCHLORIDE) TERRA-CORTRIL (PFIZER) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 061049 (pdf 61049.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062166 (pdf 62166.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 080505 (pdf 80505.pdf not found) INN (HYDROCORTISONE ACETATE) CARMOL HC (FOUGERA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080828 (pdf 80828.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (FERA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 081274 (pdf 81274.pdf not found) INN (HYDROCORTISONE ACETATE) HEMSOL-HC (ABLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083128 (pdf 83128.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 083205 (pdf 83205.pdf not found) INN (HYDROCORTISONE ACETATE) ORABASE HCA (COLGATE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083213 (pdf 83213.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (FERNDALE LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083739 (pdf 83739.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (BEL MAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083759 (pdf 83759.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083778 (pdf 83778.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1976 , NDA 085214 (pdf 85214.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085368 (pdf 85368.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1977 , NDA 085979 (pdf 85979.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 085980 (pdf 85980.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 085981 (pdf 85981.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (X GEN PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086052 (pdf 86052.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086195 (pdf 86195.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PROCTOFOAM HC (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1978 , NDA 086207 (pdf 86207.pdf not found) INN (HYDROCORTISONE ACETATE) DRICORT (INGRAM PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086457 (pdf 86457.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) EPIFOAM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1979 , NDA 089440 (pdf 89440.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% (GENUS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089472 (pdf 89472.pdf not found) INN (HYDROCORTISONE ACETATE) U-CORT (TARO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089914 (pdf 89914.pdf not found) INN (HYDROCORTISONE ACETATE) HYDROCORTISONE ACETATE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 110 ; HYDROCORTISONE VALERATE ; 57524-89-7 ; 1978 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- RAPIDLY HYDROLYZED IN HYDROCORTISONE , ; NDA 017950 (label 17950.pdf) INN (HYDROCORTISONE VALERATE) WESTCORT (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018726 (label 18726.pdf) INN (HYDROCORTISONE VALERATE) WESTCORT (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 074489 (label 74489.pdf) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (COSETTE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075042 (label 75042.pdf) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (TARO) APPROVAL= AP YEAR= 1998 , NDA 075043 (label 75043.pdf) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (TARO) APPROVAL= AP YEAR= 1998 , NDA 075085 (pdf 75085.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075666 (pdf 75666.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2000 , NDA 211129 (pdf 211129.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 211750 (pdf 211750.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 210307 (pdf 210307.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211764 (pdf 211764.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (COSETTE) APPROVAL= AP YEAR= 2020 , NDA 213724 (pdf 213724.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (COSETTE) APPROVAL= AP YEAR= 2021 , NDA 211047 (pdf 211047.pdf not found) INN (HYDROCORTISONE VALERATE) HYDROCORTISONE VALERATE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2021 , 111 ; HYDROCORTISONE BUTYRATE ; 13609-67-1 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- RAPIDLY HYDROLYZED IN HYDROCORTISONE , ; NDA 018514 (label 18514.pdf) INN (HYDROCORTISONE BUTYRATE) LOCOID (BAUSCH) APPROVAL= AP YEAR= 1982 , NDA 018652 (label 18652.pdf) INN (HYDROCORTISONE BUTYRATE) LOCOID (PRECISION DERMAT) APPROVAL= AP YEAR= 1982 , NDA 018795 (pdf 18795.pdf not found) INN (HYDROCORTISONE BUTYRATE) LOCOID (YAMANOUCHI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019106 (pdf 19106.pdf not found) INN (HYDROCORTISONE BUTYRATE) LOCOID (YAMANOUCHI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019116 (label 19116.pdf) INN (HYDROCORTISONE BUTYRATE) LOCOID (BAUSCH) APPROVAL= AP YEAR= 1987 , NDA 019819 (pdf 19819.pdf not found) INN (HYDROCORTISONE BUTYRATE) LOCOID (YAMANOUCHI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020769 (label 20769.pdf) INN (HYDROCORTISONE BUTYRATE) LOCOID LIPOCREAM (PRECISION DERMAT) APPROVAL= AP YEAR= 1997 , NDA 022076 (label 22076.pdf) INN (HYDROCORTISONE BUTYRATE) LOCOID (BAUSCH) APPROVAL= AP YEAR= 2007 , NDA 076364 (pdf 76364.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (TARO PHARM INDS) APPROVAL= AP YEAR= 2004 , NDA 076654 (pdf 76654.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (TARO PHARM INDS) APPROVAL= AP YEAR= 2005 , NDA 076842 (pdf 76842.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 202145 (label 202145.pdf) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 205134 (pdf 205134.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2017 , NDA 209556 (pdf 209556.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (THE J MOLNER) APPROVAL= AP YEAR= 2017 , NDA 210209 (pdf 210209.pdf not found) INN (HYDROCORTISONE BUTYRATE) HYDROCORTISONE BUTYRATE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , 112 ; MEPHENTERMINE ; 100-92-5 ; 1951 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- SYMPATHOMIMETICS -- VASOCONSTRICTOR AGENTS -- STIMULANT -- METHAMPHETAMINE ANALOG , ; NDA 008248 (pdf 8248.pdf not found) INN (MEPHENTERMINE SULFATE) WYAMINE SULFATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1951 DISCONTINUED , 113 ; HYDRALAZINE ; 86-54-4 ; 1953 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- VASODILATOR AGENTS -- SELECTIVE DILATOR OF ARTERIAL SMOOTH MUSCLE -- POLYPHARMACOLOGY , ; NDA 008303 (label 8303.pdf) INN (HYDRALAZINE HYDROCHLORIDE) APRESOLINE (NOVARTIS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 009296 (pdf 9296.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE RESERPINE) SERPASIL-APRESOLINE (NOVARTIS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 012026 (pdf 12026.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESOLINE-ESIDRIX (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012193 (pdf 12193.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-AP-ES (NOVARTIS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 020727 (label 20727.pdf) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) BIDIL (AZURITY) APPROVAL= AP YEAR= 2005 , NDA 040136 (label 40136.pdf) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1997 , NDA 040373 (pdf 40373.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040388 (pdf 40388.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 040901 (pdf 40901.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2008 , NDA 083241 (pdf 83241.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083560 (pdf 83560.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083561 (pdf 83561.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083770 (pdf 83770.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083877 (pdf 83877.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROSERPINE PLUS R-H-H (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084106 (pdf 84106.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084107 (pdf 84107.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084291 (pdf 84291.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE , HYDROCHLOROTHIAZIDE AND RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084301 (pdf 84301.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) DRALZINE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084437 (pdf 84437.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084443 (pdf 84443.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084469 (pdf 84469.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084503 (pdf 84503.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084504 (pdf 84504.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084581 (pdf 84581.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084617 (pdf 84617.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE RESERPINE) DRALSERP (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 084735 (pdf 84735.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084810 (pdf 84810.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084811 (pdf 84811.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084876 (pdf 84876.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRAP-ES (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084897 (pdf 84897.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) CAM-AP-ES (CHARTWELL RX) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084922 (pdf 84922.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084923 (pdf 84923.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085088 (pdf 85088.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085373 (pdf 85373.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE W/ HYDRALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085440 (pdf 85440.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085446 (pdf 85446.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085457 (pdf 85457.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085532 (pdf 85532.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085533 (pdf 85533.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085549 (pdf 85549.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085771 (pdf 85771.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE , HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085827 (pdf 85827.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085893 (pdf 85893.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086088 (pdf 86088.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086242 (pdf 86242.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 1978 , NDA 086243 (pdf 86243.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086298 (pdf 86298.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086961 (pdf 86961.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1980 , NDA 086962 (pdf 86962.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1980 , NDA 087085 (pdf 87085.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087210 (pdf 87210.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-A-GEN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087213 (pdf 87213.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087556 (pdf 87556.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087608 (pdf 87608.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087609 (pdf 87609.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087709 (pdf 87709.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDROCHLOROTHIAZIDE , AND HYDRALAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087712 (pdf 87712.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (VANGARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087751 (pdf 87751.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087780 (pdf 87780.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087836 (pdf 87836.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 , NDA 087908 (pdf 87908.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088177 (pdf 88177.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088178 (pdf 88178.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088240 (pdf 88240.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088241 (pdf 88241.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088310 (pdf 88310.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088311 (pdf 88311.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088356 (pdf 88356.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088357 (pdf 88357.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088358 (pdf 88358.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088376 (pdf 88376.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088391 (pdf 88391.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 , NDA 088467 (pdf 88467.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 , NDA 088468 (pdf 88468.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 , NDA 088517 (pdf 88517.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088518 (pdf 88518.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088560 (pdf 88560.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088570 (pdf 88570.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088649 (pdf 88649.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088652 (pdf 88652.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088657 (pdf 88657.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088671 (pdf 88671.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088686 (pdf 88686.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088728 (pdf 88728.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088729 (pdf 88729.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088787 (pdf 88787.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088788 (pdf 88788.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088789 (pdf 88789.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088846 (pdf 88846.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088847 (pdf 88847.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088848 (pdf 88848.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088849 (pdf 88849.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088946 (pdf 88946.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 088957 (pdf 88957.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 088961 (pdf 88961.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089097 (pdf 89097.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 , NDA 089098 (pdf 89098.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 , NDA 089130 (pdf 89130.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089178 (pdf 89178.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089200 (pdf 89200.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089201 (pdf 89201.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089218 (pdf 89218.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089222 (pdf 89222.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089258 (pdf 89258.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089259 (pdf 89259.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089359 (pdf 89359.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089532 (pdf 89532.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040730 (pdf 40730.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2009 , NDA 040858 (pdf 40858.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 090255 (pdf 90255.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090527 (pdf 90527.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 090413 (pdf 90413.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200737 (pdf 200737.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091679 (pdf 91679.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ACTAVIS GRP PTC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200770 (pdf 200770.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2013 , NDA 202938 (pdf 202938.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (NAVINTA LLC) APPROVAL= AP YEAR= 2013 , NDA 203845 (pdf 203845.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203110 (pdf 203110.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (ADRASTEA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204680 (pdf 204680.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205236 (pdf 205236.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209251 (pdf 209251.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213667 (pdf 213667.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 215586 (pdf 215586.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 215147 (pdf 215147.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE) HYDRALAZINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 215988 (pdf 215988.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (I3 PHARMS) APPROVAL= AP YEAR= 2024 , 114 ; CODEINE ; 76-57-3 ; 1952 ; ; NATURAL MOLECULE C00001837 ; CLASS NERVOUS SYSTEM -- ANALGESICS -- ANTITUSSIVES -- NARCOTICS -- OPIATE AGONISTS , ; NDA 008306 (label 8306.pdf) INN (CODEINE PHOSPHATE) PHENERGAN W/ CODEINE (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 009319 (pdf 9319.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) AMBENYL (FOREST LABS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 011694 (pdf 11694.pdf not found) INN (CODEINE PHOSPHATE) DIMETANE-DC (ROBINS AH) APPROVAL= AP YEAR= 1958 DISCONTINUED OBSOLETE , NDA 012366 (label 12366.pdf) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) SOMA COMPOUND W/ CODEINE (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012575 (pdf 12575.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTIFED W/ CODEINE (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018928 (pdf 18928.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) PENNTUSS (FISONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019429 (label 19429.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORINAL W/CODEINE (ALLERGAN) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020232 (label 20232.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORICET W/ CODEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1992 , NDA 021369 (pdf 21369.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) CODEPREX (LANNETT CO INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040098 (label 40098.pdf) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040118 (pdf 40118.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040119 (pdf 40119.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PAI HOLDINGS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040151 (pdf 40151.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (AKORN) APPROVAL= AP YEAR= 1997 , NDA 040223 (pdf 40223.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040283 (pdf 40283.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (OXFORD PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040419 (pdf 40419.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SPECGX LLC) APPROVAL= AP YEAR= 2001 , NDA 040441 (pdf 40441.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CODRIX (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040443 (pdf 40443.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040447 (pdf 40447.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CODRIX (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040452 (pdf 40452.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040459 (pdf 40459.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040488 (pdf 40488.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CODRIX (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040650 (pdf 40650.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE WITH CODEINE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 040660 (pdf 40660.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 040779 (pdf 40779.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 074359 (pdf 74359.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074911 (pdf 74911.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) PHRENILIN WITH CAFFEINE AND CODEINE (VALEANT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 074951 (pdf 74951.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STEVENS J) APPROVAL= AP YEAR= 1998 , NDA 075231 (pdf 75231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075351 (pdf 75351.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075618 (pdf 75618.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075929 (pdf 75929.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2002 , NDA 076528 (pdf 76528.pdf not found) INN (CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2003 , NDA 076560 (pdf 76560.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2004 , NDA 081095 (pdf 81095.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081096 (pdf 81096.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081097 (pdf 81097.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081249 (pdf 81249.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081250 (pdf 81250.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 083643 (pdf 83643.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (CARNRICK) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083871 (pdf 83871.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083872 (pdf 83872.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083951 (pdf 83951.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) EMPRACET W/ CODEINE PHOSPHATE #3 (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084360 (pdf 84360.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084444 (pdf 84444.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 2 (ROBINS AH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084445 (pdf 84445.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 3 (ROBINS AH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084446 (pdf 84446.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 4 (ROBINS AH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084656 (pdf 84656.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084659 (pdf 84659.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084667 (pdf 84667.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085055 (pdf 85055.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 1 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085056 (pdf 85056.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085057 (pdf 85057.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085217 (pdf 85217.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (EVERYLIFE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085218 (pdf 85218.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085288 (pdf 85288.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085291 (pdf 85291.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085363 (pdf 85363.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085364 (pdf 85364.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085365 (pdf 85365.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085607 (pdf 85607.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085638 (pdf 85638.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 4 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085639 (pdf 85639.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 3 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085640 (pdf 85640.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 2 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085676 (pdf 85676.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085685 (pdf 85685.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PROVAL #3 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085794 (pdf 85794.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085795 (pdf 85795.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085856 (pdf 85856.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN-650 W/ CODEINE (ROBINS AH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085861 (pdf 85861.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085868 (pdf 85868.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085883 (pdf 85883.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085896 (pdf 85896.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085917 (pdf 85917.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085964 (pdf 85964.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085992 (pdf 85992.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086024 (pdf 86024.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (VALEANT PHARMS LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086366 (pdf 86366.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ACI) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086549 (pdf 86549.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086681 (pdf 86681.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086683 (pdf 86683.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087006 (pdf 87006.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087083 (pdf 87083.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1980 , NDA 087141 (pdf 87141.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087275 (pdf 87275.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087276 (pdf 87276.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087277 (pdf 87277.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087306 (pdf 87306.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087421 (pdf 87421.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 4 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087422 (pdf 87422.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 3 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087423 (pdf 87423.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087433 (pdf 87433.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087508 (pdf 87508.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 1981 , NDA 087653 (pdf 87653.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087762 (pdf 87762.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PURACAP PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087919 (pdf 87919.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087920 (pdf 87920.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088037 (pdf 88037.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PAPA-DEINE #3 (VANGARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088324 (pdf 88324.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088343 (pdf 88343.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMANYL (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088353 (pdf 88353.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088354 (pdf 88354.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088355 (pdf 88355.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088537 (pdf 88537.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088599 (pdf 88599.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088626 (pdf 88626.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088627 (pdf 88627.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 088628 (pdf 88628.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 088629 (pdf 88629.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088704 (pdf 88704.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIACIN-C (ANIMA) APPROVAL= AP YEAR= 1985 , NDA 088715 (pdf 88715.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PAPA-DEINE #4 (VANGARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088723 (pdf 88723.pdf not found) INN (CODEINE PHOSPHATE) BROMANATE DC (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 088739 (pdf 88739.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PHERAZINE W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088763 (pdf 88763.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 , NDA 088764 (label 88764.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC W/ CODEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088814 (pdf 88814.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088816 (pdf 88816.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088833 (pdf 88833.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE , PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088870 (pdf 88870.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088875 (pdf 88875.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1984 , NDA 088896 (pdf 88896.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088904 (pdf 88904.pdf not found) INN (CODEINE PHOSPHATE) MYPHETANE DC (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 089018 (pdf 89018.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089080 (pdf 89080.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089183 (pdf 89183.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089184 (pdf 89184.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089185 (pdf 89185.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089231 (pdf 89231.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089238 (pdf 89238.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089244 (pdf 89244.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089253 (pdf 89253.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089254 (pdf 89254.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089363 (pdf 89363.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089450 (pdf 89450.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1992 , NDA 089478 (pdf 89478.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089479 (pdf 89479.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089480 (pdf 89480.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089481 (pdf 89481.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089482 (pdf 89482.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089483 (pdf 89483.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089511 (pdf 89511.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089512 (pdf 89512.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089513 (pdf 89513.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089647 (pdf 89647.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089671 (pdf 89671.pdf not found) INN (CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 089672 (pdf 89672.pdf not found) INN (CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 089673 (pdf 89673.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (RHODES PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089805 (pdf 89805.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 , NDA 089828 (pdf 89828.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 , NDA 089990 (pdf 89990.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 , NDA 089997 (pdf 89997.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 089998 (pdf 89998.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 089999 (pdf 89999.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 022402 (label 22402.pdf) INN (CODEINE SULFATE) CODEINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2009 , NDA 040860 (pdf 40860.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (INGENUS PHARMS NJ) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090180 (pdf 90180.pdf not found) INN (CODEINE PHOSPHATE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2010 , NDA 091238 (pdf 91238.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202245 (label 202245.pdf) INN (CODEINE SULFATE) CODEINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200386 (pdf 200386.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 200894 (pdf 200894.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 202800 (pdf 202800.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 040674 (pdf 40674.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AKORN) APPROVAL= AP YEAR= 2014 , NDA 203046 (pdf 203046.pdf not found) INN (CODEINE SULFATE) CODEINE SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2014 , NDA 206323 (label 206323.pdf) INN (CHLORPHENIRAMINE MALEATE CODEINE PHOSPHATE) TUXARIN ER (MAINPOINTE) APPROVAL= AP YEAR= 2015 , NDA 207768 (label 207768.pdf) INN (CHLORPHENIRAMINE POLISTIREX CODEINE POLISTIREX) TUZISTRA XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200963 (pdf 200963.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203335 (pdf 203335.pdf not found) INN (CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 211610 (pdf 211610.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WES PHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 212418 (pdf 212418.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ELITE LABS INC) APPROVAL= AP YEAR= 2019 , NDA 204649 (pdf 204649.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 214238 (pdf 214238.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 215138 (pdf 215138.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2022 , 115 ; PHENYLBUTAZONE ; 50-33-9 ; 1977 ; DISCONTINUED ; ; CLASS METABOLISM -- TREATMENT OF RHEUMATOID DISEASES -- ANALGESIC , ; NDA 008319 (pdf 8319.pdf not found) INN (PHENYLBUTAZONE) BUTAZOLIDIN (NOVARTIS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084339 (pdf 84339.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (FOSUN PHARMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086151 (pdf 86151.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087091 (pdf 87091.pdf not found) INN (PHENYLBUTAZONE) AZOLID (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087260 (pdf 87260.pdf not found) INN (PHENYLBUTAZONE) AZOLID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087674 (pdf 87674.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087756 (pdf 87756.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087774 (pdf 87774.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088218 (pdf 88218.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (IVAX PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088863 (pdf 88863.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088994 (pdf 88994.pdf not found) INN (PHENYLBUTAZONE) PHENYLBUTAZONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , 116 ; METHARBITAL ; 50-11-3 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANTS -- GABA MODULATOR , ; NDA 008322 (pdf 8322.pdf not found) INN (METHARBITAL) GEMONIL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , 117 ; ISONIAZID ; 54-85-3 ; 1952 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTITUBERCULAR -- FATTY ACID SYNTHESIS INHIBITORS , ; NDA 008392 (pdf 8392.pdf not found) INN (ISONIAZID) NYDRAZID (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008420 (pdf 8420.pdf not found) INN (ISONIAZID) RIMIFON (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008428 (pdf 8428.pdf not found) INN (ISONIAZID) ISONIAZID (PANRAY) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 008499 (pdf 8499.pdf not found) INN (ISONIAZID) ISONIAZID (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008662 (pdf 8662.pdf not found) INN (ISONIAZID) NYDRAZID (SANDOZ) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008678 (label 8678.pdf) INN (ISONIAZID) ISONIAZID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 040090 (pdf 40090.pdf not found) INN (ISONIAZID) ISONIAZID (OMNIVIUM PHARMS) APPROVAL= AP YEAR= 1997 , NDA 040648 (pdf 40648.pdf not found) INN (ISONIAZID) ISONIAZID (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 050705 (label 50705.pdf) INN (ISONIAZID PYRAZINAMIDE RIFAMPIN) RIFATER (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 061884 (pdf 61884.pdf not found) INN (ISONIAZID RIFAMPIN) RIFAMATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 065221 (pdf 65221.pdf not found) INN (ISONIAZID RIFAMPIN) RIFAMPIN AND ISONIAZID (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 080120 (pdf 80120.pdf not found) INN (ISONIAZID) ISONIAZID (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080126 (pdf 80126.pdf not found) INN (ISONIAZID) STANOZIDE (EVERYLIFE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080132 (pdf 80132.pdf not found) INN (ISONIAZID) ISONIAZID (PUREPAC PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 080134 (pdf 80134.pdf not found) INN (ISONIAZID) HYZYD (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080136 (pdf 80136.pdf not found) INN (ISONIAZID) ISONIAZID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080140 (pdf 80140.pdf not found) INN (ISONIAZID) LANIAZID (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 080153 (pdf 80153.pdf not found) INN (ISONIAZID) ISONIAZID (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080212 (pdf 80212.pdf not found) INN (ISONIAZID) ISONIAZID (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080270 (pdf 80270.pdf not found) INN (ISONIAZID) ISONIAZID (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080330 (pdf 80330.pdf not found) INN (ISONIAZID) DOW-ISONIAZID (DOW PHARM) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080368 (pdf 80368.pdf not found) INN (ISONIAZID) ISONIAZID (PHOENIX LABS NY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 080401 (pdf 80401.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080521 (pdf 80521.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080522 (pdf 80522.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080523 (pdf 80523.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080935 (pdf 80935.pdf not found) INN (ISONIAZID) INH (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080936 (pdf 80936.pdf not found) INN (ISONIAZID) ISONIAZID (BARR) APPROVAL= AP YEAR= 1972 , NDA 080937 (pdf 80937.pdf not found) INN (ISONIAZID) ISONIAZID (BARR) APPROVAL= AP YEAR= 1972 , NDA 080941 (pdf 80941.pdf not found) INN (ISONIAZID) ISONIAZID (MK LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 081118 (pdf 81118.pdf not found) INN (ISONIAZID) ISONIAZID (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 083060 (pdf 83060.pdf not found) INN (ISONIAZID) ISONIAZID (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083178 (pdf 83178.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083610 (pdf 83610.pdf not found) INN (ISONIAZID) ISONIAZID (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083632 (pdf 83632.pdf not found) INN (ISONIAZID) ISONIAZID (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083633 (pdf 83633.pdf not found) INN (ISONIAZID) ISONIAZID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084050 (pdf 84050.pdf not found) INN (ISONIAZID) ISONIAZID (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 085091 (pdf 85091.pdf not found) INN (ISONIAZID) ISONIAZID (PHARMAVITE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085784 (pdf 85784.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085790 (pdf 85790.pdf not found) INN (ISONIAZID) ISONIAZID (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087425 (pdf 87425.pdf not found) INN (ISONIAZID) ISONIAZID (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088119 (pdf 88119.pdf not found) INN (ISONIAZID) ISONIAZID (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088231 (pdf 88231.pdf not found) INN (ISONIAZID) ISONIAZID (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088235 (pdf 88235.pdf not found) INN (ISONIAZID) ISONIAZID (CMP PHARMA INC) APPROVAL= AP YEAR= 1983 , NDA 089243 (pdf 89243.pdf not found) INN (ISONIAZID) LANIAZID (LANNETT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089776 (pdf 89776.pdf not found) INN (ISONIAZID) LANIAZID (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089816 (pdf 89816.pdf not found) INN (ISONIAZID) ISONIAZID (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 202610 (pdf 202610.pdf not found) INN (ISONIAZID) ISONIAZID (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2014 , 118 ; SUCCINYLCHOLINE ; 306-40-1 ; 1952 ; ; ; CLASS METABOLISM -- ULTRA SHORT-ACTING NEUROMUSCULAR DEPOLARIZING AGENTS -- SKELETAL MUSCLE RELAXANTS -- ADJUNCT TO GENERAL ANESTHESIA , ; NDA 008453 (label 8453.pdf) INN (SUCCINYLCHOLINE CHLORIDE) ANECTINE (SANDOZ) APPROVAL= AP YEAR= 1952 NEWMOLECULARENTITY , NDA 008845 (label 8845.pdf) INN (SUCCINYLCHOLINE CHLORIDE) QUELICIN PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1953 , NDA 008847 (pdf 8847.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCOSTRIN (APOTHECON) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 080997 (pdf 80997.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (ORGANON USA INC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 085400 (pdf 85400.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 209467 (pdf 209467.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210231 (pdf 210231.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (AMRING PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211432 (pdf 211432.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210698 (pdf 210698.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 212638 (pdf 212638.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211589 (pdf 211589.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2020 , NDA 211625 (pdf 211625.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 213229 (pdf 213229.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213432 (pdf 213432.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213705 (pdf 213705.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213810 (pdf 213810.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2020 , NDA 214246 (pdf 214246.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 214308 (pdf 214308.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (INDOCO) APPROVAL= AP YEAR= 2020 , NDA 211346 (pdf 211346.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 213552 (pdf 213552.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (NEXUS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214491 (pdf 214491.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (DEVA HOLDING AS) APPROVAL= AP YEAR= 2020 , NDA 214879 (pdf 214879.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 215022 (pdf 215022.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214514 (pdf 214514.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 215143 (label 215143.pdf) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 216003 (pdf 216003.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (BE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216127 (pdf 216127.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217808 (pdf 217808.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 218467 (pdf 218467.pdf not found) INN (SUCCINYLCHOLINE CHLORIDE) SUCCINYLCHOLINE CHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2024 , 119 ; HEXYLCAINE ; 532-77-4 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- LOCAL ANESTHETICS , ; NDA 008472 (pdf 8472.pdf not found) INN (HEXYLCAINE HYDROCHLORIDE) CYCLAINE (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , 120 ; SULFAMETHIZOLE ; 144-82-1 ; 1953 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 008565 (pdf 8565.pdf not found) INN (SULFAMETHIZOLE) THIOSULFIL (WYETH AYERST) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 080273 (pdf 80273.pdf not found) INN (SULFAMETHIZOLE) PROKLAR (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086012 (pdf 86012.pdf not found) INN (SULFAMETHIZOLE) MICROSUL (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 121 ; PYRIMETHAMINE ; 58-14-0 ; 1953 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- FOLIC ACID ANTAGONISTS , ; NDA 008578 (label 8578.pdf) INN (PYRIMETHAMINE) DARAPRIM (TILDE SCIENCES) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY , NDA 018557 (label 18557.pdf) INN (PYRIMETHAMINE SULFADOXINE) FANSIDAR (ROCHE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 207127 (pdf 207127.pdf not found) INN (PYRIMETHAMINE) PYRIMETHAMINE (CEROVENE INC) APPROVAL= AP YEAR= 2020 , NDA 211271 (pdf 211271.pdf not found) INN (PYRIMETHAMINE) PYRIMETHAMINE (ALVOGEN) APPROVAL= AP YEAR= 2021 , NDA 215506 (pdf 215506.pdf not found) INN (PYRIMETHAMINE) PYRIMETHAMINE (TEVA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 216983 (pdf 216983.pdf not found) INN (PYRIMETHAMINE) PYRIMETHAMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , 122 ; PROCAINE ; 59-46-1 ; 1952 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- LOCAL ANESTHETICS , ; NDA 008592 (pdf 8592.pdf not found) INN (NOREPINEPHRINE BITARTRATE PROCAINE HYDROCHLORIDE PROPOXYCAINE HYDROCHLORIDE) RAVOCAINE AND NOVOCAIN W/ LEVOPHED (EASTMAN KODAK) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008869 (pdf 8869.pdf not found) INN (PROCAINE MERETHOXYLLINE THEOPHYLLINE) DICURIN PROCAINE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050276 (pdf 50276.pdf not found) INN (PROCAINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (LEDERLE) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060285 (pdf 60285.pdf not found) INN (PROCAINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE) TETRACYN (PFIZER) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 080384 (pdf 80384.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 080415 (pdf 80415.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (MILES) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080416 (pdf 80416.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080421 (pdf 80421.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080658 (pdf 80658.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080711 (pdf 80711.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080756 (pdf 80756.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080758 (pdf 80758.pdf not found) INN (EPINEPHRINE PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080759 (pdf 80759.pdf not found) INN (EPINEPHRINE PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE W/ EPINEPHRINE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083315 (pdf 83315.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083535 (pdf 83535.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085362 (pdf 85362.pdf not found) INN (PROCAINE HYDROCHLORIDE) NOVOCAIN (HOSPIRA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086202 (pdf 86202.pdf not found) INN (PROCAINE HYDROCHLORIDE) PROCAINE HYDROCHLORIDE (GD SEARLE LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086797 (pdf 86797.pdf not found) INN (PROCAINE HYDROCHLORIDE) NOVOCAIN (HOSPIRA) APPROVAL= AP YEAR= 1979 DISCONTINUED , 123 ; PHENOXYBENZAMINE ; 59-96-1 ; 1953 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA ANTAGONISTS -- VASODILATOR AGENTS -- TREATMENT OF PHEOCHROMOCYTOMA -- TREATMENT OF EPISODES OF HYPERTENSION , ; NDA 008708 (label 8708.pdf) INN (PHENOXYBENZAMINE HYDROCHLORIDE) DIBENZYLINE (CONCORDIA) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY , NDA 201050 (pdf 201050.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204522 (pdf 204522.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 212568 (pdf 212568.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 215042 (pdf 215042.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 204551 (pdf 204551.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2023 , NDA 215600 (pdf 215600.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 124 ; LEVONORDEFRIN ; 829-74-3 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- VASOCONSTRICTOR , ; NDA 008592 (pdf 8592.pdf not found) INN (LEVONORDEFRIN) RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN (EASTMAN KODAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012125 (pdf 12125.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) CARBOCAINE W/ NEO-COBEFRIN (EASTMAN KODAK) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 084697 (pdf 84697.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SEPTODONT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084850 (pdf 84850.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN (BELMORA LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085010 (pdf 85010.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 088388 (pdf 88388.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) SCANDONEST L (DEPROCO) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089517 (pdf 89517.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) POLOCAINE W/ LEVONORDEFRIN (DENTSPLY PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , 125 ; NITROFURANTOIN ; 67-20-9 ; 1953 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- REDUCES BY BACTERIAL FLAVOPROTEINS TO REACTIVE INTERMEDIATES -- ALTER BACTERIAL RIBOSOMAL PROTEINS , ; NDA 008693 (pdf 8693.pdf not found) INN (NITROFURANTOIN) FURADANTIN (PROCTER AND GAMBLE) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 009175 (label 9175.pdf) INN (NITROFURANTOIN) FURADANTIN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1953 , NDA 012402 (pdf 12402.pdf not found) INN (NITROFURANTOIN SODIUM) IVADANTIN (PROCTER AND GAMBLE) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 016620 (label 16620.pdf) INN (NITROFURANTOIN MACROCRYSTALLINE) MACRODANTIN (ALMATICA) APPROVAL= AP YEAR= 1970 , NDA 020064 (label 20064.pdf) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) MACROBID (ALMATICA) APPROVAL= AP YEAR= 1991 , NDA 070248 (pdf 70248.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MACROCRYSTALLINE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070249 (pdf 70249.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MACROCRYSTALLINE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 073652 (pdf 73652.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (IMPAX LABS INC) APPROVAL= AP YEAR= 1993 , NDA 073671 (pdf 73671.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (IMPAX LABS INC) APPROVAL= AP YEAR= 1993 , NDA 073696 (pdf 73696.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074336 (pdf 74336.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (ATHEM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074967 (pdf 74967.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1997 , NDA 076648 (pdf 76648.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076951 (pdf 76951.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077025 (pdf 77025.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 , NDA 077066 (pdf 77066.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 080003 (pdf 80003.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080017 (pdf 80017.pdf not found) INN (NITROFURANTOIN) FURALAN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080043 (pdf 80043.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (SANDOZ) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080078 (pdf 80078.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080447 (pdf 80447.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 084085 (pdf 84085.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (WHITEWORTH TOWN PLSN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084326 (pdf 84326.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 085796 (pdf 85796.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085797 (pdf 85797.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 201679 (pdf 201679.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 201355 (pdf 201355.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2013 , NDA 201693 (pdf 201693.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (NOVEL LABS INC) APPROVAL= AP YEAR= 2014 , NDA 091095 (pdf 91095.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202250 (pdf 202250.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (WATSON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 201722 (pdf 201722.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2016 , NDA 205180 (pdf 205180.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2016 , NDA 207372 (pdf 207372.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205005 (pdf 205005.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208516 (pdf 208516.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (SUNNY) APPROVAL= AP YEAR= 2018 , NDA 203233 (pdf 203233.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (NOVEL LABS INC) APPROVAL= AP YEAR= 2018 , NDA 211935 (pdf 211935.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 211013 (pdf 211013.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (INVENTIA) APPROVAL= AP YEAR= 2022 , NDA 215002 (pdf 215002.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (ALVOGEN) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 209225 (pdf 209225.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 212607 (pdf 212607.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216385 (pdf 216385.pdf not found) INN (NITROFURANTOIN) NITROFURANTOIN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217272 (pdf 217272.pdf not found) INN (NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217073 (pdf 217073.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (OMSAV PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217357 (pdf 217357.pdf not found) INN (NITROFURANTOIN NITROFURANTOIN MACROCRYSTALLINE) NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , 126 ; PHENOXYBENZAMINE ; 59-96-1 ; 1953 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA ANTAGONISTS -- VASODILATOR AGENTS -- TREATMENT OF PHEOCHROMOCYTOMA -- TREATMENT OF EPISODES OF HYPERTENSION , ; NDA 008708 (label 8708.pdf) INN (PHENOXYBENZAMINE HYDROCHLORIDE) DIBENZYLINE (CONCORDIA) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY , NDA 201050 (pdf 201050.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204522 (pdf 204522.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 212568 (pdf 212568.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 215042 (pdf 215042.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 204551 (pdf 204551.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2023 , NDA 215600 (pdf 215600.pdf not found) INN (PHENOXYBENZAMINE HYDROCHLORIDE) PHENOXYBENZAMINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 127 ; LEVORPHANOL ; 77-07-6 ; 1953 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- OPIOID -- NARCOTICS , ; NDA 008719 (pdf 8719.pdf not found) INN (LEVORPHANOL TARTRATE) LEVO-DROMORAN (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 008720 (pdf 8720.pdf not found) INN (LEVORPHANOL TARTRATE) LEVO-DROMORAN (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 074278 (pdf 74278.pdf not found) INN (LEVORPHANOL TARTRATE) LEVORPHANOL TARTRATE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 211484 (pdf 211484.pdf not found) INN (LEVORPHANOL TARTRATE) LEVORPHANOL TARTRATE (VIRTUS) APPROVAL= AP YEAR= 2018 , NDA 212024 (pdf 212024.pdf not found) INN (LEVORPHANOL TARTRATE) LEVORPHANOL TARTRATE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 213479 (pdf 213479.pdf not found) INN (LEVORPHANOL TARTRATE) LEVORPHANOL TARTRATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213906 (pdf 213906.pdf not found) INN (LEVORPHANOL TARTRATE) LEVORPHANOL TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2021 , 128 ; PROPANTHELINE ; 298-50-0 ; 1953 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTI-ULCER AGENTS -- ANTIMUSCARINICS -- ANTISPASMODICS , ; NDA 008732 (pdf 8732.pdf not found) INN (PROPANTHELINE BROMIDE) PRO-BANTHINE (SHIRE) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 008843 (pdf 8843.pdf not found) INN (PROPANTHELINE BROMIDE) PRO-BANTHINE (GD SEARLE LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080927 (pdf 80927.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (HIKMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080928 (pdf 80928.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 080977 (pdf 80977.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083029 (pdf 83029.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083151 (pdf 83151.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083706 (pdf 83706.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084428 (pdf 84428.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084541 (pdf 84541.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085780 (pdf 85780.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087663 (pdf 87663.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088377 (pdf 88377.pdf not found) INN (PROPANTHELINE BROMIDE) PROPANTHELINE BROMIDE (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , 129 ; PHENYTOIN ; 57-41-0 ; 1953 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTIC -- ANTICONVULSANT , ; NDA 008762 (label 8762.pdf) INN (PHENYTOIN) DILANTIN-125 (VIATRIS) APPROVAL= AP YEAR= 1953 , NDA 010151 (label 10151.pdf) INN (PHENYTOIN SODIUM) DILANTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 040298 (label 40298.pdf) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (MYLAN) APPROVAL= AP YEAR= 1998 , NDA 040342 (pdf 40342.pdf not found) INN (PHENYTOIN) PHENYTOIN (VISTAPHARM) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040420 (pdf 40420.pdf not found) INN (PHENYTOIN) PHENYTOIN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040435 (pdf 40435.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040521 (pdf 40521.pdf not found) INN (PHENYTOIN) PHENYTOIN (TARO) APPROVAL= AP YEAR= 2004 , NDA 040573 (pdf 40573.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (ACELLA) APPROVAL= AP YEAR= 2006 , NDA 040610 (pdf 40610.pdf not found) INN (PHENYTOIN) PHENYTOIN (VISTAPHARM) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 040621 (pdf 40621.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040684 (pdf 40684.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (TARO) APPROVAL= AP YEAR= 2006 , NDA 040731 (pdf 40731.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 , NDA 040732 (pdf 40732.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (WOCKHARDT USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040759 (label 40759.pdf) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040781 (pdf 40781.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (AM REGENT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 080259 (pdf 80259.pdf not found) INN (PHENYTOIN SODIUM) PROMPT PHENYTOIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 080857 (pdf 80857.pdf not found) INN (PHENYTOIN SODIUM) DIPHENYLAN SODIUM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 080905 (pdf 80905.pdf not found) INN (PHENYTOIN SODIUM) PROMPT PHENYTOIN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084307 (pdf 84307.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084349 (label 84349.pdf) INN (PHENYTOIN SODIUM) DILANTIN (VIATRIS) APPROVAL= AP YEAR= 1976 , NDA 084427 (label 84427.pdf) INN (PHENYTOIN) DILANTIN (PHARMACIA) APPROVAL= AP YEAR= 1979 , NDA 085434 (pdf 85434.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085435 (pdf 85435.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (PHARMERAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085894 (pdf 85894.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 088519 (pdf 88519.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088520 (pdf 88520.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088521 (pdf 88521.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088711 (pdf 88711.pdf not found) INN (PHENYTOIN SODIUM) PHENYTEX (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089003 (pdf 89003.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089441 (pdf 89441.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089501 (pdf 89501.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089521 (pdf 89521.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089744 (pdf 89744.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089779 (pdf 89779.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089892 (pdf 89892.pdf not found) INN (PHENYTOIN) PHENYTOIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089900 (pdf 89900.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040765 (pdf 40765.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 200691 (pdf 200691.pdf not found) INN (PHENYTOIN) PHENYTOIN (RISING) APPROVAL= AP YEAR= 2012 , NDA 040884 (pdf 40884.pdf not found) INN (PHENYTOIN) PHENYTOIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 200565 (pdf 200565.pdf not found) INN (PHENYTOIN) PHENYTOIN (TARO) APPROVAL= AP YEAR= 2014 , NDA 204309 (pdf 204309.pdf not found) INN (PHENYTOIN SODIUM) PHENYTOIN SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 211633 (pdf 211633.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213834 (pdf 213834.pdf not found) INN (PHENYTOIN SODIUM) EXTENDED PHENYTOIN SODIUM (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , 130 ; CARBINOXAMINE ; 486-16-8 ; 1974 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC , ; NDA 008915 (pdf 8915.pdf not found) INN (CARBINOXAMINE MALEATE) CLISTIN (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008955 (pdf 8955.pdf not found) INN (CARBINOXAMINE MALEATE) CLISTIN (MCNEIL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 040442 (pdf 40442.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (GENUS) APPROVAL= AP YEAR= 2003 , NDA 040458 (pdf 40458.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (GENUS) APPROVAL= AP YEAR= 2003 , NDA 040639 (pdf 40639.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2008 , NDA 040814 (pdf 40814.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090418 (pdf 90418.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (CYPRESS PHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090435 (pdf 90435.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090417 (pdf 90417.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (CYPRESS PHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090756 (pdf 90756.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (MISSION PHARMACAL) APPROVAL= AP YEAR= 2011 , NDA 022556 (label 22556.pdf) INN (CARBINOXAMINE MALEATE) KARBINAL ER (AYTU) APPROVAL= AP YEAR= 2013 , NDA 207484 (pdf 207484.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (MIKART) APPROVAL= AP YEAR= 2016 , 131 ; PHENINDIONE ; 83-12-5 ; 0 ; DISCONTINUED ; ; CLASS BLOOD -- ANTICOAGULANT , ; NDA 008767 (pdf 8767.pdf not found) INN (PHENINDIONE) HEDULIN (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , 132 ; METHSCOPOLAMINE ; 13265-10-6 ; 1953 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTISPASMODICS -- PARASYMPATHOLYTICS -- MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST , ; NDA 008848 (pdf 8848.pdf not found) INN (METHSCOPOLAMINE BROMIDE) PAMINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 040624 (pdf 40624.pdf not found) INN (METHSCOPOLAMINE BROMIDE) METHSCOPOLAMINE BROMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 080970 (pdf 80970.pdf not found) INN (METHSCOPOLAMINE BROMIDE) METHSCOPOLAMINE BROMIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 040642 (pdf 40642.pdf not found) INN (METHSCOPOLAMINE BROMIDE) METHSCOPOLAMINE BROMIDE (BRECKENRIDGE PHARM) APPROVAL= AP YEAR= 2011 , NDA 200602 (pdf 200602.pdf not found) INN (METHSCOPOLAMINE BROMIDE) METHSCOPOLAMINE BROMIDE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2012 , NDA 216786 (pdf 216786.pdf not found) INN (METHSCOPOLAMINE BROMIDE) METHSCOPOLAMINE BROMIDE (NE RX PHARMA) APPROVAL= AP YEAR= 2024 , 133 ; PHENSUXIMIDE ; 86-34-0 ; 1953 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC , ; NDA 008855 (pdf 8855.pdf not found) INN (PHENSUXIMIDE) MILONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , 134 ; PROPARACAINE ; 499-67-2 ; 1953 ; ; ; CLASS SENSORY -- LOCAL ANESTHETIC , ; NDA 008883 (pdf 8883.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) OPHTHAINE (APOTHECON) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 012583 (label 12583.pdf) INN (PROPARACAINE HYDROCHLORIDE) OPHTHETIC (ALLERGAN) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040074 (pdf 40074.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) PROPARACAINE HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 040277 (label 40277.pdf) INN (PROPARACAINE HYDROCHLORIDE) PROPARACAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2000 , NDA 080027 (pdf 80027.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) ALCAINE (ALCON LABS INC) APPROVAL= AP YEAR= 1971 , NDA 084144 (pdf 84144.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) PROPARACAINE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084151 (pdf 84151.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) PROPARACAINE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 087681 (pdf 87681.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) PARACAINE (OPTOPICS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088087 (pdf 88087.pdf not found) INN (PROPARACAINE HYDROCHLORIDE) KAINAIR (PHARMAFAIR) APPROVAL= AP YEAR= 1983 DISCONTINUED , 135 ; CARBINOXAMINE ; 486-16-8 ; 1974 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC , ; NDA 008915 (pdf 8915.pdf not found) INN (CARBINOXAMINE MALEATE) CLISTIN (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 008955 (pdf 8955.pdf not found) INN (CARBINOXAMINE MALEATE) CLISTIN (MCNEIL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 040442 (pdf 40442.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (GENUS) APPROVAL= AP YEAR= 2003 , NDA 040458 (pdf 40458.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (GENUS) APPROVAL= AP YEAR= 2003 , NDA 040639 (pdf 40639.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2008 , NDA 040814 (pdf 40814.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090418 (pdf 90418.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (CYPRESS PHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090435 (pdf 90435.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090417 (pdf 90417.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (CYPRESS PHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090756 (pdf 90756.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (MISSION PHARMACAL) APPROVAL= AP YEAR= 2011 , NDA 022556 (label 22556.pdf) INN (CARBINOXAMINE MALEATE) KARBINAL ER (AYTU) APPROVAL= AP YEAR= 2013 , NDA 207484 (pdf 207484.pdf not found) INN (CARBINOXAMINE MALEATE) CARBINOXAMINE MALEATE (MIKART) APPROVAL= AP YEAR= 2016 , 136 ; ACETAZOLAMIDE ; 59-66-5 ; 1953 ; ; ; CLASS SENSORY -- CARBONIC ANHYDRASE INHIBITOR -- ANTIGLAUCOMA -- ANTICONVULSANTS -- DIURETICS , ; NDA 008943 (label 8943.pdf) INN (ACETAZOLAMIDE) DIAMOX (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 009388 (label 9388.pdf) INN (ACETAZOLAMIDE SODIUM) DIAMOX (TEVA WOMENS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 012945 (label 12945.pdf) INN (ACETAZOLAMIDE) DIAMOX (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 040089 (pdf 40089.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 040108 (pdf 40108.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040195 (pdf 40195.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (TARO) APPROVAL= AP YEAR= 1997 , NDA 083320 (pdf 83320.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (ALRA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084498 (pdf 84498.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084840 (pdf 84840.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1978 , NDA 087654 (pdf 87654.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087686 (pdf 87686.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088882 (pdf 88882.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089619 (pdf 89619.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089752 (pdf 89752.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 089753 (pdf 89753.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040784 (pdf 40784.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (XGEN PHARMS) APPROVAL= AP YEAR= 2008 , NDA 040904 (pdf 40904.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2008 , NDA 090779 (pdf 90779.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (INDICUS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 200880 (pdf 200880.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (MYLAN ASI) APPROVAL= AP YEAR= 2012 , NDA 202693 (pdf 202693.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 , NDA 204691 (pdf 204691.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 , NDA 203434 (pdf 203434.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 205530 (pdf 205530.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205358 (label 205358.pdf) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209734 (pdf 209734.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207659 (pdf 207659.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 205301 (pdf 205301.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 206533 (pdf 206533.pdf not found) INN (ACETAZOLAMIDE SODIUM) ACETAZOLAMIDE SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210423 (pdf 210423.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 203917 (pdf 203917.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210588 (pdf 210588.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211556 (pdf 211556.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (EYWA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 207503 (pdf 207503.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 207401 (pdf 207401.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2020 , NDA 214282 (pdf 214282.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2020 , NDA 211372 (pdf 211372.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 215101 (pdf 215101.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 211069 (pdf 211069.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217197 (pdf 217197.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (NE RX PHARMA) APPROVAL= AP YEAR= 2023 , NDA 211151 (pdf 211151.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213706 (pdf 213706.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 218023 (pdf 218023.pdf not found) INN (ACETAZOLAMIDE) ACETAZOLAMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2024 , 137 ; CYCRIMINE ; 77-39-4 ; 1953 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIDYSKINETICS -- ANTIPARKINSON -- MUSCARINIC ANTAGONIST , ; NDA 008951 (pdf 8951.pdf not found) INN (CYCRIMINE HYDROCHLORIDE) PAGITANE (LILLY) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , 138 ; METHOXSALEN ; 298-81-7 ; 1954 ; ; NATURAL MOLECULE C00000576 ; CLASS ANTINEOPLASTIC AGENTS -- DERMATOLOGICALS -- PUVA TREATMENT -- CROSS-LINKING REAGENTS -- PHOTOSENSITIZING AGENTS -- PIGMENTING AGENTS -- PHOTOACTIVE SUBSTANCE FOUND IN THE SEEDS OF THE AMMI MAJUS (UMBELLIFERAE) PLANT AND IN THE ROOTS OF HERACLEUM CANDICANS -- TREATMENT OF PSORIASIS , ; NDA 009048 (label 9048.pdf) INN (METHOXSALEN) 8-MOP (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 019600 (label 19600.pdf) INN (METHOXSALEN) OXSORALEN-ULTRA (BAUSCH) APPROVAL= AP YEAR= 1986 , NDA 020969 (label 20969.pdf) INN (METHOXSALEN) UVADEX (MALLINCKRODT HOSP) APPROVAL= AP YEAR= 1999 , NDA 087781 (pdf 87781.pdf not found) INN (METHOXSALEN) METHOXSALEN (ANI PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 202687 (pdf 202687.pdf not found) INN (METHOXSALEN) METHOXSALEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 202603 (pdf 202603.pdf not found) INN (METHOXSALEN) METHOXSALEN (ACTAVIS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , 139 ; MERCAPTOPURINE ; 50-44-2 ; 1953 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL) (DRUG FOR RARE DISEASE IN EUROPE) -- ANTIMETABOLITES IMMUNOSUPPRESSIVE AGENTS -- NUCLEIC ACID SYNTHESIS INHIBITORS -- PURINE ANALOGUES -- MODIFIED BY HYPOXANTHINE-GUANINE PHOSPHORIBOSYLTRANSFERASE (HGPRT) TO TIMP (THIOINOSINE MONOPHOSPHATE) AND THEN DIVERSES KINASES (INOSINE MONOPHOSPHATE DEHYDROGENASE, GUANOSINE MONOPHOSPHATE SYNTHETASE AND KINASES) WHICH LEAD TO THE INCORPORATION OF 6-THIOGUANINE NUCLEOTIDES (6-TGN) INTO DNA , ; NDA 009053 (label 9053.pdf) INN (MERCAPTOPURINE) PURINETHOL (STASON PHARMS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY , NDA 040461 (pdf 40461.pdf not found) INN (MERCAPTOPURINE) MERCAPTOPURINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2004 , NDA 040528 (pdf 40528.pdf not found) INN (MERCAPTOPURINE) MERCAPTOPURINE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 040594 (pdf 40594.pdf not found) INN (MERCAPTOPURINE) MERCAPTOPURINE (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 205919 (label 205919.pdf) INN (MERCAPTOPURINE) PURIXAN (NOVA LABS LTD) APPROVAL= AP YEAR= 2014 , 140 ; ETHOPROPAZINE ; 522-00-9 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTICHOLINERGIC -- ANTIDYSKINETICS , ; NDA 009078 (pdf 9078.pdf not found) INN (ETHOPROPAZINE HYDROCHLORIDE) PARSIDOL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 141 ; RESERPINE ; 50-55-5 ; 1954 ; DISCONTINUED ; NATURAL MOLECULE C00001763 ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE AGENTS -- ANTIPSYCHOTIC AGENTS -- DEPLETES MONOAMINES FROM THE BRAIN AND OTHER TISSUES , ; NDA 009115 (pdf 9115.pdf not found) INN (RESERPINE) SERPASIL (NOVARTIS) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 009296 (pdf 9296.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE RESERPINE) SERPASIL-APRESOLINE (NOVARTIS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 009357 (pdf 9357.pdf not found) INN (RESERPINE) RAU-SED (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009376 (pdf 9376.pdf not found) INN (RESERPINE) SANDRIL (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009391 (pdf 9391.pdf not found) INN (RESERPINE) SERPANRAY (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009434 (pdf 9434.pdf not found) INN (RESERPINE) SERPASIL (NOVARTIS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 009453 (pdf 9453.pdf not found) INN (RESERPINE) SERPATE (VALE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009627 (pdf 9627.pdf not found) INN (RESERPINE) RESERPINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009631 (pdf 9631.pdf not found) INN (RESERPINE) HISERPIA (BOWMAN PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009645 (pdf 9645.pdf not found) INN (RESERPINE) SERPIVITE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009663 (pdf 9663.pdf not found) INN (RESERPINE) RESERPINE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009667 (pdf 9667.pdf not found) INN (RESERPINE) RESERPINE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 009838 (pdf 9838.pdf not found) INN (RESERPINE) RESERPINE (SANDOZ) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 009859 (pdf 9859.pdf not found) INN (RESERPINE) RESERPINE (CYCLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 010012 (pdf 10012.pdf not found) INN (RESERPINE) SANDRIL (LILLY) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 010124 (pdf 10124.pdf not found) INN (RESERPINE) SERPALAN (LANNETT) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 010441 (pdf 10441.pdf not found) INN (RESERPINE) RESERPINE (EVERYLIFE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 011185 (pdf 11185.pdf not found) INN (RESERPINE) RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011635 (pdf 11635.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) DIUPRES-250 (MERCK) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011878 (pdf 11878.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) SERPASIL-ESIDRIX #1 (NOVARTIS) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011958 (pdf 11958.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROPRES 25 (MERCK) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 012193 (pdf 12193.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-AP-ES (NOVARTIS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012265 (pdf 12265.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) NAQUIVAL (SCHERING) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012359 (pdf 12359.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) SALUTENSIN (SHIRE) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012708 (pdf 12708.pdf not found) INN (METHYCLOTHIAZIDE RESERPINE) DIUTENSEN-R (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 012972 (pdf 12972.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) METATENSIN #2 (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 013636 (pdf 13636.pdf not found) INN (POLYTHIAZIDE RESERPINE) RENESE-R (PFIZER) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 013927 (pdf 13927.pdf not found) INN (QUINETHAZONE RESERPINE) HYDROMOX R (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 015103 (pdf 15103.pdf not found) INN (CHLORTHALIDONE RESERPINE) REGROTON (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 080393 (pdf 80393.pdf not found) INN (RESERPINE) RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080446 (pdf 80446.pdf not found) INN (RESERPINE) RESERPINE (SOLVAY) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080457 (pdf 80457.pdf not found) INN (RESERPINE) RESERPINE (HALSEY) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080492 (pdf 80492.pdf not found) INN (RESERPINE) RESERPINE (MARSHALL PHARMA) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080525 (pdf 80525.pdf not found) INN (RESERPINE) RESERPINE (MK LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080582 (pdf 80582.pdf not found) INN (RESERPINE) RESERPINE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080637 (pdf 80637.pdf not found) INN (RESERPINE) RESERPINE (REXALL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080679 (pdf 80679.pdf not found) INN (RESERPINE) RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080721 (pdf 80721.pdf not found) INN (RESERPINE) RESERPINE (BARR) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080723 (pdf 80723.pdf not found) INN (RESERPINE) RESERPINE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080749 (pdf 80749.pdf not found) INN (RESERPINE) RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080753 (pdf 80753.pdf not found) INN (RESERPINE) RESERPINE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080975 (pdf 80975.pdf not found) INN (RESERPINE) RESERPINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083058 (pdf 83058.pdf not found) INN (RESERPINE) RESERPINE (BELL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083145 (pdf 83145.pdf not found) INN (RESERPINE) RESERPINE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083568 (pdf 83568.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083571 (pdf 83571.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083572 (pdf 83572.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083573 (pdf 83573.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083666 (pdf 83666.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083770 (pdf 83770.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083877 (pdf 83877.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROSERPINE PLUS R-H-H (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084291 (pdf 84291.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE , HYDROCHLOROTHIAZIDE AND RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084466 (pdf 84466.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084467 (pdf 84467.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084579 (pdf 84579.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084580 (pdf 84580.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084603 (pdf 84603.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084617 (pdf 84617.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE RESERPINE) DRALSERP (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 084663 (pdf 84663.pdf not found) INN (RESERPINE) RESERPINE (PHARMAVITE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084714 (pdf 84714.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-RESERP (ABC HOLDING) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084827 (pdf 84827.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-SERP "25" (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084853 (pdf 84853.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084876 (pdf 84876.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRAP-ES (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084897 (pdf 84897.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) CAM-AP-ES (CHARTWELL RX) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084974 (pdf 84974.pdf not found) INN (RESERPINE) RESERPINE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085207 (pdf 85207.pdf not found) INN (RESERPINE) RESERPINE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085213 (pdf 85213.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-SERP "50" (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085248 (pdf 85248.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085317 (pdf 85317.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085338 (pdf 85338.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) H.R.-50 (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085401 (pdf 85401.pdf not found) INN (RESERPINE) RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085420 (pdf 85420.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (PHARMERAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085421 (pdf 85421.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (PHARMERAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085549 (pdf 85549.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085771 (pdf 85771.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE , HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085775 (pdf 85775.pdf not found) INN (RESERPINE) RESERPINE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085893 (pdf 85893.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086117 (pdf 86117.pdf not found) INN (RESERPINE) RESERPINE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086298 (pdf 86298.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086330 (pdf 86330.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086331 (pdf 86331.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087085 (pdf 87085.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087210 (pdf 87210.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-A-GEN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087556 (pdf 87556.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087709 (pdf 87709.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDROCHLOROTHIAZIDE , AND HYDRALAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087744 (pdf 87744.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087745 (pdf 87745.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088110 (pdf 88110.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088127 (pdf 88127.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088151 (pdf 88151.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088189 (pdf 88189.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE-50 (WEST WARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088195 (pdf 88195.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088200 (pdf 88200.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088365 (pdf 88365.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE AND RESERPINE (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088376 (pdf 88376.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088557 (pdf 88557.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE AND RESERPINE (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088570 (pdf 88570.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088907 (pdf 88907.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) RESERPINE AND HYDROFLUMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088932 (pdf 88932.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) RESERPINE AND HYDROFLUMETHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089019 (pdf 89019.pdf not found) INN (RESERPINE) RESERPINE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089020 (pdf 89020.pdf not found) INN (RESERPINE) RESERPINE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , 142 ; CHLORPROMAZINE ; 50-53-3 ; 1957 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEMETICS -- ANTIPSYCHOTIC AGENTS -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES -- SEDATIVES , ; NDA 009149 (pdf 9149.pdf not found) INN (CHLORPROMAZINE) THORAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011120 (pdf 11120.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) THORAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 040224 (pdf 40224.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040231 (pdf 40231.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 080340 (pdf 80340.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080365 (pdf 80365.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1974 , NDA 080370 (pdf 80370.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080403 (pdf 80403.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 080439 (pdf 80439.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080983 (pdf 80983.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) SONAZINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083040 (pdf 83040.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) SONAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083329 (pdf 83329.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1974 , NDA 083386 (pdf 83386.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1974 , NDA 083549 (pdf 83549.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083574 (pdf 83574.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083575 (pdf 83575.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084112 (pdf 84112.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1974 , NDA 084113 (pdf 84113.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1974 , NDA 084114 (pdf 84114.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1974 , NDA 084115 (pdf 84115.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1974 , NDA 084411 (pdf 84411.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084412 (pdf 84412.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084413 (pdf 84413.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084414 (pdf 84414.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084415 (pdf 84415.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084423 (pdf 84423.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) PROMAPAR (PARKE DAVIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 084789 (pdf 84789.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084800 (pdf 84800.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084801 (pdf 84801.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084802 (pdf 84802.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084803 (pdf 84803.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 084911 (pdf 84911.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085331 (pdf 85331.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (CYCLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085484 (pdf 85484.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085591 (pdf 85591.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085748 (pdf 85748.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085750 (pdf 85750.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085751 (pdf 85751.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085752 (pdf 85752.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085956 (pdf 85956.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085957 (pdf 85957.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085958 (pdf 85958.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085959 (pdf 85959.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085960 (pdf 85960.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086712 (pdf 86712.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086863 (pdf 86863.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086885 (pdf 86885.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) PROMAPAR (PARKE DAVIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086886 (pdf 86886.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) PROMAPAR (PARKE DAVIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086887 (pdf 86887.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) PROMAPAR (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086888 (pdf 86888.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) PROMAPAR (PARKE DAVIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087032 (pdf 87032.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087053 (pdf 87053.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087645 (pdf 87645.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087646 (pdf 87646.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087783 (pdf 87783.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087865 (pdf 87865.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087878 (pdf 87878.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087880 (pdf 87880.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087884 (pdf 87884.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088038 (pdf 88038.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088157 (pdf 88157.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088158 (pdf 88158.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 089563 (pdf 89563.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 209755 (pdf 209755.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 211816 (pdf 211816.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213368 (pdf 213368.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ZYDUS) APPROVAL= AP YEAR= 2020 , NDA 213590 (pdf 213590.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2020 , NDA 214256 (pdf 214256.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 212144 (pdf 212144.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 212996 (pdf 212996.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2021 , NDA 214542 (pdf 214542.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2021 , NDA 212630 (pdf 212630.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ZAMEER PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215659 (pdf 215659.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214827 (pdf 214827.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 213327 (pdf 213327.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2023 , NDA 217350 (pdf 217350.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217275 (pdf 217275.pdf not found) INN (CHLORPROMAZINE HYDROCHLORIDE) CHLORPROMAZINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2024 , 143 ; TESTOSTERONE ; 58-22-0 ; 1972 ; ; NATURAL MOLECULE C00003675 ; CLASS GENITO -- ANDROGENS -- TREATMENT OF HYPOGONADISM , ; NDA 019762 (pdf 19762.pdf not found) INN (TESTOSTERONE) TESTODERM (ALZA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020489 (label 20489.pdf) INN (TESTOSTERONE) ANDRODERM (ABBVIE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020791 (pdf 20791.pdf not found) INN (TESTOSTERONE) TESTODERM TTS (ALZA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021015 (label 21015.pdf) INN (TESTOSTERONE) ANDROGEL (BESINS HLTHCARE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021454 (label 21454.pdf) INN (TESTOSTERONE) TESTIM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2002 , NDA 021543 (label 21543.pdf) INN (TESTOSTERONE) STRIANT (AUXILIUM PHARMS LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076737 (pdf 76737.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2006 , NDA 076744 (pdf 76744.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 , NDA 080911 (pdf 80911.pdf not found) INN (TESTOSTERONE) TESTOPEL (ENDO OPERATIONS) APPROVAL= AP YEAR= 1972 , NDA 086417 (pdf 86417.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (DR REDDYS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086419 (pdf 86419.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086420 (pdf 86420.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 022504 (label 22504.pdf) INN (TESTOSTERONE) AXIRON (ELI LILLY AND CO) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 021463 (label 21463.pdf) INN (TESTOSTERONE) FORTESTA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022309 (label 22309.pdf) INN (TESTOSTERONE) ANDROGEL (BESINS HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 202763 (label 202763.pdf) INN (TESTOSTERONE) TESTOSTERONE (ANI PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203098 (label 203098.pdf) INN (TESTOSTERONE) TESTOSTERONE (PERRIGO ISRAEL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204399 (label 204399.pdf) INN (TESTOSTERONE) VOGELXO (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2014 , NDA 205488 (label 205488.pdf) INN (TESTOSTERONE) NATESTO (ACERUS) APPROVAL= AP YEAR= 2014 , NDA 204571 (pdf 204571.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2015 , NDA 205328 (pdf 205328.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2017 , NDA 204255 (label 204255.pdf) INN (TESTOSTERONE) TESTOSTERONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 204268 (pdf 204268.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2015 , NDA 205781 (label 205781.pdf) INN (TESTOSTERONE) TESTOSTERONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 207337 (pdf 207337.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (SANDOZ INC) APPROVAL= TA YEAR= 2017 , NDA 091073 (pdf 91073.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2017 , NDA 208061 (pdf 208061.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 208560 (pdf 208560.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (LUPIN) APPROVAL= AP YEAR= 2019 , NDA 209533 (pdf 209533.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 204570 (pdf 204570.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2019 , NDA 207373 (pdf 207373.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 208620 (pdf 208620.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ENCUBE) APPROVAL= AP YEAR= 2019 , NDA 209390 (pdf 209390.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (TWI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210835 (pdf 210835.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 209181 (pdf 209181.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (APOTEX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212301 (pdf 212301.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 212882 (pdf 212882.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ALEMBIC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213922 (pdf 213922.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ALEMBIC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209836 (pdf 209836.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (TWI PHARMS) APPROVAL= AP YEAR= 2021 , NDA 212984 (pdf 212984.pdf not found) INN (TESTOSTERONE) TESTOSTERONE (ENCUBE) APPROVAL= AP YEAR= 2021 , 144 ; TESTOSTERONE PROPIONATE ; 57-85-2 ; 1973 ; DISCONTINUED ; ; CLASS GENITO -- ANDROGENIC -- RAPIDLY HYDROLYZED IN TESTOSTERONE , ; NDA 080188 (pdf 80188.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080254 (pdf 80254.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080276 (pdf 80276.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080741 (pdf 80741.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080742 (pdf 80742.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080743 (pdf 80743.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (BEL MAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083595 (pdf 83595.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085490 (pdf 85490.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089283 (pdf 89283.pdf not found) INN (TESTOSTERONE PROPIONATE) TESTOSTERONE PROPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 145 ; HYDROXYSTILBAMIDINE ; 495-99-8 ; 1953 ; DISCONTINUED ; ; CLASS ANTIPARASITIC , ; NDA 009166 (pdf 9166.pdf not found) INN (HYDROXYSTILBAMIDINE ISETHIONATE) HYDROXYSTILBAMIDINE ISETHIONATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1953 DISCONTINUED , 146 ; PRIMIDONE ; 125-33-7 ; 1954 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANTS -- BARBITURATES -- GABA MODULATORS , ; NDA 009170 (label 9170.pdf) INN (PRIMIDONE) MYSOLINE (VALEANT) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY , NDA 010401 (label 10401.pdf) INN (PRIMIDONE) MYSOLINE (FHTA) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 040586 (pdf 40586.pdf not found) INN (PRIMIDONE) PRIMIDONE (OXFORD PHARMS) APPROVAL= AP YEAR= 2005 , NDA 040626 (pdf 40626.pdf not found) INN (PRIMIDONE) PRIMIDONE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2005 , NDA 040667 (pdf 40667.pdf not found) INN (PRIMIDONE) PRIMIDONE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040717 (pdf 40717.pdf not found) INN (PRIMIDONE) PRIMIDONE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040866 (pdf 40866.pdf not found) INN (PRIMIDONE) PRIMIDONE (AMNEAL PHARM) APPROVAL= AP YEAR= 2008 , NDA 083551 (pdf 83551.pdf not found) INN (PRIMIDONE) PRIMIDONE (WATSON LABS) APPROVAL= AP YEAR= 1979 , NDA 084903 (pdf 84903.pdf not found) INN (PRIMIDONE) PRIMIDONE (LANNETT) APPROVAL= AP YEAR= 1978 , NDA 085052 (pdf 85052.pdf not found) INN (PRIMIDONE) PRIMIDONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040862 (pdf 40862.pdf not found) INN (PRIMIDONE) PRIMIDONE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 214896 (pdf 214896.pdf not found) INN (PRIMIDONE) PRIMIDONE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 218366 (pdf 218366.pdf not found) INN (PRIMIDONE) PRIMIDONE (CARNEGIE) APPROVAL= AP YEAR= 2024 , 147 ; WARFARIN ; 81-81-2 ; 1954 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- COUMARIN DERIVATIVES , ; NDA 009218 (label 9218.pdf) INN (WARFARIN SODIUM) COUMADIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 011771 (pdf 11771.pdf not found) INN (WARFARIN SODIUM) ATHROMBIN (PHARM RES ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017020 (pdf 17020.pdf not found) INN (WARFARIN SODIUM) PANWARFIN (ABBOTT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 040145 (pdf 40145.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040196 (pdf 40196.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040301 (label 40301.pdf) INN (WARFARIN SODIUM) WARFARIN SODIUM (TARO) APPROVAL= AP YEAR= 1999 , NDA 040415 (label 40415.pdf) INN (WARFARIN SODIUM) WARFARIN SODIUM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040416 (pdf 40416.pdf not found) INN (WARFARIN SODIUM) JANTOVEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2003 , NDA 040616 (pdf 40616.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (PLIVA) APPROVAL= AP YEAR= 2006 , NDA 040663 (pdf 40663.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 086118 (pdf 86118.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086119 (pdf 86119.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086120 (pdf 86120.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086122 (pdf 86122.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086123 (pdf 86123.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088719 (pdf 88719.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088720 (pdf 88720.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088721 (pdf 88721.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090935 (pdf 90935.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (INVAGEN PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200104 (pdf 200104.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (IPCA LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202202 (pdf 202202.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , 148 ; PROGESTERONE ; 57-83-0 ; 1974 ; ; ; CLASS GENITO -- CONTRACEPTIVES -- PROGESTINS , ; NDA 009238 (pdf 9238.pdf not found) INN (PROGESTERONE) PROGESTERONE (LILLY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017362 (label 17362.pdf) INN (PROGESTERONE) PROGESTERONE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 017553 (pdf 17553.pdf not found) INN (PROGESTERONE) PROGESTASERT (ALZA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 019781 (label 19781.pdf) INN (PROGESTERONE) PROMETRIUM (VIRTUS) APPROVAL= AP YEAR= 1998 , NDA 020701 (label 20701.pdf) INN (PROGESTERONE) CRINONE (ALLERGAN) APPROVAL= AP YEAR= 1997 , NDA 020756 (pdf 20756.pdf not found) INN (PROGESTERONE) CRINONE (WATSON LABS INC) APPROVAL= AP YEAR= 1997 , NDA 020843 (label 20843.pdf) INN (PROGESTERONE) PROMETRIUM (VIRTUS PHARMS) APPROVAL= AP YEAR= 1998 NEWAPPLICATION , NDA 022057 (label 22057.pdf) INN (PROGESTERONE) ENDOMETRIN (FERRING) APPROVAL= AP YEAR= 2007 , NDA 075906 (label 75906.pdf) INN (PROGESTERONE) PROGESTERONE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 090845 (pdf 90845.pdf not found) INN (PROGESTERONE) PROGESTERONE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091033 (pdf 91033.pdf not found) INN (PROGESTERONE) PROGESTERONE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 202121 (pdf 202121.pdf not found) INN (PROGESTERONE) PROGESTERONE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200456 (pdf 200456.pdf not found) INN (PROGESTERONE) PROGESTERONE (SOFGEN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 200900 (pdf 200900.pdf not found) INN (PROGESTERONE) PROGESTERONE (BIONPHARMA) APPROVAL= AP YEAR= 2013 , NDA 208801 (pdf 208801.pdf not found) INN (PROGESTERONE) PROGESTERONE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 205229 (pdf 205229.pdf not found) INN (PROGESTERONE) PROGESTERONE (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 207724 (pdf 207724.pdf not found) INN (PROGESTERONE) PROGESTERONE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2017 , NDA 210132 (label 210132.pdf) INN (ESTRADIOL PROGESTERONE) BIJUVA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210965 (pdf 210965.pdf not found) INN (PROGESTERONE) PROGESTERONE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211285 (pdf 211285.pdf not found) INN (PROGESTERONE) PROGESTERONE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 201110 (label 201110.pdf) INN (PROGESTERONE) MILPROSA (FERRING PHARMS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214293 (pdf 214293.pdf not found) INN (ESTRADIOL PROGESTERONE) ESTRADIOL AND PROGESTERONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215634 (pdf 215634.pdf not found) INN (PROGESTERONE) PROGESTERONE (XIROMED) APPROVAL= AP YEAR= 2022 , NDA 217707 (pdf 217707.pdf not found) INN (PROGESTERONE) PROGESTERONE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2023 , 149 ; OXTRIPHYLLINE ; 46155-92-4 ; 1981 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR AGENTS , ; NDA 009268 (pdf 9268.pdf not found) INN (OXTRIPHYLLINE) CHOLEDYL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086742 (pdf 86742.pdf not found) INN (OXTRIPHYLLINE) CHOLEDYL SA (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087835 (pdf 87835.pdf not found) INN (OXTRIPHYLLINE) OXTRIPHYLLINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087863 (pdf 87863.pdf not found) INN (OXTRIPHYLLINE) CHOLEDYL SA (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087866 (pdf 87866.pdf not found) INN (OXTRIPHYLLINE) OXTRIPHYLLINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088242 (pdf 88242.pdf not found) INN (OXTRIPHYLLINE) OXTRIPHYLLINE PEDIATRIC (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088243 (pdf 88243.pdf not found) INN (OXTRIPHYLLINE) OXTRIPHYLLINE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , 150 ; DESLANOSIDE ; 17598-65-1 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC AGENTS , ; NDA 009282 (pdf 9282.pdf not found) INN (DESLANOSIDE) CEDILANID-D (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 151 ; TRIDIHEXETHYL ; 4310-35-4 ; 1954 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC , ; NDA 009489 (pdf 9489.pdf not found) INN (TRIDIHEXETHYL CHLORIDE) PATHILON (LEDERLE) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 009729 (pdf 9729.pdf not found) INN (TRIDIHEXETHYL CHLORIDE) PATHILON (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , 152 ; DIGOXIN ; 20830-75-5 ; 1954 ; ; ; CLASS CARDIOVASCULAR -- ANTI-ARRHYTHMIA AGENTS -- CARDIOTONIC AGENTS -- DIGOXIN IS EXTRACTED FROM THE LEAVES OF DIGITALIS LANATA -- SODIUM-POTASSIUM ATPASE INHIBITOR , ; NDA 009330 (label 9330.pdf) INN (DIGOXIN) LANOXIN (COVIS) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY , NDA 018118 (pdf 18118.pdf not found) INN (DIGOXIN) LANOXICAPS (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 020405 (label 20405.pdf) INN (DIGOXIN) LANOXIN (CONCORDIA) APPROVAL= AP YEAR= 1997 , NDA 021648 (label 21648.pdf) INN (DIGOXIN) DIGOXIN (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 040092 (pdf 40092.pdf not found) INN (DIGOXIN) DIGOXIN PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040093 (pdf 40093.pdf not found) INN (DIGOXIN) DIGOXIN (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040206 (pdf 40206.pdf not found) INN (DIGOXIN) DIGOXIN (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040282 (pdf 40282.pdf not found) INN (DIGOXIN) DIGOXIN (RISING) APPROVAL= AP YEAR= 1999 , NDA 040481 (pdf 40481.pdf not found) INN (DIGOXIN) DIGOXIN (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076268 (label 76268.pdf) INN (DIGOXIN) DIGOXIN (STEVENS J) APPROVAL= AP YEAR= 2002 , NDA 076363 (pdf 76363.pdf not found) INN (DIGOXIN) DIGOXIN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2003 , NDA 077002 (pdf 77002.pdf not found) INN (DIGOXIN) DIGOXIN (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2007 , NDA 083217 (pdf 83217.pdf not found) INN (DIGOXIN) DIGOXIN (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083391 (pdf 83391.pdf not found) INN (DIGOXIN) DIGOXIN (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084386 (pdf 84386.pdf not found) INN (DIGOXIN) DIGOXIN (WYETH AYERST) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 078556 (pdf 78556.pdf not found) INN (DIGOXIN) DIGOXIN (IMPAX LABS) APPROVAL= AP YEAR= 2009 , NDA 213000 (pdf 213000.pdf not found) INN (DIGOXIN) DIGOXIN (VISTAPHARM LLC) APPROVAL= AP YEAR= 2019 , NDA 215307 (pdf 215307.pdf not found) INN (DIGOXIN) DIGOXIN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214982 (pdf 214982.pdf not found) INN (DIGOXIN) DIGOXIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215209 (pdf 215209.pdf not found) INN (DIGOXIN) DIGOXIN (AMICI) APPROVAL= AP YEAR= 2022 , 153 ; BETAZOLE ; 105-20-4 ; 0 ; DISCONTINUED ; ; CLASS VARIOUS -- DIAGNOSTIC AGENTS -- TESTS FOR GASTRIC SECRETION -- HISTAMINE AGONISTS , ; NDA 009344 (pdf 9344.pdf not found) INN (BETAZOLE HYDROCHLORIDE) HISTALOG (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 154 ; PENTOLINIUM ; 144-44-5 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE , ; NDA 009372 (pdf 9372.pdf not found) INN (PENTOLINIUM TARTRATE) ANSOLYSEN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , 155 ; BUSULFAN ; 55-98-1 ; 1954 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENTS -- IMMUNOSUPPRESSIVE AGENTS -- MYELOABLATIVE AGONISTS -- PRODUCES REACTIVE CARBONIUM IONS THAT CAN ALKYLATE DNA , ; NDA 009386 (label 9386.pdf) INN (BUSULFAN) MYLERAN (WAYLIS THERAP) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY , NDA 020954 (label 20954.pdf) INN (BUSULFAN) BUSULFEX (OTSUKA PHARM) APPROVAL= AP YEAR= 1999 , NDA 202259 (pdf 202259.pdf not found) INN (BUSULFAN) BUSULFAN (AM REGENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205106 (pdf 205106.pdf not found) INN (BUSULFAN) BUSULFAN (ARTHUR GRP) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207050 (pdf 207050.pdf not found) INN (BUSULFAN) BUSULFAN (PHARMASCIENCE INC) APPROVAL= AP YEAR= 2017 , NDA 205139 (pdf 205139.pdf not found) INN (BUSULFAN) BUSULFAN (ACTAVIS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208536 (pdf 208536.pdf not found) INN (BUSULFAN) BUSULFAN (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2017 , NDA 209580 (pdf 209580.pdf not found) INN (BUSULFAN) BUSULFAN (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 205184 (pdf 205184.pdf not found) INN (BUSULFAN) BUSULFAN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205672 (pdf 205672.pdf not found) INN (BUSULFAN) BUSULFAN (HOSPIRA) APPROVAL= AP YEAR= 2018 , NDA 207794 (pdf 207794.pdf not found) INN (BUSULFAN) BUSULFAN (NEXUS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210148 (pdf 210148.pdf not found) INN (BUSULFAN) BUSULFAN (ACCORD HLTHCARE INC) APPROVAL= AP YEAR= 2019 , NDA 210448 (pdf 210448.pdf not found) INN (BUSULFAN) BUSULFAN (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 210931 (pdf 210931.pdf not found) INN (BUSULFAN) BUSULFAN (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 212127 (pdf 212127.pdf not found) INN (BUSULFAN) BUSULFAN (MEITHEAL) APPROVAL= AP YEAR= 2020 , 156 ; TALBUTAL ; 115-44-6 ; 1954 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- SEDATIVES , ; NDA 009410 (pdf 9410.pdf not found) INN (TALBUTAL) LOTUSATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , 157 ; CHLOROPROCAINE ; 133-16-4 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 009435 (label 9435.pdf) INN (CHLOROPROCAINE HYDROCHLORIDE) NESACAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY , NDA 040273 (pdf 40273.pdf not found) INN (CHLOROPROCAINE HYDROCHLORIDE) CHLOROPROCAINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 087446 (pdf 87446.pdf not found) INN (CHLOROPROCAINE HYDROCHLORIDE) CHLOROPROCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087447 (pdf 87447.pdf not found) INN (CHLOROPROCAINE HYDROCHLORIDE) CHLOROPROCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 208791 (label 208791.pdf) INN (CHLOROPROCAINE HYDROCHLORIDE) CLOROTEKAL (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 216227 (label 216227.pdf) INN (CHLOROPROCAINE HYDROCHLORIDE) IHEEZO (HARROW EYE) APPROVAL= AP YEAR= 2022 , 158 ; ACETYLDIGITOXIN ; 1111-39-3 ; 1975 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC , ; NDA 009436 (pdf 9436.pdf not found) INN (ACETYLDIGITOXIN) ACYLANID (NOVARTIS) APPROVAL= AP YEAR= 1975 DISCONTINUED , 159 ; TRIDIHEXETHYL ; 4310-35-4 ; 1954 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC , ; NDA 009489 (pdf 9489.pdf not found) INN (TRIDIHEXETHYL CHLORIDE) PATHILON (LEDERLE) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 009729 (pdf 9729.pdf not found) INN (TRIDIHEXETHYL CHLORIDE) PATHILON (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , 160 ; METARAMINOL ; 54-49-9 ; 1954 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPOTENSIVE -- ADRENERGIC ALPHA AGONISTS -- SYMPATHOMIMETICS -- VASOCONSTRICTOR AGENTS , ; NDA 009509 (label 9509.pdf) INN (METARAMINOL BITARTRATE) ARAMINE (MERCK) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 080431 (pdf 80431.pdf not found) INN (METARAMINOL BITARTRATE) METARAMINOL BITARTRATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080722 (pdf 80722.pdf not found) INN (METARAMINOL BITARTRATE) METARAMINOL BITARTRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083363 (pdf 83363.pdf not found) INN (METARAMINOL BITARTRATE) METARAMINOL BITARTRATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086418 (pdf 86418.pdf not found) INN (METARAMINOL BITARTRATE) METARAMINOL BITARTRATE (GD SEARLE LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 211304 (pdf 211304.pdf not found) INN (METARAMINOL BITARTRATE) METARAMINOL BITARTRATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2021 , 161 ; GLUTETHIMIDE ; 77-21-4 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES -- ANXIOLYTIC , ; NDA 009519 (pdf 9519.pdf not found) INN (GLUTETHIMIDE) DORIDEN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 083234 (pdf 83234.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083475 (pdf 83475.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084362 (pdf 84362.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085171 (pdf 85171.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085571 (pdf 85571.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085763 (pdf 85763.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087297 (pdf 87297.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (VITARINE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 089458 (pdf 89458.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089459 (pdf 89459.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , 162 ; HYDROXYCHLOROQUINE ; 118-42-3 ; 1955 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- LUPUS SUPPRESSANT -- ANTIRHEUMATIC AGENTS -- AUTOPHAGY INHIBITOR , ; NDA 009768 (label 9768.pdf) INN (HYDROXYCHLOROQUINE SULFATE) PLAQUENIL (CONCORDIA) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY , NDA 040081 (pdf 40081.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 1994 , NDA 040104 (label 40104.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 040133 (pdf 40133.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040150 (label 40150.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 1996 , NDA 040274 (label 40274.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 , NDA 040657 (label 40657.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2007 , NDA 040760 (label 40760.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040766 (label 40766.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 201691 (label 201691.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ALKALOIDA ZRT) APPROVAL= AP YEAR= 2018 , NDA 210441 (label 210441.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 210577 (pdf 210577.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210543 (label 210543.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 210959 (label 210959.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (LAURUS) APPROVAL= AP YEAR= 2019 , NDA 212902 (pdf 212902.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (SENORES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213342 (pdf 213342.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214581 (label 214581.pdf) INN (HYDROXYCHLOROQUINE SULFATE) SOVUNA (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 163 ; METHYPRYLON ; 125-64-4 ; 1955 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- SEDATIVES -- HYPNOTICS , ; NDA 009660 (pdf 9660.pdf not found) INN (METHYPRYLON) NOLUDAR (ROCHE) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , 164 ; MEPROBAMATE ; 57-53-4 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- SEDATIVE -- GABA MODULATOR , ; NDA 009698 (pdf 9698.pdf not found) INN (MEPROBAMATE) MILTOWN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 010028 (pdf 10028.pdf not found) INN (MEPROBAMATE) EQUANIL (WYETH AYERST) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , NDA 010971 (pdf 10971.pdf not found) INN (ESTROGENS CONJUGATED MEPROBAMATE) PMB 400 (WYETH AYERST) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011045 (pdf 11045.pdf not found) INN (ESTROGENS CONJUGATED MEPROBAMATE) MILPREM-400 (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011284 (pdf 11284.pdf not found) INN (MEPROBAMATE) MEPROSPAN (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011702 (label 11702.pdf) INN (ASPIRIN MEPROBAMATE) EQUAGESIC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012455 (pdf 12455.pdf not found) INN (MEPROBAMATE) EQUANIL (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 014322 (pdf 14322.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 014359 (pdf 14359.pdf not found) INN (MEPROBAMATE) NEURAMATE (HALSEY) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 014368 (pdf 14368.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (MK LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 014474 (pdf 14474.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (STANLABS PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 014547 (pdf 14547.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (SANDOZ) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 014601 (pdf 14601.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PVT FORM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 014882 (pdf 14882.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 015072 (pdf 15072.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (MALLARD) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 015139 (pdf 15139.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 015417 (pdf 15417.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WEST WARD) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 015426 (pdf 15426.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 015438 (pdf 15438.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016069 (pdf 16069.pdf not found) INN (MEPROBAMATE) MEPRIAM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016249 (pdf 16249.pdf not found) INN (MEPROBAMATE) TRANMEP (SOLVAY) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016928 (pdf 16928.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040797 (pdf 40797.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2008 , NDA 080380 (pdf 80380.pdf not found) INN (MEPROBAMATE) BAMATE (ALRA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080655 (pdf 80655.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (RISING) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080699 (pdf 80699.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083304 (pdf 83304.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083308 (pdf 83308.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083343 (pdf 83343.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (SCHERER LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083442 (pdf 83442.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083494 (pdf 83494.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083618 (pdf 83618.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083830 (pdf 83830.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083919 (pdf 83919.pdf not found) INN (MEPROBAMATE) MILTOWN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084030 (pdf 84030.pdf not found) INN (MEPROBAMATE) AMOSENE (FERNDALE LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084153 (pdf 84153.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (ACELLA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084181 (pdf 84181.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084220 (pdf 84220.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084230 (pdf 84230.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (BARR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084274 (pdf 84274.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084329 (pdf 84329.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084332 (pdf 84332.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084369 (pdf 84369.pdf not found) INN (MEPROBAMATE) TRANMEP (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084435 (pdf 84435.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084438 (pdf 84438.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PHARMAVITE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084546 (pdf 84546.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PERRIGO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084547 (pdf 84547.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PERRIGO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084589 (pdf 84589.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084744 (pdf 84744.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PARKE DAVIS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084804 (pdf 84804.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084978 (pdf 84978.pdf not found) INN (ASPIRIN MEPROBAMATE) MICRAININ (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085719 (pdf 85719.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085720 (pdf 85720.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085721 (pdf 85721.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086299 (pdf 86299.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087825 (pdf 87825.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087826 (pdf 87826.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088011 (pdf 88011.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088740 (pdf 88740.pdf not found) INN (ASPIRIN MEPROBAMATE) Q-GESIC (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089126 (pdf 89126.pdf not found) INN (ASPIRIN MEPROBAMATE) MEPROBAMATE AND ASPIRIN (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089127 (pdf 89127.pdf not found) INN (ASPIRIN MEPROBAMATE) MEPRO-ASPIRIN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089538 (pdf 89538.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (LEE KM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 090122 (pdf 90122.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 200998 (pdf 200998.pdf not found) INN (MEPROBAMATE) MEPROBAMATE (TARO) APPROVAL= AP YEAR= 2011 DISCONTINUED , 165 ; ETHINAMATE ; 126-52-3 ; 1955 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES , ; NDA 009750 (pdf 9750.pdf not found) INN (ETHINAMATE) VALMID (DISTA) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , 166 ; PREDNISONE ; 53-03-2 ; 1955 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS -- ANTINEOPLASTIC AGENTS -- ADRENOCORTICAL STEROIDS , ; NDA 009766 (pdf 9766.pdf not found) INN (PREDNISONE) METICORTEN (SCHERING) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , NDA 009986 (pdf 9986.pdf not found) INN (PREDNISONE) DELTASONE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 010962 (pdf 10962.pdf not found) INN (PREDNISONE) PARACORT (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 017109 (pdf 17109.pdf not found) INN (PREDNISONE) PREDNISONE (ROXANE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 040256 (pdf 40256.pdf not found) INN (PREDNISONE) PREDNISONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2002 , NDA 040362 (pdf 40362.pdf not found) INN (PREDNISONE) PREDNISONE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2001 , NDA 040392 (pdf 40392.pdf not found) INN (PREDNISONE) PREDNISONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2003 , NDA 040538 (pdf 40538.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040581 (pdf 40581.pdf not found) INN (PREDNISONE) PREDNISONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2004 , NDA 040584 (pdf 40584.pdf not found) INN (PREDNISONE) PREDNISONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2004 , NDA 040611 (pdf 40611.pdf not found) INN (PREDNISONE) PREDNISONE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2005 , NDA 080209 (pdf 80209.pdf not found) INN (PREDNISONE) PREDNISONE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080223 (pdf 80223.pdf not found) INN (PREDNISONE) SERVISONE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080232 (pdf 80232.pdf not found) INN (PREDNISONE) PREDNISONE (REXALL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080237 (pdf 80237.pdf not found) INN (PREDNISONE) PREDNISONE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080279 (pdf 80279.pdf not found) INN (PREDNISONE) PREDNISONE (INWOOD LABS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080283 (pdf 80283.pdf not found) INN (PREDNISONE) PREDNISONE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080292 (pdf 80292.pdf not found) INN (PREDNISONE) PREDNISONE (MYLAN) APPROVAL= AP YEAR= 1972 , NDA 080293 (pdf 80293.pdf not found) INN (PREDNISONE) DELTA-DOME (BAYER PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080300 (pdf 80300.pdf not found) INN (PREDNISONE) PREDNISONE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080301 (pdf 80301.pdf not found) INN (PREDNISONE) PREDNISONE (MARSHALL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080306 (pdf 80306.pdf not found) INN (PREDNISONE) PREDNISONE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080320 (pdf 80320.pdf not found) INN (PREDNISONE) PREDNISONE (HEATHER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080321 (pdf 80321.pdf not found) INN (PREDNISONE) PREDNISONE (PHOENIX LABS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080328 (pdf 80328.pdf not found) INN (PREDNISONE) PREDNISONE (INWOOD LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080334 (pdf 80334.pdf not found) INN (PREDNISONE) PREDNISONE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080336 (pdf 80336.pdf not found) INN (PREDNISONE) PREDNISONE (SANDOZ) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080343 (pdf 80343.pdf not found) INN (PREDNISONE) PREDNISONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080350 (pdf 80350.pdf not found) INN (PREDNISONE) PREDNISONE (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080352 (pdf 80352.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1972 , NDA 080353 (pdf 80353.pdf not found) INN (PREDNISONE) PREDNISONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080356 (pdf 80356.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1972 , NDA 080359 (pdf 80359.pdf not found) INN (PREDNISONE) PREDNISONE (SPERTI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080371 (pdf 80371.pdf not found) INN (PREDNISONE) PREDNISONE (SCHERER LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080397 (pdf 80397.pdf not found) INN (PREDNISONE) PREDNISONE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080491 (pdf 80491.pdf not found) INN (PREDNISONE) PREDNISONE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080506 (pdf 80506.pdf not found) INN (PREDNISONE) PREDNISONE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080514 (pdf 80514.pdf not found) INN (PREDNISONE) PREDNISONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080563 (pdf 80563.pdf not found) INN (PREDNISONE) PREDNISONE (FERRANTE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080701 (pdf 80701.pdf not found) INN (PREDNISONE) PREDNISONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080782 (pdf 80782.pdf not found) INN (PREDNISONE) PREDNISONE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083009 (pdf 83009.pdf not found) INN (PREDNISONE) ORASONE (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083059 (pdf 83059.pdf not found) INN (PREDNISONE) PREDNISONE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 083364 (pdf 83364.pdf not found) INN (PREDNISONE) FERNISONE (FERNDALE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083676 (pdf 83676.pdf not found) INN (PREDNISONE) PREDNISONE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083677 (pdf 83677.pdf not found) INN (PREDNISONE) PREDNISONE (MYLAN) APPROVAL= AP YEAR= 1974 , NDA 083807 (pdf 83807.pdf not found) INN (PREDNISONE) PREDNISONE (PHOENIX LABS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084122 (pdf 84122.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1974 , NDA 084133 (pdf 84133.pdf not found) INN (PREDNISONE) PREDNISONE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084134 (pdf 84134.pdf not found) INN (PREDNISONE) PREDNISONE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084236 (pdf 84236.pdf not found) INN (PREDNISONE) PREDNISONE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084275 (pdf 84275.pdf not found) INN (PREDNISONE) PREDNISONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084283 (pdf 84283.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1977 , NDA 084341 (pdf 84341.pdf not found) INN (PREDNISONE) PREDNISONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084417 (pdf 84417.pdf not found) INN (PREDNISONE) PREDNISONE (HEATHER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084440 (pdf 84440.pdf not found) INN (PREDNISONE) PREDNISONE (EVERYLIFE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084634 (pdf 84634.pdf not found) INN (PREDNISONE) PREDNISONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084655 (pdf 84655.pdf not found) INN (PREDNISONE) PREDNICEN-M (SCHWARZ PHARMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084662 (pdf 84662.pdf not found) INN (PREDNISONE) PREDNISONE (PHARMAVITE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084774 (pdf 84774.pdf not found) INN (PREDNISONE) PREDNISONE (RISING) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 084913 (pdf 84913.pdf not found) INN (PREDNISONE) PREDNISONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085084 (pdf 85084.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085115 (pdf 85115.pdf not found) INN (PREDNISONE) PREDNISONE (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085151 (pdf 85151.pdf not found) INN (PREDNISONE) PREDNISONE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085161 (pdf 85161.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 085162 (pdf 85162.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 085543 (pdf 85543.pdf not found) INN (PREDNISONE) PREDNISONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085811 (pdf 85811.pdf not found) INN (PREDNISONE) PREDNISONE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085813 (pdf 85813.pdf not found) INN (PREDNISONE) PREDNISONE (RISING) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085999 (pdf 85999.pdf not found) INN (PREDNISONE) ORASONE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086061 (pdf 86061.pdf not found) INN (PREDNISONE) PREDNISONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086062 (pdf 86062.pdf not found) INN (PREDNISONE) PREDNISONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086595 (pdf 86595.pdf not found) INN (PREDNISONE) PREDNISONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086596 (pdf 86596.pdf not found) INN (PREDNISONE) PREDNISONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086813 (pdf 86813.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086867 (pdf 86867.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086946 (pdf 86946.pdf not found) INN (PREDNISONE) PREDNISONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086968 (pdf 86968.pdf not found) INN (PREDNISONE) PREDNISONE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087342 (pdf 87342.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1981 , NDA 087470 (pdf 87470.pdf not found) INN (PREDNISONE) PREDNISONE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087471 (pdf 87471.pdf not found) INN (PREDNISONE) PREDNISONE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087480 (pdf 87480.pdf not found) INN (PREDNISONE) CORTAN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087611 (pdf 87611.pdf not found) INN (PREDNISONE) LIQUID PRED (MURO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087682 (pdf 87682.pdf not found) INN (PREDNISONE) PREDNISONE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087701 (pdf 87701.pdf not found) INN (PREDNISONE) PREDNISONE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087772 (pdf 87772.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087773 (pdf 87773.pdf not found) INN (PREDNISONE) PREDNISONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087800 (pdf 87800.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 087801 (pdf 87801.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 087833 (pdf 87833.pdf not found) INN (PREDNISONE) PREDNISONE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087984 (pdf 87984.pdf not found) INN (PREDNISONE) PREDNISONE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087985 (pdf 87985.pdf not found) INN (PREDNISONE) PREDNISONE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087986 (pdf 87986.pdf not found) INN (PREDNISONE) PREDNISONE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088394 (pdf 88394.pdf not found) INN (PREDNISONE) PREDNISONE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088395 (pdf 88395.pdf not found) INN (PREDNISONE) PREDNISONE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088396 (pdf 88396.pdf not found) INN (PREDNISONE) PREDNISONE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088465 (pdf 88465.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088703 (pdf 88703.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA) APPROVAL= AP YEAR= 1984 , NDA 088810 (pdf 88810.pdf not found) INN (PREDNISONE) PREDNISONE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 088832 (pdf 88832.pdf not found) INN (PREDNISONE) PREDNISONE (MYLAN) APPROVAL= AP YEAR= 1985 , NDA 088865 (pdf 88865.pdf not found) INN (PREDNISONE) PREDNISONE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088866 (pdf 88866.pdf not found) INN (PREDNISONE) PREDNISONE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088867 (pdf 88867.pdf not found) INN (PREDNISONE) PREDNISONE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089028 (pdf 89028.pdf not found) INN (PREDNISONE) PREDNISONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089245 (pdf 89245.pdf not found) INN (PREDNISONE) PREDNISONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 089246 (pdf 89246.pdf not found) INN (PREDNISONE) PREDNISONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 089247 (pdf 89247.pdf not found) INN (PREDNISONE) PREDNISONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 , NDA 089387 (pdf 89387.pdf not found) INN (PREDNISONE) PREDNISONE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089388 (pdf 89388.pdf not found) INN (PREDNISONE) PREDNISONE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089389 (pdf 89389.pdf not found) INN (PREDNISONE) PREDNISONE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089597 (pdf 89597.pdf not found) INN (PREDNISONE) PREDNISONE (AMNEAL PHARMS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089598 (pdf 89598.pdf not found) INN (PREDNISONE) PREDNISONE (AMNEAL PHARMS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089599 (pdf 89599.pdf not found) INN (PREDNISONE) PREDNISONE (AMNEAL PHARMS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089726 (pdf 89726.pdf not found) INN (PREDNISONE) PREDNISONE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089983 (pdf 89983.pdf not found) INN (PREDNISONE) PREDNISONE (RISING) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089984 (pdf 89984.pdf not found) INN (PREDNISONE) PREDNISONE (RISING) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 040890 (pdf 40890.pdf not found) INN (PREDNISONE) PREDNISONE (HIKMA PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202020 (label 202020.pdf) INN (PREDNISONE) RAYOS (HORIZON) APPROVAL= AP YEAR= 2012 , NDA 204867 (pdf 204867.pdf not found) INN (PREDNISONE) PREDNISONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 210525 (pdf 210525.pdf not found) INN (PREDNISONE) PREDNISONE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211495 (pdf 211495.pdf not found) INN (PREDNISONE) PREDNISONE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2018 OBSOLETE , NDA 211496 (pdf 211496.pdf not found) INN (PREDNISONE) PREDNISONE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211575 (pdf 211575.pdf not found) INN (PREDNISONE) PREDNISONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 213385 (pdf 213385.pdf not found) INN (PREDNISONE) PREDNISONE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 213386 (pdf 213386.pdf not found) INN (PREDNISONE) PREDNISONE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 209727 (pdf 209727.pdf not found) INN (PREDNISONE) PREDNISONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 210785 (pdf 210785.pdf not found) INN (PREDNISONE) PREDNISONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 208412 (pdf 208412.pdf not found) INN (PREDNISONE) PREDNISONE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215246 (pdf 215246.pdf not found) INN (PREDNISONE) PREDNISONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215671 (pdf 215671.pdf not found) INN (PREDNISONE) PREDNISONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 215672 (pdf 215672.pdf not found) INN (PREDNISONE) PREDNISONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 212629 (pdf 212629.pdf not found) INN (PREDNISONE) PREDNISONE (GRANULATION TECH) APPROVAL= AP YEAR= 2023 , 167 ; HYDROXYCHLOROQUINE ; 118-42-3 ; 1955 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- LUPUS SUPPRESSANT -- ANTIRHEUMATIC AGENTS -- AUTOPHAGY INHIBITOR , ; NDA 009768 (label 9768.pdf) INN (HYDROXYCHLOROQUINE SULFATE) PLAQUENIL (CONCORDIA) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY , NDA 040081 (pdf 40081.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 1994 , NDA 040104 (label 40104.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 040133 (pdf 40133.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040150 (label 40150.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 1996 , NDA 040274 (label 40274.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 , NDA 040657 (label 40657.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2007 , NDA 040760 (label 40760.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040766 (label 40766.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 201691 (label 201691.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ALKALOIDA ZRT) APPROVAL= AP YEAR= 2018 , NDA 210441 (label 210441.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 210577 (pdf 210577.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210543 (label 210543.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 210959 (label 210959.pdf) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (LAURUS) APPROVAL= AP YEAR= 2019 , NDA 212902 (pdf 212902.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (SENORES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213342 (pdf 213342.pdf not found) INN (HYDROXYCHLOROQUINE SULFATE) HYDROXYCHLOROQUINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214581 (label 214581.pdf) INN (HYDROXYCHLOROQUINE SULFATE) SOVUNA (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 168 ; PROCYCLIDINE ; 77-37-2 ; 1955 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS , ; NDA 009818 (label 9818.pdf) INN (PROCYCLIDINE HYDROCHLORIDE) KEMADRIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , 169 ; PYRIDOSTIGMINE ; 155-97-5 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINERGIC -- ANTIMYASTHENICS -- CHOLINESTERASE INHIBITORS -- PARASYMPATHOMIMETICS -- ANALOGUE OF NEOSTIGMINE , ; NDA 009829 (label 9829.pdf) INN (PYRIDOSTIGMINE BROMIDE) MESTINON (BAUSCH) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY , NDA 009830 (label 9830.pdf) INN (PYRIDOSTIGMINE BROMIDE) MESTINON (BAUSCH) APPROVAL= AP YEAR= 1955 , NDA 011665 (label 11665.pdf) INN (PYRIDOSTIGMINE BROMIDE) MESTINON (BAUSCH) APPROVAL= AP YEAR= 1959 , NDA 015193 (label 15193.pdf) INN (PYRIDOSTIGMINE BROMIDE) MESTINON (BAUSCH) APPROVAL= AP YEAR= 1965 , NDA 017398 (label 17398.pdf) INN (PYRIDOSTIGMINE BROMIDE) REGONOL (SANDOZ) APPROVAL= AP YEAR= 1973 , NDA 020414 (label 20414.pdf) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (US ARMY) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040457 (pdf 40457.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040502 (pdf 40502.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (IMPAX LABS) APPROVAL= AP YEAR= 2003 , NDA 040512 (pdf 40512.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2003 , NDA 089572 (pdf 89572.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (SOLVAY) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 204737 (pdf 204737.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (ALVOGEN) APPROVAL= AP YEAR= 2015 , NDA 205650 (pdf 205650.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203184 (pdf 203184.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 , NDA 205464 (pdf 205464.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 211181 (pdf 211181.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (MLV) APPROVAL= AP YEAR= 2018 , NDA 211694 (pdf 211694.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 208797 (pdf 208797.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (RISING) APPROVAL= AP YEAR= 2020 , NDA 212702 (pdf 212702.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 212405 (pdf 212405.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (MILLA PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216512 (pdf 216512.pdf not found) INN (PYRIDOSTIGMINE BROMIDE) PYRIDOSTIGMINE BROMIDE (MSN) APPROVAL= AP YEAR= 2023 , 170 ; DYCLONINE ; 586-60-7 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 009925 (pdf 9925.pdf not found) INN (DYCLONINE HYDROCHLORIDE) DYCLONE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 200480 (pdf 200480.pdf not found) INN (DYCLONINE HYDROCHLORIDE) DYCLOPRO (SEPTODONT) APPROVAL= AP YEAR= 2018 , 171 ; PREDNISOLONE ; 50-24-8 ; 1955 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ADRENOCORTICAL STEROID -- ANTIINFLAMMATORY , ; NDA 009987 (pdf 9987.pdf not found) INN (PREDNISOLONE) DELTA-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , NDA 009996 (pdf 9996.pdf not found) INN (PREDNISOLONE) STERANE (PFIZER) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 010209 (pdf 10209.pdf not found) INN (PREDNISOLONE) METI-DERM (SCHERING) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 040192 (pdf 40192.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WE PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040287 (label 40287.pdf) INN (PREDNISOLONE) PREDNISOLONE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040313 (pdf 40313.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040322 (pdf 40322.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040323 (label 40323.pdf) INN (PREDNISOLONE) PREDNISOLONE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 , NDA 040364 (pdf 40364.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040399 (pdf 40399.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PHARM ASSOC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040401 (pdf 40401.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (HIKMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040423 (pdf 40423.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (NESHER PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040570 (pdf 40570.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040571 (pdf 40571.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 , NDA 040775 (pdf 40775.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (LANNETT CO INC) APPROVAL= AP YEAR= 2007 , NDA 061188 (pdf 61188.pdf not found) INN (CHLORAMPHENICOL PREDNISOLONE) CHLOROPTIC-P S.O.P. (ALLERGAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080211 (pdf 80211.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080236 (pdf 80236.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080304 (pdf 80304.pdf not found) INN (PREDNISOLONE) CORTALONE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080307 (pdf 80307.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (MARSHALL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080322 (pdf 80322.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PHOENIX LABS NY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080324 (pdf 80324.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080325 (pdf 80325.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080326 (pdf 80326.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080327 (pdf 80327.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (ROXANE) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080339 (pdf 80339.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (FOSUN PHARMA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080342 (pdf 80342.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080351 (pdf 80351.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080354 (pdf 80354.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1972 , NDA 080358 (pdf 80358.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (SPERTI) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080378 (pdf 80378.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080398 (pdf 80398.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080531 (pdf 80531.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1974 , NDA 080534 (pdf 80534.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080562 (pdf 80562.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (FERRANTE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080625 (pdf 80625.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080748 (pdf 80748.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (INWOOD LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080780 (pdf 80780.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083675 (pdf 83675.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083941 (pdf 83941.pdf not found) INN (PREDNISOLONE) FERNISOLONE-P (FERNDALE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084426 (pdf 84426.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084439 (pdf 84439.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (EVERYLIFE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084542 (pdf 84542.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (CHARTWELL RX) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084773 (pdf 84773.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (RISING) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 085085 (pdf 85085.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085170 (pdf 85170.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085415 (pdf 85415.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085416 (pdf 85416.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087987 (pdf 87987.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088892 (pdf 88892.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089081 (pdf 89081.pdf not found) INN (PREDNISOLONE) PRELONE (TEVA) APPROVAL= AP YEAR= 1986 , NDA 089654 (pdf 89654.pdf not found) INN (PREDNISOLONE) PRELONE (MURO) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 011028 (pdf 11028.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) HYDELTRASOL (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011583 (pdf 11583.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) HYDELTRASOL (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018988 (pdf 18988.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) VASOCIDIN (NOVARTIS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019157 (label 19157.pdf) INN (PREDNISOLONE SODIUM PHOSPHATE) PEDIAPRED (SETON PHARM) APPROVAL= AP YEAR= 1986 , NDA 021959 (label 21959.pdf) INN (PREDNISOLONE SODIUM PHOSPHATE) ORAPRED ODT (CONCORDIA PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 040065 (pdf 40065.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040070 (pdf 40070.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 050378 (pdf 50378.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE SODIUM PHOSPHATE) NEO-HYDELTRASOL (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073630 (pdf 73630.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074449 (pdf 74449.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 074511 (pdf 74511.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUM) SULSTER (AKORN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075099 (pdf 75099.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075117 (label 75117.pdf) INN (PREDNISOLONE SODIUM PHOSPHATE) ORAPRED (CONCORDIA PHARMS INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075181 (pdf 75181.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (WE PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075183 (pdf 75183.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075250 (pdf 75250.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (BAUSCH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075988 (pdf 75988.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 , NDA 076123 (pdf 76123.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076895 (pdf 76895.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076913 (pdf 76913.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 , NDA 076982 (pdf 76982.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (NESHER PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076988 (pdf 76988.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (NESHER PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078416 (pdf 78416.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078465 (pdf 78465.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2008 , NDA 078988 (pdf 78988.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2008 , NDA 080517 (pdf 80517.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080751 (pdf 80751.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) INFLAMASE MILD (NOVARTIS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 081043 (pdf 81043.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081044 (pdf 81044.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 083358 (pdf 83358.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083834 (pdf 83834.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) METRETON (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084168 (pdf 84168.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084169 (pdf 84169.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084171 (pdf 84171.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084172 (pdf 84172.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 088165 (pdf 88165.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDAIR FORTE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088415 (pdf 88415.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 078345 (pdf 78345.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079010 (pdf 79010.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091396 (pdf 91396.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (MISSION PHARMA) APPROVAL= AP YEAR= 2010 , NDA 202179 (pdf 202179.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (RISING) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203559 (pdf 203559.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204962 (pdf 204962.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 216715 (pdf 216715.pdf not found) INN (PREDNISOLONE SODIUM PHOSPHATE) PREDNISOLONE SODIUM PHOSPHATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215673 (pdf 215673.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 218083 (pdf 218083.pdf not found) INN (PREDNISOLONE) PREDNISOLONE (ZHEJIANG XIANJU) APPROVAL= AP YEAR= 2024 , 172 ; PREDNISOLONE ACETATE ; 52-21-1 ; 1955 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ADRENOCORTICAL STEROID -- ANTIINFLAMMATORY , ; NDA 010210 (pdf 10210.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) METIMYD (SCHERING) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 010255 (pdf 10255.pdf not found) INN (PREDNISOLONE ACETATE) METICORTELONE (SCHERING) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 011446 (pdf 11446.pdf not found) INN (PREDNISOLONE ACETATE) STERANE (PFIZER) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 012813 (label 12813.pdf) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) BLEPHAMIDE (ALLERGAN) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 017011 (label 17011.pdf) INN (PREDNISOLONE ACETATE) PRED FORTE (ABBVIE) APPROVAL= AP YEAR= 1973 , NDA 017100 (label 17100.pdf) INN (PREDNISOLONE ACETATE) PRED MILD (ABBVIE) APPROVAL= AP YEAR= 1972 , NDA 017468 (label 17468.pdf) INN (PREDNISOLONE ACETATE) ECONOPRED (HARROW EYE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017469 (label 17469.pdf) INN (PREDNISOLONE ACETATE) OMNIPRED (SANDOZ) APPROVAL= AP YEAR= 1973 , NDA 022067 (label 22067.pdf) INN (PREDNISOLONE ACETATE) FLO-PRED (TARO) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 050081 (pdf 50081.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE PREDNISOLONE ACETATE) POLY-PRED (ALLERGAN) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 050586 (label 50586.pdf) INN (GENTAMICIN SULFATE PREDNISOLONE ACETATE) PRED-G (ALLERGAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 050612 (label 50612.pdf) INN (GENTAMICIN SULFATE PREDNISOLONE ACETATE) PRED-G (ALLERGAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 061037 (pdf 61037.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE ACETATE) NEO-DELTA-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061039 (pdf 61039.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE ACETATE) NEO-DELTA-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083032 (pdf 83032.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083398 (pdf 83398.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083654 (pdf 83654.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083738 (pdf 83738.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (BEL MAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083764 (pdf 83764.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083767 (pdf 83767.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084492 (pdf 84492.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084717 (pdf 84717.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085781 (pdf 85781.pdf not found) INN (PREDNISOLONE ACETATE) PREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087547 (pdf 87547.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) ISOPTO CETAPRED (ALCON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087748 (pdf 87748.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) BLEPHAMIDE S.O.P. (ALLERGAN) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087771 (pdf 87771.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) CETAPRED (ALCON) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 088007 (pdf 88007.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR (PHARMAFAIR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088032 (pdf 88032.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088059 (pdf 88059.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDAMIDE (AKORN) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088089 (pdf 88089.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) SULPHRIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088791 (pdf 88791.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) VASOCIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088837 (pdf 88837.pdf not found) INN (PREDNISOLONE ACETATE SULFACETAMIDE SODIUM) PREDSULFAIR II (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , 173 ; RIBOFLAVIN ; 83-88-5 ; 1953 ; ; NATURAL MOLECULE C00001552 ; CLASS METABOLISM -- PHOTOSENSITIZING AGENTS -- VITAMIN B2 -- ANTIMALARIALS , ; NDA 020176 (pdf 20176.pdf not found) INN (RIBOFLAVIN) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021265 (label 21265.pdf) INN (RIBOFLAVIN) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021646 (label 21646.pdf) INN (RIBOFLAVIN) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 008809 (label 8809.pdf) INN (RIBOFLAVIN) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , 174 ; ETHCHLORVYNOL ; 113-18-8 ; 1961 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES -- ANXIOLYTIC , ; NDA 010021 (label 10021.pdf) INN (ETHCHLORVYNOL) PLACIDYL (ABBVIE) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 084463 (pdf 84463.pdf not found) INN (ETHCHLORVYNOL) ETHCHLORVYNOL (BANNER PHARMACAPS) APPROVAL= - YEAR= 0 DISCONTINUED , 175 ; FLUDROCORTISONE ACETATE ; 514-36-3 ; 1955 ; ; ; CLASS HORMONES -- MINERALOCORTICOID -- GLUCOCORTICOID , ; NDA 010060 (pdf 10060.pdf not found) INN (FLUDROCORTISONE ACETATE) FLORINEF (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 040425 (pdf 40425.pdf not found) INN (FLUDROCORTISONE ACETATE) FLUDROCORTISONE ACETATE (BARR) APPROVAL= AP YEAR= 2003 , NDA 040431 (pdf 40431.pdf not found) INN (FLUDROCORTISONE ACETATE) FLUDROCORTISONE ACETATE (IMPAX LABS) APPROVAL= AP YEAR= 2002 , NDA 091302 (pdf 91302.pdf not found) INN (FLUDROCORTISONE ACETATE) FLUDROCORTISONE ACETATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 215279 (pdf 215279.pdf not found) INN (FLUDROCORTISONE ACETATE) FLUDROCORTISONE ACETATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216013 (pdf 216013.pdf not found) INN (FLUDROCORTISONE ACETATE) FLUDROCORTISONE ACETATE (HIKMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , 176 ; M MIDODRINE ; 3600-87-1 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- VASOCONSTRICTOR -- ADRENERGIC ALPHA-AGONISTS -- SYMPATHOMIMETICS , ; 177 ; HYDROXYAMPHETAMINE ; 103-86-6 ; 1969 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- SYMPATHOMIMETICS -- CAUSES THE RELEASE OF ENDOGENOUS NOREPINEPHRINE -- MYDRIATIC EFFECT -- PROVIDES DIMINISHED PUPIL RESPONSIVENESS TO LIGHT -- ADRENERGIC AGENT , ; NDA 000004 (pdf 4.pdf not found) INN (HYDROXYAMPHETAMINE HYDROBROMIDE) PAREDRINE (PHARMICS) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 019261 (label 19261.pdf) INN (HYDROXYAMPHETAMINE HYDROBROMIDE TROPICAMIDE) PAREMYD (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1992 DISCONTINUED , 178 ; PHYTONADIONE ; 84-80-0 ; 1955 ; ; NATURAL MOLECULE C00002868 ; CLASS VITAMIN -- PROTHROMBOGENIC -- ANTIFIBRINOLYTIC AGENTS , ; NDA 010104 (label 10104.pdf) INN (PHYTONADIONE) MEPHYTON (BAUSCH) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 011745 (pdf 11745.pdf not found) INN (PHYTONADIONE) KONAKION (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012223 (label 12223.pdf) INN (PHYTONADIONE) AQUAMEPHYTON (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (PHYTONADIONE) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 020176 (pdf 20176.pdf not found) INN (PHYTONADIONE) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 083722 (label 83722.pdf) INN (PHYTONADIONE) PHYTONADIONE (INTL MEDICATION) APPROVAL= AP YEAR= 1976 , NDA 084060 (pdf 84060.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087954 (pdf 87954.pdf not found) INN (PHYTONADIONE) VITAMIN K1 (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 087955 (pdf 87955.pdf not found) INN (PHYTONADIONE) VITAMIN K1 (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 087956 (pdf 87956.pdf not found) INN (PHYTONADIONE) VITAMIN K1 (HOSPIRA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (VITAMIN K) INFUVITE ADULT (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (TOCOPHEROL ACETATE) INFUVITE PEDIATRIC (SANDOZ) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (VITAMIN K) INFUVITE ADULT (SANDOZ) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (VITAMIN K) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (VITAMIN K) M.V.I. ADULT (PHARMACY BULK PACKAGE) (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021646 (label 21646.pdf) INN (TOCOPHEROL ACETATE) INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (SANDOZ) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 209373 (pdf 209373.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 207719 (pdf 207719.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 210189 (pdf 210189.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (ZYDUS) APPROVAL= AP YEAR= 2019 , NDA 212424 (pdf 212424.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (CIPLA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214596 (pdf 214596.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 213329 (pdf 213329.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 213336 (pdf 213336.pdf not found) INN (PHYTONADIONE) PHYTONADIONE (AGNITIO) APPROVAL= AP YEAR= 2023 , 179 ; AMBENONIUM ; 7648-98-8 ; 1956 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- CHOLINESTERASE INHIBITOR-- CHOLINERGIC -- ANTIARRHYTHMIC AGENTS -- TREATMENT OF MYASTHENIA GRAVIS , ; NDA 010155 (label 10155.pdf) INN (AMBENONIUM CHLORIDE) MYTELASE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , 180 ; METHYLPHENIDATE ; 1037510-61-4 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMINE REUPTAKE INHIBITORS -- NOREPINEPHRINE REUPTAKE INHIBITOR -- NERVOUS SYSTEM , ; NDA 010187 (label 10187.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN (SANDOZ) APPROVAL= AP YEAR= 1955 , NDA 018029 (label 18029.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN-SR (NOVARTIS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 021121 (label 21121.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) CONCERTA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2000 , NDA 021259 (label 21259.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE CD (AYTU BIOPHARMA) APPROVAL= AP YEAR= 2001 , NDA 021284 (label 21284.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN LA (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 021419 (label 21419.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2002 , NDA 021475 (label 21475.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021514 (label 21514.pdf) INN (METHYLPHENIDATE) DAYTRANA (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 040220 (pdf 40220.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040300 (label 40300.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 1998 , NDA 040306 (label 40306.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040321 (pdf 40321.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040404 (pdf 40404.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040410 (pdf 40410.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075450 (pdf 75450.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075629 (pdf 75629.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN ER (SPECGX LLC) APPROVAL= AP YEAR= 2000 , NDA 076032 (pdf 76032.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 085799 (pdf 85799.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086428 (pdf 86428.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086429 (pdf 86429.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 089601 (pdf 89601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 091601 (pdf 91601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 078458 (label 78458.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 , NDA 077707 (pdf 77707.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078873 (pdf 78873.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079031 (pdf 79031.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090710 (pdf 90710.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2012 , NDA 200886 (pdf 200886.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 202100 (label 202100.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLIVANT XR (NEXTWAVE) APPROVAL= AP YEAR= 2012 , NDA 202608 (pdf 202608.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2012 , NDA 091695 (pdf 91695.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 201466 (pdf 201466.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091159 (pdf 91159.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MOUNTAIN) APPROVAL= AP YEAR= 2014 , NDA 202892 (pdf 202892.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204115 (pdf 204115.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205831 (label 205831.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) APTENSIO XR (RHODES PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207488 (pdf 207488.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2015 , NDA 203583 (pdf 203583.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2015 , NDA 204602 (pdf 204602.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207416 (pdf 207416.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 207884 (pdf 207884.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207960 (label 207960.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLICHEW ER (NEXTWAVE PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204772 (pdf 204772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 076655 (pdf 76655.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 076772 (pdf 76772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 205105 (pdf 205105.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205756 (pdf 205756.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 206726 (pdf 206726.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206840 (pdf 206840.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207485 (pdf 207485.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2016 , NDA 204954 (pdf 204954.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205327 (label 205327.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2017 , NDA 205489 (label 205489.pdf) INN (METHYLPHENIDATE) COTEMPLA XR-ODT (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 206932 (pdf 206932.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI INC) APPROVAL= AP YEAR= 2017 , NDA 207587 (pdf 207587.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208607 (pdf 208607.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208861 (pdf 208861.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2018 , NDA 210354 (pdf 210354.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 206049 (pdf 206049.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2018 , NDA 207515 (pdf 207515.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209753 (pdf 209753.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 209276 (pdf 209276.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209311 (label 209311.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) JORNAY PM (IRONSHORE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210139 (pdf 210139.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210818 (pdf 210818.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210924 (pdf 210924.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210992 (pdf 210992.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 208737 (pdf 208737.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CEDIPROF INC) APPROVAL= AP YEAR= 2019 , NDA 211796 (pdf 211796.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 211918 (pdf 211918.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANDOR PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212038 (label 212038.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) ADHANSIA XR (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 204659 (pdf 204659.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211009 (pdf 211009.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211779 (pdf 211779.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210764 (pdf 210764.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PATRIN) APPROVAL= AP YEAR= 2020 , NDA 211647 (pdf 211647.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213567 (pdf 213567.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 205135 (pdf 205135.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 207414 (pdf 207414.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212288 (pdf 212288.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212697 (pdf 212697.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 213473 (pdf 213473.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213936 (pdf 213936.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 207417 (pdf 207417.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 206497 (pdf 206497.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2022 , NDA 214111 (pdf 214111.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214202 (pdf 214202.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2023 , NDA 216117 (label 216117.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RELEXXII (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2022 , NDA 214447 (pdf 214447.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217229 (pdf 217229.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , 181 ; MECAMYLAMINE ; 60-40-2 ; 1956 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- NICOTINIC ANTAGONISTS -- ANTICHOLINERGIC -- GANGLION BLOCKERS , ; NDA 010251 (pdf 10251.pdf not found) INN (MECAMYLAMINE HYDROCHLORIDE) INVERSINE (TARGACEPT) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 204054 (pdf 204054.pdf not found) INN (MECAMYLAMINE HYDROCHLORIDE) MECAMYLAMINE HYDROCHLORIDE (LGM PHARMA) APPROVAL= AP YEAR= 2013 , 182 ; HYDROXYPROGESTERONE CAPROATE ; 630-56-8 ; 1974 ; DISCONTINUED ; ; CLASS GENITO -- PROGESTOGEN -- PROGESTIN -- REDUCE THE RISK OF PRETERM BIRTH , ; NDA 010347 (pdf 10347.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) DELALUTIN (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016911 (pdf 16911.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) DELALUTIN (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017439 (pdf 17439.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (ALLERGAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018004 (pdf 18004.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089330 (pdf 89330.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089331 (pdf 89331.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021945 (label 21945.pdf) INN (HYDROXYPROGESTERONE CAPROATE) MAKENA (COVIS) APPROVAL= AP YEAR= 2011 OBSOLETE , NDA 200271 (label 200271.pdf) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 210618 (pdf 210618.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2018 OBSOLETE , NDA 210723 (pdf 210723.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (AM REGENT) APPROVAL= AP YEAR= 2018 OBSOLETE , NDA 208381 (pdf 208381.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (SUN PHARM) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 210877 (pdf 210877.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 211070 (pdf 211070.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 211071 (pdf 211071.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 211142 (pdf 211142.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210724 (pdf 210724.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (AM REGENT) APPROVAL= AP YEAR= 2019 DISCONTINUED OBSOLETE , NDA 211777 (pdf 211777.pdf not found) INN (HYDROXYPROGESTERONE CAPROATE) HYDROXYPROGESTERONE CAPROATE (ASPEN) APPROVAL= AP YEAR= 2019 OBSOLETE , 183 ; PROMAZINE ; 58-40-2 ; 1956 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- ANXIOLYTIC -- ANTIEMETICS -- DOPAMINE ANTAGONISTS -- NEUROLEPTICS -- PHENOTHIAZINES , ; NDA 010348 (pdf 10348.pdf not found) INN (PROMAZINE HYDROCHLORIDE) SPARINE (WYETH AYERST) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 010349 (pdf 10349.pdf not found) INN (PROMAZINE HYDROCHLORIDE) SPARINE (HIKMA) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 010942 (pdf 10942.pdf not found) INN (PROMAZINE HYDROCHLORIDE) SPARINE (WYETH AYERST) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 084510 (pdf 84510.pdf not found) INN (PROMAZINE HYDROCHLORIDE) PROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084517 (pdf 84517.pdf not found) INN (PROMAZINE HYDROCHLORIDE) PROMAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 184 ; CLIDINIUM ; 3485-62-9 ; 1966 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTIARRHYTHMIC AGENTS -- ANTISPASMODICS -- PARASYMPATHOLYTICS -- MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST , ; NDA 010355 (pdf 10355.pdf not found) INN (CLIDINIUM BROMIDE) QUARZAN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012750 (label 12750.pdf) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) LIBRAX (BAUSCH) APPROVAL= AP YEAR= 1966 , NDA 211421 (pdf 211421.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 210579 (pdf 210579.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MISEMER) APPROVAL= AP YEAR= 2020 , NDA 213530 (pdf 213530.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 214065 (pdf 214065.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214698 (pdf 214698.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 211476 (pdf 211476.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215555 (pdf 215555.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 215453 (pdf 215453.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (COREPHARMA) APPROVAL= AP YEAR= 2022 , NDA 215835 (pdf 215835.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 216419 (pdf 216419.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216969 (pdf 216969.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217385 (pdf 217385.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , 185 ; LIOTHYRONINE ; 6893-02-3 ; 1956 ; ; ; CLASS HORMONES -- THYROMIMETIC -- THYROID HORMONE , ; NDA 010379 (label 10379.pdf) INN (LIOTHYRONINE SODIUM) CYTOMEL (KING PHARMS) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY , NDA 020105 (label 20105.pdf) INN (LIOTHYRONINE SODIUM) TRIOSTAT (ENDO OPERATIONS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 076923 (pdf 76923.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (XGEN PHARMS) APPROVAL= AP YEAR= 2005 , NDA 085753 (pdf 85753.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085755 (pdf 85755.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 090097 (pdf 90097.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2009 , NDA 090326 (pdf 90326.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 200295 (pdf 200295.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2012 , NDA 091382 (pdf 91382.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 211510 (pdf 211510.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 214803 (pdf 214803.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (ZYDUS) APPROVAL= AP YEAR= 2021 , NDA 218070 (pdf 218070.pdf not found) INN (LIOTHYRONINE SODIUM) LIOTHYRONINE SODIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2024 , 186 ; HYDROXYZINE ; 68-88-2 ; 1956 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTIPRURITICS -- HYPNOTICS -- HISTAMINE H1 ANTAGONISTS , ; NDA 010392 (pdf 10392.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ATARAX (PFIZER) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 010485 (pdf 10485.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ATARAX (ROERIG) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 011111 (pdf 11111.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011459 (label 11459.pdf) INN (HYDROXYZINE PAMOATE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1968 , NDA 011795 (label 11795.pdf) INN (HYDROXYZINE PAMOATE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 040010 (label 40010.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040156 (pdf 40156.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IMPAX LABS INC) APPROVAL= AP YEAR= 1996 , NDA 040391 (label 40391.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040559 (pdf 40559.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040562 (pdf 40562.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040563 (pdf 40563.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040574 (pdf 40574.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 040579 (pdf 40579.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 040580 (pdf 40580.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 , NDA 040600 (pdf 40600.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040602 (pdf 40602.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040604 (pdf 40604.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 , NDA 040786 (pdf 40786.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 , NDA 040787 (pdf 40787.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040788 (pdf 40788.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040804 (pdf 40804.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 040805 (pdf 40805.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2008 , NDA 040812 (pdf 40812.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040840 (pdf 40840.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040841 (pdf 40841.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040842 (pdf 40842.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040899 (pdf 40899.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 081054 (pdf 81054.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 081127 (pdf 81127.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081128 (pdf 81128.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081129 (pdf 81129.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081149 (pdf 81149.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081150 (pdf 81150.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081151 (pdf 81151.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081165 (pdf 81165.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 085247 (pdf 85247.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085551 (pdf 85551.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085778 (pdf 85778.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085779 (pdf 85779.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086183 (pdf 86183.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 086258 (pdf 86258.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086695 (pdf 86695.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086697 (pdf 86697.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086698 (pdf 86698.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086705 (pdf 86705.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086728 (pdf 86728.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086821 (pdf 86821.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086822 (pdf 86822.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086827 (pdf 86827.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086829 (pdf 86829.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086836 (pdf 86836.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086840 (pdf 86840.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086880 (pdf 86880.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ANIMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087014 (pdf 87014.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ORGATRAX (ORGANON USA INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087216 (pdf 87216.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087245 (pdf 87245.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087246 (pdf 87246.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087273 (pdf 87273.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087274 (pdf 87274.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087294 (label 87294.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1982 , NDA 087310 (pdf 87310.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087329 (label 87329.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087408 (pdf 87408.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1981 , NDA 087410 (pdf 87410.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087411 (pdf 87411.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087416 (pdf 87416.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087479 (pdf 87479.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 087546 (pdf 87546.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087591 (pdf 87591.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087592 (pdf 87592.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087593 (pdf 87593.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087595 (pdf 87595.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087596 (pdf 87596.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087602 (pdf 87602.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087603 (pdf 87603.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087604 (pdf 87604.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087656 (pdf 87656.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087657 (pdf 87657.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087658 (pdf 87658.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087730 (pdf 87730.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087760 (pdf 87760.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087761 (pdf 87761.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087767 (pdf 87767.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087790 (pdf 87790.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087819 (pdf 87819.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087820 (pdf 87820.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087821 (pdf 87821.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087822 (pdf 87822.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087857 (pdf 87857.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087860 (pdf 87860.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087862 (pdf 87862.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087869 (pdf 87869.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 087870 (pdf 87870.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 087871 (pdf 87871.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1982 , NDA 088120 (pdf 88120.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088121 (pdf 88121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088122 (pdf 88122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088184 (pdf 88184.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088185 (pdf 88185.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088348 (pdf 88348.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088349 (pdf 88349.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088350 (pdf 88350.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088392 (pdf 88392.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088393 (pdf 88393.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088409 (pdf 88409.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088487 (pdf 88487.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088488 (pdf 88488.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088496 (pdf 88496.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088529 (pdf 88529.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088540 (pdf 88540.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088551 (pdf 88551.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088593 (pdf 88593.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088594 (pdf 88594.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088595 (pdf 88595.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088617 (label 88617.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088618 (label 88618.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088619 (label 88619.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088713 (pdf 88713.pdf not found) INN (HYDROXYZINE PAMOATE) HY-PAM "25" (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088785 (pdf 88785.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088794 (pdf 88794.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088795 (pdf 88795.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088796 (pdf 88796.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088862 (pdf 88862.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088881 (pdf 88881.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089031 (pdf 89031.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089032 (pdf 89032.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089033 (pdf 89033.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089071 (pdf 89071.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089072 (pdf 89072.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089073 (pdf 89073.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089106 (pdf 89106.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089107 (pdf 89107.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089117 (pdf 89117.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089121 (pdf 89121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089122 (pdf 89122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089123 (pdf 89123.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089145 (pdf 89145.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089146 (pdf 89146.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089366 (pdf 89366.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089381 (pdf 89381.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089382 (pdf 89382.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089383 (pdf 89383.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089396 (pdf 89396.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040808 (pdf 40808.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 2008 , NDA 091176 (pdf 91176.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201507 (pdf 201507.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2013 , NDA 201674 (pdf 201674.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 204279 (pdf 204279.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2014 , NDA 207120 (pdf 207120.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2017 OBSOLETE , NDA 207121 (pdf 207121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207122 (pdf 207122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2017 OBSOLETE , NDA 210634 (pdf 210634.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 217652 (pdf 217652.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2023 , 187 ; METHSUXIMIDE ; 39122-23-1 ; 1957 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; NDA 010596 (label 10596.pdf) INN (METHSUXIMIDE) CELONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY , NDA 217213 (pdf 217213.pdf not found) INN (METHSUXIMIDE) METHSUXIMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , 188 ; LEVALLORPHAN ; 152-02-3 ; 1956 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- NARCOTIC ANTAGONIST -- ANALGESIC ANTAGONISTS -- MORPHINE ANTIDOTES , ; NDA 010423 (pdf 10423.pdf not found) INN (LEVALLORPHAN TARTRATE) LORFAN (ROCHE) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , 189 ; PHENMETRAZINE ; 134-49-6 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIANOREXIC -- APPETITE DEPRESSANTS -- CNS AGENTS -- SYMPATHOMIMETICS , ; NDA 010460 (pdf 10460.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011752 (pdf 11752.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , 190 ; ANILERIDINE ; 144-14-9 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- NARCOTICS -- OPIATE AGONISTS , ; NDA 010520 (pdf 10520.pdf not found) INN (ANILERIDINE PHOSPHATE) LERITINE (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 010585 (pdf 10585.pdf not found) INN (ANILERIDINE HYDROCHLORIDE) LERITINE (MERCK) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 191 ; HYDROCORTAMATE ; 76-47-1 ; 1956 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTI-INFLAMMATORY -- CORTICOSTEROID -- IMMUNOSUPPRESSIVE AGENTS , ; NDA 010554 (pdf 10554.pdf not found) INN (HYDROCORTAMATE HYDROCHLORIDE) MAGNACORT (PFIZER) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , 192 ; PROCHLORPERAZINE ; 58-38-8 ; 1956 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- ANTIEMETIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 010571 (label 10571.pdf) INN (PROCHLORPERAZINE MALEATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 010742 (pdf 10742.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011000 (pdf 11000.pdf not found) INN (PROCHLORPERAZINE MALEATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011127 (pdf 11127.pdf not found) INN (PROCHLORPERAZINE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011188 (pdf 11188.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011276 (pdf 11276.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 021019 (label 21019.pdf) INN (PROCHLORPERAZINE MALEATE) COMPAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040058 (pdf 40058.pdf not found) INN (PROCHLORPERAZINE) PROCHLORPERAZINE (COSETTE) APPROVAL= AP YEAR= 1993 , NDA 040101 (pdf 40101.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040120 (pdf 40120.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (TEVA PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040162 (label 40162.pdf) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040185 (pdf 40185.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (MYLAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040207 (pdf 40207.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040246 (pdf 40246.pdf not found) INN (PROCHLORPERAZINE) COMPRO (PADAGIS US) APPROVAL= AP YEAR= 2000 , NDA 040268 (pdf 40268.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCOMP (JUBILANT CADISTA) APPROVAL= AP YEAR= 1998 , NDA 040407 (pdf 40407.pdf not found) INN (PROCHLORPERAZINE) PROCHLORPERAZINE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040505 (pdf 40505.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040540 (pdf 40540.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (SAGENT) APPROVAL= AP YEAR= 2004 , NDA 085178 (pdf 85178.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085579 (pdf 85579.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085580 (pdf 85580.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086348 (pdf 86348.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (WYETH AYERST) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087153 (pdf 87153.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087154 (pdf 87154.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087759 (pdf 87759.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088597 (pdf 88597.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088598 (pdf 88598.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089251 (pdf 89251.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089484 (pdf 89484.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089485 (pdf 89485.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089486 (pdf 89486.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089523 (pdf 89523.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089530 (pdf 89530.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089605 (pdf 89605.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089606 (pdf 89606.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089637 (pdf 89637.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089638 (pdf 89638.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089675 (pdf 89675.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089703 (pdf 89703.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089903 (label 89903.pdf) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (HIKMA) APPROVAL= AP YEAR= 1989 , NDA 204147 (pdf 204147.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 , NDA 210710 (pdf 210710.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 204860 (pdf 204860.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (NEXUS) APPROVAL= AP YEAR= 2019 , NDA 214379 (pdf 214379.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 213626 (pdf 213626.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (VIWIT PHARM) APPROVAL= AP YEAR= 2021 , NDA 214107 (pdf 214107.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 216202 (pdf 216202.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213630 (pdf 213630.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 213873 (pdf 213873.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214192 (pdf 214192.pdf not found) INN (PROCHLORPERAZINE EDISYLATE) PROCHLORPERAZINE EDISYLATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 216495 (pdf 216495.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 216595 (pdf 216595.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 216598 (pdf 216598.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 217478 (pdf 217478.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 218515 (pdf 218515.pdf not found) INN (PROCHLORPERAZINE MALEATE) PROCHLORPERAZINE MALEATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2024 , 193 ; ORPHENADRINE ; 83-98-7 ; 1957 ; ; ; CLASS MUSCULO-SKELETAL -- SKELETAL MUSCLE RELAXANT -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 010653 (pdf 10653.pdf not found) INN (ORPHENADRINE HYDROCHLORIDE) DISIPAL (3M) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 012157 (label 12157.pdf) INN (ORPHENADRINE CITRATE) NORFLEX (BAUSCH) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 013055 (label 13055.pdf) INN (ORPHENADRINE CITRATE) NORFLEX (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 013416 (label 13416.pdf) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) NORGESIC (BAUSCH) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 040249 (label 40249.pdf) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (RISING) APPROVAL= AP YEAR= 1999 , NDA 040284 (pdf 40284.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (LUPIN) APPROVAL= AP YEAR= 1998 , NDA 040327 (pdf 40327.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 040368 (pdf 40368.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (IMPAX PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040463 (pdf 40463.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 040484 (pdf 40484.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (RISING) APPROVAL= AP YEAR= 2006 , NDA 074654 (pdf 74654.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074817 (pdf 74817.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) INVAGESIC (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074988 (pdf 74988.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (STEVENS J) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075141 (pdf 75141.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENGESIC (GALT PHARMS) APPROVAL= AP YEAR= 1998 , NDA 084303 (pdf 84303.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084779 (pdf 84779.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= AP YEAR= 1982 , NDA 085046 (pdf 85046.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087062 (pdf 87062.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088067 (pdf 88067.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090585 (pdf 90585.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SAGENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091158 (pdf 91158.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2012 , 194 ; METHSUXIMIDE ; 39122-22-0 ; 1957 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; NDA 010596 (label 10596.pdf) INN (METHSUXIMIDE) CELONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY , NDA 217213 (pdf 217213.pdf not found) INN (METHSUXIMIDE) METHSUXIMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , 195 ; FLUOXYMESTERONE ; 76-43-7 ; 1956 ; DISCONTINUED ; ; CLASS GENITO -- ANABOLIC AGENTS -- ANTINEOPLASTIC -- ANDROGENIC , ; NDA 010611 (pdf 10611.pdf not found) INN (FLUOXYMESTERONE) HALOTESTIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 011359 (pdf 11359.pdf not found) INN (FLUOXYMESTERONE) ORA-TESTRYL (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087196 (pdf 87196.pdf not found) INN (FLUOXYMESTERONE) ANDROID-F (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088221 (pdf 88221.pdf not found) INN (FLUOXYMESTERONE) FLUOXYMESTERONE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088260 (pdf 88260.pdf not found) INN (FLUOXYMESTERONE) FLUOXYMESTERONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088265 (pdf 88265.pdf not found) INN (FLUOXYMESTERONE) FLUOXYMESTERONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088309 (pdf 88309.pdf not found) INN (FLUOXYMESTERONE) FLUOXYMESTERONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088342 (pdf 88342.pdf not found) INN (FLUOXYMESTERONE) FLUOXYMESTERONE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , 196 ; ORPHENADRINE ; 83-98-7 ; 1957 ; ; ; CLASS MUSCULO-SKELETAL -- SKELETAL MUSCLE RELAXANT -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 010653 (pdf 10653.pdf not found) INN (ORPHENADRINE HYDROCHLORIDE) DISIPAL (3M) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 012157 (label 12157.pdf) INN (ORPHENADRINE CITRATE) NORFLEX (BAUSCH) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 013055 (label 13055.pdf) INN (ORPHENADRINE CITRATE) NORFLEX (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 013416 (label 13416.pdf) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) NORGESIC (BAUSCH) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 040249 (label 40249.pdf) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (RISING) APPROVAL= AP YEAR= 1999 , NDA 040284 (pdf 40284.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (LUPIN) APPROVAL= AP YEAR= 1998 , NDA 040327 (pdf 40327.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 040368 (pdf 40368.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (IMPAX PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040463 (pdf 40463.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 040484 (pdf 40484.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (RISING) APPROVAL= AP YEAR= 2006 , NDA 074654 (pdf 74654.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074817 (pdf 74817.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) INVAGESIC (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074988 (pdf 74988.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENADRINE CITRATE , ASPIRIN , AND CAFFEINE (STEVENS J) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075141 (pdf 75141.pdf not found) INN (ASPIRIN CAFFEINE ORPHENADRINE CITRATE) ORPHENGESIC (GALT PHARMS) APPROVAL= AP YEAR= 1998 , NDA 084303 (pdf 84303.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084779 (pdf 84779.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= AP YEAR= 1982 , NDA 085046 (pdf 85046.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087062 (pdf 87062.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088067 (pdf 88067.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090585 (pdf 90585.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (SAGENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091158 (pdf 91158.pdf not found) INN (ORPHENADRINE CITRATE) ORPHENADRINE CITRATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2012 , 197 ; MECLIZINE ; 569-65-3 ; 1957 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTI-ALLERGIC AGENTS -- ANTIHISTAMINES -- HISTAMINE H1 ANTAGONISTS , ; NDA 010721 (label 10721.pdf) INN (MECLIZINE HYDROCHLORIDE) ANTIVERT (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1957 , NDA 040179 (pdf 40179.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 083784 (pdf 83784.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084092 (pdf 84092.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1975 , NDA 084382 (pdf 84382.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084657 (pdf 84657.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084843 (pdf 84843.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1976 , NDA 084872 (pdf 84872.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (BUNDY) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084975 (pdf 84975.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1976 DISCONTINUED OBSOLETE , NDA 084976 (pdf 84976.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085195 (pdf 85195.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085252 (pdf 85252.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085253 (pdf 85253.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085269 (pdf 85269.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085523 (pdf 85523.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085524 (pdf 85524.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085740 (pdf 85740.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085891 (pdf 85891.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANABOLIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086392 (pdf 86392.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087127 (pdf 87127.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AUREX) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 087128 (pdf 87128.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 1981 , NDA 087620 (pdf 87620.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087877 (pdf 87877.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088256 (pdf 88256.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088257 (pdf 88257.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088732 (pdf 88732.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088733 (pdf 88733.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088734 (pdf 88734.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089113 (pdf 89113.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089114 (pdf 89114.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089674 (pdf 89674.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040659 (pdf 40659.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2010 , NDA 201451 (pdf 201451.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200294 (pdf 200294.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 202640 (pdf 202640.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2012 , NDA 205136 (pdf 205136.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 213957 (pdf 213957.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 200432 (pdf 200432.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 200791 (pdf 200791.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 203003 (pdf 203003.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2022 , 198 ; ISOFLUROPHATE ; 55-91-4 ; 1957 ; DISCONTINUED ; ; CLASS ANTIGLAUCOMIC AGENTS -- IRREVERSIBLE CHOLINESTERASE INHIBITORS -- MIOTICS , ; NDA 010656 (pdf 10656.pdf not found) INN (ISOFLUROPHATE) FLOROPRYL (MERCK) APPROVAL= AP YEAR= 1957 DISCONTINUED , 199 ; CHLORAMBUCIL ; 305-03-3 ; 1957 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING , ; NDA 010669 (label 10669.pdf) INN (CHLORAMBUCIL) LEUKERAN (WAYLIS THERAP) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY , 200 ; TOLBUTAMIDE ; 64-77-7 ; 1957 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS -- CHANNEL BLOCKER , ; NDA 010670 (pdf 10670.pdf not found) INN (TOLBUTAMIDE) ORINASE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 012095 (pdf 12095.pdf not found) INN (TOLBUTAMIDE SODIUM) ORINASE DIAGNOSTIC (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 012678 (pdf 12678.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (SANDOZ) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 086047 (pdf 86047.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086109 (pdf 86109.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086141 (pdf 86141.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (ALRA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086445 (pdf 86445.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086574 (pdf 86574.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086926 (pdf 86926.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087093 (pdf 87093.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087121 (pdf 87121.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (BARR) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087318 (pdf 87318.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087541 (pdf 87541.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087876 (pdf 87876.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (VANGARD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088893 (pdf 88893.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088950 (pdf 88950.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089110 (pdf 89110.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089111 (pdf 89111.pdf not found) INN (TOLBUTAMIDE) TOLBUTAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 201 ; MEPENZOLATE ; 25990-43-6 ; 1956 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- PARASYMPATHOLYTICS -- DIMINISHES GASTRIC ACID AND PEPSIN SECRETION -- TREATMENT OF PEPTIC ULCER -- MUSCARINIC RECEPTOR ANTAGONIST , ; NDA 010679 (label 10679.pdf) INN (MEPENZOLATE BROMIDE) CANTIL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , 202 ; RESCINNAMINE ; 24815-24-5 ; 1956 ; DISCONTINUED ; NATURAL MOLECULE C00001762 ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- INHIBITS ANGIOTENSIN-CONVERTING ENZYME (PUBCHEM CID5280954) , ; NDA 010686 (pdf 10686.pdf not found) INN (RESCINNAMINE) MODERIL (PFIZER) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 084736 (pdf 84736.pdf not found) INN (RESCINNAMINE) CINNASIL (PANRAY) APPROVAL= - YEAR= 0 DISCONTINUED , 203 ; MECLIZINE ; 569-65-3 ; 1957 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTI-ALLERGIC AGENTS -- ANTIHISTAMINES -- HISTAMINE H1 ANTAGONISTS , ; NDA 010721 (label 10721.pdf) INN (MECLIZINE HYDROCHLORIDE) ANTIVERT (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1957 , NDA 040179 (pdf 40179.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 083784 (pdf 83784.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084092 (pdf 84092.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1975 , NDA 084382 (pdf 84382.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (BUNDY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084657 (pdf 84657.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084843 (pdf 84843.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1976 , NDA 084872 (pdf 84872.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (BUNDY) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084975 (pdf 84975.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1976 DISCONTINUED OBSOLETE , NDA 084976 (pdf 84976.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085195 (pdf 85195.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085252 (pdf 85252.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085253 (pdf 85253.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085269 (pdf 85269.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085523 (pdf 85523.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085524 (pdf 85524.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085740 (pdf 85740.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085891 (pdf 85891.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANABOLIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086392 (pdf 86392.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087127 (pdf 87127.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AUREX) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 087128 (pdf 87128.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 1981 , NDA 087620 (pdf 87620.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087877 (pdf 87877.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088256 (pdf 88256.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088257 (pdf 88257.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (UDL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088732 (pdf 88732.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088733 (pdf 88733.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088734 (pdf 88734.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089113 (pdf 89113.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089114 (pdf 89114.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089674 (pdf 89674.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040659 (pdf 40659.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2010 , NDA 201451 (pdf 201451.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200294 (pdf 200294.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 202640 (pdf 202640.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2012 , NDA 205136 (pdf 205136.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 213957 (pdf 213957.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 200432 (pdf 200432.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 200791 (pdf 200791.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 203003 (pdf 203003.pdf not found) INN (MECLIZINE HYDROCHLORIDE) MECLIZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2022 , 204 ; ISOPROPAMIDE ; 7492-32-2 ; 1957 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- GASTROINTESTINAL AGENTS -- ANTISPASMODIC , ; NDA 010744 (pdf 10744.pdf not found) INN (ISOPROPAMIDE IODIDE) DARBID (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1957 DISCONTINUED , 205 ; PERPHENAZINE ; 58-39-9 ; 1957 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 010775 (label 10775.pdf) INN (PERPHENAZINE) TRILAFON (SCHERING) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011213 (label 11213.pdf) INN (PERPHENAZINE) TRILAFON (SCHERING) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011294 (pdf 11294.pdf not found) INN (PERPHENAZINE) TRILAFON (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011361 (pdf 11361.pdf not found) INN (PERPHENAZINE) TRILAFON (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011557 (pdf 11557.pdf not found) INN (PERPHENAZINE) TRILAFON (SCHERING) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 014713 (pdf 14713.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) ETRAFON-A (SCHERING) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 014715 (pdf 14715.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) TRIAVIL 2-25 (NEW RIVER) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 040226 (label 40226.pdf) INN (PERPHENAZINE) PERPHENAZINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1998 , NDA 040360 (pdf 40360.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (PHARM ASSOC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 070297 (pdf 70297.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070336 (pdf 70336.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070337 (pdf 70337.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070338 (pdf 70338.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070373 (pdf 70373.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070374 (pdf 70374.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070375 (pdf 70375.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070376 (pdf 70376.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070377 (pdf 70377.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070565 (pdf 70565.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070574 (pdf 70574.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070595 (pdf 70595.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070620 (pdf 70620.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070621 (pdf 70621.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070935 (pdf 70935.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070936 (pdf 70936.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070937 (pdf 70937.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070938 (pdf 70938.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070939 (pdf 70939.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071062 (pdf 71062.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071063 (pdf 71063.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071064 (pdf 71064.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071077 (pdf 71077.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071078 (pdf 71078.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071079 (pdf 71079.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071442 (pdf 71442.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 071443 (label 71443.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 071558 (pdf 71558.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071862 (pdf 71862.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071863 (pdf 71863.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072134 (pdf 72134.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072135 (pdf 72135.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072539 (pdf 72539.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072540 (pdf 72540.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072541 (pdf 72541.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 073007 (pdf 73007.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073008 (pdf 73008.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073009 (pdf 73009.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073010 (pdf 73010.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089456 (pdf 89456.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089457 (pdf 89457.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089683 (label 89683.pdf) INN (PERPHENAZINE) PERPHENAZINE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 089684 (label 89684.pdf) INN (PERPHENAZINE) PERPHENAZINE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 089685 (label 89685.pdf) INN (PERPHENAZINE) PERPHENAZINE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 089686 (label 89686.pdf) INN (PERPHENAZINE) PERPHENAZINE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 089707 (pdf 89707.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089708 (pdf 89708.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 205973 (pdf 205973.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 207582 (pdf 207582.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 206691 (pdf 206691.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (MYLAN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205056 (pdf 205056.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (RISING) APPROVAL= AP YEAR= 2019 , NDA 205232 (pdf 205232.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 210163 (pdf 210163.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (APPCO) APPROVAL= AP YEAR= 2022 , NDA 212545 (pdf 212545.pdf not found) INN (PERPHENAZINE) PERPHENAZINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , 206 ; DESERPIDINE ; 131-01-1 ; 1957 ; DISCONTINUED ; NATURAL MOLECULE C00001712 ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- IS A COMPETITIVE INHIBITOR OF THE ANGIOTENSIN CONVERTING ENZYME (ACE) (PUBCHEM CID8550) , ; NDA 010796 (pdf 10796.pdf not found) INN (DESERPIDINE) HARMONYL (ABBVIE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 012148 (pdf 12148.pdf not found) INN (DESERPIDINE HYDROCHLOROTHIAZIDE) ORETICYL 25 (ABBVIE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012775 (pdf 12775.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) ENDURONYL (ABBOTT) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 088452 (pdf 88452.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088486 (pdf 88486.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 207 ; DEXBROMPHENIRAMINE ; 132-21-8 ; 1957 ; ; ; CLASS RESPIRATORY -- H1 ANTIHISTAMINE ANTAGONISTS -- ANTI-ALLERGIC AGENTS -- ANTICHOLINERGIC (DRYING) AND SEDATIVE EFFECTS , ; NDA 010799 (pdf 10799.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE (WYETH CONS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011418 (pdf 11418.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE-TEN (WYETH AYERST) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011694 (pdf 11694.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE-DC (ROBINS AH) APPROVAL= AP YEAR= 1958 DISCONTINUED OBSOLETE , NDA 012436 (pdf 12436.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1960 DISCONTINUED OBSOLETE , NDA 013087 (pdf 13087.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1962 DISCONTINUED OBSOLETE , NDA 019279 (label 19279.pdf) INN (BROMPHENIRAMINE MALEATE) DIMETANE-DX (ROBINS AH) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019672 (pdf 19672.pdf not found) INN (BROMPHENIRAMINE MALEATE) EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 071099 (pdf 71099.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMATAPP (COPLEY PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 083123 (pdf 83123.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083215 (pdf 83215.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083820 (pdf 83820.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 083821 (pdf 83821.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084088 (pdf 84088.pdf not found) INN (BROMPHENIRAMINE MALEATE) VELTANE (LANNETT) APPROVAL= AP YEAR= 1974 , NDA 084351 (pdf 84351.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 084468 (pdf 84468.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (BARR) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 085466 (pdf 85466.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085521 (pdf 85521.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PHOENIX LABS NY) APPROVAL= AP YEAR= 0 , NDA 085592 (pdf 85592.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NYLOS) APPROVAL= AP YEAR= 0 , NDA 085769 (pdf 85769.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085850 (pdf 85850.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (VITARINE) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 085888 (pdf 85888.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086187 (pdf 86187.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086936 (pdf 86936.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086987 (pdf 86987.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NEWTRON PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 087009 (pdf 87009.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PAR PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 087517 (pdf 87517.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PHARM ASSOC) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 087964 (pdf 87964.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (USL PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088604 (pdf 88604.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PIONEER PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 088687 (pdf 88687.pdf not found) INN (BROMPHENIRAMINE MALEATE) BIPHETAP (MORTON GROVE) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088688 (pdf 88688.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMANATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088722 (pdf 88722.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMANATE DM (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED , NDA 088723 (pdf 88723.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMANATE DC (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 088811 (pdf 88811.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1985 , NDA 088904 (pdf 88904.pdf not found) INN (BROMPHENIRAMINE MALEATE) MYPHETANE DC (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 089681 (pdf 89681.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 011814 (pdf 11814.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE) DISOMER (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012394 (pdf 12394.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DISOPHROL (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 013483 (pdf 13483.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DRIXORAL (SCHERING PLOUGH) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 019453 (pdf 19453.pdf not found) INN (ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DRIXORAL PLUS (SCHERING PLOUGH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070770 (pdf 70770.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DISOBROM (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089116 (pdf 89116.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) BROMPHERIL (COPLEY PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089139 (pdf 89139.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) RESPORAL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 078648 (label 78648.pdf) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (AVANTHI INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202940 (pdf 202940.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2014 , NDA 205292 (pdf 205292.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PADDOCK LLC) APPROVAL= AP YEAR= 2014 , NDA 203375 (pdf 203375.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ACELLA PHARMS LLC) APPROVAL= AP YEAR= 2016 , NDA 205112 (pdf 205112.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (TARO PHARM) APPROVAL= AP YEAR= 2017 , NDA 207676 (pdf 207676.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210647 (pdf 210647.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 211170 (pdf 211170.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 213125 (pdf 213125.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 , NDA 202955 (pdf 202955.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 203997 (pdf 203997.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 , 208 ; ETHOTOIN ; 86-35-1 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC -- SODIUM CHANNEL BLOCKER , ; NDA 010841 (label 10841.pdf) INN (ETHOTOIN) PEGANONE (RECORDATI RARE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 209 ; NORETHINDRONE ; 68-22-4 ; 1962 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVES , ; NDA 010895 (pdf 10895.pdf not found) INN (NORETHINDRONE) NORLUTIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012728 (pdf 12728.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 10-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 013625 (pdf 13625.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+50 21-DAY (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 016659 (pdf 16659.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+50 28-DAY (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016709 (pdf 16709.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 1/50 28 (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016715 (pdf 16715.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 1/80 21 (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016724 (pdf 16724.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+80 21-DAY (GD SEARLE LLC) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016725 (pdf 16725.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+80 28-DAY (GD SEARLE LLC) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016954 (label 16954.pdf) INN (NORETHINDRONE) MICRONOR (JANSSEN PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017060 (pdf 17060.pdf not found) INN (NORETHINDRONE) NOR-QD (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1973 , NDA 017488 (pdf 17488.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) MODICON 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017489 (pdf 17489.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 1/35-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017565 (label 17565.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORINYL 1+35 21-DAY (ALLERGAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017566 (label 17566.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) BREVICON 21-DAY (ALLERGAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017576 (label 17576.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-50 (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017716 (pdf 17716.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-35 (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017735 (label 17735.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) MODICON 28 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017743 (label 17743.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) BREVICON 28-DAY (ALLERGAN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017919 (label 17919.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 1/35-28 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018127 (pdf 18127.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-35 (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018128 (pdf 18128.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) OVCON-50 (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018354 (pdf 18354.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 10/11-21 (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018926 (label 18926.pdf) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE) NORQUEST FE (PFIZER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 018977 (label 18977.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) TRI-NORINYL 21-DAY (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1984 , NDA 018985 (label 18985.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 7/7/7-21 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019004 (pdf 19004.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ORTHO-NOVUM 7/14-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 021490 (label 21490.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) FEMCON FE (APIL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 070684 (pdf 70684.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070685 (pdf 70685.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070686 (pdf 70686.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070687 (pdf 70687.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1987 , NDA 070758 (pdf 70758.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHINDRONE AND MESTRANOL (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070759 (pdf 70759.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHINDRONE AND MESTRANOL (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071041 (pdf 71041.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 7/14 (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071042 (pdf 71042.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 7/14 (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071043 (pdf 71043.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 10/11 (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071044 (pdf 71044.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL 10/11 (WATSON LABS TEVA) APPROVAL= AP YEAR= 1988 , NDA 071480 (pdf 71480.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHIN 1/35E-21 (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071481 (pdf 71481.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHIN 1/35E-28 (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071539 (pdf 71539.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHIN 1/50M-21 (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071540 (pdf 71540.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHIN 1/50M-28 (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071541 (pdf 71541.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) N.E.E. 1/35 21 (LPI) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071542 (pdf 71542.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) N.E.E. 1/35 28 (LPI) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071545 (pdf 71545.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORCEPT-E 1/35 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071546 (pdf 71546.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORCEPT-E 1/35 28 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072692 (pdf 72692.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 0.5/35-21 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072693 (pdf 72693.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 1/35-21 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072694 (pdf 72694.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GENCEPT 10/11-21 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072695 (pdf 72695.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 0.5/35-28 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072696 (pdf 72696.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 1/35-28 (BARR) APPROVAL= AP YEAR= 1992 , NDA 072697 (pdf 72697.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GENCEPT 10/11-28 (BARR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 075478 (pdf 75478.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORTREL 7/7/7 (BARR) APPROVAL= AP YEAR= 2002 , NDA 076177 (pdf 76177.pdf not found) INN (NORETHINDRONE) CAMILA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2002 , NDA 076198 (pdf 76198.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BALZIVA-21 (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076225 (pdf 76225.pdf not found) INN (NORETHINDRONE) ERRIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2002 , NDA 076238 (pdf 76238.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BALZIVA-28 (BARR) APPROVAL= AP YEAR= 2004 , NDA 076783 (pdf 76783.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ARANELLE (BARR) APPROVAL= AP YEAR= 2004 , NDA 076393 (pdf 76393.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078323 (pdf 78323.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 078379 (pdf 78379.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078965 (pdf 78965.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (BARR) APPROVAL= AP YEAR= 2010 , NDA 090454 (pdf 90454.pdf not found) INN (NORETHINDRONE) HEATHER (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 076337 (pdf 76337.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 1/35 (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076338 (pdf 76338.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 7/7/7 (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078892 (pdf 78892.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091209 (pdf 91209.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 022573 (label 22573.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (APIL) APPROVAL= AP YEAR= 2010 , NDA 090538 (pdf 90538.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) BRIELLYN (GLENMARK GENERICS) APPROVAL= AP YEAR= 2011 , NDA 090946 (pdf 90946.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) DASETTA 7/7/7 (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090947 (pdf 90947.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PHILITH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090948 (pdf 90948.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) DASETTA 1/35 (NOVAST LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 091325 (pdf 91325.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 091634 (pdf 91634.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) ALYACEN 1/35 (GLENMARK GENERICS) APPROVAL= AP YEAR= 2012 , NDA 091636 (pdf 91636.pdf not found) INN (NORETHINDRONE) ALYACEN 7/7/7 (GLENMARK GENERICS) APPROVAL= AP YEAR= 2012 , NDA 078376 (pdf 78376.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) GILDAGIA (VINTAGE PHARMS) APPROVAL= AP YEAR= 2012 , NDA 091204 (pdf 91204.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) WERA (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091323 (pdf 91323.pdf not found) INN (NORETHINDRONE) JENCYCLA (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 200961 (pdf 200961.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 200980 (pdf 200980.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 201483 (pdf 201483.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 201510 (pdf 201510.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PIRMELLA 7/7/7 (LUPIN LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201512 (pdf 201512.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) PIRMELLA 1/35 (LUPIN LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201886 (pdf 201886.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) VYFEMLA (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 202014 (pdf 202014.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 202260 (pdf 202260.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203006 (pdf 203006.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203371 (pdf 203371.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 200897 (pdf 200897.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202086 (pdf 202086.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 200486 (pdf 200486.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200488 (pdf 200488.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200489 (pdf 200489.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203413 (pdf 203413.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYCLAFEM 0.5/35 (VINTAGE PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203448 (pdf 203448.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) KAITLIB FE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 091332 (pdf 91332.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 017948 (label 17948.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE FERROUS FUMARATE) NORMINEST FE (GD SEARLE LLC) APPROVAL= AP YEAR= 1978 , NDA 206807 (pdf 206807.pdf not found) INN (NORETHINDRONE) NORETHINDRONE (NAARI PTE LTD) APPROVAL= AP YEAR= 2016 , NDA 207054 (pdf 207054.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NYLIA 7/7/7 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207055 (pdf 207055.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) CYONANZ (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207056 (pdf 207056.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NYLIA 1/35 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207304 (pdf 207304.pdf not found) INN (NORETHINDRONE) INCASSIA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206864 (pdf 206864.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 207066 (pdf 207066.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 207535 (pdf 207535.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) NEXESTA FE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207585 (pdf 207585.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE) RHUZDAH (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216796 (pdf 216796.pdf not found) INN (NORETHINDRONE) EMZAHH (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 210 ; NORETHINDRONE ACETATE ; 51-98-9 ; 1973 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVE -- RAPIDLY HYDROLYZED IN NORETHINDRONE , ; NDA 016723 (pdf 16723.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 28 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012184 (pdf 12184.pdf not found) INN (NORETHINDRONE ACETATE) NORLUTATE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016749 (pdf 16749.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 21 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016766 (pdf 16766.pdf not found) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE ACETATE) NORLESTRIN FE 1/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016852 (pdf 16852.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORLESTRIN 21 2.5/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016854 (pdf 16854.pdf not found) INN (ETHINYL ESTRADIOL FERROUS FUMARATE NORETHINDRONE ACETATE) NORLESTRIN FE 2.5/50 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017354 (label 17354.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN FE 1/20 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017355 (label 17355.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN FE 1.5/30 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017875 (label 17875.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 21 1.5/30 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017876 (label 17876.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 21 1/20 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 018405 (label 18405.pdf) INN (NORETHINDRONE ACETATE) AYGESTIN (DURAMED RES) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 020130 (label 20130.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) ESTROSTEP 21 (APIL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020870 (label 20870.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) COMBIPATCH (NOVEN PHARMS INC) APPROVAL= AP YEAR= 1998 , NDA 020907 (label 20907.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (AMNEAL) APPROVAL= AP YEAR= 1998 , NDA 021065 (label 21065.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FEMHRT (APIL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021102 (pdf 21102.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FEMHRT (WARNER CHILCOTT) APPROVAL= AP YEAR= 1999 NEWAPPLICATION , NDA 021103 (label 21103.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (NOVO NORDISK) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 021871 (label 21871.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LOESTRIN 24 FE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 022001 (label 22001.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE) ACTIVELLA (NOVO NORDISK INC) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 075548 (pdf 75548.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MICROGESTIN FE 1.5/30 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075647 (pdf 75647.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MICROGESTIN FE 1/20 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075951 (label 75951.pdf) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (BARR) APPROVAL= AP YEAR= 2001 , NDA 076064 (pdf 76064.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL FE 1.5/30 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076081 (pdf 76081.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL FE 1/20 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076105 (pdf 76105.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TRI-LEGEST FE (BARR) APPROVAL= AP YEAR= 2007 , NDA 076221 (pdf 76221.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (BARR LABS INC) APPROVAL= AP YEAR= 2009 , NDA 076380 (pdf 76380.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL 1/20 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076381 (pdf 76381.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) JUNEL 1.5/30 (BARR) APPROVAL= AP YEAR= 2003 , NDA 076405 (pdf 76405.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TRI-LEGEST 21 (BARR) APPROVAL= AP YEAR= 2007 , NDA 077075 (pdf 77075.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS FE 1.5/30 (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077077 (pdf 77077.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS FE 1/20 (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078324 (pdf 78324.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (BRECKENRIDGE PHARM) APPROVAL= AP YEAR= 2008 , NDA 076629 (pdf 76629.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078267 (pdf 78267.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022501 (label 22501.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO LOESTRIN FE (APIL) APPROVAL= AP YEAR= 2010 , NDA 079193 (pdf 79193.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (BARR) APPROVAL= AP YEAR= 2010 , NDA 091090 (pdf 91090.pdf not found) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 200275 (pdf 200275.pdf not found) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2012 , NDA 200747 (pdf 200747.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203696 (label 203696.pdf) INN (LEUPROLIDE ACETATE NORETHINDRONE ACETATE) LUPANETA PACK (ABBVIE ENDOCRINE) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090938 (pdf 90938.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (BARR LABS INC) APPROVAL= AP YEAR= 2014 , NDA 091453 (pdf 91453.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN FE 1.5/30 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091454 (pdf 91454.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN FE 1/20 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 202771 (pdf 202771.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202772 (pdf 202772.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202995 (pdf 202995.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 1/20 (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 203667 (label 203667.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MINASTRIN 24 FE (APIL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204426 (label 204426.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) TAYTULLA (APIL) APPROVAL= AP YEAR= 2013 , NDA 204654 (label 204654.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO MINASTRIN FE (APIL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090293 (pdf 90293.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GILDESS 24 FE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2014 , NDA 202742 (pdf 202742.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202996 (pdf 202996.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 1.5/30 (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 203113 (pdf 203113.pdf not found) INN (NORETHINDRONE ACETATE ETHINYL ESTRADIOL FERROUS FUMARATE) LO-BLISOVI FE (LUPIN LTD) APPROVAL= TA YEAR= 2014 , NDA 202741 (pdf 202741.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 202770 (pdf 202770.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 202994 (pdf 202994.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LARIN 24 FE (NOVAST LABS) APPROVAL= AP YEAR= 2015 , NDA 203038 (pdf 203038.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (GLENMARK GENERICS) APPROVAL= AP YEAR= 2015 , NDA 091398 (pdf 91398.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI 24 FE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201584 (pdf 201584.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI FE 1/20 (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201585 (pdf 201585.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) BLISOVI FE 1.5/30 (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 204213 (pdf 204213.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FYAVOLV (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 203339 (pdf 203339.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) AMABELZ (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 203435 (pdf 203435.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LERIBANE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 204236 (pdf 204236.pdf not found) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205049 (label 205049.pdf) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206287 (pdf 206287.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MIBELAS 24 FE (LUPIN) APPROVAL= AP YEAR= 2016 , NDA 206969 (pdf 206969.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207514 (pdf 207514.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208097 (pdf 208097.pdf not found) INN (NORETHINDRONE ACETATE ETHINYL ESTRADIOL ETHINYL ESTRADIOL FERROUS FUMARATE) NORETHINDRONE ACETATE ETHINYL ESTRADIOL ETHINYL ESTRADIOL FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 205278 (pdf 205278.pdf not found) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 206120 (pdf 206120.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207259 (pdf 207259.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208661 (pdf 208661.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) LO LARIN FE (NOVAST LABS LTD) APPROVAL= TA YEAR= 2016 , NDA 207260 (pdf 207260.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207261 (pdf 207261.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207504 (pdf 207504.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 24 FE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207505 (pdf 207505.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA FE 1/20 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207506 (pdf 207506.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 1/20 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207580 (pdf 207580.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA FE 1.5/30 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207581 (pdf 207581.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) AUROVELA 1.5/30 (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 204847 (pdf 204847.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY 24 FE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 206597 (pdf 206597.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY FE 1/20 (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 210369 (pdf 210369.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 208639 (pdf 208639.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (APOTEX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210233 (pdf 210233.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (NAARI PTE LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205069 (pdf 205069.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 206490 (pdf 206490.pdf not found) INN (NORETHINDRONE ACETATE) NORETHINDRONE ACETATE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 209031 (pdf 209031.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY FE 1.5/30 (GLENMARK PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209297 (pdf 209297.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) HAILEY 1.5/30 (GLENMARK PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209609 (pdf 209609.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 210612 (pdf 210612.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ESTRADIOL AND NORETHINDRONE ACETATE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 202962 (pdf 202962.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) CHABELINA FE (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 210087 (pdf 210087.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) FINZALA (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 , NDA 213388 (label 213388.pdf) INN (ELAGOLIX SODIUM ESTRADIOL NORETHINDRONE ACETATE ELAGOLIX SODIUM) ORIAHNN COPACKAGED (ABBVIE) APPROVAL= AP YEAR= 2020 , NDA 212706 (pdf 212706.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) MERZEE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213317 (pdf 213317.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) GEMMILY (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 214292 (pdf 214292.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214846 (label 214846.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE RELUGOLIX) MYFEMBREE (MYOVANT SCIENCES) APPROVAL= AP YEAR= 2021 , NDA 213901 (pdf 213901.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213418 (pdf 213418.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 214729 (pdf 214729.pdf not found) INN (ESTRADIOL NORETHINDRONE ACETATE) ETYQA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216558 (pdf 216558.pdf not found) INN (ETHINYL ESTRADIOL NORETHINDRONE ACETATE) OSHIH (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , 211 ; ANISINDIONE ; 117-37-3 ; 1957 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTICOAGULANTS -- REDUCE THE PROTHROMBIN ACTIVITY , ; NDA 010909 (pdf 10909.pdf not found) INN (ANISINDIONE) MIRADON (SCHERING) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 212 ; BUCLIZINE ; 82-95-1 ; 1957 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTIEMETIC -- ANTICHOLINERGIC AGENTS -- ANTIHISTAMINES , ; NDA 010911 (pdf 10911.pdf not found) INN (BUCLIZINE HYDROCHLORIDE) BUCLADIN-S (STUART PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , 213 ; MESTRANOL ; 72-33-3 ; 1961 ; DISCONTINUED ; NATURAL MOLECULE C00032009 ; CLASS ESTROGENIC , ; NDA 010976 (pdf 10976.pdf not found) INN (MESTRANOL NORETHYNODREL) ENOVID (GD SEARLE LLC) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 012728 (pdf 12728.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 10-21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 013625 (pdf 13625.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+50 21-DAY (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 016029 (pdf 16029.pdf not found) INN (ETHYNODIOL DIACETATE MESTRANOL) OVULEN (GD SEARLE LLC) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 016659 (pdf 16659.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+50 28-DAY (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016705 (pdf 16705.pdf not found) INN (ETHYNODIOL DIACETATE MESTRANOL) OVULEN-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016709 (pdf 16709.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 1/50 28 (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016715 (pdf 16715.pdf not found) INN (MESTRANOL NORETHINDRONE) ORTHO-NOVUM 1/80 21 (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016724 (pdf 16724.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+80 21-DAY (GD SEARLE LLC) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016725 (pdf 16725.pdf not found) INN (MESTRANOL NORETHINDRONE) NORINYL 1+80 28-DAY (GD SEARLE LLC) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 070758 (pdf 70758.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHINDRONE AND MESTRANOL (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070759 (pdf 70759.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHINDRONE AND MESTRANOL (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071539 (pdf 71539.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHIN 1/50M-21 (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071540 (pdf 71540.pdf not found) INN (MESTRANOL NORETHINDRONE) NORETHIN 1/50M-28 (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , 214 ; NORETHYNODREL ; 68-23-5 ; 1961 ; DISCONTINUED ; ; CLASS GENITO -- PROGESTOGEN , ; NDA 010976 (pdf 10976.pdf not found) INN (MESTRANOL NORETHYNODREL) ENOVID (GD SEARLE LLC) APPROVAL= AP YEAR= 1961 DISCONTINUED , 215 ; PROPOXYPHENE ; 469-62-5 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- OPIOID AGONIST -- ANTITUSSIVES -- NARCOTICS , ; NDA 010996 (pdf 10996.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) DARVON W/ ASA (XANODYNE PHARM) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 010997 (label 10997.pdf) INN (PROPOXYPHENE HYDROCHLORIDE) DARVON (XANODYNE PHARM) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 016829 (pdf 16829.pdf not found) INN (ASPIRIN PROPOXYPHENE NAPSYLATE) DARVON-N W/ ASA (AAIPHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 016844 (pdf 16844.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) DARVOCET (AAIPHARMA LLC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 016861 (pdf 16861.pdf not found) INN (PROPOXYPHENE NAPSYLATE) DARVON-N (AAIPHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 016862 (label 16862.pdf) INN (PROPOXYPHENE NAPSYLATE) DARVON-N (XANODYNE PHARM) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 016863 (pdf 16863.pdf not found) INN (ASPIRIN PROPOXYPHENE NAPSYLATE) DARVON-N W/ ASA (AAIPHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 017122 (label 17122.pdf) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) DARVOCET-N 50 (XANODYNE PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 040139 (pdf 40139.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040507 (pdf 40507.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040569 (pdf 40569.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 070107 (pdf 70107.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPACET 100 (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070115 (pdf 70115.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070116 (pdf 70116.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070145 (pdf 70145.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070146 (pdf 70146.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070398 (pdf 70398.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070399 (pdf 70399.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070443 (pdf 70443.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070615 (pdf 70615.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070732 (pdf 70732.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070771 (pdf 70771.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070775 (pdf 70775.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070910 (pdf 70910.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071319 (pdf 71319.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072105 (pdf 72105.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072106 (pdf 72106.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072195 (pdf 72195.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 074119 (pdf 74119.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074843 (pdf 74843.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075738 (pdf 75738.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075838 (pdf 75838.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076429 (pdf 76429.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) DARVOCET A500 (XANODYNE PHARM) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076609 (pdf 76609.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076743 (pdf 76743.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (CORNERSTONE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076750 (pdf 76750.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (CORNERSTONE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077196 (pdf 77196.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077677 (pdf 77677.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WOCKHARDT LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077821 (pdf 77821.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MIRROR PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080044 (pdf 80044.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (SANDOZ) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 080269 (pdf 80269.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080530 (pdf 80530.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) DOLENE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080783 (pdf 80783.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080908 (pdf 80908.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083077 (pdf 83077.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083089 (pdf 83089.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083101 (pdf 83101.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND-65 (SANDOZ) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083113 (pdf 83113.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083125 (pdf 83125.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083184 (pdf 83184.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (ALRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083185 (pdf 83185.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083186 (pdf 83186.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083278 (pdf 83278.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083299 (pdf 83299.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083317 (pdf 83317.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083464 (pdf 83464.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083501 (pdf 83501.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083528 (pdf 83528.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083538 (pdf 83538.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPHENE 65 (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083544 (pdf 83544.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) KESSO-GESIC (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083597 (pdf 83597.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083688 (pdf 83688.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083689 (pdf 83689.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083786 (pdf 83786.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE 65 (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083870 (pdf 83870.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083978 (pdf 83978.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084014 (pdf 84014.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084551 (pdf 84551.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084553 (pdf 84553.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) COMPOUND 65 (ALRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084999 (pdf 84999.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) WYGESIC (CARACO) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085100 (pdf 85100.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) DOLENE AP-65 (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085190 (pdf 85190.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085732 (pdf 85732.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086495 (pdf 86495.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 088615 (pdf 88615.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089025 (pdf 89025.pdf not found) INN (ASPIRIN CAFFEINE PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE COMPOUND 65 (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089959 (pdf 89959.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 040908 (pdf 40908.pdf not found) INN (PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , 216 ; METHOCARBAMOL ; 532-03-6 ; 1957 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- MUSCLE RELAXANT -- SEDATIVE -- CARBAMATE DERIVATIVE OF GUAIFENESIN , ; NDA 011011 (label 11011.pdf) INN (METHOCARBAMOL) ROBAXIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011790 (label 11790.pdf) INN (METHOCARBAMOL) ROBAXIN (HIKMA) APPROVAL= AP YEAR= 1959 , NDA 012281 (pdf 12281.pdf not found) INN (ASPIRIN METHOCARBAMOL) ROBAXISAL (ROBINS AH) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 040413 (pdf 40413.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040489 (pdf 40489.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (OXFORD PHARMS) APPROVAL= AP YEAR= 2003 , NDA 081145 (pdf 81145.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (STEVENS J) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 083605 (pdf 83605.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084231 (pdf 84231.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PURACAP PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084259 (pdf 84259.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084276 (pdf 84276.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084277 (pdf 84277.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084323 (pdf 84323.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084448 (pdf 84448.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084449 (pdf 84449.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084471 (pdf 84471.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PURACAP PHARM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084486 (pdf 84486.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084488 (pdf 84488.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084615 (pdf 84615.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FOSUN PHARMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084616 (pdf 84616.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FOSUN PHARMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084648 (pdf 84648.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084649 (pdf 84649.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084675 (pdf 84675.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084756 (pdf 84756.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084846 (pdf 84846.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084924 (pdf 84924.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084927 (pdf 84927.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084928 (pdf 84928.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085033 (pdf 85033.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085123 (pdf 85123.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085136 (pdf 85136.pdf not found) INN (METHOCARBAMOL) FORBAXIN (FOREST LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085137 (pdf 85137.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085159 (pdf 85159.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085180 (pdf 85180.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085192 (pdf 85192.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085454 (pdf 85454.pdf not found) INN (METHOCARBAMOL) DELAXIN (FERNDALE LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085658 (pdf 85658.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (KV PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085660 (pdf 85660.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (KV PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085718 (pdf 85718.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085961 (pdf 85961.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CLONMEL HLTHCARE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085963 (pdf 85963.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CLONMEL HLTHCARE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086459 (pdf 86459.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (DR REDDYS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086988 (pdf 86988.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PRINSTON INC) APPROVAL= AP YEAR= 1979 , NDA 086989 (pdf 86989.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PRINSTON INC) APPROVAL= AP YEAR= 1979 OBSOLETE , NDA 087211 (pdf 87211.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087282 (pdf 87282.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087283 (pdf 87283.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087453 (pdf 87453.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087454 (pdf 87454.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087589 (pdf 87589.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087590 (pdf 87590.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087660 (pdf 87660.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ASCOT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087661 (pdf 87661.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ASCOT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088646 (pdf 88646.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088647 (pdf 88647.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088731 (pdf 88731.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089082 (pdf 89082.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089193 (pdf 89193.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089417 (pdf 89417.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089418 (pdf 89418.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089657 (pdf 89657.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089849 (pdf 89849.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 090200 (pdf 90200.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HETERO LABS LTD III) APPROVAL= AP YEAR= 2009 , NDA 200958 (pdf 200958.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HANGZHOU BINJIANG) APPROVAL= AP YEAR= 2011 , NDA 204404 (pdf 204404.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 206128 (pdf 206128.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205354 (pdf 205354.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MONTEREY PHARMS LLC) APPROVAL= AP YEAR= 2016 , NDA 203550 (pdf 203550.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (DBL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205404 (pdf 205404.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207496 (pdf 207496.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM REGENT) APPROVAL= AP YEAR= 2017 , NDA 207522 (pdf 207522.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 208116 (pdf 208116.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208507 (pdf 208507.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 206071 (pdf 206071.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (NAVINTA LLC) APPROVAL= AP YEAR= 2017 , NDA 209312 (pdf 209312.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 209331 (pdf 209331.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 211504 (pdf 211504.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 213967 (pdf 213967.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212623 (pdf 212623.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MLV) APPROVAL= AP YEAR= 2021 , NDA 215065 (pdf 215065.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212707 (pdf 212707.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MIKART) APPROVAL= AP YEAR= 2023 , 217 ; ETHOXZOLAMIDE ; 452-35-7 ; 1966 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC , ; NDA 011047 (pdf 11047.pdf not found) INN (ETHOXZOLAMIDE) CARDRASE (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016144 (pdf 16144.pdf not found) INN (ETHOXZOLAMIDE) ETHAMIDE (ALLERGAN) APPROVAL= AP YEAR= 1966 DISCONTINUED , 218 ; NIACIN ; 59-67-6 ; 1957 ; ; ; CLASS CARDIOVASCULAR -- VITAMIN B3 -- ANTILIPEMIC AGENTS -- PARTIAL INHIBITION OF RELEASE OF FREE FATTY ACIDS FROM ADIPOSE TISSUE -- INCREASED LIPOPROTEIN LIPASE ACTIVITY , ; NDA 011073 (pdf 11073.pdf not found) INN (NIACIN) WAMPOCAP (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 020381 (label 20381.pdf) INN (NIACIN) NIASPAN (ABBVIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021249 (label 21249.pdf) INN (NIACIN) ADVICOR (ABBVIE) APPROVAL= AP YEAR= 2001 OBSOLETE , NDA 022078 (label 22078.pdf) INN (NIACIN) SIMCOR (ABBVIE) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040378 (label 40378.pdf) INN (NIACIN) NIACOR (AVONDALE PHARMS) APPROVAL= AP YEAR= 2000 , NDA 076250 (pdf 76250.pdf not found) INN (NIACIN) NIACIN (BARR) APPROVAL= AP YEAR= 2005 , NDA 076378 (pdf 76378.pdf not found) INN (NIACIN) NIACIN (BARR) APPROVAL= AP YEAR= 2005 , NDA 081134 (pdf 81134.pdf not found) INN (NIACIN) NIACIN (WOCKHARDT) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 083115 (pdf 83115.pdf not found) INN (NIACIN) NIACIN (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083136 (pdf 83136.pdf not found) INN (NIACIN) NIACIN (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083180 (pdf 83180.pdf not found) INN (NIACIN) NIACIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083203 (pdf 83203.pdf not found) INN (NIACIN) NIACIN (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083271 (pdf 83271.pdf not found) INN (NIACIN) NIACIN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083305 (pdf 83305.pdf not found) INN (NIACIN) NIACIN (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083306 (pdf 83306.pdf not found) INN (NIACIN) NIACIN (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083453 (pdf 83453.pdf not found) INN (NIACIN) NIACIN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083525 (pdf 83525.pdf not found) INN (NIACIN) NIACIN (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083718 (pdf 83718.pdf not found) INN (NIACIN) NIACIN (HIKMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083823 (pdf 83823.pdf not found) INN (NIACIN) NICOLAR (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084237 (pdf 84237.pdf not found) INN (NIACIN) NIACIN (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085172 (pdf 85172.pdf not found) INN (NIACIN) NIACIN (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 090446 (pdf 90446.pdf not found) INN (NIACIN) NIACIN (CHARTWELL RX) APPROVAL= AP YEAR= 2014 , NDA 090860 (pdf 90860.pdf not found) INN (NIACIN) NIACIN (CHARTWELL RX) APPROVAL= AP YEAR= 2014 , NDA 090892 (pdf 90892.pdf not found) INN (NIACIN) NIACIN (CHARTWELL RX) APPROVAL= AP YEAR= 2014 , NDA 200484 (pdf 200484.pdf not found) INN (NIACIN) NIACIN (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 201273 (pdf 201273.pdf not found) INN (NIACIN) NIACIN (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 203578 (pdf 203578.pdf not found) INN (NIACIN) NIACIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204178 (pdf 204178.pdf not found) INN (NIACIN) NIACIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203899 (pdf 203899.pdf not found) INN (NIACIN) NIACIN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 , NDA 209156 (pdf 209156.pdf not found) INN (NIACIN) NIACIN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209236 (pdf 209236.pdf not found) INN (NIACIN) NIACIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 203742 (pdf 203742.pdf not found) INN (NIACIN) NIACIN (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212017 (pdf 212017.pdf not found) INN (NIACIN) NIACIN (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 214428 (pdf 214428.pdf not found) INN (NIACIN) NIACIN (BEIJING) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 204934 (pdf 204934.pdf not found) INN (NIACIN) NIACIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 213090 (pdf 213090.pdf not found) INN (NIACIN) NIACIN (EYWA) APPROVAL= AP YEAR= 2023 , 219 ; TRIPROLIDINE ; 486-12-4 ; 1977 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 011110 (pdf 11110.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) ACTIDIL (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011496 (pdf 11496.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) ACTIDIL (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012575 (pdf 12575.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTIFED W/ CODEINE (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018996 (pdf 18996.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTIFED (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071798 (pdf 71798.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072758 (pdf 72758.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085094 (pdf 85094.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085273 (pdf 85273.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 085610 (pdf 85610.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085940 (pdf 85940.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087514 (pdf 87514.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087963 (pdf 87963.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) MYIDYL (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088116 (pdf 88116.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) MYFED (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088117 (pdf 88117.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WEST WARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088193 (pdf 88193.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088283 (pdf 88283.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) HISTAFED (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088318 (pdf 88318.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088344 (pdf 88344.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTAHIST (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088474 (pdf 88474.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088515 (pdf 88515.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088578 (pdf 88578.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088602 (pdf 88602.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) CORPHED (FOSUN PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088630 (pdf 88630.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPHED (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088704 (pdf 88704.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIACIN-C (ANIMA) APPROVAL= AP YEAR= 1985 , NDA 088735 (pdf 88735.pdf not found) INN (TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088833 (pdf 88833.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE , PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088860 (pdf 88860.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ALLERFED (PVT FORM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089018 (pdf 89018.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1986 DISCONTINUED , 220 ; TRIFLUPROMAZINE ; 146-54-3 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC , ; NDA 011123 (pdf 11123.pdf not found) INN (TRIFLUPROMAZINE HYDROCHLORIDE) VESPRIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011325 (pdf 11325.pdf not found) INN (TRIFLUPROMAZINE HYDROCHLORIDE) VESPRIN (APOTHECON) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011491 (pdf 11491.pdf not found) INN (TRIFLUPROMAZINE) VESPRIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , 221 ; CHLOROTHIAZIDE ; 58-94-6 ; 1958 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- MAY INVOLVE CARBONIC ANHYDRASE INHIBITION (PMID24352504) , ; NDA 011145 (pdf 11145.pdf not found) INN (CHLOROTHIAZIDE) DIURIL (RISING) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , NDA 011635 (pdf 11635.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) DIUPRES-250 (MERCK) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011870 (label 11870.pdf) INN (CHLOROTHIAZIDE) DIURIL (SALIX PHARMS) APPROVAL= AP YEAR= 1961 , NDA 016016 (pdf 16016.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) ALDOCLOR-150 (MERCK) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 070654 (pdf 70654.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND CHLOROTHIAZIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070783 (pdf 70783.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND CHLOROTHIAZIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084026 (pdf 84026.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084217 (pdf 84217.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084388 (pdf 84388.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1975 OBSOLETE , NDA 084853 (pdf 84853.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085165 (pdf 85165.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085173 (pdf 85173.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085485 (pdf 85485.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085569 (pdf 85569.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (ABC HOLDING) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086028 (pdf 86028.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086795 (pdf 86795.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086796 (pdf 86796.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086938 (pdf 86938.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086940 (pdf 86940.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087736 (pdf 87736.pdf not found) INN (CHLOROTHIAZIDE) CHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087744 (pdf 87744.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087745 (pdf 87745.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088151 (pdf 88151.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088365 (pdf 88365.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE AND RESERPINE (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088557 (pdf 88557.pdf not found) INN (CHLOROTHIAZIDE RESERPINE) CHLOROTHIAZIDE AND RESERPINE (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 090896 (pdf 90896.pdf not found) INN (CHLOROTHIAZIDE SODIUM) CHLOROTHIAZIDE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 , NDA 091546 (pdf 91546.pdf not found) INN (CHLOROTHIAZIDE SODIUM) CHLOROTHIAZIDE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 202561 (pdf 202561.pdf not found) INN (CHLOROTHIAZIDE SODIUM) CHLOROTHIAZIDE SODIUM (AM REGENT) APPROVAL= AP YEAR= 2013 , NDA 202493 (pdf 202493.pdf not found) INN (CHLOROTHIAZIDE SODIUM) CHLOROTHIAZIDE SODIUM (RK PHARMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202462 (pdf 202462.pdf not found) INN (CHLOROTHIAZIDE SODIUM) CHLOROTHIAZIDE SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2015 , 222 ; METHYLPREDNISOLONE ; 83-43-2 ; 1957 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS , ; NDA 011153 (label 11153.pdf) INN (METHYLPREDNISOLONE) MEDROL (PFIZER) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY , NDA 040183 (label 40183.pdf) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1998 , NDA 040189 (pdf 40189.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (JUBILANT CADISTA) APPROVAL= AP YEAR= 1997 , NDA 040194 (pdf 40194.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 040232 (pdf 40232.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1997 , NDA 060645 (pdf 60645.pdf not found) INN (METHYLPREDNISOLONE NEOMYCIN SULFATE) NEO-MEDROL (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085650 (pdf 85650.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086159 (pdf 86159.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086161 (pdf 86161.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087341 (pdf 87341.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (INVATECH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088497 (pdf 88497.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089207 (pdf 89207.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089208 (pdf 89208.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089209 (pdf 89209.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 204072 (pdf 204072.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (TIANJIN TIANYAO) APPROVAL= AP YEAR= 2018 , NDA 206751 (pdf 206751.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209097 (pdf 209097.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210985 (pdf 210985.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212262 (pdf 212262.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (PRAXGEN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207481 (pdf 207481.pdf not found) INN (METHYLPREDNISOLONE) METHYLPREDNISOLONE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , 223 ; METHYLPREDNISOLONE SUCCINATE ; 2921-57-5 ; 1959 ; ; ; CLASS GLUCOCORTICOID -- ANTIINFLAMMATORY , ; NDA 011856 (label 11856.pdf) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) SOLU-MEDROL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1959 , NDA 040583 (pdf 40583.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 040612 (pdf 40612.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 040641 (pdf 40641.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (BEDFORD LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040662 (pdf 40662.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (BEDFORD LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040664 (pdf 40664.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040665 (pdf 40665.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040709 (pdf 40709.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (BEDFORD LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 081266 (pdf 81266.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081267 (pdf 81267.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081268 (pdf 81268.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 085852 (pdf 85852.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085853 (pdf 85853.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085854 (pdf 85854.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085855 (pdf 85855.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086906 (pdf 86906.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ELKINS SINN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086953 (pdf 86953.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087030 (pdf 87030.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087535 (pdf 87535.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE (ORGANON USA INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087812 (pdf 87812.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087813 (pdf 87813.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087851 (pdf 87851.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087852 (pdf 87852.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088523 (pdf 88523.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088524 (pdf 88524.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088676 (pdf 88676.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088677 (pdf 88677.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088678 (pdf 88678.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088679 (pdf 88679.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089143 (pdf 89143.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089144 (pdf 89144.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089173 (pdf 89173.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089174 (pdf 89174.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089186 (pdf 89186.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089187 (pdf 89187.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089188 (pdf 89188.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089189 (pdf 89189.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089264 (pdf 89264.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089265 (pdf 89265.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089266 (pdf 89266.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089267 (pdf 89267.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089573 (pdf 89573.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (ABBOTT) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089574 (pdf 89574.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (ABBOTT) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089575 (pdf 89575.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (ABBOTT) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089576 (pdf 89576.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (ABBOTT) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 040793 (pdf 40793.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040827 (pdf 40827.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) A-METHAPRED (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040888 (pdf 40888.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 207667 (pdf 207667.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202691 (pdf 202691.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 207549 (label 207549.pdf) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (AMNEAL) APPROVAL= AP YEAR= 2016 , NDA 212396 (pdf 212396.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (TIANJIN KINGYORK) APPROVAL= AP YEAR= 2021 , NDA 203125 (pdf 203125.pdf not found) INN (METHYLPREDNISOLONE SODIUM SUCCINATE) METHYLPREDNISOLONE SODIUM SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2022 , 224 ; TRIAMCINOLONE ; 124-94-7 ; 1957 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS , ; NDA 011161 (pdf 11161.pdf not found) INN (TRIAMCINOLONE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011283 (pdf 11283.pdf not found) INN (TRIAMCINOLONE) KENACORT (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 083750 (pdf 83750.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084020 (pdf 84020.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084267 (pdf 84267.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084268 (pdf 84268.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084270 (pdf 84270.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084286 (pdf 84286.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084318 (pdf 84318.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084319 (pdf 84319.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084320 (pdf 84320.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084340 (pdf 84340.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (IMPAX LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084406 (pdf 84406.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084707 (pdf 84707.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084708 (pdf 84708.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084709 (pdf 84709.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084775 (pdf 84775.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085601 (pdf 85601.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085834 (pdf 85834.pdf not found) INN (TRIAMCINOLONE) TRIAMCINOLONE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , 225 ; TRIAMCINOLONE ACETONIDE ; 76-25-5 ; 1958 ; ; ; CLASS ANTIINFLAMMATORY -- GLUCOCORTICOID -- ANTIPRURITIC -- VASOCONSTRICTIVE , ; NDA 011600 (label 11600.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MYLAN) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 011601 (label 11601.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MYLAN) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011602 (pdf 11602.pdf not found) INN (TRIAMCINOLONE ACETONIDE) KENALOG (DELCOR ASSET CORP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012041 (label 12041.pdf) INN (TRIAMCINOLONE ACETONIDE) KENALOG-10 (APOTHECON) APPROVAL= AP YEAR= 1960 , NDA 012097 (label 12097.pdf) INN (TRIAMCINOLONE ACETONIDE) KENALOG IN ORABASE (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012104 (label 12104.pdf) INN (TRIAMCINOLONE ACETONIDE) KENALOG (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 014901 (label 14901.pdf) INN (TRIAMCINOLONE ACETONIDE) KENALOG-40 (APOTHECON) APPROVAL= AP YEAR= 1965 , NDA 018117 (label 18117.pdf) INN (TRIAMCINOLONE ACETONIDE) AZMACORT (ABBVIE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 019503 (pdf 19503.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PARNELL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019798 (pdf 19798.pdf not found) INN (TRIAMCINOLONE ACETONIDE) NASACORT (CHATTEM SANOFI) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020120 (label 20120.pdf) INN (TRIAMCINOLONE ACETONIDE) ALLERNAZE (LUPIN ATLANTIS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 020468 (label 20468.pdf) INN (TRIAMCINOLONE ACETONIDE) NASACORT ALLERGY 24 HOUR (CHATTEM SANOFI) APPROVAL= AP YEAR= 1996 , NDA 020784 (pdf 20784.pdf not found) INN (TRIAMCINOLONE ACETONIDE) NASACORT HFA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022048 (label 22048.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIESENCE (HARROW EYE) APPROVAL= AP YEAR= 2007 , NDA 022220 (label 22220.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIVARIS (ALLERGAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022223 (label 22223.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIESENCE (ALCON RES) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 040037 (pdf 40037.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 , NDA 040038 (pdf 40038.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040039 (pdf 40039.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1997 , NDA 040040 (pdf 40040.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040374 (label 40374.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040386 (label 40386.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040467 (pdf 40467.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 040671 (pdf 40671.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MICRO LABS) APPROVAL= AP YEAR= 2006 , NDA 040672 (pdf 40672.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MICRO LABS) APPROVAL= AP YEAR= 2006 , NDA 060572 (pdf 60572.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 060576 (pdf 60576.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 061954 (pdf 61954.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCO-TRIACET II (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062045 (pdf 62045.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCO-TRIACET II (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062186 (pdf 62186.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062280 (pdf 62280.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062347 (pdf 62347.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062364 (pdf 62364.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1987 , NDA 062367 (pdf 62367.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYKACET (COSETTE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062595 (pdf 62595.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062596 (pdf 62596.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062597 (pdf 62597.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYTREX F (SAVAGE LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062598 (pdf 62598.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) MYTREX A (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062599 (pdf 62599.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1985 , NDA 062600 (pdf 62600.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062601 (pdf 62601.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYTREX F (SAVAGE LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062602 (pdf 62602.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1985 , NDA 062603 (pdf 62603.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062606 (pdf 62606.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062607 (pdf 62607.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062608 (pdf 62608.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062609 (pdf 62609.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) MYTREX A (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062656 (pdf 62656.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062657 (pdf 62657.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062733 (pdf 62733.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYKACET (COSETTE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 063010 (pdf 63010.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063305 (pdf 63305.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1993 , NDA 070730 (pdf 70730.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1986 , NDA 071383 (pdf 71383.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ORALONE (TARO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 080745 (pdf 80745.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080750 (pdf 80750.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083015 (pdf 83015.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083016 (pdf 83016.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083017 (pdf 83017.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083380 (pdf 83380.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOGEL (ASTELLAS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083943 (pdf 83943.pdf not found) INN (TRIAMCINOLONE ACETONIDE) KENALOG (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083944 (pdf 83944.pdf not found) INN (TRIAMCINOLONE ACETONIDE) KENALOG (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084343 (pdf 84343.pdf not found) INN (TRIAMCINOLONE ACETONIDE) KENALOG (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084908 (pdf 84908.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIACET (TEVA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085539 (pdf 85539.pdf not found) INN (TRIAMCINOLONE ACETONIDE) FLUTEX (IVAX PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085691 (pdf 85691.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1978 , NDA 085692 (pdf 85692.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1978 , NDA 085825 (pdf 85825.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086240 (pdf 86240.pdf not found) INN (TRIAMCINOLONE ACETONIDE) KENALOG-H (DELCOR ASSET CORP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086275 (pdf 86275.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086276 (pdf 86276.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086277 (pdf 86277.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086413 (pdf 86413.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 086414 (pdf 86414.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 086415 (pdf 86415.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 087113 (pdf 87113.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIACORT (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087191 (pdf 87191.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087192 (pdf 87192.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087356 (pdf 87356.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 087357 (pdf 87357.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 087375 (pdf 87375.pdf not found) INN (TRIAMCINOLONE ACETONIDE) FLUTEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087376 (pdf 87376.pdf not found) INN (TRIAMCINOLONE ACETONIDE) FLUTEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087377 (pdf 87377.pdf not found) INN (TRIAMCINOLONE ACETONIDE) FLUTEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087385 (pdf 87385.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 087428 (pdf 87428.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIATEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087429 (pdf 87429.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIATEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087430 (pdf 87430.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIATEX (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 087797 (pdf 87797.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087798 (pdf 87798.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087799 (pdf 87799.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087902 (pdf 87902.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087912 (pdf 87912.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087921 (pdf 87921.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087922 (pdf 87922.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087932 (pdf 87932.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (AMBIX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087990 (pdf 87990.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087991 (pdf 87991.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087992 (pdf 87992.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088042 (pdf 88042.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIDERM (CROWN LABS) APPROVAL= AP YEAR= 1984 , NDA 088090 (pdf 88090.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088091 (pdf 88091.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088092 (pdf 88092.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088094 (pdf 88094.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088095 (pdf 88095.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088096 (pdf 88096.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088196 (pdf 88196.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRYMEX (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088197 (pdf 88197.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRYMEX (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088198 (pdf 88198.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRYMEX (SAVAGE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088450 (pdf 88450.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088451 (pdf 88451.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088690 (pdf 88690.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088691 (pdf 88691.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRYMEX (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088692 (pdf 88692.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088693 (pdf 88693.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRYMEX (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088780 (pdf 88780.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088781 (pdf 88781.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088818 (pdf 88818.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088819 (pdf 88819.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088820 (pdf 88820.pdf not found) INN (TRIAMCINOLONE ACETONIDE) ARISTOCORT A (ASTELLAS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089129 (pdf 89129.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1986 , NDA 089274 (pdf 89274.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TOPIDERM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089275 (pdf 89275.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TOPIDERM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089276 (pdf 89276.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TOPIDERM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089595 (pdf 89595.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIANEX (CMP PHARMA INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089795 (pdf 89795.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1988 , NDA 089796 (pdf 89796.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1988 , NDA 089797 (pdf 89797.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1991 , NDA 089798 (pdf 89798.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1991 , NDA 089913 (pdf 89913.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 078104 (label 78104.pdf) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2009 , NDA 090164 (pdf 90164.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090166 (pdf 90166.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 040771 (pdf 40771.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (LYNE) APPROVAL= AP YEAR= 2010 , NDA 202374 (pdf 202374.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 205782 (pdf 205782.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2015 , NDA 205373 (pdf 205373.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ENCUBE) APPROVAL= AP YEAR= 2016 , NDA 208300 (pdf 208300.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 204606 (pdf 204606.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204608 (pdf 204608.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206312 (pdf 206312.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206379 (pdf 206379.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206785 (pdf 206785.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 207094 (pdf 207094.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207117 (pdf 207117.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207380 (pdf 207380.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2016 , NDA 208136 (pdf 208136.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 208287 (pdf 208287.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208326 (pdf 208326.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 205592 (pdf 205592.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 2017 , NDA 207217 (pdf 207217.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 , NDA 207741 (pdf 207741.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 208479 (pdf 208479.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 208590 (pdf 208590.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208763 (pdf 208763.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 206786 (pdf 206786.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 207550 (pdf 207550.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 207651 (pdf 207651.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207730 (pdf 207730.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CROWN LABS INC) APPROVAL= AP YEAR= 2017 , NDA 207731 (pdf 207731.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CROWN LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208320 (pdf 208320.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 208845 (label 208845.pdf) INN (TRIAMCINOLONE ACETONIDE) ZILRETTA (PACIRA PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208848 (pdf 208848.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ENCUBE) APPROVAL= AP YEAR= 2017 , NDA 208925 (pdf 208925.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208205 (pdf 208205.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 209535 (pdf 209535.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 209990 (pdf 209990.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210077 (pdf 210077.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 207365 (pdf 207365.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 207764 (pdf 207764.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 209828 (pdf 209828.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 209852 (pdf 209852.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 210346 (pdf 210346.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 207316 (pdf 207316.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212384 (pdf 212384.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (ENCUBE) APPROVAL= AP YEAR= 2019 , NDA 211315 (pdf 211315.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212356 (pdf 212356.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213142 (pdf 213142.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TORRENT) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213559 (pdf 213559.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 213619 (pdf 213619.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (CINTEX SVCS) APPROVAL= AP YEAR= 2020 , NDA 212460 (pdf 212460.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 214090 (pdf 214090.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 211950 (label 211950.pdf) INN (TRIAMCINOLONE ACETONIDE) XIPERE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2021 , NDA 214751 (pdf 214751.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 212400 (pdf 212400.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213543 (pdf 213543.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214186 (pdf 214186.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 212567 (pdf 212567.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 214181 (pdf 214181.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 214582 (pdf 214582.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (QUAGEN) APPROVAL= AP YEAR= 2022 , NDA 214532 (pdf 214532.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2023 , NDA 214615 (pdf 214615.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 216625 (pdf 216625.pdf not found) INN (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , 226 ; TRIAMCINOLONE DIACETATE ; 67-78-7 ; 1959 ; DISCONTINUED ; ; CLASS ANTIINFLAMMATORY -- GLUCOCORTICOID , ; NDA 011685 (label 11685.pdf) INN (TRIAMCINOLONE DIACETATE) ARISTOCORT (FOSUN PHARMA) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011960 (pdf 11960.pdf not found) INN (TRIAMCINOLONE DIACETATE) ARISTOCORT (ASTELLAS) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012515 (pdf 12515.pdf not found) INN (TRIAMCINOLONE DIACETATE) KENACORT (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 012802 (label 12802.pdf) INN (TRIAMCINOLONE DIACETATE) ARISTOCORT (FOSUN PHARMA) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 084072 (pdf 84072.pdf not found) INN (TRIAMCINOLONE DIACETATE) TRIAMCINOLONE DIACETATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085122 (pdf 85122.pdf not found) INN (TRIAMCINOLONE DIACETATE) TRIAMCINOLONE DIACETATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085529 (pdf 85529.pdf not found) INN (TRIAMCINOLONE DIACETATE) TRIAMCINOLONE DIACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086394 (pdf 86394.pdf not found) INN (TRIAMCINOLONE DIACETATE) TRIAMCINOLONE DIACETATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , 227 ; BENZONATATE ; 104-31-4 ; 1958 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTITUSSIVE -- INHIBITION OF PULMONARY STRETCH RECEPTORS , ; NDA 011210 (label 11210.pdf) INN (BENZONATATE) TESSALON (PFIZER) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY , NDA 040587 (pdf 40587.pdf not found) INN (BENZONATATE) BENZONATATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040597 (pdf 40597.pdf not found) INN (BENZONATATE) BENZONATATE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 040627 (pdf 40627.pdf not found) INN (BENZONATATE) BENZONATATE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040682 (pdf 40682.pdf not found) INN (BENZONATATE) BENZONATATE (HERITAGE PHARMS LABS) APPROVAL= AP YEAR= 2007 , NDA 040749 (pdf 40749.pdf not found) INN (BENZONATATE) BENZONATATE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2007 , NDA 040795 (pdf 40795.pdf not found) INN (BENZONATATE) BENZONATATE (NESHER PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 081297 (pdf 81297.pdf not found) INN (BENZONATATE) BENZONATATE (BIONPHARMA) APPROVAL= AP YEAR= 1993 , NDA 040851 (pdf 40851.pdf not found) INN (BENZONATATE) BENZONATATE (MIKART) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091133 (pdf 91133.pdf not found) INN (BENZONATATE) BENZONATATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 202765 (pdf 202765.pdf not found) INN (BENZONATATE) BENZONATATE (CSPC-NBP PHARM) APPROVAL= AP YEAR= 2015 , NDA 201209 (pdf 201209.pdf not found) INN (BENZONATATE) BENZONATATE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2014 , NDA 091310 (pdf 91310.pdf not found) INN (BENZONATATE) BENZONATATE (ACELLA) APPROVAL= AP YEAR= 2015 , NDA 206948 (pdf 206948.pdf not found) INN (BENZONATATE) BENZONATATE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2018 , NDA 210562 (pdf 210562.pdf not found) INN (BENZONATATE) BENZONATATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211518 (pdf 211518.pdf not found) INN (BENZONATATE) BENZONATATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , 228 ; PHENPROCOUMON ; 435-97-2 ; 1957 ; DISCONTINUED ; ; CLASS BLOOD -- ANTICOAGULANT -- VITAMIN K ANTAGONIST , ; NDA 011228 (pdf 11228.pdf not found) INN (PHENPROCOUMON) LIQUAMAR (ORGANON USA INC) APPROVAL= AP YEAR= 1957 DISCONTINUED , 229 ; DEXTROMETHORPHAN ; 125-71-3 ; 1957 ; ; ; CLASS NERVOUS SYSTEM -- ANTITUSSIVE -- UNCOMPETITIVE GLUTAMATE [NMDA] RECEPTOR ANTAGONIST -- SIGMA 1-TYPE RECEPTOR AGONIST -- TREATMENT OF PSEUDOBULBAR AFFECT (PBA) -- SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITOR , ; NDA 011265 (label 11265.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 018658 (label 18658.pdf) INN (DEXTROMETHORPHAN POLISTIREX) DELSYM (RB HLTH) APPROVAL= AP YEAR= 1982 , NDA 019279 (label 19279.pdf) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) DIMETANE-DX (ROBINS AH) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 021620 (label 21620.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) MUCINEX DM (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 040027 (pdf 40027.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (AKORN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040649 (pdf 40649.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE DM (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2006 , NDA 088722 (pdf 88722.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMANATE DM (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088762 (pdf 88762.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETH W/ DEXTROMETHORPHAN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088811 (pdf 88811.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088864 (pdf 88864.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ DEXTROMETHORPHAN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088913 (pdf 88913.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE DM (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089681 (pdf 89681.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 021879 (label 21879.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) NUEDEXTA (AVANIR PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090575 (pdf 90575.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091135 (pdf 91135.pdf not found) INN (DEXTROMETHORPHAN POLISTIREX) DEXTROMETHORPHAN POLISTIREX (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 091687 (pdf 91687.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 202940 (pdf 202940.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2014 , NDA 202993 (pdf 202993.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (PAR PHARM INC) APPROVAL= TA YEAR= 2015 , NDA 205292 (pdf 205292.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 091070 (pdf 91070.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 203375 (pdf 203375.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ACELLA) APPROVAL= AP YEAR= 2016 , NDA 203133 (pdf 203133.pdf not found) INN (DEXTROMETHORPHAN POLISTIREX) DEXTROMETHORPHAN POLISTIREX (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 205112 (pdf 205112.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (TARO) APPROVAL= AP YEAR= 2017 , NDA 206941 (pdf 206941.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 202934 (pdf 202934.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE QUINIDINE SULFATE) DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2017 , NDA 209692 (pdf 209692.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207602 (pdf 207602.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 207676 (pdf 207676.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 210647 (pdf 210647.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 211170 (pdf 211170.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (EYWA) APPROVAL= AP YEAR= 2020 , NDA 213125 (pdf 213125.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 , NDA 202955 (pdf 202955.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 203997 (pdf 203997.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214781 (pdf 214781.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 215430 (label 215430.pdf) INN (BUPROPION HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE) AUVELITY (AXSOME) APPROVAL= AP YEAR= 2022 , NDA 217340 (pdf 217340.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2023 , 230 ; CHLORMEZANONE ; 80-77-3 ; 1960 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANTS , ; NDA 011467 (pdf 11467.pdf not found) INN (CHLORMEZANONE) TRANCOPAL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , 231 ; FURAZOLIDONE ; 67-45-8 ; 1958 ; DISCONTINUED ; ; CLASS GENITO -- ANTIPROTOZOAL -- ANTIINFECTIVES -- ANTITRICHOMONAL AGENTS -- MONOAMINE OXIDASE INHIBITORS (SECONDARY EFFECT) -- NITROFURANS , ; NDA 011270 (pdf 11270.pdf not found) INN (FURAZOLIDONE) FUROXONE (SHIRE) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 011323 (pdf 11323.pdf not found) INN (FURAZOLIDONE) FUROXONE (SHIRE) APPROVAL= AP YEAR= 1958 DISCONTINUED , 232 ; CHLORZOXAZONE ; 95-25-0 ; 1958 ; ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANT -- SEDATIVES , ; NDA 011300 (pdf 11300.pdf not found) INN (CHLORZOXAZONE) PARAFLEX (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011529 (pdf 11529.pdf not found) INN (CHLORZOXAZONE) PARAFON FORTE DSC (JANSSEN R AND D) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 040113 (pdf 40113.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040137 (pdf 40137.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 081008 (pdf 81008.pdf not found) INN (CHLORZOXAZONE) STRIFON FORTE DSC (FERNDALE LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 081019 (pdf 81019.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081040 (pdf 81040.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081298 (pdf 81298.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (OHM LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 081299 (pdf 81299.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (OHM LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 086901 (pdf 86901.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086948 (pdf 86948.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087981 (pdf 87981.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088928 (pdf 88928.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089592 (pdf 89592.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089852 (pdf 89852.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089853 (pdf 89853.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1988 , NDA 089859 (pdf 89859.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 089895 (pdf 89895.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089948 (pdf 89948.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089970 (pdf 89970.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 040861 (pdf 40861.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (MIKART) APPROVAL= AP YEAR= 2010 , NDA 207483 (pdf 207483.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (MIKART) APPROVAL= AP YEAR= 2016 , NDA 212253 (pdf 212253.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212254 (pdf 212254.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212185 (pdf 212185.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212898 (pdf 212898.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 , NDA 211849 (pdf 211849.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 , NDA 212053 (pdf 212053.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (APTAPHARMA INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212743 (pdf 212743.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2020 , NDA 215158 (pdf 215158.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213126 (pdf 213126.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (RISING) APPROVAL= AP YEAR= 2022 , NDA 214941 (pdf 214941.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (COREPHARMA) APPROVAL= AP YEAR= 2022 , NDA 212047 (pdf 212047.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2023 , NDA 214365 (pdf 214365.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (ACME LABS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214702 (pdf 214702.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (COREPHARMA) APPROVAL= AP YEAR= 2023 , NDA 215540 (pdf 215540.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (BELCHER) APPROVAL= AP YEAR= 2023 , NDA 216925 (pdf 216925.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 210961 (pdf 210961.pdf not found) INN (CHLORZOXAZONE) CHLORZOXAZONE (SENORES PHARMS) APPROVAL= AP YEAR= 2024 , 233 ; TRIMEPRAZINE ; 84-96-8 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- PHENOTHIAZINE -- ANTIHISTAMINIC -- NEUROLEPTIC -- SEDATIVE -- ANTIMUSCARINIC -- AMINE BINDING GPCR RECEPTOR ANTAGONIST , ; NDA 011316 (pdf 11316.pdf not found) INN (TRIMEPRAZINE TARTRATE) TEMARIL (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085015 (pdf 85015.pdf not found) INN (TRIMEPRAZINE TARTRATE) TRIMEPRAZINE TARTRATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088285 (pdf 88285.pdf not found) INN (TRIMEPRAZINE TARTRATE) TRIMEPRAZINE TARTRATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , 234 ; HALOTHANE ; 151-67-7 ; 1958 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 011338 (pdf 11338.pdf not found) INN (HALOTHANE) FLUOTHANE (WYETH AYERST) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , NDA 080810 (pdf 80810.pdf not found) INN (HALOTHANE) HALOTHANE (HALOCARBON) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083254 (pdf 83254.pdf not found) INN (HALOTHANE) HALOTHANE (HOSPIRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084977 (pdf 84977.pdf not found) INN (HALOTHANE) HALOTHANE (BH) APPROVAL= AP YEAR= 1976 DISCONTINUED , 235 ; DICHLORPHENAMIDE ; 120-97-8 ; 1958 ; ; ; CLASS SENSORY -- ANTIGLAUCOMIC AGENTS -- CARBONIC ANHYDRASE INHIBITORS -- OPHTHALMICS , ; NDA 011366 (label 11366.pdf) INN (DICHLORPHENAMIDE) DARANIDE (XERIS) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY , NDA 215924 (pdf 215924.pdf not found) INN (DICHLORPHENAMIDE) ORMALVI (TORRENT) APPROVAL= AP YEAR= 2022 , 236 ; CHLORMEZANONE ; 80-77-3 ; 1960 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANTS , ; NDA 011467 (pdf 11467.pdf not found) INN (CHLORMEZANONE) TRANCOPAL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , 237 ; TRIFLUOPERAZINE ; 117-89-5 ; 1959 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- ANXIOLYTIC -- DOPAMINE RECEPTOR ANTAGONISTS -- PHENOTHIAZINES , ; NDA 011552 (pdf 11552.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) STELAZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 040153 (pdf 40153.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (ATHEM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040209 (pdf 40209.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1997 , NDA 085785 (pdf 85785.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 085786 (pdf 85786.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 085787 (pdf 85787.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085788 (pdf 85788.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 085789 (pdf 85789.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 085973 (pdf 85973.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085975 (pdf 85975.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085976 (pdf 85976.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087328 (pdf 87328.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087612 (pdf 87612.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087613 (pdf 87613.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087614 (pdf 87614.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088143 (pdf 88143.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088710 (pdf 88710.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088967 (pdf 88967.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088968 (pdf 88968.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088969 (pdf 88969.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088970 (pdf 88970.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089893 (pdf 89893.pdf not found) INN (TRIFLUOPERAZINE HYDROCHLORIDE) TRIFLUOPERAZINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 238 ; SULFINPYRAZONE ; 57-96-5 ; 1959 ; DISCONTINUED ; ; CLASS METABOLISM -- URICOSURIC AGENTS , ; NDA 011556 (pdf 11556.pdf not found) INN (SULFINPYRAZONE) ANTURANE (NOVARTIS) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 087665 (pdf 87665.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (BARR) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087666 (pdf 87666.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (BARR) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087667 (pdf 87667.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087769 (pdf 87769.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087770 (pdf 87770.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088666 (pdf 88666.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (VANGARD) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088933 (pdf 88933.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (PAR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088934 (pdf 88934.pdf not found) INN (SULFINPYRAZONE) SULFINPYRAZONE (PAR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , 239 ; METHOHEXITAL ; 151-83-7 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- ANESTHETIC -- BARBITURATES -- GABA ALLOSTERIC MODULATOR , ; NDA 011559 (label 11559.pdf) INN (METHOHEXITAL SODIUM) BREVITAL SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , 240 ; OXYPHENCYCLIMINE ; 125-53-1 ; 0 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTISPASMODICS , ; NDA 011612 (pdf 11612.pdf not found) INN (OXYPHENCYCLIMINE HYDROCHLORIDE) DARICON (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , 241 ; PHENTERMINE ; 122-09-8 ; 1959 ; ; ; CLASS METABOLISM -- ANOREXIGENIC AGENTS -- APPETITE DEPRESSANTS -- SYMPATHOMIMETICS -- AMPHETAMINE ANALOGS -- POLYPHARMACOLOGY , ; NDA 011613 (label 11613.pdf) INN (PHENTERMINE RESIN COMPLEX) IONAMIN (UCB INC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 017352 (pdf 17352.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) FASTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 040083 (pdf 40083.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TG UNITED INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040190 (pdf 40190.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 1997 , NDA 040227 (pdf 40227.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040228 (pdf 40228.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 1997 , NDA 040276 (label 40276.pdf) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040377 (pdf 40377.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 040402 (pdf 40402.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040403 (pdf 40403.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040427 (pdf 40427.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040448 (pdf 40448.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040460 (pdf 40460.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040497 (pdf 40497.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040525 (pdf 40525.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040526 (pdf 40526.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 , NDA 040527 (pdf 40527.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040555 (pdf 40555.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040790 (pdf 40790.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040875 (pdf 40875.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 040876 (pdf 40876.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 040886 (pdf 40886.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 040887 (pdf 40887.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 083804 (pdf 83804.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083923 (pdf 83923.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084035 (pdf 84035.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) TORA (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084487 (pdf 84487.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085128 (label 85128.pdf) INN (PHENTERMINE HYDROCHLORIDE) ADIPEX-P (TEVA) APPROVAL= AP YEAR= 1980 , NDA 085319 (pdf 85319.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085411 (pdf 85411.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ABC HOLDING) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085417 (pdf 85417.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085553 (pdf 85553.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085671 (pdf 85671.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085689 (pdf 85689.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085739 (pdf 85739.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086260 (pdf 86260.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) ONA-MAST (MAST MM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086329 (pdf 86329.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086453 (pdf 86453.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (VITARINE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086456 (pdf 86456.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (VITARINE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086511 (pdf 86511.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) ONA-MAST (MAST MM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086516 (pdf 86516.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) ONA-MAST (MAST MM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086732 (pdf 86732.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086735 (pdf 86735.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CAMALL) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086740 (pdf 86740.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086911 (pdf 86911.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086945 (pdf 86945.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1983 , NDA 087022 (pdf 87022.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087126 (pdf 87126.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087144 (pdf 87144.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) OBESTIN-30 (FERNDALE LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087190 (pdf 87190.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 087202 (pdf 87202.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087208 (pdf 87208.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087215 (pdf 87215.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087223 (pdf 87223.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087226 (pdf 87226.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CAMALL) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087235 (pdf 87235.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (VITARINE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087301 (pdf 87301.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087764 (pdf 87764.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) OBY-TRIM (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087777 (pdf 87777.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087805 (pdf 87805.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087915 (pdf 87915.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087918 (pdf 87918.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087930 (pdf 87930.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088023 (label 88023.pdf) INN (PHENTERMINE HYDROCHLORIDE) ADIPEX-P (TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088414 (pdf 88414.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088430 (pdf 88430.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088576 (pdf 88576.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088596 (pdf 88596.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088605 (pdf 88605.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (SANDOZ INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088610 (pdf 88610.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088611 (pdf 88611.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088612 (pdf 88612.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088613 (pdf 88613.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088614 (pdf 88614.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088625 (pdf 88625.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088797 (pdf 88797.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088910 (pdf 88910.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088917 (pdf 88917.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088948 (pdf 88948.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089120 (pdf 89120.pdf not found) INN (PHENTERMINE RESIN COMPLEX) PHENTERMINE RESIN 30 (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090470 (pdf 90470.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090591 (pdf 90591.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091359 (pdf 91359.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200272 (pdf 200272.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS) APPROVAL= AP YEAR= 2011 , NDA 012737 (pdf 12737.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) WILPO (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040872 (pdf 40872.pdf not found) INN (PHENTERMINE RESIN COMPLEX) PHENTERMINE RESIN COMPLEX (LANNETT CO INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201961 (pdf 201961.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202088 (label 202088.pdf) INN (PHENTERMINE HYDROCHLORIDE) SUPRENZA (CITIUS PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022580 (label 22580.pdf) INN (PHENTERMINE HYDROCHLORIDE TOPIRAMATE) QSYMIA (VIVUS LLC) APPROVAL= AP YEAR= 2012 , NDA 091451 (pdf 91451.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202248 (pdf 202248.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ELITE LABS) APPROVAL= AP YEAR= 2012 , NDA 202846 (pdf 202846.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202858 (pdf 202858.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202942 (pdf 202942.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203068 (pdf 203068.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 204414 (pdf 204414.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205008 (pdf 205008.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2014 , NDA 205017 (pdf 205017.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2014 , NDA 205019 (pdf 205019.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2014 , NDA 203495 (pdf 203495.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) LOMAIRA (AVANTHI INC) APPROVAL= AP YEAR= 2016 , NDA 204318 (pdf 204318.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206342 (pdf 206342.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (MERRO PHARM USA) APPROVAL= AP YEAR= 2016 , NDA 203436 (pdf 203436.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (KVK TECH INC) APPROVAL= AP YEAR= 2017 , NDA 204663 (pdf 204663.pdf not found) INN (PHENTERMINE HYDROCHLORIDE) PHENTERMINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , 242 ; CHLORPROPAMIDE ; 94-20-2 ; 1958 ; DISCONTINUED ; ; CLASS METABOLISM -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS -- ANTIDIABETIC -- STIMULATING THE RELEASE OF INSULIN , ; NDA 011641 (label 11641.pdf) INN (CHLORPROPAMIDE) DIABINESE (PFIZER) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , NDA 084669 (pdf 84669.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086865 (pdf 86865.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 086866 (pdf 86866.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087353 (pdf 87353.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088175 (pdf 88175.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088176 (pdf 88176.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088549 (pdf 88549.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088568 (pdf 88568.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088608 (pdf 88608.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088641 (pdf 88641.pdf not found) INN (CHLORPROPAMIDE) GLUCAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088662 (pdf 88662.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088694 (pdf 88694.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088695 (pdf 88695.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088708 (pdf 88708.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088709 (pdf 88709.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088725 (pdf 88725.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (RISING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088726 (pdf 88726.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (RISING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088768 (pdf 88768.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088812 (pdf 88812.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088813 (pdf 88813.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088826 (pdf 88826.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088840 (pdf 88840.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088852 (pdf 88852.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088918 (pdf 88918.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088919 (pdf 88919.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088921 (pdf 88921.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088922 (pdf 88922.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089321 (pdf 89321.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089446 (pdf 89446.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089447 (pdf 89447.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089561 (pdf 89561.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089562 (pdf 89562.pdf not found) INN (CHLORPROPAMIDE) CHLORPROPAMIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , 243 ; DEXAMETHASONE ; 50-02-2 ; 1958 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS , ; NDA 011664 (label 11664.pdf) INN (DEXAMETHASONE) DECADRON (MERCK) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , NDA 012376 (pdf 12376.pdf not found) INN (DEXAMETHASONE) DECADRON (MERCK) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012674 (label 12674.pdf) INN (DEXAMETHASONE) HEXADROL (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012675 (label 12675.pdf) INN (DEXAMETHASONE) HEXADROL (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 012731 (pdf 12731.pdf not found) INN (DEXAMETHASONE) DECASPRAY (MERCK) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 013422 (label 13422.pdf) INN (DEXAMETHASONE) MAXIDEX (HARROW EYE) APPROVAL= AP YEAR= 1962 , NDA 013538 (pdf 13538.pdf not found) INN (DEXAMETHASONE) DECADERM (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021537 (label 21537.pdf) INN (CIPROFLOXACIN DEXAMETHASONE) CIPRODEX (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 040700 (pdf 40700.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (BAUSCH) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 050023 (label 50023.pdf) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (HARROW EYE) APPROVAL= AP YEAR= 1963 , NDA 050065 (label 50065.pdf) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (SANDOZ) APPROVAL= AP YEAR= 1963 , NDA 050592 (label 50592.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 050616 (label 50616.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX (NOVARTIS) APPROVAL= AP YEAR= 1988 , NDA 062341 (pdf 62341.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (SANDOZ) APPROVAL= AP YEAR= 1984 , NDA 062411 (pdf 62411.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062428 (pdf 62428.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062544 (pdf 62544.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062566 (pdf 62566.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062721 (pdf 62721.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062938 (pdf 62938.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (PADAGIS US) APPROVAL= AP YEAR= 1989 , NDA 064063 (pdf 64063.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 064134 (label 64134.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1999 , NDA 064135 (pdf 64135.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 080399 (pdf 80399.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (PRASCO) APPROVAL= AP YEAR= 1971 , NDA 080968 (pdf 80968.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083296 (pdf 83296.pdf not found) INN (DEXAMETHASONE) AEROSEB-DEX (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083420 (pdf 83420.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083806 (pdf 83806.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (PHOENIX LABS NY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084013 (pdf 84013.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084081 (pdf 84081.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084084 (pdf 84084.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084086 (pdf 84086.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084327 (pdf 84327.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084457 (pdf 84457.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084610 (pdf 84610.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084611 (pdf 84611.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084612 (pdf 84612.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1978 , NDA 084613 (pdf 84613.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084614 (pdf 84614.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084754 (pdf 84754.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ANIMA) APPROVAL= AP YEAR= 1976 , NDA 084763 (pdf 84763.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084764 (pdf 84764.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084765 (pdf 84765.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084766 (pdf 84766.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084990 (pdf 84990.pdf not found) INN (DEXAMETHASONE) DEXONE 1.5 (SOLVAY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084991 (pdf 84991.pdf not found) INN (DEXAMETHASONE) DEXONE 0.5 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084992 (pdf 84992.pdf not found) INN (DEXAMETHASONE) DEXONE 4 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084993 (pdf 84993.pdf not found) INN (DEXAMETHASONE) DEXONE 0.75 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085376 (pdf 85376.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085455 (pdf 85455.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085456 (pdf 85456.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085458 (pdf 85458.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085818 (pdf 85818.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085840 (pdf 85840.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087533 (pdf 87533.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087534 (pdf 87534.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087916 (pdf 87916.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 088148 (pdf 88148.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (FERA PHARMS LLC) APPROVAL= AP YEAR= 1983 OBSOLETE , NDA 088149 (pdf 88149.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (PANGEA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088160 (pdf 88160.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (FERA PHARMS LLC) APPROVAL= AP YEAR= 1983 OBSOLETE , NDA 088237 (pdf 88237.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (KEY THERAP) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088238 (pdf 88238.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (FERA PHARMS LLC) APPROVAL= AP YEAR= 1983 OBSOLETE , NDA 088248 (pdf 88248.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1983 , NDA 088252 (pdf 88252.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1983 , NDA 088254 (pdf 88254.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088306 (pdf 88306.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1983 , NDA 088316 (pdf 88316.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (HIKMA) APPROVAL= AP YEAR= 1983 , NDA 088481 (pdf 88481.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ALVOGEN) APPROVAL= AP YEAR= 1983 , NDA 088997 (pdf 88997.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089170 (pdf 89170.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 022315 (label 22315.pdf) INN (DEXAMETHASONE) OZURDEX (ABBVIE) APPROVAL= AP YEAR= 2009 , NDA 050818 (label 50818.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX ST (HARROW EYE) APPROVAL= AP YEAR= 2009 , NDA 091188 (pdf 91188.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 090891 (pdf 90891.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (LYNE) APPROVAL= AP YEAR= 2011 , NDA 201270 (pdf 201270.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (LARKEN LABS INC) APPROVAL= AP YEAR= 2017 , NDA 208912 (label 208912.pdf) INN (DEXAMETHASONE) DEXYCU KIT (EYEPOINT PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208742 (label 208742.pdf) INN (DEXAMETHASONE) DEXTENZA (OCULAR THERAPEUTIX) APPROVAL= AP YEAR= 2018 , NDA 211379 (label 211379.pdf) INN (DEXAMETHASONE) HEMADY (DEXCEL) APPROVAL= AP YEAR= 2019 , NDA 205548 (pdf 205548.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 212991 (pdf 212991.pdf not found) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215106 (pdf 215106.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 212715 (pdf 212715.pdf not found) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (PADAGIS US) APPROVAL= AP YEAR= 2022 , NDA 210470 (pdf 210470.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (SUN PHARM) APPROVAL= AP YEAR= 2022 , NDA 215604 (pdf 215604.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216295 (pdf 216295.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215768 (pdf 215768.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (SENTISS) APPROVAL= AP YEAR= 2023 , NDA 217001 (pdf 217001.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217538 (pdf 217538.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217696 (pdf 217696.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217695 (pdf 217695.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 216282 (pdf 216282.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , NDA 216283 (pdf 216283.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , NDA 216284 (pdf 216284.pdf not found) INN (DEXAMETHASONE) DEXAMETHASONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , NDA 216501 (pdf 216501.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2024 , 244 ; DEXAMETHASONE PHOSPHATE ; 312-93-6 ; 1959 ; ; ; CLASS GLUCOCORTICOID -- ANTIINFLAMMATORY , ; NDA 011977 (pdf 11977.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DECADRON (MERCK) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011983 (pdf 11983.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DECADRON (MERCK) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011984 (pdf 11984.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DECADRON (MERCK) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012071 (pdf 12071.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DECADRON (MERCK) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 013334 (pdf 13334.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE LIDOCAINE HYDROCHLORIDE) DECADRON W/ XYLOCAINE (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 013413 (pdf 13413.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXACORT (UCB INC) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 014242 (pdf 14242.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXACORT (UCB INC) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 014694 (label 14694.pdf) INN (DEXAMETHASONE SODIUM PHOSPHATE) HEXADROL (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 040069 (pdf 40069.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 , NDA 040491 (label 40491.pdf) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2003 , NDA 040572 (label 40572.pdf) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 , NDA 040802 (pdf 40802.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 040803 (pdf 40803.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 050322 (pdf 50322.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEODECADRON (MERCK) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 050324 (pdf 50324.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEODECADRON (MERCK) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 062539 (pdf 62539.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062714 (pdf 62714.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 064055 (pdf 64055.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 081125 (pdf 81125.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081126 (pdf 81126.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 083161 (pdf 83161.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (DELL LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083342 (pdf 83342.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) MAXIDEX (ALCON) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083702 (pdf 83702.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084170 (pdf 84170.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084173 (pdf 84173.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084282 (pdf 84282.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1975 , NDA 084342 (pdf 84342.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXACEN-4 (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084355 (pdf 84355.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084493 (pdf 84493.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084752 (pdf 84752.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (BEL MAR) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084855 (pdf 84855.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084916 (label 84916.pdf) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1977 , NDA 085606 (pdf 85606.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085641 (pdf 85641.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087065 (pdf 87065.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (LYPHOMED) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087440 (pdf 87440.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (LUITPOLD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087668 (pdf 87668.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087702 (pdf 87702.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 088071 (pdf 88071.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088433 (pdf 88433.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088448 (pdf 88448.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088469 (pdf 88469.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088522 (pdf 88522.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088771 (pdf 88771.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089169 (pdf 89169.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (DR REDDYS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089280 (pdf 89280.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089281 (pdf 89281.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089282 (pdf 89282.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089372 (pdf 89372.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 203129 (pdf 203129.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 206781 (pdf 206781.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 207442 (pdf 207442.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 , NDA 207521 (pdf 207521.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (SOMERSET) APPROVAL= AP YEAR= 2018 , NDA 208689 (pdf 208689.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 208690 (pdf 208690.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 209192 (pdf 209192.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210967 (pdf 210967.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211036 (pdf 211036.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 210966 (pdf 210966.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 215654 (pdf 215654.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 211451 (pdf 211451.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 214890 (pdf 214890.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214891 (pdf 214891.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217797 (pdf 217797.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE) DEXAMETHASONE SODIUM PHOSPHATE (MICRO LABS) APPROVAL= AP YEAR= 2024 , 245 ; DEXAMETHASONE ACETATE ; 1177-87-3 ; 1973 ; DISCONTINUED ; ; CLASS GLUCOCORTICOID -- ANTIINFLAMMATORY , ; NDA 016675 (pdf 16675.pdf not found) INN (DEXAMETHASONE ACETATE) DECADRON-LA (MERCK) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084315 (pdf 84315.pdf not found) INN (DEXAMETHASONE ACETATE) DEXAMETHASONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087711 (pdf 87711.pdf not found) INN (DEXAMETHASONE ACETATE) DEXAMETHASONE ACETATE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1982 DISCONTINUED , 246 ; DIETHYLPROPION ; 90-84-6 ; 1959 ; ; ; CLASS METABOLISM -- ANOREXIGENIC AGENTS -- STIMULANTS -- SYMPATHOMIMETIC , ; NDA 011673 (pdf 11673.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TEPANIL (3M) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011722 (label 11722.pdf) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012546 (label 12546.pdf) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE DOSPAN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 017668 (pdf 17668.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017669 (pdf 17669.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017956 (pdf 17956.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TEPANIL TEN-TAB (3M) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085544 (pdf 85544.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085741 (pdf 85741.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085916 (pdf 85916.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088267 (pdf 88267.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088268 (pdf 88268.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088642 (pdf 88642.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 040828 (pdf 40828.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201212 (pdf 201212.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (AVANTHI INC) APPROVAL= AP YEAR= 2010 , NDA 091680 (pdf 91680.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 200177 (pdf 200177.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , 247 ; THIOPENTAL ; 76-75-5 ; 1959 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 011679 (pdf 11679.pdf not found) INN (THIOPENTAL SODIUM) PENTOTHAL (ABBOTT) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , 248 ; THIOTEPA ; 52-24-4 ; 1959 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENT OF DNA , ; NDA 011683 (pdf 11683.pdf not found) INN (THIOTEPA) THIOTEPA (IMMUNEX) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 020058 (pdf 20058.pdf not found) INN (THIOTEPA) THIOPLEX (IMMUNEX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 075547 (label 75547.pdf) INN (THIOTEPA) THIOTEPA (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2001 , NDA 075698 (pdf 75698.pdf not found) INN (THIOTEPA) THIOTEPA (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075730 (pdf 75730.pdf not found) INN (THIOTEPA) THIOTEPA (TEVA PARENTERAL) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 208264 (label 208264.pdf) INN (THIOTEPA) TEPADINA (ADIENNE SA) APPROVAL= AP YEAR= 2017 , NDA 209150 (pdf 209150.pdf not found) INN (THIOTEPA) THIOTEPA (HENGRUI PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210337 (pdf 210337.pdf not found) INN (THIOTEPA) THIOTEPA (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 208242 (pdf 208242.pdf not found) INN (THIOTEPA) THIOTEPA (PENN LIFE) APPROVAL= AP YEAR= 2020 , NDA 213049 (pdf 213049.pdf not found) INN (THIOTEPA) THIOTEPA (MSN) APPROVAL= AP YEAR= 2020 , NDA 214222 (pdf 214222.pdf not found) INN (THIOTEPA) THIOTEPA (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 211831 (pdf 211831.pdf not found) INN (THIOTEPA) THIOTEPA (BELOTECA) APPROVAL= AP YEAR= 2021 , NDA 211755 (pdf 211755.pdf not found) INN (THIOTEPA) THIOTEPA (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 216037 (pdf 216037.pdf not found) INN (THIOTEPA) THIOTEPA (KINDOS) APPROVAL= AP YEAR= 2023 , 249 ; PHENYLPROPANOLAMINE ; 14838-15-4 ; 1958 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- APPETITE DEPRESSANTS -- NASAL DECONGESTANTS -- SYMPATHOMIMETICS -- ALPHA-1 ADRENERGIC RECEPTOR PARTIAL AGONIST , ; NDA 011694 (pdf 11694.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) DIMETANE-DC (ROBINS AH) APPROVAL= AP YEAR= 1958 DISCONTINUED OBSOLETE , NDA 012152 (pdf 12152.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) ORNADE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1959 DISCONTINUED OBSOLETE , NDA 012436 (pdf 12436.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1960 DISCONTINUED OBSOLETE , NDA 013087 (pdf 13087.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1962 DISCONTINUED OBSOLETE , NDA 018050 (pdf 18050.pdf not found) INN (CHLORPHENIRAMINE POLISTIREX PHENYLPROPANOLAMINE POLISTIREX) CORSYM (UCB INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018099 (pdf 18099.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) CONTAC 12 HOUR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1980 DISCONTINUED OBSOLETE , NDA 018115 (pdf 18115.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) TRIAMINIC-12 (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018298 (pdf 18298.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) TAVIST-D (NOVARTIS) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 018556 (pdf 18556.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) DEMAZIN (SCHERING PLOUGH) APPROVAL= AP YEAR= 1984 DISCONTINUED OBSOLETE , NDA 018793 (pdf 18793.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) COLD CAPSULE IV (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018794 (pdf 18794.pdf not found) INN (CHLORPHENIRAMINE MALEATE PHENYLPROPANOLAMINE HYDROCHLORIDE) COLD CAPSULE V (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018809 (pdf 18809.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED OBSOLETE , NDA 019410 (pdf 19410.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) HYCOMINE (ENDO PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 019411 (pdf 19411.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) HYCOMINE PEDIATRIC (ENDO PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 019613 (pdf 19613.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) CONTAC (NOVARTIS) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 020640 (pdf 20640.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) TAVIST-D (NOVARTIS) APPROVAL= AP YEAR= 1996 DISCONTINUED OBSOLETE , NDA 071099 (pdf 71099.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) BROMATAPP (COPLEY PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 075103 (pdf 75103.pdf not found) INN (HYDROCODONE BITARTRATE PHENYLPROPANOLAMINE HYDROCHLORIDE) CODAMINE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 088359 (pdf 88359.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) DRIZE (ASCHER) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 088681 (pdf 88681.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088687 (pdf 88687.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) BIPHETAP (MORTON GROVE) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088688 (pdf 88688.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) BROMANATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088723 (pdf 88723.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) BROMANATE DC (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 088904 (pdf 88904.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) MYPHETANE DC (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 088940 (pdf 88940.pdf not found) INN (PHENYLPROPANOLAMINE HYDROCHLORIDE) CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , 250 ; OXYMORPHONE ; 76-41-5 ; 1959 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- ADJUVANTS, ANESTHESIA -- NARCOTICS -- OPIATE AGONISTS , ; NDA 011707 (label 11707.pdf) INN (OXYMORPHONE HYDROCHLORIDE) OPANA (ENDO PHARMS) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011738 (pdf 11738.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) NUMORPHAN (ENDO PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 021610 (label 21610.pdf) INN (OXYMORPHONE HYDROCHLORIDE) OPANA ER (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021611 (label 21611.pdf) INN (OXYMORPHONE HYDROCHLORIDE) OPANA (ENDO PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 079087 (pdf 79087.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2010 , NDA 090964 (pdf 90964.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2010 , NDA 079046 (label 79046.pdf) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091443 (pdf 91443.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2011 , NDA 201655 (label 201655.pdf) INN (OXYMORPHONE HYDROCHLORIDE) OPANA ER (ENDO PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200822 (pdf 200822.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202321 (pdf 202321.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203601 (pdf 203601.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (AVANTHI INC) APPROVAL= AP YEAR= 2013 , NDA 200792 (pdf 200792.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201187 (pdf 201187.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 202946 (pdf 202946.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203506 (pdf 203506.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204459 (pdf 204459.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 210175 (pdf 210175.pdf not found) INN (OXYMORPHONE HYDROCHLORIDE) OXYMORPHONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2018 , 251 ; METHAZOLAMIDE ; 554-57-4 ; 1959 ; ; ; CLASS SENSORY -- CARBONIC ANHYDRASE INHIBITORS -- DIURETICS -- LOWERING INTRAOCULAR PRESSURE , ; NDA 011721 (pdf 11721.pdf not found) INN (METHAZOLAMIDE) NEPTAZANE (LEDERLE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 040001 (pdf 40001.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1993 , NDA 040011 (pdf 40011.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (APPLIED ANAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040036 (pdf 40036.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (SANDOZ) APPROVAL= AP YEAR= 1993 , NDA 040062 (pdf 40062.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (MIKART) APPROVAL= AP YEAR= 1994 , NDA 040102 (pdf 40102.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (ATHEM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 207438 (pdf 207438.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2018 , NDA 215615 (pdf 215615.pdf not found) INN (METHAZOLAMIDE) METHAZOLAMIDE (TAGI) APPROVAL= AP YEAR= 2022 , 252 ; FLUOROMETHOLONE ; 426-13-1 ; 1972 ; ; ; CLASS DERMATOLOGICALS -- ANTI-INFLAMMATORY AGENTS -- GLUCOCORTICOIDS , ; NDA 011748 (pdf 11748.pdf not found) INN (FLUOROMETHOLONE) OXYLONE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 016851 (label 16851.pdf) INN (FLUOROMETHOLONE) FML (ABBVIE) APPROVAL= AP YEAR= 1972 , NDA 017760 (label 17760.pdf) INN (FLUOROMETHOLONE) FML (ALLERGAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019079 (label 19079.pdf) INN (FLUOROMETHOLONE ACETATE) FLAREX (HARROW EYE) APPROVAL= AP YEAR= 1986 , NDA 019216 (label 19216.pdf) INN (FLUOROMETHOLONE) FML FORTE (ABBVIE) APPROVAL= AP YEAR= 1986 , NDA 019525 (label 19525.pdf) INN (FLUOROMETHOLONE SULFACETAMIDE SODIUM) FML-S (ALLERGAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050628 (label 50628.pdf) INN (FLUOROMETHOLONE ACETATE TOBRAMYCIN) TOBRASONE (HARROW EYE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070185 (pdf 70185.pdf not found) INN (FLUOROMETHOLONE) FLUOR-OP (NOVARTIS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 216348 (pdf 216348.pdf not found) INN (FLUOROMETHOLONE) FLUOROMETHOLONE (AMNEAL) APPROVAL= AP YEAR= 2024 , 253 ; FLUPHENAZINE ; 69-23-8 ; 1959 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTICS -- DOPAMINE ANTAGONISTS (PMID24150997) -- PHENOTHIAZINES , ; NDA 011751 (pdf 11751.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PROLIXIN (APOTHECON) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012034 (pdf 12034.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PERMITIL (SCHERING) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012145 (pdf 12145.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PROLIXIN (APOTHECON) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012419 (pdf 12419.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PERMITIL (SCHERING) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 016008 (pdf 16008.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PERMITIL (SCHERING) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 040146 (pdf 40146.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1996 , NDA 070533 (pdf 70533.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) PROLIXIN (APOTHECON) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 073058 (pdf 73058.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074725 (pdf 74725.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1996 , NDA 081310 (pdf 81310.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 088527 (pdf 88527.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088544 (pdf 88544.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088550 (pdf 88550.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088555 (pdf 88555.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089556 (pdf 89556.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 089583 (pdf 89583.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 089584 (pdf 89584.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 089585 (pdf 89585.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 089586 (pdf 89586.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089740 (pdf 89740.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1988 , NDA 089741 (pdf 89741.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1988 , NDA 089742 (pdf 89742.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 1988 , NDA 089743 (pdf 89743.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1988 , NDA 089800 (pdf 89800.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089804 (pdf 89804.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (PRASCO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 213647 (pdf 213647.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 214534 (pdf 214534.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 214552 (pdf 214552.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 214674 (pdf 214674.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215141 (pdf 215141.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (ZAMEER PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215674 (pdf 215674.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2022 , NDA 215848 (pdf 215848.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 213784 (pdf 213784.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2022 , NDA 216649 (pdf 216649.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 216891 (pdf 216891.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 217410 (pdf 217410.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216350 (pdf 216350.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 217189 (pdf 217189.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2023 , NDA 218055 (pdf 218055.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217094 (pdf 217094.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 218283 (pdf 218283.pdf not found) INN (FLUPHENAZINE HYDROCHLORIDE) FLUPHENAZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2024 , 254 ; CARISOPRODOL ; 78-44-4 ; 1959 ; ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANTS -- RELIEVING DISCOMFORT ASSOCIATED WITH CUTE PAINFUL MUSCULOSKELETAL CONDITIONS -- ALLOSTERIC EFFECTS ON GABA(A) RECEPTOR (PMID25896767) , ; NDA 011792 (label 11792.pdf) INN (CARISOPRODOL) SOMA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , NDA 012155 (pdf 12155.pdf not found) INN (CARISOPRODOL) RELA (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012365 (label 12365.pdf) INN (ASPIRIN CARISOPRODOL) SOMA COMPOUND (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012366 (label 12366.pdf) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) SOMA COMPOUND W/ CODEINE (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 040116 (pdf 40116.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040118 (pdf 40118.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040124 (pdf 40124.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040152 (pdf 40152.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040188 (pdf 40188.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 , NDA 040245 (pdf 40245.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (CHARTWELL RX) APPROVAL= AP YEAR= 1997 , NDA 040252 (pdf 40252.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040283 (pdf 40283.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (OXFORD PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040397 (pdf 40397.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040421 (pdf 40421.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040576 (pdf 40576.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ACCELRX LABS) APPROVAL= AP YEAR= 2005 , NDA 040755 (pdf 40755.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 081025 (pdf 81025.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WANBANG BIOPHARMS) APPROVAL= AP YEAR= 1989 , NDA 085433 (pdf 85433.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086179 (pdf 86179.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087499 (pdf 87499.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= AP YEAR= 1982 , NDA 088809 (pdf 88809.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL COMPOUND (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089346 (pdf 89346.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089390 (pdf 89390.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089566 (pdf 89566.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089594 (pdf 89594.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 040792 (pdf 40792.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 040823 (pdf 40823.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NOVAST LABS) APPROVAL= AP YEAR= 2008 , NDA 040832 (pdf 40832.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (NOVAST LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040860 (pdf 40860.pdf not found) INN (CARISOPRODOL) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (INGENUS PHARMS NJ) APPROVAL= AP YEAR= 2010 , NDA 090988 (pdf 90988.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NATCO) APPROVAL= AP YEAR= 2014 , NDA 203374 (pdf 203374.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 205085 (pdf 205085.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ORIENT PHARMA CO LTD) APPROVAL= AP YEAR= 2014 , NDA 205126 (pdf 205126.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 205513 (pdf 205513.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207237 (pdf 207237.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 211789 (pdf 211789.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (MLV) APPROVAL= AP YEAR= 2021 , 255 ; CARISOPRODOL ; 78-44-4 ; 1959 ; ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANTS -- RELIEVING DISCOMFORT ASSOCIATED WITH CUTE PAINFUL MUSCULOSKELETAL CONDITIONS -- ALLOSTERIC EFFECTS ON GABA(A) RECEPTOR (PMID25896767) , ; NDA 011792 (label 11792.pdf) INN (CARISOPRODOL) SOMA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , NDA 012155 (pdf 12155.pdf not found) INN (CARISOPRODOL) RELA (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012365 (label 12365.pdf) INN (ASPIRIN CARISOPRODOL) SOMA COMPOUND (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012366 (label 12366.pdf) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) SOMA COMPOUND W/ CODEINE (MEDA PHARMS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 040116 (pdf 40116.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040118 (pdf 40118.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040124 (pdf 40124.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040152 (pdf 40152.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040188 (pdf 40188.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 , NDA 040245 (pdf 40245.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (CHARTWELL RX) APPROVAL= AP YEAR= 1997 , NDA 040252 (pdf 40252.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040283 (pdf 40283.pdf not found) INN (ASPIRIN CARISOPRODOL CODEINE PHOSPHATE) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (OXFORD PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040397 (pdf 40397.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040421 (pdf 40421.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040576 (pdf 40576.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ACCELRX LABS) APPROVAL= AP YEAR= 2005 , NDA 040755 (pdf 40755.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 081025 (pdf 81025.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WANBANG BIOPHARMS) APPROVAL= AP YEAR= 1989 , NDA 085433 (pdf 85433.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086179 (pdf 86179.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087499 (pdf 87499.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WATSON LABS) APPROVAL= AP YEAR= 1982 , NDA 088809 (pdf 88809.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL COMPOUND (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089346 (pdf 89346.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089390 (pdf 89390.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089566 (pdf 89566.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089594 (pdf 89594.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 040792 (pdf 40792.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 040823 (pdf 40823.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NOVAST LABS) APPROVAL= AP YEAR= 2008 , NDA 040832 (pdf 40832.pdf not found) INN (ASPIRIN CARISOPRODOL) CARISOPRODOL AND ASPIRIN (NOVAST LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040860 (pdf 40860.pdf not found) INN (CARISOPRODOL) CARISOPRODOL , ASPIRIN AND CODEINE PHOSPHATE (INGENUS PHARMS NJ) APPROVAL= AP YEAR= 2010 , NDA 090988 (pdf 90988.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NATCO) APPROVAL= AP YEAR= 2014 , NDA 203374 (pdf 203374.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 205085 (pdf 205085.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (ORIENT PHARMA CO LTD) APPROVAL= AP YEAR= 2014 , NDA 205126 (pdf 205126.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 205513 (pdf 205513.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207237 (pdf 207237.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 211789 (pdf 211789.pdf not found) INN (CARISOPRODOL) CARISOPRODOL (MLV) APPROVAL= AP YEAR= 2021 , 256 ; HYDROCHLOROTHIAZIDE ; 58-93-5 ; 1959 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE AGENTS -- DIURETICS -- MAY INVOLVE CARBONIC ANHYDRASE INHIBITION (PMID24352504) , ; NDA 011793 (pdf 11793.pdf not found) INN (HYDROCHLOROTHIAZIDE) ESIDRIX (NOVARTIS) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 011835 (pdf 11835.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDRODIURIL (MERCK) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011878 (pdf 11878.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) SERPASIL-ESIDRIX #1 (NOVARTIS) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011958 (pdf 11958.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROPRES 25 (MERCK) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 011971 (pdf 11971.pdf not found) INN (HYDROCHLOROTHIAZIDE) ORETIC (ABBVIE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012026 (pdf 12026.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESOLINE-ESIDRIX (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012148 (pdf 12148.pdf not found) INN (DESERPIDINE HYDROCHLOROTHIAZIDE) ORETICYL 25 (ABBVIE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 012193 (pdf 12193.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-AP-ES (NOVARTIS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012616 (label 12616.pdf) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) ALDACTAZIDE (PFIZER) APPROVAL= AP YEAR= 1961 , NDA 013402 (pdf 13402.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) ALDORIL 15 (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 013553 (pdf 13553.pdf not found) INN (GUANETHIDINE MONOSULFATE HYDROCHLOROTHIAZIDE) ESIMIL (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016042 (label 16042.pdf) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) DYAZIDE (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 018031 (label 18031.pdf) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE-40/25 (WYETH PHARMS INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018061 (pdf 18061.pdf not found) INN (HYDROCHLOROTHIAZIDE TIMOLOL MALEATE) TIMOLIDE 10-25 (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018201 (label 18201.pdf) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) MODURETIC 5-50 (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018303 (label 18303.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) LOPRESSOR HCT (VALIDUS PHARMS) APPROVAL= AP YEAR= 1984 , NDA 018709 (pdf 18709.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPOZIDE 25/15 (APOTHECON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018872 (pdf 18872.pdf not found) INN (HYDROCHLOROTHIAZIDE PINDOLOL) VISKAZIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019046 (pdf 19046.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) NORMOZIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019059 (pdf 19059.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE LA 80/50 (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019129 (label 19129.pdf) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) MAXZIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1984 , NDA 019174 (pdf 19174.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) TRANDATE HCT (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019221 (label 19221.pdf) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) VASERETIC (BAUSCH) APPROVAL= AP YEAR= 1986 , NDA 019778 (label 19778.pdf) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) PRINZIDE (MERCK) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019888 (label 19888.pdf) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) ZESTORETIC (ALMATICA) APPROVAL= AP YEAR= 1989 , NDA 020033 (label 20033.pdf) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) LOTENSIN HCT (VALIDUS PHARMS) APPROVAL= AP YEAR= 1992 , NDA 020125 (label 20125.pdf) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) ACCURETIC (PFIZER PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 020186 (label 20186.pdf) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) ZIAC (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1993 , NDA 020286 (pdf 20286.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) MONOPRIL-HCT (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020387 (label 20387.pdf) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) HYZAAR (ORGANON) APPROVAL= AP YEAR= 1995 , NDA 020504 (label 20504.pdf) INN (HYDROCHLOROTHIAZIDE) MICROZIDE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1996 , NDA 020729 (label 20729.pdf) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) UNIRETIC (UCB INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020758 (label 20758.pdf) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) AVALIDE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 , NDA 020818 (label 20818.pdf) INN (HYDROCHLOROTHIAZIDE VALSARTAN) DIOVAN HCT (NOVARTIS) APPROVAL= AP YEAR= 1998 , NDA 021093 (label 21093.pdf) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) ATACAND HCT (ANI PHARMS) APPROVAL= AP YEAR= 2000 , NDA 021162 (label 21162.pdf) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) MICARDIS HCT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2000 , NDA 021268 (label 21268.pdf) INN (EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE) TEVETEN HCT (ABBVIE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021532 (label 21532.pdf) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) BENICAR HCT (COSETTE) APPROVAL= AP YEAR= 2003 , NDA 021956 (label 21956.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL SUCCINATE) DUTOPROL (CONCORDIA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 022107 (label 22107.pdf) INN (ALISKIREN HEMIFUMARATE HYDROCHLOROTHIAZIDE) TEKTURNA HCT (NODEN PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040412 (pdf 40412.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 040702 (pdf 40702.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (LEADING) APPROVAL= AP YEAR= 2007 , NDA 040707 (pdf 40707.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2007 , NDA 040735 (label 40735.pdf) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040770 (label 40770.pdf) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040774 (pdf 40774.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040780 (pdf 40780.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 040807 (pdf 40807.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 040809 (pdf 40809.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040810 (pdf 40810.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040857 (pdf 40857.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040907 (pdf 40907.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2008 , NDA 070182 (pdf 70182.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070183 (pdf 70183.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070264 (pdf 70264.pdf not found) INN (HYDROCHLOROTHIAZIDE) METHYLDOPA AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070265 (pdf 70265.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070301 (pdf 70301.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070305 (pdf 70305.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070347 (pdf 70347.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRO-RIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070365 (pdf 70365.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070366 (pdf 70366.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070367 (pdf 70367.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070368 (pdf 70368.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070543 (pdf 70543.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070544 (pdf 70544.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070612 (pdf 70612.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070613 (pdf 70613.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070614 (pdf 70614.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070616 (pdf 70616.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070688 (pdf 70688.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070689 (pdf 70689.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070704 (pdf 70704.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070705 (pdf 70705.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070795 (pdf 70795.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070829 (pdf 70829.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070830 (pdf 70830.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070851 (pdf 70851.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070852 (pdf 70852.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070853 (pdf 70853.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070854 (pdf 70854.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070946 (pdf 70946.pdf not found) INN (HYDROCHLOROTHIAZIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 070947 (pdf 70947.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070958 (pdf 70958.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070959 (pdf 70959.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070960 (pdf 70960.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071060 (pdf 71060.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071061 (pdf 71061.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071069 (pdf 71069.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071111 (pdf 71111.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1988 , NDA 071126 (pdf 71126.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071127 (pdf 71127.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071251 (pdf 71251.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 1987 , NDA 071458 (pdf 71458.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071459 (pdf 71459.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071460 (pdf 71460.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071461 (pdf 71461.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071498 (pdf 71498.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071501 (pdf 71501.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071552 (pdf 71552.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071553 (pdf 71553.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071737 (pdf 71737.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071771 (pdf 71771.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071772 (pdf 71772.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071819 (pdf 71819.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071820 (pdf 71820.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071821 (pdf 71821.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071822 (pdf 71822.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071851 (pdf 71851.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 071897 (pdf 71897.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071898 (pdf 71898.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071899 (pdf 71899.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071900 (pdf 71900.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071920 (pdf 71920.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071921 (pdf 71921.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071922 (pdf 71922.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071923 (pdf 71923.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071969 (pdf 71969.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071980 (pdf 71980.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072011 (pdf 72011.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 072022 (pdf 72022.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072042 (pdf 72042.pdf not found) INN (HYDROCHLOROTHIAZIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 072043 (pdf 72043.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072507 (pdf 72507.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072508 (pdf 72508.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072509 (pdf 72509.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072510 (pdf 72510.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 073191 (pdf 73191.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073209 (pdf 73209.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1991 , NDA 073281 (pdf 73281.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1992 , NDA 073334 (pdf 73334.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073357 (pdf 73357.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073449 (pdf 73449.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 , NDA 073467 (pdf 73467.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074026 (pdf 74026.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074259 (pdf 74259.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074701 (pdf 74701.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074788 (pdf 74788.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074821 (pdf 74821.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074827 (pdf 74827.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074832 (pdf 74832.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074857 (pdf 74857.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074896 (pdf 74896.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1997 , NDA 074970 (pdf 74970.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075052 (pdf 75052.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075055 (pdf 75055.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075469 (pdf 75469.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075527 (pdf 75527.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075579 (pdf 75579.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 075624 (pdf 75624.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075632 (pdf 75632.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075640 (pdf 75640.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075642 (pdf 75642.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075672 (pdf 75672.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075686 (pdf 75686.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075727 (pdf 75727.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (COSETTE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075736 (pdf 75736.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075768 (pdf 75768.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2000 , NDA 075776 (pdf 75776.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075788 (pdf 75788.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (TARO PHARM INDS) APPROVAL= AP YEAR= 2001 , NDA 075869 (pdf 75869.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075907 (pdf 75907.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 075909 (label 75909.pdf) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2001 , NDA 075926 (pdf 75926.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076007 (pdf 76007.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 , NDA 076113 (pdf 76113.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076116 (pdf 76116.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076194 (pdf 76194.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 , NDA 076230 (pdf 76230.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 076262 (pdf 76262.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 076265 (pdf 76265.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076342 (pdf 76342.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076348 (pdf 76348.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076374 (pdf 76374.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076486 (pdf 76486.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076608 (pdf 76608.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076612 (pdf 76612.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076631 (pdf 76631.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 076674 (pdf 76674.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (COREPHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076688 (pdf 76688.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076739 (pdf 76739.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076792 (pdf 76792.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 076945 (pdf 76945.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076961 (pdf 76961.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 076980 (pdf 76980.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2007 , NDA 077005 (pdf 77005.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077093 (pdf 77093.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077144 (pdf 77144.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077157 (pdf 77157.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 077369 (pdf 77369.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2012 , NDA 077446 (pdf 77446.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 077483 (pdf 77483.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077606 (pdf 77606.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (AUROBINDO) APPROVAL= AP YEAR= 2006 , NDA 077705 (pdf 77705.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077732 (pdf 77732.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077885 (pdf 77885.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077912 (pdf 77912.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 077948 (pdf 77948.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 077969 (pdf 77969.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078020 (pdf 78020.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 078164 (pdf 78164.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078385 (pdf 78385.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 078389 (pdf 78389.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078391 (pdf 78391.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2008 , NDA 078450 (pdf 78450.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 081189 (pdf 81189.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081190 (pdf 81190.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 083177 (pdf 83177.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 , NDA 083232 (pdf 83232.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083456 (pdf 83456.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083458 (pdf 83458.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083554 (pdf 83554.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ALRA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083568 (pdf 83568.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083571 (pdf 83571.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083572 (pdf 83572.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083573 (pdf 83573.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083607 (pdf 83607.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083666 (pdf 83666.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083770 (pdf 83770.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083809 (pdf 83809.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083877 (pdf 83877.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDROSERPINE PLUS R-H-H (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083891 (pdf 83891.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDRO-D (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083899 (pdf 83899.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (AUROLIFE PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083925 (pdf 83925.pdf not found) INN (HYDROCHLOROTHIAZIDE) ZIDE (SOLVAY) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083965 (pdf 83965.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083972 (pdf 83972.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084029 (pdf 84029.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084135 (pdf 84135.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084291 (pdf 84291.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE , HYDROCHLOROTHIAZIDE AND RESERPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084324 (pdf 84324.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084325 (pdf 84325.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084466 (pdf 84466.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084467 (pdf 84467.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084536 (pdf 84536.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084579 (pdf 84579.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084580 (pdf 84580.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084603 (pdf 84603.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084658 (pdf 84658.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084714 (pdf 84714.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-RESERP (ABC HOLDING) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084735 (pdf 84735.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084771 (pdf 84771.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084776 (pdf 84776.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (INWOOD LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084810 (pdf 84810.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084811 (pdf 84811.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) APRESAZIDE (NOVARTIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084827 (pdf 84827.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-SERP "25" (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084876 (pdf 84876.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRAP-ES (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084878 (pdf 84878.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084880 (pdf 84880.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084897 (pdf 84897.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) CAM-AP-ES (CHARTWELL RX) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 084899 (pdf 84899.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084912 (pdf 84912.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085004 (pdf 85004.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085005 (pdf 85005.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085022 (pdf 85022.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085054 (pdf 85054.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085067 (pdf 85067.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085098 (pdf 85098.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085099 (pdf 85099.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085112 (pdf 85112.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085152 (pdf 85152.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085182 (pdf 85182.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 1978 , NDA 085208 (pdf 85208.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085213 (pdf 85213.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDRO-SERP "50" (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085219 (pdf 85219.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085232 (pdf 85232.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085233 (pdf 85233.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085317 (pdf 85317.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085323 (pdf 85323.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085338 (pdf 85338.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) H.R.-50 (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085347 (pdf 85347.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085373 (pdf 85373.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE W/ HYDRALAZINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085420 (pdf 85420.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (PHARMERAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085421 (pdf 85421.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (PHARMERAL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085440 (pdf 85440.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085446 (pdf 85446.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085457 (pdf 85457.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085549 (pdf 85549.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085672 (pdf 85672.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085683 (pdf 85683.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085771 (pdf 85771.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE , HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085827 (pdf 85827.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085893 (pdf 85893.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085974 (pdf 85974.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086026 (pdf 86026.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086087 (label 86087.pdf) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086192 (pdf 86192.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086298 (pdf 86298.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) UNIPRES (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086330 (pdf 86330.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086331 (pdf 86331.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) HYDROCHLOROTHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086369 (pdf 86369.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ALRA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086504 (pdf 86504.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDRO-D (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086513 (pdf 86513.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1979 , NDA 086594 (pdf 86594.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086597 (pdf 86597.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086881 (pdf 86881.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087002 (pdf 87002.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087004 (pdf 87004.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087059 (pdf 87059.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 1980 , NDA 087060 (pdf 87060.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087068 (pdf 87068.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 1980 , NDA 087085 (pdf 87085.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087210 (pdf 87210.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) SER-A-GEN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087213 (pdf 87213.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087267 (pdf 87267.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087398 (pdf 87398.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087511 (pdf 87511.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (LEDERLE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087539 (pdf 87539.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087540 (pdf 87540.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087553 (pdf 87553.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087556 (pdf 87556.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087565 (pdf 87565.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087586 (pdf 87586.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087587 (pdf 87587.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087608 (pdf 87608.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087609 (pdf 87609.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087610 (pdf 87610.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087638 (pdf 87638.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (VANGARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087651 (pdf 87651.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087655 (pdf 87655.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087709 (pdf 87709.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDROCHLOROTHIAZIDE , AND HYDRALAZINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087752 (pdf 87752.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087827 (pdf 87827.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087948 (pdf 87948.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087999 (pdf 87999.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088025 (pdf 88025.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088054 (pdf 88054.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088189 (pdf 88189.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE-50 (WEST WARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088200 (pdf 88200.pdf not found) INN (HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088356 (pdf 88356.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088357 (pdf 88357.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088358 (pdf 88358.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088376 (pdf 88376.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088570 (pdf 88570.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE RESERPINE) RESERPINE , HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088587 (pdf 88587.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ROXANE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088588 (pdf 88588.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088827 (pdf 88827.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088828 (pdf 88828.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088829 (pdf 88829.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088923 (pdf 88923.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088924 (pdf 88924.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088946 (pdf 88946.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 088957 (pdf 88957.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 088961 (pdf 88961.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRA-ZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089137 (pdf 89137.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089200 (pdf 89200.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089201 (pdf 89201.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089534 (pdf 89534.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 , NDA 089661 (pdf 89661.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 022314 (label 22314.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) EXFORGE HCT (NOVARTIS) APPROVAL= AP YEAR= 2009 , NDA 078211 (pdf 78211.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078827 (pdf 78827.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 079237 (pdf 79237.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 079245 (pdf 79245.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090096 (pdf 90096.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090150 (pdf 90150.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090228 (pdf 90228.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090510 (pdf 90510.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2010 , NDA 090528 (pdf 90528.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090718 (pdf 90718.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091652 (pdf 91652.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078245 (pdf 78245.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 079025 (pdf 79025.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079106 (pdf 79106.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2010 , NDA 085181 (pdf 85181.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 1978 DISCONTINUED OBSOLETE , NDA 091629 (pdf 91629.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 200175 (label 200175.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) TRIBENZOR (COSETTE) APPROVAL= AP YEAR= 2010 , NDA 200645 (pdf 200645.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200045 (label 200045.pdf) INN (ALISKIREN HEMIFUMARATE AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE) AMTURNIDE (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090351 (pdf 90351.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HIKMA) APPROVAL= AP YEAR= 2012 , NDA 090815 (pdf 90815.pdf not found) INN (IRBESARTAN HYDROCHLOROTHIAZIDE) IRBESARTAN HYDROCHLOROTHIAZIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2011 , NDA 200180 (label 200180.pdf) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201356 (pdf 201356.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090704 (pdf 90704.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2012 , NDA 091084 (pdf 91084.pdf not found) INN (TELMISARTAN HYDROCHLOROTHIAZIDE) TELMISARTAN HYDROCHLOROTHIAZIDE (WATSON LABS FLORIDA) APPROVAL= TA YEAR= 2011 , NDA 201407 (pdf 201407.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 202414 (pdf 202414.pdf not found) INN (IRBESARTAN HYDROCHLOROTHIAZIDE) IRBESARTAN HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 090654 (pdf 90654.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091370 (pdf 91370.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2012 , NDA 091662 (pdf 91662.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091351 (pdf 91351.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 091519 (pdf 91519.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091539 (pdf 91539.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091617 (pdf 91617.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091654 (pdf 91654.pdf not found) INN (VALSARTAN HYDROCHLOROTHIAZIDE) VALSARTAN HYDROCHLOROTHIAZIDE (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 200435 (pdf 200435.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200887 (pdf 200887.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2012 , NDA 201505 (pdf 201505.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201616 (pdf 201616.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) HYDROCHLOROTHIAZIDE IRBESARTAN (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 201845 (pdf 201845.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2012 , NDA 202289 (pdf 202289.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202556 (pdf 202556.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2012 , NDA 202884 (pdf 202884.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203500 (pdf 203500.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 078946 (pdf 78946.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 091524 (pdf 91524.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 200797 (pdf 200797.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201087 (pdf 201087.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 201524 (pdf 201524.pdf not found) INN (IRBESARTAN HYDROCHLOROTHIAZIDE) IRBESARTAN HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 201662 (pdf 201662.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 201682 (pdf 201682.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202519 (pdf 202519.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 202870 (pdf 202870.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 202965 (pdf 202965.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 203026 (pdf 203026.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203145 (pdf 203145.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 203630 (pdf 203630.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 078794 (pdf 78794.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 090651 (pdf 90651.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 091648 (pdf 91648.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 200532 (pdf 200532.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 201192 (pdf 201192.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201593 (pdf 201593.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202150 (pdf 202150.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203010 (pdf 203010.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2014 , NDA 203018 (pdf 203018.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 203072 (pdf 203072.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2014 , NDA 204100 (pdf 204100.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 204169 (pdf 204169.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204801 (pdf 204801.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 202491 (pdf 202491.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 203036 (pdf 203036.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ATLAS PHARMS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205391 (pdf 205391.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206083 (pdf 206083.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2016 , NDA 207804 (pdf 207804.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 203580 (pdf 203580.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 206137 (label 206137.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 207896 (pdf 207896.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2016 , NDA 208727 (pdf 208727.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204058 (pdf 204058.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204233 (pdf 204233.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 204832 (pdf 204832.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2017 , NDA 206515 (pdf 206515.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203466 (pdf 203466.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 204221 (pdf 204221.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204901 (pdf 204901.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 205439 (pdf 205439.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) HYDROCHLOROTHIAZIDE VALSARTAN (HUAREN PHARMACEUTICAL CO LTD) APPROVAL= TA YEAR= 2017 , NDA 206180 (pdf 206180.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207018 (pdf 207018.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209028 (pdf 209028.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 207455 (pdf 207455.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 208360 (pdf 208360.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 202544 (pdf 202544.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 203000 (pdf 203000.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 203561 (pdf 203561.pdf not found) INN (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 208358 (pdf 208358.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 209281 (pdf 209281.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 208847 (pdf 208847.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (UMEDICA) APPROVAL= AP YEAR= 2019 , NDA 212678 (pdf 212678.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 215562 (pdf 215562.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215995 (pdf 215995.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 216211 (pdf 216211.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 215666 (pdf 215666.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2022 , NDA 206377 (pdf 206377.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204382 (pdf 204382.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2023 , NDA 218015 (pdf 218015.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (GRANULES) APPROVAL= AP YEAR= 2023 DISCONTINUED , 257 ; THIORIDAZINE ; 50-52-2 ; 1962 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- MANAGEMENT OF SCHIZOPHRENIC PATIENTS -- ANXIOLYTIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 011808 (pdf 11808.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) MELLARIL (NOVARTIS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 017923 (pdf 17923.pdf not found) INN (THIORIDAZINE) MELLARIL-S (NOVARTIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 040125 (pdf 40125.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040126 (pdf 40126.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040187 (pdf 40187.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040213 (pdf 40213.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 087264 (pdf 87264.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087766 (pdf 87766.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088004 (pdf 88004.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1983 , NDA 088131 (pdf 88131.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088132 (pdf 88132.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088133 (pdf 88133.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088134 (pdf 88134.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088135 (pdf 88135.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088136 (pdf 88136.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088137 (pdf 88137.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088194 (pdf 88194.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088227 (pdf 88227.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088229 (pdf 88229.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088258 (pdf 88258.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088270 (pdf 88270.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088271 (pdf 88271.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088272 (pdf 88272.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088273 (pdf 88273.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088284 (pdf 88284.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088296 (pdf 88296.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088307 (pdf 88307.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088308 (pdf 88308.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088322 (pdf 88322.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088323 (pdf 88323.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088332 (pdf 88332.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088333 (pdf 88333.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088334 (pdf 88334.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088335 (pdf 88335.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088336 (pdf 88336.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088345 (pdf 88345.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088351 (pdf 88351.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088352 (pdf 88352.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088370 (pdf 88370.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088375 (pdf 88375.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088379 (pdf 88379.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088381 (pdf 88381.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088410 (pdf 88410.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088412 (pdf 88412.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088456 (pdf 88456.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088461 (pdf 88461.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088476 (pdf 88476.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088477 (pdf 88477.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088478 (pdf 88478.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088479 (pdf 88479.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088480 (pdf 88480.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088493 (pdf 88493.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088561 (pdf 88561.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088562 (pdf 88562.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088563 (pdf 88563.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088564 (pdf 88564.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088567 (pdf 88567.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088658 (pdf 88658.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088659 (pdf 88659.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088660 (pdf 88660.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088661 (pdf 88661.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088663 (pdf 88663.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088664 (pdf 88664.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088665 (pdf 88665.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088736 (pdf 88736.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088737 (pdf 88737.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088738 (pdf 88738.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088755 (pdf 88755.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088869 (pdf 88869.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088872 (pdf 88872.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088941 (pdf 88941.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088942 (pdf 88942.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089048 (pdf 89048.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089103 (pdf 89103.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089104 (pdf 89104.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089105 (pdf 89105.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089431 (pdf 89431.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089432 (pdf 89432.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089433 (pdf 89433.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089602 (pdf 89602.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089603 (pdf 89603.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089764 (pdf 89764.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089765 (pdf 89765.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089953 (pdf 89953.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , 258 ; IMIPRAMINE ; 50-49-7 ; 1959 ; ; ; CLASS NERVOUS SYSTEM -- TRICYCLIC ANTIDEPRESSANT -- NOREPINEPHRINE REUPTAKE INHIBITOR , ; NDA 011836 (pdf 11836.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) PRESAMINE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 011838 (pdf 11838.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) TOFRANIL (NOVARTIS) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 017090 (label 17090.pdf) INN (IMIPRAMINE PAMOATE) TOFRANIL-PM (SPECGX LLC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017895 (pdf 17895.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) JANIMINE (ABBOTT) APPROVAL= AP YEAR= 1974 NEWAPPLICATION DISCONTINUED , NDA 040751 (pdf 40751.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2008 , NDA 040752 (pdf 40752.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (PROSAM LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 040753 (pdf 40753.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (PROSAM LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 081048 (pdf 81048.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081049 (pdf 81049.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 , NDA 081050 (pdf 81050.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 , NDA 083729 (pdf 83729.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083745 (pdf 83745.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1976 , NDA 083799 (pdf 83799.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083827 (pdf 83827.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) PRAMINE (ALRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084252 (pdf 84252.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084869 (pdf 84869.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 084936 (pdf 84936.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1976 , NDA 084937 (pdf 84937.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1976 , NDA 085133 (pdf 85133.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085200 (pdf 85200.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085220 (pdf 85220.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085221 (pdf 85221.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085875 (pdf 85875.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085877 (pdf 85877.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085878 (pdf 85878.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086267 (pdf 86267.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086268 (pdf 86268.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086269 (pdf 86269.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086765 (pdf 86765.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087619 (pdf 87619.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087631 (pdf 87631.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087776 (pdf 87776.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087844 (label 87844.pdf) INN (IMIPRAMINE HYDROCHLORIDE) TOFRANIL (MALLINCKRODT INC) APPROVAL= AP YEAR= 1984 OBSOLETE , NDA 087845 (label 87845.pdf) INN (IMIPRAMINE HYDROCHLORIDE) TOFRANIL (MALLINCKRODT INC) APPROVAL= AP YEAR= 1984 OBSOLETE , NDA 087846 (label 87846.pdf) INN (IMIPRAMINE HYDROCHLORIDE) TOFRANIL (SPECGX LLC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088036 (pdf 88036.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088222 (pdf 88222.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088223 (pdf 88223.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088262 (pdf 88262.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 , NDA 088276 (pdf 88276.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 , NDA 088292 (pdf 88292.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 , NDA 089422 (pdf 89422.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089497 (pdf 89497.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 090441 (pdf 90441.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090442 (pdf 90442.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2010 OBSOLETE , NDA 090443 (pdf 90443.pdf not found) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2010 OBSOLETE , NDA 090444 (pdf 90444.pdf not found) INN (IMIPRAMINE PAMOATE) IMIPRAMINE PAMOATE (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 091099 (pdf 91099.pdf not found) INN (IMIPRAMINE PAMOATE) IMIPRAMINE PAMOATE (HIKMA) APPROVAL= AP YEAR= 2010 , NDA 040903 (label 40903.pdf) INN (IMIPRAMINE HYDROCHLORIDE) IMIPRAMINE HYDROCHLORIDE (LEADING) APPROVAL= AP YEAR= 2012 , NDA 202338 (pdf 202338.pdf not found) INN (IMIPRAMINE PAMOATE) IMIPRAMINE PAMOATE (RISING) APPROVAL= AP YEAR= 2013 DISCONTINUED , 259 ; METHDILAZINE ; 1982-37-2 ; 1981 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINES -- ANTIPRURITIC -- PHENOTIAZINE , ; NDA 011950 (pdf 11950.pdf not found) INN (METHDILAZINE HYDROCHLORIDE) TACARYL (WESTWOOD SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087122 (pdf 87122.pdf not found) INN (METHDILAZINE HYDROCHLORIDE) METHDILAZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , 260 ; MEDROXYPROGESTERONE ACETATE ; 71-58-9 ; 1959 ; ; ; CLASS GENITO -- CONTRACEPTIVE -- PROGESTIN , ; NDA 011839 (label 11839.pdf) INN (MEDROXYPROGESTERONE ACETATE) PROVERA (PFIZER) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , NDA 012541 (label 12541.pdf) INN (MEDROXYPROGESTERONE ACETATE) DEPO-PROVERA (PFIZER) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 020246 (label 20246.pdf) INN (MEDROXYPROGESTERONE ACETATE) DEPO-PROVERA (PFIZER) APPROVAL= AP YEAR= 1992 , NDA 020303 (pdf 20303.pdf not found) INN (ESTROGENS CONJUGATED MEDROXYPROGESTERONE ACETATE) PREMPRO PREMARINCYCRIN (WYETH PHARMS INC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020527 (label 20527.pdf) INN (ESTROGENS CONJUGATED MEDROXYPROGESTERONE ACETATE) PREMPRO (WYETH PHARMS) APPROVAL= AP YEAR= 1995 , NDA 020874 (label 20874.pdf) INN (ESTRADIOL CYPIONATE MEDROXYPROGESTERONE ACETATE) LUNELLE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021583 (label 21583.pdf) INN (MEDROXYPROGESTERONE ACETATE) DEPO-SUBQ PROVERA 104 (PFIZER) APPROVAL= AP YEAR= 2004 , NDA 021584 (label 21584.pdf) INN (MEDROXYPROGESTERONE ACETATE) DEPO-SUBQ PROVERA 104 (PFIZER) APPROVAL= AP YEAR= 2005 NEWAPPLICATION OBSOLETE , NDA 040159 (pdf 40159.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (BARR) APPROVAL= AP YEAR= 1996 , NDA 040311 (pdf 40311.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076552 (pdf 76552.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076553 (pdf 76553.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (HONG KONG) APPROVAL= AP YEAR= 2004 , NDA 081239 (pdf 81239.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) CYCRIN (ESI) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081240 (pdf 81240.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) CYCRIN (ESI) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 083242 (pdf 83242.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) AMEN (AMARIN PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 085686 (pdf 85686.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) CURRETAB (SOLVAY) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 088484 (pdf 88484.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089386 (pdf 89386.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) CYCRIN (ESI) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 021396 (label 21396.pdf) INN (CONJUGATED ESTROGENS MEDROXYPROGESTERONE ACETATE) PREMPRO/PREMPHASE (WYETH AYERST) APPROVAL= AP YEAR= 2003 NEWAPPLICATION , NDA 078711 (pdf 78711.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077235 (pdf 77235.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 077334 (pdf 77334.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 210227 (pdf 210227.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 210335 (pdf 210335.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210760 (pdf 210760.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210761 (pdf 210761.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212824 (pdf 212824.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 212844 (pdf 212844.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214309 (pdf 214309.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (HIKMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215397 (pdf 215397.pdf not found) INN (MEDROXYPROGESTERONE ACETATE) MEDROXYPROGESTERONE ACETATE (AMNEAL) APPROVAL= AP YEAR= 2023 , 261 ; DEMECARIUM ; 16505-84-3 ; 1959 ; DISCONTINUED ; ; CLASS SENSORY -- CHOLINERGIC -- MIOTICS -- TREATMENT OF OPEN-ANGLE GLAUCOMA -- VASODILATATION -- ERYTHROCYTE CHOLINESTERASE INHIBITOR , ; NDA 011860 (pdf 11860.pdf not found) INN (DEMECARIUM BROMIDE) HUMORSOL (MERCK) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , 262 ; NANDROLONE ; 434-22-0 ; 0 ; ; ; CLASS METABOLISM -- ANABOLIC -- ANDROGENS , ; 263 ; PHENELZINE ; 51-71-8 ; 1961 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- MONOAMINE OXIDASE INHIBITORS , ; NDA 011909 (label 11909.pdf) INN (PHENELZINE SULFATE) NARDIL (PARKE DAVIS) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY , NDA 200181 (pdf 200181.pdf not found) INN (PHENELZINE SULFATE) PHENELZINE SULFATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2010 , 264 ; DIPHENYLPYRALINE ; 147-20-6 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC , ; NDA 011945 (pdf 11945.pdf not found) INN (DIPHENYLPYRALINE HYDROCHLORIDE) HISPRIL (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , 265 ; HYDROFLUMETHIAZIDE ; 135-09-1 ; 1959 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- CARBONIC ANHYDRASE INHIBITORS (PMID23488823)-- ADJUNCTIVE THERAPY IN EDEMA , ; NDA 011949 (pdf 11949.pdf not found) INN (HYDROFLUMETHIAZIDE) SALURON (SHIRE LLC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012359 (pdf 12359.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) SALUTENSIN (SHIRE) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 083383 (pdf 83383.pdf not found) INN (HYDROFLUMETHIAZIDE) DIUCARDIN (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 088031 (pdf 88031.pdf not found) INN (HYDROFLUMETHIAZIDE) HYDROFLUMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088110 (pdf 88110.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088127 (pdf 88127.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088195 (pdf 88195.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) HYDROFLUMETHIAZIDE AND RESERPINE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088528 (pdf 88528.pdf not found) INN (HYDROFLUMETHIAZIDE) HYDROFLUMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088850 (pdf 88850.pdf not found) INN (HYDROFLUMETHIAZIDE) HYDROFLUMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088907 (pdf 88907.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) RESERPINE AND HYDROFLUMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088932 (pdf 88932.pdf not found) INN (HYDROFLUMETHIAZIDE RESERPINE) RESERPINE AND HYDROFLUMETHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , 266 ; METHDILAZINE ; 1982-37-2 ; 1981 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINES -- ANTIPRURITIC -- PHENOTIAZINE , ; NDA 011950 (pdf 11950.pdf not found) INN (METHDILAZINE HYDROCHLORIDE) TACARYL (WESTWOOD SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087122 (pdf 87122.pdf not found) INN (METHDILAZINE HYDROCHLORIDE) METHDILAZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , 267 ; ISOCARBOXAZID ; 59-63-2 ; 1959 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- MONOAMINE OXIDASE INHIBITORS , ; NDA 011961 (label 11961.pdf) INN (ISOCARBOXAZID) MARPLAN (VALIDUS PHARMS INC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , 268 ; ECHOTHIOPHATE ; 6736-03-4 ; 1960 ; ; ; CLASS CHOLINESTERASE INHIBITORS -- MIOTICS -- PARASYMPATHOMIMETICS -- TREATMENT OF CHRONIC OPEN-ANGLE GLAUCOMA , ; NDA 011963 (label 11963.pdf) INN (ECHOTHIOPHATE IODIDE) PHOSPHOLINE IODIDE (FERA PHARMS LLC) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , 269 ; PYRVINIUM ; 7187-62-4 ; 0 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF PINWORM -- NONCOMPETITIVE INHIBITOR OF THE ANDROGEN RECEPTOR (AR) DNA BINDING DOMAIN (DBD) (PMID24354286) , ; NDA 011964 (pdf 11964.pdf not found) INN (PYRVINIUM PAMOATE) POVAN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012485 (pdf 12485.pdf not found) INN (PYRVINIUM PAMOATE) POVAN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 270 ; BIPERIDEN ; 514-65-8 ; 1959 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- PERIPHERAL ANTICHOLINERGIC -- ANTISPASMODIC -- ANTIDYSKINETICS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 012003 (pdf 12003.pdf not found) INN (BIPERIDEN HYDROCHLORIDE) AKINETON (ABBVIE) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012418 (pdf 12418.pdf not found) INN (BIPERIDEN LACTATE) AKINETON (ABBVIE) APPROVAL= AP YEAR= 1961 DISCONTINUED , 271 ; ISOSORBIDE DINITRATE ; 87-33-2 ; 1959 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR FROM THE RELEASE OF NITRIC OXIDE AND THE SUBSEQUENT ACTIVATION OF GUANYLYL CYCLASE AND ULTIMATE RELAXATION OF VASCULAR SMOOTH MUSCLE -- ANTIANGINAL , ; NDA 012093 (label 12093.pdf) INN (ISOSORBIDE DINITRATE) ISORDIL (BAUSCH) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , NDA 012882 (pdf 12882.pdf not found) INN (ISOSORBIDE DINITRATE) ISORDIL (WYETH AYERST) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 012940 (pdf 12940.pdf not found) INN (ISOSORBIDE DINITRATE) ISORDIL (BIOVAIL) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 016191 (pdf 16191.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016192 (pdf 16192.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016776 (pdf 16776.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 019790 (label 19790.pdf) INN (ISOSORBIDE DINITRATE) DILATRATE-SR (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 020727 (label 20727.pdf) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) BIDIL (AZURITY) APPROVAL= AP YEAR= 2005 , NDA 040009 (pdf 40009.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040591 (pdf 40591.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040723 (pdf 40723.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 084204 (pdf 84204.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086031 (pdf 86031.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086032 (pdf 86032.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ANI PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086033 (pdf 86033.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086034 (pdf 86034.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 086054 (pdf 86054.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086055 (pdf 86055.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086066 (pdf 86066.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 , NDA 086067 (pdf 86067.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1982 , NDA 086166 (pdf 86166.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086167 (pdf 86167.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086168 (pdf 86168.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 086169 (pdf 86169.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086221 (pdf 86221.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SANDOZ) APPROVAL= AP YEAR= 1982 , NDA 086222 (pdf 86222.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086223 (pdf 86223.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SANDOZ) APPROVAL= AP YEAR= 1982 , NDA 086225 (pdf 86225.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086405 (pdf 86405.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086923 (pdf 86923.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1983 , NDA 086925 (pdf 86925.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1982 , NDA 087537 (pdf 87537.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1982 , NDA 087545 (pdf 87545.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087564 (pdf 87564.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087946 (pdf 87946.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1984 , NDA 088088 (pdf 88088.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1984 , NDA 088124 (pdf 88124.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088125 (pdf 88125.pdf not found) INN (ISOSORBIDE DINITRATE) SORBITRATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089190 (pdf 89190.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089191 (pdf 89191.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089192 (pdf 89192.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089367 (pdf 89367.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 213057 (pdf 213057.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ZYDUS) APPROVAL= AP YEAR= 2019 , NDA 211290 (pdf 211290.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 215586 (pdf 215586.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 215723 (pdf 215723.pdf not found) INN (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 215988 (pdf 215988.pdf not found) INN (HYDRALAZINE HYDROCHLORIDE ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (I3 PHARMS) APPROVAL= AP YEAR= 2024 , 272 ; ISOSORBIDE MONONITRATE ; 16051-77-7 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR FROM THE RELEASE OF NITRIC OXIDE , ; NDA 019091 (pdf 19091.pdf not found) INN (ISOSORBIDE MONONITRATE) ISMO (PROMIUS PHARMA) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020215 (label 20215.pdf) INN (ISOSORBIDE MONONITRATE) MONOKET (OMNIVIUM PHARMS) APPROVAL= AP YEAR= 1993 , NDA 020225 (pdf 20225.pdf not found) INN (ISOSORBIDE MONONITRATE) IMDUR (SCHERING PLOUGH) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 075037 (pdf 75037.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 , NDA 075041 (label 75041.pdf) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ALKERMES GAINESVILLE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075147 (label 75147.pdf) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075155 (label 75155.pdf) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1998 , NDA 075166 (pdf 75166.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (SKYEPHARMA AG) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075306 (pdf 75306.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075361 (pdf 75361.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075395 (pdf 75395.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ZYDUS HLTHCARE) APPROVAL= AP YEAR= 2000 , NDA 075448 (pdf 75448.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075522 (pdf 75522.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (DEXCEL LTD) APPROVAL= AP YEAR= 2000 , NDA 076813 (pdf 76813.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 090598 (pdf 90598.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200270 (pdf 200270.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200495 (pdf 200495.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 209684 (pdf 209684.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210822 (pdf 210822.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (DEXCEL LTD) APPROVAL= AP YEAR= 2018 , NDA 210918 (pdf 210918.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 214115 (pdf 214115.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (SHANDONG) APPROVAL= AP YEAR= 2022 , NDA 216557 (pdf 216557.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 218255 (pdf 218255.pdf not found) INN (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2024 , 273 ; TROPICAMIDE ; 1508-75-4 ; 1960 ; ; ; CLASS SENSORY -- ANTISPASMODIC -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- MYDRIATICS , ; NDA 012111 (pdf 12111.pdf not found) INN (TROPICAMIDE) MYDRIACYL (ALCON) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 019261 (label 19261.pdf) INN (HYDROXYAMPHETAMINE HYDROBROMIDE TROPICAMIDE) PAREMYD (AKORN) APPROVAL= AP YEAR= 1992 , NDA 040064 (pdf 40064.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040067 (pdf 40067.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040314 (pdf 40314.pdf not found) INN (TROPICAMIDE) TROPICACYL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 040315 (pdf 40315.pdf not found) INN (TROPICAMIDE) TROPICACYL (RISING) APPROVAL= AP YEAR= 2000 , NDA 084305 (pdf 84305.pdf not found) INN (TROPICAMIDE) MYDRIACYL (SANDOZ) APPROVAL= AP YEAR= 1974 , NDA 084306 (pdf 84306.pdf not found) INN (TROPICAMIDE) MYDRIACYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 087636 (pdf 87636.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (MIZA PHARMS USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087637 (pdf 87637.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (MIZA PHARMS USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088230 (pdf 88230.pdf not found) INN (TROPICAMIDE) MYDRIAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088274 (pdf 88274.pdf not found) INN (TROPICAMIDE) MYDRIAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088447 (pdf 88447.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089171 (pdf 89171.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089172 (pdf 89172.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 207524 (pdf 207524.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 215352 (label 215352.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE TROPICAMIDE) MYDCOMBI (EYENOVIA) APPROVAL= AP YEAR= 2023 , 274 ; MEPIVACAINE ; 96-88-8 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC LOCAL -- BLOCKER , ; NDA 012125 (pdf 12125.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) CARBOCAINE W/ NEO-COBEFRIN (EASTMAN KODAK) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012250 (label 12250.pdf) INN (MEPIVACAINE HYDROCHLORIDE) CARBOCAINE (HOSPIRA) APPROVAL= AP YEAR= 1960 , NDA 040806 (pdf 40806.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080925 (pdf 80925.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) ISOCAINE HYDROCHLORIDE (SEPTODONT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083559 (pdf 83559.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (BELMORA LLC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084697 (pdf 84697.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SEPTODONT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084777 (pdf 84777.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) ARESTOCAINE HYDROCHLORIDE (SOLVAY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084850 (pdf 84850.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN (BELMORA LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085010 (pdf 85010.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 087509 (pdf 87509.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088387 (pdf 88387.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) SCANDONEST PLAIN (DEPROCO) APPROVAL= AP YEAR= 1984 , NDA 088388 (pdf 88388.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) SCANDONEST L (DEPROCO) APPROVAL= AP YEAR= 1984 , NDA 088653 (pdf 88653.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (DENTSPLY PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088769 (pdf 88769.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088770 (pdf 88770.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089406 (pdf 89406.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089407 (pdf 89407.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089408 (pdf 89408.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089409 (pdf 89409.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089410 (pdf 89410.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089517 (pdf 89517.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) POLOCAINE W/ LEVONORDEFRIN (DENTSPLY PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , 275 ; CHLOPHEDIANOL ; 791-35-5 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTITUSSIVE , ; NDA 012126 (pdf 12126.pdf not found) INN (CHLOPHEDIANOL HYDROCHLORIDE) ULO (3M) APPROVAL= - YEAR= 0 DISCONTINUED , 276 ; BENZTHIAZIDE ; 91-33-8 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE , ; NDA 012128 (pdf 12128.pdf not found) INN (BENZTHIAZIDE) FOVANE (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012489 (pdf 12489.pdf not found) INN (BENZTHIAZIDE) EXNA (AH ROBINS INC) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 016001 (pdf 16001.pdf not found) INN (BENZTHIAZIDE) AQUATAG (SOLVAY) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 083206 (pdf 83206.pdf not found) INN (BENZTHIAZIDE) BENZTHIAZIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , 277 ; CYCLOPHOSPHAMIDE ; 50-18-0 ; 1959 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING , ; NDA 012141 (label 12141.pdf) INN (CYCLOPHOSPHAMIDE) CYTOXAN (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY , NDA 012142 (label 12142.pdf) INN (CYCLOPHOSPHAMIDE) CYTOXAN (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 040015 (pdf 40015.pdf not found) INN (CYCLOPHOSPHAMIDE) NEOSAR (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 040032 (pdf 40032.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (ROXANE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040745 (label 40745.pdf) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 087442 (pdf 87442.pdf not found) INN (CYCLOPHOSPHAMIDE) NEOSAR (BEDFORD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088371 (pdf 88371.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088372 (pdf 88372.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088373 (pdf 88373.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088374 (pdf 88374.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 203856 (label 203856.pdf) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 204555 (pdf 204555.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2014 , NDA 207014 (pdf 207014.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209872 (pdf 209872.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (ANIMA) APPROVAL= AP YEAR= 2018 , NDA 210046 (pdf 210046.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211608 (pdf 211608.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 212501 (label 212501.pdf) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 210735 (label 210735.pdf) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2021 , NDA 211757 (pdf 211757.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215892 (pdf 215892.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 210852 (label 210852.pdf) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 211552 (pdf 211552.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 214529 (pdf 214529.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 215089 (pdf 215089.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (SUNNY) APPROVAL= AP YEAR= 2023 , NDA 216958 (pdf 216958.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 217150 (pdf 217150.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (SANDOZ) APPROVAL= AP YEAR= 2023 , NDA 217651 (pdf 217651.pdf not found) INN (CYCLOPHOSPHAMIDE) CYCLOPHOSPHAMIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 DISCONTINUED , 278 ; SPIRONOLACTONE ; 52-01-7 ; 1960 ; ; ; CLASS CARDIOVASCULAR -- ALDOSTERONE ANTAGONISTS -- DIURETICS , ; NDA 012151 (label 12151.pdf) INN (SPIRONOLACTONE) ALDACTONE (PFIZER) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , NDA 012616 (label 12616.pdf) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) ALDACTAZIDE (PFIZER) APPROVAL= AP YEAR= 1961 , NDA 040353 (pdf 40353.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040424 (label 40424.pdf) INN (SPIRONOLACTONE) SPIRONOLACTONE (MYLAN) APPROVAL= AP YEAR= 2001 , NDA 040750 (pdf 40750.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (OXFORD PHARMS) APPROVAL= AP YEAR= 2006 , NDA 085974 (pdf 85974.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086026 (pdf 86026.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086513 (pdf 86513.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1979 , NDA 086809 (pdf 86809.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086881 (pdf 86881.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086898 (pdf 86898.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087004 (pdf 87004.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087078 (pdf 87078.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087086 (pdf 87086.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (MYLAN) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087108 (pdf 87108.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (IVAX PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087265 (pdf 87265.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087267 (pdf 87267.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087398 (pdf 87398.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087511 (pdf 87511.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (LEDERLE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087553 (pdf 87553.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087554 (pdf 87554.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087634 (pdf 87634.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087648 (pdf 87648.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087651 (pdf 87651.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087655 (pdf 87655.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (VANGARD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087687 (pdf 87687.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087948 (pdf 87948.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087952 (pdf 87952.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087998 (pdf 87998.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087999 (pdf 87999.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088025 (pdf 88025.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088053 (pdf 88053.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088054 (pdf 88054.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089137 (pdf 89137.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089364 (pdf 89364.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089424 (pdf 89424.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 089534 (pdf 89534.pdf not found) INN (HYDROCHLOROTHIAZIDE SPIRONOLACTONE) SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 , NDA 091426 (pdf 91426.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 , NDA 202187 (pdf 202187.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2014 , NDA 203253 (pdf 203253.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2014 , NDA 203512 (pdf 203512.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 209478 (label 209478.pdf) INN (SPIRONOLACTONE) CAROSPIR (CMP DEV LLC) APPROVAL= AP YEAR= 2017 , NDA 205936 (pdf 205936.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 215572 (pdf 215572.pdf not found) INN (SPIRONOLACTONE) SPIRONOLACTONE (AMNEAL) APPROVAL= AP YEAR= 2023 , 279 ; BENDROFLUMETHIAZIDE ; 73-48-3 ; 1959 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012164 (pdf 12164.pdf not found) INN (BENDROFLUMETHIAZIDE) NATURETIN-2.5 (APOTHECON) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 018647 (label 18647.pdf) INN (BENDROFLUMETHIAZIDE NADOLOL) CORZIDE (KING PHARMS LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 077833 (pdf 77833.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078688 (pdf 78688.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , 280 ; FLUOROURACIL ; 51-21-8 ; 1962 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- IMMUNOSUPPRESSIVE AGENTS , ; NDA 012209 (label 12209.pdf) INN (FLUOROURACIL) FLUOROURACIL (SPECTRUM PHARMS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 016765 (pdf 16765.pdf not found) INN (FLUOROURACIL) FLUOROPLEX (ELORAC) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016831 (label 16831.pdf) INN (FLUOROURACIL) EFUDEX (BAUSCH) APPROVAL= AP YEAR= 1970 , NDA 016988 (label 16988.pdf) INN (FLUOROURACIL) FLUOROPLEX (CHARTWELL RX) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 017959 (pdf 17959.pdf not found) INN (FLUOROURACIL) ADRUCIL (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020985 (label 20985.pdf) INN (FLUOROURACIL) CARAC (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2000 , NDA 040023 (pdf 40023.pdf not found) INN (FLUOROURACIL) ADRUCIL (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 040278 (label 40278.pdf) INN (FLUOROURACIL) FLUOROURACIL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 , NDA 040279 (label 40279.pdf) INN (FLUOROURACIL) FLUOROURACIL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 , NDA 040291 (pdf 40291.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040333 (label 40333.pdf) INN (FLUOROURACIL) FLUOROURACIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040334 (label 40334.pdf) INN (FLUOROURACIL) FLUOROURACIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040379 (pdf 40379.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040743 (label 40743.pdf) INN (FLUOROURACIL) FLUOROURACIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 040772 (pdf 40772.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (EBEWE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040798 (label 40798.pdf) INN (FLUOROURACIL) FLUOROURACIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 076526 (pdf 76526.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (TARO) APPROVAL= AP YEAR= 2003 , NDA 077524 (pdf 77524.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2008 , NDA 081222 (pdf 81222.pdf not found) INN (FLUOROURACIL) ADRUCIL (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 081225 (pdf 81225.pdf not found) INN (FLUOROURACIL) ADRUCIL (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 087791 (pdf 87791.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (MARCHAR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087792 (pdf 87792.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (SPECTRUM PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088766 (pdf 88766.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088767 (pdf 88767.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088929 (pdf 88929.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089152 (pdf 89152.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089368 (pdf 89368.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089428 (pdf 89428.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089434 (pdf 89434.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089455 (pdf 89455.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089508 (pdf 89508.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (BEDFORD) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089519 (pdf 89519.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090368 (pdf 90368.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (TARO) APPROVAL= AP YEAR= 2010 , NDA 091299 (pdf 91299.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202668 (label 202668.pdf) INN (FLUOROURACIL) FLUOROURACIL (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2012 , NDA 202669 (label 202669.pdf) INN (FLUOROURACIL) FLUOROURACIL (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2012 , NDA 203122 (pdf 203122.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 022259 (label 22259.pdf) INN (FLUOROURACIL) TOLAK (HILL DERMACEUTICALS) APPROVAL= AP YEAR= 2015 , NDA 203609 (label 203609.pdf) INN (FLUOROURACIL) FLUOROURACIL (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 203608 (label 203608.pdf) INN (FLUOROURACIL) FLUOROURACIL (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 210123 (label 210123.pdf) INN (FLUOROURACIL) FLUOROURACIL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 210124 (label 210124.pdf) INN (FLUOROURACIL) FLUOROURACIL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 209219 (label 209219.pdf) INN (FLUOROURACIL) FLUOROURACIL (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209271 (label 209271.pdf) INN (FLUOROURACIL) FLUOROURACIL (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 214845 (pdf 214845.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 217295 (label 217295.pdf) INN (FLUOROURACIL) FLUOROURACIL (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 215612 (pdf 215612.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 217676 (pdf 217676.pdf not found) INN (FLUOROURACIL) FLUOROURACIL (ALEMBIC) APPROVAL= AP YEAR= 2023 , 281 ; PHENDIMETRAZINE ; 634-03-7 ; 1975 ; ; ; CLASS METABOLISM -- ANOREXIGENIC -- ANTIOBESITY -- LOW-POTENCY MONOAMINE-UPTAKE INHIBITOR -- PRODRUG FOR THE MONOAMINE-RELEASER PHENMETRAZINE (PM) , ; NDA 012248 (pdf 12248.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PLEGINE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018074 (label 18074.pdf) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1979 , NDA 040762 (pdf 40762.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (ELITE LABS INC) APPROVAL= AP YEAR= 2008 , NDA 083644 (pdf 83644.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083655 (pdf 83655.pdf not found) INN (PHENDIMETRAZINE TARTRATE) ADPHEN (FERNDALE LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083682 (pdf 83682.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083684 (pdf 83684.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083686 (pdf 83686.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083687 (pdf 83687.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083754 (pdf 83754.pdf not found) INN (PHENDIMETRAZINE TARTRATE) METRA (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083790 (pdf 83790.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (NUMARK) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083805 (pdf 83805.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083922 (pdf 83922.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083993 (pdf 83993.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084138 (pdf 84138.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084141 (pdf 84141.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084398 (pdf 84398.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084399 (pdf 84399.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084740 (pdf 84740.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084741 (pdf 84741.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084742 (pdf 84742.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084743 (pdf 84743.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084831 (pdf 84831.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084834 (pdf 84834.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084835 (pdf 84835.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (BARR) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085034 (pdf 85034.pdf not found) INN (PHENDIMETRAZINE TARTRATE) ALPHAZINE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085095 (pdf 85095.pdf not found) INN (PHENDIMETRAZINE TARTRATE) STATOBEX-G (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085199 (pdf 85199.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085272 (pdf 85272.pdf not found) INN (PHENDIMETRAZINE TARTRATE) BONTRIL PDM (VALEANT) APPROVAL= AP YEAR= 1976 , NDA 085318 (pdf 85318.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085320 (pdf 85320.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085321 (pdf 85321.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085402 (pdf 85402.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085497 (pdf 85497.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085507 (pdf 85507.pdf not found) INN (PHENDIMETRAZINE TARTRATE) STATOBEX (TEVA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085511 (pdf 85511.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085512 (pdf 85512.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENAZINE-35 (ABC HOLDING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085519 (pdf 85519.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085525 (pdf 85525.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085588 (pdf 85588.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1977 , NDA 085611 (pdf 85611.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (IVAX PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085612 (pdf 85612.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (IVAX PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085633 (pdf 85633.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085634 (pdf 85634.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085645 (pdf 85645.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085670 (pdf 85670.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085694 (pdf 85694.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085695 (pdf 85695.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085697 (pdf 85697.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085698 (pdf 85698.pdf not found) INN (PHENDIMETRAZINE TARTRATE) DI-METREX (PVT FORM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085702 (pdf 85702.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085756 (pdf 85756.pdf not found) INN (PHENDIMETRAZINE TARTRATE) CAM-METRAZINE (CAMALL) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085761 (pdf 85761.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085767 (pdf 85767.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085768 (pdf 85768.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085770 (pdf 85770.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085773 (pdf 85773.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085830 (pdf 85830.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085897 (pdf 85897.pdf not found) INN (PHENDIMETRAZINE TARTRATE) SPRX-3 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085914 (pdf 85914.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (MFG CHEMISTS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085941 (pdf 85941.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086005 (pdf 86005.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086013 (pdf 86013.pdf not found) INN (PHENDIMETRAZINE TARTRATE) STATOBEX (TEVA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086020 (pdf 86020.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086106 (pdf 86106.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086365 (pdf 86365.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086370 (pdf 86370.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086403 (pdf 86403.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086408 (pdf 86408.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086410 (pdf 86410.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086523 (pdf 86523.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENAZINE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086524 (pdf 86524.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENAZINE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086525 (pdf 86525.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENAZINE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086550 (pdf 86550.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086551 (pdf 86551.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086552 (pdf 86552.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086553 (pdf 86553.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086554 (pdf 86554.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086834 (pdf 86834.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (FERNDALE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087214 (pdf 87214.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087305 (pdf 87305.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENAZINE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087371 (pdf 87371.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE L.A. (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087378 (pdf 87378.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VIRTUS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087394 (pdf 87394.pdf not found) INN (PHENDIMETRAZINE TARTRATE) X-TROZINE (SHIRE RICHWOOD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087424 (pdf 87424.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087487 (pdf 87487.pdf not found) INN (PHENDIMETRAZINE TARTRATE) MELFIAT-105 (NUMARK) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088020 (pdf 88020.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088021 (pdf 88021.pdf not found) INN (PHENDIMETRAZINE TARTRATE) BONTRIL (VALEANT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088024 (pdf 88024.pdf not found) INN (PHENDIMETRAZINE TARTRATE) SPRX-105 (NUMARK) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088028 (pdf 88028.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088062 (pdf 88062.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088063 (pdf 88063.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088111 (pdf 88111.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (GRAHAM DM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 089452 (pdf 89452.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (CHARTWELL) APPROVAL= AP YEAR= 1991 , NDA 091042 (pdf 91042.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (KVK TECH) APPROVAL= AP YEAR= 2010 , NDA 203600 (pdf 203600.pdf not found) INN (PHENDIMETRAZINE TARTRATE) PHENDIMETRAZINE TARTRATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 282 ; CHLORDIAZEPOXIDE ; 58-25-3 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- BENZODIAZEPINES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 012249 (label 12249.pdf) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LIBRIUM (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012301 (pdf 12301.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LIBRIUM (BAUSCH) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 014740 (pdf 14740.pdf not found) INN (CHLORDIAZEPOXIDE ESTROGENS ESTERIFIED) MENRIUM 5-2 (ROCHE) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 016949 (label 16949.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) LIMBITROL (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017813 (pdf 17813.pdf not found) INN (CHLORDIAZEPOXIDE) LIBRELEASE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 070477 (pdf 70477.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070478 (pdf 70478.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070765 (pdf 70765.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070766 (pdf 70766.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071296 (pdf 71296.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 071297 (label 71297.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1986 , NDA 072052 (pdf 72052.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072053 (pdf 72053.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072277 (pdf 72277.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072278 (pdf 72278.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 083116 (pdf 83116.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1976 , NDA 083570 (pdf 83570.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083741 (pdf 83741.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083742 (pdf 83742.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084041 (pdf 84041.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 , NDA 084598 (pdf 84598.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084601 (pdf 84601.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084623 (pdf 84623.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084639 (pdf 84639.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZACHEL (RACHELLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084644 (pdf 84644.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084645 (pdf 84645.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084678 (pdf 84678.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 , NDA 084679 (pdf 84679.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1976 , NDA 084685 (pdf 84685.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084700 (pdf 84700.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084705 (pdf 84705.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084706 (pdf 84706.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084768 (pdf 84768.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1976 , NDA 084769 (pdf 84769.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1976 , NDA 084823 (pdf 84823.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084886 (pdf 84886.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084887 (pdf 84887.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084919 (pdf 84919.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084920 (pdf 84920.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084939 (pdf 84939.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085000 (pdf 85000.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085009 (pdf 85009.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LYGEN (ALRA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085014 (pdf 85014.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085086 (pdf 85086.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZACHEL (RACHELLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085087 (pdf 85087.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZACHEL (RACHELLE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085107 (pdf 85107.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LYGEN (ALRA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085108 (pdf 85108.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LYGEN (ALRA) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085113 (pdf 85113.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085118 (pdf 85118.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (FERRANTE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085119 (pdf 85119.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (FERRANTE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085120 (pdf 85120.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (FERRANTE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085144 (pdf 85144.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085155 (pdf 85155.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085163 (pdf 85163.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085164 (pdf 85164.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085294 (pdf 85294.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085339 (pdf 85339.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085340 (pdf 85340.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085447 (pdf 85447.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) A-POXIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085461 (pdf 85461.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LIBRIUM (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1977 , NDA 085472 (pdf 85472.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LIBRIUM (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1977 , NDA 085475 (pdf 85475.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) LIBRIUM (BAUSCH) APPROVAL= AP YEAR= 1977 , NDA 085481 (pdf 85481.pdf not found) INN (CHLORDIAZEPOXIDE) LIBRITABS (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085482 (pdf 85482.pdf not found) INN (CHLORDIAZEPOXIDE) LIBRITABS (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085488 (pdf 85488.pdf not found) INN (CHLORDIAZEPOXIDE) LIBRITABS (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085513 (pdf 85513.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) A-POXIDE (ABBOTT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085517 (pdf 85517.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) A-POXIDE (ABBOTT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085518 (pdf 85518.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) A-POXIDE (ABBOTT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086212 (pdf 86212.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086213 (pdf 86213.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086217 (pdf 86217.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086294 (pdf 86294.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086382 (pdf 86382.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086383 (pdf 86383.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086494 (pdf 86494.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086876 (pdf 86876.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086892 (pdf 86892.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086893 (pdf 86893.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087037 (pdf 87037.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087231 (pdf 87231.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087234 (pdf 87234.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087512 (pdf 87512.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087524 (pdf 87524.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087525 (pdf 87525.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (ASCOT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088010 (pdf 88010.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088129 (pdf 88129.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088130 (pdf 88130.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088705 (pdf 88705.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088706 (pdf 88706.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088707 (pdf 88707.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088986 (pdf 88986.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088987 (pdf 88987.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088988 (pdf 88988.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089533 (pdf 89533.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089558 (pdf 89558.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012750 (label 12750.pdf) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) LIBRAX (BAUSCH) APPROVAL= AP YEAR= 1966 , NDA 211421 (pdf 211421.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 210579 (pdf 210579.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MISEMER) APPROVAL= AP YEAR= 2020 , NDA 213530 (pdf 213530.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 214065 (pdf 214065.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214698 (pdf 214698.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 211476 (pdf 211476.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215555 (pdf 215555.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 211925 (pdf 211925.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 215453 (pdf 215453.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (COREPHARMA) APPROVAL= AP YEAR= 2022 , NDA 215835 (pdf 215835.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 216419 (pdf 216419.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216969 (pdf 216969.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217385 (pdf 217385.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , 283 ; TRICHLORMETHIAZIDE ; 133-67-5 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012265 (pdf 12265.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) NAQUIVAL (SCHERING) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012594 (pdf 12594.pdf not found) INN (TRICHLORMETHIAZIDE) METAHYDRIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 012972 (pdf 12972.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) METATENSIN #2 (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083436 (pdf 83436.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLOREX (LANNETT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 083462 (pdf 83462.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083847 (pdf 83847.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083855 (pdf 83855.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083967 (pdf 83967.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085248 (pdf 85248.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085568 (pdf 85568.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085630 (pdf 85630.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLOREX (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085962 (pdf 85962.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086171 (pdf 86171.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086259 (pdf 86259.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMAS (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086458 (pdf 86458.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087005 (pdf 87005.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087007 (pdf 87007.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , 284 ; CHLORTHALIDONE ; 77-36-1 ; 1960 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012283 (pdf 12283.pdf not found) INN (CHLORTHALIDONE) HYGROTON (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 015103 (pdf 15103.pdf not found) INN (CHLORTHALIDONE RESERPINE) REGROTON (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 017503 (pdf 17503.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) COMBIPRES (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018760 (label 18760.pdf) INN (ATENOLOL CHLORTHALIDONE) TENORETIC 100 (TWI PHARMS) APPROVAL= AP YEAR= 1984 , NDA 019451 (pdf 19451.pdf not found) INN (CHLORTHALIDONE METOPROLOL TARTRATE) LOPRESSIDONE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019574 (label 19574.pdf) INN (CHLORTHALIDONE) THALITONE (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 019807 (label 19807.pdf) INN (BETAXOLOL HYDROCHLORIDE CHLORTHALIDONE) KERLEDEX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 071142 (pdf 71142.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071178 (pdf 71178.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071179 (pdf 71179.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071325 (pdf 71325.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLORPRES (MYLAN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072301 (pdf 72301.pdf not found) INN (CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ALVOGEN MALTA) APPROVAL= AP YEAR= 1990 OBSOLETE , NDA 072302 (pdf 72302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (TWI PHARMS) APPROVAL= AP YEAR= 1990 , NDA 073581 (pdf 73581.pdf not found) INN (CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073582 (pdf 73582.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073665 (pdf 73665.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1992 , NDA 074107 (pdf 74107.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074203 (pdf 74203.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074404 (pdf 74404.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOSTRUM LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 086831 (pdf 86831.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MYLAN) APPROVAL= AP YEAR= 1981 , NDA 087029 (pdf 87029.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087050 (pdf 87050.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087082 (pdf 87082.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087100 (pdf 87100.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087118 (pdf 87118.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087176 (pdf 87176.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087247 (pdf 87247.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUPERPHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087292 (pdf 87292.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087293 (pdf 87293.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087296 (pdf 87296.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087311 (pdf 87311.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087312 (pdf 87312.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087364 (pdf 87364.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ABBOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087380 (pdf 87380.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087381 (pdf 87381.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087384 (pdf 87384.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ABBOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087450 (pdf 87450.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087451 (pdf 87451.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087473 (pdf 87473.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087515 (pdf 87515.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087516 (pdf 87516.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087521 (pdf 87521.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087555 (pdf 87555.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087689 (pdf 87689.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087698 (pdf 87698.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087699 (pdf 87699.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087706 (pdf 87706.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087947 (pdf 87947.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088012 (pdf 88012.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088051 (pdf 88051.pdf not found) INN (CHLORTHALIDONE) THALITONE (MONARCH PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088073 (pdf 88073.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088139 (pdf 88139.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088140 (pdf 88140.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088164 (pdf 88164.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088651 (pdf 88651.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (COSETTE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088902 (pdf 88902.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (BARR LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088903 (pdf 88903.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (BARR LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089051 (pdf 89051.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089052 (pdf 89052.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089285 (pdf 89285.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089286 (pdf 89286.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 089591 (pdf 89591.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089738 (pdf 89738.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089739 (pdf 89739.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 202331 (label 202331.pdf) INN (AZILSARTAN KAMEDOXOMIL CHLORTHALIDONE) EDARBYCLOR (AZURITY) APPROVAL= AP YEAR= 2011 , NDA 206904 (pdf 206904.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 207222 (pdf 207222.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (UMEDICA) APPROVAL= AP YEAR= 2018 , NDA 210742 (pdf 210742.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207813 (pdf 207813.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210028 (pdf 210028.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211063 (pdf 211063.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 207204 (pdf 207204.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 211627 (pdf 211627.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 213412 (pdf 213412.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213302 (pdf 213302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 214129 (pdf 214129.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 215560 (pdf 215560.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 209068 (pdf 209068.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUNNY) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211320 (pdf 211320.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (INVENTIA) APPROVAL= AP YEAR= 2022 , NDA 212875 (pdf 212875.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (TAGI) APPROVAL= AP YEAR= 2022 , NDA 212878 (pdf 212878.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (TAGI) APPROVAL= AP YEAR= 2022 , NDA 215587 (pdf 215587.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216262 (pdf 216262.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 285 ; OXYTOCIN ; 50-56-6 ; 1980 ; ; ; CLASS HORMONES -- OXYTOCIC -- ANTI-TOCOLYTIC AGENTS -- LABOR INDUCTION AGENTS , ; NDA 012285 (pdf 12285.pdf not found) INN (OXYTOCIN) SYNTOCINON (RTRX) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018243 (pdf 18243.pdf not found) INN (OXYTOCIN) OXYTOCIN (HIKMA) APPROVAL= AP YEAR= 1980 , NDA 018245 (pdf 18245.pdf not found) INN (OXYTOCIN) SYNTOCINON (NOVARTIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018248 (label 18248.pdf) INN (OXYTOCIN) OXYTOCIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1980 , NDA 018261 (label 18261.pdf) INN (OXYTOCIN) PITOCIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1980 , NDA 019185 (pdf 19185.pdf not found) INN (OXYTOCIN) OXYTOCIN 5 USP UNITS IN DEXTROSE 5% (ABBOTT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 077453 (label 77453.pdf) INN (OXYTOCIN) OXYTOCIN (DR REDDYS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 200219 (pdf 200219.pdf not found) INN (OXYTOCIN) OXYTOCIN (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2013 , NDA 091676 (pdf 91676.pdf not found) INN (OXYTOCIN) OXYTOCIN (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , 286 ; DEXTROTHYROXINE ; 51-49-0 ; 1967 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERLIPIDEMICS , ; NDA 012302 (pdf 12302.pdf not found) INN (DEXTROTHYROXINE SODIUM) CHOLOXIN (ABBVIE) APPROVAL= AP YEAR= 1967 DISCONTINUED , 287 ; ISOETHARINE ; 788763-51-9 ; 1978 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- ADRENERGIC BETA2 AGONISTS (PMID6990745) , ; NDA 012339 (pdf 12339.pdf not found) INN (ISOETHARINE MESYLATE) BRONKOMETER (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085889 (pdf 85889.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085997 (pdf 85997.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086651 (pdf 86651.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086711 (pdf 86711.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) BETA-2 (NEPHRON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086763 (pdf 86763.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086899 (pdf 86899.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087025 (pdf 87025.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087101 (pdf 87101.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087324 (pdf 87324.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087389 (pdf 87389.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087390 (pdf 87390.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087396 (pdf 87396.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087858 (pdf 87858.pdf not found) INN (ISOETHARINE MESYLATE) ISOETHARINE MESYLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087937 (pdf 87937.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087938 (pdf 87938.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088144 (pdf 88144.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088145 (pdf 88145.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088146 (pdf 88146.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088187 (pdf 88187.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088188 (pdf 88188.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088226 (pdf 88226.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088275 (pdf 88275.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088470 (pdf 88470.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088471 (pdf 88471.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088472 (pdf 88472.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089252 (pdf 89252.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089614 (pdf 89614.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089615 (pdf 89615.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089616 (pdf 89616.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089617 (pdf 89617.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089618 (pdf 89618.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089817 (pdf 89817.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089818 (pdf 89818.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089819 (pdf 89819.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089820 (pdf 89820.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , 288 ; TRANYLCYPROMINE ; 155-09-9 ; 1961 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- MONOAMINE OXIDASE (MAO) INHIBITORS , ; NDA 012342 (label 12342.pdf) INN (TRANYLCYPROMINE SULFATE) PARNATE (CONCORDIA) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY , NDA 040640 (pdf 40640.pdf not found) INN (TRANYLCYPROMINE SULFATE) TRANYLCYPROMINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 206856 (pdf 206856.pdf not found) INN (TRANYLCYPROMINE SULFATE) TRANYLCYPROMINE SULFATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2018 , NDA 213503 (pdf 213503.pdf not found) INN (TRANYLCYPROMINE SULFATE) TRANYLCYPROMINE SULFATE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2022 , 289 ; ETHOSUXIMIDE ; 77-67-8 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- SUCCINIMIDES , ; NDA 012380 (label 12380.pdf) INN (ETHOSUXIMIDE) ZARONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , NDA 040253 (label 40253.pdf) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2000 , NDA 040430 (pdf 40430.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2002 , NDA 040506 (pdf 40506.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (MIKART) APPROVAL= AP YEAR= 2003 , NDA 040686 (pdf 40686.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 , NDA 080258 (label 80258.pdf) INN (ETHOSUXIMIDE) ZARONTIN (PARKE-DAVIS) APPROVAL= AP YEAR= 1974 , NDA 081306 (pdf 81306.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 200892 (pdf 200892.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 211928 (pdf 211928.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 210654 (pdf 210654.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2020 , 290 ; PROPIOMAZINE ; 362-29-8 ; 1960 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- SEDATIVES -- HYPNOTICS -- GPCRS AMINE BINDING ANTAGONIST , ; NDA 012382 (pdf 12382.pdf not found) INN (PROPIOMAZINE HYDROCHLORIDE) LARGON (HIKMA) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , 291 ; COLCHICINE ; 64-86-8 ; 1961 ; ; NATURAL MOLECULE C00002327 ; CLASS MUSCULO-SKELETAL -- ANTIMITOTIC -- INHIBITION OF BETA-TUBULIN POLYMERIZATION -- ALKALOID -- GOUT SUPPRESSANT , ; NDA 012383 (pdf 12383.pdf not found) INN (COLCHICINE PROBENECID) COLBENEMID (MERCK) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040618 (pdf 40618.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (NOVAST LABS) APPROVAL= AP YEAR= 2008 , NDA 083221 (pdf 83221.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID W/ COLCHICINE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083720 (pdf 83720.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083734 (pdf 83734.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (ANI PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084279 (pdf 84279.pdf not found) INN (COLCHICINE PROBENECID) COL-PROBENECID (WATSON LABS) APPROVAL= AP YEAR= 1976 , NDA 084321 (pdf 84321.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (BEECHAM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085552 (pdf 85552.pdf not found) INN (COLCHICINE PROBENECID) PROBEN-C (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086130 (pdf 86130.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086954 (pdf 86954.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID W/ COLCHICINE (LEDERLE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 022351 (label 22351.pdf) INN (COLCHICINE) COLCRYS (AR HOLDING CO INC) APPROVAL= AP YEAR= 2009 , NDA 022352 (label 22352.pdf) INN (COLCHICINE) COLCRYS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022353 (label 22353.pdf) INN (COLCHICINE) COLCRYS (AR HOLDING CO INC) APPROVAL= AP YEAR= 2009 , NDA 204820 (label 204820.pdf) INN (COLCHICINE) MITIGARE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203976 (pdf 203976.pdf not found) INN (COLCHICINE) COLCHICINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 204461 (pdf 204461.pdf not found) INN (COLCHICINE) COLCHICINE (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 204711 (pdf 204711.pdf not found) INN (COLCHICINE) COLCHICINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 208678 (pdf 208678.pdf not found) INN (COLCHICINE) COLCHICINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 , NDA 210942 (label 210942.pdf) INN (COLCHICINE) GLOPERBA (SCILEX PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211250 (pdf 211250.pdf not found) INN (COLCHICINE) COLCHICINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 211519 (pdf 211519.pdf not found) INN (COLCHICINE) COLCHICINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209470 (pdf 209470.pdf not found) INN (COLCHICINE) COLCHICINE (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209876 (pdf 209876.pdf not found) INN (COLCHICINE) COLCHICINE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 210425 (pdf 210425.pdf not found) INN (COLCHICINE) COLCHICINE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 208993 (pdf 208993.pdf not found) INN (COLCHICINE) COLCHICINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , NDA 209173 (pdf 209173.pdf not found) INN (COLCHICINE) COLCHICINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215444 (pdf 215444.pdf not found) INN (COLCHICINE) COLCHICINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215727 (label 215727.pdf) INN (COLCHICINE) LODOCO (AGEPHA PHARMA FZ) APPROVAL= AP YEAR= 2023 , NDA 217030 (pdf 217030.pdf not found) INN (COLCHICINE PROBENECID) PROBENECID AND COLCHICINE (RISING) APPROVAL= AP YEAR= 2023 , NDA 210757 (pdf 210757.pdf not found) INN (COLCHICINE) COLCHICINE (GRANULES) APPROVAL= AP YEAR= 2024 , NDA 215463 (pdf 215463.pdf not found) INN (COLCHICINE) COLCHICINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217620 (pdf 217620.pdf not found) INN (COLCHICINE) COLCHICINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , 292 ; PSEUDOEPHEDRINE ; 90-82-4 ; 1963 ; ; NATURAL MOLECULE C00031097 ; CLASS RESPIRATORY SYSTEM -- ADRENERGIC -- NASAL DECONGESTANTS -- SYMPATHOMIMETICS , ; NDA 012394 (pdf 12394.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DISOPHROL (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 012575 (pdf 12575.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTIFED W/ CODEINE (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 013483 (pdf 13483.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DRIXORAL (SCHERING PLOUGH) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 017603 (pdf 17603.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) NOVAFED (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017941 (pdf 17941.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 12 HOUR (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018191 (pdf 18191.pdf not found) INN (PSEUDOEPHEDRINE SULFATE) AFRINOL (SCHERING PLOUGH) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018397 (pdf 18397.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) CHLOR-TRIMETON (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018506 (pdf 18506.pdf not found) INN (AZATADINE MALEATE PSEUDOEPHEDRINE SULFATE) TRINALIN (SCHERING) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018747 (pdf 18747.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) ISOCLOR (FISONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 018843 (pdf 18843.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018844 (pdf 18844.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018935 (pdf 18935.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) CODIMAL-L.A. 12 (SCHWARZ PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018996 (pdf 18996.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTIFED (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019014 (pdf 19014.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BENYLIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019279 (label 19279.pdf) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) DIMETANE-DX (ROBINS AH) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019401 (pdf 19401.pdf not found) INN (PSEUDOEPHEDRINE POLISTIREX) PSEUDO-12 (UCB INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019428 (pdf 19428.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019453 (pdf 19453.pdf not found) INN (ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DRIXORAL PLUS (SCHERING PLOUGH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019670 (label 19670.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) CLARITIN-D (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1994 , NDA 019672 (pdf 19672.pdf not found) INN (BROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 019771 (label 19771.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1989 , NDA 019806 (label 19806.pdf) INN (ACRIVASTINE PSEUDOEPHEDRINE HYDROCHLORIDE) SEMPREX-D (ENDO OPERATIONS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 019899 (label 19899.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) SINE-AID IB (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1992 , NDA 020021 (label 20021.pdf) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 24 HOUR (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1992 , NDA 020470 (label 20470.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) CLARITIN-D 24 HOUR (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 , NDA 020786 (label 20786.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 1997 , NDA 021076 (label 21076.pdf) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) ALEVE-D SINUS & COLD (BAYER) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021082 (label 21082.pdf) INN (ACETAMINOPHEN CLEMASTINE FUMARATE PSEUDOEPHEDRINE HYDROCHLORIDE) TAVIST ALLERGY/SINUS/HEADACHE (NOVARTIS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021128 (label 21128.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S MOTRIN COLD (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2000 , NDA 021150 (label 21150.pdf) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ZYRTEC-D 12 HOUR (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2001 , NDA 021313 (label 21313.pdf) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) CLARINEX-D 12 HOUR (ORGANON LLC) APPROVAL= AP YEAR= 2006 , NDA 021373 (label 21373.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL COLD (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002 , NDA 021374 (label 21374.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002 , NDA 021441 (label 21441.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021585 (label 21585.pdf) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) MUCINEX D (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 021587 (label 21587.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2004 , NDA 021605 (label 21605.pdf) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) CLARINEX D 24 HOUR (ORGANON) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021704 (label 21704.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 2004 , NDA 070770 (pdf 70770.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DISOBROM (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071455 (pdf 71455.pdf not found) INN (CHLORPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071798 (pdf 71798.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072758 (pdf 72758.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073585 (pdf 73585.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 12 HOUR (MCNEIL CONS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074567 (pdf 74567.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROHM COLD AND SINUS (OHM LABS) APPROVAL= AP YEAR= 2001 , NDA 075153 (pdf 75153.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 1999 , NDA 075588 (label 75588.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075706 (label 75706.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (P AND L) APPROVAL= AP YEAR= 2003 , NDA 075989 (pdf 75989.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2004 , NDA 076050 (pdf 76050.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2003 , NDA 076208 (pdf 76208.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076236 (pdf 76236.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076298 (pdf 76298.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076478 (pdf 76478.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076518 (pdf 76518.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076538 (pdf 76538.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HCL PSEUDOEPHEDRINE HCL (MYLAN) APPROVAL= TA YEAR= 2004 , NDA 076557 (pdf 76557.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 , NDA 077170 (label 77170.pdf) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077381 (pdf 77381.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077442 (pdf 77442.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005 , NDA 077628 (pdf 77628.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 077991 (pdf 77991.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS) APPROVAL= AP YEAR= 2008 , NDA 085273 (pdf 85273.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088116 (pdf 88116.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) MYFED (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088117 (pdf 88117.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WEST WARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088193 (pdf 88193.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088283 (pdf 88283.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) HISTAFED (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088318 (pdf 88318.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088344 (pdf 88344.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ACTAHIST (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088474 (pdf 88474.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088515 (pdf 88515.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088578 (pdf 88578.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088602 (pdf 88602.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) CORPHED (FOSUN PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088630 (pdf 88630.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPHED (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088704 (pdf 88704.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) TRIACIN-C (STI PHARMA LLC) APPROVAL= AP YEAR= 1985 , NDA 088722 (pdf 88722.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMANATE DM (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088811 (pdf 88811.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088833 (pdf 88833.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE , PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088860 (pdf 88860.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) ALLERFED (PVT FORM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089018 (pdf 89018.pdf not found) INN (CODEINE PHOSPHATE PSEUDOEPHEDRINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089116 (pdf 89116.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) BROMPHERIL (COPLEY PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089139 (pdf 89139.pdf not found) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) RESPORAL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089681 (pdf 89681.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 076667 (pdf 76667.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 077999 (pdf 77999.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS LLC) APPROVAL= TA YEAR= 2010 , NDA 079043 (pdf 79043.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 079115 (pdf 79115.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= TA YEAR= 2010 , NDA 022439 (label 22439.pdf) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) ZUTRIPRO (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022442 (label 22442.pdf) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) REZIRA (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078366 (pdf 78366.pdf not found) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090922 (pdf 90922.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012 , NDA 078648 (label 78648.pdf) INN (DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (AVANTHI INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202940 (pdf 202940.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203838 (pdf 203838.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203839 (pdf 203839.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204627 (pdf 204627.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 204658 (pdf 204658.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205292 (pdf 205292.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 022279 (label 22279.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYCOFENIX (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090818 (pdf 90818.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015 , NDA 091071 (pdf 91071.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 205657 (pdf 205657.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205658 (pdf 205658.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203375 (pdf 203375.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ACELLA) APPROVAL= AP YEAR= 2016 , NDA 208369 (pdf 208369.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 205112 (pdf 205112.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (TARO) APPROVAL= AP YEAR= 2017 , NDA 206660 (pdf 206660.pdf not found) INN (CHLORPHENIRAMINE MALEATE HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE , CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209008 (pdf 209008.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209116 (pdf 209116.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209235 (pdf 209235.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207676 (pdf 207676.pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210719 (pdf 210719.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 206661 (pdf 206661.pdf not found) INN (HYDROCODONE BITARTRATE PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210647 (pdf 210647.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 211170 (pdf 211170.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (EYWA) APPROVAL= AP YEAR= 2020 , NDA 212542 (pdf 212542.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 213125 (pdf 213125.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 , NDA 213203 (pdf 213203.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 202955 (pdf 202955.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 203997 (pdf 203997.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 , NDA 211360 (pdf 211360.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214407 (pdf 214407.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2022 , NDA 215434 (pdf 215434.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 216082 (pdf 216082.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212409 (pdf 212409.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213565 (pdf 213565.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 218017 (pdf 218017.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (BIONPHARMA) APPROVAL= AP YEAR= 2024 , 293 ; ATROPINE ; 51-55-8 ; 1960 ; ; NATURAL MOLECULE C00002277 ; CLASS METABOLISM -- ALKALOID -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- MYDRIATICS -- PARASYMPATHOLYTICS -- ACTIVITY IS DUE ALMOST ENTIRELY TO THE LEVO ISOMER -- TREATMENT OF POISONING BY ORGANOPHOSPHOROUS NERVE AGENTS , ; NDA 012462 (label 12462.pdf) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (PFIZER) APPROVAL= AP YEAR= 1960 , NDA 012699 (pdf 12699.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (GD SEARLE LLC) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 017106 (label 17106.pdf) INN (ATROPINE) ATROPEN (MMT) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017744 (label 17744.pdf) INN (ATROPINE SULFATE DIFENOXIN HYDROCHLORIDE) MOTOFEN HALF-STRENGTH (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 019677 (label 19677.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019678 (label 19678.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020056 (pdf 20056.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (US ARMY) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 021146 (label 21146.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 2001 , NDA 021175 (label 21175.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) ATNAA (US ARMY) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021983 (label 21983.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) DUODOTE (MMT) APPROVAL= AP YEAR= 2006 , NDA 040357 (pdf 40357.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040395 (pdf 40395.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ABLE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 071295 (pdf 71295.pdf not found) INN (ATROPINE) ATROPINE (ABBVIE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 085035 (pdf 85035.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (R AND S PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085121 (pdf 85121.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) MEPERIDINE AND ATROPINE SULFATE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085211 (pdf 85211.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOW-QUEL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085266 (pdf 85266.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DI-ATRO (MD PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085311 (pdf 85311.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LONOX (FOSUN PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085372 (pdf 85372.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1978 , NDA 085506 (pdf 85506.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085509 (pdf 85509.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (INWOOD LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085659 (pdf 85659.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085735 (pdf 85735.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085737 (pdf 85737.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085746 (pdf 85746.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMANATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085762 (pdf 85762.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (MYLAN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085766 (pdf 85766.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085876 (pdf 85876.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086057 (pdf 86057.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086173 (pdf 86173.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086440 (pdf 86440.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE (SCHERER RP) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086727 (pdf 86727.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086798 (pdf 86798.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086950 (pdf 86950.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087131 (pdf 87131.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PARKE DAVIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087195 (pdf 87195.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 087708 (pdf 87708.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 087765 (pdf 87765.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087842 (pdf 87842.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087847 (pdf 87847.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087848 (pdf 87848.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087853 (pdf 87853.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087934 (pdf 87934.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088009 (pdf 88009.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LO-TROL (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088962 (pdf 88962.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOGEN (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 206289 (label 206289.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (RISING) APPROVAL= AP YEAR= 2014 , NDA 208151 (label 208151.pdf) INN (ATROPINE SULFATE) ISOPTO ATROPINE (ALCON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 209260 (label 209260.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210571 (pdf 210571.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210819 (pdf 210819.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2018 , NDA 212319 (label 212319.pdf) INN (ATROPINE) ATROPINE AUTOINJECTOR (RAFA LABS LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210789 (pdf 210789.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213413 (pdf 213413.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEADING) APPROVAL= AP YEAR= 2020 , NDA 207128 (pdf 207128.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 212461 (pdf 212461.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2020 , NDA 213335 (pdf 213335.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2020 , NDA 214652 (label 214652.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 211362 (pdf 211362.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021 , NDA 213424 (pdf 213424.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 212868 (pdf 212868.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 213561 (pdf 213561.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 214752 (pdf 214752.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215624 (pdf 215624.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 213581 (label 213581.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2022 , NDA 215342 (pdf 215342.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 216120 (pdf 216120.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AM REGENT) APPROVAL= AP YEAR= 2022 , NDA 214970 (pdf 214970.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (MEDEFIL INC) APPROVAL= AP YEAR= 2022 , NDA 217791 (pdf 217791.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (SOMERSET) APPROVAL= AP YEAR= 2024 , NDA 218148 (pdf 218148.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , 294 ; BENZPHETAMINE ; 156-08-1 ; 1960 ; ; ; CLASS METABOLISM -- ANTIANOREXIC -- APPETITE SUPPRESSION -- ANORECTIC AGENT , ; NDA 012427 (label 12427.pdf) INN (BENZPHETAMINE HYDROCHLORIDE) DIDREX (PFIZER) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 040578 (pdf 40578.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (SCINOPHARM TAIWAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040714 (pdf 40714.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040747 (pdf 40747.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (TEDOR PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040773 (pdf 40773.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040845 (pdf 40845.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090473 (pdf 90473.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2010 , NDA 090968 (pdf 90968.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2010 , NDA 202061 (pdf 202061.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090346 (pdf 90346.pdf not found) INN (BENZPHETAMINE HYDROCHLORIDE) BENZPHETAMINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , 295 ; THIOGUANINE ; 154-42-7 ; 1966 ; ; NATURAL MOLECULE C00018807 NPA015811 ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- TREATMENT OF ACUTE NONLYMPHOCYTIC LEUKEMIAS -- THIOGUANINE IS INCORPORATED INTO THE DNA AND THE RNA OF HUMAN BONE MARROW CELLS , ; NDA 012429 (label 12429.pdf) INN (THIOGUANINE) THIOGUANINE (WAYLIS THERAP) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY , 296 ; ATROPINE ; 51-55-8 ; 1960 ; ; NATURAL MOLECULE C00002293 ; CLASS METABOLISM -- ALKALOID -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- MYDRIATICS -- PARASYMPATHOLYTICS -- ACTIVITY IS DUE ALMOST ENTIRELY TO THE LEVO ISOMER -- TREATMENT OF POISONING BY ORGANOPHOSPHOROUS NERVE AGENTS , ; NDA 012462 (label 12462.pdf) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (PFIZER) APPROVAL= AP YEAR= 1960 , NDA 012699 (pdf 12699.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (GD SEARLE LLC) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 017106 (label 17106.pdf) INN (ATROPINE) ATROPEN (MMT) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017744 (label 17744.pdf) INN (ATROPINE SULFATE DIFENOXIN HYDROCHLORIDE) MOTOFEN HALF-STRENGTH (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 019677 (label 19677.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019678 (label 19678.pdf) INN (ATROPINE SULFATE EDROPHONIUM CHLORIDE) ENLON-PLUS (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020056 (pdf 20056.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (US ARMY) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 021146 (label 21146.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 2001 , NDA 021175 (label 21175.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) ATNAA (US ARMY) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021983 (label 21983.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) DUODOTE (MMT) APPROVAL= AP YEAR= 2006 , NDA 040357 (pdf 40357.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040395 (pdf 40395.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ABLE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 071295 (pdf 71295.pdf not found) INN (ATROPINE) ATROPINE (ABBVIE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 085035 (pdf 85035.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (R AND S PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085121 (pdf 85121.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) MEPERIDINE AND ATROPINE SULFATE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085211 (pdf 85211.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOW-QUEL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085266 (pdf 85266.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DI-ATRO (MD PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085311 (pdf 85311.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LONOX (FOSUN PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085372 (pdf 85372.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1978 , NDA 085506 (pdf 85506.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085509 (pdf 85509.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (INWOOD LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085659 (pdf 85659.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085735 (pdf 85735.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085737 (pdf 85737.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085746 (pdf 85746.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMANATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085762 (pdf 85762.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (MYLAN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085766 (pdf 85766.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085876 (pdf 85876.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086057 (pdf 86057.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086173 (pdf 86173.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086440 (pdf 86440.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE (SCHERER RP) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086727 (pdf 86727.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086798 (pdf 86798.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086950 (pdf 86950.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087131 (pdf 87131.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PARKE DAVIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087195 (pdf 87195.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 087708 (pdf 87708.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 087765 (pdf 87765.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087842 (pdf 87842.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087847 (pdf 87847.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087848 (pdf 87848.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087853 (pdf 87853.pdf not found) INN (ATROPINE SULFATE MEPERIDINE HYDROCHLORIDE) ATROPINE AND DEMEROL (ABBVIE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087934 (pdf 87934.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088009 (pdf 88009.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LO-TROL (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088962 (pdf 88962.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOGEN (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 206289 (label 206289.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (RISING) APPROVAL= AP YEAR= 2014 , NDA 208151 (label 208151.pdf) INN (ATROPINE SULFATE) ISOPTO ATROPINE (ALCON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 209260 (label 209260.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210571 (pdf 210571.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210819 (pdf 210819.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2018 , NDA 212319 (label 212319.pdf) INN (ATROPINE) ATROPINE AUTOINJECTOR (RAFA LABS LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210789 (pdf 210789.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213413 (pdf 213413.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEADING) APPROVAL= AP YEAR= 2020 , NDA 207128 (pdf 207128.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 212461 (pdf 212461.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2020 , NDA 213335 (pdf 213335.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2020 , NDA 214652 (label 214652.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 211362 (pdf 211362.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021 , NDA 213424 (pdf 213424.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 212868 (pdf 212868.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 213561 (pdf 213561.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 214752 (pdf 214752.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215624 (pdf 215624.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 213581 (label 213581.pdf) INN (ATROPINE SULFATE) ATROPINE SULFATE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2022 , NDA 215342 (pdf 215342.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 216120 (pdf 216120.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (AM REGENT) APPROVAL= AP YEAR= 2022 , NDA 214970 (pdf 214970.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (MEDEFIL INC) APPROVAL= AP YEAR= 2022 , NDA 217791 (pdf 217791.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (SOMERSET) APPROVAL= AP YEAR= 2024 , NDA 218148 (pdf 218148.pdf not found) INN (ATROPINE SULFATE) ATROPINE SULFATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , 297 ; DIPHENOXYLATE ; 915-30-0 ; 1960 ; ; ; CLASS METABOLISM -- ANTIPERISTALTIC -- NARCOTICS -- ADJUNCTIVE THERAPY IN THE MANAGEMENT OF DIARRHEA , ; NDA 012462 (label 12462.pdf) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (PFIZER) APPROVAL= AP YEAR= 1960 , NDA 012699 (pdf 12699.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMOTIL (GD SEARLE LLC) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040357 (pdf 40357.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040395 (pdf 40395.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ABLE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 085035 (pdf 85035.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (R AND S PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085211 (pdf 85211.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOW-QUEL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085266 (pdf 85266.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DI-ATRO (MD PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085311 (pdf 85311.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LONOX (FOSUN PHARMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085372 (pdf 85372.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1978 , NDA 085506 (pdf 85506.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085509 (pdf 85509.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (INWOOD LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085659 (pdf 85659.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (KV PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085735 (pdf 85735.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085737 (pdf 85737.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) COLONAID (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085746 (pdf 85746.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOMANATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085762 (pdf 85762.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (MYLAN) APPROVAL= AP YEAR= 1977 , NDA 085766 (pdf 85766.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085876 (pdf 85876.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086057 (pdf 86057.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086173 (pdf 86173.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086440 (pdf 86440.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE (SCHERER RP) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086727 (pdf 86727.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 1979 , NDA 086798 (pdf 86798.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086950 (pdf 86950.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087131 (pdf 87131.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (PARKE DAVIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087195 (pdf 87195.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 087708 (pdf 87708.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 087765 (pdf 87765.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087842 (pdf 87842.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087934 (pdf 87934.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088009 (pdf 88009.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LO-TROL (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088962 (pdf 88962.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) LOGEN (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 210571 (pdf 210571.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210819 (pdf 210819.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2018 , NDA 210789 (pdf 210789.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213413 (pdf 213413.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (LEADING) APPROVAL= AP YEAR= 2020 , NDA 207128 (pdf 207128.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 213335 (pdf 213335.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2020 , NDA 211362 (pdf 211362.pdf not found) INN (ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE) DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021 , 298 ; ACRISORCIN ; 7527-91-5 ; 0 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL , ; NDA 012470 (pdf 12470.pdf not found) INN (ACRISORCIN) AKRINOL (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , 299 ; CHLORPROTHIXENE ; 113-59-7 ; 1962 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE D2 ANTAGONISTS , ; NDA 012486 (pdf 12486.pdf not found) INN (CHLORPROTHIXENE) TARACTAN (ROCHE) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 012487 (pdf 12487.pdf not found) INN (CHLORPROTHIXENE) TARACTAN (ROCHE) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 016149 (pdf 16149.pdf not found) INN (CHLORPROTHIXENE) TARACTAN (ROCHE) APPROVAL= AP YEAR= 1967 DISCONTINUED , 300 ; METHYCLOTHIAZIDE ; 135-07-9 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC THIAZIDE -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012524 (pdf 12524.pdf not found) INN (METHYCLOTHIAZIDE) ENDURON (ABBVIE) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012708 (pdf 12708.pdf not found) INN (METHYCLOTHIAZIDE RESERPINE) DIUTENSEN-R (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 012775 (pdf 12775.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) ENDURONYL (ABBOTT) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 016047 (pdf 16047.pdf not found) INN (METHYCLOTHIAZIDE PARGYLINE HYDROCHLORIDE) EUTRON (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017364 (pdf 17364.pdf not found) INN (METHYCLOTHIAZIDE) AQUATENSEN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085476 (pdf 85476.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085487 (pdf 85487.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087671 (pdf 87671.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087672 (pdf 87672.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087786 (pdf 87786.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087913 (pdf 87913.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088452 (pdf 88452.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088486 (pdf 88486.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088724 (pdf 88724.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088745 (pdf 88745.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088750 (pdf 88750.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089135 (pdf 89135.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089136 (pdf 89136.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089835 (pdf 89835.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089837 (pdf 89837.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , 301 ; OXYPHENBUTAZONE ; 129-20-4 ; 1960 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- ANTIRHEUMATIC -- ANTIINFLAMMATORY -- NSAID -- INHIBITOR , ; NDA 012542 (pdf 12542.pdf not found) INN (OXYPHENBUTAZONE) TANDEARIL (NOVARTIS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 088399 (pdf 88399.pdf not found) INN (OXYPHENBUTAZONE) OXYPHENBUTAZONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 302 ; METRONIDAZOLE ; 443-48-1 ; 1963 ; ; ; CLASS ANTIINFECTIVES -- ANTIPROTOZOAL -- TREATMENT OF ROSACEA -- FREE RADICALS ARE FORMED WHICH REACT WITH CELLULAR COMPONENTS RESULTING IN DEATH OF THE MICROORGANISM. , ; NDA 012623 (label 12623.pdf) INN (METRONIDAZOLE) FLAGYL (PFIZER) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018353 (label 18353.pdf) INN (METRONIDAZOLE) FLAGYL I.V. RTU IN PLASTIC CONTAINER (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018517 (pdf 18517.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018599 (pdf 18599.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018620 (label 18620.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018657 (label 18657.pdf) INN (METRONIDAZOLE) FLAGYL I.V. RTU IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 , NDA 018674 (pdf 18674.pdf not found) INN (METRONIDAZOLE) METRO I.V. (B BRAUN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018740 (label 18740.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018764 (label 18764.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018818 (pdf 18818.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018845 (label 18845.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018871 (pdf 18871.pdf not found) INN (METRONIDAZOLE) PROTOSTAT (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018889 (pdf 18889.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ABBOTT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018890 (label 18890.pdf) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018900 (label 18900.pdf) INN (METRONIDAZOLE) METRO I.V. IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1983 , NDA 018907 (label 18907.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (HIKMA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018930 (label 18930.pdf) INN (METRONIDAZOLE) METRONIDAZOLE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 019029 (pdf 19029.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (LNK) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019737 (pdf 19737.pdf not found) INN (METRONIDAZOLE) METROGEL (GALDERMA LABS LP) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 020208 (pdf 20208.pdf not found) INN (METRONIDAZOLE) METROGEL-VAGINAL (BAUSCH) APPROVAL= AP YEAR= 1992 , NDA 020334 (label 20334.pdf) INN (METRONIDAZOLE) FLAGYL (PFIZER) APPROVAL= AP YEAR= 1995 , NDA 020531 (pdf 20531.pdf not found) INN (METRONIDAZOLE) METROCREAM (GALDERMA LABS LP) APPROVAL= AP YEAR= 1995 , NDA 020743 (label 20743.pdf) INN (METRONIDAZOLE) NORITATE (BAUSCH) APPROVAL= AP YEAR= 1997 , NDA 020868 (label 20868.pdf) INN (METRONIDAZOLE) FLAGYL ER (PFIZER) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020901 (label 20901.pdf) INN (METRONIDAZOLE) METROLOTION (GALDERMA LABS LP) APPROVAL= AP YEAR= 1998 , NDA 021789 (label 21789.pdf) INN (METRONIDAZOLE) METROGEL (GALDERMA LABS LP) APPROVAL= AP YEAR= 2005 , NDA 021806 (label 21806.pdf) INN (METRONIDAZOLE) VANDAZOLE (TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 050719 (label 50719.pdf) INN (BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) HELIDAC (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050786 (label 50786.pdf) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) PYLERA (LABS JUVISE) APPROVAL= AP YEAR= 2006 , NDA 070004 (pdf 70004.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070008 (pdf 70008.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070009 (pdf 70009.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070021 (pdf 70021.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070027 (pdf 70027.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1984 , NDA 070029 (pdf 70029.pdf not found) INN (METRONIDAZOLE) SATRIC (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070033 (pdf 70033.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (PLIVA) APPROVAL= AP YEAR= 1984 , NDA 070035 (pdf 70035.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS) APPROVAL= AP YEAR= 1984 , NDA 070039 (pdf 70039.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 070040 (pdf 70040.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 070042 (pdf 70042.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070044 (pdf 70044.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS INC) APPROVAL= AP YEAR= 1985 , NDA 070071 (pdf 70071.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070170 (pdf 70170.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070295 (pdf 70295.pdf not found) INN (METRONIDAZOLE HYDROCHLORIDE) METRONIDAZOLE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070593 (pdf 70593.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070731 (pdf 70731.pdf not found) INN (METRONIDAZOLE) SATRIC (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070772 (pdf 70772.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (INNOGENIX) APPROVAL= AP YEAR= 1986 , NDA 070773 (pdf 70773.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALLIED PHARMA INC) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 074523 (pdf 74523.pdf not found) INN (METRONIDAZOLE) METROMIDOL (LABS AF) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 076408 (pdf 76408.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076462 (pdf 76462.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076505 (pdf 76505.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076519 (pdf 76519.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076522 (pdf 76522.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 , NDA 077018 (pdf 77018.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 , NDA 077197 (pdf 77197.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 , NDA 077264 (pdf 77264.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ENCUBE) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077547 (pdf 77547.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ENCUBE) APPROVAL= AP YEAR= 2006 , NDA 077549 (pdf 77549.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (COSETTE) APPROVAL= AP YEAR= 2007 , NDA 077819 (pdf 77819.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (TARO) APPROVAL= AP YEAR= 2006 , NDA 078084 (pdf 78084.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2008 , NDA 079065 (pdf 79065.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2009 , NDA 079067 (pdf 79067.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 090222 (pdf 90222.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090903 (pdf 90903.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078178 (pdf 78178.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (COSETTE) APPROVAL= AP YEAR= 2011 , NDA 203458 (pdf 203458.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (UNICHEM) APPROVAL= AP YEAR= 2014 , NDA 205223 (label 205223.pdf) INN (METRONIDAZOLE) NUVESSA (CHEMO RESEARCH SL) APPROVAL= AP YEAR= 2014 , NDA 203974 (pdf 203974.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 205245 (pdf 205245.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 208162 (pdf 208162.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207309 (pdf 207309.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (FLAMINGO PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206560 (pdf 206560.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (CADILA) APPROVAL= AP YEAR= 2016 , NDA 204651 (pdf 204651.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (TARO) APPROVAL= AP YEAR= 2017 , NDA 205531 (pdf 205531.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208681 (pdf 208681.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209096 (pdf 209096.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 209794 (pdf 209794.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 202584 (pdf 202584.pdf not found) INN (BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBSALICYLATE , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 , NDA 206191 (pdf 206191.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (INFORLIFE) APPROVAL= AP YEAR= 2019 , NDA 211786 (pdf 211786.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 , NDA 212435 (pdf 212435.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212646 (pdf 212646.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 213648 (pdf 213648.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2021 , NDA 215794 (pdf 215794.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 205770 (pdf 205770.pdf not found) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBCITRATE POTASSIUM , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , NDA 215610 (pdf 215610.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 216692 (pdf 216692.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (COSETTE) APPROVAL= AP YEAR= 2023 , NDA 217128 (pdf 217128.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217665 (pdf 217665.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE IN PLASTIC CONTAINER (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 216323 (pdf 216323.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (COSETTE) APPROVAL= AP YEAR= 2023 , NDA 216755 (pdf 216755.pdf not found) INN (METRONIDAZOLE) LIKMEZ (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217511 (pdf 217511.pdf not found) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBCITRATE POTASSIUM , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 216795 (pdf 216795.pdf not found) INN (METRONIDAZOLE) METRONIDAZOLE (ENCUBE) APPROVAL= AP YEAR= 2024 , 303 ; CYPROHEPTADINE ; 129-03-3 ; 1961 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTISEROTONERGIC AGENT -- ANTI-ALLERGIC AGENTS -- HISTAMINE H1 ANTAGONISTS -- SEROTONIN ANTAGONISTS -- ANTICHOLINERGIC -- SEDATIVE , ; NDA 012649 (pdf 12649.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) PERIACTIN (MERCK) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 013220 (pdf 13220.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) PERIACTIN (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 040537 (pdf 40537.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (MOUNTAIN) APPROVAL= AP YEAR= 2003 , NDA 040644 (pdf 40644.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (KENTON) APPROVAL= AP YEAR= 2006 , NDA 040668 (pdf 40668.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (LYNE) APPROVAL= AP YEAR= 2006 , NDA 085245 (pdf 85245.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086165 (pdf 86165.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086580 (pdf 86580.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086678 (pdf 86678.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086737 (pdf 86737.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086808 (pdf 86808.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086833 (pdf 86833.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087001 (pdf 87001.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087056 (label 87056.pdf) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087129 (pdf 87129.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087284 (pdf 87284.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (VITARINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087405 (pdf 87405.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087566 (pdf 87566.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (MD PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087685 (pdf 87685.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087839 (pdf 87839.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088205 (pdf 88205.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088212 (pdf 88212.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 , NDA 088232 (pdf 88232.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088798 (pdf 88798.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089021 (pdf 89021.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (NASKA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089057 (pdf 89057.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089199 (pdf 89199.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 091295 (pdf 91295.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 205087 (pdf 205087.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2015 , NDA 204823 (pdf 204823.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (PATRIN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206553 (pdf 206553.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2016 , NDA 207783 (pdf 207783.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203191 (pdf 203191.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2017 , NDA 207555 (pdf 207555.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 208938 (pdf 208938.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209172 (pdf 209172.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209108 (pdf 209108.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (ELYSIUM) APPROVAL= AP YEAR= 2018 , NDA 206676 (pdf 206676.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 212423 (pdf 212423.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2019 , NDA 212491 (pdf 212491.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 205431 (pdf 205431.pdf not found) INN (CYPROHEPTADINE HYDROCHLORIDE) CYPROHEPTADINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , 304 ; BETAMETHASONE ; 378-44-9 ; 1961 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIPSORIATIC -- ANTIINFLAMMATORY -- CORTICOSTEROID -- ANTIPRURITIC -- VASOCONSTRICTIVE PROPERTIES , ; NDA 012657 (pdf 12657.pdf not found) INN (BETAMETHASONE) CELESTONE (SCHERING) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 014215 (label 14215.pdf) INN (BETAMETHASONE) CELESTONE (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 014762 (pdf 14762.pdf not found) INN (BETAMETHASONE) CELESTONE (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , 305 ; BETAMETHASONE ACETATE ; 987-24-6 ; 1965 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIPSORIATIC -- ANTIINFLAMMATORY -- CORTICOSTEROID -- ANTIPRURITIC -- VASOCONSTRICTIVE PROPERTIES , ; NDA 014602 (label 14602.pdf) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) CELESTONE SOLUSPAN (ORGANON) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY , NDA 090747 (pdf 90747.pdf not found) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (AM REGENT) APPROVAL= AP YEAR= 2009 , NDA 077838 (pdf 77838.pdf not found) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2023 , 306 ; BETAMETHASONE VALERATE ; 2152-44-5 ; 1967 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIPSORIATIC -- ANTIINFLAMMATORY -- CORTICOSTEROID -- ANTIPRURITIC -- VASOCONSTRICTIVE PROPERTIES , ; NDA 016322 (pdf 16322.pdf not found) INN (BETAMETHASONE VALERATE) VALISONE (SCHERING) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016740 (pdf 16740.pdf not found) INN (BETAMETHASONE VALERATE) VALISONE (SCHERING) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 016932 (pdf 16932.pdf not found) INN (BETAMETHASONE VALERATE) VALISONE (SCHERING) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 018642 (pdf 18642.pdf not found) INN (BETAMETHASONE VALERATE) BETA-VAL (COSETTE) APPROVAL= AP YEAR= 1983 , NDA 018839 (pdf 18839.pdf not found) INN (BETAMETHASONE VALERATE) BETADERM (ROACO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018860 (pdf 18860.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018861 (pdf 18861.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1983 , NDA 018862 (pdf 18862.pdf not found) INN (BETAMETHASONE VALERATE) BETATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018863 (pdf 18863.pdf not found) INN (BETAMETHASONE VALERATE) BETATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018864 (pdf 18864.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018865 (pdf 18865.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1983 , NDA 018866 (pdf 18866.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1983 , NDA 018867 (pdf 18867.pdf not found) INN (BETAMETHASONE VALERATE) BETATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018870 (pdf 18870.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020934 (label 20934.pdf) INN (BETAMETHASONE VALERATE) LUXIQ (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 070050 (pdf 70050.pdf not found) INN (BETAMETHASONE VALERATE) VALNAC (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 , NDA 070051 (pdf 70051.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 , NDA 070052 (pdf 70052.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (ANIMA) APPROVAL= AP YEAR= 1985 , NDA 070053 (pdf 70053.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 070062 (pdf 70062.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (TARO) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070069 (pdf 70069.pdf not found) INN (BETAMETHASONE VALERATE) BETA-VAL (COSETTE) APPROVAL= AP YEAR= 1985 , NDA 070072 (pdf 70072.pdf not found) INN (BETAMETHASONE VALERATE) BETA-VAL (COSETTE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070484 (pdf 70484.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070485 (pdf 70485.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070486 (pdf 70486.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071478 (pdf 71478.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071883 (pdf 71883.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (TEVA PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072041 (pdf 72041.pdf not found) INN (BETAMETHASONE VALERATE) DERMABET (TARO) APPROVAL= AP YEAR= 1988 , NDA 078337 (pdf 78337.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , NDA 208204 (pdf 208204.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (TARO) APPROVAL= AP YEAR= 2017 , NDA 207144 (pdf 207144.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (NOVAST LABS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210639 (pdf 210639.pdf not found) INN (BETAMETHASONE VALERATE) BETAMETHASONE VALERATE (XIROMED) APPROVAL= AP YEAR= 2023 , 307 ; VINBLASTINE ; 865-21-4 ; 1965 ; ; ; CLASS ANTINEOPLASTIC -- ALKALOID EXTRACTED FROM VINCA ROSEA LINN -- TUBULIN MODULATORS -- INHIBITION OF MICROTUBULE FORMATION IN THE MITOTIC SPINDLE RESULTING IN AN ARREST OF DIVIDING CELLS AT THE METAPHASE STAGE , ; NDA 012665 (pdf 12665.pdf not found) INN (VINBLASTINE SULFATE) VELBAN (LILLY) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 089011 (pdf 89011.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089311 (pdf 89311.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089365 (pdf 89365.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089395 (pdf 89395.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 089515 (pdf 89515.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 089565 (pdf 89565.pdf not found) INN (VINBLASTINE SULFATE) VINBLASTINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , 308 ; TRIOXSALEN ; 3902-71-4 ; 1964 ; DISCONTINUED ; NATURAL MOLECULE C00002502 ; CLASS DERMATOLOGICAL -- ANTIPSORIATIC -- ULTRAVIOLET-A RADIATION (UVA) AFTER PHOTOSENSITIZATION (PUVA THERAPY) , ; NDA 012697 (pdf 12697.pdf not found) INN (TRIOXSALEN) TRISORALEN (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , 309 ; AMITRIPTYLINE ; 50-48-6 ; 1961 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- NOREPINEPHRINE REUPTAKE INHIBITORS , ; NDA 012703 (pdf 12703.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) ELAVIL (ASTRAZENECA) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 012704 (pdf 12704.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) ELAVIL (ASTRAZENECA) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 014713 (pdf 14713.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) ETRAFON-A (SCHERING) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 014715 (pdf 14715.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) TRIAVIL 2-25 (NEW RIVER) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 016949 (label 16949.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) LIMBITROL (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 040218 (pdf 40218.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040815 (pdf 40815.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CARACO) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040816 (pdf 40816.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040817 (pdf 40817.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CARACO) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040818 (pdf 40818.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CARACO) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040819 (pdf 40819.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CARACO) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040820 (pdf 40820.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CARACO) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 070297 (pdf 70297.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070336 (pdf 70336.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070337 (pdf 70337.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070338 (pdf 70338.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 070373 (pdf 70373.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070374 (pdf 70374.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070375 (pdf 70375.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070376 (pdf 70376.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070377 (pdf 70377.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070477 (pdf 70477.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070478 (pdf 70478.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070565 (pdf 70565.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070574 (pdf 70574.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070595 (pdf 70595.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070620 (pdf 70620.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070621 (pdf 70621.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070765 (pdf 70765.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (UNITED RES LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070766 (pdf 70766.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (UNITED RES LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070935 (pdf 70935.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070936 (pdf 70936.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070937 (pdf 70937.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070938 (pdf 70938.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070939 (pdf 70939.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071062 (pdf 71062.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071063 (pdf 71063.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071064 (pdf 71064.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071077 (pdf 71077.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071078 (pdf 71078.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071079 (pdf 71079.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071296 (pdf 71296.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 071297 (label 71297.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1986 , NDA 071442 (pdf 71442.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 071443 (label 71443.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1988 , NDA 071558 (pdf 71558.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071862 (pdf 71862.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071863 (pdf 71863.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072052 (pdf 72052.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072053 (pdf 72053.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072134 (pdf 72134.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072135 (pdf 72135.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072277 (pdf 72277.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072278 (pdf 72278.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072539 (pdf 72539.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072540 (pdf 72540.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072541 (pdf 72541.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 073007 (pdf 73007.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073008 (pdf 73008.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073009 (pdf 73009.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073010 (pdf 73010.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE) PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 083639 (pdf 83639.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) ENDEP (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083937 (pdf 83937.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083938 (pdf 83938.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083939 (pdf 83939.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084910 (pdf 84910.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1976 DISCONTINUED OBSOLETE , NDA 084957 (pdf 84957.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085030 (pdf 85030.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1976 DISCONTINUED OBSOLETE , NDA 085031 (pdf 85031.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085032 (pdf 85032.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085093 (pdf 85093.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085303 (pdf 85303.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) ENDEP (ROCHE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085594 (pdf 85594.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085627 (pdf 85627.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085742 (pdf 85742.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085743 (pdf 85743.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085744 (pdf 85744.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085745 (pdf 85745.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085749 (pdf 85749.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) ENDEP (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085815 (pdf 85815.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085816 (pdf 85816.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085817 (pdf 85817.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085819 (pdf 85819.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085820 (pdf 85820.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085821 (pdf 85821.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085836 (pdf 85836.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085864 (pdf 85864.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085922 (pdf 85922.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085923 (pdf 85923.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085925 (pdf 85925.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085926 (pdf 85926.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085927 (pdf 85927.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085935 (pdf 85935.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085936 (pdf 85936.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085944 (pdf 85944.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085945 (pdf 85945.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085966 (label 85966.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 OBSOLETE , NDA 085967 (label 85967.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 OBSOLETE , NDA 085968 (label 85968.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 , NDA 085969 (label 85969.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 OBSOLETE , NDA 085970 (label 85970.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 , NDA 085971 (label 85971.pdf) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1977 OBSOLETE , NDA 086002 (pdf 86002.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086003 (pdf 86003.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086004 (pdf 86004.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086009 (pdf 86009.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086010 (pdf 86010.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1978 , NDA 086011 (pdf 86011.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1978 , NDA 086090 (pdf 86090.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086143 (pdf 86143.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086144 (pdf 86144.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086145 (pdf 86145.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086146 (pdf 86146.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086147 (pdf 86147.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086148 (pdf 86148.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086153 (pdf 86153.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1978 , NDA 086157 (pdf 86157.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1978 , NDA 086158 (pdf 86158.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1978 , NDA 086295 (pdf 86295.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIL (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086335 (pdf 86335.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086336 (pdf 86336.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086337 (pdf 86337.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086454 (pdf 86454.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITID (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086610 (pdf 86610.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086743 (pdf 86743.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086744 (pdf 86744.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086745 (pdf 86745.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086746 (pdf 86746.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086747 (pdf 86747.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086853 (pdf 86853.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086854 (pdf 86854.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086857 (pdf 86857.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086859 (pdf 86859.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086860 (pdf 86860.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087181 (pdf 87181.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087278 (pdf 87278.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087366 (pdf 87366.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087367 (pdf 87367.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087368 (pdf 87368.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087369 (pdf 87369.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087370 (pdf 87370.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087557 (pdf 87557.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087616 (pdf 87616.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087617 (pdf 87617.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087632 (pdf 87632.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087639 (pdf 87639.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087647 (pdf 87647.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WEST WARD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087775 (pdf 87775.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088075 (pdf 88075.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088076 (pdf 88076.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088077 (pdf 88077.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088078 (pdf 88078.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088079 (pdf 88079.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088084 (pdf 88084.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088085 (pdf 88085.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088105 (pdf 88105.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088106 (pdf 88106.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088107 (pdf 88107.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088421 (pdf 88421.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088422 (pdf 88422.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088423 (pdf 88423.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088424 (pdf 88424.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088425 (pdf 88425.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088426 (pdf 88426.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088620 (pdf 88620.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088621 (pdf 88621.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088622 (pdf 88622.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088633 (pdf 88633.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088634 (pdf 88634.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088635 (pdf 88635.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088672 (pdf 88672.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088673 (pdf 88673.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088674 (pdf 88674.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088675 (pdf 88675.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088697 (pdf 88697.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088698 (pdf 88698.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088699 (pdf 88699.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088700 (pdf 88700.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088701 (pdf 88701.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088702 (pdf 88702.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088853 (pdf 88853.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088854 (pdf 88854.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088855 (pdf 88855.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088856 (pdf 88856.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088857 (pdf 88857.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088883 (pdf 88883.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088884 (pdf 88884.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088885 (pdf 88885.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088886 (pdf 88886.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088887 (pdf 88887.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088888 (pdf 88888.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089398 (pdf 89398.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 089399 (pdf 89399.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1987 , NDA 089400 (pdf 89400.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 , NDA 089401 (pdf 89401.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 089402 (pdf 89402.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 , NDA 089403 (pdf 89403.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 089423 (pdf 89423.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 202446 (pdf 202446.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 210086 (pdf 210086.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 212654 (pdf 212654.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (AIPING PHARM INC) APPROVAL= AP YEAR= 2020 , NDA 213999 (pdf 213999.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214548 (pdf 214548.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2021 , NDA 211925 (pdf 211925.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 216243 (pdf 216243.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2022 , NDA 215376 (pdf 215376.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 217411 (pdf 217411.pdf not found) INN (AMITRIPTYLINE HYDROCHLORIDE) AMITRIPTYLINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2023 , 310 ; SULFAMETHOXAZOLE ; 723-46-6 ; 1965 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- SULFONAMIDES -- INHIBITS BACTERIAL SYNTHESIS OF DIHYDROFOLIC ACID BY COMPETING WITH PARA-AMINOBENZOIC ACID (PABA) -- DIHYDROPTEROATE SYNTHASE INHIBITOR -- ANTIMALARIALS , ; NDA 012715 (pdf 12715.pdf not found) INN (SULFAMETHOXAZOLE) GANTANOL (ROCHE) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 013294 (pdf 13294.pdf not found) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE) AZO GANTANOL (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 013664 (pdf 13664.pdf not found) INN (SULFAMETHOXAZOLE) GANTANOL (ROCHE) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 017376 (label 17376.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1973 , NDA 017377 (label 17377.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1973 , NDA 017560 (label 17560.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017598 (label 17598.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 018242 (pdf 18242.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018374 (label 18374.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018452 (label 18452.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018598 (label 18598.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018615 (label 18615.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM PEDIATRIC (PHARM ASSOC) APPROVAL= AP YEAR= 1983 , NDA 018812 (pdf 18812.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018852 (pdf 18852.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018854 (pdf 18854.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018946 (pdf 18946.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021105 (label 21105.pdf) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 070000 (pdf 70000.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070002 (pdf 70002.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070006 (pdf 70006.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MUTUAL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070007 (pdf 70007.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (MUTUAL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070022 (pdf 70022.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM (NOVEL LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070028 (pdf 70028.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070030 (pdf 70030.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070032 (pdf 70032.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM-DS (NOVEL LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070034 (pdf 70034.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) COTRIM (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070037 (pdf 70037.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070048 (pdf 70048.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) COTRIM D.S. (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070063 (pdf 70063.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULMEPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070064 (pdf 70064.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULMEPRIM PEDIATRIC (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070065 (pdf 70065.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM-SS (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070066 (pdf 70066.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM-DS (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070203 (pdf 70203.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070204 (pdf 70204.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070215 (pdf 70215.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070216 (pdf 70216.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070223 (pdf 70223.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070627 (pdf 70627.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070628 (pdf 70628.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070889 (pdf 70889.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070890 (pdf 70890.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071016 (pdf 71016.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 071017 (pdf 71017.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 071299 (pdf 71299.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071300 (pdf 71300.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071341 (pdf 71341.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071556 (pdf 71556.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071815 (pdf 71815.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) UROPLUS SS (SHIONOGI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071816 (pdf 71816.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) UROPLUS DS (SHIONOGI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072289 (pdf 72289.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072383 (pdf 72383.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072398 (pdf 72398.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072399 (pdf 72399.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (NASKA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072408 (pdf 72408.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MARTEC USA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072417 (pdf 72417.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (MARTEC USA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072768 (pdf 72768.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ROXANE) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072769 (pdf 72769.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073199 (pdf 73199.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073303 (label 73303.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1991 , NDA 074650 (label 74650.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 076817 (pdf 76817.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (VISTA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076899 (pdf 76899.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2005 , NDA 077612 (label 77612.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PRASCO) APPROVAL= AP YEAR= 2006 , NDA 077785 (pdf 77785.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 , NDA 078060 (pdf 78060.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2007 , NDA 085053 (pdf 85053.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085844 (pdf 85844.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (RISING) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086000 (pdf 86000.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086163 (pdf 86163.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087189 (pdf 87189.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (BARR) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087307 (pdf 87307.pdf not found) INN (SULFAMETHOXAZOLE) UROBAK (SHIONOGI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087662 (pdf 87662.pdf not found) INN (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090624 (pdf 90624.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091348 (pdf 91348.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090828 (pdf 90828.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 206607 (pdf 206607.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 212231 (pdf 212231.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (SOMERSET) APPROVAL= AP YEAR= 2019 , NDA 212699 (pdf 212699.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (LUPIN LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214330 (pdf 214330.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 311 ; THIETHYLPERAZINE ; 1420-55-9 ; 1961 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIEMETIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINE CLASS -- RELIEF OF NAUSEA AND VOMITING , ; NDA 012753 (pdf 12753.pdf not found) INN (THIETHYLPERAZINE MALEATE) TORECAN (NOVARTIS) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 012754 (pdf 12754.pdf not found) INN (THIETHYLPERAZINE MALATE) TORECAN (NOVARTIS) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 013247 (pdf 13247.pdf not found) INN (THIETHYLPERAZINE MALEATE) TORECAN (NOVARTIS) APPROVAL= AP YEAR= 1963 DISCONTINUED , 312 ; FLUOCINOLONE ACETONIDE ; 67-73-2 ; 1963 ; ; ; CLASS DERMATOLOGICALS -- ANTI-INFLAMMATORY AGENTS -- ANTIPRURITICS -- GLUCOCORTICOID -- SYNTHETIC FLUORINATED CORTICOSTEROID -- VASOCONSTRICTIVE PROPERTIES , ; NDA 012787 (label 12787.pdf) INN (FLUOCINOLONE ACETONIDE) SYNALAR (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY , NDA 013960 (pdf 13960.pdf not found) INN (FLUOCINOLONE ACETONIDE) SYNALAR (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1963 , NDA 015296 (label 15296.pdf) INN (FLUOCINOLONE ACETONIDE) SYNALAR (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1964 , NDA 016161 (pdf 16161.pdf not found) INN (FLUOCINOLONE ACETONIDE) SYNALAR-HP (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 019452 (label 19452.pdf) INN (FLUOCINOLONE ACETONIDE) DERMA-SMOOTHE/FS (HILL DERMAC) APPROVAL= AP YEAR= 1988 , NDA 020001 (pdf 20001.pdf not found) INN (FLUOCINOLONE ACETONIDE) CAPEX (GALDERMA LABS LP) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 021112 (label 21112.pdf) INN (FLUOCINOLONE ACETONIDE HYDROQUINONE TRETINOIN) TRI-LUMA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2002 , NDA 021737 (label 21737.pdf) INN (FLUOCINOLONE ACETONIDE) RETISERT (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2005 , NDA 040035 (pdf 40035.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040041 (pdf 40041.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 , NDA 040042 (pdf 40042.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040059 (pdf 40059.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 060700 (pdf 60700.pdf not found) INN (FLUOCINOLONE ACETONIDE NEOMYCIN SULFATE) NEO-SYNALAR (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1963 , NDA 086810 (pdf 86810.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086811 (pdf 86811.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087102 (pdf 87102.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087104 (pdf 87104.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1982 , NDA 087156 (pdf 87156.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUONID (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087157 (pdf 87157.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUONID (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087158 (pdf 87158.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUONID (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087159 (pdf 87159.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087300 (pdf 87300.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUONID (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088045 (pdf 88045.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (INVATECH) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088046 (pdf 88046.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088047 (pdf 88047.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ALLIED) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088048 (pdf 88048.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ALLIED) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088167 (pdf 88167.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1982 , NDA 088168 (pdf 88168.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1982 , NDA 088169 (pdf 88169.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1982 , NDA 088170 (pdf 88170.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1982 , NDA 088171 (pdf 88171.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOTREX (SAVAGE LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088172 (pdf 88172.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOTREX (SAVAGE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088173 (pdf 88173.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOTREX (SAVAGE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088174 (pdf 88174.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOTREX (SAVAGE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088312 (pdf 88312.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088360 (pdf 88360.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCET (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088361 (pdf 88361.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088449 (pdf 88449.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088499 (pdf 88499.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088506 (pdf 88506.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088507 (pdf 88507.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088742 (pdf 88742.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088756 (pdf 88756.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (USL PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088757 (pdf 88757.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (USL PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089124 (pdf 89124.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1985 , NDA 089524 (pdf 89524.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1988 , NDA 089525 (pdf 89525.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089526 (pdf 89526.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 1988 , NDA 021930 (label 21930.pdf) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (HILL DERMAC) APPROVAL= AP YEAR= 2005 NEWAPPLICATION OBSOLETE , NDA 091306 (pdf 91306.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201759 (pdf 201759.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201764 (pdf 201764.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202847 (pdf 202847.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2013 , NDA 202848 (pdf 202848.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2013 , NDA 201923 (label 201923.pdf) INN (FLUOCINOLONE ACETONIDE) ILUVIEN (ALIMERA SCIENCES INC) APPROVAL= AP YEAR= 2014 , NDA 091514 (pdf 91514.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206422 (pdf 206422.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (LUPIN) APPROVAL= AP YEAR= 2015 , NDA 090982 (pdf 90982.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (LYNE) APPROVAL= AP YEAR= 2016 , NDA 202368 (pdf 202368.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 2016 , NDA 203377 (pdf 203377.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (LYNE) APPROVAL= AP YEAR= 2016 , NDA 203378 (pdf 203378.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (LYNE) APPROVAL= AP YEAR= 2016 , NDA 208251 (label 208251.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE FLUOCINOLONE ACETONIDE) OTOVEL (LABORATORIOS SALVAT) APPROVAL= AP YEAR= 2016 , NDA 209336 (pdf 209336.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 2016 , NDA 202705 (pdf 202705.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207441 (pdf 207441.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208386 (pdf 208386.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202849 (pdf 202849.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 209596 (pdf 209596.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 210736 (pdf 210736.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLAC (PATRIN) APPROVAL= AP YEAR= 2018 , NDA 210331 (pdf 210331.pdf not found) INN (FLUOCINOLONE ACETONIDE) YUTIQ (ALIMERA SCIENCES INC) APPROVAL= AP YEAR= 2018 , NDA 210539 (pdf 210539.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINONIDE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 210556 (pdf 210556.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 210747 (pdf 210747.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (COSETTE) APPROVAL= AP YEAR= 2018 , NDA 211815 (pdf 211815.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINONIDE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 209913 (pdf 209913.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2019 , NDA 212760 (pdf 212760.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 212761 (pdf 212761.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 212762 (pdf 212762.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 213264 (pdf 213264.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (TASMAN PHARMA) APPROVAL= AP YEAR= 2021 , NDA 207345 (pdf 207345.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2023 , NDA 207347 (pdf 207347.pdf not found) INN (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2023 , 313 ; FLURANDRENOLIDE ; 1524-88-5 ; 1963 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS -- ANTIPRURITIC -- VASOCONSTRICTIVE , ; NDA 012806 (label 12806.pdf) INN (FLURANDRENOLIDE) CORDRAN (ALMIRALL) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 013790 (label 13790.pdf) INN (FLURANDRENOLIDE) CORDRAN (ALMIRALL) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 016455 (pdf 16455.pdf not found) INN (FLURANDRENOLIDE) CORDRAN (ALMIRALL) APPROVAL= AP YEAR= 1969 , NDA 050345 (pdf 50345.pdf not found) INN (FLURANDRENOLIDE NEOMYCIN SULFATE) CORDRAN N (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050346 (pdf 50346.pdf not found) INN (FLURANDRENOLIDE NEOMYCIN SULFATE) CORDRAN N (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087203 (pdf 87203.pdf not found) INN (FLURANDRENOLIDE) FLURANDRENOLIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 205342 (label 205342.pdf) INN (FLURANDRENOLIDE) FLURANDRENOLIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205343 (pdf 205343.pdf not found) INN (FLURANDRENOLIDE) FLURANDRENOLIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207133 (pdf 207133.pdf not found) INN (FLURANDRENOLIDE) FLURANDRENOLIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2016 , NDA 207851 (pdf 207851.pdf not found) INN (FLURANDRENOLIDE) FLURANDRENOLIDE (TELIGENT) APPROVAL= AP YEAR= 2016 , 314 ; GLYCOPYRROLATE ; 596-51-0 ; 1961 ; ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ADJUVANTS DURING ANESTHESIA -- MUSCARINIC ANTAGONISTS -- TREATMENT OF PEPTIC ULCER , ; NDA 012827 (label 12827.pdf) INN (GLYCOPYRROLATE) ROBINUL (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY , NDA 014764 (pdf 14764.pdf not found) INN (GLYCOPYRROLATE) ROBINUL (ROBINS AH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017558 (label 17558.pdf) INN (GLYCOPYRROLATE) ROBINUL (HIKMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 040568 (pdf 40568.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040653 (pdf 40653.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 , NDA 040847 (pdf 40847.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 081169 (pdf 81169.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 085562 (pdf 85562.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085563 (pdf 85563.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086178 (pdf 86178.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 086900 (pdf 86900.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086902 (pdf 86902.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086947 (pdf 86947.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088475 (pdf 88475.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089335 (pdf 89335.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (AM REGENT) APPROVAL= AP YEAR= 1986 , NDA 089393 (pdf 89393.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089397 (pdf 89397.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040821 (pdf 40821.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (RISING) APPROVAL= AP YEAR= 2008 , NDA 040836 (pdf 40836.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 040844 (pdf 40844.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 , NDA 022571 (label 22571.pdf) INN (GLYCOPYRROLATE) CUVPOSA (MERZ PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090020 (pdf 90020.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (OXFORD PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090963 (pdf 90963.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2011 , NDA 090195 (pdf 90195.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (LEADING) APPROVAL= AP YEAR= 2012 , NDA 091522 (pdf 91522.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (LGM PHARMA) APPROVAL= AP YEAR= 2012 , NDA 202675 (pdf 202675.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2013 , NDA 091182 (pdf 91182.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (INDOCO) APPROVAL= AP YEAR= 2014 , NDA 207923 (label 207923.pdf) INN (GLYCOPYRROLATE) SEEBRI (NOVARTIS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207930 (label 207930.pdf) INN (GLYCOPYRROLATE INDACATEROL MALEATE) UTIBRON (NOVARTIS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091413 (pdf 91413.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (NATCO) APPROVAL= AP YEAR= 2016 , NDA 208294 (label 208294.pdf) INN (FORMOTEROL FUMARATE GLYCOPYRROLATE) BEVESPI AEROSPHERE (ASTRAZENECA) APPROVAL= AP YEAR= 2016 , NDA 207201 (pdf 207201.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207639 (pdf 207639.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 208973 (pdf 208973.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 208437 (label 208437.pdf) INN (GLYCOPYRROLATE) LONHALA MAGNAIR KIT (SUMITOMO PHARMA AM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209328 (pdf 209328.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 , NDA 203657 (pdf 203657.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 209024 (pdf 209024.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210244 (pdf 210244.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210842 (pdf 210842.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2018 , NDA 210927 (pdf 210927.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 210997 (label 210997.pdf) INN (GLYCOPYRROLATE) GLYRX-PF (EXELA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211334 (pdf 211334.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (SANDOZ) APPROVAL= AP YEAR= 2019 , NDA 211705 (pdf 211705.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (CAPLIN) APPROVAL= AP YEAR= 2019 , NDA 210361 (label 210361.pdf) INN (GLYCOPYRRONIUM TOSYLATE) QBREXZA (DERMIRA INC) APPROVAL= AP YEAR= 2018 , NDA 210246 (pdf 210246.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 212612 (pdf 212612.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 210083 (pdf 210083.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (SAGENT) APPROVAL= AP YEAR= 2020 , NDA 213238 (pdf 213238.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 212122 (label 212122.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE GLYCOPYRROLATE) BREZTRI AEROSPHERE (ASTRAZENECA AB) APPROVAL= AP YEAR= 2020 , NDA 212467 (pdf 212467.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (SUVEN PHARMS) APPROVAL= AP YEAR= 2022 , NDA 212227 (pdf 212227.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (XIROMED) APPROVAL= AP YEAR= 2021 , NDA 204438 (pdf 204438.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 212591 (pdf 212591.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 212802 (pdf 212802.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 214213 (pdf 214213.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215019 (label 215019.pdf) INN (GLYCOPYRROLATE) DARTISLA ODT (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213698 (pdf 213698.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214919 (label 214919.pdf) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2022 , NDA 212871 (pdf 212871.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ASPEN) APPROVAL= AP YEAR= 2022 , NDA 214635 (pdf 214635.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 215333 (pdf 215333.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 213655 (pdf 213655.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216903 (label 216903.pdf) INN (GLYCOPYRROLATE NEOSTIGMINE METHYLSULFATE) PREVDUO (AZURITY) APPROVAL= AP YEAR= 2023 , NDA 217354 (pdf 217354.pdf not found) INN (GLYCOPYRROLATE) GLYCOPYRROLATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , 315 ; DIPYRIDAMOLE ; 58-32-2 ; 1961 ; ; NATURAL MOLECULE C00031079 ; CLASS BLOOD -- CORONARY VASODILATOR -- PHOSPHODIESTERASE INHIBITORS -- ANTIPLATELET AGENT -- INHIBITS THE UPTAKE OF ADENOSINE INTO PLATELETS , ; NDA 012836 (label 12836.pdf) INN (DIPYRIDAMOLE) PERSANTINE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 019817 (pdf 19817.pdf not found) INN (DIPYRIDAMOLE) IV PERSANTINE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020884 (label 20884.pdf) INN (ASPIRIN DIPYRIDAMOLE) AGGRENOX (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040542 (pdf 40542.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (OXFORD PHARMS) APPROVAL= AP YEAR= 2006 , NDA 040733 (pdf 40733.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (RISING) APPROVAL= AP YEAR= 2007 , NDA 040782 (pdf 40782.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (IMPAX LABS) APPROVAL= AP YEAR= 2007 , NDA 040874 (pdf 40874.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2008 , NDA 040898 (pdf 40898.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (GENUS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 074521 (pdf 74521.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (HIKMA) APPROVAL= AP YEAR= 1996 , NDA 074601 (pdf 74601.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074939 (pdf 74939.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 1998 , NDA 074952 (pdf 74952.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (DR REDDYS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074956 (pdf 74956.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075769 (pdf 75769.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 086944 (pdf 86944.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (ANI PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087160 (pdf 87160.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087184 (pdf 87184.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (BARR) APPROVAL= AP YEAR= 1980 , NDA 087561 (pdf 87561.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 087562 (pdf 87562.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 087716 (pdf 87716.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (BARR) APPROVAL= AP YEAR= 1984 , NDA 087717 (pdf 87717.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (BARR) APPROVAL= AP YEAR= 1987 , NDA 088999 (pdf 88999.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (GLENMARK GENERICS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089000 (pdf 89000.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (GLENMARK GENERICS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089001 (pdf 89001.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (GLENMARK GENERICS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089425 (pdf 89425.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089426 (pdf 89426.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089427 (pdf 89427.pdf not found) INN (DIPYRIDAMOLE) DIPYRIDAMOLE (PUREPAC PHARM) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 078804 (pdf 78804.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (BARR) APPROVAL= AP YEAR= 2009 , NDA 206392 (pdf 206392.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206739 (pdf 206739.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (SANDOZ) APPROVAL= AP YEAR= 2017 , NDA 206964 (pdf 206964.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207944 (pdf 207944.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (PAR PHARM INC) APPROVAL= AP YEAR= 2017 , NDA 206753 (pdf 206753.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208572 (pdf 208572.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (SUN PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209048 (pdf 209048.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 204552 (pdf 204552.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210318 (pdf 210318.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (GLENMARK PHARMS SA) APPROVAL= AP YEAR= 2019 , NDA 209929 (pdf 209929.pdf not found) INN (ASPIRIN DIPYRIDAMOLE) ASPIRIN AND DIPYRIDAMOLE (MICRO LABS) APPROVAL= AP YEAR= 2021 , 316 ; POLYTHIAZIDE ; 346-18-9 ; 1961 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012845 (pdf 12845.pdf not found) INN (POLYTHIAZIDE) RENESE (PFIZER) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 013636 (pdf 13636.pdf not found) INN (POLYTHIAZIDE RESERPINE) RENESE-R (PFIZER) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 017986 (pdf 17986.pdf not found) INN (POLYTHIAZIDE PRAZOSIN HYDROCHLORIDE) MINIZIDE (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , 317 ; URACIL MUSTARD ; 66-75-1 ; 1962 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENT -- TREATMENT OF LYMPHOMA, CHRONIC LYMPHATIC LEUKEMIA, AND THROMBOCYTHEMIA , ; NDA 012892 (label 12892.pdf) INN (URACIL MUSTARD) URACIL MUSTARD (SHIRE) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , 318 ; METYRAPONE ; 54-36-4 ; 1961 ; ; ; CLASS VARIOUS -- ANTIMETABOLITES -- INHIBITOR OF ENDOGENOUS ADRENAL CORTICOSTEROID SYNTHESIS -- REDUCE CORTISOL AND CORTICOSTERONE PRODUCTION BY INHIBITING THE 11-BETA-HYDROXYLATION REACTION IN THE ADRENAL CORTEX RESULTING IN AN INCREASE IN ADRENOCORTICOTROPIC HORMONE (ACTH) PRODUCTION BY THE PITUITARY -- ALSO SUPPRESS BIOSYNTHESIS OF ALDOSTERONE -- CYP11B1 INHIBITOR , ; NDA 012911 (label 12911.pdf) INN (METYRAPONE) METOPIRONE (HRA PHARMA) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY , 319 ; ETHIONAMIDE ; 536-33-4 ; 1965 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTITUBERCULAR AGENTS -- FATTY ACID SYNTHESIS INHIBITORS -- LEPROSTATIC AGENTS , ; NDA 013026 (label 13026.pdf) INN (ETHIONAMIDE) TRECATOR (WYETH PHARMS) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY , 320 ; METHOXYFLURANE ; 76-38-0 ; 1962 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 013056 (pdf 13056.pdf not found) INN (METHOXYFLURANE) PENTHRANE (ABBOTT) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , 321 ; CYCLOTHIAZIDE ; 177468-84-7 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 322 ; TRIAMTERENE ; 396-01-0 ; 1964 ; ; ; CLASS CARDIOVASCULAR -- ANTIKALIURETIC , ; NDA 013174 (pdf 13174.pdf not found) INN (TRIAMTERENE) DYRENIUM (CONCORDIA) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY , NDA 016042 (label 16042.pdf) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) DYAZIDE (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 019129 (label 19129.pdf) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) MAXZIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1984 , NDA 071251 (pdf 71251.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 1987 , NDA 071737 (pdf 71737.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071851 (pdf 71851.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 071969 (pdf 71969.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071980 (pdf 71980.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072011 (pdf 72011.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 072022 (pdf 72022.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073191 (pdf 73191.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073281 (pdf 73281.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1992 , NDA 073449 (pdf 73449.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 , NDA 073467 (pdf 73467.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074026 (pdf 74026.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074259 (pdf 74259.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074701 (pdf 74701.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074821 (pdf 74821.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074857 (pdf 74857.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074970 (pdf 74970.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075052 (pdf 75052.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 201407 (pdf 201407.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 208360 (pdf 208360.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208358 (pdf 208358.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 211581 (pdf 211581.pdf not found) INN (TRIAMTERENE) TRIAMTERENE (AGNITIO) APPROVAL= AP YEAR= 2019 , NDA 214768 (pdf 214768.pdf not found) INN (TRIAMTERENE) TRIAMTERENE (EYWA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216211 (pdf 216211.pdf not found) INN (HYDROCHLOROTHIAZIDE TRIAMTERENE) TRIAMTERENE AND HYDROCHLOROTHIAZIDE (RUBICON) APPROVAL= AP YEAR= 2022 , 323 ; METAXALONE ; 1665-48-1 ; 1962 ; ; ; CLASS NERVOUS SYSTEM -- MUSCLE RELAXANT -- ANALGESICS -- HYPNOTICS -- SEDATIVES , ; NDA 013217 (label 13217.pdf) INN (METAXALONE) SKELAXIN (KING PHARMS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 040486 (pdf 40486.pdf not found) INN (METAXALONE) METAXALONE (MOUNTAIN) APPROVAL= AP YEAR= 2015 , NDA 040445 (pdf 40445.pdf not found) INN (METAXALONE) METAXALONE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 203399 (pdf 203399.pdf not found) INN (METAXALONE) METAXALONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 022503 (label 22503.pdf) INN (METAXALONE) METAXALONE (PRIMUS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204770 (pdf 204770.pdf not found) INN (METAXALONE) METAXALONE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 203695 (pdf 203695.pdf not found) INN (METAXALONE) METAXALONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 207466 (pdf 207466.pdf not found) INN (METAXALONE) METAXALONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208774 (pdf 208774.pdf not found) INN (METAXALONE) METAXALONE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 213836 (pdf 213836.pdf not found) INN (METAXALONE) METAXALONE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , 324 ; DIAZEPAM ; 439-14-5 ; 1963 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANESTHETICS -- ANTICONVULSANTS -- ANTIEMETICS -- GABA AGONIST -- HYPNOTICS AND SEDATIVES -- MUSCLE RELAXANTS, CENTRAL -- BENZODIAZEPINE , ; NDA 013263 (label 13263.pdf) INN (DIAZEPAM) VALIUM (WAYLIS THERAP) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY , NDA 016087 (pdf 16087.pdf not found) INN (DIAZEPAM) VALIUM (ROCHE) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 018179 (pdf 18179.pdf not found) INN (DIAZEPAM) VALRELEASE (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019287 (pdf 19287.pdf not found) INN (DIAZEPAM) DIZAC (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020124 (label 20124.pdf) INN (DIAZEPAM) DIAZEPAM (US ARMY) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020648 (label 20648.pdf) INN (DIAZEPAM) DIASTAT (BAUSCH) APPROVAL= AP YEAR= 1997 , NDA 070152 (pdf 70152.pdf not found) INN (DIAZEPAM) DIAZEPAM (BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070153 (pdf 70153.pdf not found) INN (DIAZEPAM) DIAZEPAM (TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070154 (pdf 70154.pdf not found) INN (DIAZEPAM) DIAZEPAM (BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070209 (pdf 70209.pdf not found) INN (DIAZEPAM) DIAZEPAM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070210 (pdf 70210.pdf not found) INN (DIAZEPAM) DIAZEPAM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070222 (pdf 70222.pdf not found) INN (DIAZEPAM) DIAZEPAM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070226 (pdf 70226.pdf not found) INN (DIAZEPAM) DIAZEPAM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070227 (pdf 70227.pdf not found) INN (DIAZEPAM) DIAZEPAM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070228 (pdf 70228.pdf not found) INN (DIAZEPAM) DIAZEPAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070296 (pdf 70296.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070302 (pdf 70302.pdf not found) INN (DIAZEPAM) DIAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070303 (pdf 70303.pdf not found) INN (DIAZEPAM) DIAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070304 (pdf 70304.pdf not found) INN (DIAZEPAM) DIAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070311 (label 70311.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 070312 (label 70312.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070313 (label 70313.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 070325 (pdf 70325.pdf not found) INN (DIAZEPAM) DIAZEPAM (MYLAN) APPROVAL= AP YEAR= 1985 , NDA 070356 (pdf 70356.pdf not found) INN (DIAZEPAM) DIAZEPAM (ROXANE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 070357 (pdf 70357.pdf not found) INN (DIAZEPAM) DIAZEPAM (ROXANE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 070358 (pdf 70358.pdf not found) INN (DIAZEPAM) DIAZEPAM (ROXANE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 070360 (pdf 70360.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070361 (pdf 70361.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070362 (pdf 70362.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070423 (pdf 70423.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070424 (pdf 70424.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070425 (pdf 70425.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070456 (pdf 70456.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070457 (pdf 70457.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070458 (pdf 70458.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070462 (pdf 70462.pdf not found) INN (DIAZEPAM) DIAZEPAM (VIRTUS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070463 (pdf 70463.pdf not found) INN (DIAZEPAM) DIAZEPAM (VIRTUS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070464 (pdf 70464.pdf not found) INN (DIAZEPAM) DIAZEPAM (NUVO PHARM) APPROVAL= AP YEAR= 1986 , NDA 070662 (pdf 70662.pdf not found) INN (DIAZEPAM) DIAZEPAM (ABRAXIS PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070706 (pdf 70706.pdf not found) INN (DIAZEPAM) DIAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070707 (pdf 70707.pdf not found) INN (DIAZEPAM) DIAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070776 (pdf 70776.pdf not found) INN (DIAZEPAM) DIAZEPAM (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070781 (pdf 70781.pdf not found) INN (DIAZEPAM) DIAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070787 (pdf 70787.pdf not found) INN (DIAZEPAM) DIAZEPAM (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070788 (pdf 70788.pdf not found) INN (DIAZEPAM) DIAZEPAM (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070894 (pdf 70894.pdf not found) INN (DIAZEPAM) DIAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070895 (pdf 70895.pdf not found) INN (DIAZEPAM) DIAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070896 (pdf 70896.pdf not found) INN (DIAZEPAM) DIAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070903 (pdf 70903.pdf not found) INN (DIAZEPAM) DIAZEPAM (FERNDALE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070904 (pdf 70904.pdf not found) INN (DIAZEPAM) DIAZEPAM (FERNDALE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070905 (pdf 70905.pdf not found) INN (DIAZEPAM) DIAZEPAM (FERNDALE LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070911 (pdf 70911.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070912 (pdf 70912.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070928 (pdf 70928.pdf not found) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 070930 (pdf 70930.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070956 (pdf 70956.pdf not found) INN (DIAZEPAM) DIAZEPAM (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070987 (pdf 70987.pdf not found) INN (DIAZEPAM) DIAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070996 (pdf 70996.pdf not found) INN (DIAZEPAM) DIAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071134 (pdf 71134.pdf not found) INN (DIAZEPAM) DIAZEPAM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1987 , NDA 071135 (pdf 71135.pdf not found) INN (DIAZEPAM) DIAZEPAM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1987 , NDA 071136 (pdf 71136.pdf not found) INN (DIAZEPAM) DIAZEPAM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1987 , NDA 071307 (pdf 71307.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 , NDA 071308 (label 71308.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071309 (label 71309.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071310 (label 71310.pdf) INN (DIAZEPAM) DIAZEPAM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071321 (pdf 71321.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 , NDA 071322 (pdf 71322.pdf not found) INN (DIAZEPAM) DIAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 , NDA 071415 (pdf 71415.pdf not found) INN (DIAZEPAM) DIAZEPAM INTENSOL (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 071583 (pdf 71583.pdf not found) INN (DIAZEPAM) DIAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 071584 (pdf 71584.pdf not found) INN (DIAZEPAM) DIAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071613 (pdf 71613.pdf not found) INN (DIAZEPAM) DIAZEPAM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071614 (pdf 71614.pdf not found) INN (DIAZEPAM) DIAZEPAM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072079 (pdf 72079.pdf not found) INN (DIAZEPAM) DIAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 072370 (label 72370.pdf) INN (DIAZEPAM) DIAZEPAM (WATSON LABS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072371 (pdf 72371.pdf not found) INN (DIAZEPAM) DIAZEPAM (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072397 (pdf 72397.pdf not found) INN (DIAZEPAM) DIAZEPAM (WATSON LABS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072402 (pdf 72402.pdf not found) INN (DIAZEPAM) DIAZEPAM (MARTEC USA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072431 (pdf 72431.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072432 (pdf 72432.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072433 (pdf 72433.pdf not found) INN (DIAZEPAM) Q-PAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 076815 (pdf 76815.pdf not found) INN (DIAZEPAM) DIAZEPAM (PARENTA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077749 (pdf 77749.pdf not found) INN (DIAZEPAM) DIAZEPAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 204433 (pdf 204433.pdf not found) INN (DIAZEPAM) DIAZEPAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2014 , NDA 206477 (pdf 206477.pdf not found) INN (DIAZEPAM) DIAZEPAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2016 , NDA 210363 (label 210363.pdf) INN (DIAZEPAM) DIAZEPAM (BELOTECA) APPROVAL= AP YEAR= 2019 , NDA 211998 (label 211998.pdf) INN (DIAZEPAM) DIAZEPAM (BELOTECA) APPROVAL= AP YEAR= 2019 , NDA 211635 (label 211635.pdf) INN (DIAZEPAM) VALTOCO (NEURELIS INC) APPROVAL= AP YEAR= 2020 , NDA 212641 (pdf 212641.pdf not found) INN (DIAZEPAM) LIBERVANT (AQUESTIVE) APPROVAL= TA YEAR= 2022 NEWAPPLICATION , NDA 214745 (pdf 214745.pdf not found) INN (DIAZEPAM) DIAZEPAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2022 , NDA 091076 (pdf 91076.pdf not found) INN (DIAZEPAM) DIAZEPAM (NOVEL LABS INC) APPROVAL= AP YEAR= 2023 , NDA 217843 (pdf 217843.pdf not found) INN (DIAZEPAM) DIAZEPAM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 218450 (pdf 218450.pdf not found) INN (DIAZEPAM) DIAZEPAM (ALEMBIC) APPROVAL= AP YEAR= 2024 , NDA 218623 (pdf 218623.pdf not found) INN (DIAZEPAM) LIBERVANT (AQUESTIVE) APPROVAL= AP YEAR= 2024 , 325 ; QUINETHAZONE ; 73-49-4 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- CARBONIC ANHYDRASE INHIBITOR (PMID23488823) , ; NDA 013264 (pdf 13264.pdf not found) INN (QUINETHAZONE) HYDROMOX (LEDERLE) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 013927 (pdf 13927.pdf not found) INN (QUINETHAZONE RESERPINE) HYDROMOX R (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , 326 ; PHENAZOPYRIDINE ; 94-78-0 ; 1990 ; DISCONTINUED ; ; CLASS GENITO -- URINARY TRACT ANALGESIC AGENT , ; NDA 013294 (pdf 13294.pdf not found) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE) AZO GANTANOL (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019358 (pdf 19358.pdf not found) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE) AZO GANTRISIN (ROCHE) APPROVAL= AP YEAR= 1990 NEWAPPLICATION DISCONTINUED , NDA 021105 (label 21105.pdf) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , 327 ; ACETOHEXAMIDE ; 968-81-0 ; 1964 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS , ; NDA 013378 (pdf 13378.pdf not found) INN (ACETOHEXAMIDE) DYMELOR (LILLY) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 070753 (pdf 70753.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070754 (pdf 70754.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070869 (pdf 70869.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 070870 (pdf 70870.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071893 (pdf 71893.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071894 (pdf 71894.pdf not found) INN (ACETOHEXAMIDE) ACETOHEXAMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , 328 ; METHYLDOPA ; 555-30-6 ; 1962 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- L-ISOMER OF ALPHA-METHYLDOPA -- DOPA DECARBOXYLASE INHIBITOR TO DEPLETE ANIMAL TISSUES OF NOREPINEPHRINE -- SYMPATHOLYTICS -- PROBABLY IS DUE TO ITS METABOLISM TO ALPHA-METHYL-NOREPINEPHRINE WHICH THEN LOWERS ARTERIAL PRESSURE , ; NDA 013400 (label 13400.pdf) INN (METHYLDOPA) ALDOMET (MERCK) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 013402 (pdf 13402.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) ALDORIL 15 (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 016016 (pdf 16016.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) ALDOCLOR-150 (MERCK) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 018389 (pdf 18389.pdf not found) INN (METHYLDOPA) ALDOMET (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018934 (pdf 18934.pdf not found) INN (METHYLDOPA) METHYLDOPA (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070060 (pdf 70060.pdf not found) INN (METHYLDOPA) METHYLDOPA (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070070 (pdf 70070.pdf not found) INN (METHYLDOPA) METHYLDOPA (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070073 (pdf 70073.pdf not found) INN (METHYLDOPA) METHYLDOPA (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070074 (pdf 70074.pdf not found) INN (METHYLDOPA) METHYLDOPA (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070075 (pdf 70075.pdf not found) INN (METHYLDOPA) METHYLDOPA (MYLAN) APPROVAL= AP YEAR= 1985 , NDA 070076 (pdf 70076.pdf not found) INN (METHYLDOPA) METHYLDOPA (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070084 (pdf 70084.pdf not found) INN (METHYLDOPA) METHYLDOPA (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070085 (pdf 70085.pdf not found) INN (METHYLDOPA) METHYLDOPA (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070098 (pdf 70098.pdf not found) INN (METHYLDOPA) METHYLDOPA (HERITAGE PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070182 (pdf 70182.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070183 (pdf 70183.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070192 (pdf 70192.pdf not found) INN (METHYLDOPA) METHYLDOPA (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070193 (pdf 70193.pdf not found) INN (METHYLDOPA) METHYLDOPA (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070194 (pdf 70194.pdf not found) INN (METHYLDOPA) METHYLDOPA (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070245 (pdf 70245.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070246 (pdf 70246.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070247 (pdf 70247.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070260 (pdf 70260.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070261 (pdf 70261.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070262 (pdf 70262.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070264 (pdf 70264.pdf not found) INN (METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070265 (pdf 70265.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070331 (pdf 70331.pdf not found) INN (METHYLDOPA) METHYLDOPA (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070332 (pdf 70332.pdf not found) INN (METHYLDOPA) METHYLDOPA (PARKE DAVIS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070333 (pdf 70333.pdf not found) INN (METHYLDOPA) METHYLDOPA (PARKE DAVIS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070343 (pdf 70343.pdf not found) INN (METHYLDOPA) METHYLDOPA (HERITAGE PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070365 (pdf 70365.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070366 (pdf 70366.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070367 (pdf 70367.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070368 (pdf 70368.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070452 (pdf 70452.pdf not found) INN (METHYLDOPA) METHYLDOPA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070535 (pdf 70535.pdf not found) INN (METHYLDOPA) METHYLDOPA (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070536 (pdf 70536.pdf not found) INN (METHYLDOPA) METHYLDOPA (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070537 (pdf 70537.pdf not found) INN (METHYLDOPA) METHYLDOPA (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070543 (pdf 70543.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070544 (pdf 70544.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070612 (pdf 70612.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070613 (pdf 70613.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070614 (pdf 70614.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070616 (pdf 70616.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070625 (pdf 70625.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070654 (pdf 70654.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND CHLOROTHIAZIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070669 (pdf 70669.pdf not found) INN (METHYLDOPA) METHYLDOPA (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070670 (pdf 70670.pdf not found) INN (METHYLDOPA) METHYLDOPA (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070688 (pdf 70688.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070689 (pdf 70689.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070703 (pdf 70703.pdf not found) INN (METHYLDOPA) METHYLDOPA (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070749 (pdf 70749.pdf not found) INN (METHYLDOPA) METHYLDOPA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070750 (pdf 70750.pdf not found) INN (METHYLDOPA) METHYLDOPA (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070783 (pdf 70783.pdf not found) INN (CHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND CHLOROTHIAZIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070829 (pdf 70829.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070830 (pdf 70830.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070853 (pdf 70853.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070854 (pdf 70854.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070958 (pdf 70958.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070959 (pdf 70959.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070960 (pdf 70960.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071006 (pdf 71006.pdf not found) INN (METHYLDOPA) METHYLDOPA (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071009 (pdf 71009.pdf not found) INN (METHYLDOPA) METHYLDOPA (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071067 (pdf 71067.pdf not found) INN (METHYLDOPA) METHYLDOPA (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071069 (pdf 71069.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071105 (pdf 71105.pdf not found) INN (METHYLDOPA) METHYLDOPA (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071106 (pdf 71106.pdf not found) INN (METHYLDOPA) METHYLDOPA (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071458 (pdf 71458.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071459 (pdf 71459.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071460 (pdf 71460.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071461 (pdf 71461.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071700 (pdf 71700.pdf not found) INN (METHYLDOPA) METHYLDOPA (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071751 (pdf 71751.pdf not found) INN (METHYLDOPA) METHYLDOPA (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071752 (pdf 71752.pdf not found) INN (METHYLDOPA) METHYLDOPA (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071753 (pdf 71753.pdf not found) INN (METHYLDOPA) METHYLDOPA (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071819 (pdf 71819.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071820 (pdf 71820.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071821 (pdf 71821.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071822 (pdf 71822.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071897 (pdf 71897.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071898 (pdf 71898.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071899 (pdf 71899.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071900 (pdf 71900.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071920 (pdf 71920.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071921 (pdf 71921.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071922 (pdf 71922.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071923 (pdf 71923.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072126 (pdf 72126.pdf not found) INN (METHYLDOPA) METHYLDOPA (PLIVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072127 (pdf 72127.pdf not found) INN (METHYLDOPA) METHYLDOPA (PLIVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072128 (pdf 72128.pdf not found) INN (METHYLDOPA) METHYLDOPA (PLIVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072507 (pdf 72507.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072508 (pdf 72508.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072509 (pdf 72509.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072510 (pdf 72510.pdf not found) INN (HYDROCHLOROTHIAZIDE METHYLDOPA) METHYLDOPA AND HYDROCHLOROTHIAZIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , 329 ; METHYLDOPATE ; 2508-79-4 ; 1962 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ALKALOID -- ANTIHYPERTENSIVE , ; NDA 013401 (pdf 13401.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) ALDOMET (MERCK) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 070291 (pdf 70291.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070652 (pdf 70652.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070691 (pdf 70691.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070698 (pdf 70698.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070699 (pdf 70699.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070841 (pdf 70841.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070849 (pdf 70849.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071024 (pdf 71024.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071279 (pdf 71279.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071812 (pdf 71812.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072974 (pdf 72974.pdf not found) INN (METHYLDOPATE HYDROCHLORIDE) METHYLDOPATE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , 330 ; ANISOTROPINE ; 25333-49-7 ; 1962 ; DISCONTINUED ; ; CLASS SENSORY -- ANTISPASMODIC -- ANTICHOLINERGIC , ; NDA 013428 (pdf 13428.pdf not found) INN (ANISOTROPINE METHYLBROMIDE) VALPIN 50 (ENDO PHARMS) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 086046 (pdf 86046.pdf not found) INN (ANISOTROPINE METHYLBROMIDE) ANISOTROPINE METHYLBROMIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , 331 ; PARGYLINE ; 555-57-7 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- MONOAMINE OXIDASE INHIBITOR , ; NDA 013448 (pdf 13448.pdf not found) INN (PARGYLINE HYDROCHLORIDE) EUTONYL (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016047 (pdf 16047.pdf not found) INN (METHYCLOTHIAZIDE PARGYLINE HYDROCHLORIDE) EUTRON (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , 332 ; ACETYLCYSTEINE ; 616-91-1 ; 1963 ; ; ; CLASS RESPIRATORY SYSTEM -- MUCOLYTIC -- ANTIVIRAL AGENTS -- EXPECTORANTS -- TREATMENT OF ACETAMINOPHEN OVERDOSE -- MAINTAINING OR RESTORING THE GLUTATHIONE LEVELS , ; NDA 013601 (pdf 13601.pdf not found) INN (ACETYLCYSTEINE) MUCOMYST (APOTHECON) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 017366 (pdf 17366.pdf not found) INN (ACETYLCYSTEINE ISOPROTERENOL HYDROCHLORIDE) MUCOMYST W/ ISOPROTERENOL (MEAD JOHNSON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021539 (label 21539.pdf) INN (ACETYLCYSTEINE) ACETADOTE (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2004 , NDA 070575 (pdf 70575.pdf not found) INN (ACETYLCYSTEINE) MUCOSIL-10 (DEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070576 (pdf 70576.pdf not found) INN (ACETYLCYSTEINE) MUCOSIL-20 (DEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071364 (pdf 71364.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 071365 (pdf 71365.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 071740 (pdf 71740.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071741 (pdf 71741.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072323 (pdf 72323.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072324 (pdf 72324.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072489 (pdf 72489.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (AM REGENT) APPROVAL= AP YEAR= 1995 , NDA 072547 (pdf 72547.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (AM REGENT) APPROVAL= AP YEAR= 1995 , NDA 072621 (pdf 72621.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072622 (pdf 72622.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073664 (pdf 73664.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074037 (pdf 74037.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 200644 (pdf 200644.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2012 , NDA 203853 (pdf 203853.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ALVOGEN) APPROVAL= AP YEAR= 2012 , NDA 204674 (pdf 204674.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ALVOGEN) APPROVAL= AP YEAR= 2014 , NDA 203173 (pdf 203173.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (RISING) APPROVAL= AP YEAR= 2015 , NDA 203624 (pdf 203624.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (RISING) APPROVAL= TA YEAR= 2015 , NDA 207358 (pdf 207358.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207916 (label 207916.pdf) INN (ACETYLCYSTEINE) CETYLEV (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 091684 (pdf 91684.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208166 (pdf 208166.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204797 (pdf 204797.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (EXELA PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213693 (pdf 213693.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (ASPEN) APPROVAL= AP YEAR= 2022 , NDA 215620 (pdf 215620.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (INDOCO) APPROVAL= AP YEAR= 2022 , NDA 217182 (pdf 217182.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (STERISCIENCE) APPROVAL= AP YEAR= 2023 , NDA 205643 (pdf 205643.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (EXELA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215040 (pdf 215040.pdf not found) INN (ACETYLCYSTEINE LYSINE) LEGUBETI (GALEPHAR) APPROVAL= AP YEAR= 2024 , NDA 218397 (pdf 218397.pdf not found) INN (ACETYLCYSTEINE) ACETYLCYSTEINE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2024 , 333 ; DESIPRAMINE ; 50-47-5 ; 1964 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC REUPTAKE INHIBITORS -- NOREPINEPHRINE REUPTAKE INHIBITORS , ; NDA 013621 (pdf 13621.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) PERTOFRANE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 014399 (label 14399.pdf) INN (DESIPRAMINE HYDROCHLORIDE) NORPRAMIN (VALIDUS PHARMS) APPROVAL= AP YEAR= 1964 , NDA 071588 (pdf 71588.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 1987 , NDA 071601 (pdf 71601.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 1987 , NDA 071602 (pdf 71602.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 1987 , NDA 071766 (pdf 71766.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 1987 , NDA 071800 (pdf 71800.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071801 (pdf 71801.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071802 (pdf 71802.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071803 (pdf 71803.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 071804 (pdf 71804.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED OBSOLETE , NDA 071864 (pdf 71864.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071865 (pdf 71865.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071866 (pdf 71866.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071867 (pdf 71867.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072099 (pdf 72099.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072100 (pdf 72100.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072101 (pdf 72101.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072102 (pdf 72102.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072103 (pdf 72103.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 072104 (pdf 72104.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 074430 (pdf 74430.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 1996 , NDA 207433 (pdf 207433.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2016 , NDA 208105 (pdf 208105.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2016 , NDA 205153 (pdf 205153.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204963 (pdf 204963.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 209785 (pdf 209785.pdf not found) INN (DESIPRAMINE HYDROCHLORIDE) DESIPRAMINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , 334 ; OXANDROLONE ; 53-39-4 ; 1964 ; DISCONTINUED ; ; CLASS METABOLISME -- ANDROGENIC AND ANABOLIC AGENT -- SYNTHETIC DERIVATIVE OF TESTOSTERONE -- PROMOTE WEIGHT GAIN , ; NDA 013718 (label 13718.pdf) INN (OXANDROLONE) OXANDRIN (GEMINI LABS LLC) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , NDA 076761 (label 76761.pdf) INN (OXANDROLONE) OXANDROLONE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076897 (label 76897.pdf) INN (OXANDROLONE) OXANDROLONE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077249 (pdf 77249.pdf not found) INN (OXANDROLONE) OXANDROLONE (ROXANE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077827 (pdf 77827.pdf not found) INN (OXANDROLONE) OXANDROLONE (PAR PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078033 (pdf 78033.pdf not found) INN (OXANDROLONE) OXANDROLONE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , 335 ; IDOXURIDINE ; 54-42-2 ; 1963 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGENTS -- NUCLEIC ACID SYNTHESIS INHIBITORS -- INTERFER WITH DNA SYNTHESIS , ; NDA 013934 (pdf 13934.pdf not found) INN (IDOXURIDINE) STOXIL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 013935 (pdf 13935.pdf not found) INN (IDOXURIDINE) HERPLEX (ALLERGAN) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 014169 (pdf 14169.pdf not found) INN (IDOXURIDINE) DENDRID (ALCON) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 015868 (pdf 15868.pdf not found) INN (IDOXURIDINE) STOXIL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1967 DISCONTINUED , 336 ; ETHYLESTRENOL ; 965-90-2 ; 1964 ; DISCONTINUED ; ; CLASS METABOLISM -- ANABOLIC , ; NDA 014005 (pdf 14005.pdf not found) INN (ETHYLESTRENOL) MAXIBOLIN (ORGANON USA INC) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 014006 (pdf 14006.pdf not found) INN (ETHYLESTRENOL) MAXIBOLIN (ORGANON USA INC) APPROVAL= AP YEAR= 1965 DISCONTINUED , 337 ; VINCRISTINE ; 57-22-7 ; 1963 ; ; ; CLASS ANTINEOPLASTIC -- ALKALOID FROM A COMMON FLOWERING HERB THE PERIWINKLE PLANT (VINCA ROSEA LINN) -- TUBULIN MODULATORS -- TREATMENT OF ACUTE LEUKEMIA -- INHIBITION OF MICROTUBULE FORMATION IN MITOTIC SPINDLE, RESULTING IN AN ARREST OF DIVIDING CELLS AT THE METAPHASE STAGE , ; NDA 014103 (pdf 14103.pdf not found) INN (VINCRISTINE SULFATE) ONCOVIN (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 070411 (pdf 70411.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070777 (pdf 70777.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070778 (pdf 70778.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070867 (pdf 70867.pdf not found) INN (VINCRISTINE SULFATE) VINCREX (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070873 (pdf 70873.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071222 (pdf 71222.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071223 (pdf 71223.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071426 (pdf 71426.pdf not found) INN (VINCRISTINE SULFATE) VINCASAR PFS (TEVA PARENTERAL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071484 (label 71484.pdf) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE PFS (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071559 (pdf 71559.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071560 (pdf 71560.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071561 (pdf 71561.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071937 (pdf 71937.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 075493 (pdf 75493.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE PFS (TEVA PHARMS USA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076296 (pdf 76296.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076401 (pdf 76401.pdf not found) INN (VINCRISTINE SULFATE) VINCRISTINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 202497 (label 202497.pdf) INN (VINCRISTINE SULFATE) MARQIBO KIT (ACROTECH) APPROVAL= AP YEAR= 2012 DISCONTINUED , 338 ; PRALIDOXIME ; 6735-59-7 ; 1964 ; ; ; CLASS VARIOUS -- ANTIDOTES AGAINST ORGANOPHOSPHATE PESTICIDES -- REACTIVATE CHOLINESTERASE WHICH HAS BEEN INACTIVATED BY PHOSPHORYLATION (ORGANOPHOSPHATES INACTIVATE ACETYLCHOLINESTERASE BY REACTING COVALENTLY WITH THE ACTIVE CENTER SERINE) , ; NDA 014122 (pdf 14122.pdf not found) INN (PRALIDOXIME CHLORIDE) PROTOPAM CHLORIDE (WYETH AYERST) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 014134 (label 14134.pdf) INN (PRALIDOXIME CHLORIDE) PROTOPAM CHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY , NDA 018799 (pdf 18799.pdf not found) INN (PRALIDOXIME CHLORIDE) PRALIDOXIME CHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018986 (pdf 18986.pdf not found) INN (PRALIDOXIME CHLORIDE) PRALIDOXIME CHLORIDE AUTOINJECTOR (MERIDIAN MEDCL TECHN) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 021175 (label 21175.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) ATNAA (US ARMY) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021983 (label 21983.pdf) INN (ATROPINE PRALIDOXIME CHLORIDE) DUODOTE (MMT) APPROVAL= AP YEAR= 2006 , NDA 072224 (pdf 72224.pdf not found) INN (PRALIDOXIME CHLORIDE) PRALIDOXIME CHLORIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 339 ; NALIDIXIC ACID ; 389-08-2 ; 1964 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- GRAM-NEGATIVE BACTERIA -- QUINOLONE ANTIBACTERIAL AGENT -- NUCLEIC ACID SYNTHESIS INHIBITORS , ; NDA 014214 (label 14214.pdf) INN (NALIDIXIC ACID) NEGGRAM (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 017430 (label 17430.pdf) INN (NALIDIXIC ACID) NEGGRAM (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 070270 (pdf 70270.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070271 (pdf 70271.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070272 (pdf 70272.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071919 (pdf 71919.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071936 (pdf 71936.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072061 (pdf 72061.pdf not found) INN (NALIDIXIC ACID) NALIDIXIC ACID (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , 340 ; NONOXYNOL-9 ; 26027-38-3 ; 1963 ; DISCONTINUED ; ; CLASS GENITO -- SPERMATOCIDE -- CONTRACEPTIVE , ; NDA 014349 (pdf 14349.pdf not found) INN (NONOXYNOL-9) DELFEN (PERSONAL PRODS) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 018683 (label 18683.pdf) INN (NONOXYNOL-9) TODAY (MAYER LABS INC) APPROVAL= AP YEAR= 1983 DISCONTINUED , 341 ; NORTRIPTYLINE ; 72-69-5 ; 1964 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC UPTAKE INHIBITORS -- NOREPINEPHRINE-REUPTAKE INHIBITORS , ; NDA 014684 (pdf 14684.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) AVENTYL HYDROCHLORIDE (LILLY) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 014685 (label 14685.pdf) INN (NORTRIPTYLINE HYDROCHLORIDE) AVENTYL (RANBAXY) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 018012 (label 18012.pdf) INN (NORTRIPTYLINE HYDROCHLORIDE) PAMELOR (SPECGX LLC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018013 (label 18013.pdf) INN (NORTRIPTYLINE HYDROCHLORIDE) PAMELOR (SPECGX LLC) APPROVAL= AP YEAR= 1977 , NDA 073553 (pdf 73553.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (MAYNE PHARMA) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073554 (pdf 73554.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (MAYNE PHARMA) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073555 (pdf 73555.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (MAYNE PHARMA) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073556 (pdf 73556.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073667 (pdf 73667.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074054 (pdf 74054.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074132 (pdf 74132.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074234 (pdf 74234.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074835 (pdf 74835.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075520 (pdf 75520.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2000 , NDA 075606 (pdf 75606.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2000 , NDA 077965 (pdf 77965.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 213441 (pdf 213441.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 217731 (pdf 217731.pdf not found) INN (NORTRIPTYLINE HYDROCHLORIDE) NORTRIPTYLINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , 342 ; MELPHALAN ; 148-82-3 ; 1964 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- MYELOABLATIVE AGONISTS , ; NDA 014691 (label 14691.pdf) INN (MELPHALAN) ALKERAN (APOTEX) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 020207 (label 20207.pdf) INN (MELPHALAN HYDROCHLORIDE) ALKERAN (APOTEX) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 090270 (pdf 90270.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2009 , NDA 090299 (pdf 90299.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090303 (pdf 90303.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2010 , NDA 207155 (label 207155.pdf) INN (MELPHALAN HYDROCHLORIDE) EVOMELA (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2016 , NDA 204773 (pdf 204773.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206018 (pdf 206018.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ACTAVIS LLC) APPROVAL= AP YEAR= 2016 , NDA 201379 (pdf 201379.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207809 (pdf 207809.pdf not found) INN (MELPHALAN) MELPHALAN (ALVOGEN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203393 (pdf 203393.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 , NDA 203655 (label 203655.pdf) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 204817 (pdf 204817.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ALMAJECT) APPROVAL= AP YEAR= 2019 , NDA 207032 (pdf 207032.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (USWM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209826 (pdf 209826.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211463 (pdf 211463.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ARTHUR GRP) APPROVAL= AP YEAR= 2019 , NDA 209197 (pdf 209197.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (BPI LABS) APPROVAL= AP YEAR= 2020 , NDA 209323 (pdf 209323.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (ACTAVIS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210947 (pdf 210947.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 212960 (pdf 212960.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 201848 (pdf 201848.pdf not found) INN (MELPHALAN HYDROCHLORIDE) HEPZATO (DELCATH SYSTEMS INC) APPROVAL= AP YEAR= 2023 , NDA 217110 (pdf 217110.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 215024 (pdf 215024.pdf not found) INN (MELPHALAN HYDROCHLORIDE) MELPHALAN HYDROCHLORIDE (HETERO LABS) APPROVAL= AP YEAR= 2024 , 343 ; CHLORPHENTERMINE ; 461-78-9 ; 0 ; DISCONTINUED ; ; CLASS ANTIANOREXIC -- APPETITE DEPRESSANTS -- SYMPATHOMIMETICS -- INCREASES EXTRACELLULAR LEVELS OF DOPAMINE -- POLYPHARMACOLOGY , ; NDA 014696 (pdf 14696.pdf not found) INN (CHLORPHENTERMINE HYDROCHLORIDE) PRE-SATE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 344 ; PRILOCAINE ; 721-50-6 ; 1965 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC (LOCAL) , ; NDA 014763 (pdf 14763.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE (ASTRAZENECA) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 019941 (label 19941.pdf) INN (LIDOCAINE PRILOCAINE) EMLA (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020962 (pdf 20962.pdf not found) INN (LIDOCAINE PRILOCAINE) EMLA (ASTRAZENECA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021382 (label 21382.pdf) INN (PRILOCAINE HYDROCHLORIDE) CITANEST PLAIN DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 021383 (label 21383.pdf) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1965 , NDA 021451 (label 21451.pdf) INN (LIDOCAINE PRILOCAINE) ORAQIX (DENTSPLY PHARM) APPROVAL= AP YEAR= 2003 , NDA 076290 (pdf 76290.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (AKORN) APPROVAL= AP YEAR= 2003 , NDA 076320 (pdf 76320.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ENCUBE) APPROVAL= AP YEAR= 2003 , NDA 076453 (pdf 76453.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 079235 (pdf 79235.pdf not found) INN (PRILOCAINE HYDROCHLORIDE) PRILOCAINE HYDROCHLORIDE (SEPTODONT INC) APPROVAL= AP YEAR= 2010 , NDA 078959 (pdf 78959.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (SEPTODONT INC) APPROVAL= AP YEAR= 2011 , NDA 205887 (pdf 205887.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213253 (pdf 213253.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212482 (pdf 212482.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PADAGIS US) APPROVAL= AP YEAR= 2021 , NDA 213923 (pdf 213923.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 345 ; DOXAPRAM ; 309-29-5 ; 1965 ; ; ; CLASS RESPIRATORY SYSTEM -- RESPIRATORY STIMULANT -- CENTRAL NERVOUS SYSTEM STIMULANTS , ; NDA 014879 (label 14879.pdf) INN (DOXAPRAM HYDROCHLORIDE) DOPRAM (HIKMA) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY , NDA 073529 (pdf 73529.pdf not found) INN (DOXAPRAM HYDROCHLORIDE) DOXAPRAM HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 076266 (pdf 76266.pdf not found) INN (DOXAPRAM HYDROCHLORIDE) DOXAPRAM HYDROCHLORIDE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2003 , 346 ; MEFENAMIC ACID ; 61-68-7 ; 1967 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY -- ANALGESIC -- ANTIPYRETIC -- PROSTAGLANDIN SYNTHETASE INHIBITION , ; NDA 015034 (label 15034.pdf) INN (MEFENAMIC ACID) PONSTEL (AVION PHARMS) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY , NDA 090562 (pdf 90562.pdf not found) INN (MEFENAMIC ACID) MEFENAMIC ACID (MICRO LABS) APPROVAL= AP YEAR= 2010 , NDA 091322 (pdf 91322.pdf not found) INN (MEFENAMIC ACID) MEFENAMIC ACID (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 090359 (pdf 90359.pdf not found) INN (MEFENAMIC ACID) MEFENAMIC ACID (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091608 (pdf 91608.pdf not found) INN (MEFENAMIC ACID) MEFENAMIC ACID (BELCHER) APPROVAL= AP YEAR= 2014 , NDA 209209 (pdf 209209.pdf not found) INN (MEFENAMIC ACID) MEFENAMIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2020 DISCONTINUED , 347 ; AMINOCAPROIC ACID ; 60-32-2 ; 1964 ; ; ; CLASS BLOOD -- HEMOSTATIC -- ANTIFIBRINOLYTIC AGENTS -- COMPETITIVE INHIBITOR OF PLASMIN , ; NDA 015197 (label 15197.pdf) INN (AMINOCAPROIC ACID) AMICAR (HIKMA) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 015229 (pdf 15229.pdf not found) INN (AMINOCAPROIC ACID) AMICAR (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 015230 (label 15230.pdf) INN (AMINOCAPROIC ACID) AMICAR (HIKMA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 018590 (pdf 18590.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 070010 (pdf 70010.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070522 (pdf 70522.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070694 (pdf 70694.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070888 (pdf 70888.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071192 (pdf 71192.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (LUITPOLD) APPROVAL= AP YEAR= 1987 , NDA 074759 (label 74759.pdf) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075602 (pdf 75602.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC (HIKMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 209060 (pdf 209060.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (SUNNY) APPROVAL= AP YEAR= 2018 , NDA 212492 (pdf 212492.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 212780 (pdf 212780.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 212814 (pdf 212814.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (VISTAPHARM LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211629 (pdf 211629.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (ANI PHARMS) APPROVAL= AP YEAR= 2020 , NDA 212494 (pdf 212494.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (TULEX PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212938 (pdf 212938.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (MSN) APPROVAL= AP YEAR= 2020 , NDA 212110 (pdf 212110.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213825 (pdf 213825.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (BELCHER) APPROVAL= AP YEAR= 2021 , NDA 213928 (pdf 213928.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (CARNEGIE) APPROVAL= AP YEAR= 2021 , NDA 214140 (pdf 214140.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (CARNEGIE) APPROVAL= AP YEAR= 2021 , NDA 215510 (pdf 215510.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (FLORIDA) APPROVAL= AP YEAR= 2022 , NDA 213944 (pdf 213944.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (OPTIMUS) APPROVAL= AP YEAR= 2022 , NDA 216464 (pdf 216464.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216804 (pdf 216804.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214458 (pdf 214458.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (TARO) APPROVAL= AP YEAR= 2023 , NDA 213213 (pdf 213213.pdf not found) INN (AMINOCAPROIC ACID) AMINOCAPROIC ACID (SUNNY) APPROVAL= AP YEAR= 2023 , 348 ; TOLAZAMIDE ; 1156-19-0 ; 1966 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREA CLASS , ; NDA 015500 (pdf 15500.pdf not found) INN (TOLAZAMIDE) TOLINASE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY DISCONTINUED , NDA 018894 (pdf 18894.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (COSETTE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070159 (pdf 70159.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070160 (pdf 70160.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070161 (pdf 70161.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070162 (pdf 70162.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070163 (pdf 70163.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070164 (pdf 70164.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070165 (pdf 70165.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070166 (pdf 70166.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070167 (pdf 70167.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070168 (pdf 70168.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070169 (pdf 70169.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070242 (pdf 70242.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070243 (pdf 70243.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070244 (pdf 70244.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070259 (pdf 70259.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070289 (pdf 70289.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070290 (pdf 70290.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070513 (pdf 70513.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070514 (pdf 70514.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070515 (pdf 70515.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070763 (pdf 70763.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070764 (pdf 70764.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071270 (pdf 71270.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071271 (pdf 71271.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071355 (pdf 71355.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071357 (pdf 71357.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071358 (pdf 71358.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071359 (pdf 71359.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071633 (pdf 71633.pdf not found) INN (TOLAZAMIDE) TOLAZAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , 349 ; OXAZEPAM ; 604-75-1 ; 1965 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTI-ANXIETY AGENTS -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 015539 (label 15539.pdf) INN (OXAZEPAM) SERAX (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 070640 (pdf 70640.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070641 (pdf 70641.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070650 (pdf 70650.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070683 (pdf 70683.pdf not found) INN (OXAZEPAM) OXAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070943 (pdf 70943.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070944 (pdf 70944.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070945 (pdf 70945.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071026 (pdf 71026.pdf not found) INN (OXAZEPAM) OXAZEPAM (UNITED RES LABS) APPROVAL= AP YEAR= 1987 , NDA 071494 (pdf 71494.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071508 (pdf 71508.pdf not found) INN (OXAZEPAM) OXAZEPAM (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071713 (pdf 71713.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071714 (pdf 71714.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071715 (pdf 71715.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071756 (pdf 71756.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071813 (pdf 71813.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071814 (pdf 71814.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071955 (pdf 71955.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071956 (pdf 71956.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071957 (pdf 71957.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072251 (pdf 72251.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072252 (pdf 72252.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072253 (pdf 72253.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 , NDA 072952 (pdf 72952.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072953 (pdf 72953.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072954 (pdf 72954.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1990 DISCONTINUED , 350 ; HALOPERIDOL ; 52-86-8 ; 1967 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- ANTIDYSKINETICS -- DOPAMINE ANTAGONISTS -- A BUTYROPHENONE NEUROLEPTIC AGENT , ; NDA 015921 (pdf 15921.pdf not found) INN (HALOPERIDOL) HALDOL (ORTHO MCNEIL) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 017079 (pdf 17079.pdf not found) INN (HALOPERIDOL) HALDOL SOLUTAB (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070278 (pdf 70278.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070720 (pdf 70720.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070721 (pdf 70721.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070722 (pdf 70722.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070723 (pdf 70723.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070724 (pdf 70724.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070725 (pdf 70725.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070981 (pdf 70981.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070982 (pdf 70982.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070983 (pdf 70983.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070984 (pdf 70984.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071071 (pdf 71071.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071072 (pdf 71072.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071073 (pdf 71073.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071074 (pdf 71074.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071075 (pdf 71075.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071076 (pdf 71076.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071128 (pdf 71128.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (AIPING PHARM INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071129 (pdf 71129.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (AIPING PHARM INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071130 (pdf 71130.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 1987 , NDA 071131 (pdf 71131.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (CYCLE) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071132 (pdf 71132.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (CYCLE) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071133 (pdf 71133.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (AIPING PHARM INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071156 (pdf 71156.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071157 (pdf 71157.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071172 (pdf 71172.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071173 (pdf 71173.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1988 , NDA 071177 (pdf 71177.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 071206 (pdf 71206.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SANDOZ) APPROVAL= AP YEAR= 1986 , NDA 071207 (pdf 71207.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SANDOZ) APPROVAL= AP YEAR= 1986 , NDA 071208 (pdf 71208.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071209 (pdf 71209.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (CHARTWELL RX) APPROVAL= AP YEAR= 1986 , NDA 071210 (pdf 71210.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071211 (pdf 71211.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071212 (pdf 71212.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (INNOGENIX) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 071216 (pdf 71216.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071217 (pdf 71217.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071218 (pdf 71218.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071219 (pdf 71219.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071220 (pdf 71220.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071221 (pdf 71221.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071233 (pdf 71233.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (VINTAGE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071234 (pdf 71234.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (VINTAGE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071235 (pdf 71235.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071236 (pdf 71236.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (VINTAGE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071237 (pdf 71237.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (VINTAGE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071255 (pdf 71255.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071256 (pdf 71256.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071257 (pdf 71257.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071269 (pdf 71269.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071328 (pdf 71328.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071374 (pdf 71374.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071375 (pdf 71375.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071376 (pdf 71376.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071571 (pdf 71571.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071572 (pdf 71572.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071573 (pdf 71573.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071722 (pdf 71722.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071723 (pdf 71723.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071724 (pdf 71724.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071725 (pdf 71725.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072113 (pdf 72113.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072121 (pdf 72121.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072122 (pdf 72122.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072353 (pdf 72353.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072727 (pdf 72727.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072728 (pdf 72728.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072729 (pdf 72729.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072730 (pdf 72730.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072731 (pdf 72731.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072732 (pdf 72732.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077580 (pdf 77580.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 020074 (pdf 20074.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (SAGENT PHARMS) APPROVAL= - YEAR= 0 , NDA 211061 (pdf 211061.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2020 , NDA 200854 (pdf 200854.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (ACTAVIS GROUP) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216004 (pdf 216004.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (MSN) APPROVAL= AP YEAR= 2022 , NDA 216918 (pdf 216918.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , NDA 218789 (pdf 218789.pdf not found) INN (HALOPERIDOL) HALOPERIDOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 351 ; SULFAMETER ; 651-06-9 ; 1966 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 016000 (pdf 16000.pdf not found) INN (SULFAMETER) SULLA (BAYER HLTHCARE) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY DISCONTINUED , 352 ; PROTRIPTYLINE ; 438-60-8 ; 1967 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- POLYPHARMACOLOGY , ; NDA 016012 (label 16012.pdf) INN (PROTRIPTYLINE HYDROCHLORIDE) VIVACTIL (TEVA WOMENS) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 073644 (label 73644.pdf) INN (PROTRIPTYLINE HYDROCHLORIDE) VIVACTIL (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073645 (label 73645.pdf) INN (PROTRIPTYLINE HYDROCHLORIDE) VIVACTIL (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 078913 (pdf 78913.pdf not found) INN (PROTRIPTYLINE HYDROCHLORIDE) PROTRIPTYLINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 090462 (pdf 90462.pdf not found) INN (PROTRIPTYLINE HYDROCHLORIDE) PROTRIPTYLINE HYDROCHLORIDE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2010 , NDA 202220 (pdf 202220.pdf not found) INN (PROTRIPTYLINE HYDROCHLORIDE) PROTRIPTYLINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , 353 ; AMANTADINE ; 768-94-5 ; 1968 ; ; ; CLASS NERVOUS SYSTEM -- ANTIVIRAL -- ANTIPARKINSONIAN -- TREATMENT OF DRUG-INDUCED EXTRAPYRIMIDAL REACTIONS , ; NDA 016020 (pdf 16020.pdf not found) INN (AMANTADINE HYDROCHLORIDE) SYMMETREL (ENDO PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016023 (label 16023.pdf) INN (AMANTADINE HYDROCHLORIDE) SYMMETREL (ENDO PHARMS) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 017118 (label 17118.pdf) INN (AMANTADINE HYDROCHLORIDE) SYMMETREL (ENDO PHARMS) APPROVAL= AP YEAR= 1976 NEWAPPLICATION DISCONTINUED , NDA 018101 (label 18101.pdf) INN (AMANTADINE HYDROCHLORIDE) SYMMETREL (ENDO PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 070589 (pdf 70589.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1987 , NDA 071000 (pdf 71000.pdf not found) INN (AMANTADINE HYDROCHLORIDE) SYMADINE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071293 (pdf 71293.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 071382 (pdf 71382.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072655 (pdf 72655.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (G AND W LABS INC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 073115 (pdf 73115.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074028 (pdf 74028.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1993 , NDA 074170 (pdf 74170.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1994 , NDA 074509 (pdf 74509.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1995 , NDA 075060 (pdf 75060.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075819 (pdf 75819.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (CMP PHARMA INC) APPROVAL= AP YEAR= 2002 , NDA 076186 (pdf 76186.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2002 , NDA 076352 (pdf 76352.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077659 (pdf 77659.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077992 (pdf 77992.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078720 (pdf 78720.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 208278 (pdf 208278.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207570 (pdf 207570.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208096 (pdf 208096.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 208107 (pdf 208107.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207571 (pdf 207571.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208966 (pdf 208966.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209035 (pdf 209035.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209047 (pdf 209047.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209171 (pdf 209171.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209221 (pdf 209221.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208944 (label 208944.pdf) INN (AMANTADINE HYDROCHLORIDE) GOCOVRI (ADAMAS OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209410 (label 209410.pdf) INN (AMANTADINE HYDROCHLORIDE) OSMOLEX ER (ADAMAS OPERATIONS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210403 (pdf 210403.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210129 (pdf 210129.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2020 , NDA 210215 (pdf 210215.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ATHEM) APPROVAL= AP YEAR= 2020 , NDA 212044 (pdf 212044.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2020 , NDA 214284 (pdf 214284.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 214178 (pdf 214178.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (ELYSIUM) APPROVAL= AP YEAR= 2021 , NDA 211354 (pdf 211354.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 212407 (pdf 212407.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214580 (pdf 214580.pdf not found) INN (AMANTADINE HYDROCHLORIDE) AMANTADINE HYDROCHLORIDE (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2022 , NDA 214897 (pdf 214897.pdf not found) INN (AMANTADINE) AMANTADINE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2022 , 354 ; ETHYNODIOL DIACETATE ; 297-76-7 ; 1966 ; ; ; CLASS GENITO -- CONTRACEPTIVES -- PROGESTIN -- RAPIDLY CONVERTED TO NORETHINDRONE , ; NDA 016029 (pdf 16029.pdf not found) INN (ETHYNODIOL DIACETATE MESTRANOL) OVULEN (GD SEARLE LLC) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 016705 (pdf 16705.pdf not found) INN (ETHYNODIOL DIACETATE MESTRANOL) OVULEN-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 016927 (pdf 16927.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/50-21 (GD SEARLE LLC) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016936 (pdf 16936.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/50-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 018160 (pdf 18160.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/35-28 (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018168 (pdf 18168.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) DEMULEN 1/35-21 (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 072720 (pdf 72720.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/35E-21 (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072721 (pdf 72721.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/35E-28 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072722 (pdf 72722.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/50E-21 (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072723 (pdf 72723.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ZOVIA 1/50E-28 (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 076785 (pdf 76785.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) KELNOR (BARR) APPROVAL= AP YEAR= 2005 , NDA 204704 (pdf 204704.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 204703 (pdf 204703.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 209547 (pdf 209547.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) MALMOREDE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 209548 (pdf 209548.pdf not found) INN (ETHINYL ESTRADIOL ETHYNODIOL DIACETATE) LO-MALMOREDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , 355 ; DIPHENIDOL ; 972-02-1 ; 1967 ; DISCONTINUED ; ; CLASS ANTIEMETIC -- ANTIVERTIGO AGENTS -- MUSCARINIC ACETYLCHOLINE RECEPTOR M2 ANTAGONIST , ; NDA 016033 (label 16033.pdf) INN (DIPHENIDOL HYDROCHLORIDE) VONTROL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , 356 ; DROPERIDOL ; 548-73-2 ; 1970 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- ANESTHESIA -- ANTIEMETICS -- DOPAMINE ANTAGONISTS -- A NEUROLEPTIC (TRANQUILIZER) AGENT , ; NDA 016049 (pdf 16049.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) INNOVAR (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016796 (pdf 16796.pdf not found) INN (DROPERIDOL) INAPSINE (RISING) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 070992 (pdf 70992.pdf not found) INN (DROPERIDOL) DROPERIDOL (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070993 (pdf 70993.pdf not found) INN (DROPERIDOL) DROPERIDOL (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071645 (pdf 71645.pdf not found) INN (DROPERIDOL) DROPERIDOL (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071750 (pdf 71750.pdf not found) INN (DROPERIDOL) DROPERIDOL (SMITH AND NEPHEW) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071754 (pdf 71754.pdf not found) INN (DROPERIDOL) DROPERIDOL (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071755 (pdf 71755.pdf not found) INN (DROPERIDOL) DROPERIDOL (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071941 (pdf 71941.pdf not found) INN (DROPERIDOL) DROPERIDOL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071942 (pdf 71942.pdf not found) INN (DROPERIDOL) DROPERIDOL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071981 (pdf 71981.pdf not found) INN (DROPERIDOL) DROPERIDOL (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071982 (pdf 71982.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072018 (pdf 72018.pdf not found) INN (DROPERIDOL) DROPERIDOL (ASTRAZENECA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072019 (pdf 72019.pdf not found) INN (DROPERIDOL) DROPERIDOL (IGI LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072020 (pdf 72020.pdf not found) INN (DROPERIDOL) DROPERIDOL (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072021 (pdf 72021.pdf not found) INN (DROPERIDOL) DROPERIDOL (IGI LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072026 (pdf 72026.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072027 (pdf 72027.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072028 (pdf 72028.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072123 (pdf 72123.pdf not found) INN (DROPERIDOL) DROPERIDOL (AM REGENT) APPROVAL= AP YEAR= 1988 , NDA 072272 (pdf 72272.pdf not found) INN (DROPERIDOL) DROPERIDOL (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 072335 (pdf 72335.pdf not found) INN (DROPERIDOL) DROPERIDOL (LUITPOLD) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 073520 (pdf 73520.pdf not found) INN (DROPERIDOL) DROPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073521 (pdf 73521.pdf not found) INN (DROPERIDOL) DROPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073523 (pdf 73523.pdf not found) INN (DROPERIDOL) DROPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 208197 (pdf 208197.pdf not found) INN (DROPERIDOL) DROPERIDOL (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , 357 ; FENTANYL ; 437-38-7 ; 1968 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- ANESTHETICS -- NARCOTICS -- MU-TYPE OPIOID RECEPTOR AGONISTS , ; NDA 016049 (pdf 16049.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) INNOVAR (AKORN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016619 (label 16619.pdf) INN (FENTANYL CITRATE) SUBLIMAZE PRESERVATIVE FREE (RISING) APPROVAL= AP YEAR= 1968 , NDA 019101 (label 19101.pdf) INN (FENTANYL CITRATE) FENTANYL CITRATE (HIKMA) APPROVAL= AP YEAR= 1984 , NDA 019115 (label 19115.pdf) INN (FENTANYL CITRATE) FENTANYL CITRATE (HOSPIRA) APPROVAL= AP YEAR= 1985 , NDA 019813 (label 19813.pdf) INN (FENTANYL) DURAGESIC-100 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020195 (pdf 20195.pdf not found) INN (FENTANYL CITRATE) FENTANYL (CEPHALON) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020747 (label 20747.pdf) INN (FENTANYL CITRATE) ACTIQ (CEPHALON) APPROVAL= AP YEAR= 1998 , NDA 021338 (label 21338.pdf) INN (FENTANYL HYDROCHLORIDE) IONSYS (THE MEDICINES CO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021947 (label 21947.pdf) INN (FENTANYL CITRATE) FENTORA (CEPHALON) APPROVAL= AP YEAR= 2006 , NDA 070636 (pdf 70636.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (ABBOTT) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 070637 (pdf 70637.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (ABBOTT) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 071982 (pdf 71982.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072026 (pdf 72026.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072027 (pdf 72027.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072028 (pdf 72028.pdf not found) INN (DROPERIDOL FENTANYL CITRATE) FENTANYL CITRATE AND DROPERIDOL (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072786 (pdf 72786.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1991 , NDA 073488 (pdf 73488.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074917 (pdf 74917.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE PRESERVATIVE FREE (DR REDDYS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076258 (pdf 76258.pdf not found) INN (FENTANYL) FENTANYL-25 (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2005 , NDA 076709 (pdf 76709.pdf not found) INN (FENTANYL) FENTANYL-25 (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077051 (pdf 77051.pdf not found) INN (FENTANYL) FENTANYL-25 (LAVIPHARM LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077062 (pdf 77062.pdf not found) INN (FENTANYL) FENTANYL-25 (MAYNE PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022266 (label 22266.pdf) INN (FENTANYL CITRATE) ONSOLIS (ADALVO) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077312 (label 77312.pdf) INN (FENTANYL CITRATE) FENTANYL CITRATE (PAR PHARM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077449 (pdf 77449.pdf not found) INN (FENTANYL) FENTANYL-25 (AVEVA) APPROVAL= AP YEAR= 2008 , NDA 077775 (pdf 77775.pdf not found) INN (FENTANYL) FENTANYL-25 (NOVEN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078907 (label 78907.pdf) INN (FENTANYL CITRATE) FENTANYL CITRATE (SPECGX LLC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079075 (pdf 79075.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (WATSON LABS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022510 (label 22510.pdf) INN (FENTANYL CITRATE) ABSTRAL (SENTYNL THERAPS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077154 (pdf 77154.pdf not found) INN (FENTANYL) FENTANYL-25 (SPECGX LLC) APPROVAL= AP YEAR= 2011 , NDA 022569 (label 22569.pdf) INN (FENTANYL CITRATE) LAZANDA (BTCP PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202788 (label 202788.pdf) INN (FENTANYL) SUBSYS (BTCP PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202577 (pdf 202577.pdf not found) INN (FENTANYL) FENTANYL (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2015 , NDA 202097 (pdf 202097.pdf not found) INN (FENTANYL) FENTANYL-12 (KINDEVA) APPROVAL= AP YEAR= 2016 , NDA 207338 (pdf 207338.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210762 (pdf 210762.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 212086 (pdf 212086.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 206329 (pdf 206329.pdf not found) INN (FENTANYL CITRATE) FENTANYL CITRATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 209655 (pdf 209655.pdf not found) INN (FENTANYL) FENTANYL-12 (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215870 (label 215870.pdf) INN (FENTANYL CITRATE) FENTANYL CITRATE (EXELA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , 358 ; INDOMETHACIN ; 53-86-1 ; 1965 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANALGESIC -- ANTIPYRETIC -- ANTIINFLAMMATORY -- CARDIOVASCULAR AGENTS -- CYCLOOXYGENASE INHIBITORS -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS (NSAIDS) , ; NDA 016059 (label 16059.pdf) INN (INDOMETHACIN) INDOCIN (ZYLA LIFE SCIENCES) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 017814 (label 17814.pdf) INN (INDOMETHACIN) INDOCIN (ZYLA LIFE SCIENCES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018185 (label 18185.pdf) INN (INDOMETHACIN) INDOCIN SR (ZYLA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018332 (label 18332.pdf) INN (INDOMETHACIN) INDOCIN (ZYLA) APPROVAL= AP YEAR= 1985 , NDA 018690 (pdf 18690.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018730 (pdf 18730.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018806 (pdf 18806.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018829 (label 18829.pdf) INN (INDOMETHACIN) INDOMETHACIN (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1984 , NDA 018851 (label 18851.pdf) INN (INDOMETHACIN) INDOMETHACIN (HERITAGE PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018858 (label 18858.pdf) INN (INDOMETHACIN) INDOMETHACIN (RISING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018878 (label 18878.pdf) INN (INDOMETHACIN SODIUM) INDOCIN (RECORDATI RARE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070067 (pdf 70067.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070068 (pdf 70068.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070266 (pdf 70266.pdf not found) INN (INDOMETHACIN) INDO-LEMMON (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070267 (pdf 70267.pdf not found) INN (INDOMETHACIN) INDO-LEMMON (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070326 (pdf 70326.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070327 (pdf 70327.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070353 (pdf 70353.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (CYCLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070354 (pdf 70354.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (CYCLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070487 (pdf 70487.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070488 (pdf 70488.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070529 (pdf 70529.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070530 (pdf 70530.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070592 (pdf 70592.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070624 (pdf 70624.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070635 (pdf 70635.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070651 (pdf 70651.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1986 , NDA 070673 (pdf 70673.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 070674 (pdf 70674.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 070719 (pdf 70719.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HERITAGE PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070756 (pdf 70756.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HERITAGE PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070782 (pdf 70782.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070784 (pdf 70784.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070785 (pdf 70785.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070813 (pdf 70813.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070899 (pdf 70899.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 070900 (pdf 70900.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071148 (pdf 71148.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071149 (pdf 71149.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071342 (pdf 71342.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071343 (pdf 71343.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071412 (pdf 71412.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071635 (pdf 71635.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072410 (pdf 72410.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072996 (pdf 72996.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072997 (pdf 72997.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073314 (pdf 73314.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (COSETTE) APPROVAL= AP YEAR= 1992 , NDA 074464 (pdf 74464.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SANDOZ) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076114 (pdf 76114.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076666 (pdf 76666.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 078713 (pdf 78713.pdf not found) INN (INDOMETHACIN SODIUM) INDOMETHACIN SODIUM (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 , NDA 022536 (label 22536.pdf) INN (INDOMETHACIN) INDOMETHACIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 079175 (pdf 79175.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (AVANTHI INC) APPROVAL= AP YEAR= 2009 , NDA 090403 (pdf 90403.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2010 , NDA 091549 (pdf 91549.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 , NDA 200529 (pdf 200529.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (CHARTWELL RX) APPROVAL= AP YEAR= 2010 , NDA 091276 (pdf 91276.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 091240 (pdf 91240.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2011 , NDA 201807 (pdf 201807.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2012 , NDA 091401 (pdf 91401.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202572 (pdf 202572.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (WATSON LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202139 (pdf 202139.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204768 (label 204768.pdf) INN (INDOMETHACIN) TIVORBEX (GENUS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202706 (pdf 202706.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204118 (pdf 204118.pdf not found) INN (INDOMETHACIN SODIUM) INDOMETHACIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2016 , NDA 204243 (pdf 204243.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203501 (pdf 203501.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 204853 (pdf 204853.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 206561 (label 206561.pdf) INN (INDOMETHACIN SODIUM) INDOMETHACIN SODIUM (NAVINTA LLC) APPROVAL= AP YEAR= 2017 , NDA 202711 (pdf 202711.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205215 (pdf 205215.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 216184 (pdf 216184.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217883 (pdf 217883.pdf not found) INN (INDOMETHACIN) INDOMETHACIN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2024 , 359 ; ALLOPURINOL ; 315-30-0 ; 1966 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- TREATMENT OF HYPERURICEMIA (GOUT SUPPRESSANT) -- XANTHINE OXIDASE INHIBITOR -- ANTIMETABOLITES -- ACTS ON PURINE CATABOLISM AND REDUCES THE PRODUCTION OF URIC ACID , ; NDA 016084 (label 16084.pdf) INN (ALLOPURINOL) ZYLOPRIM (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY , NDA 018241 (pdf 18241.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018297 (pdf 18297.pdf not found) INN (ALLOPURINOL) LOPURIN (ABBOTT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018659 (pdf 18659.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 018785 (pdf 18785.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018832 (label 18832.pdf) INN (ALLOPURINOL) ALLOPURINOL (WATSON LABS) APPROVAL= AP YEAR= 1984 , NDA 018877 (label 18877.pdf) INN (ALLOPURINOL) ALLOPURINOL (WATSON LABS) APPROVAL= AP YEAR= 1984 , NDA 020298 (label 20298.pdf) INN (ALLOPURINOL SODIUM) ALOPRIM (MYLAN) APPROVAL= AP YEAR= 1996 , NDA 070147 (pdf 70147.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (PURACAP PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070150 (pdf 70150.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (PURACAP PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070268 (pdf 70268.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (AIPING PHARM INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070269 (pdf 70269.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (SANDOZ) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070466 (pdf 70466.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070467 (pdf 70467.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070579 (pdf 70579.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070580 (pdf 70580.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070950 (pdf 70950.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070951 (pdf 70951.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071449 (pdf 71449.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071450 (pdf 71450.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 , NDA 071586 (pdf 71586.pdf not found) INN (ALLOPURINOL) LOPURIN (DR REDDYS LA) APPROVAL= AP YEAR= 1987 , NDA 071587 (pdf 71587.pdf not found) INN (ALLOPURINOL) LOPURIN (DR REDDYS LA) APPROVAL= AP YEAR= 1987 , NDA 075798 (pdf 75798.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (ENDO OPERATIONS) APPROVAL= AP YEAR= 2003 , NDA 076870 (pdf 76870.pdf not found) INN (ALLOPURINOL SODIUM) ALLOPURINOL SODIUM (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 077353 (pdf 77353.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (CHARTWELL) APPROVAL= AP YEAR= 2005 , NDA 078253 (pdf 78253.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 078390 (pdf 78390.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 090637 (pdf 90637.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (IPCA LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 203154 (pdf 203154.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 204467 (pdf 204467.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (INDOCO) APPROVAL= AP YEAR= 2016 , NDA 209203 (label 209203.pdf) INN (ALLOPURINOL LESINURAD) DUZALLO (IRONWOOD PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210117 (pdf 210117.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 211820 (pdf 211820.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 212363 (pdf 212363.pdf not found) INN (ALLOPURINOL SODIUM) ALLOPURINOL SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 214443 (pdf 214443.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (HARMAN FINOCHEM) APPROVAL= AP YEAR= 2022 , NDA 211807 (pdf 211807.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217748 (pdf 217748.pdf not found) INN (ALLOPURINOL) ALLOPURINOL (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , 360 ; M MIDODRINE ; 3600-87-1 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- VASOCONSTRICTOR -- ADRENERGIC ALPHA-AGONISTS -- SYMPATHOMIMETICS , ; 361 ; THIABENDAZOLE ; 148-79-8 ; 1967 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- ANTINEMATODAL AGENTS , ; NDA 016096 (label 16096.pdf) INN (THIABENDAZOLE) MINTEZOL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 016097 (label 16097.pdf) INN (THIABENDAZOLE) MINTEZOL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1967 DISCONTINUED , 362 ; CLOFIBRATE ; 637-07-0 ; 1967 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- ANTILIPIDEMIC AGENTS -- REDUCE THE VERY LOW-DENSITY LIPOPROTEIN FRACTION , ; NDA 016099 (pdf 16099.pdf not found) INN (CLOFIBRATE) ATROMID-S (WYETH AYERST) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 070531 (pdf 70531.pdf not found) INN (CLOFIBRATE) CLOFIBRATE (USL PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071603 (pdf 71603.pdf not found) INN (CLOFIBRATE) CLOFIBRATE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072191 (pdf 72191.pdf not found) INN (CLOFIBRATE) CLOFIBRATE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072600 (pdf 72600.pdf not found) INN (CLOFIBRATE) CLOFIBRATE (TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073396 (pdf 73396.pdf not found) INN (CLOFIBRATE) CLOFIBRATE (BANNER PHARMACAPS) APPROVAL= AP YEAR= 1992 DISCONTINUED , 363 ; TESTOLACTONE ; 968-93-4 ; 1969 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- INHIBITION OF STEROID AROMATASE ACTIVITY AND CONSEQUENT REDUCTION IN ESTRONE SYNTHESIS FROM ADRENAL ANDROSTENEDIONE -- TREATMENT OF BREAST CANCER IN POSTMENOPAUSAL WOMEN , ; NDA 016118 (label 16118.pdf) INN (TESTOLACTONE) TESLAC (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016119 (pdf 16119.pdf not found) INN (TESTOLACTONE) TESLAC (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , 364 ; CLOMIPHENE ; 911-45-5 ; 1967 ; ; ; CLASS GENITO -- INITIATION OF OVULATION -- FERTILITY AGENTS, FEMALE -- ESTROGEN RECEPTOR ANTAGONIST -- ZUCLOMIPHENE (CIS) HAS A LONGER HALF-LIFE THAN ENCLOMIPHENE (TRANS) , ; NDA 016131 (label 16131.pdf) INN (CLOMIPHENE CITRATE) CLOMID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 018361 (pdf 18361.pdf not found) INN (CLOMIPHENE CITRATE) SEROPHENE (EMD SERONO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 072196 (pdf 72196.pdf not found) INN (CLOMIPHENE CITRATE) MILOPHENE (GRANATA BIO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 075528 (pdf 75528.pdf not found) INN (CLOMIPHENE CITRATE) CLOMIPHENE CITRATE (COSETTE) APPROVAL= AP YEAR= 1999 , 365 ; PENTAZOCINE ; 359-83-1 ; 1967 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS, OPIOID WITH AGONIST/ANTAGONIST ACTION -- NARCOTIC ANTAGONISTS -- (+)-PENTAZOCINE IS A SELECTIVE SIGMA-1 RECEPTOR (SIG-1R) AGONIST (PMID25065832) , ; NDA 016194 (label 16194.pdf) INN (PENTAZOCINE LACTATE) TALWIN (HOSPIRA) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 016732 (pdf 16732.pdf not found) INN (PENTAZOCINE HYDROCHLORIDE) TALWIN 50 (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 016891 (pdf 16891.pdf not found) INN (ASPIRIN PENTAZOCINE HYDROCHLORIDE) TALWIN COMPOUND (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 018458 (label 18458.pdf) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) TALACEN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018733 (label 18733.pdf) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) TALWIN NX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 074699 (pdf 74699.pdf not found) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074736 (pdf 74736.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 , NDA 075523 (pdf 75523.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 , NDA 075735 (pdf 75735.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2001 , NDA 076202 (pdf 76202.pdf not found) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE (GAVIS PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , 366 ; ACETYLCHOLINE ; 51-84-3 ; 1973 ; ; ; CLASS SENSORY -- ACETYLCHOLINESTERASE INHIBITOR -- CHOLINERGIC AGENTS -- VASODILATOR AGENTS -- PARASYMPATHOMIMETIC -- ACETYLCHOLINE RECEPTOR: MUSCARINIC ACHRS AND NICOTINIC ACHRS -- AQUEOUS SOLUTIONS OF ACETYLCHOLINE CHLORIDE ARE UNSTABLE , ; NDA 016211 (pdf 16211.pdf not found) INN (ACETYLCHOLINE CHLORIDE) MIOCHOL (NOVARTIS) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 020213 (label 20213.pdf) INN (ACETYLCHOLINE CHLORIDE) MIOCHOL-E (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1993 , 367 ; PIPOBROMAN ; 54-91-1 ; 1966 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENT -- INHIBITING DNA AND RNA POLYMERASE -- REDUCING PYRIMIDINE NUCLEOTIDE INCORPORATION INTO DNA , ; NDA 016245 (pdf 16245.pdf not found) INN (PIPOBROMAN) VERCYTE (ABBOTT) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY DISCONTINUED , 368 ; DEFEROXAMINE ; 70-51-9 ; 1968 ; ; NATURAL MOLECULE NPA009012 ; CLASS VARIOUS -- IRON CHELATING AGENT -- ANTIMALARIALS , ; NDA 016267 (label 16267.pdf) INN (DEFEROXAMINE MESYLATE) DESFERAL (NOVARTIS) APPROVAL= AP YEAR= 1968 NEWMOLECULARENTITY , NDA 076019 (pdf 76019.pdf not found) INN (DEFEROXAMINE MESYLATE) DEFEROXAMINE MESYLATE (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 076806 (pdf 76806.pdf not found) INN (DEFEROXAMINE MESYLATE) DEFEROXAMINE MESYLATE (DR REDDYS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078086 (pdf 78086.pdf not found) INN (DEFEROXAMINE MESYLATE) DEFEROXAMINE MESYLATE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2007 , NDA 078718 (pdf 78718.pdf not found) INN (DEFEROXAMINE MESYLATE) DEFEROXAMINE MESYLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 , NDA 207384 (pdf 207384.pdf not found) INN (DEFEROXAMINE MESYLATE) DEFEROXAMINE MESYLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , 369 ; FUROSEMIDE ; 54-31-9 ; 1966 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) BLOCKER (PMID24117047) -- NA+, K+, 2CL- CO-TRANSPORTER ISOFORM 1 (NKCC1) BLOCKER (PMID24117047) , ; NDA 016273 (label 16273.pdf) INN (FUROSEMIDE) LASIX (VALIDUS PHARMS) APPROVAL= AP YEAR= 1966 NEWMOLECULARENTITY , NDA 016363 (pdf 16363.pdf not found) INN (FUROSEMIDE) LASIX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 017688 (pdf 17688.pdf not found) INN (FUROSEMIDE) LASIX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018025 (pdf 18025.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018267 (label 18267.pdf) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018369 (pdf 18369.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018370 (pdf 18370.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SUPERPHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 018413 (pdf 18413.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018415 (label 18415.pdf) INN (FUROSEMIDE) FUROSEMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018419 (pdf 18419.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018420 (pdf 18420.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018487 (label 18487.pdf) INN (FUROSEMIDE) FUROSEMIDE (MYLAN) APPROVAL= AP YEAR= 1981 , NDA 018507 (pdf 18507.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018569 (label 18569.pdf) INN (FUROSEMIDE) FUROSEMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1981 , NDA 018579 (label 18579.pdf) INN (FUROSEMIDE) FUROSEMIDE (AM REGENT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018667 (label 18667.pdf) INN (FUROSEMIDE) FUROSEMIDE (HOSPIRA) APPROVAL= AP YEAR= 1982 , NDA 018670 (pdf 18670.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018750 (pdf 18750.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 018753 (pdf 18753.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018790 (pdf 18790.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018823 (label 18823.pdf) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1983 , NDA 018868 (pdf 18868.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (KALAPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018902 (label 18902.pdf) INN (FUROSEMIDE) FUROSEMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1984 , NDA 019036 (pdf 19036.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070014 (pdf 70014.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070017 (pdf 70017.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1986 , NDA 070019 (pdf 70019.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070023 (pdf 70023.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070043 (pdf 70043.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070078 (pdf 70078.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070082 (pdf 70082.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070086 (pdf 70086.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 070095 (pdf 70095.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070096 (pdf 70096.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070100 (pdf 70100.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070412 (pdf 70412.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070413 (pdf 70413.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070433 (pdf 70433.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 070434 (label 70434.pdf) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 070449 (pdf 70449.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070450 (pdf 70450.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070528 (pdf 70528.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070578 (pdf 70578.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070604 (pdf 70604.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070655 (pdf 70655.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071379 (pdf 71379.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071439 (pdf 71439.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HIKMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 071594 (pdf 71594.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072080 (pdf 72080.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074017 (pdf 74017.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (MARSAM PHARMS LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074337 (pdf 74337.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 075241 (label 75241.pdf) INN (FUROSEMIDE) FUROSEMIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 076796 (pdf 76796.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (PRINSTON INC) APPROVAL= AP YEAR= 2004 , NDA 077293 (pdf 77293.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (LEADING) APPROVAL= AP YEAR= 2005 , NDA 077941 (pdf 77941.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 078010 (pdf 78010.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 091258 (pdf 91258.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202747 (pdf 202747.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2014 , NDA 203428 (pdf 203428.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 , NDA 207552 (pdf 207552.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2016 , NDA 212174 (pdf 212174.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 213902 (pdf 213902.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 208435 (pdf 208435.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (AREVA PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214766 (pdf 214766.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SAGENT) APPROVAL= AP YEAR= 2021 , NDA 212803 (pdf 212803.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 209988 (label 209988.pdf) INN (FUROSEMIDE) FUROSCIX (SCPHARMACEUTICALS) APPROVAL= AP YEAR= 2022 , NDA 216629 (pdf 216629.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216860 (pdf 216860.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215856 (pdf 215856.pdf not found) INN (FUROSEMIDE) FUROSEMIDE (SABA ILAC SANAYIVE) APPROVAL= AP YEAR= 2024 , 370 ; HYDROXYUREA ; 127-07-1 ; 1967 ; ; ; CLASS ANTINEOPLASTIC -- ANTISICKLING AGENTS (SICKLE CELL DISEASE) -- NUCLEIC ACID SYNTHESIS INHIBITORS -- INHIBITION OF DNA SYNTHESIS BY ACTING AS A RIBONUCLEOTIDE REDUCTASE INHIBITOR , ; NDA 016295 (label 16295.pdf) INN (HYDROXYUREA) HYDREA (CHEPLAPHARM) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY , NDA 074476 (pdf 74476.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075020 (pdf 75020.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (BARR LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075143 (pdf 75143.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (BARR) APPROVAL= AP YEAR= 1998 , NDA 075340 (pdf 75340.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (ENDO OPERATIONS) APPROVAL= AP YEAR= 1999 , NDA 075734 (pdf 75734.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 208843 (label 208843.pdf) INN (HYDROXYUREA) SIKLOS (THERAVIA) APPROVAL= AP YEAR= 2017 , NDA 213438 (pdf 213438.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (LEADING) APPROVAL= AP YEAR= 2020 , NDA 216593 (pdf 216593.pdf not found) INN (HYDROXYUREA) XROMI (NOVA LABS LTD) APPROVAL= AP YEAR= 2024 , NDA 218021 (pdf 218021.pdf not found) INN (HYDROXYUREA) HYDROXYUREA (QILU) APPROVAL= AP YEAR= 2024 , 371 ; ETHAMBUTOL ; 74-55-5 ; 1967 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- INHIBITS THE BIOSYNTHESIS OF CELL WALL ARABINOGALACTAN (AG) RESULTING IN ACCUMULATION OF MYCOLIC ACIDS AND CELL DEATH (PMID25547657) -- , ; NDA 016320 (label 16320.pdf) INN (ETHAMBUTOL HYDROCHLORIDE) MYAMBUTOL (STI PHARMA LLC) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY , NDA 075095 (pdf 75095.pdf not found) INN (ETHAMBUTOL HYDROCHLORIDE) ETHAMBUTOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1999 , NDA 076057 (pdf 76057.pdf not found) INN (ETHAMBUTOL HYDROCHLORIDE) ETHAMBUTOL HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 078939 (pdf 78939.pdf not found) INN (ETHAMBUTOL HYDROCHLORIDE) ETHAMBUTOL HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2009 , 372 ; AZATHIOPRINE ; 446-86-6 ; 1968 ; ; ; CLASS ANTINEOPLASTIC -- IMMUNOSUPPRESSIVE ANTIMETABOLITES -- ANTIRHEUMATIC AGENTS -- AZATHIOPRINE IS METABOLIZED TO 6-MERCAPTOPURINE (6-MP) AND THEN BY HYPOXANTHINE-GUANINE PHOSPHORIBOSYLTRANSFERASE (HGPRT) AND DIVERSES KINASES WHICH LEAD TO THE INCORPORATION OF 6-THIOGUANINE NUCLEOTIDES (6-TGN) INTO DNA , ; NDA 016324 (label 16324.pdf) INN (AZATHIOPRINE) IMURAN (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1968 NEWMOLECULARENTITY , NDA 017391 (label 17391.pdf) INN (AZATHIOPRINE SODIUM) IMURAN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 071056 (pdf 71056.pdf not found) INN (AZATHIOPRINE SODIUM) AZATHIOPRINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074069 (pdf 74069.pdf not found) INN (AZATHIOPRINE) AZATHIOPRINE (AMNEAL) APPROVAL= AP YEAR= 1996 , NDA 074419 (pdf 74419.pdf not found) INN (AZATHIOPRINE SODIUM) AZATHIOPRINE SODIUM (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 075252 (pdf 75252.pdf not found) INN (AZATHIOPRINE) AZASAN (AAIPHARMA LLC) APPROVAL= AP YEAR= 1999 , NDA 075568 (pdf 75568.pdf not found) INN (AZATHIOPRINE) AZATHIOPRINE (RISING) APPROVAL= AP YEAR= 1999 , NDA 077621 (pdf 77621.pdf not found) INN (AZATHIOPRINE) AZATHIOPRINE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 208687 (pdf 208687.pdf not found) INN (AZATHIOPRINE) AZATHIOPRINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , 373 ; FLUMETHASONE PIVALATE ; 2002-29-1 ; 0 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTI-INFLAMMATORY AGENTS -- ANTIPRURITICS , ; NDA 016379 (pdf 16379.pdf not found) INN (FLUMETHASONE PIVALATE) LOCORTEN (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 374 ; ACETAMINOPHEN ; 103-90-2 ; 1968 ; ; NATURAL MOLECULE C00044491 ; CLASS NERVOUS SYSTEM -- ANTIPYRETIC -- ANALGESIC -- NON-SALICYLATE ANALGESIC -- MECHANISM IS NOT ESTABLISHED BUT IT INVOLVES CENTRAL ACTIONS , ; NDA 016401 (pdf 16401.pdf not found) INN (ACETAMINOPHEN) NEOPAP (POLYMEDICA) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016844 (pdf 16844.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) DARVOCET (AAIPHARMA LLC) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 017122 (label 17122.pdf) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) DARVOCET-N 50 (XANODYNE PHARM) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 017756 (pdf 17756.pdf not found) INN (ACETAMINOPHEN) TYLENOL (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017785 (pdf 17785.pdf not found) INN (ACETAMINOPHEN) INJECTAPAP (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018060 (label 18060.pdf) INN (ACETAMINOPHEN) ACEPHEN (COSETTE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018337 (label 18337.pdf) INN (ACETAMINOPHEN) ACETAMINOPHEN (TARO) APPROVAL= AP YEAR= 1980 , NDA 018458 (label 18458.pdf) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) TALACEN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 019453 (pdf 19453.pdf not found) INN (ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE SULFATE) DRIXORAL PLUS (SCHERING PLOUGH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019872 (label 19872.pdf) INN (ACETAMINOPHEN) TYLENOL (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1994 , NDA 020232 (label 20232.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORICET W/ CODEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1992 , NDA 020802 (label 20802.pdf) INN (ACETAMINOPHEN) EXCEDRIN MIGRAINE (GLAXOSMITHKLINE CONS) APPROVAL= AP YEAR= 1998 , NDA 021082 (label 21082.pdf) INN (ACETAMINOPHEN CLEMASTINE FUMARATE PSEUDOEPHEDRINE HYDROCHLORIDE) TAVIST ALLERGY/SINUS/HEADACHE (NOVARTIS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021123 (label 21123.pdf) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) ULTRACET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040061 (pdf 40061.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXILOX (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040084 (pdf 40084.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040085 (pdf 40085.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040094 (pdf 40094.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 040098 (label 40098.pdf) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040099 (label 40099.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCO (APIL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040100 (pdf 40100.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORTAB (UCB INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040105 (pdf 40105.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040106 (pdf 40106.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040109 (pdf 40109.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040117 (pdf 40117.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN HP (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040119 (pdf 40119.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AKORN) APPROVAL= AP YEAR= 1996 , NDA 040122 (pdf 40122.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040123 (pdf 40123.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040134 (pdf 40134.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (UCB INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040139 (pdf 40139.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040143 (pdf 40143.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040144 (pdf 40144.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040148 (label 40148.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCO (APIL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040149 (pdf 40149.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040155 (pdf 40155.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040157 (pdf 40157.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040171 (pdf 40171.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040182 (pdf 40182.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040199 (label 40199.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040201 (pdf 40201.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040203 (pdf 40203.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040210 (pdf 40210.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (UCB INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040219 (pdf 40219.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040223 (pdf 40223.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040234 (pdf 40234.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040236 (pdf 40236.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040240 (pdf 40240.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040248 (pdf 40248.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040257 (label 40257.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040261 (label 40261.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040267 (pdf 40267.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040272 (pdf 40272.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040280 (pdf 40280.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040281 (label 40281.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040288 (pdf 40288.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ZYDONE (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040289 (pdf 40289.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040303 (label 40303.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040304 (pdf 40304.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040307 (pdf 40307.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040308 (label 40308.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040309 (label 40309.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040316 (pdf 40316.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040330 (label 40330.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 , NDA 040336 (pdf 40336.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040341 (label 40341.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040355 (pdf 40355.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 , NDA 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HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2003 , NDA 040434 (label 40434.pdf) INN (ACETAMINOPHEN) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2001 OBSOLETE , NDA 040441 (pdf 40441.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CODRIX (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040443 (pdf 40443.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040447 (pdf 40447.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CODRIX (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040452 (pdf 40452.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040459 (pdf 40459.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040464 (pdf 40464.pdf not 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HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040495 (pdf 40495.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040496 (pdf 40496.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040507 (pdf 40507.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040508 (pdf 40508.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040511 (pdf 40511.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 , NDA 040513 (pdf 40513.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040520 (pdf 40520.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040535 (pdf 40535.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040545 (pdf 40545.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 040550 (pdf 40550.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040556 (pdf 40556.pdf not found) INN (ACETAMINOPHEN) HYDROCODONE BITARTRATE AND ACETAMINOPHEN () APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040601 (pdf 40601.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 040608 (pdf 40608.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2005 , NDA 040637 (pdf 40637.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WEST-WARD PHARM CORP) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040655 (pdf 40655.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040656 (pdf 40656.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040658 (pdf 40658.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2006 , NDA 040676 (pdf 40676.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040679 (pdf 40679.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040680 (pdf 40680.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040687 (pdf 40687.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040688 (pdf 40688.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WRASER PHARMS LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040692 (pdf 40692.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040698 (pdf 40698.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040701 (pdf 40701.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (BOCA PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040729 (pdf 40729.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040736 (pdf 40736.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 040746 (pdf 40746.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 040748 (pdf 40748.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040754 (pdf 40754.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040757 (pdf 40757.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040769 (pdf 40769.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040777 (pdf 40777.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2007 , NDA 040778 (pdf 40778.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 040779 (pdf 40779.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 040789 (pdf 40789.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040813 (pdf 40813.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040822 (pdf 40822.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040824 (pdf 40824.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040825 (pdf 40825.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RANBAXY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040826 (pdf 40826.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040834 (pdf 40834.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PHARM ASSOC) APPROVAL= AP YEAR= 2008 , NDA 070107 (pdf 70107.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPACET 100 (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070115 (pdf 70115.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070116 (pdf 70116.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070145 (pdf 70145.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070146 (pdf 70146.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070398 (pdf 70398.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070399 (pdf 70399.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070443 (pdf 70443.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070607 (pdf 70607.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1987 , NDA 070608 (pdf 70608.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1986 , NDA 070615 (pdf 70615.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070732 (pdf 70732.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070771 (pdf 70771.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070775 (pdf 70775.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070910 (pdf 70910.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071010 (pdf 71010.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ACINO PRODS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071011 (pdf 71011.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ACINO PRODS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071319 (pdf 71319.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072105 (pdf 72105.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072106 (pdf 72106.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072195 (pdf 72195.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072218 (pdf 72218.pdf not found) INN (ACETAMINOPHEN) ACEPHEN (COSETTE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072237 (pdf 72237.pdf not found) INN (ACETAMINOPHEN) ACEPHEN (COSETTE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072344 (pdf 72344.pdf not found) INN (ACETAMINOPHEN) ACEPHEN (COSETTE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073106 (pdf 73106.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ABLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073107 (pdf 73107.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ABLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073108 (pdf 73108.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ABLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074119 (pdf 74119.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074699 (pdf 74699.pdf not found) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074843 (pdf 74843.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074911 (pdf 74911.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) PHRENILIN WITH CAFFEINE AND CODEINE (VALEANT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075077 (pdf 75077.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (PERRIGO) APPROVAL= AP YEAR= 2000 , NDA 075618 (pdf 75618.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075738 (pdf 75738.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075794 (pdf 75794.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (PERRIGO) APPROVAL= AP YEAR= 2001 , NDA 075838 (pdf 75838.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075929 (pdf 75929.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2002 , NDA 076200 (pdf 76200.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (OHM LABS) APPROVAL= AP YEAR= 2002 , NDA 076202 (pdf 76202.pdf not found) INN (ACETAMINOPHEN PENTAZOCINE HYDROCHLORIDE) ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE (GAVIS PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076429 (pdf 76429.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) DARVOCET A500 (XANODYNE PHARM) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076475 (pdf 76475.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076528 (pdf 76528.pdf not found) INN (ACETAMINOPHEN) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2003 , NDA 076560 (pdf 76560.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2004 , NDA 076609 (pdf 76609.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076743 (pdf 76743.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (CORNERSTONE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076750 (pdf 76750.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (CORNERSTONE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076914 (pdf 76914.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077184 (pdf 77184.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2005 , NDA 077196 (pdf 77196.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077677 (pdf 77677.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (WOCKHARDT LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077821 (pdf 77821.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE NAPSYLATE) PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (MIRROR PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077858 (pdf 77858.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2008 , NDA 081051 (pdf 81051.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081067 (pdf 81067.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081068 (pdf 81068.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081069 (pdf 81069.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081070 (pdf 81070.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 081079 (pdf 81079.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081080 (pdf 81080.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081083 (pdf 81083.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081095 (pdf 81095.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081096 (pdf 81096.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081097 (pdf 81097.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) ACETAMINOPHEN , ASPIRIN , AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 081223 (pdf 81223.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081226 (pdf 81226.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081249 (pdf 81249.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 081250 (pdf 81250.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 083643 (pdf 83643.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (CARNRICK) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083689 (pdf 83689.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083871 (pdf 83871.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083872 (pdf 83872.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083951 (pdf 83951.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) EMPRACET W/ CODEINE PHOSPHATE #3 (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083978 (pdf 83978.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084360 (pdf 84360.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084444 (pdf 84444.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 2 (ROBINS AH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084445 (pdf 84445.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 3 (ROBINS AH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084446 (pdf 84446.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN W/ CODEINE NO. 4 (ROBINS AH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084656 (pdf 84656.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084659 (pdf 84659.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084667 (pdf 84667.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084999 (pdf 84999.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) WYGESIC (CARACO) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085055 (pdf 85055.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 1 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085056 (pdf 85056.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085057 (pdf 85057.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE (ORTHO MCNEIL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085100 (pdf 85100.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) DOLENE AP-65 (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085106 (pdf 85106.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) PERCOCET (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085217 (pdf 85217.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (EVERYLIFE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085218 (pdf 85218.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085288 (pdf 85288.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085291 (pdf 85291.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085363 (pdf 85363.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085364 (pdf 85364.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085365 (pdf 85365.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085375 (pdf 85375.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE OXYCODONE TEREPHTHALATE) TYLOX (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085607 (pdf 85607.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085638 (pdf 85638.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 4 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085639 (pdf 85639.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 3 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085640 (pdf 85640.pdf not found) INN (ACETAMINOPHEN ASPIRIN CODEINE PHOSPHATE) CODEINE , ASPIRIN , APAP FORMULA NO. 2 (SCHERER LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085667 (pdf 85667.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN (ABBOTT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 085676 (pdf 85676.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085685 (pdf 85685.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PROVAL #3 (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085794 (pdf 85794.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085795 (pdf 85795.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085856 (pdf 85856.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PHENAPHEN-650 W/ CODEINE (ROBINS AH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085861 (pdf 85861.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085868 (pdf 85868.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1978 , NDA 085883 (pdf 85883.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085896 (pdf 85896.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085910 (pdf 85910.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE 2.5/APAP 500 (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085911 (pdf 85911.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE 5/APAP 500 (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085917 (pdf 85917.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085964 (pdf 85964.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085992 (pdf 85992.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086024 (pdf 86024.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) CAPITAL AND CODEINE (VALEANT PHARMS LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086366 (pdf 86366.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ACI) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086549 (pdf 86549.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086681 (pdf 86681.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086683 (pdf 86683.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087003 (pdf 87003.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET (HIKMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087006 (pdf 87006.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087083 (pdf 87083.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1980 , NDA 087141 (pdf 87141.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087275 (pdf 87275.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087276 (pdf 87276.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087277 (pdf 87277.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087306 (pdf 87306.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087336 (pdf 87336.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORCET-HD (MALLINCKRODT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087406 (pdf 87406.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087421 (pdf 87421.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 4 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087422 (pdf 87422.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) TYLENOL W/ CODEINE NO. 3 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087423 (pdf 87423.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087433 (pdf 87433.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087463 (pdf 87463.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCET (SPECGX LLC) APPROVAL= AP YEAR= 1983 , NDA 087508 (pdf 87508.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 1981 , NDA 087550 (pdf 87550.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087628 (pdf 87628.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ANOQUAN (SHIRE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087629 (pdf 87629.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087653 (pdf 87653.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087677 (pdf 87677.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HY-PHEN (ASCHER) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087722 (pdf 87722.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) LORTAB (UCB INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087757 (pdf 87757.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) CO-GESIC (UCB INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087762 (pdf 87762.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PURACAP PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087804 (pdf 87804.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SPECGX LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087809 (pdf 87809.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) DURADYNE DHC (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087811 (pdf 87811.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) PHRENILIN (VALEANT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087919 (pdf 87919.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087920 (pdf 87920.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (USL PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087961 (pdf 87961.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) BANCAP HC (FOREST PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088037 (pdf 88037.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PAPA-DEINE #3 (VANGARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088058 (label 88058.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN (ABBVIE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088246 (pdf 88246.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) TYLOX-325 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088324 (pdf 88324.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088353 (pdf 88353.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088354 (pdf 88354.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088355 (pdf 88355.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088537 (pdf 88537.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088577 (pdf 88577.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088584 (pdf 88584.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) DHC PLUS (PHARM RES ASSOC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088599 (pdf 88599.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088616 (pdf 88616.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1984 , NDA 088627 (pdf 88627.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 088628 (pdf 88628.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN AND CODEINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 088629 (pdf 88629.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088715 (pdf 88715.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) PAPA-DEINE #4 (VANGARD) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088743 (pdf 88743.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088758 (pdf 88758.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088765 (pdf 88765.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088790 (pdf 88790.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) TYLOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088825 (pdf 88825.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088831 (pdf 88831.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) PHRENILIN FORTE (VALEANT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088871 (pdf 88871.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) NORCET (ABANA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088889 (pdf 88889.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BANCAP (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088898 (pdf 88898.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ACETAMINOPHEN AND HYDROCODONE BITARTRATE (CENT PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088944 (pdf 88944.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) SEDAPAP (MAYRAND) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088956 (pdf 88956.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088991 (pdf 88991.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUCET (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089006 (pdf 89006.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089007 (pdf 89007.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1986 , NDA 089008 (pdf 89008.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089023 (pdf 89023.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) TRIAD (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089067 (pdf 89067.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089080 (pdf 89080.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089102 (pdf 89102.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) FEMCET (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089115 (pdf 89115.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) MEDIGESIC PLUS (US CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089160 (pdf 89160.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ANEXSIA (MALLINCKRODT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089166 (pdf 89166.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC-A (LEITNER PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089175 (pdf 89175.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 1987 , NDA 089183 (pdf 89183.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089184 (pdf 89184.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089185 (pdf 89185.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089231 (pdf 89231.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089238 (pdf 89238.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089244 (pdf 89244.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089253 (pdf 89253.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089254 (pdf 89254.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089268 (pdf 89268.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) TRIAPRIN (DUNHALL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089271 (pdf 89271.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089290 (pdf 89290.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089291 (pdf 89291.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089351 (pdf 89351.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089360 (pdf 89360.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) CO-GESIC (CENT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089363 (pdf 89363.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (MIKART) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089385 (pdf 89385.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) TYCOLET (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089405 (pdf 89405.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) TENCON (MALLINCKRODT) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 089450 (pdf 89450.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1992 , NDA 089451 (pdf 89451.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089478 (pdf 89478.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089479 (pdf 89479.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089480 (pdf 89480.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089481 (pdf 89481.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089482 (pdf 89482.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089483 (pdf 89483.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (AM THERAP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089511 (pdf 89511.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089512 (pdf 89512.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089513 (pdf 89513.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089536 (pdf 89536.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089554 (pdf 89554.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089557 (pdf 89557.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089568 (pdf 89568.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089660 (pdf 89660.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089671 (pdf 89671.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN AND CODEINE PHOSPHATE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 089672 (pdf 89672.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN AND CODEINE PHOSPHATE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 089673 (pdf 89673.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (RHODES PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089689 (pdf 89689.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089696 (pdf 89696.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (IVAX PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089697 (pdf 89697.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089698 (pdf 89698.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089699 (pdf 89699.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089718 (pdf 89718.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089725 (pdf 89725.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ANEXSIA 7.5/650 (MALLINCKRODT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089736 (label 89736.pdf) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) VICODIN ES (ABBVIE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089775 (pdf 89775.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ROXICET 5/500 (ROXANE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089805 (pdf 89805.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089828 (pdf 89828.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089831 (pdf 89831.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089883 (pdf 89883.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089907 (pdf 89907.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ALLAY (IVAX PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089959 (pdf 89959.pdf not found) INN (ACETAMINOPHEN PROPOXYPHENE HYDROCHLORIDE) PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089971 (pdf 89971.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089987 (pdf 89987.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTAPAP (MIKART) APPROVAL= AP YEAR= 1992 , NDA 089988 (pdf 89988.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTAPAP (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 089990 (pdf 89990.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089994 (pdf 89994.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (HALSEY) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 089997 (pdf 89997.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (CHARTWELL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 089998 (pdf 89998.pdf not found) INN (ACETAMINOPHEN CODEINE 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BITARTRATE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090177 (pdf 90177.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090205 (pdf 90205.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090265 (pdf 90265.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CARACO) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090380 (pdf 90380.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CARACO) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090485 (pdf 90485.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 022450 (label 22450.pdf) INN (ACETAMINOPHEN) OFIRMEV (MALLINCKRODT HOSP) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040846 (pdf 40846.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 040849 (pdf 40849.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090415 (pdf 90415.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 040894 (pdf 40894.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (GENUS) APPROVAL= AP YEAR= 2011 , NDA 078569 (pdf 78569.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 , NDA 090956 (pdf 90956.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (LGM PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091238 (pdf 91238.pdf not found) INN (ACETAMINOPHEN 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OXYCODONE AND ACETAMINOPHEN (RHODES PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203573 (pdf 203573.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204031 (label 204031.pdf) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) XARTEMIS XR (MALLINCKRODT INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204785 (label 204785.pdf) INN (ACETAMINOPHEN) TREZIX (WRASER PHARMS LLC) APPROVAL= AP YEAR= 2014 , NDA 203484 (pdf 203484.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) ALLZITAL (LARKEN LABS INC) APPROVAL= AP YEAR= 2015 , NDA 204767 (label 204767.pdf) INN (ACETAMINOPHEN) ACETAMINOPHEN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 205120 (pdf 205120.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090468 (pdf 90468.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) ZYFREL (CYPRESS PHARM INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202605 (pdf 202605.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 202935 (pdf 202935.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 202991 (pdf 202991.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (RHODES PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204052 (pdf 204052.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (SANDOZ) APPROVAL= AP YEAR= 2016 , NDA 206470 (pdf 206470.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204209 (pdf 204209.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE AND DIHYDROCODEINE BITARTRATE (LARKEN LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205001 (pdf 205001.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206142 (pdf 206142.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 206245 (pdf 206245.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 207113 (pdf 207113.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) ACETAMINOPHEN OXYCODONE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2016 , NDA 207118 (pdf 207118.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 207137 (pdf 207137.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207229 (pdf 207229.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207386 (pdf 207386.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2016 , NDA 207574 (pdf 207574.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (CEROVENE INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204407 (pdf 204407.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204984 (pdf 204984.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ALVOGEN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206484 (pdf 206484.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206615 (pdf 206615.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (XSPIRE PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206718 (pdf 206718.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SPECGX LLC) APPROVAL= AP YEAR= 2017 , NDA 206869 (pdf 206869.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2017 , NDA 206885 (pdf 206885.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207152 (pdf 207152.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207171 (pdf 207171.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207172 (pdf 207172.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207419 (pdf 207419.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207635 (pdf 207635.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209036 (pdf 209036.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 209037 (pdf 209037.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 207313 (pdf 207313.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 207333 (pdf 207333.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED 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HYDROCHLORIDE) APADAZ (ZEVRA THERAP) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210644 (pdf 210644.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 202142 (pdf 202142.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2018 , NDA 203864 (pdf 203864.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 204733 (pdf 204733.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 207509 (pdf 207509.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 207709 (pdf 207709.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 208540 (pdf 208540.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209385 (pdf 209385.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209587 (pdf 209587.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209924 (pdf 209924.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209958 (pdf 209958.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211106 (pdf 211106.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 211487 (pdf 211487.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 211499 (pdf 211499.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 211023 (pdf 211023.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (WES PHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 211544 (pdf 211544.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 207834 (pdf 207834.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (CHARTWELL) APPROVAL= AP YEAR= 2019 , NDA 210817 (pdf 210817.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2019 , NDA 211610 (pdf 211610.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (EYWA) APPROVAL= AP YEAR= 2019 , NDA 211708 (pdf 211708.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212082 (pdf 212082.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 212083 (pdf 212083.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 212418 (pdf 212418.pdf not found) INN (ACETAMINOPHEN CODEINE PHOSPHATE) ACETAMINOPHEN AND CODEINE PHOSPHATE (ELITE LABS INC) APPROVAL= AP YEAR= 2019 , NDA 213115 (pdf 213115.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 204649 (pdf 204649.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 211543 (pdf 211543.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NESHER PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211690 (pdf 211690.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (CEROVENE INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211729 (pdf 211729.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211733 (label 211733.pdf) INN (ACETAMINOPHEN IBUPROFEN) ADVIL DUAL ACTION WITH ACETAMINOPHEN (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2020 , NDA 213046 (pdf 213046.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (TARO) APPROVAL= AP YEAR= 2020 , NDA 213321 (pdf 213321.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 203647 (pdf 203647.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 210969 (pdf 210969.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213255 (pdf 213255.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 204957 (label 204957.pdf) INN (ACETAMINOPHEN) ACETAMINOPHEN (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2021 , NDA 206610 (label 206610.pdf) INN (ACETAMINOPHEN) ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214039 (pdf 214039.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 201295 (pdf 201295.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 201448 (pdf 201448.pdf not found) INN (ACETAMINOPHEN OXYCODONE HYDROCHLORIDE) OXYCODONE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2021 , NDA 214087 (pdf 214087.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214331 (pdf 214331.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2021 , NDA 214928 (pdf 214928.pdf not found) INN (ACETAMINOPHEN HYDROCODONE BITARTRATE) HYDROCODONE BITARTRATE AND ACETAMINOPHEN (PRINSTON INC) APPROVAL= AP YEAR= 2021 , NDA 215047 (pdf 215047.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NOVAST LABS) APPROVAL= AP YEAR= 2021 , NDA 215486 (pdf 215486.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2021 , NDA 206968 (label 206968.pdf) INN (ACETAMINOPHEN) ACETAMINOPHEN (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 211695 (pdf 211695.pdf not found) INN (ACETAMINOPHEN ASPIRIN CAFFEINE) ACETAMINOPHEN , ASPIRIN AND CAFFEINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 214088 (pdf 214088.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (SENORES PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215135 (pdf 215135.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215138 (pdf 215138.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 214955 (pdf 214955.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (NE RX PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216467 (pdf 216467.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216617 (pdf 216617.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 205746 (pdf 205746.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2023 , NDA 209471 (label 209471.pdf) INN (ACETAMINOPHEN IBUPROFEN) COMBOGESIC (AFT PHARMS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214836 (pdf 214836.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 2023 , NDA 215403 (pdf 215403.pdf not found) INN (ACETAMINOPHEN) ACETAMINOPHEN (INFORLIFE) APPROVAL= AP YEAR= 2023 , NDA 215320 (pdf 215320.pdf not found) INN (ACETAMINOPHEN IBUPROFEN SODIUM) COMBOGESIC IV (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 216592 (pdf 216592.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 216994 (pdf 216994.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216999 (pdf 216999.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 214287 (pdf 214287.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214288 (pdf 214288.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214291 (pdf 214291.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214305 (pdf 214305.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 216376 (pdf 216376.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 218311 (pdf 218311.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 218359 (pdf 218359.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 375 ; PROPRANOLOL ; 525-66-6 ; 1967 ; ; ; CLASS CARDIOVASCULAR -- NON SELECTIVE BETA ADRENERGIC ANTAGONISTS -- ANTIARRHYTHMIC AGENTS -- ANTIHYPERTENSIVE AGENTS -- VASODILATOR AGENTS , ; NDA 016418 (label 16418.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (WYETH PHARMS) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 016419 (label 16419.pdf) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 018031 (label 18031.pdf) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE-40/25 (WYETH PHARMS INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018553 (label 18553.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL LA (ANI PHARMS) APPROVAL= AP YEAR= 1983 , NDA 019059 (pdf 19059.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE LA 80/50 (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019536 (pdf 19536.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (WYETH AYERST) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 021438 (label 21438.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INNOPRAN XL (ANI PHARMS) APPROVAL= AP YEAR= 2003 , NDA 070103 (pdf 70103.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070120 (pdf 70120.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070121 (pdf 70121.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070122 (pdf 70122.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070123 (pdf 70123.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070124 (pdf 70124.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070125 (pdf 70125.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070126 (pdf 70126.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070127 (pdf 70127.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070128 (pdf 70128.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070135 (pdf 70135.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070136 (pdf 70136.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070137 (pdf 70137.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070140 (pdf 70140.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070141 (pdf 70141.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070142 (pdf 70142.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070143 (pdf 70143.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070144 (pdf 70144.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070175 (pdf 70175.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070176 (pdf 70176.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070177 (pdf 70177.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070178 (pdf 70178.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070213 (pdf 70213.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1985 , NDA 070217 (pdf 70217.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070218 (pdf 70218.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070219 (pdf 70219.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 , NDA 070220 (pdf 70220.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070221 (pdf 70221.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 , NDA 070232 (pdf 70232.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070233 (pdf 70233.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070234 (pdf 70234.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070301 (pdf 70301.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070305 (pdf 70305.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070306 (pdf 70306.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070307 (pdf 70307.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070308 (pdf 70308.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070309 (pdf 70309.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070310 (pdf 70310.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070319 (pdf 70319.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070320 (pdf 70320.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070321 (pdf 70321.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070322 (pdf 70322.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1986 , NDA 070378 (pdf 70378.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070379 (pdf 70379.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070380 (pdf 70380.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070381 (pdf 70381.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070382 (pdf 70382.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070438 (pdf 70438.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070439 (pdf 70439.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070440 (pdf 70440.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070441 (pdf 70441.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070442 (pdf 70442.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070516 (pdf 70516.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070517 (pdf 70517.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070518 (pdf 70518.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070519 (pdf 70519.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070520 (pdf 70520.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070521 (pdf 70521.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070548 (pdf 70548.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070549 (pdf 70549.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070550 (pdf 70550.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070551 (pdf 70551.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070663 (pdf 70663.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070664 (pdf 70664.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070665 (pdf 70665.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070666 (pdf 70666.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070667 (pdf 70667.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070690 (pdf 70690.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 070704 (pdf 70704.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070705 (pdf 70705.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070757 (pdf 70757.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070814 (pdf 70814.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070815 (pdf 70815.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070816 (pdf 70816.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070817 (pdf 70817.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070851 (pdf 70851.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070852 (pdf 70852.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070946 (pdf 70946.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 070947 (pdf 70947.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070979 (pdf 70979.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 071060 (pdf 71060.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071061 (pdf 71061.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071098 (pdf 71098.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071126 (pdf 71126.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071127 (pdf 71127.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071183 (pdf 71183.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071288 (pdf 71288.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071327 (pdf 71327.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071368 (pdf 71368.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071369 (pdf 71369.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071370 (pdf 71370.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071371 (pdf 71371.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071388 (pdf 71388.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071495 (pdf 71495.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071496 (pdf 71496.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071498 (pdf 71498.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071501 (pdf 71501.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071515 (pdf 71515.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071516 (pdf 71516.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071517 (pdf 71517.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071518 (pdf 71518.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071552 (pdf 71552.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071553 (pdf 71553.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071658 (pdf 71658.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071687 (pdf 71687.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071688 (pdf 71688.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071689 (pdf 71689.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071771 (pdf 71771.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071772 (pdf 71772.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071791 (pdf 71791.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071792 (pdf 71792.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071972 (pdf 71972.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 , NDA 071973 (pdf 71973.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071974 (pdf 71974.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071975 (pdf 71975.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071976 (pdf 71976.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 , NDA 071977 (pdf 71977.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071984 (pdf 71984.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071985 (pdf 71985.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072042 (pdf 72042.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072043 (pdf 72043.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072063 (pdf 72063.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072066 (pdf 72066.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072067 (pdf 72067.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072068 (pdf 72068.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072069 (pdf 72069.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072117 (pdf 72117.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072118 (pdf 72118.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072119 (pdf 72119.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072120 (pdf 72120.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072197 (pdf 72197.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072198 (pdf 72198.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072275 (pdf 72275.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072499 (pdf 72499.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072500 (pdf 72500.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072501 (pdf 72501.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072502 (pdf 72502.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 075792 (pdf 75792.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075826 (pdf 75826.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 076400 (pdf 76400.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077760 (pdf 77760.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 , NDA 078022 (pdf 78022.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078065 (label 78065.pdf) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (NORTEC DEV ASSOC) APPROVAL= AP YEAR= 2007 , NDA 078213 (pdf 78213.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 078494 (pdf 78494.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2007 , NDA 078955 (pdf 78955.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078311 (pdf 78311.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 016762 (label 16762.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (AKRIMAX PHARMS) APPROVAL= AP YEAR= 1973 OBSOLETE , NDA 017683 (label 17683.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (AKRIMAX PHARMS) APPROVAL= AP YEAR= 1976 OBSOLETE , NDA 090321 (pdf 90321.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 078703 (pdf 78703.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ADARE PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 205410 (label 205410.pdf) INN (PROPRANOLOL HYDROCHLORIDE) HEMANGEOL (PIERRE FABRE) APPROVAL= AP YEAR= 2014 , NDA 212026 (pdf 212026.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (AMTA) APPROVAL= AP YEAR= 2020 , NDA 204349 (pdf 204349.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2024 DISCONTINUED , 376 ; THIOTHIXENE ; 3313-26-6 ; 1967 ; ; ; CLASS NERVOUS SYSTEM -- FIRST-GENERATION ANTIPSYCHOTIC -- MANAGEMENT OF SCHIZOPHRENIA , ; NDA 016584 (label 16584.pdf) INN (THIOTHIXENE) NAVANE (PFIZER) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 016758 (label 16758.pdf) INN (THIOTHIXENE HYDROCHLORIDE) NAVANE (PFIZER) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016904 (label 16904.pdf) INN (THIOTHIXENE HYDROCHLORIDE) NAVANE (PFIZER) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 070600 (pdf 70600.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070601 (pdf 70601.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070602 (pdf 70602.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070603 (pdf 70603.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070969 (pdf 70969.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071093 (pdf 71093.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (RISING) APPROVAL= AP YEAR= 1987 , NDA 071184 (pdf 71184.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071529 (pdf 71529.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071530 (pdf 71530.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071554 (pdf 71554.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071570 (pdf 71570.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071610 (pdf 71610.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071626 (pdf 71626.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071627 (pdf 71627.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071628 (pdf 71628.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071884 (pdf 71884.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071885 (pdf 71885.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071886 (pdf 71886.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071887 (pdf 71887.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071917 (pdf 71917.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071939 (pdf 71939.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072200 (pdf 72200.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073494 (pdf 73494.pdf not found) INN (THIOTHIXENE HYDROCHLORIDE) THIOTHIXENE HYDROCHLORIDE INTENSOL (HIKMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 211642 (pdf 211642.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 215456 (pdf 215456.pdf not found) INN (THIOTHIXENE) THIOTHIXENE (AMNEAL) APPROVAL= AP YEAR= 2022 , 377 ; CARBAMAZEPINE ; 298-46-4 ; 1968 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANALGESIC -- ANTIMANIC AGENTS -- SPECIFIC ANALGESIC FOR TRIGEMINAL NEURALGIA -- CARBAMAZEPINE INDUCES ITS OWN METABOLISM -- MECHANISM OF ACTION UNKNOWN (NUMEROUS PHARMACOLOGICAL EFFECTS HAVE BEEN DESCRIBED MODULATION OF ION CHANNELS (SODIUM AND CALCIUM), RECEPTOR-MEDIATED NEUROTRANSMISSION (GABAERGIC, GLUTAMATERGIC, AND MONOAMINERGIC), AND INTRACELLULAR SIGNALING PATHWAYS) , ; NDA 016608 (label 16608.pdf) INN (CARBAMAZEPINE) TEGRETOL (NOVARTIS) APPROVAL= AP YEAR= 1968 NEWMOLECULARENTITY , NDA 018281 (label 18281.pdf) INN (CARBAMAZEPINE) TEGRETOL (NOVARTIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018927 (label 18927.pdf) INN (CARBAMAZEPINE) TEGRETOL (NOVARTIS) APPROVAL= AP YEAR= 1987 , NDA 020234 (label 20234.pdf) INN (CARBAMAZEPINE) TEGRETOL-XR (NOVARTIS) APPROVAL= AP YEAR= 1996 , NDA 020712 (label 20712.pdf) INN (CARBAMAZEPINE) CARBATROL (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1997 , NDA 021710 (label 21710.pdf) INN (CARBAMAZEPINE) EQUETRO (VALIDUS PHARMS) APPROVAL= AP YEAR= 2004 , NDA 070231 (pdf 70231.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (INWOOD LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070300 (pdf 70300.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070429 (pdf 70429.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070541 (pdf 70541.pdf not found) INN (CARBAMAZEPINE) EPITOL (TEVA) APPROVAL= AP YEAR= 1986 , NDA 071479 (pdf 71479.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071696 (pdf 71696.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071940 (pdf 71940.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (JUBILANT CADISTA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 073524 (pdf 73524.pdf not found) INN (CARBAMAZEPINE) EPITOL (TEVA) APPROVAL= AP YEAR= 1992 , NDA 074649 (pdf 74649.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TARO) APPROVAL= AP YEAR= 1996 , NDA 075687 (pdf 75687.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TARO PHARM INDS) APPROVAL= AP YEAR= 2000 , NDA 075712 (pdf 75712.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TORRENT PHARMS) APPROVAL= AP YEAR= 2001 , NDA 075714 (pdf 75714.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 , NDA 075875 (pdf 75875.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TARO) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075948 (pdf 75948.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (APOTEX INC) APPROVAL= AP YEAR= 2002 , NDA 076525 (pdf 76525.pdf not found) INN (CARBAMAZEPINE) TERIL (TARO) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076729 (pdf 76729.pdf not found) INN (CARBAMAZEPINE) TERIL (TARO) APPROVAL= AP YEAR= 2004 , NDA 077272 (pdf 77272.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TORRENT PHARMS) APPROVAL= AP YEAR= 2005 , NDA 078115 (pdf 78115.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TARO) APPROVAL= AP YEAR= 2009 , NDA 076697 (pdf 76697.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2011 , NDA 078986 (pdf 78986.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 078592 (pdf 78592.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078746 (pdf 78746.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2012 , NDA 201106 (pdf 201106.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (TARO) APPROVAL= AP YEAR= 2013 , NDA 206030 (label 206030.pdf) INN (CARBAMAZEPINE) CARNEXIV (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205571 (pdf 205571.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 207798 (pdf 207798.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (UMEDICA) APPROVAL= AP YEAR= 2020 , NDA 211623 (pdf 211623.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (UNIQUE PHARM) APPROVAL= AP YEAR= 2020 , NDA 213311 (pdf 213311.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (CSPC OUYI) APPROVAL= AP YEAR= 2021 , NDA 212948 (pdf 212948.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (ANBISON LAB) APPROVAL= AP YEAR= 2021 , NDA 214328 (pdf 214328.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (RK PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215591 (pdf 215591.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (ZHEJIANG JIUZHOU) APPROVAL= AP YEAR= 2022 , NDA 213284 (pdf 213284.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (UNICHEM) APPROVAL= AP YEAR= 2022 , NDA 214277 (pdf 214277.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216404 (pdf 216404.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 216594 (pdf 216594.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (UMEDICA) APPROVAL= AP YEAR= 2022 , NDA 216193 (pdf 216193.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216235 (pdf 216235.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (SCIECURE PHARMA INC) APPROVAL= AP YEAR= 2023 , NDA 212704 (pdf 212704.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213159 (pdf 213159.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 218221 (pdf 218221.pdf not found) INN (CARBAMAZEPINE) CARBAMAZEPINE (BIONPHARMA) APPROVAL= AP YEAR= 2024 , 378 ; MEDRYSONE ; 2668-66-8 ; 1969 ; DISCONTINUED ; ; CLASS SENSORY -- CORTICOSTEROID -- TOPICAL ANTI-INFLAMMATORY -- TREATMENT OF ALLERGIC CONJUCTIVITIS , ; NDA 016624 (label 16624.pdf) INN (MEDRYSONE) HMS (ALLERGAN) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , 379 ; NALOXONE ; 465-65-6 ; 1971 ; ; ; CLASS VARIOUS -- ALKALOID -- NARCOTIC ANTAGONIST -- ANTINARCOTIC AGENTS -- DEPRESSANTS -- OPIATE ANTAGONISTS -- RELIEF OF MODERATE TO SEVERE PAIN -- TREATMENT OF OPIOID DEPENDANCE , ; NDA 016636 (label 16636.pdf) INN (NALOXONE HYDROCHLORIDE) NARCAN (ADAPT) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY DISCONTINUED , NDA 018733 (label 18733.pdf) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) TALWIN NX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 020733 (label 20733.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 070171 (pdf 70171.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 070172 (pdf 70172.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 070188 (pdf 70188.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070189 (pdf 70189.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070190 (pdf 70190.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070191 (pdf 70191.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070252 (pdf 70252.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070253 (pdf 70253.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070254 (pdf 70254.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070255 (pdf 70255.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070256 (pdf 70256.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070257 (pdf 70257.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070298 (pdf 70298.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (HIKMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070299 (pdf 70299.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (HIKMA) APPROVAL= AP YEAR= 1985 , NDA 070417 (pdf 70417.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070496 (pdf 70496.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE (HIKMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070639 (pdf 70639.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070648 (pdf 70648.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070649 (pdf 70649.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070661 (pdf 70661.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070678 (pdf 70678.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070679 (pdf 70679.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070680 (pdf 70680.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071083 (pdf 71083.pdf not found) INN (NALOXONE HYDROCHLORIDE) NARCAN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071084 (pdf 71084.pdf not found) INN (NALOXONE HYDROCHLORIDE) NARCAN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071272 (pdf 71272.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071273 (pdf 71273.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071274 (pdf 71274.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071287 (pdf 71287.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071311 (pdf 71311.pdf not found) INN (NALOXONE HYDROCHLORIDE) NARCAN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071339 (pdf 71339.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071604 (pdf 71604.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071671 (pdf 71671.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071672 (pdf 71672.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071681 (pdf 71681.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071682 (pdf 71682.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071683 (pdf 71683.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071811 (pdf 71811.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072076 (pdf 72076.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1988 , NDA 072081 (pdf 72081.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072082 (pdf 72082.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072083 (pdf 72083.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072084 (pdf 72084.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072085 (pdf 72085.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072086 (pdf 72086.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072087 (pdf 72087.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072088 (pdf 72088.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072089 (pdf 72089.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072090 (pdf 72090.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072091 (pdf 72091.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072092 (pdf 72092.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072093 (pdf 72093.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072115 (pdf 72115.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074736 (pdf 74736.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 , NDA 075523 (pdf 75523.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 , NDA 075735 (pdf 75735.pdf not found) INN (NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2001 , NDA 022410 (label 22410.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2010 , NDA 091422 (pdf 91422.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 203136 (pdf 203136.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 204242 (label 204242.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) ZUBSOLV (OREXO US INC) APPROVAL= AP YEAR= 2013 , NDA 091149 (pdf 91149.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203326 (pdf 203326.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 , NDA 204997 (pdf 204997.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 , NDA 205637 (label 205637.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUNAVAIL (BDSI) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205777 (label 205777.pdf) INN (NALOXONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE) TARGINIQ (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205787 (label 205787.pdf) INN (NALOXONE HYDROCHLORIDE) EVZIO (KALEO INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204431 (label 204431.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ETHYPHARM USA CORP) APPROVAL= AP YEAR= 2015 , NDA 208411 (label 208411.pdf) INN (NALOXONE HYDROCHLORIDE) NARCAN (EMERGENT) APPROVAL= AP YEAR= 2015 , NDA 205014 (pdf 205014.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2016 , NDA 201633 (pdf 201633.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 205022 (pdf 205022.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 209862 (label 209862.pdf) INN (NALOXONE HYDROCHLORIDE) EVZIO AUTOINJECTOR (KALEO INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207633 (pdf 207633.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 207634 (pdf 207634.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 208871 (pdf 208871.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 208872 (pdf 208872.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 204383 (pdf 204383.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2017 , NDA 207000 (pdf 207000.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2017 , NDA 205299 (pdf 205299.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 205806 (pdf 205806.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 207607 (pdf 207607.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2018 , NDA 207846 (pdf 207846.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208042 (label 208042.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) CASSIPA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205954 (pdf 205954.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2019 , NDA 209522 (pdf 209522.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 206953 (pdf 206953.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209069 (pdf 209069.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 212455 (pdf 212455.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212456 (pdf 212456.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 205601 (pdf 205601.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 211286 (pdf 211286.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (PAR STERILE PRODUCTS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211785 (pdf 211785.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2020 , NDA 213209 (pdf 213209.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 211951 (pdf 211951.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2022 , NDA 212045 (label 212045.pdf) INN (NALOXONE HYDROCHLORIDE) KLOXXADO (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 213279 (pdf 213279.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214785 (pdf 214785.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2021 , NDA 214930 (pdf 214930.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 212854 (label 212854.pdf) INN (NALOXONE HYDROCHLORIDE) ZIMHI (ZMI PHARMA) APPROVAL= AP YEAR= 2021 , NDA 212300 (pdf 212300.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 212756 (pdf 212756.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AVEVA) APPROVAL= AP YEAR= 2022 , NDA 213843 (pdf 213843.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 214737 (pdf 214737.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= TA YEAR= 2023 , NDA 215457 (label 215457.pdf) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE AUTOINJECTOR (KALEO INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214792 (pdf 214792.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , NDA 215964 (pdf 215964.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 , NDA 216624 (pdf 216624.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 208969 (label 208969.pdf) INN (NALOXONE HYDROCHLORIDE) REXTOVY (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 216977 (pdf 216977.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (BPI LABS) APPROVAL= AP YEAR= 2023 , NDA 217722 (pdf 217722.pdf not found) INN (NALOXONE HYDROCHLORIDE) RIVIVE (HARM REDUCTION THERP) APPROVAL= AP YEAR= 2023 , NDA 213573 (pdf 213573.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2024 , NDA 215487 (pdf 215487.pdf not found) INN (NALOXONE HYDROCHLORIDE) REZENOPY (SUMMIT BIOSCI) APPROVAL= AP YEAR= 2024 , NDA 217992 (pdf 217992.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2024 , NDA 218404 (pdf 218404.pdf not found) INN (NALOXONE HYDROCHLORIDE) NALOXONE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , 380 ; NORGESTREL ; 6533-00-2 ; 1968 ; ; ; CLASS GENITO -- CONTRACEPTIVE -- PROGESTIN , ; NDA 016672 (pdf 16672.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) OVRAL (WYETH PHARMS) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 016806 (pdf 16806.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) OVRAL-28 (WYETH PHARMS) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 017031 (label 17031.pdf) INN (NORGESTREL) OPILL (LABORATOIRE HRA) APPROVAL= AP YEAR= 1973 , NDA 017612 (label 17612.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LO/OVRAL (CADENCE HEALTH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017802 (label 17802.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LO/OVRAL-28 (WYETH PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 075288 (label 75288.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) LOW-OGESTREL-21 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1999 , NDA 075406 (label 75406.pdf) INN (ETHINYL ESTRADIOL NORGESTREL) OGESTREL 0.5/50-21 (WATSON LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075840 (pdf 75840.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) CRYSELLE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 091105 (pdf 91105.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) ELINEST (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 201828 (pdf 201828.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) NORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202875 (pdf 202875.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) NORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 202980 (pdf 202980.pdf not found) INN (ETHINYL ESTRADIOL NORGESTREL) TURQOZ (LUPIN LTD) APPROVAL= AP YEAR= 2023 , 381 ; FLURAZEPAM ; 17617-23-1 ; 1970 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- GABA MODULATORS -- SEDATIVES -- TREATMENT OF INSOMNIA , ; NDA 016721 (label 16721.pdf) INN (FLURAZEPAM HYDROCHLORIDE) DALMANE (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 070345 (pdf 70345.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1985 , NDA 070444 (pdf 70444.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070445 (pdf 70445.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070454 (pdf 70454.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070455 (pdf 70455.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070562 (pdf 70562.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070563 (pdf 70563.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (USL PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071068 (pdf 71068.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071107 (pdf 71107.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071108 (pdf 71108.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071205 (pdf 71205.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071551 (pdf 71551.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071659 (pdf 71659.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071660 (pdf 71660.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071716 (pdf 71716.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 071717 (pdf 71717.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071767 (pdf 71767.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071768 (pdf 71768.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071808 (pdf 71808.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071809 (pdf 71809.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071927 (pdf 71927.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072368 (pdf 72368.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 , NDA 072369 (pdf 72369.pdf not found) INN (FLURAZEPAM HYDROCHLORIDE) FLURAZEPAM HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 , 382 ; CYCLOTHIAZIDE ; 134077-76-2 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 383 ; QUINESTROL ; 152-43-2 ; 1996 ; DISCONTINUED ; ; CLASS GENITO -- ESTROGENS , ; NDA 016768 (pdf 16768.pdf not found) INN (QUINESTROL) ESTROVIS (PARKE DAVIS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , 384 ; FLAVOXATE ; 15301-69-6 ; 1970 ; ; ; CLASS GENITO -- MUSCLE RELAXANT -- SYNTHETIC URINARY TRACT SPASMOLYTIC (PMID25480503) , ; NDA 016769 (pdf 16769.pdf not found) INN (FLAVOXATE HYDROCHLORIDE) URISPAS (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 076234 (pdf 76234.pdf not found) INN (FLAVOXATE HYDROCHLORIDE) FLAVOXATE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076831 (pdf 76831.pdf not found) INN (FLAVOXATE HYDROCHLORIDE) FLAVOXATE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 076835 (pdf 76835.pdf not found) INN (FLAVOXATE HYDROCHLORIDE) FLAVOXATE HYDROCHLORIDE (EPIC PHARMA) APPROVAL= AP YEAR= 2005 , 385 ; PROCARBAZINE ; 671-16-9 ; 1969 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF STAGE III AND IV HODGKIN'S DISEASE -- MAY INHIBIT TRANSMETHYLATION OF METHYL GROUPS OF METHIONINE INTO T-RNA -- HYDROGEN PEROXIDE FORMED DURING THE AUTO-OXIDATION OF THE DRUG MAY ATTACK PROTEIN SULFHYDRYL GROUPS CONTAINED IN RESIDUAL PROTEIN WHICH IS TIGHTLY BOUND TO DNA , ; NDA 016785 (pdf 16785.pdf not found) INN (PROCARBAZINE HYDROCHLORIDE) MATULANE (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY , 386 ; TRIMIPRAMINE ; 739-71-9 ; 1979 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC UPTAKE INHIBITORS -- NOREPINEPHRINE-REUPTAKE INHIBITORS , ; NDA 016792 (label 16792.pdf) INN (TRIMIPRAMINE MALEATE) SURMONTIL (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 071283 (pdf 71283.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071284 (pdf 71284.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071285 (pdf 71285.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077361 (pdf 77361.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (ELITE LABS INC) APPROVAL= AP YEAR= 2006 , NDA 208127 (pdf 208127.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2016 , 387 ; CYTARABINE ; 147-94-4 ; 1969 ; ; ; CLASS ANTINEOPLASTIC -- -- ANTIMETABOLITES , ; NDA 016793 (label 16793.pdf) INN (CYTARABINE) CYTARABINE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , NDA 021041 (label 21041.pdf) INN (CYTARABINE) DEPOCYT (PACIRA PHARMS INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 071248 (pdf 71248.pdf not found) INN (CYTARABINE) CYTARABINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071249 (pdf 71249.pdf not found) INN (CYTARABINE) CYTARABINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071471 (pdf 71471.pdf not found) INN (CYTARABINE) CYTARABINE (HIKMA) APPROVAL= AP YEAR= 1989 , NDA 071472 (pdf 71472.pdf not found) INN (CYTARABINE) CYTARABINE (HIKMA) APPROVAL= AP YEAR= 1989 , NDA 071868 (label 71868.pdf) INN (CYTARABINE) CYTARABINE (HOSPIRA) APPROVAL= AP YEAR= 1990 , NDA 072168 (pdf 72168.pdf not found) INN (CYTARABINE) CYTARABINE (HOSPIRA) APPROVAL= AP YEAR= 1990 , NDA 072945 (pdf 72945.pdf not found) INN (CYTARABINE) CYTARABINE (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074245 (pdf 74245.pdf not found) INN (CYTARABINE) CYTARABINE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1994 , NDA 075206 (pdf 75206.pdf not found) INN (CYTARABINE) CYTOSAR-U (TEVA PHARMS USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075383 (pdf 75383.pdf not found) INN (CYTARABINE) CYTARABINE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 076512 (pdf 76512.pdf not found) INN (CYTARABINE) CYTARABINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 200914 (pdf 200914.pdf not found) INN (CYTARABINE) CYTARABINE (RISING) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200915 (pdf 200915.pdf not found) INN (CYTARABINE) CYTARABINE (RISING) APPROVAL= AP YEAR= 2011 , NDA 200916 (pdf 200916.pdf not found) INN (CYTARABINE) CYTARABINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201784 (pdf 201784.pdf not found) INN (CYTARABINE) CYTARABINE (RISING) APPROVAL= AP YEAR= 2012 , NDA 209401 (label 209401.pdf) INN (CYTARABINE DAUNORUBICIN) VYXEOS (CELATOR PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206190 (pdf 206190.pdf not found) INN (CYTARABINE) CYTARABINE (MEITHEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205696 (pdf 205696.pdf not found) INN (CYTARABINE) CYTARABINE (MEITHEAL) APPROVAL= AP YEAR= 2018 , NDA 211937 (pdf 211937.pdf not found) INN (CYTARABINE) CYTARABINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211938 (pdf 211938.pdf not found) INN (CYTARABINE) CYTARABINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 206189 (pdf 206189.pdf not found) INN (CYTARABINE) CYTARABINE (MEITHEAL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208485 (pdf 208485.pdf not found) INN (CYTARABINE) CYTARABINE (MEITHEAL) APPROVAL= AP YEAR= 2022 , 388 ; DOXEPIN ; 1668-19-5 ; 1969 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- TRICYCLIC PSYCHOTHERAPEUTIC AGENT -- ANTI-PRURITIC -- HISTAMINE RECEPTOR ANTAGONIST -- TREATMENT OF INSOMNIA , ; NDA 016798 (label 16798.pdf) INN (DOXEPIN HYDROCHLORIDE) SINEQUAN (PFIZER) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , NDA 016987 (pdf 16987.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (NEW RIVER) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 017516 (label 17516.pdf) INN (DOXEPIN HYDROCHLORIDE) SINEQUAN (PFIZER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 020126 (label 20126.pdf) INN (DOXEPIN HYDROCHLORIDE) ZONALON (MYLAN) APPROVAL= AP YEAR= 1994 , NDA 070789 (pdf 70789.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070790 (pdf 70790.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070791 (label 70791.pdf) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1986 , NDA 070792 (pdf 70792.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070793 (pdf 70793.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070825 (pdf 70825.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070827 (pdf 70827.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070828 (pdf 70828.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070931 (pdf 70931.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070932 (pdf 70932.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070952 (pdf 70952.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070953 (pdf 70953.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070954 (pdf 70954.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070955 (pdf 70955.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070972 (pdf 70972.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070973 (pdf 70973.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071238 (pdf 71238.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071239 (pdf 71239.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071326 (pdf 71326.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071422 (pdf 71422.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 , NDA 071437 (pdf 71437.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 , NDA 071485 (pdf 71485.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071486 (pdf 71486.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071487 (pdf 71487.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071502 (pdf 71502.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071521 (pdf 71521.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071562 (pdf 71562.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071595 (pdf 71595.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071608 (pdf 71608.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071609 (label 71609.pdf) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071653 (pdf 71653.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071654 (pdf 71654.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071669 (pdf 71669.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071673 (pdf 71673.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071674 (pdf 71674.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071675 (pdf 71675.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071676 (pdf 71676.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071685 (pdf 71685.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071686 (pdf 71686.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071697 (pdf 71697.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071763 (pdf 71763.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071764 (pdf 71764.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071918 (pdf 71918.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072109 (pdf 72109.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072110 (pdf 72110.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072375 (pdf 72375.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072376 (pdf 72376.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072386 (pdf 72386.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072387 (pdf 72387.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072985 (pdf 72985.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072986 (pdf 72986.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072987 (pdf 72987.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073054 (pdf 73054.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 073055 (pdf 73055.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 074721 (pdf 74721.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1998 , NDA 075924 (pdf 75924.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022036 (label 22036.pdf) INN (DOXEPIN HYDROCHLORIDE) SILENOR (CURRAX) APPROVAL= AP YEAR= 2010 , NDA 202510 (pdf 202510.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 201951 (pdf 201951.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 202761 (pdf 202761.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 202337 (pdf 202337.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (RK PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207482 (pdf 207482.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 211603 (pdf 211603.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212624 (pdf 212624.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 213063 (pdf 213063.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2020 , NDA 210268 (pdf 210268.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 210675 (pdf 210675.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212997 (pdf 212997.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213474 (pdf 213474.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2020 , NDA 211618 (pdf 211618.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LEADING) APPROVAL= AP YEAR= 2021 , NDA 211619 (pdf 211619.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2021 , NDA 214908 (pdf 214908.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 215076 (pdf 215076.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 213796 (pdf 213796.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215113 (pdf 215113.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 215483 (pdf 215483.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2022 , NDA 215710 (pdf 215710.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210140 (pdf 210140.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 210700 (pdf 210700.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 212357 (pdf 212357.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 214823 (pdf 214823.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2023 , NDA 215408 (pdf 215408.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217688 (pdf 217688.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 217975 (pdf 217975.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (UNIQUE PHARM) APPROVAL= AP YEAR= 2023 , 389 ; ESKETAMINE ; 33643-46-8 ; 1970 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- ANALGESICS -- N-METHYL-D-ASPARTATE (NMDA) RECEPTORS ANTAGONIST -- ANTIDEPRESSANT , ; NDA 016812 (label 16812.pdf) INN (KETAMINE HYDROCHLORIDE) KETALAR (PAR STERILE PRODUCTS) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY , NDA 071949 (pdf 71949.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071950 (pdf 71950.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071951 (pdf 71951.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074524 (pdf 74524.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1996 , NDA 074549 (pdf 74549.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 , NDA 076092 (pdf 76092.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2001 , NDA 211243 (label 211243.pdf) INN (ESKETAMINE HYDROCHLORIDE) SPRAVATO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 215808 (pdf 215808.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2023 , NDA 216809 (pdf 216809.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 390 ; BENZQUINAMIDE ; 23844-24-8 ; 1974 ; DISCONTINUED ; ; CLASS ANTIEMETIC -- ANTIPSYCHOTICS -- NERVOUS SYSTEM , ; NDA 016818 (pdf 16818.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (ROERIG) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 016820 (pdf 16820.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (PFIZER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , 391 ; PEMOLINE ; 2152-34-3 ; 1975 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMIMETIC DRUG , ; NDA 016832 (label 16832.pdf) INN (PEMOLINE) CYLERT (ABBOTT) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 017703 (label 17703.pdf) INN (PEMOLINE) CYLERT (ABBOTT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 075030 (pdf 75030.pdf not found) INN (PEMOLINE) PEMOLINE (TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075286 (pdf 75286.pdf not found) INN (PEMOLINE) PEMOLINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075287 (pdf 75287.pdf not found) INN (PEMOLINE) PEMOLINE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075328 (pdf 75328.pdf not found) INN (PEMOLINE) PEMOLINE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075555 (pdf 75555.pdf not found) INN (PEMOLINE) PEMOLINE (TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075595 (pdf 75595.pdf not found) INN (PEMOLINE) PEMOLINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075678 (pdf 75678.pdf not found) INN (PEMOLINE) PEMOLINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075726 (pdf 75726.pdf not found) INN (PEMOLINE) PEMOLINE (MALLINCKRODT) APPROVAL= AP YEAR= 2001 DISCONTINUED , 392 ; MITOTANE ; 53-19-0 ; 1970 ; ; ; CLASS ANTINEOPLASTIC -- ADRENAL CYTOTOXIC AGENT -- TREATMENT OF INOPERABLE ADRENAL CORTICAL CARCINOMA -- STEROID AND XENOBIOTIC RECEPTOR (SXR) AGONIST (PMID23179081) , ; NDA 016885 (label 16885.pdf) INN (MITOTANE) LYSODREN (HRA PHARMA) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY , 393 ; FLUOCINONIDE ; 356-12-7 ; 1971 ; ; ; CLASS DERMATOLOGICAL -- GLUCOCORTICOID AGONIST -- ANTI-ALLERGIC AGENTS -- ANTI-INFLAMMATORY AGENTS , ; NDA 016908 (pdf 16908.pdf not found) INN (FLUOCINONIDE) LIDEX (ALVOGEN) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY DISCONTINUED , NDA 016909 (label 16909.pdf) INN (FLUOCINONIDE) LIDEX (ALVOGEN) APPROVAL= AP YEAR= 1971 , NDA 017373 (pdf 17373.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (ALVOGEN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 018849 (pdf 18849.pdf not found) INN (FLUOCINONIDE) LIDEX (ALVOGEN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019117 (pdf 19117.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 021758 (label 21758.pdf) INN (FLUOCINONIDE) VANOS (BAUSCH) APPROVAL= AP YEAR= 2005 , NDA 071500 (pdf 71500.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1987 , NDA 071535 (pdf 71535.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (COSETTE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071790 (pdf 71790.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072488 (pdf 72488.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TEVA) APPROVAL= AP YEAR= 1989 , NDA 072490 (pdf 72490.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE EMULSIFIED BASE (TEVA) APPROVAL= AP YEAR= 1989 , NDA 072494 (pdf 72494.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE EMULSIFIED BASE (TARO) APPROVAL= AP YEAR= 1989 , NDA 072511 (pdf 72511.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072522 (pdf 72522.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072537 (pdf 72537.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (COSETTE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072857 (pdf 72857.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072933 (pdf 72933.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1994 , NDA 072934 (pdf 72934.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1995 , NDA 073030 (pdf 73030.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1994 , NDA 073085 (pdf 73085.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (COSETTE) APPROVAL= AP YEAR= 1992 , NDA 073481 (pdf 73481.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TEVA) APPROVAL= AP YEAR= 1991 , NDA 074204 (pdf 74204.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE EMULSIFIED BASE (COSETTE) APPROVAL= AP YEAR= 1995 , NDA 074799 (pdf 74799.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1996 , NDA 074905 (pdf 74905.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1997 , NDA 074935 (pdf 74935.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1997 , NDA 075008 (pdf 75008.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 1999 , NDA 076586 (pdf 76586.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE EMULSIFIED BASE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 090256 (pdf 90256.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 091282 (pdf 91282.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 200734 (pdf 200734.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (TARO) APPROVAL= AP YEAR= 2014 , NDA 200735 (pdf 200735.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 206003 (pdf 206003.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 207538 (pdf 207538.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 209118 (pdf 209118.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 209283 (pdf 209283.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 207680 (pdf 207680.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208948 (pdf 208948.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209030 (pdf 209030.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PADAGIS US) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209699 (pdf 209699.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2018 , NDA 210554 (pdf 210554.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211111 (pdf 211111.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211410 (pdf 211410.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207554 (pdf 207554.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211758 (pdf 211758.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212976 (pdf 212976.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (XIROMED) APPROVAL= AP YEAR= 2019 , NDA 208989 (pdf 208989.pdf not found) INN (FLUOCINONIDE) FLUOCINONIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , 394 ; LEVODOPA ; 59-92-7 ; 1970 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- METABOLIC PRECURSOR OF DOPAMINE , ; NDA 016912 (pdf 16912.pdf not found) INN (LEVODOPA) LARODOPA (ROCHE) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 016913 (pdf 16913.pdf not found) INN (LEVODOPA) DOPAR (SHIRE) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016948 (pdf 16948.pdf not found) INN (LEVODOPA) BENDOPA (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017555 (label 17555.pdf) INN (CARBIDOPA LEVODOPA) SINEMET (ORGANON) APPROVAL= AP YEAR= 1975 , NDA 019856 (label 19856.pdf) INN (CARBIDOPA LEVODOPA) SINEMET CR (ORGANON LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 021485 (label 21485.pdf) INN (CARBIDOPA ENTACAPONE LEVODOPA) STALEVO 50 (ORION PHARMA) APPROVAL= AP YEAR= 2003 , NDA 073381 (pdf 73381.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073382 (pdf 73382.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073383 (pdf 73383.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073586 (pdf 73586.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073587 (pdf 73587.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ANI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073589 (pdf 73589.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073607 (pdf 73607.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073618 (pdf 73618.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073620 (pdf 73620.pdf not found) INN (LEVODOPA) CARBIDOPA AND LEVODOPA (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1995 DISCONTINUED OBSOLETE , NDA 074080 (pdf 74080.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074260 (pdf 74260.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1993 , NDA 075091 (label 75091.pdf) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (MYLAN) APPROVAL= AP YEAR= 1999 , NDA 076212 (pdf 76212.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (APOTEX) APPROVAL= AP YEAR= 2004 , NDA 076521 (pdf 76521.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 076643 (pdf 76643.pdf not found) INN (CARBIDOPA LEVODOPA) CARBILEV (RANBAXY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076663 (pdf 76663.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (KV PHARM) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076699 (pdf 76699.pdf not found) INN (CARBIDOPA LEVODOPA) PARCOPA (UCB INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077120 (pdf 77120.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 077828 (pdf 77828.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 078893 (pdf 78893.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RISING) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078536 (pdf 78536.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 , NDA 078690 (pdf 78690.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 090324 (pdf 90324.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 079085 (pdf 79085.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 090631 (pdf 90631.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IMPAX LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090786 (pdf 90786.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090833 (pdf 90833.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202323 (pdf 202323.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 203312 (label 203312.pdf) INN (CARBIDOPA LEVODOPA) RYTARY (IMPAX) APPROVAL= AP YEAR= 2015 , NDA 203952 (label 203952.pdf) INN (CARBIDOPA LEVODOPA) DUOPA (ABBVIE) APPROVAL= AP YEAR= 2015 , NDA 209184 (label 209184.pdf) INN (LEVODOPA) INBRIJA (ACORDA) APPROVAL= AP YEAR= 2018 , NDA 210341 (pdf 210341.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 203424 (pdf 203424.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214092 (pdf 214092.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214091 (pdf 214091.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214869 (label 214869.pdf) INN (CARBIDOPA LEVODOPA) DHIVY (AVION PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213212 (pdf 213212.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (RISING) APPROVAL= AP YEAR= 2022 , NDA 216505 (pdf 216505.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 216537 (pdf 216537.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 208895 (pdf 208895.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA LEVODOPA (SANDOZ INC) APPROVAL= TA YEAR= 2023 , NDA 215999 (pdf 215999.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217482 (pdf 217482.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RUBICON) APPROVAL= AP YEAR= 2024 , 395 ; TRETINOIN ; 302-79-4 ; 1971 ; ; ; CLASS DERMATOLOGICALS -- KERATOLYTIC -- ANTINEOPLASTIC AGENTS -- RETINOIC ACID RECEPTOR (RAR) AGONIST -- TREATMENT OF ACNE -- ENDOGENOUS RETINOID METABOLITE OF VITAMIN A -- INDUCES DIFFERENTIATION AND INHIBITS PROLIFERATION -- INDUCES ITS OWN METABOLISM , ; NDA 016921 (label 16921.pdf) INN (TRETINOIN) RETIN-A (VALEANT INTL) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY DISCONTINUED , NDA 017340 (label 17340.pdf) INN (TRETINOIN) RETIN-A (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1973 , NDA 017522 (label 17522.pdf) INN (TRETINOIN) RETIN-A (VALEANT BERMUDA) APPROVAL= AP YEAR= 1974 , NDA 017579 (label 17579.pdf) INN (TRETINOIN) RETIN-A (VALEANT INTL) APPROVAL= AP YEAR= 1975 , NDA 017955 (label 17955.pdf) INN (TRETINOIN) RETIN-A (VALEANT INTL) APPROVAL= AP YEAR= 1978 , NDA 019049 (label 19049.pdf) INN (TRETINOIN) RETIN-A (BAUSCH) APPROVAL= AP YEAR= 1988 , NDA 019963 (label 19963.pdf) INN (TRETINOIN) RENOVA (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020400 (label 20400.pdf) INN (TRETINOIN) AVITA (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020404 (pdf 20404.pdf not found) INN (TRETINOIN) AVITA (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1997 , NDA 020438 (label 20438.pdf) INN (TRETINOIN) VESANOID (CHEPLAPHARM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020475 (label 20475.pdf) INN (TRETINOIN) RETIN-A MICRO (BAUSCH) APPROVAL= AP YEAR= 1997 , NDA 020922 (label 20922.pdf) INN (MEQUINOL TRETINOIN) SOLAGE (ALMIRALL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021108 (label 21108.pdf) INN (TRETINOIN) RENOVA (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2000 , NDA 021112 (label 21112.pdf) INN (FLUOCINOLONE ACETONIDE HYDROQUINONE TRETINOIN) TRI-LUMA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2002 , NDA 022070 (label 22070.pdf) INN (TRETINOIN) ATRALIN (DOW PHARM) APPROVAL= AP YEAR= 2007 , NDA 050802 (label 50802.pdf) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) ZIANA (BAUSCH) APPROVAL= AP YEAR= 2006 , NDA 074873 (pdf 74873.pdf not found) INN (TRETINOIN) TRETINOIN (TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075213 (label 75213.pdf) INN (TRETINOIN) TRETINOIN (PADAGIS US) APPROVAL= AP YEAR= 1998 , NDA 075260 (label 75260.pdf) INN (TRETINOIN) TRETINOIN (WOCKHARDT) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075264 (label 75264.pdf) INN (TRETINOIN) TRETINOIN (PADAGIS US) APPROVAL= AP YEAR= 1998 , NDA 075265 (label 75265.pdf) INN (TRETINOIN) TRETINOIN (PADAGIS US) APPROVAL= AP YEAR= 1998 , NDA 075529 (pdf 75529.pdf not found) INN (TRETINOIN) TRETINOIN (PADAGIS US) APPROVAL= AP YEAR= 2000 , NDA 075589 (pdf 75589.pdf not found) INN (TRETINOIN) TRETINOIN (PADAGIS US) APPROVAL= AP YEAR= 2002 , NDA 076498 (pdf 76498.pdf not found) INN (TRETINOIN) TRETINOIN (ZO SKIN HEALTH) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077684 (pdf 77684.pdf not found) INN (TRETINOIN) TRETINOIN (BARR LABS INC) APPROVAL= AP YEAR= 2007 , NDA 090098 (pdf 90098.pdf not found) INN (TRETINOIN) TRETINOIN (ALLERGAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 050803 (label 50803.pdf) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) VELTIN (ALMIRALL) APPROVAL= AP YEAR= 2010 , NDA 201687 (pdf 201687.pdf not found) INN (TRETINOIN) TRETINOIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 202209 (pdf 202209.pdf not found) INN (TRETINOIN) TRETINOIN (ALLERGAN) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202026 (label 202026.pdf) INN (TRETINOIN) TRETINOIN (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202567 (label 202567.pdf) INN (TRETINOIN) TRETINOIN (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202564 (pdf 202564.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 , NDA 207955 (pdf 207955.pdf not found) INN (TRETINOIN) TRETINOIN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 208279 (pdf 208279.pdf not found) INN (TRETINOIN) TRETINOIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 209353 (label 209353.pdf) INN (TRETINOIN) ALTRENO (DOW PHARM) APPROVAL= AP YEAR= 2018 , NDA 211644 (pdf 211644.pdf not found) INN (TRETINOIN) TRETINOIN (TARO) APPROVAL= AP YEAR= 2019 , NDA 211645 (pdf 211645.pdf not found) INN (TRETINOIN) TRETINOIN (TARO) APPROVAL= AP YEAR= 2019 , NDA 214902 (label 214902.pdf) INN (BENZOYL PEROXIDE TRETINOIN) TWYNEO (GALDERMA LABS LP) APPROVAL= AP YEAR= 2021 , NDA 212845 (pdf 212845.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2022 , NDA 215713 (pdf 215713.pdf not found) INN (TRETINOIN) TRETINOIN (TARO) APPROVAL= AP YEAR= 2023 , NDA 215609 (pdf 215609.pdf not found) INN (TRETINOIN) TRETINOIN MICROSPHERE (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 216943 (pdf 216943.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 217804 (pdf 217804.pdf not found) INN (TRETINOIN) TRETINOIN (ALEMBIC) APPROVAL= AP YEAR= 2024 , NDA 218561 (pdf 218561.pdf not found) INN (TRETINOIN) TRETINOIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 396 ; FLOXURIDINE ; 50-91-9 ; 1970 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- INTERFERE WITH THE SYNTHESIS OF DNA AND RNA -- RAPIDLY CATABOLIZED TO 5-FLUOROURACIL , ; NDA 016929 (pdf 16929.pdf not found) INN (FLOXURIDINE) FUDR (HOSPIRA) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 071055 (pdf 71055.pdf not found) INN (FLOXURIDINE) FLOXURIDINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 075387 (pdf 75387.pdf not found) INN (FLOXURIDINE) FLOXURIDINE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075837 (pdf 75837.pdf not found) INN (FLOXURIDINE) FLOXURIDINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 203008 (pdf 203008.pdf not found) INN (FLOXURIDINE) FLOXURIDINE (AM REGENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , 397 ; HALOPROGIN ; 777-11-7 ; 1971 ; DISCONTINUED ; ; CLASS DERMATOLOGICAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTI-FUNGAL AGENTS , ; NDA 016942 (pdf 16942.pdf not found) INN (HALOPROGIN) HALOTEX (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY DISCONTINUED , NDA 016943 (pdf 16943.pdf not found) INN (HALOPROGIN) HALOTEX (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1971 DISCONTINUED , 398 ; TAPENTADOL ; 175591-23-8 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- OPIOID ANALGESIC -- NOREPINEPHRINE REUPTAKE INHIBITOR -- MU OPIOD RECEPTOR AGONIST , ; NDA 022304 (label 22304.pdf) INN (TAPENTADOL HYDROCHLORIDE) NUCYNTA (COLLEGIUM PHARM INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 200533 (label 200533.pdf) INN (TAPENTADOL HYDROCHLORIDE) NUCYNTA ER (COLLEGIUM PHARM INC) APPROVAL= AP YEAR= 2011 , NDA 203794 (label 203794.pdf) INN (TAPENTADOL HYDROCHLORIDE) NUCYNTA (COLLEGIUM PHARM INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204971 (pdf 204971.pdf not found) INN (TAPENTADOL) TAPENTADOL (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 2015 , NDA 204972 (pdf 204972.pdf not found) INN (TAPENTADOL) TAPENTADOL (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 2017 , NDA 205057 (pdf 205057.pdf not found) INN (TAPENTADOL) TAPENTADOL (ROXANE) APPROVAL= TA YEAR= 2015 , NDA 205015 (pdf 205015.pdf not found) INN (TAPENTADOL) TAPENTADOL (ALKEM LABS LTD) APPROVAL= TA YEAR= 2016 , NDA 206657 (pdf 206657.pdf not found) INN (TAPENTADOL HYDROCHLORIDE) TAPENTADOL HYDROCHLORIDE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2016 , NDA 206418 (pdf 206418.pdf not found) INN (TAPENTADOL) TAPENTADOL (WEST-WARD PHARMS INT) APPROVAL= TA YEAR= 2017 , NDA 209369 (pdf 209369.pdf not found) INN (TAPENTADOL HYDROCHLORIDE) TAPENTADOL HYDROCHLORIDE (RHODES PHARMS) APPROVAL= TA YEAR= 2017 , NDA 214378 (pdf 214378.pdf not found) INN (TAPENTADOL HYDROCHLORIDE) TAPENTADOL HYDROCHLORIDE (HUMANWELL PHARMACEUTICAL US INC) APPROVAL= TA YEAR= 2022 , 399 ; CARBACHOL ; 51-83-2 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINERGIC (PARASYMPATHOMIMETIC) AGENT -- REDUCTION OF INTRAOCULAR PRESSURE -- VASODILATATOR -- INDUCES RELEASE OF CA2+ FROM INTRACELLULAR STORES WHICH MAY BE MODULATED BY MITOCHONDRIA , ; NDA 016968 (label 16968.pdf) INN (CARBACHOL) MIOSTAT (ALCON) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 070292 (pdf 70292.pdf not found) INN (CARBACHOL) CARBACHOL (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073677 (pdf 73677.pdf not found) INN (CARBACHOL) CARBASTAT (NOVARTIS) APPROVAL= AP YEAR= 1995 DISCONTINUED , 400 ; MEGESTROL ACETATE ; 595-33-5 ; 1971 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ANOREXIA AND CACHEXIA -- APPETITE ENHANCING , ; NDA 016979 (pdf 16979.pdf not found) INN (MEGESTROL ACETATE) MEGACE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY DISCONTINUED , NDA 020264 (label 20264.pdf) INN (MEGESTROL ACETATE) MEGACE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 021778 (label 21778.pdf) INN (MEGESTROL ACETATE) MEGACE ES (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 , NDA 070646 (pdf 70646.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070647 (pdf 70647.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072422 (pdf 72422.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 , NDA 072423 (pdf 72423.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 , NDA 074458 (pdf 74458.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074621 (pdf 74621.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (BARR) APPROVAL= AP YEAR= 1995 , NDA 074745 (pdf 74745.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075671 (pdf 75671.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075681 (pdf 75681.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075997 (pdf 75997.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076721 (pdf 76721.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077404 (pdf 77404.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2006 , NDA 203139 (pdf 203139.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (TWI PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203960 (pdf 203960.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204688 (pdf 204688.pdf not found) INN (MEGESTROL ACETATE) MEGESTROL ACETATE (CHARTWELL) APPROVAL= AP YEAR= 2017 DISCONTINUED , 401 ; CROMOLYN ; 16110-51-3 ; 1982 ; ; ; CLASS METABOLISM -- ANTIASTHMATIC -- ANTIALLERGY -- ANTI-INFLAMMATORY AGENT -- INHIBIT THE RELEASE OF HISTAMINE AND LEUKOTRIENES (SRS-A) FROM THE MAST CELL , ; NDA 016990 (pdf 16990.pdf not found) INN (CROMOLYN SODIUM) INTAL (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018155 (pdf 18155.pdf not found) INN (CROMOLYN SODIUM) OPTICROM (ALLERGAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018596 (label 18596.pdf) INN (CROMOLYN SODIUM) INTAL (KING PHARMS LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018887 (label 18887.pdf) INN (CROMOLYN SODIUM) INTAL (KING PHARMS LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019188 (pdf 19188.pdf not found) INN (CROMOLYN SODIUM) GASTROCROM (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020463 (pdf 20463.pdf not found) INN (CROMOLYN SODIUM) NASALCROM (BLACKSMITH BRANDS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020479 (pdf 20479.pdf not found) INN (CROMOLYN SODIUM) GASTROCROM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1996 , NDA 074209 (pdf 74209.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074443 (pdf 74443.pdf not found) INN (CROMOLYN SODIUM) CROLOM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074706 (pdf 74706.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074800 (pdf 74800.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075067 (pdf 75067.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075088 (pdf 75088.pdf not found) INN (CROMOLYN SODIUM) CROMOPTIC (KING PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075175 (label 75175.pdf) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (ROXANE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075271 (label 75271.pdf) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2000 , NDA 075282 (pdf 75282.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1999 , NDA 075333 (pdf 75333.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075346 (pdf 75346.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1999 , NDA 075427 (pdf 75427.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (PERRIGO) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075437 (pdf 75437.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (VIRTUS) APPROVAL= AP YEAR= 2000 , NDA 075585 (pdf 75585.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (BAUSCH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075615 (pdf 75615.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075702 (label 75702.pdf) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2001 , NDA 076469 (pdf 76469.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077976 (pdf 77976.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (HH AND P) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 090954 (label 90954.pdf) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (GENERA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 202583 (pdf 202583.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (RISING) APPROVAL= AP YEAR= 2011 , NDA 202745 (pdf 202745.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2013 , NDA 209264 (pdf 209264.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (AILEX PHARMS LLC) APPROVAL= AP YEAR= 2017 , NDA 209453 (pdf 209453.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (AILEX PHARMS LLC) APPROVAL= AP YEAR= 2017 , NDA 213658 (pdf 213658.pdf not found) INN (CROMOLYN SODIUM) CROMOLYN SODIUM (MICRO LABS) APPROVAL= AP YEAR= 2022 , 402 ; DIAZOXIDE ; 364-98-7 ; 1973 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- NONDIURETIC BENZOTHIADIAZINE -- VASODILATOR AGENTS -- MANAGEMENT OF SYMPTOMATIC HYPOGLYCEMIA -- INCREASE IN BLOOD GLUCOSE LEVEL SELECTIVE MITOCHONDRIAL KATP-CHANNEL AGONIST , ; NDA 016996 (pdf 16996.pdf not found) INN (DIAZOXIDE) HYPERSTAT (SCHERING) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 017425 (label 17425.pdf) INN (DIAZOXIDE) PROGLYCEM (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017453 (label 17453.pdf) INN (DIAZOXIDE) PROGLYCEM (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 , NDA 071519 (pdf 71519.pdf not found) INN (DIAZOXIDE) DIAZOXIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071908 (pdf 71908.pdf not found) INN (DIAZOXIDE) DIAZOXIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 211050 (pdf 211050.pdf not found) INN (DIAZOXIDE) DIAZOXIDE (E5 PHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 210799 (pdf 210799.pdf not found) INN (DIAZOXIDE) DIAZOXIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2020 , 403 ; FLUCYTOSINE ; 2022-85-7 ; 1971 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- ANTIMETABOLITES , ; NDA 017001 (label 17001.pdf) INN (FLUCYTOSINE) ANCOBON (BAUSCH) APPROVAL= AP YEAR= 1971 NEWMOLECULARENTITY , NDA 201566 (pdf 201566.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2011 , NDA 204652 (pdf 204652.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 206550 (pdf 206550.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207536 (pdf 207536.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 212632 (pdf 212632.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213665 (pdf 213665.pdf not found) INN (FLUCYTOSINE) FLUCYTOSINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , 404 ; DESONIDE ; 638-94-8 ; 1972 ; ; ; CLASS DERMATOLOGICALS -- ANTIINFLAMMATORY -- CORTICOSTEROID , ; NDA 017010 (pdf 17010.pdf not found) INN (DESONIDE) DESONIDE (PADAGIS US) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 017426 (pdf 17426.pdf not found) INN (DESONIDE) DESONIDE (PADAGIS US) APPROVAL= AP YEAR= 1974 , NDA 017914 (pdf 17914.pdf not found) INN (ACETIC ACID GLACIAL DESONIDE) TRIDESILON (BAYER PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 019048 (pdf 19048.pdf not found) INN (DESONIDE) DESOWEN (GALDERMA LABS LP) APPROVAL= AP YEAR= 1984 , NDA 021844 (label 21844.pdf) INN (DESONIDE) DESONATE (LEO PHARMA AS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021978 (label 21978.pdf) INN (DESONIDE) VERDESO (ALMIRALL) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 071425 (pdf 71425.pdf not found) INN (DESONIDE) DESOWEN (GALDERMA LABS LP) APPROVAL= AP YEAR= 1988 , NDA 072354 (pdf 72354.pdf not found) INN (DESONIDE) DESOWEN (GALDERMA LABS LP) APPROVAL= AP YEAR= 1992 , NDA 073548 (pdf 73548.pdf not found) INN (DESONIDE) DESONIDE (TARO) APPROVAL= AP YEAR= 1992 , NDA 074027 (pdf 74027.pdf not found) INN (DESONIDE) DESONIDE (COSETTE) APPROVAL= AP YEAR= 1992 , NDA 074254 (pdf 74254.pdf not found) INN (DESONIDE) DESONIDE (TARO) APPROVAL= AP YEAR= 1994 , NDA 075751 (pdf 75751.pdf not found) INN (DESONIDE) DESONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2001 , NDA 075860 (pdf 75860.pdf not found) INN (DESONIDE) DESONIDE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2002 , NDA 202161 (pdf 202161.pdf not found) INN (DESONIDE) DESONIDE (TARO) APPROVAL= AP YEAR= 2014 , NDA 208836 (pdf 208836.pdf not found) INN (DESONIDE) DESONIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209729 (pdf 209729.pdf not found) INN (DESONIDE) DESONIDE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 207855 (pdf 207855.pdf not found) INN (DESONIDE) DESONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209494 (pdf 209494.pdf not found) INN (DESONIDE) DESONIDE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 209996 (pdf 209996.pdf not found) INN (DESONIDE) DESONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 210998 (pdf 210998.pdf not found) INN (DESONIDE) DESONIDE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2019 , NDA 212002 (pdf 212002.pdf not found) INN (DESONIDE) DESONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210198 (pdf 210198.pdf not found) INN (DESONIDE) DESONIDE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 212473 (pdf 212473.pdf not found) INN (DESONIDE) DESONIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 202470 (pdf 202470.pdf not found) INN (DESONIDE) DESONIDE (CINTEX SVCS) APPROVAL= AP YEAR= 2020 , NDA 213632 (pdf 213632.pdf not found) INN (DESONIDE) DESONIDE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 214396 (pdf 214396.pdf not found) INN (DESONIDE) DESONIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 405 ; PANCURONIUM ; 15500-66-0 ; 1972 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS (CURARIFORM) -- ANTAGONISM TO ACETYLCHOLINE , ; NDA 017015 (label 17015.pdf) INN (PANCURONIUM BROMIDE) PAVULON (ORGANON USA INC) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY DISCONTINUED , NDA 072058 (pdf 72058.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (ELKINS SINN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072059 (pdf 72059.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (ELKINS SINN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072060 (pdf 72060.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (ELKINS SINN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072208 (pdf 72208.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072209 (pdf 72209.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072210 (pdf 72210.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072211 (pdf 72211.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072212 (pdf 72212.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072213 (pdf 72213.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072320 (pdf 72320.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072321 (pdf 72321.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072759 (pdf 72759.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (DR REDDYS) APPROVAL= AP YEAR= 1990 , NDA 072760 (pdf 72760.pdf not found) INN (PANCURONIUM BROMIDE) PANCURONIUM BROMIDE (DR REDDYS) APPROVAL= AP YEAR= 1990 , 406 ; PENTAGASTRIN ; 5534-95-2 ; 1974 ; DISCONTINUED ; ; CLASS VARIOUS -- DIAGNOSTIC AID -- GASTRIC FUNCTION , ; NDA 017048 (pdf 17048.pdf not found) INN (PENTAGASTRIN) PEPTAVLON (WYETH AYERST) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , 407 ; ENFLURANE ; 13838-16-9 ; 1972 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA INDUCER (POSITIVE ALLOSTERIC MODULATORS) , ; NDA 017087 (label 17087.pdf) INN (ENFLURANE) ETHRANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY DISCONTINUED , NDA 070803 (pdf 70803.pdf not found) INN (ENFLURANE) ENFLURANE (ABBOTT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 074396 (pdf 74396.pdf not found) INN (ENFLURANE) ENFLURANE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 1994 DISCONTINUED , 408 ; MOLINDONE ; 7416-34-4 ; 1974 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- MANAGEMENT OF SCHIZOPHRENIA -- DOPAMINE RECEPTOR ANTAGONIST , ; NDA 017111 (label 17111.pdf) INN (MOLINDONE HYDROCHLORIDE) MOBAN (CHARTWELL RX) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 017938 (pdf 17938.pdf not found) INN (MOLINDONE HYDROCHLORIDE) MOBAN (ENDO PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 090453 (pdf 90453.pdf not found) INN (MOLINDONE HYDROCHLORIDE) MOLINDONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , 409 ; MAZINDOL ; 22232-71-9 ; 1973 ; DISCONTINUED ; ; CLASS METABOLISM -- CNS STIMULANT -- ANTIANOREXIC -- ADRENERGIC UPTAKE INHIBITORS -- DOPAMINE UPTAKE INHIBITORS , ; NDA 017247 (pdf 17247.pdf not found) INN (MAZINDOL) SANOREX (NOVARTIS) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 017980 (pdf 17980.pdf not found) INN (MAZINDOL) MAZANOR (WYETH AYERST) APPROVAL= AP YEAR= 1980 DISCONTINUED , 410 ; TRIMETHOPRIM ; 738-70-5 ; 1973 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTIMALARIALS -- FOLIC ACID ANTAGONISTS , ; NDA 017376 (label 17376.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1973 , NDA 017377 (label 17377.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1973 , NDA 017560 (label 17560.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017598 (label 17598.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017943 (label 17943.pdf) INN (TRIMETHOPRIM) PROLOPRIM (MONARCH PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 017952 (pdf 17952.pdf not found) INN (TRIMETHOPRIM) TRIMPEX (ROCHE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018242 (pdf 18242.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018374 (label 18374.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) BACTRIM (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018452 (label 18452.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SEPTRA (MONARCH PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018598 (label 18598.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018615 (label 18615.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM PEDIATRIC (PHARM ASSOC) APPROVAL= AP YEAR= 1983 , NDA 018679 (label 18679.pdf) INN (TRIMETHOPRIM) TRIMETHOPRIM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1982 , NDA 018812 (pdf 18812.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018852 (pdf 18852.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018854 (pdf 18854.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018946 (pdf 18946.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021105 (label 21105.pdf) INN (PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 050567 (pdf 50567.pdf not found) INN (POLYMYXIN B SULFATE TRIMETHOPRIM SULFATE) POLYTRIM (ALLERGAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 064120 (pdf 64120.pdf not found) INN (POLYMYXIN B SULFATE TRIMETHOPRIM SULFATE) TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1997 , NDA 064211 (pdf 64211.pdf not found) INN (POLYMYXIN B SULFATE TRIMETHOPRIM SULFATE) TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 065006 (pdf 65006.pdf not found) INN (POLYMYXIN B SULFATE TRIMETHOPRIM SULFATE) TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 , NDA 070000 (pdf 70000.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070002 (pdf 70002.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070006 (pdf 70006.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MUTUAL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070007 (pdf 70007.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (MUTUAL PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 070022 (pdf 70022.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM (NOVEL LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070028 (pdf 70028.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070030 (pdf 70030.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070032 (pdf 70032.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM-DS (NOVEL LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070034 (pdf 70034.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) COTRIM (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070037 (pdf 70037.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070048 (pdf 70048.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) COTRIM D.S. (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070049 (pdf 70049.pdf not found) INN (TRIMETHOPRIM) TRIMETHOPRIM (WATSON LABS) APPROVAL= AP YEAR= 1985 , NDA 070063 (pdf 70063.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULMEPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070064 (pdf 70064.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULMEPRIM PEDIATRIC (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070065 (pdf 70065.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM-SS (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070066 (pdf 70066.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFATRIM-DS (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070203 (pdf 70203.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070204 (pdf 70204.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070215 (pdf 70215.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070216 (pdf 70216.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PLIVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070223 (pdf 70223.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070494 (pdf 70494.pdf not found) INN (TRIMETHOPRIM) TRIMETHOPRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070495 (pdf 70495.pdf not found) INN (TRIMETHOPRIM) TRIMETHOPRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070627 (pdf 70627.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070628 (pdf 70628.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070889 (pdf 70889.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070890 (pdf 70890.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (FOSUN PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071016 (pdf 71016.pdf not found) INN (TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 071017 (pdf 71017.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 071259 (label 71259.pdf) INN (TRIMETHOPRIM) TRIMETHOPRIM (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071299 (pdf 71299.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071300 (pdf 71300.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071341 (pdf 71341.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOPRIM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071556 (pdf 71556.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071815 (pdf 71815.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) UROPLUS SS (SHIONOGI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071816 (pdf 71816.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) UROPLUS DS (SHIONOGI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072289 (pdf 72289.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072383 (pdf 72383.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072398 (pdf 72398.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072399 (pdf 72399.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) TRIMETH/SULFA (NASKA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072408 (pdf 72408.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MARTEC USA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072417 (pdf 72417.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (MARTEC USA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072768 (pdf 72768.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (ROXANE) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072769 (pdf 72769.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073199 (pdf 73199.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073303 (label 73303.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1991 , NDA 074374 (pdf 74374.pdf not found) INN (TRIMETHOPRIM HYDROCHLORIDE) PRIMSOL (ALLEGIS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074650 (label 74650.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AKORN) APPROVAL= AP YEAR= 1997 , NDA 074973 (label 74973.pdf) INN (TRIMETHOPRIM HYDROCHLORIDE) PRIMSOL (ALLEGIS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076817 (pdf 76817.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (VISTA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076899 (pdf 76899.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2005 , NDA 077612 (label 77612.pdf) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (PRASCO) APPROVAL= AP YEAR= 2006 , NDA 077785 (pdf 77785.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (LANNETT CO INC) APPROVAL= AP YEAR= 2007 , NDA 078060 (pdf 78060.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2007 , NDA 090624 (pdf 90624.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091348 (pdf 91348.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091437 (pdf 91437.pdf not found) INN (TRIMETHOPRIM) TRIMETHOPRIM (NOVEL LABS INC) APPROVAL= AP YEAR= 2011 , NDA 090828 (pdf 90828.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (GLENMARK GENERICS) APPROVAL= AP YEAR= 2010 , NDA 206607 (pdf 206607.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 212231 (pdf 212231.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (SOMERSET) APPROVAL= AP YEAR= 2019 , NDA 212699 (pdf 212699.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (LUPIN LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214330 (pdf 214330.pdf not found) INN (SULFAMETHOXAZOLE TRIMETHOPRIM) SULFAMETHOXAZOLE AND TRIMETHOPRIM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216393 (pdf 216393.pdf not found) INN (TRIMETHOPRIM) TRIMETHOPRIM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 411 ; METOLAZONE ; 17560-51-9 ; 1973 ; ; ; CLASS CARDIOVASCULAR -- QUINAZOLINE DIURETIC -- ANTIHYPERTENSIVE -- BLOCKER , ; NDA 017386 (label 17386.pdf) INN (METOLAZONE) ZAROXOLYN (I3 PHARMS) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 018535 (pdf 18535.pdf not found) INN (METOLAZONE) DIULO (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019532 (label 19532.pdf) INN (METOLAZONE) MYKROX (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 075543 (pdf 75543.pdf not found) INN (METOLAZONE) METOLAZONE (ANI PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076466 (pdf 76466.pdf not found) INN (METOLAZONE) METOLAZONE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076482 (pdf 76482.pdf not found) INN (METOLAZONE) METOLAZONE (ROXANE) APPROVAL= AP YEAR= 2004 , NDA 076600 (pdf 76600.pdf not found) INN (METOLAZONE) METOLAZONE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 076698 (pdf 76698.pdf not found) INN (METOLAZONE) METOLAZONE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 076732 (pdf 76732.pdf not found) INN (METOLAZONE) METOLAZONE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076833 (pdf 76833.pdf not found) INN (METOLAZONE) METOLAZONE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 076891 (pdf 76891.pdf not found) INN (METOLAZONE) METOLAZONE (WATSON LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 213251 (pdf 213251.pdf not found) INN (METOLAZONE) METOLAZONE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 213827 (pdf 213827.pdf not found) INN (METOLAZONE) METOLAZONE (INNOGENIX) APPROVAL= AP YEAR= 2021 , NDA 214799 (pdf 214799.pdf not found) INN (METOLAZONE) METOLAZONE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2021 , NDA 215184 (pdf 215184.pdf not found) INN (METOLAZONE) METOLAZONE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 215616 (pdf 215616.pdf not found) INN (METOLAZONE) METOLAZONE (RENATA) APPROVAL= AP YEAR= 2022 , NDA 216216 (pdf 216216.pdf not found) INN (METOLAZONE) METOLAZONE (NE RX PHARMA) APPROVAL= AP YEAR= 2022 , NDA 218606 (pdf 218606.pdf not found) INN (METOLAZONE) METOLAZONE (LEADING) APPROVAL= AP YEAR= 2024 , 412 ; DYDROGESTERONE ; 152-62-5 ; 0 ; DISCONTINUED ; ; CLASS GENITO -- PROGESTIN -- PREGNADIEN DERIVATIVES -- PROGESTERONES , ; NDA 017388 (pdf 17388.pdf not found) INN (DYDROGESTERONE) GYNOREST (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , 413 ; DOPAMINE ; 51-61-6 ; 1974 ; ; NATURAL MOLECULE C00001408 ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- DOPAMINE RECEPTOR AGONIST -- TREATMENT OF HYPOTENSION -- BETA ADRENOCEPTOR AGONIST , ; NDA 017395 (pdf 17395.pdf not found) INN (DOPAMINE HYDROCHLORIDE) INTROPIN (HOSPIRA) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 018014 (pdf 18014.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018132 (label 18132.pdf) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1981 , NDA 018138 (pdf 18138.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018398 (pdf 18398.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018549 (pdf 18549.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (LYPHOMED) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018656 (pdf 18656.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (TELIGENT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018826 (label 18826.pdf) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 019099 (pdf 19099.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019615 (label 19615.pdf) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1987 , NDA 020542 (pdf 20542.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 070011 (pdf 70011.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070012 (pdf 70012.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070013 (pdf 70013.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070046 (pdf 70046.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070047 (pdf 70047.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070058 (pdf 70058.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070059 (pdf 70059.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070087 (pdf 70087.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070089 (pdf 70089.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070090 (pdf 70090.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070091 (pdf 70091.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070092 (pdf 70092.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070093 (pdf 70093.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070094 (pdf 70094.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070364 (pdf 70364.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070558 (pdf 70558.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070559 (pdf 70559.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070656 (pdf 70656.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070657 (pdf 70657.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070799 (pdf 70799.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070820 (pdf 70820.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070826 (pdf 70826.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072999 (pdf 72999.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073000 (pdf 73000.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074403 (pdf 74403.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 207707 (pdf 207707.pdf not found) INN (DOPAMINE HYDROCHLORIDE) DOPAMINE HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2018 , 414 ; CLONIDINE ; 4205-90-7 ; 1974 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA AGONISTS -- ANTIMIGRAINE -- SYMPATHOMIMETICS IN GLAUCOMA THERAPY -- IMIDAZOLINE DERIVATIVE , ; NDA 017407 (label 17407.pdf) INN (CLONIDINE HYDROCHLORIDE) CATAPRES (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017503 (pdf 17503.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) COMBIPRES (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018891 (label 18891.pdf) INN (CLONIDINE) CATAPRES-TTS-1 (LAVIPHARM) APPROVAL= AP YEAR= 1984 , NDA 020615 (label 20615.pdf) INN (CLONIDINE HYDROCHLORIDE) DURACLON (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1996 , NDA 070317 (pdf 70317.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070395 (pdf 70395.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070396 (label 70396.pdf) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070397 (pdf 70397.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070459 (pdf 70459.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070460 (pdf 70460.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070461 (pdf 70461.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070659 (pdf 70659.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070702 (pdf 70702.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070747 (pdf 70747.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070881 (pdf 70881.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070882 (pdf 70882.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070883 (pdf 70883.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070886 (pdf 70886.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1988 , NDA 070887 (pdf 70887.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 070923 (pdf 70923.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (URL LABS) APPROVAL= AP YEAR= 1987 , NDA 070924 (pdf 70924.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 070925 (pdf 70925.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (FRONTIDA BIOPHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 070963 (pdf 70963.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070964 (pdf 70964.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070965 (pdf 70965.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070974 (pdf 70974.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 , NDA 070975 (pdf 70975.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 , NDA 070976 (pdf 70976.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 , NDA 071101 (pdf 71101.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071102 (pdf 71102.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071103 (pdf 71103.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071142 (pdf 71142.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071178 (pdf 71178.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071179 (pdf 71179.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071252 (pdf 71252.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071253 (pdf 71253.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071254 (pdf 71254.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071294 (pdf 71294.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 071325 (pdf 71325.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLORPRES (MYLAN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071783 (pdf 71783.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 071784 (pdf 71784.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1988 DISCONTINUED OBSOLETE , NDA 071785 (pdf 71785.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1988 , NDA 072138 (pdf 72138.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072139 (pdf 72139.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072140 (pdf 72140.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077901 (pdf 77901.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2007 , NDA 022331 (label 22331.pdf) INN (CLONIDINE HYDROCHLORIDE) JENLOGA (CONCORDIA PHARMS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022499 (label 22499.pdf) INN (CLONIDINE) CLONIDINE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022500 (label 22500.pdf) INN (CLONIDINE) NEXICLON XR (ATHENA) APPROVAL= AP YEAR= 2009 , NDA 076157 (pdf 76157.pdf not found) INN (CLONIDINE) CLONIDINE (AVEVA) APPROVAL= AP YEAR= 2009 , NDA 078099 (pdf 78099.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2009 , NDA 078895 (pdf 78895.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2009 , NDA 091104 (pdf 91104.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076166 (pdf 76166.pdf not found) INN (CLONIDINE) CLONIDINE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2010 , NDA 079090 (pdf 79090.pdf not found) INN (CLONIDINE) CLONIDINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 , NDA 200300 (pdf 200300.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2011 , NDA 091368 (pdf 91368.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200673 (pdf 200673.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2011 , NDA 202297 (pdf 202297.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2013 , NDA 202984 (pdf 202984.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203167 (pdf 203167.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2013 , NDA 090329 (pdf 90329.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090873 (pdf 90873.pdf not found) INN (CLONIDINE) CLONIDINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2014 , NDA 202601 (pdf 202601.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 202983 (pdf 202983.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202792 (pdf 202792.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203320 (pdf 203320.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 , NDA 209285 (pdf 209285.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 209686 (pdf 209686.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 209757 (pdf 209757.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (XIAMEN LP PHARM CO) APPROVAL= AP YEAR= 2017 , NDA 210052 (pdf 210052.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210338 (pdf 210338.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2018 , NDA 210680 (pdf 210680.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211433 (pdf 211433.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209675 (pdf 209675.pdf not found) INN (CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 217645 (pdf 217645.pdf not found) INN (CLONIDINE HYDROCHLORIDE) ONYDA XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2024 , 415 ; PRAZEPAM ; 2955-38-6 ; 1979 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 017415 (pdf 17415.pdf not found) INN (PRAZEPAM) CENTRAX (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018144 (pdf 18144.pdf not found) INN (PRAZEPAM) CENTRAX (PARKE DAVIS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 070427 (pdf 70427.pdf not found) INN (PRAZEPAM) PRAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070428 (pdf 70428.pdf not found) INN (PRAZEPAM) PRAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , 416 ; CARMUSTINE ; 154-93-8 ; 1977 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- NITROSOUREAS -- CARBAMOYLATION OF AMINO ACIDS IN PROTEINS , ; NDA 017422 (label 17422.pdf) INN (CARMUSTINE) BICNU (AVET LIFESCIENCES) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 020637 (label 20637.pdf) INN (CARMUSTINE) GLIADEL (AZURITY) APPROVAL= AP YEAR= 1996 , NDA 210179 (pdf 210179.pdf not found) INN (CARMUSTINE) CARMUSTINE (NAVINTA LLC) APPROVAL= AP YEAR= 2018 , NDA 211229 (pdf 211229.pdf not found) INN (CARMUSTINE) CARMUSTINE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 209278 (pdf 209278.pdf not found) INN (CARMUSTINE) CARMUSTINE (PENN LIFE) APPROVAL= AP YEAR= 2019 , NDA 213207 (pdf 213207.pdf not found) INN (CARMUSTINE) CARMUSTINE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 211202 (pdf 211202.pdf not found) INN (CARMUSTINE) CARMUSTINE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213460 (pdf 213460.pdf not found) INN (CARMUSTINE) CARMUSTINE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 211011 (pdf 211011.pdf not found) INN (CARMUSTINE) CARMUSTINE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215000 (label 215000.pdf) INN (CARMUSTINE) CARMUSTINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214117 (pdf 214117.pdf not found) INN (CARMUSTINE) CARMUSTINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214814 (pdf 214814.pdf not found) INN (CARMUSTINE) CARMUSTINE (MSN) APPROVAL= AP YEAR= 2023 , NDA 215368 (pdf 215368.pdf not found) INN (CARMUSTINE) CARMUSTINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215730 (pdf 215730.pdf not found) INN (CARMUSTINE) CARMUSTINE (ALEMBIC) APPROVAL= AP YEAR= 2023 , 417 ; PILOCARPINE ; 92-13-7 ; 1974 ; ; NATURAL MOLECULE C00002355 ; CLASS NERVOUS SYSTEM -- CHOLINERGIC -- ANTIGLAUCOMA -- MIOTICS -- MUSCARINIC AGONISTS , ; NDA 017431 (pdf 17431.pdf not found) INN (PILOCARPINE) OCUSERT PILO-20 (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017548 (pdf 17548.pdf not found) INN (PILOCARPINE) OCUSERT PILO-40 (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018796 (label 18796.pdf) INN (PILOCARPINE HYDROCHLORIDE) PILOPINE HS (ALCON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 020237 (label 20237.pdf) INN (PILOCARPINE HYDROCHLORIDE) SALAGEN (CONCORDIA) APPROVAL= AP YEAR= 1994 , NDA 020619 (pdf 20619.pdf not found) INN (BETAXOLOL HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE) BETOPTIC PILO (ALCON) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 076746 (pdf 76746.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 076963 (pdf 76963.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 2004 , NDA 077220 (pdf 77220.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 077248 (pdf 77248.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 , NDA 200890 (label 200890.pdf) INN (PILOCARPINE HYDROCHLORIDE) ISOPTO CARPINE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 204398 (pdf 204398.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 210384 (pdf 210384.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 212377 (pdf 212377.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 214193 (pdf 214193.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) PILOCARPINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 214028 (label 214028.pdf) INN (PILOCARPINE HYDROCHLORIDE) VUITY (ABBVIE) APPROVAL= AP YEAR= 2021 , NDA 217836 (pdf 217836.pdf not found) INN (PILOCARPINE HYDROCHLORIDE) QLOSI (ORASIS PHARMS) APPROVAL= AP YEAR= 2023 , 418 ; DINOPROST ; 551-11-1 ; 1975 ; DISCONTINUED ; ; CLASS GENITO -- PROSTAGLANDIN -- OXYTOCIC -- PROSTAGLANDIN E2 (PGE2) , ; NDA 017434 (pdf 17434.pdf not found) INN (DINOPROST TROMETHAMINE) PROSTIN F2 ALPHA (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1975 DISCONTINUED , 419 ; PRAZOSIN ; 19216-56-9 ; 1976 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA-ANTAGONISTS -- ALPHA-ADRENERGIC BLOCKING AGENTS , ; NDA 017442 (label 17442.pdf) INN (PRAZOSIN HYDROCHLORIDE) MINIPRESS (PFIZER) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY , NDA 017986 (pdf 17986.pdf not found) INN (POLYTHIAZIDE PRAZOSIN HYDROCHLORIDE) MINIZIDE (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 019775 (pdf 19775.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) MINIPRESS XL (PFIZER) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 071745 (pdf 71745.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 071994 (pdf 71994.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 071995 (pdf 71995.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072333 (pdf 72333.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072352 (pdf 72352.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072573 (pdf 72573.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1989 , NDA 072574 (pdf 72574.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1989 , NDA 072575 (pdf 72575.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1989 , NDA 072576 (pdf 72576.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1989 DISCONTINUED OBSOLETE , NDA 072577 (pdf 72577.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072578 (pdf 72578.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1989 DISCONTINUED OBSOLETE , NDA 072609 (pdf 72609.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072705 (pdf 72705.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072706 (pdf 72706.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072707 (pdf 72707.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072782 (pdf 72782.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072783 (pdf 72783.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072784 (pdf 72784.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072921 (pdf 72921.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072991 (pdf 72991.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072992 (pdf 72992.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 210971 (pdf 210971.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2018 , NDA 214608 (pdf 214608.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 213406 (pdf 213406.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2022 , NDA 215697 (pdf 215697.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213052 (pdf 213052.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217268 (pdf 217268.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 214083 (pdf 214083.pdf not found) INN (PRAZOSIN HYDROCHLORIDE) PRAZOSIN HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2024 , 420 ; DANTROLENE ; 7261-97-4 ; 1974 ; ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANT -- RYANODINE RECEPTOR 1 ANTAGONIST , ; NDA 017443 (label 17443.pdf) INN (DANTROLENE SODIUM) DANTRIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY , NDA 018264 (label 18264.pdf) INN (DANTROLENE SODIUM) DANTRIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 1979 , NDA 076686 (pdf 76686.pdf not found) INN (DANTROLENE SODIUM) DANTROLENE SODIUM (ELITE LABS INC) APPROVAL= AP YEAR= 2005 , NDA 076856 (pdf 76856.pdf not found) INN (DANTROLENE SODIUM) DANTROLENE SODIUM (IMPAX LABS) APPROVAL= AP YEAR= 2005 , NDA 078378 (pdf 78378.pdf not found) INN (DANTROLENE SODIUM) REVONTO (USWM) APPROVAL= AP YEAR= 2007 , NDA 205579 (label 205579.pdf) INN (DANTROLENE SODIUM) RYANODEX (EAGLE PHARMS) APPROVAL= AP YEAR= 2014 , NDA 205239 (label 205239.pdf) INN (DANTROLENE SODIUM) DANTROLENE SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204762 (pdf 204762.pdf not found) INN (DANTROLENE SODIUM) DANTROLENE SODIUM (HIKMA) APPROVAL= AP YEAR= 2017 , 421 ; DISOPYRAMIDE ; 3737-09-5 ; 1977 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- SODIUM CHANNEL BLOCKERS -- POTASSIUM CHANNEL BLOCKERS , ; NDA 017447 (pdf 17447.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) NORPACE (PFIZER) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 018655 (pdf 18655.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) NORPACE CR (PFIZER) APPROVAL= AP YEAR= 1982 , NDA 070101 (pdf 70101.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 070102 (pdf 70102.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 070138 (pdf 70138.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070139 (pdf 70139.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070173 (pdf 70173.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1985 , NDA 070174 (pdf 70174.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MAYNE PHARMA) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 070186 (pdf 70186.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070187 (pdf 70187.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070240 (pdf 70240.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070241 (pdf 70241.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070351 (pdf 70351.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070352 (pdf 70352.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070470 (pdf 70470.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070471 (pdf 70471.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070940 (pdf 70940.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070941 (pdf 70941.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071190 (pdf 71190.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071191 (pdf 71191.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071200 (pdf 71200.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (NESHER PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , 422 ; MICONAZOLE ; 22916-47-8 ; 1974 ; ; ; CLASS METABOLISM -- ANTIFUNGAL (TOPICAL) -- CYTOCHROME P450 14ALPHA-DEMETHYLASE INHIBITOR -- INHIBITION OF ERGOSTEROL SYNTHESIS (FUNGAL CELL MEMBRANE) , ; NDA 017450 (label 17450.pdf) INN (MICONAZOLE NITRATE) MONISTAT 7 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY , NDA 017494 (pdf 17494.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT-DERM (INSIGHT PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017739 (pdf 17739.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT-DERM (INSIGHT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018040 (pdf 18040.pdf not found) INN (MICONAZOLE) MONISTAT (JANSSEN PHARMA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018520 (pdf 18520.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 7 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1982 , NDA 018592 (pdf 18592.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 5 (PERSONAL PRODS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 018888 (pdf 18888.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 3 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1984 , NDA 020288 (pdf 20288.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 7 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1993 , NDA 020670 (label 20670.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1996 , NDA 020827 (label 20827.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1998 , NDA 020968 (label 20968.pdf) INN (MICONAZOLE NITRATE) MONISTAT DUAL- PAK (PERSONAL PRODS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021026 (label 21026.pdf) INN (MICONAZOLE NITRATE WHITE PETROLATUM ZINC OXIDE) VUSION (MYLAN) APPROVAL= AP YEAR= 2006 , NDA 021261 (label 21261.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 COMBINATION PACK PREFILLED (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 2001 , NDA 021308 (label 21308.pdf) INN (MICONAZOLE NITRATE) MONISTAT 1 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 2001 , NDA 073507 (pdf 73507.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1993 , NDA 073508 (pdf 73508.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (ACTAVIS PHARMA) APPROVAL= AP YEAR= 1993 , NDA 074030 (pdf 74030.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074136 (pdf 74136.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074164 (pdf 74164.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 7 (P AND L) APPROVAL= AP YEAR= 1996 , NDA 074366 (pdf 74366.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074395 (pdf 74395.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074414 (pdf 74414.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074444 (pdf 74444.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TARO) APPROVAL= AP YEAR= 1997 , NDA 074586 (pdf 74586.pdf not found) INN (MICONAZOLE NITRATE) M-ZOLE 7 DUAL PACK (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074760 (pdf 74760.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO) APPROVAL= AP YEAR= 1997 , NDA 074926 (label 74926.pdf) INN (MICONAZOLE NITRATE) M-ZOLE 3 COMBINATION PACK (COSETTE) APPROVAL= AP YEAR= 1999 , NDA 075329 (label 75329.pdf) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE COMBINATION PACK (L PERRIGO CO) APPROVAL= AP YEAR= 1999 , NDA 076357 (pdf 76357.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 3 COMBINATION PACK (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076585 (pdf 76585.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 7 COMBINATION PACK (COSETTE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076773 (pdf 76773.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 3 (TARO) APPROVAL= AP YEAR= 2005 , NDA 022404 (label 22404.pdf) INN (MICONAZOLE) ORAVIG (GALT PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091366 (pdf 91366.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2010 , NDA 079114 (pdf 79114.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2010 , 423 ; IBUPROFEN ; 15687-27-1 ; 1974 ; ; ; CLASS MUSCULO-SKELETAL -- ANALGESICS -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL (NSAIDS) -- CYCLOOXYGENASE INHIBITORS -- TREATMENT OF A HAEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PRETERM NEWBORN INFANTS (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 017463 (label 17463.pdf) INN (IBUPROFEN) MOTRIN (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 018197 (pdf 18197.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018989 (label 18989.pdf) INN (IBUPROFEN) ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1984 , NDA 019012 (label 19012.pdf) INN (IBUPROFEN) NUPRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1984 , NDA 019771 (label 19771.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1989 , NDA 019784 (pdf 19784.pdf not found) INN (IBUPROFEN) IBU (ABBOTT) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019833 (pdf 19833.pdf not found) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019842 (label 19842.pdf) INN (IBUPROFEN) MOTRIN (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019899 (label 19899.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) SINE-AID IB (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1992 , NDA 020135 (pdf 20135.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL PED) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020267 (label 20267.pdf) INN (IBUPROFEN) JUNIOR STRENGTH ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1996 , NDA 020402 (label 20402.pdf) INN (IBUPROFEN) ADVIL LIQUI-GELS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1995 , NDA 020418 (pdf 20418.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL PED) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020476 (pdf 20476.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020516 (label 20516.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1995 , NDA 020589 (label 20589.pdf) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1996 , NDA 020601 (label 20601.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020602 (label 20602.pdf) INN (IBUPROFEN) JUNIOR STRENGTH MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 , NDA 020603 (label 20603.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 , NDA 020716 (label 20716.pdf) INN (HYDROCODONE BITARTRATE IBUPROFEN) VICOPROFEN (ABBVIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020812 (label 20812.pdf) INN (IBUPROFEN) PEDIATRIC ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1998 , NDA 020944 (label 20944.pdf) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1998 , NDA 021128 (label 21128.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S MOTRIN COLD (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2000 , NDA 021373 (label 21373.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL COLD (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021374 (label 21374.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021378 (label 21378.pdf) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) COMBUNOX (FOREST LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021393 (label 21393.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) ADVIL PM (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2005 , NDA 021394 (label 21394.pdf) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) ADVIL PM (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2005 , NDA 021441 (label 21441.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021472 (label 21472.pdf) INN (IBUPROFEN) MIDOL LIQUID GELS (BIONPHARMA) APPROVAL= AP YEAR= 2002 , NDA 021587 (label 21587.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2004 , NDA 021604 (label 21604.pdf) INN (IBUPROFEN) CHILDREN'S ELIXSURE (MOBERG PHARMA NORTH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021903 (label 21903.pdf) INN (IBUPROFEN LYSINE) NEOPROFEN (RECORDATI RARE) APPROVAL= AP YEAR= 2006 , NDA 070038 (pdf 70038.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070041 (pdf 70041.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070045 (pdf 70045.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070057 (pdf 70057.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070079 (pdf 70079.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070080 (pdf 70080.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070081 (pdf 70081.pdf not found) INN (IBUPROFEN) IBUPROFEN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070083 (pdf 70083.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070088 (pdf 70088.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070099 (pdf 70099.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070328 (pdf 70328.pdf not found) INN (IBUPROFEN) IBUPROFEN (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070329 (pdf 70329.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070330 (pdf 70330.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070435 (pdf 70435.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070436 (pdf 70436.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070437 (pdf 70437.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070469 (pdf 70469.pdf not found) INN (IBUPROFEN) IBUPROHM (OHM LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070475 (pdf 70475.pdf not found) INN (IBUPROFEN) MEDIPREN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070476 (pdf 70476.pdf not found) INN (IBUPROFEN) IBUPROFEN (MCNEIL) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070481 (pdf 70481.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 070493 (pdf 70493.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070556 (pdf 70556.pdf not found) INN (IBUPROFEN) IBUPROFEN (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070591 (pdf 70591.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070626 (pdf 70626.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070629 (pdf 70629.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEDERLE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070630 (pdf 70630.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEDERLE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070709 (pdf 70709.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070733 (pdf 70733.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L DEV LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070734 (pdf 70734.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070735 (pdf 70735.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070736 (pdf 70736.pdf not found) INN (IBUPROFEN) IBUPROFEN (RISING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070745 (pdf 70745.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070818 (pdf 70818.pdf not found) INN (IBUPROFEN) IBUPROFEN (OHM LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070908 (pdf 70908.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070985 (pdf 70985.pdf not found) INN (IBUPROFEN) IBUPROFEN (MERRO PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070986 (pdf 70986.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071001 (pdf 71001.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071002 (pdf 71002.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071027 (pdf 71027.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071028 (pdf 71028.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071029 (pdf 71029.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071030 (pdf 71030.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071057 (pdf 71057.pdf not found) INN (IBUPROFEN) IBU-TAB 200 (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071058 (pdf 71058.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071059 (pdf 71059.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071065 (pdf 71065.pdf not found) INN (IBUPROFEN) ACHES-N-PAIN (LEDERLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071122 (pdf 71122.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071123 (pdf 71123.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071124 (pdf 71124.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071125 (pdf 71125.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071144 (pdf 71144.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071145 (pdf 71145.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071146 (pdf 71146.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071154 (pdf 71154.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071163 (pdf 71163.pdf not found) INN (IBUPROFEN) IBUPROFEN (OHM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071214 (pdf 71214.pdf not found) INN (IBUPROFEN) IBUPROHM (OHM LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071215 (pdf 71215.pdf not found) INN (IBUPROFEN) MEDIPREN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071229 (pdf 71229.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 , NDA 071230 (pdf 71230.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071231 (pdf 71231.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071232 (pdf 71232.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071264 (pdf 71264.pdf not found) INN (IBUPROFEN) IBUPROFEN (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071265 (pdf 71265.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071266 (pdf 71266.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEINER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071267 (pdf 71267.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 , NDA 071268 (pdf 71268.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 , NDA 071333 (pdf 71333.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1987 , NDA 071334 (pdf 71334.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1986 , NDA 071335 (pdf 71335.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1986 , NDA 071338 (pdf 71338.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071448 (pdf 71448.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071462 (pdf 71462.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071547 (pdf 71547.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071575 (pdf 71575.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071639 (pdf 71639.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071644 (pdf 71644.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071664 (pdf 71664.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071666 (pdf 71666.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071667 (pdf 71667.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071668 (pdf 71668.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071732 (pdf 71732.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071735 (pdf 71735.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071765 (pdf 71765.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071769 (pdf 71769.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071773 (pdf 71773.pdf not found) INN (IBUPROFEN) IBUPRIN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071807 (pdf 71807.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071870 (pdf 71870.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071905 (pdf 71905.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 071911 (pdf 71911.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071935 (pdf 71935.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1987 , NDA 071938 (pdf 71938.pdf not found) INN (IBUPROFEN) IBUPROFEN (RISING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071964 (pdf 71964.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071965 (pdf 71965.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071999 (pdf 71999.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072004 (pdf 72004.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072035 (pdf 72035.pdf not found) INN (IBUPROFEN) NUPRIN (BRISTOL MYERS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072036 (pdf 72036.pdf not found) INN (IBUPROFEN) NUPRIN (BRISTOL MYERS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072040 (pdf 72040.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072064 (pdf 72064.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072065 (pdf 72065.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072095 (pdf 72095.pdf not found) INN (IBUPROFEN) TAB-PROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072096 (pdf 72096.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 , NDA 072097 (pdf 72097.pdf not found) INN (IBUPROFEN) CAP-PROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072098 (pdf 72098.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072137 (pdf 72137.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072169 (pdf 72169.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072199 (pdf 72199.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1988 , NDA 072249 (pdf 72249.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072299 (pdf 72299.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1988 , NDA 072300 (pdf 72300.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1988 , NDA 072901 (pdf 72901.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072903 (pdf 72903.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073019 (pdf 73019.pdf not found) INN (IBUPROFEN) IBUPROFEN (MCNEIL) APPROVAL= AP YEAR= 1994 , NDA 073141 (pdf 73141.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073343 (pdf 73343.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073344 (pdf 73344.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073345 (pdf 73345.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073691 (pdf 73691.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074525 (pdf 74525.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074533 (pdf 74533.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074567 (pdf 74567.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROHM COLD AND SINUS (OHM LABS) APPROVAL= AP YEAR= 2001 , NDA 074782 (pdf 74782.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074916 (pdf 74916.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L) APPROVAL= AP YEAR= 1999 , NDA 074931 (label 74931.pdf) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074937 (label 74937.pdf) INN (IBUPROFEN) CHILDREN'S IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1998 , NDA 074978 (label 74978.pdf) INN (IBUPROFEN) IBUPROFEN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1998 , NDA 075010 (pdf 75010.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 1999 , NDA 075139 (pdf 75139.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 1999 , NDA 075217 (label 75217.pdf) INN (IBUPROFEN) IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 1998 , NDA 075367 (pdf 75367.pdf not found) INN (IBUPROFEN) JUNIOR STRENGTH IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075588 (label 75588.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075661 (label 75661.pdf) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LA) APPROVAL= AP YEAR= 2001 , NDA 075682 (pdf 75682.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LA) APPROVAL= AP YEAR= 2001 , NDA 075995 (pdf 75995.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076023 (pdf 76023.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076112 (pdf 76112.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2001 , NDA 076117 (pdf 76117.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2001 , NDA 076359 (pdf 76359.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076460 (pdf 76460.pdf not found) INN (IBUPROFEN) IBUPROFEN (AVEMA PHARMA) APPROVAL= AP YEAR= 2003 , NDA 076478 (pdf 76478.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076604 (pdf 76604.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 , NDA 076642 (pdf 76642.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2004 , NDA 076741 (pdf 76741.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076925 (pdf 76925.pdf not found) INN (IBUPROFEN) IBUPROFEN (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 077114 (pdf 77114.pdf not found) INN (IBUPROFEN) IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077349 (pdf 77349.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO R AND D) APPROVAL= AP YEAR= 2005 , NDA 077628 (pdf 77628.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 077723 (pdf 77723.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077727 (pdf 77727.pdf not found) INN (IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078132 (pdf 78132.pdf not found) INN (IBUPROFEN) IBUPROFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078316 (pdf 78316.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (BARR LABS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078394 (pdf 78394.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078558 (pdf 78558.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 078769 (pdf 78769.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022348 (label 22348.pdf) INN (IBUPROFEN) CALDOLOR (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2009 , NDA 077338 (pdf 77338.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L DEV LLC) APPROVAL= AP YEAR= 2009 , NDA 078329 (pdf 78329.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078682 (pdf 78682.pdf not found) INN (IBUPROFEN) IBUPROFEN (BIONPHARMA) APPROVAL= AP YEAR= 2009 , NDA 079058 (pdf 79058.pdf not found) INN (IBUPROFEN) IBUPROFEN (TRIS PHARMA INC) APPROVAL= AP YEAR= 2009 , NDA 079113 (pdf 79113.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 079205 (pdf 79205.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090619 (pdf 90619.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 022565 (label 22565.pdf) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL CONGESTION RELIEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2010 , NDA 077454 (pdf 77454.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090397 (pdf 90397.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2010 , NDA 079174 (pdf 79174.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES INDIA) APPROVAL= AP YEAR= 2010 , NDA 090796 (pdf 90796.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2010 , NDA 022519 (label 22519.pdf) INN (FAMOTIDINE IBUPROFEN) DUEXIS (HORIZON) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079129 (pdf 79129.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091237 (pdf 91237.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091239 (pdf 91239.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091355 (pdf 91355.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 022113 (label 22113.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL ALLERGY AND CONGESTION RELIEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2011 , NDA 200457 (pdf 200457.pdf not found) INN (IBUPROFEN) IBUPROFEN (ARISE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202300 (pdf 202300.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 079233 (pdf 79233.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 200888 (pdf 200888.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 , NDA 201803 (label 201803.pdf) INN (IBUPROFEN SODIUM) ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2012 , NDA 091633 (pdf 91633.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203200 (pdf 203200.pdf not found) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2014 , NDA 091625 (pdf 91625.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2015 , NDA 206581 (label 206581.pdf) INN (IBUPROFEN SODIUM) IBUPROFEN SODIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202402 (label 202402.pdf) INN (IBUPROFEN LYSINE) IBUPROFEN LYSINE (XGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204575 (pdf 204575.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206568 (pdf 206568.pdf not found) INN (IBUPROFEN) IBUPROFEN (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2016 , NDA 202312 (pdf 202312.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2016 , NDA 202413 (pdf 202413.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2016 , NDA 203599 (pdf 203599.pdf not found) INN (IBUPROFEN) IBUPROFEN (SOFGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205647 (pdf 205647.pdf not found) INN (IBUPROFEN) IBUPROFEN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207052 (pdf 207052.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207095 (pdf 207095.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2017 , NDA 209204 (pdf 209204.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2017 , NDA 209207 (pdf 209207.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2017 , NDA 206999 (pdf 206999.pdf not found) INN (IBUPROFEN) IBUPROFEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208865 (pdf 208865.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209235 (pdf 209235.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 204469 (pdf 204469.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209178 (pdf 209178.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 209179 (pdf 209179.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 204062 (pdf 204062.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206989 (pdf 206989.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 206990 (pdf 206990.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2018 OBSOLETE , NDA 207753 (pdf 207753.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210149 (pdf 210149.pdf not found) INN (IBUPROFEN) IBUPROFEN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2018 , NDA 210602 (pdf 210602.pdf not found) INN (IBUPROFEN) IBUPROFEN (APTAPHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210755 (pdf 210755.pdf not found) INN (IBUPROFEN) IBUPROFEN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2018 , NDA 210676 (pdf 210676.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 209076 (pdf 209076.pdf not found) INN (IBUPROFEN) IBUPROFEN (ULTRATAB LABS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211733 (label 211733.pdf) INN (ACETAMINOPHEN IBUPROFEN) ADVIL DUAL ACTION WITH ACETAMINOPHEN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2020 , NDA 213794 (pdf 213794.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211890 (pdf 211890.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214003 (pdf 214003.pdf not found) INN (IBUPROFEN) IBUPROFEN (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211666 (pdf 211666.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211278 (pdf 211278.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 214699 (pdf 214699.pdf not found) INN (IBUPROFEN) IBUPROFEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214071 (pdf 214071.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215311 (pdf 215311.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215318 (pdf 215318.pdf not found) INN (IBUPROFEN) IBUPROFEN (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2022 , NDA 216204 (pdf 216204.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 209471 (label 209471.pdf) INN (ACETAMINOPHEN IBUPROFEN) COMBOGESIC (AFT PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 213565 (pdf 213565.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 214836 (pdf 214836.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 2023 , NDA 216814 (pdf 216814.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 215320 (pdf 215320.pdf not found) INN (ACETAMINOPHEN IBUPROFEN SODIUM) COMBOGESIC IV (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215777 (pdf 215777.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216592 (pdf 216592.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 216994 (pdf 216994.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216999 (pdf 216999.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217261 (pdf 217261.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2023 , NDA 203658 (pdf 203658.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2024 , NDA 211404 (pdf 211404.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 2024 , NDA 213506 (pdf 213506.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 215925 (pdf 215925.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE AND IBUPROFEN (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 217236 (pdf 217236.pdf not found) INN (IBUPROFEN) IBUPROFEN (PATHEON SOFTGELS) APPROVAL= AP YEAR= 2024 , NDA 218311 (pdf 218311.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 218359 (pdf 218359.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 424 ; PIMOZIDE ; 2062-78-4 ; 1984 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- ANTI-DYSKINESIA AGENTS -- DOPAMINE ANTAGONISTS , ; NDA 017473 (label 17473.pdf) INN (PIMOZIDE) ORAP (TEVA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 204521 (pdf 204521.pdf not found) INN (PIMOZIDE) PIMOZIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 , 425 ; MEBENDAZOLE ; 31431-39-7 ; 1974 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- ANTINEMATODAL AGENTS -- INHIBITS THE FORMATION OF THE WORMS' MICROTUBULES , ; NDA 017481 (label 17481.pdf) INN (MEBENDAZOLE) VERMOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 073580 (pdf 73580.pdf not found) INN (MEBENDAZOLE) EMVERM (IMPAX LABS INC) APPROVAL= AP YEAR= 1995 , NDA 208398 (label 208398.pdf) INN (MEBENDAZOLE) VERMOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , 426 ; LOXAPINE ; 1977-10-2 ; 1975 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- DIBENZOXAZEPINE ANTIPSYCHOTIC AGENTS -- DOPAMINE ANTAGONISTS -- TREATMENT OF SCHIZOPHRENIA , ; NDA 017525 (label 17525.pdf) INN (LOXAPINE SUCCINATE) LOXITANE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 017658 (label 17658.pdf) INN (LOXAPINE HYDROCHLORIDE) LOXITANE C (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 018039 (label 18039.pdf) INN (LOXAPINE HYDROCHLORIDE) LOXITANE IM (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 072062 (pdf 72062.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 072204 (pdf 72204.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 072205 (pdf 72205.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 072206 (pdf 72206.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 076762 (pdf 76762.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (RISING) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076868 (pdf 76868.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (ELITE LABS INC) APPROVAL= AP YEAR= 2005 , NDA 090695 (pdf 90695.pdf not found) INN (LOXAPINE SUCCINATE) LOXAPINE SUCCINATE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 022549 (label 22549.pdf) INN (LOXAPINE) ADASUVE (ALEXZA PHARMS) APPROVAL= AP YEAR= 2012 , 427 ; OXYBUTYNIN ; 5633-20-5 ; 1975 ; ; ; CLASS GENITO -- ANTISPASMODIC -- ANTICHOLINERGIC -- GENITOURINARY SMOOTH MUSCLE RELAXANTS -- MUSCARINIC ANTAGONISTS , ; NDA 017577 (label 17577.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 018211 (label 18211.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 020897 (label 20897.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN XL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021351 (label 21351.pdf) INN (OXYBUTYNIN) OXYTROL (ALLERGAN) APPROVAL= AP YEAR= 2003 , NDA 070746 (pdf 70746.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071655 (pdf 71655.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1988 , NDA 072296 (pdf 72296.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072485 (pdf 72485.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074520 (pdf 74520.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1996 , NDA 074625 (pdf 74625.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1996 , NDA 074868 (pdf 74868.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074997 (pdf 74997.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075039 (pdf 75039.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 , NDA 075079 (pdf 75079.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 , NDA 075137 (pdf 75137.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076644 (pdf 76644.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076682 (pdf 76682.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076702 (pdf 76702.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076745 (pdf 76745.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078293 (pdf 78293.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 , NDA 022204 (label 22204.pdf) INN (OXYBUTYNIN CHLORIDE) GELNIQUE (ABBVIE) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078503 (pdf 78503.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2009 , NDA 202513 (label 202513.pdf) INN (OXYBUTYNIN) GELNIQUE 3% (ALLERGAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202211 (label 202211.pdf) INN (OXYBUTYNIN) OXYTROL FOR WOMEN (ABBVIE) APPROVAL= AP YEAR= 2013 , NDA 090526 (pdf 90526.pdf not found) INN (OXYBUTYNIN) OXYBUTYNIN (BARR LABS DIV TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204010 (pdf 204010.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206121 (pdf 206121.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2016 , NDA 207138 (pdf 207138.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 202332 (pdf 202332.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209025 (pdf 209025.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 209335 (pdf 209335.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 209823 (pdf 209823.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207329 (pdf 207329.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210125 (pdf 210125.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (TULEX PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 211062 (pdf 211062.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211655 (pdf 211655.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211682 (pdf 211682.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210611 (pdf 210611.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 210717 (pdf 210717.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 212798 (pdf 212798.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LEADING) APPROVAL= AP YEAR= 2020 , NDA 208165 (pdf 208165.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 214415 (pdf 214415.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (RUBICON) APPROVAL= AP YEAR= 2020 , NDA 213550 (pdf 213550.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2022 , 428 ; TRIMETHOBENZAMIDE ; 138-56-7 ; 1974 ; ; ; CLASS METABOLISM -- ANTIEMETIC , ; NDA 017530 (label 17530.pdf) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TIGAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1974 , NDA 017531 (label 17531.pdf) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TIGAN (KING PHARMS LLC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 076546 (pdf 76546.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2003 , NDA 076570 (pdf 76570.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 , NDA 086577 (pdf 86577.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087939 (pdf 87939.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088804 (pdf 88804.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088960 (pdf 88960.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089043 (pdf 89043.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089094 (pdf 89094.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017529 (pdf 17529.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TIGAN (KING PHARMS) APPROVAL= AP YEAR= 1974 OBSOLETE , NDA 091329 (pdf 91329.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE (AM REGENT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091330 (pdf 91330.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 205950 (pdf 205950.pdf not found) INN (TRIMETHOBENZAMIDE HYDROCHLORIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2023 , 429 ; CLONAZEPAM ; 1622-61-3 ; 1975 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- BENZODIAZEPINES -- GABA MODULATORS , ; NDA 017533 (label 17533.pdf) INN (CLONAZEPAM) KLONOPIN (CHEPLAPHARM) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY , NDA 020813 (label 20813.pdf) INN (CLONAZEPAM) KLONOPIN RAPIDLY DISINTEGRATING (ROCHE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074569 (pdf 74569.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (TEVA) APPROVAL= AP YEAR= 1996 , NDA 074869 (pdf 74869.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1996 , NDA 074920 (pdf 74920.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074925 (pdf 74925.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074940 (pdf 74940.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074964 (pdf 74964.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074979 (pdf 74979.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 075150 (pdf 75150.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 , NDA 075423 (pdf 75423.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075468 (pdf 75468.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (RUBICON) APPROVAL= AP YEAR= 2000 , NDA 077147 (pdf 77147.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2005 , NDA 077171 (pdf 77171.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 , NDA 077194 (pdf 77194.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (BARR) APPROVAL= AP YEAR= 2005 , NDA 077856 (pdf 77856.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (PRINSTON INC) APPROVAL= AP YEAR= 2006 , NDA 078654 (pdf 78654.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2014 , NDA 211033 (pdf 211033.pdf not found) INN (CLONAZEPAM) CLONAZEPAM (ALEMBIC) APPROVAL= AP YEAR= 2019 , 430 ; BUTALBITAL ; 77-26-9 ; 1976 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- BARBITURATE , ; NDA 017534 (label 17534.pdf) INN (ASPIRIN BUTALBITAL CAFFEINE) FIORINAL (ALLERGAN) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 019429 (label 19429.pdf) INN (BUTALBITAL) FIORINAL W/CODEINE (ALLERGAN) APPROVAL= AP YEAR= 1990 , NDA 020232 (label 20232.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) FIORICET W/ CODEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1992 , NDA 040085 (pdf 40085.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040261 (label 40261.pdf) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040267 (pdf 40267.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040336 (pdf 40336.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040387 (pdf 40387.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2003 , NDA 040390 (pdf 40390.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040394 (pdf 40394.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040496 (pdf 40496.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040511 (pdf 40511.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 , NDA 040513 (pdf 40513.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040601 (pdf 40601.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 074359 (pdf 74359.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074911 (pdf 74911.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) PHRENILIN WITH CAFFEINE AND CODEINE (VALEANT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 074951 (pdf 74951.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (STEVENS J) APPROVAL= AP YEAR= 1998 , NDA 075231 (pdf 75231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075351 (pdf 75351.pdf not found) INN (BUTALBITAL) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075618 (pdf 75618.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075929 (pdf 75929.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076528 (pdf 76528.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (ABLE) APPROVAL= AP YEAR= 2003 , NDA 076560 (pdf 76560.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (LGM PHARMA) APPROVAL= AP YEAR= 2004 , NDA 078149 (pdf 78149.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2007 , NDA 085441 (pdf 85441.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (IVAX PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086162 (pdf 86162.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086231 (pdf 86231.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086237 (pdf 86237.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086398 (pdf 86398.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086710 (pdf 86710.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086986 (pdf 86986.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (LANNETT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086996 (pdf 86996.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) LANORINAL (LANNETT) APPROVAL= AP YEAR= 1981 , NDA 087048 (pdf 87048.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (PURACAP PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087550 (pdf 87550.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087628 (pdf 87628.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ANOQUAN (SHIRE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 087629 (pdf 87629.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087804 (pdf 87804.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SPECGX LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 087811 (pdf 87811.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) PHRENILIN (VALEANT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088305 (pdf 88305.pdf not found) INN (ASPIRIN BUTALBITAL) AXOTAL (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088616 (pdf 88616.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 1984 , NDA 088743 (pdf 88743.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088758 (pdf 88758.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088765 (pdf 88765.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088825 (pdf 88825.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GILBERT LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088831 (pdf 88831.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) PHRENILIN FORTE (VALEANT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088889 (pdf 88889.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BANCAP (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088944 (pdf 88944.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) SEDAPAP (MAYRAND) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088972 (pdf 88972.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088991 (pdf 88991.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUCET (MALLINCKRODT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089007 (pdf 89007.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 1986 , NDA 089023 (pdf 89023.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) TRIAD (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089067 (pdf 89067.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089102 (pdf 89102.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) FEMCET (MALLINCKRODT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089115 (pdf 89115.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) MEDIGESIC PLUS (US CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089175 (pdf 89175.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIKART) APPROVAL= AP YEAR= 1987 , NDA 089268 (pdf 89268.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) TRIAPRIN (DUNHALL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089405 (pdf 89405.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) TENCON (MALLINCKRODT) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 089448 (pdf 89448.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089451 (pdf 89451.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC-PLUS (MIKART) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089536 (pdf 89536.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089568 (pdf 89568.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089660 (pdf 89660.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) ESGIC (FOREST PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089718 (pdf 89718.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 089987 (pdf 89987.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTAPAP (MIKART) APPROVAL= AP YEAR= 1992 , NDA 089988 (pdf 89988.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTAPAP (MIKART) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 040864 (pdf 40864.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NOVAST LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040883 (pdf 40883.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MIRROR PHARMS LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040885 (pdf 40885.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090956 (pdf 90956.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (LGM PHARMA) APPROVAL= AP YEAR= 2011 , NDA 200243 (pdf 200243.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2012 , NDA 203335 (pdf 203335.pdf not found) INN (BUTALBITAL) BUTALBITAL , ASPIRIN , CAFFEINE , AND CODEINE PHOSPHATE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 203484 (pdf 203484.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) ALLZITAL (LARKEN LABS INC) APPROVAL= AP YEAR= 2015 , NDA 205120 (pdf 205120.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204195 (pdf 204195.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207118 (pdf 207118.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 207386 (pdf 207386.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (MIKART) APPROVAL= AP YEAR= 2016 , NDA 204984 (pdf 204984.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (CNTY LINE PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206615 (pdf 206615.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (XSPIRE PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207635 (pdf 207635.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (ALVOGEN) APPROVAL= AP YEAR= 2017 , NDA 207313 (pdf 207313.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 204733 (pdf 204733.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 209587 (pdf 209587.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211106 (pdf 211106.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 210817 (pdf 210817.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 212082 (pdf 212082.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 212083 (pdf 212083.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (LANNETT CO INC) APPROVAL= AP YEAR= 2019 , NDA 213115 (pdf 213115.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 204649 (pdf 204649.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 211543 (pdf 211543.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (NESHER PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213046 (pdf 213046.pdf not found) INN (BUTALBITAL) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (TARO PHARM INDS LTD) APPROVAL= AP YEAR= 2020 , NDA 213321 (pdf 213321.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 203647 (pdf 203647.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 205230 (pdf 205230.pdf not found) INN (ASPIRIN BUTALBITAL CAFFEINE) BUTALBITAL , ASPIRIN AND CAFFEINE (LGM PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214087 (pdf 214087.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215047 (pdf 215047.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2021 , NDA 214088 (pdf 214088.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (SENORES PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215135 (pdf 215135.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 215138 (pdf 215138.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE CODEINE PHOSPHATE) BUTALBITAL , ACETAMINOPHEN , CAFFEINE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 214955 (pdf 214955.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (AACE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214287 (pdf 214287.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214288 (pdf 214288.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214291 (pdf 214291.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 214305 (pdf 214305.pdf not found) INN (ACETAMINOPHEN BUTALBITAL) BUTALBITAL AND ACETAMINOPHEN (QUAGEN) APPROVAL= AP YEAR= 2024 , NDA 216376 (pdf 216376.pdf not found) INN (ACETAMINOPHEN BUTALBITAL CAFFEINE) BUTALBITAL , ACETAMINOPHEN AND CAFFEINE (QUAGEN) APPROVAL= AP YEAR= 2024 , 431 ; PROBUCOL ; 23288-49-5 ; 1977 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- ANTI-INFLAMMATORY AND ANTIOXIDANT , ; NDA 017535 (pdf 17535.pdf not found) INN (PROBUCOL) LORELCO (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , 432 ; MAPROTILINE ; 10262-69-8 ; 1980 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- NOREPINEPHRINE UPTAKE INHIBITORS , ; NDA 017543 (pdf 17543.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) LUDIOMIL (NOVARTIS) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 071943 (pdf 71943.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071944 (pdf 71944.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071945 (pdf 71945.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072129 (pdf 72129.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072130 (pdf 72130.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072131 (pdf 72131.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072162 (pdf 72162.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072163 (pdf 72163.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072164 (pdf 72164.pdf not found) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072285 (label 72285.pdf) INN (MAPROTILINE HYDROCHLORIDE) MAPROTILINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , 433 ; CARBIDOPA ; 28860-95-9 ; 1975 ; ; ; CLASS NERVOUS SYSTEM -- ENZYME INHIBITOR (DECARBOXYLASE) -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS , ; NDA 017555 (label 17555.pdf) INN (CARBIDOPA LEVODOPA) SINEMET (ORGANON) APPROVAL= AP YEAR= 1975 , NDA 017830 (label 17830.pdf) INN (CARBIDOPA) LODOSYN (ATON) APPROVAL= AP YEAR= 1977 , NDA 019856 (label 19856.pdf) INN (CARBIDOPA LEVODOPA) SINEMET CR (ORGANON LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 021485 (label 21485.pdf) INN (CARBIDOPA ENTACAPONE LEVODOPA) STALEVO 50 (ORION PHARMA) APPROVAL= AP YEAR= 2003 , NDA 073381 (pdf 73381.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073382 (pdf 73382.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073383 (pdf 73383.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073586 (pdf 73586.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073587 (pdf 73587.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ANI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073589 (pdf 73589.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073607 (pdf 73607.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073618 (pdf 73618.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1992 , NDA 073620 (pdf 73620.pdf not found) INN (CARBIDOPA) CARBIDOPA AND LEVODOPA (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1995 DISCONTINUED OBSOLETE , NDA 074080 (pdf 74080.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074260 (pdf 74260.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1993 , NDA 075091 (label 75091.pdf) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (MYLAN) APPROVAL= AP YEAR= 1999 , NDA 076212 (pdf 76212.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (APOTEX) APPROVAL= AP YEAR= 2004 , NDA 076521 (pdf 76521.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 076643 (pdf 76643.pdf not found) INN (CARBIDOPA LEVODOPA) CARBILEV (RANBAXY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076663 (pdf 76663.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (KV PHARM) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076699 (pdf 76699.pdf not found) INN (CARBIDOPA LEVODOPA) PARCOPA (UCB INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077120 (pdf 77120.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 077828 (pdf 77828.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 078893 (pdf 78893.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RISING) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078536 (pdf 78536.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 , NDA 078690 (pdf 78690.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 090324 (pdf 90324.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 079085 (pdf 79085.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 090631 (pdf 90631.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (IMPAX LABS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090786 (pdf 90786.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090833 (pdf 90833.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202323 (pdf 202323.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 203261 (pdf 203261.pdf not found) INN (CARBIDOPA) CARBIDOPA (ANI PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203312 (label 203312.pdf) INN (CARBIDOPA LEVODOPA) RYTARY (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203952 (label 203952.pdf) INN (CARBIDOPA LEVODOPA) DUOPA (ABBVIE) APPROVAL= AP YEAR= 2015 , NDA 204291 (pdf 204291.pdf not found) INN (CARBIDOPA) CARBIDOPA (ALVOGEN) APPROVAL= AP YEAR= 2016 , NDA 205304 (pdf 205304.pdf not found) INN (CARBIDOPA) CARBIDOPA (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204763 (pdf 204763.pdf not found) INN (CARBIDOPA) CARBIDOPA (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 209910 (pdf 209910.pdf not found) INN (CARBIDOPA) CARBIDOPA (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210341 (pdf 210341.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 211055 (pdf 211055.pdf not found) INN (CARBIDOPA) CARBIDOPA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 203424 (pdf 203424.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214092 (pdf 214092.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214091 (pdf 214091.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214869 (label 214869.pdf) INN (CARBIDOPA LEVODOPA) DHIVY (AVION PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213212 (pdf 213212.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (RISING) APPROVAL= AP YEAR= 2022 , NDA 216505 (pdf 216505.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 216537 (pdf 216537.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 208895 (pdf 208895.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA LEVODOPA (SANDOZ INC) APPROVAL= TA YEAR= 2023 , NDA 215999 (pdf 215999.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217961 (pdf 217961.pdf not found) INN (CARBIDOPA) CARBIDOPA (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2023 , NDA 217482 (pdf 217482.pdf not found) INN (CARBIDOPA LEVODOPA) CARBIDOPA AND LEVODOPA (RUBICON) APPROVAL= AP YEAR= 2024 , 434 ; HALCINONIDE ; 3093-35-4 ; 1974 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- CORTICOSTEROIDS -- ANTIPRURITIC -- VASOCONSTRICTOR , ; NDA 017556 (label 17556.pdf) INN (HALCINONIDE) HALOG (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY , NDA 017818 (pdf 17818.pdf not found) INN (HALCINONIDE) HALOG (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017823 (label 17823.pdf) INN (HALCINONIDE) HALOG (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017824 (label 17824.pdf) INN (HALCINONIDE) HALOG (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018125 (pdf 18125.pdf not found) INN (HALCINONIDE) HALOG (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018234 (label 18234.pdf) INN (HALCINONIDE) HALOG-E (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 211027 (pdf 211027.pdf not found) INN (HALCINONIDE) HALCINONIDE (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 214723 (pdf 214723.pdf not found) INN (HALCINONIDE) HALCINONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2021 , NDA 217671 (pdf 217671.pdf not found) INN (HALCINONIDE) HALCINONIDE (ENCUBE) APPROVAL= AP YEAR= 2024 , 435 ; DANAZOL ; 17230-88-5 ; 1976 ; ; ; CLASS GENITO -- ANTERIOR PITUITARY SUPPRESSANT -- NUCLEAR RECEPTOR ANTAGONISTS , ; NDA 017557 (label 17557.pdf) INN (DANAZOL) DANOCRINE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 071569 (pdf 71569.pdf not found) INN (DANAZOL) DANAZOL (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074582 (pdf 74582.pdf not found) INN (DANAZOL) DANAZOL (BARR) APPROVAL= AP YEAR= 1996 , NDA 077246 (pdf 77246.pdf not found) INN (DANAZOL) DANAZOL (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 078214 (pdf 78214.pdf not found) INN (DANAZOL) DANAZOL (LANNETT) APPROVAL= AP YEAR= 2007 , 436 ; FENOPROFEN ; 29679-58-1 ; 1976 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS -- NSAID -- ANTIARTHRITIC -- ANTIPYRETIC , ; NDA 017604 (label 17604.pdf) INN (FENOPROFEN CALCIUM) NALFON (KEY THERAP) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 017710 (pdf 17710.pdf not found) INN (FENOPROFEN CALCIUM) NALFON (DISTA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 071738 (pdf 71738.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072165 (pdf 72165.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072194 (pdf 72194.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072214 (pdf 72214.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072267 (pdf 72267.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (KEY THERAP) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072274 (pdf 72274.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072293 (pdf 72293.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072294 (pdf 72294.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072307 (pdf 72307.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072308 (pdf 72308.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072309 (pdf 72309.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072326 (pdf 72326.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072355 (pdf 72355.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072356 (pdf 72356.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072357 (pdf 72357.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072362 (pdf 72362.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072394 (pdf 72394.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072395 (pdf 72395.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072396 (pdf 72396.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072407 (pdf 72407.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072429 (pdf 72429.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072437 (pdf 72437.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072438 (pdf 72438.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072472 (pdf 72472.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072557 (pdf 72557.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072602 (pdf 72602.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072902 (label 72902.pdf) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072946 (pdf 72946.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072981 (pdf 72981.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072982 (pdf 72982.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 214475 (pdf 214475.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 2022 , NDA 215548 (pdf 215548.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (MISEMER) APPROVAL= AP YEAR= 2023 , 437 ; SULFACYTINE ; 17784-12-2 ; 1975 ; DISCONTINUED ; ; CLASS ANTIBIOTIC -- ANTIBACTERIAL -- ANTI-INFECTIVE AGENTS, URINARY -- SULFONAMIDES , ; NDA 017569 (pdf 17569.pdf not found) INN (SULFACYTINE) RENOQUID (GLENWOOD) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , 438 ; BECLOMETHASONE DIPROPIONATE ; 5534-09-8 ; 1976 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- CORTICOSTEROIDS -- VASOCONSTRICTOR , ; NDA 017573 (pdf 17573.pdf not found) INN (BECLOMETHASONE DIPROPIONATE) VANCERIL (SCHERING) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 018153 (pdf 18153.pdf not found) INN (BECLOMETHASONE DIPROPIONATE) BECLOVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018521 (pdf 18521.pdf not found) INN (BECLOMETHASONE DIPROPIONATE) VANCENASE (SCHERING) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018584 (label 18584.pdf) INN (BECLOMETHASONE DIPROPIONATE) BECONASE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019389 (label 19389.pdf) INN (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) BECONASE AQ (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019589 (pdf 19589.pdf not found) INN (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) VANCENASE AQ (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 020469 (pdf 20469.pdf not found) INN (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) VANCENASE AQ (SCHERING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020486 (pdf 20486.pdf not found) INN (BECLOMETHASONE DIPROPIONATE) VANCERIL DOUBLE STRENGTH (SCHERING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020911 (label 20911.pdf) INN (BECLOMETHASONE DIPROPIONATE) QVAR 80 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 202813 (label 202813.pdf) INN (BECLOMETHASONE DIPROPIONATE) QNASL (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2012 , NDA 207921 (label 207921.pdf) INN (BECLOMETHASONE DIPROPIONATE) QVAR REDIHALER (NORTON WATERFORD) APPROVAL= AP YEAR= 2017 , 439 ; ISOFLURANE ; 26675-46-7 ; 1979 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 017624 (label 17624.pdf) INN (ISOFLURANE) FORANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 074097 (pdf 74097.pdf not found) INN (ISOFLURANE) ISOFLURANE (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074393 (pdf 74393.pdf not found) INN (ISOFLURANE) ISOFLURANE (WATSON LABS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074416 (pdf 74416.pdf not found) INN (ISOFLURANE) ISOFLURANE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 1994 , NDA 074502 (pdf 74502.pdf not found) INN (ISOFLURANE) ISOFLURANE (PIRAMAL PHARMA) APPROVAL= AP YEAR= 1995 , NDA 075225 (pdf 75225.pdf not found) INN (ISOFLURANE) ISOFLURANE (HALOCARBON PRODS) APPROVAL= AP YEAR= 1999 , 440 ; DACARBAZINE ; 4342-03-4 ; 1975 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- HYPOTHESIS OF INHIBITION OF DNA SYNTHESIS BY ACTING AS A PURINE ANALOG , ; NDA 017575 (pdf 17575.pdf not found) INN (DACARBAZINE) DTIC-DOME (BAYER HLTHCARE) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 070821 (pdf 70821.pdf not found) INN (DACARBAZINE) DACARBAZINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070822 (pdf 70822.pdf not found) INN (DACARBAZINE) DACARBAZINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070962 (pdf 70962.pdf not found) INN (DACARBAZINE) DACARBAZINE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070990 (pdf 70990.pdf not found) INN (DACARBAZINE) DACARBAZINE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071563 (pdf 71563.pdf not found) INN (DACARBAZINE) DACARBAZINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 075259 (pdf 75259.pdf not found) INN (DACARBAZINE) DACARBAZINE (MEITHEAL) APPROVAL= AP YEAR= 1998 , NDA 075371 (pdf 75371.pdf not found) INN (DACARBAZINE) DACARBAZINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 075812 (pdf 75812.pdf not found) INN (DACARBAZINE) DACARBAZINE (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 075940 (pdf 75940.pdf not found) INN (DACARBAZINE) DACARBAZINE (HOSPIRA) APPROVAL= AP YEAR= 2001 , 441 ; OXYBUTYNIN ; 5633-20-5 ; 1975 ; ; ; CLASS GENITO -- ANTISPASMODIC -- ANTICHOLINERGIC -- GENITOURINARY SMOOTH MUSCLE RELAXANTS -- MUSCARINIC ANTAGONISTS , ; NDA 017577 (label 17577.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 018211 (label 18211.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 020897 (label 20897.pdf) INN (OXYBUTYNIN CHLORIDE) DITROPAN XL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021351 (label 21351.pdf) INN (OXYBUTYNIN) OXYTROL (ALLERGAN) APPROVAL= AP YEAR= 2003 , NDA 070746 (pdf 70746.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071655 (pdf 71655.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1988 , NDA 072296 (pdf 72296.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072485 (pdf 72485.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074520 (pdf 74520.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1996 , NDA 074625 (pdf 74625.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1996 , NDA 074868 (pdf 74868.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074997 (pdf 74997.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075039 (pdf 75039.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 , NDA 075079 (pdf 75079.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 , NDA 075137 (pdf 75137.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076644 (pdf 76644.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076682 (pdf 76682.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076702 (pdf 76702.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076745 (pdf 76745.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078293 (pdf 78293.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 , NDA 022204 (label 22204.pdf) INN (OXYBUTYNIN CHLORIDE) GELNIQUE (ABBVIE) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078503 (pdf 78503.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2009 , NDA 202513 (label 202513.pdf) INN (OXYBUTYNIN) GELNIQUE 3% (ALLERGAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202211 (label 202211.pdf) INN (OXYBUTYNIN) OXYTROL FOR WOMEN (ABBVIE) APPROVAL= AP YEAR= 2013 , NDA 090526 (pdf 90526.pdf not found) INN (OXYBUTYNIN) OXYBUTYNIN (BARR LABS DIV TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204010 (pdf 204010.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206121 (pdf 206121.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2016 , NDA 207138 (pdf 207138.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 202332 (pdf 202332.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209025 (pdf 209025.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 209335 (pdf 209335.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2017 , NDA 209823 (pdf 209823.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207329 (pdf 207329.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210125 (pdf 210125.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (TULEX PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 211062 (pdf 211062.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211655 (pdf 211655.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211682 (pdf 211682.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210611 (pdf 210611.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 210717 (pdf 210717.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 212798 (pdf 212798.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (LEADING) APPROVAL= AP YEAR= 2020 , NDA 208165 (pdf 208165.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 214415 (pdf 214415.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (RUBICON) APPROVAL= AP YEAR= 2020 , NDA 213550 (pdf 213550.pdf not found) INN (OXYBUTYNIN CHLORIDE) OXYBUTYNIN CHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2022 , 442 ; NAPROXEN ; 22204-53-1 ; 1976 ; ; ; CLASS MUSCULO-SKELETAL -- CYCLOOXYGENASE INHIBITORS -- ANTIPYRETIC -- ANTIINFLAMMATORY -- ANALGESIC -- NSAID , ; NDA 017581 (label 17581.pdf) INN (NAPROXEN) NAPROSYN (ATNAHS PHARMA US) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY , NDA 018164 (label 18164.pdf) INN (NAPROXEN SODIUM) ANAPROX (ATNAHS PHARMA US) APPROVAL= AP YEAR= 1980 , NDA 018965 (label 18965.pdf) INN (NAPROXEN) NAPROSYN (ATNAHS PHARMA US) APPROVAL= AP YEAR= 1987 , NDA 020067 (label 20067.pdf) INN (NAPROXEN) EC-NAPROSYN (ATNAHS PHARMA US) APPROVAL= AP YEAR= 1994 , NDA 020204 (label 20204.pdf) INN (NAPROXEN SODIUM) ALEVE (BAYER) APPROVAL= AP YEAR= 1994 , NDA 020353 (label 20353.pdf) INN (NAPROXEN SODIUM) NAPRELAN (TWI PHARMS) APPROVAL= AP YEAR= 1996 , NDA 021076 (label 21076.pdf) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) ALEVE-D SINUS & COLD (BAYER) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021507 (label 21507.pdf) INN (LANSOPRAZOLE NAPROXEN) PREVACID NAPRAPAC 250 COPACKAGED (TAKEDA PHARMS NA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021920 (label 21920.pdf) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (BIONPHARMA) APPROVAL= AP YEAR= 2006 , NDA 021926 (label 21926.pdf) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) TREXIMET (CURRAX) APPROVAL= AP YEAR= 2008 , NDA 074105 (pdf 74105.pdf not found) INN (NAPROXEN) NAPROXEN (DAVA PHARMS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074106 (pdf 74106.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (HAMILTON PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074110 (pdf 74110.pdf not found) INN (NAPROXEN) NAPROXEN (HAMILTON PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074111 (pdf 74111.pdf not found) INN (NAPROXEN) NAPROXEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074121 (pdf 74121.pdf not found) INN (NAPROXEN) NAPROXEN (MYLAN) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074129 (pdf 74129.pdf not found) INN (NAPROXEN) NAPROXEN (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074140 (pdf 74140.pdf not found) INN (NAPROXEN) NAPROXEN (GRANULES) APPROVAL= AP YEAR= 1993 , NDA 074142 (pdf 74142.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074162 (pdf 74162.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074163 (pdf 74163.pdf not found) INN (NAPROXEN) NAPROXEN (WATSON LABS TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074182 (pdf 74182.pdf not found) INN (NAPROXEN) NAPROXEN (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074190 (pdf 74190.pdf not found) INN (NAPROXEN) NAPROXEN (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 074195 (pdf 74195.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074198 (pdf 74198.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074201 (pdf 74201.pdf not found) INN (NAPROXEN) NAPROXEN (TEVA) APPROVAL= AP YEAR= 1993 , NDA 074207 (pdf 74207.pdf not found) INN (NAPROXEN) NAPROXEN (TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074211 (pdf 74211.pdf not found) INN (NAPROXEN) NAPROXEN (ROXANE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074216 (pdf 74216.pdf not found) INN (NAPROXEN) NAPROXEN (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074230 (pdf 74230.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074242 (pdf 74242.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074257 (pdf 74257.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (ROXANE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074263 (pdf 74263.pdf not found) INN (NAPROXEN) NAPROXEN (PUREPAC PHARM) APPROVAL= TA YEAR= 1993 , NDA 074289 (pdf 74289.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074319 (pdf 74319.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074367 (pdf 74367.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074410 (pdf 74410.pdf not found) INN (NAPROXEN) NAPROXEN (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074455 (pdf 74455.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074457 (pdf 74457.pdf not found) INN (NAPROXEN) NAPROXEN (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074480 (pdf 74480.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (HIKMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074495 (pdf 74495.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074635 (pdf 74635.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1997 , NDA 074646 (pdf 74646.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074661 (pdf 74661.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PERRIGO) APPROVAL= AP YEAR= 1997 , NDA 074789 (pdf 74789.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074936 (label 74936.pdf) INN (NAPROXEN) NAPROXEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075061 (pdf 75061.pdf not found) INN (NAPROXEN) NAPROXEN (FOSUN PHARMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075168 (pdf 75168.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (DR REDDYS LABS INC) APPROVAL= AP YEAR= 1998 , NDA 075227 (pdf 75227.pdf not found) INN (NAPROXEN) NAPROXEN (TEVA) APPROVAL= AP YEAR= 1998 , NDA 075337 (pdf 75337.pdf not found) INN (NAPROXEN) NAPROXEN (PLIVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075390 (label 75390.pdf) INN (NAPROXEN) NAPROXEN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075416 (pdf 75416.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2002 , NDA 075927 (pdf 75927.pdf not found) INN (NAPROXEN) NAPROXEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2001 , NDA 076494 (pdf 76494.pdf not found) INN (NAPROXEN) NAPROXEN (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076518 (pdf 76518.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076544 (pdf 76544.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077339 (pdf 77339.pdf not found) INN (NAPROXEN) NAPROXEN (L PERRIGO CO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077381 (pdf 77381.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 078250 (pdf 78250.pdf not found) INN (NAPROXEN) NAPROXEN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078314 (pdf 78314.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078432 (pdf 78432.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 078486 (pdf 78486.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 078620 (pdf 78620.pdf not found) INN (NAPROXEN) NAPROXEN (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 079096 (pdf 79096.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 022511 (label 22511.pdf) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) VIMOVO (HORIZON) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090545 (pdf 90545.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 090753 (pdf 90753.pdf not found) INN (SUMATRIPTAN NAPROXEN SODIUM) SUMATRIPTAN NAPROXEN SODIUM (PAR PHARM) APPROVAL= TA YEAR= 2013 , NDA 090930 (pdf 90930.pdf not found) INN (SUMATRIPTAN NAPROXEN SODIUM) SUMATRIPTAN NAPROXEN SODIUM (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091183 (pdf 91183.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091416 (pdf 91416.pdf not found) INN (NAPROXEN) NAPROXEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091305 (pdf 91305.pdf not found) INN (NAPROXEN) NAPROXEN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091353 (pdf 91353.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (GRANULES INDIA) APPROVAL= AP YEAR= 2011 , NDA 091432 (pdf 91432.pdf not found) INN (NAPROXEN) NAPROXEN (NUVO PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 200429 (pdf 200429.pdf not found) INN (NAPROXEN) NAPROXEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2011 , NDA 200629 (pdf 200629.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 090872 (pdf 90872.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (RISING) APPROVAL= AP YEAR= 2018 , NDA 202461 (pdf 202461.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2018 , NDA 205352 (label 205352.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) ALEVE PM (BAYER HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 202807 (pdf 202807.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (CATALENT) APPROVAL= AP YEAR= 2019 , NDA 205497 (pdf 205497.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204872 (pdf 204872.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (LNK INTL INC) APPROVAL= AP YEAR= 2017 , NDA 207457 (pdf 207457.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 202803 (pdf 202803.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 204206 (pdf 204206.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 207612 (pdf 207612.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (NOVELGENIX THERAPS) APPROVAL= AP YEAR= 2018 , NDA 208363 (pdf 208363.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2018 , NDA 209726 (pdf 209726.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 207597 (pdf 207597.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (P AND L) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208499 (pdf 208499.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2019 , NDA 211830 (pdf 211830.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2019 , NDA 212033 (pdf 212033.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2019 , NDA 212199 (pdf 212199.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 212517 (pdf 212517.pdf not found) INN (NAPROXEN) NAPROXEN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212705 (pdf 212705.pdf not found) INN (NAPROXEN) NAPROXEN (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 213663 (pdf 213663.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 211910 (pdf 211910.pdf not found) INN (NAPROXEN) NAPROXEN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 204920 (pdf 204920.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211360 (pdf 211360.pdf not found) INN (NAPROXEN SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215776 (pdf 215776.pdf not found) INN (NAPROXEN) NAPROXEN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 204470 (pdf 204470.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211065 (pdf 211065.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 213699 (pdf 213699.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215472 (pdf 215472.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214463 (pdf 214463.pdf not found) INN (NAPROXEN SODIUM) NAPROXEN SODIUM (PATHEON SOFTGELS) APPROVAL= AP YEAR= 2023 , NDA 216908 (pdf 216908.pdf not found) INN (NAPROXEN) NAPROXEN (TULEX PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217738 (pdf 217738.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 218497 (pdf 218497.pdf not found) INN (NAPROXEN) NAPROXEN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2024 , 443 ; LOMUSTINE ; 13010-47-4 ; 1976 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- NITROSOUREAS , ; NDA 017588 (label 17588.pdf) INN (LOMUSTINE) GLEOSTINE (LATINA PHARMA) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY , 444 ; CHLOROXINE ; 773-76-2 ; 1976 ; DISCONTINUED ; ; CLASS ANTISEPTIC , ; NDA 017594 (pdf 17594.pdf not found) INN (CHLOROXINE) CAPITROL (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , 445 ; FENOPROFEN ; 29679-58-1 ; 1976 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS -- NSAID -- ANTIARTHRITIC -- ANTIPYRETIC , ; NDA 017604 (label 17604.pdf) INN (FENOPROFEN CALCIUM) NALFON (KEY THERAP) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 017710 (pdf 17710.pdf not found) INN (FENOPROFEN CALCIUM) NALFON (DISTA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 071738 (pdf 71738.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072165 (pdf 72165.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072194 (pdf 72194.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072214 (pdf 72214.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072267 (pdf 72267.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (KEY THERAP) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072274 (pdf 72274.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072293 (pdf 72293.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072294 (pdf 72294.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072307 (pdf 72307.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072308 (pdf 72308.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072309 (pdf 72309.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072326 (pdf 72326.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072355 (pdf 72355.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072356 (pdf 72356.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072357 (pdf 72357.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072362 (pdf 72362.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072394 (pdf 72394.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072395 (pdf 72395.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072396 (pdf 72396.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072407 (pdf 72407.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072429 (pdf 72429.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072437 (pdf 72437.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072438 (pdf 72438.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072472 (pdf 72472.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072557 (pdf 72557.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072602 (pdf 72602.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072902 (label 72902.pdf) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072946 (pdf 72946.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072981 (pdf 72981.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072982 (pdf 72982.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 214475 (pdf 214475.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (RISING) APPROVAL= AP YEAR= 2022 , NDA 215548 (pdf 215548.pdf not found) INN (FENOPROFEN CALCIUM) FENOPROFEN CALCIUM (MISEMER) APPROVAL= AP YEAR= 2023 , 446 ; CLOTRIMAZOLE ; 23593-75-1 ; 1975 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- ANTI-INFECTIVE -- IMIDAZOLE CLASS -- INHIBIT 14-ALPHA-DEMETHYLATION OF LANOSTEROL IN FUNGI , ; NDA 017613 (pdf 17613.pdf not found) INN (CLOTRIMAZOLE) LOTRIMIN (SCHERING PLOUGH) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 017619 (pdf 17619.pdf not found) INN (CLOTRIMAZOLE) LOTRIMIN (SCHERING PLOUGH) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017717 (pdf 17717.pdf not found) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 018052 (label 18052.pdf) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018181 (pdf 18181.pdf not found) INN (CLOTRIMAZOLE) MYCELEX (BAYER HLTHCARE) APPROVAL= AP YEAR= 1979 , NDA 018182 (pdf 18182.pdf not found) INN (CLOTRIMAZOLE) MYCELEX-7 (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018183 (pdf 18183.pdf not found) INN (CLOTRIMAZOLE) MYCELEX (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018230 (pdf 18230.pdf not found) INN (CLOTRIMAZOLE) MYCELEX-7 (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018713 (label 18713.pdf) INN (CLOTRIMAZOLE) MYCELEX (BAYER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018813 (pdf 18813.pdf not found) INN (CLOTRIMAZOLE) LOTRIMIN (SCHERING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018827 (label 18827.pdf) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) LOTRISONE (ORGANON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019069 (pdf 19069.pdf not found) INN (CLOTRIMAZOLE) MYCELEX-G (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020010 (label 20010.pdf) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) LOTRISONE (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 020289 (pdf 20289.pdf not found) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN COMBINATION PACK (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020389 (pdf 20389.pdf not found) INN (CLOTRIMAZOLE) MYCELEX-7 COMBINATION PACK (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020525 (pdf 20525.pdf not found) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN 3 (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020526 (pdf 20526.pdf not found) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN 3 COMBINATION PACK (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020574 (label 20574.pdf) INN (CLOTRIMAZOLE) GYNE-LOTRIMIN 3 (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020888 (label 20888.pdf) INN (CLOTRIMAZOLE) LOTRIMIN AF (SCHERING PLOUGH) APPROVAL= AP YEAR= 1989 , NDA 020889 (label 20889.pdf) INN (CLOTRIMAZOLE) LOTRIMIN AF (SCHERING PLOUGH) APPROVAL= AP YEAR= 1989 , NDA 020890 (label 20890.pdf) INN (CLOTRIMAZOLE) LOTRIMIN AF (SCHERING PLOUGH) APPROVAL= AP YEAR= 1989 , NDA 021143 (label 21143.pdf) INN (CLOTRIMAZOLE) TRIVAGIZOLE 3 (TARO) APPROVAL= AP YEAR= 2000 , NDA 072640 (pdf 72640.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (TARO) APPROVAL= AP YEAR= 1993 , NDA 072641 (pdf 72641.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (TARO) APPROVAL= AP YEAR= 1995 , NDA 073249 (pdf 73249.pdf not found) INN (CLOTRIMAZOLE) GYNIX (TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 073306 (pdf 73306.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074165 (pdf 74165.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (P AND L) APPROVAL= AP YEAR= 1993 , NDA 074580 (pdf 74580.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (TARO) APPROVAL= AP YEAR= 1996 , NDA 075502 (pdf 75502.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2001 , NDA 075673 (pdf 75673.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2001 , NDA 076002 (pdf 76002.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2002 , NDA 076387 (pdf 76387.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076493 (pdf 76493.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076516 (pdf 76516.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076763 (pdf 76763.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (PADAGIS US) APPROVAL= AP YEAR= 2005 , NDA 078338 (pdf 78338.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 090219 (pdf 90219.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (GLENMARK PHARMS) APPROVAL= AP YEAR= 2010 , NDA 202894 (pdf 202894.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (GLENMARK PHARMS) APPROVAL= AP YEAR= 2015 , NDA 209815 (pdf 209815.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212281 (pdf 212281.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (TASMAN PHARMA) APPROVAL= AP YEAR= 2019 , NDA 216569 (pdf 216569.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 215641 (pdf 215641.pdf not found) INN (CLOTRIMAZOLE) CLOTRIMAZOLE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2024 , 447 ; ISOFLURANE ; 26675-46-7 ; 1979 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 017624 (label 17624.pdf) INN (ISOFLURANE) FORANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 074097 (pdf 74097.pdf not found) INN (ISOFLURANE) ISOFLURANE (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074393 (pdf 74393.pdf not found) INN (ISOFLURANE) ISOFLURANE (WATSON LABS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074416 (pdf 74416.pdf not found) INN (ISOFLURANE) ISOFLURANE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 1994 , NDA 074502 (pdf 74502.pdf not found) INN (ISOFLURANE) ISOFLURANE (PIRAMAL PHARMA) APPROVAL= AP YEAR= 1995 , NDA 075225 (pdf 75225.pdf not found) INN (ISOFLURANE) ISOFLURANE (HALOCARBON PRODS) APPROVAL= AP YEAR= 1999 , 448 ; TOLMETIN ; 26171-23-3 ; 1976 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITORS -- NSAID -- ANALGESIC -- ANTI-INFLAMMATORY -- ANTIPYRETIC -- TREATMENT OF RHEUMATOID ARTHRITIS , ; NDA 017628 (label 17628.pdf) INN (TOLMETIN SODIUM) TOLECTIN (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 018084 (label 18084.pdf) INN (TOLMETIN SODIUM) TOLECTIN DS (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 073290 (pdf 73290.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073308 (pdf 73308.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073310 (pdf 73310.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073311 (pdf 73311.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073392 (pdf 73392.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073393 (pdf 73393.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (RISING) APPROVAL= AP YEAR= 1993 , NDA 073462 (pdf 73462.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073519 (pdf 73519.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073527 (pdf 73527.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073588 (pdf 73588.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (FOSUN PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074002 (pdf 74002.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (FOSUN PHARMA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074399 (pdf 74399.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074473 (pdf 74473.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (RISING) APPROVAL= AP YEAR= 1994 , NDA 074729 (pdf 74729.pdf not found) INN (TOLMETIN SODIUM) TOLMETIN SODIUM (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , 449 ; LACTULOSE ; 4618-18-2 ; 1976 ; ; ; CLASS METABOLISM -- SYNTHETIC DISACCHARIDE -- A COLONIC ACIDIFIER FOR TREATMENT AND PREVENTION OF PORTAL-SYSTEMIC ENCEPHALOPATHY -- REDUCES THE BLOOD AMMONIA LEVELS , ; NDA 017657 (pdf 17657.pdf not found) INN (LACTULOSE) CEPHULAC (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 017884 (pdf 17884.pdf not found) INN (LACTULOSE) CHRONULAC (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 017906 (pdf 17906.pdf not found) INN (LACTULOSE) LACTULOSE (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070288 (pdf 70288.pdf not found) INN (LACTULOSE) CONSTULOSE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071054 (pdf 71054.pdf not found) INN (LACTULOSE) CONSTILAC (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071331 (pdf 71331.pdf not found) INN (LACTULOSE) CHOLAC (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071548 (pdf 71548.pdf not found) INN (LACTULOSE) ENULOSE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071841 (pdf 71841.pdf not found) INN (LACTULOSE) LACTULOSE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071842 (pdf 71842.pdf not found) INN (LACTULOSE) GENERLAC (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072029 (pdf 72029.pdf not found) INN (LACTULOSE) LACTULOSE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072372 (pdf 72372.pdf not found) INN (LACTULOSE) DUPHALAC (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072374 (pdf 72374.pdf not found) INN (LACTULOSE) PORTALAC (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073160 (pdf 73160.pdf not found) INN (LACTULOSE) LACTULOSE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073497 (pdf 73497.pdf not found) INN (LACTULOSE) EVALOSE (TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073504 (pdf 73504.pdf not found) INN (LACTULOSE) HEPTALAC (TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073590 (pdf 73590.pdf not found) INN (LACTULOSE) LACTULOSE (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073591 (pdf 73591.pdf not found) INN (LACTULOSE) LACTULOSE (HIKMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073685 (pdf 73685.pdf not found) INN (LACTULOSE) ACILAC (NOSTRUM LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073686 (pdf 73686.pdf not found) INN (LACTULOSE) LAXILOSE (NOSTRUM LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074076 (pdf 74076.pdf not found) INN (LACTULOSE) LACTULOSE (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074077 (pdf 74077.pdf not found) INN (LACTULOSE) LACTULOSE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074138 (pdf 74138.pdf not found) INN (LACTULOSE) LACTULOSE (VISTAPHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074602 (pdf 74602.pdf not found) INN (LACTULOSE) LACTULOSE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1996 , NDA 074603 (pdf 74603.pdf not found) INN (LACTULOSE) GENERLAC (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1996 , NDA 074623 (pdf 74623.pdf not found) INN (LACTULOSE) LACTULOSE (PHARM ASSOC) APPROVAL= AP YEAR= 1996 , NDA 074712 (pdf 74712.pdf not found) INN (LACTULOSE) LACTULOSE (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 1997 , NDA 075911 (pdf 75911.pdf not found) INN (LACTULOSE) LACTULOSE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 2002 , NDA 075993 (pdf 75993.pdf not found) INN (LACTULOSE) LACTULOSE (LANNETT CO INC) APPROVAL= AP YEAR= 2001 , NDA 076645 (pdf 76645.pdf not found) INN (LACTULOSE) LACTULOSE (BAJAJ) APPROVAL= AP YEAR= 2003 , NDA 078430 (pdf 78430.pdf not found) INN (LACTULOSE) LACTULOSE (ANI PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 090426 (pdf 90426.pdf not found) INN (LACTULOSE) LACTULOSE (ANI PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090502 (pdf 90502.pdf not found) INN (LACTULOSE) LACTULOSE (FRESENIUS KABI) APPROVAL= AP YEAR= 2012 , NDA 090503 (pdf 90503.pdf not found) INN (LACTULOSE) LACTULOSE (FRESENIUS KABI) APPROVAL= AP YEAR= 2012 , NDA 203762 (pdf 203762.pdf not found) INN (LACTULOSE) LACTULOSE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207786 (pdf 207786.pdf not found) INN (LACTULOSE) LACTULOSE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209517 (pdf 209517.pdf not found) INN (LACTULOSE) LACTULOSE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , 450 ; LOPERAMIDE ; 53179-11-6 ; 1976 ; ; ; CLASS METABOLISM -- ANTIPERISTALTIC -- ANTIDIARRHEALS -- MU-TYPE OPIOID RECEPTOR AGONIST , ; NDA 017690 (label 17690.pdf) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017694 (label 17694.pdf) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 019037 (pdf 19037.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM (JANSSEN PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019487 (label 19487.pdf) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM A-D (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1988 , NDA 019860 (label 19860.pdf) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM A-D (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1989 , NDA 020448 (label 20448.pdf) INN (LOPERAMIDE HYDROCHLORIDE) IMODIUM A-D EZ CHEWS (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020606 (label 20606.pdf) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) IMODIUM MULTI-SYMPTOM RELIEF (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021140 (label 21140.pdf) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) IMODIUM MULTI-SYMPTOM RELIEF (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2000 , NDA 021855 (label 21855.pdf) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2005 , NDA 072741 (pdf 72741.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1991 , NDA 072993 (pdf 72993.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073062 (pdf 73062.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073079 (pdf 73079.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (ALLIED) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073080 (pdf 73080.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073122 (pdf 73122.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073187 (pdf 73187.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073192 (pdf 73192.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073243 (pdf 73243.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073254 (pdf 73254.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073478 (pdf 73478.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073528 (pdf 73528.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074091 (pdf 74091.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (OHM LABS) APPROVAL= AP YEAR= 1992 , NDA 074194 (pdf 74194.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074352 (pdf 74352.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074730 (pdf 74730.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1997 , NDA 074991 (pdf 74991.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075232 (label 75232.pdf) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2000 , NDA 076029 (pdf 76029.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076497 (pdf 76497.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (LNK) APPROVAL= AP YEAR= 2003 , NDA 077500 (pdf 77500.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 091292 (pdf 91292.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 , NDA 206548 (pdf 206548.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 209837 (pdf 209837.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 211059 (pdf 211059.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211438 (pdf 211438.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , NDA 214541 (pdf 214541.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (GUARDIAN DRUG) APPROVAL= AP YEAR= 2021 , NDA 213070 (pdf 213070.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213484 (pdf 213484.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (BIONPHARMA) APPROVAL= AP YEAR= 2021 , NDA 215001 (pdf 215001.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215579 (pdf 215579.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2021 , NDA 215981 (pdf 215981.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE SIMETHICONE) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216876 (pdf 216876.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 217471 (pdf 217471.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217840 (pdf 217840.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2023 , NDA 218122 (pdf 218122.pdf not found) INN (LOPERAMIDE HYDROCHLORIDE) LOPERAMIDE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 451 ; HALAZEPAM ; 23092-17-3 ; 1981 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- BENZODIAZEPINES -- MUSCLE RELAXANTS -- SEDATIVE -- PRECUSOR OF DESMETHYLDIAZEPAM (PMID6123659) , ; NDA 017736 (pdf 17736.pdf not found) INN (HALAZEPAM) PAXIPAM (SCHERING) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , 452 ; DIFENOXIN ; 28782-42-5 ; 1978 ; ; ; CLASS METABOLISM -- ANTIPERISTALTIC -- ANTIDIARRHEAL AGENT -- CHEMICALLY RELATED TO THE NARCOTIC MEPERIDINE -- INHIBIT NET FLUID SECRETION BY INDIRECT MECHANISMS (PMID8386327) , ; NDA 017744 (label 17744.pdf) INN (ATROPINE SULFATE DIFENOXIN HYDROCHLORIDE) MOTOFEN HALF-STRENGTH (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , 453 ; GLIPIZIDE ; 29094-61-9 ; 1984 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREA CLASS , ; NDA 017783 (label 17783.pdf) INN (GLIPIZIDE) GLUCOTROL (PFIZER) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 020329 (label 20329.pdf) INN (GLIPIZIDE) GLUCOTROL XL (PFIZER) APPROVAL= AP YEAR= 1994 , NDA 021460 (label 21460.pdf) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) METAGLIP (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 074223 (pdf 74223.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1995 , NDA 074226 (pdf 74226.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1994 , NDA 074305 (pdf 74305.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074370 (pdf 74370.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074378 (pdf 74378.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074387 (pdf 74387.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074438 (pdf 74438.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (MYLAN) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074497 (pdf 74497.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 , NDA 074542 (pdf 74542.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074550 (pdf 74550.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074619 (pdf 74619.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (BARR LABS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075795 (pdf 75795.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (APOTEX) APPROVAL= AP YEAR= 2001 , NDA 076159 (pdf 76159.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 076467 (pdf 76467.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (WATSON LABS) APPROVAL= AP YEAR= 2003 , NDA 077270 (pdf 77270.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077507 (pdf 77507.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 , NDA 077620 (pdf 77620.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077820 (pdf 77820.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078083 (pdf 78083.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (DASH PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078728 (pdf 78728.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078905 (pdf 78905.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 203499 (pdf 203499.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 202298 (pdf 202298.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204720 (pdf 204720.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (UNIQUE) APPROVAL= AP YEAR= 2016 , NDA 206928 (pdf 206928.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 214874 (pdf 214874.pdf not found) INN (GLIPIZIDE) GLIPIZIDE (RUBICON) APPROVAL= AP YEAR= 2023 , 454 ; VASOPRESSIN ; 11000-17-2 ; 2014 ; ; ; CLASS HORMONE -- ANTIDIURETICS -- OXYTOCICS -- VASOCONSTRICTOR AGENTS -- TREATMENT OF POSTOPERATIVE ABDOMINAL DISTENTION , ; NDA 003402 (pdf 3402.pdf not found) INN (VASOPRESSIN TANNATE) PITRESSIN TANNATE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 204485 (label 204485.pdf) INN (VASOPRESSIN) VASOSTRICT (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 212593 (label 212593.pdf) INN (VASOPRESSIN) VASOPRESSIN (AM REGENT) APPROVAL= AP YEAR= 2020 , NDA 211538 (pdf 211538.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (EAGLE PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211857 (pdf 211857.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 212944 (pdf 212944.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 212945 (pdf 212945.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (AMNEAL EU LTD) APPROVAL= TA YEAR= 2022 , NDA 214314 (pdf 214314.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213206 (pdf 213206.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2023 , NDA 217569 (pdf 217569.pdf not found) INN (VASOPRESSIN) VASOPRESSIN IN SODIUM CHLORIDE 0.9% (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 , NDA 217987 (pdf 217987.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (CIPLA) APPROVAL= AP YEAR= 2023 , NDA 213988 (pdf 213988.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 216963 (pdf 216963.pdf not found) INN (VASOPRESSIN) VASOPRESSIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217766 (pdf 217766.pdf not found) INN (VASOPRESSIN) VASOPRESSIN IN SODIUM CHLORIDE INJECTION (LONG GROVE PHARMS) APPROVAL= TA YEAR= 2024 , 455 ; LORAZEPAM ; 846-49-1 ; 1977 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTICONVULSANTS -- ANTIEMETICS -- BENZODIAZEPINES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 017794 (label 17794.pdf) INN (LORAZEPAM) ATIVAN (BAUSCH) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 018140 (label 18140.pdf) INN (LORAZEPAM) ATIVAN (HIKMA) APPROVAL= AP YEAR= 1980 , NDA 070200 (pdf 70200.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070201 (pdf 70201.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070202 (pdf 70202.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070472 (pdf 70472.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070473 (pdf 70473.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070474 (pdf 70474.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070539 (pdf 70539.pdf not found) INN (LORAZEPAM) LORAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070540 (pdf 70540.pdf not found) INN (LORAZEPAM) LORAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070675 (pdf 70675.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070676 (pdf 70676.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070677 (pdf 70677.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070727 (pdf 70727.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070728 (pdf 70728.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070729 (pdf 70729.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071038 (pdf 71038.pdf not found) INN (LORAZEPAM) LORAZEPAM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071039 (pdf 71039.pdf not found) INN (LORAZEPAM) LORAZEPAM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071086 (pdf 71086.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071087 (pdf 71087.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071088 (pdf 71088.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071110 (pdf 71110.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071117 (pdf 71117.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071118 (pdf 71118.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071141 (pdf 71141.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 071193 (pdf 71193.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071194 (pdf 71194.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071195 (pdf 71195.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071245 (pdf 71245.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071246 (pdf 71246.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071247 (pdf 71247.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071403 (pdf 71403.pdf not found) INN (LORAZEPAM) LORAZEPAM () APPROVAL= AP YEAR= 1987 , NDA 071404 (pdf 71404.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 071434 (pdf 71434.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071435 (pdf 71435.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071436 (pdf 71436.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071589 (pdf 71589.pdf not found) INN (LORAZEPAM) LORAZEPAM (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071590 (pdf 71590.pdf not found) INN (LORAZEPAM) LORAZEPAM (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071591 (pdf 71591.pdf not found) INN (LORAZEPAM) LORAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072553 (pdf 72553.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072554 (pdf 72554.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072555 (pdf 72555.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072755 (pdf 72755.pdf not found) INN (LORAZEPAM) LORAZEPAM INTENSOL (HIKMA) APPROVAL= AP YEAR= 1991 , NDA 072926 (pdf 72926.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 072927 (pdf 72927.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 072928 (pdf 72928.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 074243 (pdf 74243.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074276 (pdf 74276.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074280 (pdf 74280.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074282 (pdf 74282.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074300 (pdf 74300.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074496 (label 74496.pdf) INN (LORAZEPAM) LORAZEPAM (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074535 (pdf 74535.pdf not found) INN (LORAZEPAM) LORAZEPAM (DR REDDYS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074551 (pdf 74551.pdf not found) INN (LORAZEPAM) LORAZEPAM (DR REDDYS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074648 (pdf 74648.pdf not found) INN (LORAZEPAM) LORAZEPAM (ROXANE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074793 (label 74793.pdf) INN (LORAZEPAM) LORAZEPAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074974 (pdf 74974.pdf not found) INN (LORAZEPAM) LORAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075025 (pdf 75025.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 1998 , NDA 076045 (pdf 76045.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2001 , NDA 076150 (pdf 76150.pdf not found) INN (LORAZEPAM) LORAZEPAM (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2004 , NDA 077074 (pdf 77074.pdf not found) INN (LORAZEPAM) LORAZEPAM PRESERVATIVE FREE (BEDFORD LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077076 (pdf 77076.pdf not found) INN (LORAZEPAM) LORAZEPAM (BEDFORD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077396 (pdf 77396.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077657 (pdf 77657.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077754 (pdf 77754.pdf not found) INN (LORAZEPAM) LORAZEPAM (OXFORD PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078203 (pdf 78203.pdf not found) INN (LORAZEPAM) LORAZEPAM (LEADING) APPROVAL= AP YEAR= 2007 , NDA 079244 (label 79244.pdf) INN (LORAZEPAM) LORAZEPAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091383 (pdf 91383.pdf not found) INN (LORAZEPAM) LORAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078826 (pdf 78826.pdf not found) INN (LORAZEPAM) LORAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090260 (pdf 90260.pdf not found) INN (LORAZEPAM) LORAZEPAM (PHARM ASSOC) APPROVAL= AP YEAR= 2010 , NDA 200169 (pdf 200169.pdf not found) INN (LORAZEPAM) LORAZEPAM (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091407 (pdf 91407.pdf not found) INN (LORAZEPAM) LORAZEPAM (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 200217 (label 200217.pdf) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 200542 (pdf 200542.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203572 (pdf 203572.pdf not found) INN (LORAZEPAM) LORAZEPAM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2017 , NDA 214826 (label 214826.pdf) INN (LORAZEPAM) LOREEV XR (ALMATICA) APPROVAL= AP YEAR= 2021 , 456 ; DINOPROSTONE ; 363-24-6 ; 1977 ; ; ; CLASS GENITO -- PROSTAGLANDIN -- OXYTOCIC -- NATURALLY OCCURRING FORM OF PROSTAGLANDIN E2 (PGE2) , ; NDA 017810 (label 17810.pdf) INN (DINOPROSTONE) PROSTIN E2 (PFIZER) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 019617 (label 19617.pdf) INN (DINOPROSTONE) PREPIDIL (PFIZER) APPROVAL= AP YEAR= 1992 , NDA 020411 (label 20411.pdf) INN (DINOPROSTONE) CERVIDIL (FERRING PHARMS INC) APPROVAL= AP YEAR= 1995 , 457 ; DOBUTAMINE ; 34368-04-2 ; 1978 ; ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETIC -- CATECHOLAMINE , ; NDA 017820 (pdf 17820.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTREX (LILLY) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 020201 (label 20201.pdf) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1993 , NDA 020255 (label 20255.pdf) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1993 , NDA 020269 (pdf 20269.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074086 (pdf 74086.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1993 , NDA 074098 (pdf 74098.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (TELIGENT) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074114 (pdf 74114.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074206 (pdf 74206.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074277 (pdf 74277.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 074279 (pdf 74279.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074292 (pdf 74292.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074381 (pdf 74381.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074545 (pdf 74545.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074634 (pdf 74634.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074995 (pdf 74995.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 216131 (pdf 216131.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HAINAN POLY) APPROVAL= AP YEAR= 2022 , 458 ; CYCLOBENZAPRINE ; 303-53-7 ; 1977 ; ; ; CLASS MUSCULO-SKELETAL -- MUSCLE RELAXANT (SKELETAL) -- RELIEVES SKELETAL MUSCLE SPASM OF LOCAL ORIGIN WITHOUT INTERFERING WITH MUSCLE FUNCTION -- 5-HT2 RECEPTOR ANTAGONIST (PMID12498911) -- STRUCTURAL ANALOG OF TRICYCLIC ANTIDEPRESSANTS , ; NDA 017821 (label 17821.pdf) INN (CYCLOBENZAPRINE HYDROCHLORIDE) FLEXERIL (JANSSEN RES AND DEV) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 021777 (label 21777.pdf) INN (CYCLOBENZAPRINE HYDROCHLORIDE) AMRIX (TEVA PHARMS INTL) APPROVAL= AP YEAR= 2007 , NDA 071611 (pdf 71611.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1988 , NDA 072854 (pdf 72854.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073143 (pdf 73143.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073144 (pdf 73144.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073541 (pdf 73541.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 1995 , NDA 073683 (pdf 73683.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074421 (pdf 74421.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074436 (pdf 74436.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 077209 (pdf 77209.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077291 (pdf 77291.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (PROSAM LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED OBSOLETE , NDA 077563 (pdf 77563.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2006 , NDA 077797 (pdf 77797.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2007 , NDA 078218 (pdf 78218.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 078722 (pdf 78722.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2008 , NDA 078643 (pdf 78643.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 090478 (pdf 90478.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078048 (pdf 78048.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2011 , NDA 090738 (pdf 90738.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 OBSOLETE , NDA 090864 (pdf 90864.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (PAR PHARM INC) APPROVAL= TA YEAR= 2013 , NDA 091281 (pdf 91281.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (TWI PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 208170 (pdf 208170.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2017 , NDA 206703 (pdf 206703.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213324 (pdf 213324.pdf not found) INN (CYCLOBENZAPRINE HYDROCHLORIDE) CYCLOBENZAPRINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2020 , 459 ; ETIDRONATE ; 2809-21-4 ; 1977 ; DISCONTINUED ; ; CLASS METABOLISM -- BONE RESORPTION INHIBITOR -- ANTIHYPOCALCEMIC AGENTS -- BISPHOSPHONATES -- OSTEOPOROSIS PROPHYLACTIC -- IT CAN INHIBIT THE FORMATION GROWTH AND DISSOLUTION OF HYDROXYAPATITE CRYSTALS AND THEIR AMORPHOUS PRECURSORS BY CHEMISORPTION TO CALCIUM PHOSPHATE SURFACES , ; NDA 017831 (label 17831.pdf) INN (ETIDRONATE DISODIUM) DIDRONEL (APIL) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 019545 (pdf 19545.pdf not found) INN (ETIDRONATE DISODIUM) DIDRONEL (MGI PHARMA INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 075800 (pdf 75800.pdf not found) INN (ETIDRONATE DISODIUM) ETIDRONATE DISODIUM (MYLAN) APPROVAL= AP YEAR= 2003 DISCONTINUED , 460 ; BACLOFEN ; 1134-47-0 ; 1977 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- MUSCLE RELAXANT -- GABA AGONISTS , ; NDA 017851 (pdf 17851.pdf not found) INN (BACLOFEN) LIORESAL (NOVARTIS) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 020075 (label 20075.pdf) INN (BACLOFEN) LIORESAL (AMNEAL) APPROVAL= AP YEAR= 1992 , NDA 021589 (label 21589.pdf) INN (BACLOFEN) KEMSTRO (UCB INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 071260 (pdf 71260.pdf not found) INN (BACLOFEN) BACLOFEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071261 (pdf 71261.pdf not found) INN (BACLOFEN) BACLOFEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072234 (pdf 72234.pdf not found) INN (BACLOFEN) BACLOFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072235 (pdf 72235.pdf not found) INN (BACLOFEN) BACLOFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072824 (pdf 72824.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072825 (pdf 72825.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073043 (pdf 73043.pdf not found) INN (BACLOFEN) BACLOFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073044 (pdf 73044.pdf not found) INN (BACLOFEN) BACLOFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073092 (pdf 73092.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073093 (pdf 73093.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074584 (pdf 74584.pdf not found) INN (BACLOFEN) BACLOFEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1996 , NDA 074698 (pdf 74698.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 077068 (pdf 77068.pdf not found) INN (BACLOFEN) BACLOFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 , NDA 077088 (pdf 77088.pdf not found) INN (BACLOFEN) BACLOFEN (OXFORD PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077089 (pdf 77089.pdf not found) INN (BACLOFEN) BACLOFEN () APPROVAL= AP YEAR= 2007 , NDA 077121 (pdf 77121.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 077156 (pdf 77156.pdf not found) INN (BACLOFEN) BACLOFEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 077181 (pdf 77181.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077241 (pdf 77241.pdf not found) INN (BACLOFEN) BACLOFEN (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 077862 (pdf 77862.pdf not found) INN (BACLOFEN) BACLOFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077971 (pdf 77971.pdf not found) INN (BACLOFEN) BACLOFEN (IMPAX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077984 (pdf 77984.pdf not found) INN (BACLOFEN) BACLOFEN (CARACO) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 078146 (pdf 78146.pdf not found) INN (BACLOFEN) BACLOFEN (IMPAX LABS) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078220 (pdf 78220.pdf not found) INN (BACLOFEN) BACLOFEN (LANNETT) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078401 (pdf 78401.pdf not found) INN (BACLOFEN) BACLOFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 078504 (pdf 78504.pdf not found) INN (BACLOFEN) BACLOFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 090334 (pdf 90334.pdf not found) INN (BACLOFEN) BACLOFEN (APPCO) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022462 (label 22462.pdf) INN (BACLOFEN) GABLOFEN (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2010 , NDA 091193 (pdf 91193.pdf not found) INN (BACLOFEN) BACLOFEN (AMNEAL) APPROVAL= AP YEAR= 2016 , NDA 209102 (pdf 209102.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= AP YEAR= 2017 , NDA 209592 (label 209592.pdf) INN (BACLOFEN) BACLOFEN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 209594 (pdf 209594.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 211659 (pdf 211659.pdf not found) INN (BACLOFEN) BACLOFEN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 211555 (pdf 211555.pdf not found) INN (BACLOFEN) BACLOFEN (EYWA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 208193 (label 208193.pdf) INN (BACLOFEN) OZOBAX (METACEL PHARMS LLC) APPROVAL= AP YEAR= 2019 , NDA 210048 (pdf 210048.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210315 (pdf 210315.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 212067 (pdf 212067.pdf not found) INN (BACLOFEN) BACLOFEN (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 212378 (pdf 212378.pdf not found) INN (BACLOFEN) BACLOFEN (INNOGENIX) APPROVAL= AP YEAR= 2020 , NDA 210777 (pdf 210777.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214374 (pdf 214374.pdf not found) INN (BACLOFEN) BACLOFEN (RISING) APPROVAL= AP YEAR= 2021 , NDA 214099 (pdf 214099.pdf not found) INN (BACLOFEN) BACLOFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214114 (pdf 214114.pdf not found) INN (BACLOFEN) BACLOFEN (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215422 (label 215422.pdf) INN (BACLOFEN) LYVISPAH (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 215602 (label 215602.pdf) INN (BACLOFEN) FLEQSUVY (AZURITY) APPROVAL= AP YEAR= 2022 , NDA 215885 (pdf 215885.pdf not found) INN (BACLOFEN) BACLOFEN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214445 (pdf 214445.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= TA YEAR= 2023 , NDA 217252 (pdf 217252.pdf not found) INN (BACLOFEN) BACLOFEN (ANI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217324 (pdf 217324.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 216309 (pdf 216309.pdf not found) INN (BACLOFEN) BACLOFEN (ACIC PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217687 (pdf 217687.pdf not found) INN (BACLOFEN) BACLOFEN (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 217788 (pdf 217788.pdf not found) INN (BACLOFEN) BACLOFEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2024 , 461 ; METOCLOPRAMIDE ; 364-62-5 ; 1979 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- DOPAMINE ANTAGONISTS -- TREATMENT OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX , ; NDA 017854 (label 17854.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) REGLAN (ANI PHARMS) APPROVAL= AP YEAR= 1980 , NDA 017862 (label 17862.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) REGLAN (HIKMA) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 018821 (pdf 18821.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) REGLAN (ROBINS AH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 021793 (label 21793.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) REGLAN ODT (MEDA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 070106 (pdf 70106.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) MAXOLON (KING PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070184 (pdf 70184.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 070293 (pdf 70293.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (LYPHOMED) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070294 (pdf 70294.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) CLOPRA (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070339 (pdf 70339.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070342 (pdf 70342.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070363 (pdf 70363.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070453 (pdf 70453.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070505 (pdf 70505.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070506 (pdf 70506.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070511 (pdf 70511.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070581 (pdf 70581.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 070598 (pdf 70598.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070622 (pdf 70622.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070623 (pdf 70623.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070632 (pdf 70632.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) CLOPRA-"YELLOW" (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070645 (pdf 70645.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070660 (pdf 70660.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070671 (pdf 70671.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070819 (pdf 70819.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070847 (pdf 70847.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070850 (pdf 70850.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070892 (pdf 70892.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (NORBROOK) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070906 (pdf 70906.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070926 (pdf 70926.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070949 (pdf 70949.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (MORTON GROVE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071213 (pdf 71213.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071250 (pdf 71250.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 , NDA 071291 (pdf 71291.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071315 (pdf 71315.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071340 (pdf 71340.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071402 (pdf 71402.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1993 , NDA 071536 (pdf 71536.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071665 (pdf 71665.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071990 (pdf 71990.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072038 (pdf 72038.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072155 (pdf 72155.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072215 (pdf 72215.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (AIPING PHARM INC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072244 (pdf 72244.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072247 (pdf 72247.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072384 (pdf 72384.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) CLOPRA (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072436 (pdf 72436.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072639 (pdf 72639.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (CLONMEL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072744 (pdf 72744.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 1991 , NDA 072750 (pdf 72750.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1995 OBSOLETE , NDA 072801 (pdf 72801.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1993 , NDA 072995 (pdf 72995.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073117 (pdf 73117.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073118 (pdf 73118.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1991 , NDA 073135 (pdf 73135.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1991 , NDA 073680 (pdf 73680.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074147 (pdf 74147.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074478 (pdf 74478.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074703 (pdf 74703.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075051 (label 75051.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (VISTAPHARM) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 077878 (pdf 77878.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078374 (pdf 78374.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078807 (pdf 78807.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 022246 (label 22246.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOZOLV ODT (SALIX PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091392 (pdf 91392.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 204756 (pdf 204756.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 , NDA 202191 (pdf 202191.pdf not found) INN (METOCLOPRAMIDE HYDROCHLORIDE) METOCLOPRAMIDE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2014 , NDA 209388 (label 209388.pdf) INN (METOCLOPRAMIDE HYDROCHLORIDE) GIMOTI (EVOKE PHARMA INC) APPROVAL= AP YEAR= 2020 , 462 ; DESOXIMETASONE ; 382-67-2 ; 1977 ; ; ; CLASS DERMATOLOGICALS -- ANTIINFLAMMATORY -- GLUCOCORTICOIDS -- CORTICOSTEROIDS -- ANTI-PRURITIC -- VASOCONSTRICTIVE , ; NDA 017856 (label 17856.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 018309 (label 18309.pdf) INN (DESOXIMETASONE) TOPICORT LP (TARO) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018586 (label 18586.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018594 (label 18594.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1985 , NDA 018763 (label 18763.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 073193 (label 73193.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1990 , NDA 073210 (label 73210.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1990 , NDA 073440 (pdf 73440.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (ALTANA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074286 (label 74286.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074904 (label 74904.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 1998 , NDA 076510 (pdf 76510.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003 , NDA 077552 (pdf 77552.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (PADAGIS US) APPROVAL= AP YEAR= 2006 , NDA 078369 (pdf 78369.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090727 (pdf 90727.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2011 , NDA 078657 (pdf 78657.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202838 (pdf 202838.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 204141 (label 204141.pdf) INN (DESOXIMETASONE) TOPICORT (TARO) APPROVAL= AP YEAR= 2013 , NDA 201005 (pdf 201005.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 077770 (pdf 77770.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2015 , NDA 203234 (pdf 203234.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205082 (pdf 205082.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 , NDA 206792 (pdf 206792.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 208101 (pdf 208101.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204272 (pdf 204272.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (RISING) APPROVAL= AP YEAR= 2016 , NDA 204675 (pdf 204675.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (RISING) APPROVAL= AP YEAR= 2016 , NDA 204965 (pdf 204965.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2016 , NDA 206740 (pdf 206740.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (COSETTE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208044 (pdf 208044.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (LUPIN) APPROVAL= AP YEAR= 2016 , NDA 208104 (pdf 208104.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (LUPIN) APPROVAL= AP YEAR= 2016 , NDA 203787 (pdf 203787.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206441 (pdf 206441.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 208163 (pdf 208163.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (LUPIN) APPROVAL= AP YEAR= 2017 , NDA 208164 (pdf 208164.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (LUPIN) APPROVAL= AP YEAR= 2017 , NDA 205206 (pdf 205206.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 208124 (pdf 208124.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (LUPIN) APPROVAL= AP YEAR= 2018 , NDA 205594 (pdf 205594.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (RISING) APPROVAL= AP YEAR= 2018 , NDA 205620 (pdf 205620.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 209973 (pdf 209973.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (THE J MOLNER) APPROVAL= AP YEAR= 2018 , NDA 210980 (pdf 210980.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (RISING) APPROVAL= AP YEAR= 2018 , NDA 209595 (pdf 209595.pdf not found) INN (DESOXIMETASONE) DESOXIMETASONE (COSETTE) APPROVAL= AP YEAR= 2020 DISCONTINUED , 463 ; BUTORPHANOL ; 42408-82-2 ; 1978 ; ; ; CLASS NERVOUS SYSTEM -- ANTITUSSIVE -- ANALGESIC -- NARCOTIC ANTAGONISTS -- A MIXED AGONIST-ANTAGONIST OF MU-TYPE OPIOID RECEPTOR -- AGONIST OF KAPPA-TYPE OPIOID RECEPTOR , ; NDA 017857 (pdf 17857.pdf not found) INN (BUTORPHANOL TARTRATE) STADOL PRESERVATIVE FREE (APOTHECON) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 019890 (label 19890.pdf) INN (BUTORPHANOL TARTRATE) STADOL (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074620 (pdf 74620.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074626 (pdf 74626.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 , NDA 075045 (pdf 75045.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 075046 (pdf 75046.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 075170 (pdf 75170.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075342 (pdf 75342.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075499 (pdf 75499.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075559 (pdf 75559.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075695 (pdf 75695.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE PRESERVATIVE FREE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075697 (pdf 75697.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075759 (pdf 75759.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (RISING) APPROVAL= AP YEAR= 2001 , NDA 075824 (pdf 75824.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 078247 (pdf 78247.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078400 (pdf 78400.pdf not found) INN (BUTORPHANOL TARTRATE) BUTORPHANOL TARTRATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , 464 ; METOPROLOL ; 37350-58-6 ; 1978 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIARRHYTHMIC -- ANTIANGINAL -- ADRENERGIC (BETA-1) BLOCKER -- SYMPATHOLYTICS , ; NDA 017963 (label 17963.pdf) INN (METOPROLOL TARTRATE) LOPRESSOR (VALIDUS PHARMS) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY , NDA 018303 (label 18303.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) LOPRESSOR HCT (VALIDUS PHARMS) APPROVAL= AP YEAR= 1984 , NDA 018704 (label 18704.pdf) INN (METOPROLOL TARTRATE) LOPRESSOR (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019451 (pdf 19451.pdf not found) INN (CHLORTHALIDONE METOPROLOL TARTRATE) LOPRESSIDONE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019786 (pdf 19786.pdf not found) INN (METOPROLOL FUMARATE) LOPRESSOR (NOVARTIS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019962 (label 19962.pdf) INN (METOPROLOL SUCCINATE) TOPROL-XL (TOPROL) APPROVAL= AP YEAR= 1992 , NDA 021956 (label 21956.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL SUCCINATE) DUTOPROL (CONCORDIA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 073288 (pdf 73288.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073289 (pdf 73289.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073653 (pdf 73653.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073654 (pdf 73654.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073666 (pdf 73666.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MYLAN) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074032 (pdf 74032.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074133 (pdf 74133.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074141 (pdf 74141.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074143 (pdf 74143.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074217 (pdf 74217.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074258 (pdf 74258.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (APOTHECON) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074333 (pdf 74333.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074380 (pdf 74380.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074453 (pdf 74453.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (RENATA) APPROVAL= AP YEAR= 1995 , NDA 074644 (pdf 74644.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1996 , NDA 075160 (pdf 75160.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076495 (pdf 76495.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076640 (pdf 76640.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076670 (pdf 76670.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2004 , NDA 076704 (pdf 76704.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 076792 (pdf 76792.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 076969 (pdf 76969.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077176 (pdf 77176.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077360 (pdf 77360.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077739 (pdf 77739.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077761 (pdf 77761.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2007 , NDA 077779 (pdf 77779.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078085 (pdf 78085.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 078459 (pdf 78459.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 076862 (pdf 76862.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 077118 (pdf 77118.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 OBSOLETE , NDA 077298 (pdf 77298.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090317 (pdf 90317.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090386 (pdf 90386.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090615 (pdf 90615.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (WOCKHARDT) APPROVAL= AP YEAR= 2010 , NDA 091045 (pdf 91045.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 091307 (pdf 91307.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (LUITPOLD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202033 (pdf 202033.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 090654 (pdf 90654.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 , NDA 078889 (pdf 78889.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (REDDYS) APPROVAL= AP YEAR= 2012 , NDA 090617 (pdf 90617.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 078950 (pdf 78950.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 , NDA 202870 (pdf 202870.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 202871 (pdf 202871.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 200981 (pdf 200981.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (RUBICON) APPROVAL= AP YEAR= 2014 , NDA 204205 (pdf 204205.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 204161 (pdf 204161.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 203894 (pdf 203894.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204106 (pdf 204106.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 210428 (label 210428.pdf) INN (METOPROLOL SUCCINATE) KAPSPARGO SPRINKLE (SPIL) APPROVAL= AP YEAR= 2018 , NDA 207206 (pdf 207206.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (VISUM PHARM) APPROVAL= AP YEAR= 2018 , NDA 207465 (pdf 207465.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 203028 (pdf 203028.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PHARMADAX INC) APPROVAL= AP YEAR= 2020 , NDA 203699 (pdf 203699.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PHARMADAX INC) APPROVAL= AP YEAR= 2020 , NDA 208955 (pdf 208955.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (YOUNGTECH PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 205541 (pdf 205541.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 211143 (pdf 211143.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213854 (pdf 213854.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2021 , NDA 210597 (pdf 210597.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214004 (pdf 214004.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (SUNSHINE) APPROVAL= AP YEAR= 2022 , NDA 215637 (pdf 215637.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212402 (pdf 212402.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216916 (pdf 216916.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 209272 (pdf 209272.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (LUPIN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216509 (pdf 216509.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (GRANULES) APPROVAL= AP YEAR= 2023 DISCONTINUED , 465 ; METYROSINE ; 672-87-7 ; 1979 ; ; ; CLASS ANTIHYPERTENSIVE -- TREATMENT OF PHEOCHROMOCYTOMA (TUMOR OF THE ADRENAL GLAND) -- DECREASES ENDOGENOUS LEVELS OF CATECHOLAMINES , ; NDA 017871 (pdf 17871.pdf not found) INN (METYROSINE) DEMSER (BAUSCH) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 213734 (pdf 213734.pdf not found) INN (METYROSINE) METYROSINE (AMNEAL) APPROVAL= AP YEAR= 2020 , 466 ; SCOPOLAMINE ; 51-34-3 ; 1979 ; ; NATURAL MOLECULE C00002292 ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTIMUSCARINICS -- MYDRIATICS -- A BELLADONNA ALKALOID -- PREVENTION OF NAUSEA -- NONSELECTIVE MUSCARINIC RECEPTOR ANTAGONIST , ; NDA 017874 (label 17874.pdf) INN (SCOPOLAMINE) TRANSDERM SCOP (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1979 , NDA 078830 (label 78830.pdf) INN (SCOPOLAMINE) SCOPOLAMINE (PADAGIS US) APPROVAL= AP YEAR= 2015 , NDA 203753 (pdf 203753.pdf not found) INN (SCOPOLAMINE) SCOPOLAMINE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2019 , NDA 212342 (pdf 212342.pdf not found) INN (SCOPOLAMINE) SCOPOLAMINE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 208769 (pdf 208769.pdf not found) INN (SCOPOLAMINE) SCOPOLAMINE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2022 , NDA 215329 (pdf 215329.pdf not found) INN (SCOPOLAMINE) SCOPOLAMINE (RHODES PHARMS) APPROVAL= AP YEAR= 2024 , 467 ; TRIAZOLAM ; 28911-01-5 ; 1982 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- BENZODIAZEPINES -- GABA MODULATORS -- A TRIAZOLOBENZODIAZEPINE HYPNOTIC AGENT , ; NDA 017892 (label 17892.pdf) INN (TRIAZOLAM) HALCION (PFIZER) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 074031 (pdf 74031.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074224 (pdf 74224.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (HIKMA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074445 (pdf 74445.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 214219 (pdf 214219.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 213003 (pdf 213003.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216890 (pdf 216890.pdf not found) INN (TRIAZOLAM) TRIAZOLAM (SANDOZ) APPROVAL= AP YEAR= 2022 , 468 ; SULINDAC ; 38194-50-2 ; 1978 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- NSAID -- CYCLOOXYGENASE INHIBITORS , ; NDA 017911 (label 17911.pdf) INN (SULINDAC) CLINORIL (MERCK) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 071795 (pdf 71795.pdf not found) INN (SULINDAC) SULINDAC (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 071891 (pdf 71891.pdf not found) INN (SULINDAC) SULINDAC (WATSON LABS) APPROVAL= AP YEAR= 1988 , NDA 072050 (pdf 72050.pdf not found) INN (SULINDAC) SULINDAC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 , NDA 072051 (pdf 72051.pdf not found) INN (SULINDAC) SULINDAC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 , NDA 072710 (pdf 72710.pdf not found) INN (SULINDAC) SULINDAC (EPIC PHARMA) APPROVAL= AP YEAR= 1991 , NDA 072711 (pdf 72711.pdf not found) INN (SULINDAC) SULINDAC (EPIC PHARMA) APPROVAL= AP YEAR= 1991 , NDA 072712 (pdf 72712.pdf not found) INN (SULINDAC) SULINDAC (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072713 (pdf 72713.pdf not found) INN (SULINDAC) SULINDAC (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072972 (pdf 72972.pdf not found) INN (SULINDAC) SULINDAC (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED OBSOLETE , NDA 072973 (pdf 72973.pdf not found) INN (SULINDAC) SULINDAC (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073038 (pdf 73038.pdf not found) INN (SULINDAC) SULINDAC (MYLAN) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073039 (pdf 73039.pdf not found) INN (SULINDAC) SULINDAC (RISING) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073261 (pdf 73261.pdf not found) INN (SULINDAC) SULINDAC (RADIUS PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073262 (pdf 73262.pdf not found) INN (SULINDAC) SULINDAC (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , 469 ; CIMETIDINE ; 51481-61-9 ; 1977 ; ; ; CLASS METABOLISM -- HISTAMINE H2 RECEPTOR BLOCKER -- ANTIHISTAMINE -- INHIBIT GASTRIC ACID SECRETION , ; NDA 017920 (pdf 17920.pdf not found) INN (CIMETIDINE) TAGAMET (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 017924 (pdf 17924.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) TAGAMET (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017939 (pdf 17939.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) TAGAMET (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 019434 (pdf 19434.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 020238 (label 20238.pdf) INN (CIMETIDINE) TAGAMET HB (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1995 , NDA 020951 (label 20951.pdf) INN (CIMETIDINE) TAGAMET HB 200 (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074005 (pdf 74005.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074100 (pdf 74100.pdf not found) INN (CIMETIDINE) CIMETIDINE (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074151 (pdf 74151.pdf not found) INN (CIMETIDINE) CIMETIDINE (TEVA) APPROVAL= AP YEAR= 1994 , NDA 074176 (pdf 74176.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (G AND W LABS INC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074246 (pdf 74246.pdf not found) INN (CIMETIDINE) CIMETIDINE (MYLAN) APPROVAL= AP YEAR= 1994 , NDA 074250 (pdf 74250.pdf not found) INN (CIMETIDINE) CIMETIDINE (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074251 (pdf 74251.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074252 (pdf 74252.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074269 (pdf 74269.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074281 (pdf 74281.pdf not found) INN (CIMETIDINE) CIMETIDINE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1994 DISCONTINUED OBSOLETE , NDA 074296 (pdf 74296.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074316 (pdf 74316.pdf not found) INN (CIMETIDINE) CIMETIDINE (WATSON LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074329 (pdf 74329.pdf not found) INN (CIMETIDINE) CIMETIDINE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074339 (pdf 74339.pdf not found) INN (CIMETIDINE) CIMETIDINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074340 (pdf 74340.pdf not found) INN (CIMETIDINE) CIMETIDINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074344 (pdf 74344.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074345 (pdf 74345.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074349 (pdf 74349.pdf not found) INN (CIMETIDINE) CIMETIDINE (WATSON LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074353 (pdf 74353.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074361 (pdf 74361.pdf not found) INN (CIMETIDINE) CIMETIDINE (CYCLE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074365 (pdf 74365.pdf not found) INN (CIMETIDINE) CIMETIDINE (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074371 (pdf 74371.pdf not found) INN (CIMETIDINE) CIMETIDINE (CYCLE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074401 (pdf 74401.pdf not found) INN (CIMETIDINE) CIMETIDINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074402 (pdf 74402.pdf not found) INN (CIMETIDINE) CIMETIDINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074412 (pdf 74412.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074422 (pdf 74422.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074424 (pdf 74424.pdf not found) INN (CIMETIDINE) CIMETIDINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074428 (pdf 74428.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074463 (pdf 74463.pdf not found) INN (CIMETIDINE) CIMETIDINE (TEVA) APPROVAL= AP YEAR= 1994 , NDA 074468 (pdf 74468.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074506 (pdf 74506.pdf not found) INN (CIMETIDINE) CIMETIDINE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074541 (pdf 74541.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (CYCLE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074553 (pdf 74553.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074566 (pdf 74566.pdf not found) INN (CIMETIDINE) CIMETIDINE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074568 (pdf 74568.pdf not found) INN (CIMETIDINE) CIMETIDINE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074610 (pdf 74610.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074664 (pdf 74664.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074757 (pdf 74757.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074859 (pdf 74859.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074890 (label 74890.pdf) INN (CIMETIDINE) CIMETIDINE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074948 (pdf 74948.pdf not found) INN (CIMETIDINE) CIMETIDINE (APOTEX) APPROVAL= AP YEAR= 1998 , NDA 074961 (pdf 74961.pdf not found) INN (CIMETIDINE) CIMETIDINE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074963 (pdf 74963.pdf not found) INN (CIMETIDINE) CIMETIDINE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074972 (pdf 74972.pdf not found) INN (CIMETIDINE) CIMETIDINE (PERRIGO) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075110 (pdf 75110.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075122 (pdf 75122.pdf not found) INN (CIMETIDINE) CIMETIDINE (SANDOZ) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075285 (pdf 75285.pdf not found) INN (CIMETIDINE) CIMETIDINE (L PERRIGO CO) APPROVAL= AP YEAR= 1998 , NDA 075345 (pdf 75345.pdf not found) INN (CIMETIDINE) CIMETIDINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075425 (pdf 75425.pdf not found) INN (CIMETIDINE) CIMETIDINE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075560 (pdf 75560.pdf not found) INN (CIMETIDINE HYDROCHLORIDE) CIMETIDINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2000 DISCONTINUED , 470 ; BROMOCRIPTINE ; 25614-03-3 ; 1978 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- DOPAMINE AGONISTS -- ERGOT DERIVATIVE -- SIGNIFICANTLY REDUCES PLASMA LEVELS OF PROLACTIN , ; NDA 017962 (label 17962.pdf) INN (BROMOCRIPTINE MESYLATE) PARLODEL (SS PHARMA) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY , NDA 074631 (pdf 74631.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075100 (pdf 75100.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (LEK PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076962 (pdf 76962.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077226 (pdf 77226.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 078899 (pdf 78899.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2008 , NDA 020866 (label 20866.pdf) INN (BROMOCRIPTINE MESYLATE) CYCLOSET (VEROSCIENCE) APPROVAL= AP YEAR= 2009 , NDA 077646 (pdf 77646.pdf not found) INN (BROMOCRIPTINE MESYLATE) BROMOCRIPTINE MESYLATE (PADAGIS US) APPROVAL= AP YEAR= 2008 , 471 ; METOPROLOL ; 37350-58-6 ; 1978 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIARRHYTHMIC -- ANTIANGINAL -- ADRENERGIC (BETA-1) BLOCKER -- SYMPATHOLYTICS , ; NDA 017963 (label 17963.pdf) INN (METOPROLOL TARTRATE) LOPRESSOR (VALIDUS PHARMS) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY , NDA 018303 (label 18303.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) LOPRESSOR HCT (VALIDUS PHARMS) APPROVAL= AP YEAR= 1984 , NDA 018704 (label 18704.pdf) INN (METOPROLOL TARTRATE) LOPRESSOR (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019451 (pdf 19451.pdf not found) INN (CHLORTHALIDONE METOPROLOL TARTRATE) LOPRESSIDONE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019786 (pdf 19786.pdf not found) INN (METOPROLOL FUMARATE) LOPRESSOR (NOVARTIS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019962 (label 19962.pdf) INN (METOPROLOL SUCCINATE) TOPROL-XL (TOPROL) APPROVAL= AP YEAR= 1992 , NDA 021956 (label 21956.pdf) INN (HYDROCHLOROTHIAZIDE METOPROLOL SUCCINATE) DUTOPROL (CONCORDIA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 073288 (pdf 73288.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073289 (pdf 73289.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073653 (pdf 73653.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073654 (pdf 73654.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073666 (pdf 73666.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MYLAN) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074032 (pdf 74032.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074133 (pdf 74133.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074141 (pdf 74141.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074143 (pdf 74143.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074217 (pdf 74217.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074258 (pdf 74258.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (APOTHECON) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074333 (pdf 74333.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074380 (pdf 74380.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074453 (pdf 74453.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (RENATA) APPROVAL= AP YEAR= 1995 , NDA 074644 (pdf 74644.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1996 , NDA 075160 (pdf 75160.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 076495 (pdf 76495.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076640 (pdf 76640.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076670 (pdf 76670.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2004 , NDA 076704 (pdf 76704.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 076792 (pdf 76792.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 076969 (pdf 76969.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077176 (pdf 77176.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077360 (pdf 77360.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077739 (pdf 77739.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077761 (pdf 77761.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2007 , NDA 077779 (pdf 77779.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NESHER PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078085 (pdf 78085.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 078459 (pdf 78459.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 076862 (pdf 76862.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 077118 (pdf 77118.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 OBSOLETE , NDA 077298 (pdf 77298.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090317 (pdf 90317.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090386 (pdf 90386.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090615 (pdf 90615.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (WOCKHARDT) APPROVAL= AP YEAR= 2010 , NDA 091045 (pdf 91045.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 091307 (pdf 91307.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (LUITPOLD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202033 (pdf 202033.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 090654 (pdf 90654.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 , NDA 078889 (pdf 78889.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (REDDYS) APPROVAL= AP YEAR= 2012 , NDA 090617 (pdf 90617.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 078950 (pdf 78950.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 , NDA 202870 (pdf 202870.pdf not found) INN (HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 202871 (pdf 202871.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 200981 (pdf 200981.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (RUBICON) APPROVAL= AP YEAR= 2014 , NDA 204205 (pdf 204205.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 204161 (pdf 204161.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 203894 (pdf 203894.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204106 (pdf 204106.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 210428 (label 210428.pdf) INN (METOPROLOL SUCCINATE) KAPSPARGO SPRINKLE (SPIL) APPROVAL= AP YEAR= 2018 , NDA 207206 (pdf 207206.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (VISUM PHARM) APPROVAL= AP YEAR= 2018 , NDA 207465 (pdf 207465.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 203028 (pdf 203028.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PHARMADAX INC) APPROVAL= AP YEAR= 2020 , NDA 203699 (pdf 203699.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PHARMADAX INC) APPROVAL= AP YEAR= 2020 , NDA 208955 (pdf 208955.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (YOUNGTECH PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 205541 (pdf 205541.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 211143 (pdf 211143.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213854 (pdf 213854.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2021 , NDA 210597 (pdf 210597.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214004 (pdf 214004.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (SUNSHINE) APPROVAL= AP YEAR= 2022 , NDA 215637 (pdf 215637.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212402 (pdf 212402.pdf not found) INN (METOPROLOL TARTRATE) METOPROLOL TARTRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216916 (pdf 216916.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 209272 (pdf 209272.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (LUPIN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216509 (pdf 216509.pdf not found) INN (METOPROLOL SUCCINATE) METOPROLOL SUCCINATE (GRANULES) APPROVAL= AP YEAR= 2023 DISCONTINUED , 472 ; NADOLOL ; 42200-33-9 ; 1979 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIARRHYTHMIC -- ANTIANGINAL -- ADRENERGIC (BETA) BLOCKER -- SYMPATHOLYTICS -- BETA-2 ADRENERGIC RECEPTOR INVERSE AGONIST , ; NDA 018063 (label 18063.pdf) INN (NADOLOL) CORGARD (USWM) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 018647 (label 18647.pdf) INN (BENDROFLUMETHIAZIDE NADOLOL) CORZIDE (KING PHARMS LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 074172 (pdf 74172.pdf not found) INN (NADOLOL) NADOLOL (RISING) APPROVAL= AP YEAR= 1993 , NDA 074229 (pdf 74229.pdf not found) INN (NADOLOL) NADOLOL (HERITAGE PHARMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074255 (pdf 74255.pdf not found) INN (NADOLOL) NADOLOL (HERITAGE PHARMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074368 (pdf 74368.pdf not found) INN (NADOLOL) NADOLOL (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074501 (pdf 74501.pdf not found) INN (NADOLOL) NADOLOL (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 077833 (pdf 77833.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078688 (pdf 78688.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201893 (pdf 201893.pdf not found) INN (NADOLOL) NADOLOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 203455 (pdf 203455.pdf not found) INN (NADOLOL) NADOLOL (INVAGEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207761 (pdf 207761.pdf not found) INN (NADOLOL) NADOLOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208832 (pdf 208832.pdf not found) INN (NADOLOL) NADOLOL (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 209309 (pdf 209309.pdf not found) INN (NADOLOL) NADOLOL (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 210786 (pdf 210786.pdf not found) INN (NADOLOL) NADOLOL (NOVAST LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210955 (pdf 210955.pdf not found) INN (NADOLOL) NADOLOL (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 212856 (pdf 212856.pdf not found) INN (NADOLOL) NADOLOL (RK PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211763 (pdf 211763.pdf not found) INN (NADOLOL) NADOLOL (ALEMBIC) APPROVAL= AP YEAR= 2023 , 473 ; TAMOXIFEN ; 10540-29-1 ; 1977 ; ; ; CLASS ANTINEOPLASTIC -- ESTROGEN ANTAGONIST -- BONE DENSITY CONSERVATION AGENTS -- OMPETES WITH ESTRADIOL FOR ESTROGEN RECEPTOR , ; NDA 017970 (label 17970.pdf) INN (TAMOXIFEN CITRATE) NOLVADEX (ASTRAZENECA) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 021807 (label 21807.pdf) INN (TAMOXIFEN CITRATE) SOLTAMOX (MAYNE PHARMA COMMRCL) APPROVAL= AP YEAR= 2005 , NDA 070929 (pdf 70929.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 , NDA 074504 (pdf 74504.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 074539 (pdf 74539.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (PHARMACHEMIE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 074732 (pdf 74732.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 074858 (pdf 74858.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (MAYNE PHARMA) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 075740 (pdf 75740.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075797 (pdf 75797.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2003 , NDA 076027 (pdf 76027.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (ROXANE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076179 (pdf 76179.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076398 (pdf 76398.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (AEGIS PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 090878 (pdf 90878.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 206694 (pdf 206694.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 213358 (pdf 213358.pdf not found) INN (TAMOXIFEN CITRATE) TAMOXIFEN CITRATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , 474 ; OXAMNIQUINE ; 21738-42-1 ; 1980 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTISCHISTOSOMAL -- SCHISTOSOMICIDES , ; NDA 018069 (pdf 18069.pdf not found) INN (OXAMNIQUINE) VANSIL (PFIZER) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , 475 ; CARBOPROST ; 35700-23-3 ; 1979 ; ; ; CLASS GENITO -- OXYTOCIC -- ABORTIFACIENT AGENTS, NONSTEROIDAL -- STIMULATES THE SMOOTH MUSCLE OF GASTROINTESTINAL TRACT -- ANALOG OF NATURALLY OCCURRING PROSTAGLANDIN F2ALPHA , ; NDA 017989 (label 17989.pdf) INN (CARBOPROST TROMETHAMINE) HEMABATE (PFIZER) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 211941 (pdf 211941.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 213118 (pdf 213118.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (SUNNY) APPROVAL= AP YEAR= 2021 , NDA 215337 (pdf 215337.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 214499 (pdf 214499.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216824 (pdf 216824.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (SOLA PHARMS) APPROVAL= AP YEAR= 2023 , NDA 216882 (pdf 216882.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (CAPLIN) APPROVAL= AP YEAR= 2023 , NDA 216939 (pdf 216939.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217198 (pdf 217198.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 216897 (pdf 216897.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (STERISCIENCE) APPROVAL= AP YEAR= 2023 , NDA 217657 (pdf 217657.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 215901 (pdf 215901.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (ANI PHARMS) APPROVAL= AP YEAR= 2024 , NDA 218013 (pdf 218013.pdf not found) INN (CARBOPROST TROMETHAMINE) CARBOPROST TROMETHAMINE (MICRO LABS) APPROVAL= AP YEAR= 2024 , 476 ; MECLOFENAMATE ; 644-62-2 ; 1980 ; ; ; CLASS MUSCULO-SKELETAL -- ANALGESIC -- ANTIINFLAMMATORY -- ANTIPYRETIC -- CYCLOOXYGENASE INHIBITORS -- NSAID , ; NDA 018006 (pdf 18006.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOMEN (PARKE DAVIS) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 070400 (pdf 70400.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070401 (pdf 70401.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071007 (pdf 71007.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071008 (pdf 71008.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071081 (pdf 71081.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 071362 (pdf 71362.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071363 (pdf 71363.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071380 (pdf 71380.pdf not found) INN (MECLOFENAMATE SODIUM) MECLODIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071381 (pdf 71381.pdf not found) INN (MECLOFENAMATE SODIUM) MECLODIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071468 (pdf 71468.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (ANI PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED OBSOLETE , NDA 071469 (pdf 71469.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071640 (pdf 71640.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071641 (pdf 71641.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071684 (pdf 71684.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071710 (pdf 71710.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072077 (pdf 72077.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072078 (pdf 72078.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072262 (pdf 72262.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072263 (pdf 72263.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072809 (pdf 72809.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (BARR) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072848 (pdf 72848.pdf not found) INN (MECLOFENAMATE SODIUM) MECLOFENAMATE SODIUM (BARR) APPROVAL= AP YEAR= 1989 DISCONTINUED , 477 ; TIMOLOL ; 26839-75-8 ; 1978 ; ; ; CLASS CARDIOVASCULAR -- NON-SELECTIVE BETA ADRENERGIC BLOCKER -- ANTI-ARRHYTHMIA AGENTS -- ANTIHYPERTENSIVE AGENTS -- ANTIMIGRAINE -- ANTIGLAUCOMA -- ANTIANGINAL , ; NDA 018017 (pdf 18017.pdf not found) INN (TIMOLOL MALEATE) BLOCADREN (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018061 (pdf 18061.pdf not found) INN (HYDROCHLOROTHIAZIDE TIMOLOL MALEATE) TIMOLIDE 10-25 (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018086 (label 18086.pdf) INN (TIMOLOL MALEATE) TIMOPTIC (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY , NDA 019463 (label 19463.pdf) INN (TIMOLOL MALEATE) TIMOPTIC IN OCUDOSE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 1986 , NDA 020330 (label 20330.pdf) INN (TIMOLOL MALEATE) TIMOPTIC-XE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 1993 , NDA 020439 (label 20439.pdf) INN (TIMOLOL) BETIMOL (THEA PHARMA) APPROVAL= AP YEAR= 1995 , NDA 020869 (label 20869.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) COSOPT (THEA PHARMA) APPROVAL= AP YEAR= 1998 , NDA 020963 (label 20963.pdf) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 021398 (label 21398.pdf) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) COMBIGAN (ABBVIE) APPROVAL= AP YEAR= 2007 , NDA 021516 (label 21516.pdf) INN (TIMOLOL MALEATE) ISTALOL (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2004 , NDA 072001 (pdf 72001.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072002 (pdf 72002.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072003 (pdf 72003.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072269 (pdf 72269.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072270 (pdf 72270.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072271 (pdf 72271.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072466 (pdf 72466.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072467 (pdf 72467.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072468 (pdf 72468.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072550 (pdf 72550.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072551 (pdf 72551.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072552 (pdf 72552.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072648 (pdf 72648.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072649 (pdf 72649.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072650 (pdf 72650.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072668 (pdf 72668.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (MYLAN) APPROVAL= AP YEAR= 1990 , NDA 072917 (pdf 72917.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072918 (pdf 72918.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072919 (pdf 72919.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074261 (pdf 74261.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 074262 (pdf 74262.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 074465 (pdf 74465.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074466 (pdf 74466.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074515 (pdf 74515.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074516 (pdf 74516.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074667 (pdf 74667.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (FOUGERA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074668 (pdf 74668.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (FOUGERA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074746 (pdf 74746.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (PACIFIC PHARMA) APPROVAL= AP YEAR= 1997 , NDA 074747 (pdf 74747.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (PACIFIC PHARMA) APPROVAL= AP YEAR= 1997 , NDA 074776 (pdf 74776.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1997 , NDA 074778 (pdf 74778.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1997 , NDA 075163 (pdf 75163.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075411 (label 75411.pdf) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075412 (label 75412.pdf) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077259 (pdf 77259.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (FDC LTD) APPROVAL= AP YEAR= 2008 , NDA 077847 (pdf 77847.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078201 (pdf 78201.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (RUBICON) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078704 (pdf 78704.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (TEVA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078749 (pdf 78749.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078771 (pdf 78771.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090037 (pdf 90037.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2009 , NDA 090604 (pdf 90604.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 091574 (pdf 91574.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE TIMOLOL MALEATE (ALCON) APPROVAL= TA YEAR= 2010 , NDA 091086 (pdf 91086.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (SENTISS) APPROVAL= AP YEAR= 2022 , NDA 091087 (pdf 91087.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 202667 (label 202667.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) COSOPT PF (THEA PHARMA) APPROVAL= AP YEAR= 2012 , NDA 091180 (pdf 91180.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (ZAMBON SPA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201998 (pdf 201998.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202054 (pdf 202054.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (INDOCO) APPROVAL= AP YEAR= 2014 , NDA 203058 (label 203058.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 204936 (pdf 204936.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 204912 (pdf 204912.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (AKORN INC) APPROVAL= TA YEAR= 2015 , NDA 205309 (pdf 205309.pdf not found) INN (TIMOLOL) TIMOLOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207630 (pdf 207630.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 207556 (pdf 207556.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (RISING) APPROVAL= AP YEAR= 2019 , NDA 205295 (pdf 205295.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (FDC LTD) APPROVAL= AP YEAR= 2019 , NDA 207523 (pdf 207523.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SOMERSET) APPROVAL= AP YEAR= 2019 , NDA 204777 (pdf 204777.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 212291 (pdf 212291.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212942 (pdf 212942.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 207629 (pdf 207629.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213099 (pdf 213099.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 212592 (pdf 212592.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (AMRING PHARMS) APPROVAL= AP YEAR= 2021 , NDA 091442 (pdf 91442.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 214645 (pdf 214645.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215936 (pdf 215936.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 201949 (pdf 201949.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (FLORIDA) APPROVAL= AP YEAR= 2022 , NDA 215520 (pdf 215520.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215598 (pdf 215598.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2022 , NDA 215733 (pdf 215733.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 216533 (pdf 216533.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2022 , NDA 216596 (pdf 216596.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 213540 (pdf 213540.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217195 (pdf 217195.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (SENTISS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217260 (pdf 217260.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2023 , NDA 217343 (pdf 217343.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 215230 (pdf 215230.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 214987 (pdf 214987.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 216343 (pdf 216343.pdf not found) INN (TIMOLOL MALEATE) TIMOLOL MALEATE (AMNEAL) APPROVAL= AP YEAR= 2024 , 478 ; AMOXAPINE ; 14028-44-5 ; 1980 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- BLOCKS THE REUPTAKE OF NOREPINEPHRINE AND TO A LESSER EXTENT SEROTONIN INTO THEIR RESPECTIVE NEURONS -- BLOCKS THE RESPONSE OF DOPAMINERGIC RECEPTORS TO DOPAMINE -- ACTS ON MULTIPLE RECEPTORS AND CHANNELS (PMID24294487) , ; NDA 018021 (pdf 18021.pdf not found) INN (AMOXAPINE) ASENDIN (LEDERLE) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 072418 (pdf 72418.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072419 (pdf 72419.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072420 (pdf 72420.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072421 (pdf 72421.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072688 (pdf 72688.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON LABS) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 072689 (pdf 72689.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON LABS) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 072690 (pdf 72690.pdf not found) INN (AMOXAPINE) AMOXAPINE (WATSON LABS) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 072691 (label 72691.pdf) INN (AMOXAPINE) AMOXAPINE (WATSON LABS) APPROVAL= AP YEAR= 1992 , NDA 072878 (pdf 72878.pdf not found) INN (AMOXAPINE) AMOXAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072879 (pdf 72879.pdf not found) INN (AMOXAPINE) AMOXAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072943 (pdf 72943.pdf not found) INN (AMOXAPINE) AMOXAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072944 (pdf 72944.pdf not found) INN (AMOXAPINE) AMOXAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , 479 ; NALBUPHINE ; 20594-83-6 ; 1979 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTIC -- ANALGESIC -- KAPPA OPIOID RECEPTOR AGONIST -- PARTIAL MU OPIOID RECEPTOR ANTAGONIST , ; NDA 018024 (label 18024.pdf) INN (NALBUPHINE HYDROCHLORIDE) NUBAIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 020200 (pdf 20200.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (ABBVIE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 070692 (pdf 70692.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070693 (pdf 70693.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070751 (pdf 70751.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070752 (pdf 70752.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070914 (pdf 70914.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 , NDA 070915 (pdf 70915.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 , NDA 070916 (pdf 70916.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 , NDA 070917 (pdf 70917.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (ABBOTT) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070918 (pdf 70918.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1989 , NDA 072070 (pdf 72070.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072071 (pdf 72071.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072072 (pdf 72072.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072073 (pdf 72073.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072074 (pdf 72074.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072075 (pdf 72075.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074471 (pdf 74471.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 206506 (pdf 206506.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207595 (pdf 207595.pdf not found) INN (NALBUPHINE HYDROCHLORIDE) NALBUPHINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , 480 ; CALCITRIOL ; 32222-06-3 ; 1978 ; ; ; CLASS METABOLISM -- ANTIHYPOCALCEMIC AGENTS -- BONE DENSITY CONSERVATION AGENTS -- VITAMINS (VITAMIN D) , ; NDA 018044 (pdf 18044.pdf not found) INN (CALCITRIOL) ROCALTROL (SS PHARMA) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY , NDA 018874 (label 18874.pdf) INN (CALCITRIOL) CALCIJEX (ABBVIE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 021068 (label 21068.pdf) INN (CALCITRIOL) ROCALTROL (SS PHARMA) APPROVAL= AP YEAR= 1998 , NDA 075746 (pdf 75746.pdf not found) INN (CALCITRIOL) CALCITRIOL (AM REGENT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075765 (pdf 75765.pdf not found) INN (CALCITRIOL) CALCITRIOL (TEVA) APPROVAL= AP YEAR= 2001 , NDA 075766 (pdf 75766.pdf not found) INN (CALCITRIOL) CALCITRIOL (FRESENIUS MEDCL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075816 (pdf 75816.pdf not found) INN (CALCITRIOL) CALCITRIOL (HOSPIRA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075823 (pdf 75823.pdf not found) INN (CALCITRIOL) CALCITRIOL (TEVA PARENTERAL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075836 (pdf 75836.pdf not found) INN (CALCITRIOL) CALCITRIOL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076206 (pdf 76206.pdf not found) INN (CALCITRIOL) CALCITRIOL (ROCKWELL MEDCL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076242 (pdf 76242.pdf not found) INN (CALCITRIOL) CALCITRIOL (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076917 (pdf 76917.pdf not found) INN (CALCITRIOL) CALCITRIOL (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077102 (pdf 77102.pdf not found) INN (CALCITRIOL) CALCITRIOL (SAGENT PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078066 (pdf 78066.pdf not found) INN (CALCITRIOL) CALCITRIOL (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2008 , NDA 022087 (label 22087.pdf) INN (CALCITRIOL) VECTICAL (GALDERMA LABS LP) APPROVAL= AP YEAR= 2009 , NDA 091174 (pdf 91174.pdf not found) INN (CALCITRIOL) CALCITRIOL (BIONPHARMA) APPROVAL= AP YEAR= 2013 , NDA 091356 (pdf 91356.pdf not found) INN (CALCITRIOL) CALCITRIOL (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 203289 (pdf 203289.pdf not found) INN (CALCITRIOL) CALCITRIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209798 (pdf 209798.pdf not found) INN (CALCITRIOL) CALCITRIOL (RISING) APPROVAL= AP YEAR= 2018 , NDA 204556 (pdf 204556.pdf not found) INN (CALCITRIOL) CALCITRIOL (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 211030 (pdf 211030.pdf not found) INN (CALCITRIOL) CALCITRIOL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 203973 (pdf 203973.pdf not found) INN (CALCITRIOL) CALCITRIOL (PATRIN) APPROVAL= AP YEAR= 2023 , 481 ; GUANADREL ; 40580-59-4 ; 1982 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC NEURON BLOCKER , ; NDA 018104 (pdf 18104.pdf not found) INN (GUANADREL SULFATE) HYLOREL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , 482 ; NADOLOL ; 42200-33-9 ; 1979 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIARRHYTHMIC -- ANTIANGINAL -- ADRENERGIC (BETA) BLOCKER -- SYMPATHOLYTICS -- BETA-2 ADRENERGIC RECEPTOR INVERSE AGONIST , ; NDA 018063 (label 18063.pdf) INN (NADOLOL) CORGARD (USWM) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY , NDA 018647 (label 18647.pdf) INN (BENDROFLUMETHIAZIDE NADOLOL) CORZIDE (KING PHARMS LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 074172 (pdf 74172.pdf not found) INN (NADOLOL) NADOLOL (RISING) APPROVAL= AP YEAR= 1993 , NDA 074229 (pdf 74229.pdf not found) INN (NADOLOL) NADOLOL (HERITAGE PHARMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074255 (pdf 74255.pdf not found) INN (NADOLOL) NADOLOL (HERITAGE PHARMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074368 (pdf 74368.pdf not found) INN (NADOLOL) NADOLOL (TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074501 (pdf 74501.pdf not found) INN (NADOLOL) NADOLOL (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 077833 (pdf 77833.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078688 (pdf 78688.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201893 (pdf 201893.pdf not found) INN (NADOLOL) NADOLOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 203455 (pdf 203455.pdf not found) INN (NADOLOL) NADOLOL (INVAGEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207761 (pdf 207761.pdf not found) INN (NADOLOL) NADOLOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208832 (pdf 208832.pdf not found) INN (NADOLOL) NADOLOL (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 209309 (pdf 209309.pdf not found) INN (NADOLOL) NADOLOL (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 210786 (pdf 210786.pdf not found) INN (NADOLOL) NADOLOL (NOVAST LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210955 (pdf 210955.pdf not found) INN (NADOLOL) NADOLOL (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 212856 (pdf 212856.pdf not found) INN (NADOLOL) NADOLOL (RK PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211763 (pdf 211763.pdf not found) INN (NADOLOL) NADOLOL (ALEMBIC) APPROVAL= AP YEAR= 2023 , 483 ; CINOXACIN ; 28657-80-9 ; 1980 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 018067 (label 18067.pdf) INN (CINOXACIN) CINOBAC (LILLY) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 073005 (pdf 73005.pdf not found) INN (CINOXACIN) CINOXACIN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073006 (pdf 73006.pdf not found) INN (CINOXACIN) CINOXACIN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , 484 ; OXAMNIQUINE ; 21738-42-1 ; 1980 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTISCHISTOSOMAL -- SCHISTOSOMICIDES , ; NDA 018069 (pdf 18069.pdf not found) INN (OXAMNIQUINE) VANSIL (PFIZER) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , 485 ; VALPROIC ACID ; 99-66-1 ; 1978 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIMANIC AGENTS -- INCREASE GAMMA-AMINO-BUTYRIC ACID (GABA)ERGIC TRANSMISSION , ; NDA 018081 (label 18081.pdf) INN (VALPROIC ACID) DEPAKENE (ABBVIE) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 018082 (label 18082.pdf) INN (VALPROIC ACID) DEPAKENE (ABBVIE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 022152 (label 22152.pdf) INN (VALPROIC ACID) STAVZOR (BIONPHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 070195 (pdf 70195.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (SCHERER RP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070431 (pdf 70431.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070631 (pdf 70631.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070868 (pdf 70868.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 073178 (pdf 73178.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (ANI PHARMS) APPROVAL= AP YEAR= 1992 , NDA 073229 (pdf 73229.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (CATALENT) APPROVAL= AP YEAR= 1991 , NDA 073484 (pdf 73484.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (BIONPHARMA) APPROVAL= AP YEAR= 1993 , NDA 074060 (pdf 74060.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075379 (pdf 75379.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (PHARM ASSOC) APPROVAL= AP YEAR= 2000 , NDA 075782 (pdf 75782.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2000 , NDA 077105 (pdf 77105.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077960 (pdf 77960.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (LANNETT CO INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 018723 (label 18723.pdf) INN (DIVALPROEX SODIUM) DEPAKOTE (ABBVIE) APPROVAL= AP YEAR= 1983 , NDA 019680 (label 19680.pdf) INN (DIVALPROEX SODIUM) DEPAKOTE (ABBVIE) APPROVAL= AP YEAR= 1989 , NDA 019794 (pdf 19794.pdf not found) INN (DIVALPROEX SODIUM) DEPAKOTE CP (ABBOTT) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020782 (label 20782.pdf) INN (DIVALPROEX SODIUM) DEPAKOTE ER (ABBOTT) APPROVAL= AP YEAR= 2002 , NDA 021168 (label 21168.pdf) INN (DIVALPROEX SODIUM) DEPAKOTE ER (ABBVIE) APPROVAL= AP YEAR= 2000 , NDA 022267 (label 22267.pdf) INN (DIVALPROEX SODIUM) DEPAKOTE ER (ABBVIE INC) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 075112 (pdf 75112.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX (APOTEX INC) APPROVAL= TA YEAR= 2001 OBSOLETE , NDA 076941 (label 76941.pdf) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (TEVA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077100 (pdf 77100.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 077143 (pdf 77143.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX (RANBAXY) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 077254 (pdf 77254.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (MYLAN) APPROVAL= TA YEAR= 2006 , NDA 077296 (pdf 77296.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 077567 (label 77567.pdf) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 077615 (pdf 77615.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (APOTEX) APPROVAL= AP YEAR= 2008 , NDA 078182 (pdf 78182.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2008 , NDA 078239 (pdf 78239.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 078290 (pdf 78290.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (INVATECH) APPROVAL= AP YEAR= 2008 , NDA 078597 (pdf 78597.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 , NDA 078755 (pdf 78755.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078790 (pdf 78790.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (LUPIN) APPROVAL= AP YEAR= 2008 , NDA 020593 (label 20593.pdf) INN (VALPROATE SODIUM) DEPACON (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 076295 (pdf 76295.pdf not found) INN (VALPROATE SODIUM) VALPROATE SODIUM (SAGENT) APPROVAL= AP YEAR= 2002 , NDA 076539 (pdf 76539.pdf not found) INN (VALPROATE SODIUM) VALPROATE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2003 , NDA 078411 (pdf 78411.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078445 (pdf 78445.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078700 (pdf 78700.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (COSETTE) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078705 (pdf 78705.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (WOCKHARDT) APPROVAL= AP YEAR= 2009 , NDA 078791 (pdf 78791.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (IMPAX LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078853 (pdf 78853.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ORBION PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078919 (pdf 78919.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 078979 (pdf 78979.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090062 (pdf 90062.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090210 (pdf 90210.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (PRINSTON INC) APPROVAL= AP YEAR= 2009 , NDA 078523 (pdf 78523.pdf not found) INN (VALPROATE SODIUM) VALPROATE SODIUM (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 090517 (pdf 90517.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (QUAGEN) APPROVAL= AP YEAR= 2010 , NDA 079080 (pdf 79080.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079163 (pdf 79163.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (UNICHEM LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090407 (pdf 90407.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (RISING) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090554 (pdf 90554.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091037 (pdf 91037.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090070 (pdf 90070.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (REDDYS) APPROVAL= AP YEAR= 2012 , NDA 090161 (pdf 90161.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202419 (pdf 202419.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 203730 (pdf 203730.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207611 (pdf 207611.pdf not found) INN (VALPROIC ACID) VALPROIC ACID (EYWA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209286 (pdf 209286.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 213181 (pdf 213181.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211505 (pdf 211505.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214462 (pdf 214462.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (AMTA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214643 (pdf 214643.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (UNICHEM) APPROVAL= AP YEAR= 2022 , NDA 208120 (pdf 208120.pdf not found) INN (VALPROATE SODIUM) VALPROATE SODIUM (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215527 (pdf 215527.pdf not found) INN (DIVALPROEX SODIUM) DIVALPROEX SODIUM (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , 486 ; GUANADREL ; 40580-59-4 ; 1982 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC NEURON BLOCKER , ; NDA 018104 (pdf 18104.pdf not found) INN (GUANADREL SULFATE) HYLOREL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , 487 ; AMCINONIDE ; 51022-69-6 ; 1979 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- CORTICOSTEROIDS, TOPICAL -- ANTI-INFLAMMATORY -- ANTIPRURITIC , ; NDA 018116 (pdf 18116.pdf not found) INN (AMCINONIDE) CYCLOCORT (ASTELLAS) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 018498 (label 18498.pdf) INN (AMCINONIDE) CYCLOCORT (ASTELLAS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019729 (pdf 19729.pdf not found) INN (AMCINONIDE) CYCLOCORT (ASTELLAS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 076065 (pdf 76065.pdf not found) INN (AMCINONIDE) AMCINONIDE (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2003 , NDA 076096 (pdf 76096.pdf not found) INN (AMCINONIDE) AMCINONIDE (GENUS) APPROVAL= AP YEAR= 2002 , NDA 076229 (pdf 76229.pdf not found) INN (AMCINONIDE) AMCINONIDE (TARO PHARM INDS) APPROVAL= AP YEAR= 2002 , NDA 076329 (pdf 76329.pdf not found) INN (AMCINONIDE) AMCINONIDE (GENUS) APPROVAL= AP YEAR= 2002 , NDA 076367 (pdf 76367.pdf not found) INN (AMCINONIDE) AMCINONIDE (TARO PHARM INDS) APPROVAL= AP YEAR= 2003 , 488 ; PIROXICAM ; 36322-90-4 ; 1982 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITORS -- NSAID , ; NDA 018147 (label 18147.pdf) INN (PIROXICAM) FELDENE (PFIZER) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 073535 (pdf 73535.pdf not found) INN (PIROXICAM) PIROXICAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073536 (pdf 73536.pdf not found) INN (PIROXICAM) PIROXICAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073637 (pdf 73637.pdf not found) INN (PIROXICAM) PIROXICAM (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073638 (pdf 73638.pdf not found) INN (PIROXICAM) PIROXICAM (TEVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073651 (pdf 73651.pdf not found) INN (PIROXICAM) PIROXICAM (CYCLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074036 (pdf 74036.pdf not found) INN (PIROXICAM) PIROXICAM (SCS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074043 (pdf 74043.pdf not found) INN (PIROXICAM) PIROXICAM (MYLAN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074102 (pdf 74102.pdf not found) INN (PIROXICAM) PIROXICAM (MYLAN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074103 (pdf 74103.pdf not found) INN (PIROXICAM) PIROXICAM (TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074116 (pdf 74116.pdf not found) INN (PIROXICAM) PIROXICAM (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 074118 (pdf 74118.pdf not found) INN (PIROXICAM) PIROXICAM (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1993 , NDA 074131 (pdf 74131.pdf not found) INN (PIROXICAM) PIROXICAM (TEVA) APPROVAL= AP YEAR= 1992 , NDA 074148 (pdf 74148.pdf not found) INN (PIROXICAM) PIROXICAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074287 (pdf 74287.pdf not found) INN (PIROXICAM) PIROXICAM (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074460 (pdf 74460.pdf not found) INN (PIROXICAM) PIROXICAM (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074808 (pdf 74808.pdf not found) INN (PIROXICAM) PIROXICAM (EGIS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 207938 (pdf 207938.pdf not found) INN (PIROXICAM) PIROXICAM (FLAMINGO PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206136 (pdf 206136.pdf not found) INN (PIROXICAM) PIROXICAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208340 (pdf 208340.pdf not found) INN (PIROXICAM) PIROXICAM (UNICHEM) APPROVAL= AP YEAR= 2017 , NDA 209256 (pdf 209256.pdf not found) INN (PIROXICAM) PIROXICAM (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206152 (pdf 206152.pdf not found) INN (PIROXICAM) PIROXICAM (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 208991 (pdf 208991.pdf not found) INN (PIROXICAM) PIROXICAM (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210347 (pdf 210347.pdf not found) INN (PIROXICAM) PIROXICAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 205585 (pdf 205585.pdf not found) INN (PIROXICAM) PIROXICAM (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , 489 ; FLUNISOLIDE ; 3385-03-3 ; 1981 ; ; ; CLASS RESPIRATORY SYSTEM -- GLUCOCORTICOID -- ANTI-ASTHMATIC AGENTS -- ANTI-INFLAMMATORY , ; NDA 018148 (pdf 18148.pdf not found) INN (FLUNISOLIDE) NASALIDE (IVAX RES) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 018340 (pdf 18340.pdf not found) INN (FLUNISOLIDE) AEROBID (ROCHE PALO) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 020409 (pdf 20409.pdf not found) INN (FLUNISOLIDE) NASAREL (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 021247 (label 21247.pdf) INN (FLUNISOLIDE) AEROSPAN HFA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 074805 (pdf 74805.pdf not found) INN (FLUNISOLIDE) FLUNISOLIDE (BAUSCH) APPROVAL= AP YEAR= 2002 , NDA 077436 (pdf 77436.pdf not found) INN (FLUNISOLIDE) FLUNISOLIDE (APOTEX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077704 (pdf 77704.pdf not found) INN (FLUNISOLIDE) FLUNISOLIDE (RISING) APPROVAL= AP YEAR= 2006 , NDA 207802 (label 207802.pdf) INN (FLUNISOLIDE) FLUNISOLIDE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2022 , 490 ; MINOXIDIL ; 38304-91-5 ; 1979 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIALOPECIA -- VASODILATOR AGENTS , ; NDA 018154 (label 18154.pdf) INN (MINOXIDIL) LONITEN (PFIZER) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 019501 (label 19501.pdf) INN (MINOXIDIL) ROGAINE FOR MEN (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1988 , NDA 020834 (label 20834.pdf) INN (MINOXIDIL) ROGAINE EXTRA STRENGTH FOR MEN (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1997 , NDA 021812 (label 21812.pdf) INN (MINOXIDIL) MEN'S ROGAINE (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 2006 , NDA 071344 (pdf 71344.pdf not found) INN (MINOXIDIL) MINOXIDIL (WATSON LABS) APPROVAL= AP YEAR= 1987 , NDA 071345 (pdf 71345.pdf not found) INN (MINOXIDIL) MINOXIDIL (WATSON LABS) APPROVAL= AP YEAR= 1987 , NDA 071534 (pdf 71534.pdf not found) INN (MINOXIDIL) MINODYL (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071537 (pdf 71537.pdf not found) INN (MINOXIDIL) MINOXIDIL (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071796 (pdf 71796.pdf not found) INN (MINOXIDIL) MINOXIDIL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071799 (pdf 71799.pdf not found) INN (MINOXIDIL) MINOXIDIL (ROYCE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071826 (pdf 71826.pdf not found) INN (MINOXIDIL) MINOXIDIL (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 , NDA 071839 (pdf 71839.pdf not found) INN (MINOXIDIL) MINOXIDIL (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 , NDA 072153 (pdf 72153.pdf not found) INN (MINOXIDIL) MINODYL (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072708 (pdf 72708.pdf not found) INN (MINOXIDIL) MINOXIDIL (MUTUAL PHARM) APPROVAL= AP YEAR= 1995 OBSOLETE , NDA 072709 (pdf 72709.pdf not found) INN (MINOXIDIL) MINOXIDIL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1995 , NDA 074500 (pdf 74500.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (COPLEY PHARM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074588 (pdf 74588.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (P AND L) APPROVAL= AP YEAR= 1996 , NDA 074589 (pdf 74589.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074643 (pdf 74643.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074731 (pdf 74731.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (HIKMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074743 (pdf 74743.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR WOMEN (SIGHT PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074767 (pdf 74767.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1997 , NDA 074924 (pdf 74924.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (APOTEX INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075357 (pdf 75357.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (L PERRIGO CO) APPROVAL= AP YEAR= 1999 , NDA 075438 (pdf 75438.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2003 , NDA 075518 (pdf 75518.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (P AND L) APPROVAL= AP YEAR= 2000 , NDA 075598 (pdf 75598.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (PERRIGO) APPROVAL= AP YEAR= 2001 , NDA 075619 (pdf 75619.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (AVACOR PRODS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075737 (pdf 75737.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (PERRIGO NEW YORK) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075839 (pdf 75839.pdf not found) INN (MINOXIDIL) MINOXIDIL EXTRA STRENGTH FOR MEN (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076239 (pdf 76239.pdf not found) INN (MINOXIDIL) THEROXIDIL (PURE SOURCE) APPROVAL= AP YEAR= 2004 , NDA 078176 (pdf 78176.pdf not found) INN (MINOXIDIL) THEROXIDIL (PURE SOURCE) APPROVAL= AP YEAR= 2007 , NDA 091344 (pdf 91344.pdf not found) INN (MINOXIDIL) MINOXIDIL (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2011 , NDA 208092 (pdf 208092.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (P AND L) APPROVAL= AP YEAR= 2017 , NDA 209074 (pdf 209074.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (TARO) APPROVAL= AP YEAR= 2018 , NDA 218616 (pdf 218616.pdf not found) INN (MINOXIDIL) MINOXIDIL FOR MEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , 491 ; TEMAZEPAM ; 846-50-4 ; 1981 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS AND SEDATIVES -- BENZODIAZEPINES -- GABA MODULATORS -- ALLOSTERIC POSITIVE , ; NDA 018163 (label 18163.pdf) INN (TEMAZEPAM) RESTORIL (SPECGX LLC) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 070383 (pdf 70383.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070384 (pdf 70384.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070489 (pdf 70489.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070490 (pdf 70490.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070547 (pdf 70547.pdf not found) INN (TEMAZEPAM) TEMAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070564 (pdf 70564.pdf not found) INN (TEMAZEPAM) TEMAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070920 (pdf 70920.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071174 (pdf 71174.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071175 (pdf 71175.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071427 (pdf 71427.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071428 (pdf 71428.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071446 (pdf 71446.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071447 (pdf 71447.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071456 (pdf 71456.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (NOVEL LABS INC) APPROVAL= AP YEAR= 1987 , NDA 071457 (pdf 71457.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (NOVEL LABS INC) APPROVAL= AP YEAR= 1987 , NDA 071620 (pdf 71620.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 , NDA 071638 (pdf 71638.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071708 (pdf 71708.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071709 (pdf 71709.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 078581 (pdf 78581.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2009 , NDA 201781 (pdf 201781.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 203482 (pdf 203482.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 211542 (pdf 211542.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 217875 (pdf 217875.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , 492 ; OXPRENOLOL ; 6452-71-7 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- CORONARY VASODILATOR -- ADRENERGIC BETA ANTAGONISTS -- ANTI-ARRHYTHMIA AGENTS -- ANTI-ANXIETY AGENTS -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS , ; NDA 018166 (pdf 18166.pdf not found) INN (OXPRENOLOL HYDROCHLORIDE) TRASICOR (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 493 ; AMILORIDE ; 2609-46-3 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- POTASSIUM CONSERVING AGENT -- SODIUM CHANNEL BLOCKERS -- CYSTIC FIBROSIS , ; NDA 018200 (label 18200.pdf) INN (AMILORIDE HYDROCHLORIDE) MIDAMOR (PADAGIS US) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 018201 (label 18201.pdf) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) MODURETIC 5-50 (MERCK) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 070346 (pdf 70346.pdf not found) INN (AMILORIDE HYDROCHLORIDE) AMILORIDE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 , NDA 070347 (pdf 70347.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) HYDRO-RIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070795 (pdf 70795.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071111 (pdf 71111.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BARR) APPROVAL= AP YEAR= 1988 , NDA 073209 (pdf 73209.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1991 , NDA 073334 (pdf 73334.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073357 (pdf 73357.pdf not found) INN (AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE) AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 079133 (pdf 79133.pdf not found) INN (AMILORIDE HYDROCHLORIDE) AMILORIDE HYDROCHLORIDE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2009 , NDA 204180 (pdf 204180.pdf not found) INN (AMILORIDE HYDROCHLORIDE) AMILORIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , 494 ; AMINOGLUTETHIMIDE ; 125-84-8 ; 1980 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- AROMATASE INHIBITORS -- INHIBITOR OF ADRENOCORTICAL STEROID SYNTHESIS -- ANTICONVULSANT (WITHDRAWN) -- SUPPRESSION OF ADRENAL FUNCTION IN SELECTED PATIENTS WITH CUSHING’S SYNDROME , ; NDA 018202 (label 18202.pdf) INN (AMINOGLUTETHIMIDE) CYTADREN (NOVARTIS) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , 495 ; TRAZODONE ; 19794-93-5 ; 1981 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- TRIAZOLOPYRIDINE -- INHIBITS NEURONAL REUPTAKE OF SEROTONIN -- 5-HYDROXYTRYPTAMINE 2A/2C RECEPTOR ANTAGONIST -- ALPHA 1-ADRENERGIC RECEPTOR ANTAGONIST , ; NDA 018207 (label 18207.pdf) INN (TRAZODONE HYDROCHLORIDE) DESYREL (PRAGMA) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 070491 (pdf 70491.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070492 (pdf 70492.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070857 (pdf 70857.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070858 (pdf 70858.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070921 (pdf 70921.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070942 (pdf 70942.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRIALODINE (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071112 (pdf 71112.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071113 (pdf 71113.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071139 (pdf 71139.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071140 (pdf 71140.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071196 (label 71196.pdf) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 1987 , NDA 071258 (pdf 71258.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 1987 , NDA 071405 (pdf 71405.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071406 (pdf 71406.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071514 (pdf 71514.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071523 (pdf 71523.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1987 , NDA 071524 (pdf 71524.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1987 , NDA 071525 (pdf 71525.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1988 , NDA 071636 (pdf 71636.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072192 (pdf 72192.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 1989 , NDA 072193 (pdf 72193.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 1989 , NDA 072483 (pdf 72483.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072484 (pdf 72484.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 073137 (pdf 73137.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 , NDA 074357 (pdf 74357.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 022411 (label 22411.pdf) INN (TRAZODONE HYDROCHLORIDE) OLEPTRO (ANGELINI PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090514 (pdf 90514.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 202180 (pdf 202180.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2013 , NDA 205253 (pdf 205253.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206923 (pdf 206923.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 204852 (pdf 204852.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2020 , NDA 211116 (pdf 211116.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2024 , NDA 217740 (pdf 217740.pdf not found) INN (TRAZODONE HYDROCHLORIDE) TRAZODONE HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= TA YEAR= 2024 , 496 ; BUMETANIDE ; 28395-03-1 ; 1983 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- NA(+)-K(+)-2CL(-) COTRANSPORTER ISOFORM 1 INHIBITOR (PMID23788048) , ; NDA 018225 (label 18225.pdf) INN (BUMETANIDE) BUMEX (VALIDUS PHARMS) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY , NDA 018226 (label 18226.pdf) INN (BUMETANIDE) BUMEX (VALIDUS PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 074160 (pdf 74160.pdf not found) INN (BUMETANIDE) BUMETANIDE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074225 (pdf 74225.pdf not found) INN (BUMETANIDE) BUMETANIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1995 , NDA 074332 (pdf 74332.pdf not found) INN (BUMETANIDE) BUMETANIDE (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074441 (pdf 74441.pdf not found) INN (BUMETANIDE) BUMETANIDE (SAGENT) APPROVAL= AP YEAR= 1995 , NDA 074613 (pdf 74613.pdf not found) INN (BUMETANIDE) BUMETANIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074700 (pdf 74700.pdf not found) INN (BUMETANIDE) BUMETANIDE (SANDOZ) APPROVAL= AP YEAR= 1996 , NDA 079196 (pdf 79196.pdf not found) INN (BUMETANIDE) BUMETANIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 , NDA 209724 (pdf 209724.pdf not found) INN (BUMETANIDE) BUMETANIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 202900 (pdf 202900.pdf not found) INN (BUMETANIDE) BUMETANIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209916 (pdf 209916.pdf not found) INN (BUMETANIDE) BUMETANIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 , NDA 212019 (pdf 212019.pdf not found) INN (BUMETANIDE) BUMETANIDE (RISING) APPROVAL= AP YEAR= 2019 , NDA 216434 (pdf 216434.pdf not found) INN (BUMETANIDE) BUMETANIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215364 (pdf 215364.pdf not found) INN (BUMETANIDE) BUMETANIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 213458 (pdf 213458.pdf not found) INN (BUMETANIDE) BUMETANIDE (TARO) APPROVAL= AP YEAR= 2023 , 497 ; ETOMIDATE ; 33125-97-2 ; 1982 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- SEDATIVES , ; NDA 018227 (label 18227.pdf) INN (ETOMIDATE) AMIDATE (HOSPIRA) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 074593 (pdf 74593.pdf not found) INN (ETOMIDATE) ETOMIDATE (HIKMA) APPROVAL= AP YEAR= 1996 , NDA 078289 (pdf 78289.pdf not found) INN (ETOMIDATE) ETOMIDATE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078867 (pdf 78867.pdf not found) INN (ETOMIDATE) ETOMIDATE (LUITPOLD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091297 (pdf 91297.pdf not found) INN (ETOMIDATE) ETOMIDATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202360 (pdf 202360.pdf not found) INN (ETOMIDATE) ETOMIDATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204618 (pdf 204618.pdf not found) INN (ETOMIDATE) ETOMIDATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202354 (pdf 202354.pdf not found) INN (ETOMIDATE) ETOMIDATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 201044 (pdf 201044.pdf not found) INN (ETOMIDATE) ETOMIDATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 206126 (pdf 206126.pdf not found) INN (ETOMIDATE) ETOMIDATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209058 (pdf 209058.pdf not found) INN (ETOMIDATE) ETOMIDATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 215028 (pdf 215028.pdf not found) INN (ETOMIDATE) ETOMIDATE (CAPLIN) APPROVAL= AP YEAR= 2020 , 498 ; DIPIVEFRIN ; 52365-63-6 ; 1980 ; DISCONTINUED ; ; CLASS SENSORY -- ADRENERGIC AGONISTS -- SYMPATHOMIMETICS -- CONTROL OF INTRAOCULAR PRESSURE IN CHRONIC OPEN-ANGLE GLAUCOMA , ; NDA 018239 (label 18239.pdf) INN (DIPIVEFRIN HYDROCHLORIDE) PROPINE (ALLERGAN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 073636 (pdf 73636.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) DIPIVEFRIN HYDROCHLORIDE (FALCON PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074188 (pdf 74188.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) DIPIVEFRIN HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074382 (pdf 74382.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) AKPRO (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1995 DISCONTINUED , 499 ; ATENOLOL ; 29122-68-7 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- ANTIHYPERTENSIVE -- ADRENERGIC (BETA-1) BLOCKER , ; NDA 018240 (label 18240.pdf) INN (ATENOLOL) TENORMIN (TWI PHARMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 018760 (label 18760.pdf) INN (ATENOLOL CHLORTHALIDONE) TENORETIC 100 (ALMATICA) APPROVAL= AP YEAR= 1984 , NDA 019058 (pdf 19058.pdf not found) INN (ATENOLOL) TENORMIN (ASTRAZENECA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072301 (pdf 72301.pdf not found) INN (ATENOLOL) ATENOLOL AND CHLORTHALIDONE (ALVOGEN MALTA) APPROVAL= AP YEAR= 1990 OBSOLETE , NDA 072302 (pdf 72302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ALVOGEN) APPROVAL= AP YEAR= 1990 , NDA 072303 (pdf 72303.pdf not found) INN (ATENOLOL) ATENOLOL (ALVOGEN MALTA) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072304 (pdf 72304.pdf not found) INN (ATENOLOL) ATENOLOL (TWI PHARMS) APPROVAL= AP YEAR= 1988 , NDA 073025 (pdf 73025.pdf not found) INN (ATENOLOL) ATENOLOL (SANDOZ) APPROVAL= AP YEAR= 1991 OBSOLETE , NDA 073026 (pdf 73026.pdf not found) INN (ATENOLOL) ATENOLOL (HLTHCARE) APPROVAL= AP YEAR= 1991 , NDA 073315 (pdf 73315.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073316 (pdf 73316.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073317 (pdf 73317.pdf not found) INN (ATENOLOL) ATENOLOL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073318 (pdf 73318.pdf not found) INN (ATENOLOL) ATENOLOL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073352 (pdf 73352.pdf not found) INN (ATENOLOL) ATENOLOL (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073353 (pdf 73353.pdf not found) INN (ATENOLOL) ATENOLOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073456 (pdf 73456.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073457 (pdf 73457.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1992 , NDA 073475 (pdf 73475.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073476 (pdf 73476.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073542 (pdf 73542.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073543 (pdf 73543.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073581 (pdf 73581.pdf not found) INN (ATENOLOL) ATENOLOL AND CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073582 (pdf 73582.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073646 (pdf 73646.pdf not found) INN (ATENOLOL) ATENOLOL (ALVOGEN MALTA) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073665 (pdf 73665.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1992 , NDA 073676 (pdf 73676.pdf not found) INN (ATENOLOL) ATENOLOL (SCS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074052 (pdf 74052.pdf not found) INN (ATENOLOL) ATENOLOL (SANDOZ) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 074056 (pdf 74056.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074099 (pdf 74099.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074101 (pdf 74101.pdf not found) INN (ATENOLOL) ATENOLOL (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074107 (pdf 74107.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074120 (pdf 74120.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074126 (pdf 74126.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074127 (pdf 74127.pdf not found) INN (ATENOLOL) ATENOLOL (NOSTRUM LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074203 (pdf 74203.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074265 (pdf 74265.pdf not found) INN (ATENOLOL) ATENOLOL (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074404 (pdf 74404.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOSTRUM LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074499 (pdf 74499.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 076900 (pdf 76900.pdf not found) INN (ATENOLOL) ATENOLOL (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 076907 (pdf 76907.pdf not found) INN (ATENOLOL) ATENOLOL (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077443 (pdf 77443.pdf not found) INN (ATENOLOL) ATENOLOL (UNIQUE) APPROVAL= AP YEAR= 2006 , NDA 077877 (pdf 77877.pdf not found) INN (ATENOLOL) ATENOLOL (IPCA LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 078210 (pdf 78210.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078512 (pdf 78512.pdf not found) INN (ATENOLOL) ATENOLOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078254 (pdf 78254.pdf not found) INN (ATENOLOL) ATENOLOL (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 210028 (pdf 210028.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 213136 (pdf 213136.pdf not found) INN (ATENOLOL) ATENOLOL (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 213302 (pdf 213302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 215560 (pdf 215560.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , 500 ; TOCAINIDE ; 41708-72-9 ; 1984 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTI-ARRHYTHMIA AGENTS -- SODIUM CHANNEL BLOCKERS , ; NDA 018257 (pdf 18257.pdf not found) INN (TOCAINIDE HYDROCHLORIDE) TONOCARD (ASTRAZENECA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , 501 ; ALPRAZOLAM ; 28981-97-7 ; 1981 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTI-ANXIETY AGENTS -- BENZODIAZEPINES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 018276 (label 18276.pdf) INN (ALPRAZOLAM) XANAX (UPJOHN) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 021434 (label 21434.pdf) INN (ALPRAZOLAM) XANAX XR (UPJOHN) APPROVAL= AP YEAR= 2003 , NDA 021726 (label 21726.pdf) INN (ALPRAZOLAM) NIRAVAM (UCB INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 074046 (pdf 74046.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074085 (pdf 74085.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ANI PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074112 (pdf 74112.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 074174 (pdf 74174.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1993 , NDA 074199 (pdf 74199.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ROXANE) APPROVAL= TA YEAR= 1993 , NDA 074215 (pdf 74215.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074294 (pdf 74294.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074312 (pdf 74312.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 074314 (pdf 74314.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ROXANE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074342 (pdf 74342.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1993 , NDA 074456 (pdf 74456.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074479 (pdf 74479.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074909 (pdf 74909.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 077391 (pdf 77391.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077725 (pdf 77725.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ANI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077741 (pdf 77741.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 077777 (pdf 77777.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (SANDOZ INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077968 (pdf 77968.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (IMPAX LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077979 (pdf 77979.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ANI PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077996 (pdf 77996.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (IMPAX LABS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078056 (pdf 78056.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2007 , NDA 078088 (pdf 78088.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 , NDA 078387 (pdf 78387.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 078442 (pdf 78442.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078449 (pdf 78449.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 078489 (pdf 78489.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078491 (pdf 78491.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (OXFORD PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078561 (pdf 78561.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2010 , NDA 077198 (pdf 77198.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090082 (pdf 90082.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 090248 (pdf 90248.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090871 (pdf 90871.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2011 , NDA 078469 (pdf 78469.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200739 (pdf 200739.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (NATCO) APPROVAL= AP YEAR= 2015 , NDA 203346 (pdf 203346.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 207507 (pdf 207507.pdf not found) INN (ALPRAZOLAM) ALPRAZOLAM (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , 502 ; PINDOLOL ; 13523-86-9 ; 1982 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE AGENTS -- NON SELECTIVE BETA ADRENERGIC RECEPTOR ANTAGONISTS -- VASODILATOR AGENTS -- SYMPATHOMIMETIC , ; NDA 018285 (label 18285.pdf) INN (PINDOLOL) VISKEN (NOVARTIS) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 018872 (pdf 18872.pdf not found) INN (HYDROCHLOROTHIAZIDE PINDOLOL) VISKAZIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073608 (pdf 73608.pdf not found) INN (PINDOLOL) PINDOLOL (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073609 (pdf 73609.pdf not found) INN (PINDOLOL) PINDOLOL (ANI PHARMS) APPROVAL= AP YEAR= 1993 , NDA 073661 (pdf 73661.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073687 (pdf 73687.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074013 (pdf 74013.pdf not found) INN (PINDOLOL) PINDOLOL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074018 (pdf 74018.pdf not found) INN (PINDOLOL) PINDOLOL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074019 (pdf 74019.pdf not found) INN (PINDOLOL) PINDOLOL (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1992 , NDA 074063 (pdf 74063.pdf not found) INN (PINDOLOL) PINDOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1994 , NDA 074123 (pdf 74123.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074125 (pdf 74125.pdf not found) INN (PINDOLOL) PINDOLOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074437 (pdf 74437.pdf not found) INN (PINDOLOL) PINDOLOL (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074474 (pdf 74474.pdf not found) INN (PINDOLOL) PINDOLOL (NOSTRUM LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 205415 (pdf 205415.pdf not found) INN (PINDOLOL) PINDOLOL (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 , NDA 209866 (pdf 209866.pdf not found) INN (PINDOLOL) PINDOLOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 211712 (pdf 211712.pdf not found) INN (PINDOLOL) PINDOLOL (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2019 , 503 ; TRIFLURIDINE ; 70-00-8 ; 1980 ; ; ; CLASS SENSORY -- ANTIVIRAL -- ANTIMETABOLITES -- TOPICAL TREATMENT OF EPITHELIAL KERATITIS CAUSED BY HERPES SIMPLEX VIRUS -- INTERFER WITH DNA SYNTHESIS -- IS SEQUENTIALLY PHOSPHORYLATED AND NOT ONLY INHIBITS THYMIDYLATE SYNTHASE ACTIVITY BUT IS ALSO INCORPORATED INTO DNA , ; NDA 018299 (pdf 18299.pdf not found) INN (TRIFLURIDINE) VIROPTIC (MONARCH PHARMS) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY , NDA 074311 (pdf 74311.pdf not found) INN (TRIFLURIDINE) TRIFLURIDINE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 207981 (label 207981.pdf) INN (TIPIRACIL HYDROCHLORIDE TRIFLURIDINE) LONSURF (TAIHO ONCOLOGY) APPROVAL= AP YEAR= 2015 , NDA 205438 (pdf 205438.pdf not found) INN (TRIFLURIDINE) TRIFLURIDINE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 214036 (pdf 214036.pdf not found) INN (TRIFLURIDINE TIPIRACIL) TRIFLURIDINE TIPIRACIL (INTAS PHARMS LTD) APPROVAL= TA YEAR= 2022 , NDA 214008 (pdf 214008.pdf not found) INN (TIPIRACIL HYDROCHLORIDE TRIFLURIDINE) TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (NATCO) APPROVAL= AP YEAR= 2023 , 504 ; CAPTOPRIL ; 62571-86-2 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS , ; NDA 018343 (label 18343.pdf) INN (CAPTOPRIL) CAPOTEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 018709 (pdf 18709.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPOZIDE 25/15 (APOTHECON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 074322 (pdf 74322.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074363 (pdf 74363.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074386 (pdf 74386.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074418 (pdf 74418.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (OXFORD PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074423 (pdf 74423.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (DAVA PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074433 (pdf 74433.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074434 (pdf 74434.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074451 (pdf 74451.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074462 (pdf 74462.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074472 (pdf 74472.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (APOTHECON) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074477 (pdf 74477.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (PRINSTON INC) APPROVAL= AP YEAR= 1996 , NDA 074481 (pdf 74481.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074483 (pdf 74483.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074493 (pdf 74493.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (STRIDES PHARMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074505 (pdf 74505.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1996 , NDA 074519 (pdf 74519.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074532 (pdf 74532.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (WOCKHARDT) APPROVAL= AP YEAR= 1997 , NDA 074576 (pdf 74576.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074590 (pdf 74590.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (G AND W LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074640 (pdf 74640.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074677 (pdf 74677.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (INNOGENIX) APPROVAL= AP YEAR= 1997 , NDA 074737 (pdf 74737.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (COREPHARMA) APPROVAL= AP YEAR= 1998 , NDA 074748 (pdf 74748.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (EGIS PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074788 (pdf 74788.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074827 (pdf 74827.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074832 (pdf 74832.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074896 (pdf 74896.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1997 , NDA 075055 (pdf 75055.pdf not found) INN (CAPTOPRIL HYDROCHLOROTHIAZIDE) CAPTOPRIL AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 212223 (pdf 212223.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (SETON PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212809 (pdf 212809.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 214442 (pdf 214442.pdf not found) INN (CAPTOPRIL) CAPTOPRIL (CHANGZHOU PHARM) APPROVAL= AP YEAR= 2023 , 505 ; VERAPAMIL ; 52-53-9 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- CALCIUM ION INFLUX INHIBITOR -- L-TYPE CALCIUM CHANNEL BLOCKER -- CORONARY VASODILATOR -- ANTIARRHYTHMIC , ; NDA 018485 (label 18485.pdf) INN (VERAPAMIL HYDROCHLORIDE) ISOPTIN (MT ADAMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 018593 (pdf 18593.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) ISOPTIN (MT ADAMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018817 (label 18817.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN (PFIZER) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018925 (label 18925.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (EXELA PHARMA) APPROVAL= AP YEAR= 1984 , NDA 019038 (label 19038.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN (GD SEARLE LLC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019152 (label 19152.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN SR (PFIZER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019614 (label 19614.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERELAN (SOCIETAL CDMO) APPROVAL= AP YEAR= 1990 , NDA 020552 (label 20552.pdf) INN (VERAPAMIL HYDROCHLORIDE) COVERA-HS (PFIZER) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020591 (label 20591.pdf) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TARKA (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020943 (label 20943.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERELAN PM (SOCIETAL CDMO) APPROVAL= AP YEAR= 1998 , NDA 070225 (pdf 70225.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070340 (pdf 70340.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070341 (pdf 70341.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070348 (pdf 70348.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070451 (pdf 70451.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070468 (pdf 70468.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070482 (pdf 70482.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070483 (pdf 70483.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070577 (pdf 70577.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070617 (pdf 70617.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070672 (pdf 70672.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070695 (pdf 70695.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070696 (pdf 70696.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070697 (pdf 70697.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070737 (pdf 70737.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070738 (pdf 70738.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070739 (pdf 70739.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070740 (pdf 70740.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070855 (pdf 70855.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070856 (pdf 70856.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070994 (pdf 70994.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070995 (pdf 70995.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 071019 (pdf 71019.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071366 (pdf 71366.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071367 (pdf 71367.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071423 (pdf 71423.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071424 (pdf 71424.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071482 (pdf 71482.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1989 OBSOLETE , NDA 071483 (pdf 71483.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071489 (pdf 71489.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071880 (pdf 71880.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071881 (pdf 71881.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072124 (pdf 72124.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072125 (pdf 72125.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072233 (pdf 72233.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072751 (pdf 72751.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 072799 (pdf 72799.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072888 (pdf 72888.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (BEDFORD) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 072922 (pdf 72922.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 072923 (pdf 72923.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072924 (pdf 72924.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 , NDA 073168 (pdf 73168.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073485 (pdf 73485.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073568 (pdf 73568.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074330 (pdf 74330.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074587 (pdf 74587.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075072 (label 75072.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 , NDA 075136 (pdf 75136.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1998 , NDA 075138 (label 75138.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1999 , NDA 078306 (pdf 78306.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078906 (pdf 78906.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 079135 (pdf 79135.pdf not found) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090529 (pdf 90529.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090700 (pdf 90700.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200878 (pdf 200878.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (APOTEX CORP) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 206173 (pdf 206173.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 210994 (pdf 210994.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211015 (pdf 211015.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 , NDA 211035 (pdf 211035.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOMERSET) APPROVAL= AP YEAR= 2018 , NDA 211370 (pdf 211370.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 212965 (pdf 212965.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213232 (pdf 213232.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2020 , NDA 213352 (pdf 213352.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (NEPHRON) APPROVAL= AP YEAR= 2020 , NDA 214215 (pdf 214215.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214361 (pdf 214361.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 214653 (pdf 214653.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215829 (pdf 215829.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACIC PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216471 (pdf 216471.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2024 DISCONTINUED , 506 ; BUPRENORPHINE ; 52485-79-7 ; 1981 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- NARCOTIC ANTAGONISTS -- TREATMENT OF OPIOID DEPENDENCE -- MU-TYPE OPIOID RECEPTOR PARTIAL AGONIST -- KAPPA-TYPE OPIOID RECEPTOR ANTAGONIST , ; NDA 018401 (label 18401.pdf) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENEX (INDIVIOR) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 020732 (label 20732.pdf) INN (BUPRENORPHINE HYDROCHLORIDE) SUBUTEX (INDIVIOR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 020733 (label 20733.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 074137 (pdf 74137.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 , NDA 076931 (pdf 76931.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2005 , NDA 078331 (pdf 78331.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078633 (pdf 78633.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2009 , NDA 021306 (label 21306.pdf) INN (BUPRENORPHINE) BUTRANS (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2010 , NDA 022410 (label 22410.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2010 , NDA 090360 (pdf 90360.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090622 (pdf 90622.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ETHYPHARM) APPROVAL= AP YEAR= 2010 , NDA 018410 (pdf 18410.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENEX (NORWICH-EATON PHARMA) APPROVAL= AP YEAR= 1981 OBSOLETE , NDA 091422 (pdf 91422.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 203136 (pdf 203136.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 204242 (label 204242.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) ZUBSOLV (OREXO US INC) APPROVAL= AP YEAR= 2013 , NDA 091149 (pdf 91149.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203326 (pdf 203326.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 , NDA 205637 (label 205637.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUNAVAIL (BDSI) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090279 (pdf 90279.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2015 , NDA 090819 (pdf 90819.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 , NDA 201066 (pdf 201066.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206586 (pdf 206586.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 , NDA 204431 (label 204431.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ETHYPHARM USA CORP) APPROVAL= AP YEAR= 2015 , NDA 207932 (label 207932.pdf) INN (BUPRENORPHINE HYDROCHLORIDE) BELBUCA (BDSI) APPROVAL= AP YEAR= 2015 , NDA 201760 (pdf 201760.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 204442 (label 204442.pdf) INN (BUPRENORPHINE HYDROCHLORIDE) PROBUPHINE (REACX PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 201633 (pdf 201633.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 205022 (pdf 205022.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 207276 (pdf 207276.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204383 (pdf 204383.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2017 , NDA 207000 (pdf 207000.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2017 , NDA 209819 (label 209819.pdf) INN (BUPRENORPHINE) SUBLOCADE (INDIVIOR) APPROVAL= AP YEAR= 2017 , NDA 204937 (pdf 204937.pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2018 , NDA 205299 (pdf 205299.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 205806 (pdf 205806.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 207607 (pdf 207607.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2018 , NDA 208042 (label 208042.pdf) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) CASSIPA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210136 (label 210136.pdf) INN (BUPRENORPHINE) BRIXADI (BRAEBURN) APPROVAL= AP YEAR= 2023 , NDA 205954 (pdf 205954.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2019 , NDA 206953 (pdf 206953.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209069 (pdf 209069.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 205601 (pdf 205601.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 211586 (pdf 211586.pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 211785 (pdf 211785.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2020 , NDA 210162 (pdf 210162.pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214930 (pdf 214930.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 210272 (pdf 210272.pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (AVEVA) APPROVAL= AP YEAR= 2021 , NDA 211594 (pdf 211594.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 207490 (pdf 207490.pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (ALVOGEN) APPROVAL= AP YEAR= 2022 , NDA 212756 (pdf 212756.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AVEVA) APPROVAL= AP YEAR= 2022 , NDA 214737 (pdf 214737.pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE) 0 (SUN PHARM INDUSTRIES) APPROVAL= TA YEAR= 2022 , 507 ; GEMFIBROZIL ; 25812-30-0 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- FRIBIC ACID DERIVATIVES -- STIMULATING THE EXPRESSION OF MYELIN-SPECIFIC GENES , ; NDA 018422 (label 18422.pdf) INN (GEMFIBROZIL) LOPID (PFIZER PHARMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 072929 (pdf 72929.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (PUREPAC PHARM) APPROVAL= TA YEAR= 1991 , NDA 073466 (pdf 73466.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (MYLAN) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074156 (pdf 74156.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074256 (pdf 74256.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074270 (pdf 74270.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1993 , NDA 074360 (pdf 74360.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074442 (pdf 74442.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074452 (pdf 74452.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (MYLAN) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074615 (pdf 74615.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075034 (pdf 75034.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (APOTEX) APPROVAL= AP YEAR= 1998 , NDA 077836 (pdf 77836.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (INVAGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078012 (pdf 78012.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (CARIBE HOLDINGS) APPROVAL= AP YEAR= 2007 , NDA 078207 (pdf 78207.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (IMPAX PHARMS) APPROVAL= AP YEAR= 2007 , NDA 079239 (pdf 79239.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078599 (pdf 78599.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (HIKMA PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079072 (pdf 79072.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 202726 (pdf 202726.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 203266 (pdf 203266.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 204189 (pdf 204189.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (CADILA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 214603 (pdf 214603.pdf not found) INN (GEMFIBROZIL) GEMFIBROZIL (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , 508 ; DIFLUNISAL ; 22494-42-4 ; 1982 ; ; ; CLASS NERVOUS SYSTEM -- ANTIINFLAMMATORY -- ANALGESIC -- NSAID -- CYCLOOXYGENASE INHIBITORS -- SYMPTOMATIC TREATMENT OF MILD TO MODERATE PAIN, OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS -- ANTIPYRETIC , ; NDA 018445 (label 18445.pdf) INN (DIFLUNISAL) DOLOBID (MERCK) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 073562 (pdf 73562.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (DASTECH INTL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073563 (pdf 73563.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (DASTECH INTL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073673 (pdf 73673.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073679 (pdf 73679.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074285 (pdf 74285.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (PUREPAC PHARM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074400 (pdf 74400.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074604 (pdf 74604.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 202845 (pdf 202845.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (HERITAGE PHARMA) APPROVAL= AP YEAR= 2012 , NDA 203547 (pdf 203547.pdf not found) INN (DIFLUNISAL) DIFLUNISAL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , 509 ; OXYMETAZOLINE ; 1491-59-4 ; 1986 ; ; ; CLASS RESPIRATORY SYSTEM -- ADRENERGIC ALPHA 1 AND ALPHA 2 AGONIST -- NASAL DECONGESTANT , ; NDA 018471 (pdf 18471.pdf not found) INN (OXYMETAZOLINE HYDROCHLORIDE) OCUCLEAR (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019407 (pdf 19407.pdf not found) INN (OXYMETAZOLINE HYDROCHLORIDE) VISINE L.R. (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1989 , NDA 208032 (label 208032.pdf) INN (OXYMETAZOLINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE) KOVANAZE (ST RENATUS) APPROVAL= AP YEAR= 2016 , NDA 208552 (label 208552.pdf) INN (OXYMETAZOLINE HYDROCHLORIDE) RHOFADE (MAYNE PHARMA) APPROVAL= AP YEAR= 2017 NEWAPPLICATION , NDA 212520 (label 212520.pdf) INN (OXYMETAZOLINE HYDROCHLORIDE) UPNEEQ (RVL PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213584 (pdf 213584.pdf not found) INN (OXYMETAZOLINE HYDROCHLORIDE) OXYMETAZOLINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211812 (pdf 211812.pdf not found) INN (OXYMETAZOLINE) OXYMETAZOLINE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2022 , 510 ; NIFEDIPINE ; 21829-25-4 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- CORONARY VASODILATOR -- CALCIUM CHANNEL BLOCKERS -- DIHYDROPYRIDINES , ; NDA 018482 (label 18482.pdf) INN (NIFEDIPINE) PROCARDIA (PFIZER) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 019478 (pdf 19478.pdf not found) INN (NIFEDIPINE) ADALAT (BAYER PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019684 (label 19684.pdf) INN (NIFEDIPINE) PROCARDIA XL (PFIZER) APPROVAL= AP YEAR= 1989 , NDA 020198 (label 20198.pdf) INN (NIFEDIPINE) ADALAT CC (NORWICH) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072409 (pdf 72409.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (CHASE LABS NJ) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072556 (pdf 72556.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1989 , NDA 072579 (pdf 72579.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1989 , NDA 072651 (pdf 72651.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072781 (pdf 72781.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ACELLA) APPROVAL= AP YEAR= 1993 , NDA 073250 (pdf 73250.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (LEADING) APPROVAL= AP YEAR= 1991 , NDA 073421 (pdf 73421.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (CHASE LABS NJ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074045 (pdf 74045.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (LEADING) APPROVAL= AP YEAR= 1992 , NDA 075108 (label 75108.pdf) INN (NIFEDIPINE) NIFEDIPINE (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075128 (pdf 75128.pdf not found) INN (NIFEDIPINE) AFEDITAB CR (WATSON LABS TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075269 (pdf 75269.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2000 , NDA 075289 (pdf 75289.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2000 , NDA 075414 (pdf 75414.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (MARTEC USA LLC) APPROVAL= AP YEAR= 2004 , NDA 075659 (pdf 75659.pdf not found) INN (NIFEDIPINE) AFEDITAB CR (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076070 (pdf 76070.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2002 , NDA 077127 (pdf 77127.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2005 , NDA 077410 (pdf 77410.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 077899 (pdf 77899.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 090602 (pdf 90602.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090649 (pdf 90649.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201071 (pdf 201071.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202644 (pdf 202644.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2013 , NDA 203126 (pdf 203126.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (TWI PHARMS) APPROVAL= AP YEAR= 2014 , NDA 202987 (pdf 202987.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 210012 (pdf 210012.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 210184 (pdf 210184.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210614 (pdf 210614.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 210838 (pdf 210838.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (SPIL) APPROVAL= AP YEAR= 2019 , NDA 212016 (pdf 212016.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ELITE PHARM SOLUTION) APPROVAL= AP YEAR= 2020 , NDA 213361 (pdf 213361.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216067 (pdf 216067.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 216019 (pdf 216019.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (VITRUVIAS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216896 (pdf 216896.pdf not found) INN (NIFEDIPINE) NIFEDIPINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 511 ; ALPROSTADIL ; 745-65-3 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- SMOOTH MUSCLE RELAXANT -- VASODILATOR -- FIBRINOLYTIC AGENTS -- PLATELET AGGREGATION INHIBITORS -- PROSTAGLANDIN E1 (PGE1) , ; NDA 018484 (label 18484.pdf) INN (ALPROSTADIL) PROSTIN VR PEDIATRIC (PFIZER) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 020379 (label 20379.pdf) INN (ALPROSTADIL) CAVERJECT (PFIZER) APPROVAL= AP YEAR= 1995 , NDA 020649 (label 20649.pdf) INN (ALPROSTADIL) EDEX (ENDO OPERATIONS) APPROVAL= AP YEAR= 1997 , NDA 020700 (label 20700.pdf) INN (ALPROSTADIL) MUSE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1996 , NDA 020755 (pdf 20755.pdf not found) INN (ALPROSTADIL) CAVERJECT (PFIZER) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021212 (label 21212.pdf) INN (ALPROSTADIL) CAVERJECT IMPULSE (PFIZER) APPROVAL= AP YEAR= 2002 , NDA 074815 (pdf 74815.pdf not found) INN (ALPROSTADIL) ALPROSTADIL (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 075196 (pdf 75196.pdf not found) INN (ALPROSTADIL) ALPROSTADIL (MEITHEAL) APPROVAL= AP YEAR= 1999 , 512 ; VERAPAMIL ; 52-53-9 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- CALCIUM ION INFLUX INHIBITOR -- L-TYPE CALCIUM CHANNEL BLOCKER -- CORONARY VASODILATOR -- ANTIARRHYTHMIC , ; NDA 018485 (label 18485.pdf) INN (VERAPAMIL HYDROCHLORIDE) ISOPTIN (MT ADAMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 018593 (pdf 18593.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) ISOPTIN (MT ADAMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018817 (label 18817.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN (PFIZER) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018925 (label 18925.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (EXELA PHARMA) APPROVAL= AP YEAR= 1984 , NDA 019038 (label 19038.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN (GD SEARLE LLC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019152 (label 19152.pdf) INN (VERAPAMIL HYDROCHLORIDE) CALAN SR (PFIZER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019614 (label 19614.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERELAN (SOCIETAL CDMO) APPROVAL= AP YEAR= 1990 , NDA 020552 (label 20552.pdf) INN (VERAPAMIL HYDROCHLORIDE) COVERA-HS (PFIZER) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020591 (label 20591.pdf) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TARKA (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020943 (label 20943.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERELAN PM (SOCIETAL CDMO) APPROVAL= AP YEAR= 1998 , NDA 070225 (pdf 70225.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070340 (pdf 70340.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070341 (pdf 70341.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070348 (pdf 70348.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070451 (pdf 70451.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070468 (pdf 70468.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070482 (pdf 70482.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070483 (pdf 70483.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070577 (pdf 70577.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070617 (pdf 70617.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070672 (pdf 70672.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070695 (pdf 70695.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070696 (pdf 70696.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070697 (pdf 70697.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070737 (pdf 70737.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070738 (pdf 70738.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070739 (pdf 70739.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070740 (pdf 70740.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070855 (pdf 70855.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070856 (pdf 70856.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070994 (pdf 70994.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070995 (pdf 70995.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 071019 (pdf 71019.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071366 (pdf 71366.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071367 (pdf 71367.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071423 (pdf 71423.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071424 (pdf 71424.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071482 (pdf 71482.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1989 OBSOLETE , NDA 071483 (pdf 71483.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071489 (pdf 71489.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071880 (pdf 71880.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071881 (pdf 71881.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072124 (pdf 72124.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072125 (pdf 72125.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072233 (pdf 72233.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072751 (pdf 72751.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 072799 (pdf 72799.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072888 (pdf 72888.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (BEDFORD) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 072922 (pdf 72922.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 072923 (pdf 72923.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072924 (pdf 72924.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 , NDA 073168 (pdf 73168.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073485 (pdf 73485.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073568 (pdf 73568.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074330 (pdf 74330.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074587 (pdf 74587.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075072 (label 75072.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 , NDA 075136 (pdf 75136.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1998 , NDA 075138 (label 75138.pdf) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1999 , NDA 078306 (pdf 78306.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078906 (pdf 78906.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 079135 (pdf 79135.pdf not found) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090529 (pdf 90529.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090700 (pdf 90700.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200878 (pdf 200878.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (APOTEX CORP) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 206173 (pdf 206173.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 210994 (pdf 210994.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211015 (pdf 211015.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 , NDA 211035 (pdf 211035.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (SOMERSET) APPROVAL= AP YEAR= 2018 , NDA 211370 (pdf 211370.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 212965 (pdf 212965.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213232 (pdf 213232.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2020 , NDA 213352 (pdf 213352.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (NEPHRON) APPROVAL= AP YEAR= 2020 , NDA 214215 (pdf 214215.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214361 (pdf 214361.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 214653 (pdf 214653.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215829 (pdf 215829.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (ACIC PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216471 (pdf 216471.pdf not found) INN (VERAPAMIL HYDROCHLORIDE) VERAPAMIL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2024 DISCONTINUED , 513 ; CHENODIOL ; 474-25-9 ; 1983 ; ; ; CLASS STEROL -- ANTICHOLELITHOGENIC -- CHOLAGOGUE -- CHOLERETIC LAXATIVE -- ANTILIPEMIC AGENT -- BILE ACID USED TO DISSOLVE CERTAIN TYPES OF GALLSTONES (NON-CALCIFIED) , ; NDA 018513 (pdf 18513.pdf not found) INN (CHENODIOL) CHENIX (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 091019 (pdf 91019.pdf not found) INN (CHENODIOL) CHENODIOL (LGM PHARMA) APPROVAL= AP YEAR= 2009 , 514 ; INDAPAMIDE ; 26807-65-8 ; 1983 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- DECREASES SERUM POTASSIUM , ; NDA 018538 (label 18538.pdf) INN (INDAPAMIDE) LOZOL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 074299 (pdf 74299.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 , NDA 074461 (pdf 74461.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (RISING) APPROVAL= AP YEAR= 1996 , NDA 074498 (pdf 74498.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074585 (pdf 74585.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074594 (pdf 74594.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074665 (pdf 74665.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074722 (pdf 74722.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1996 , NDA 075105 (label 75105.pdf) INN (INDAPAMIDE) INDAPAMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075201 (pdf 75201.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , 515 ; NITROGLYCERIN ; 55-63-0 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- TREATMENT OF ANGINAL ATTACK -- RELAXATION OF VASCULAR SMOOTH MUSCLE -- VASODILATATOR -- NITROGLYCERIN FORMS FREE RADICAL NITRIC OXIDE (NO) WHICH ACTIVATES GUANYLATE CYCLASE , ; NDA 018531 (pdf 18531.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018537 (pdf 18537.pdf not found) INN (NITROGLYCERIN) TRIDIL (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018588 (pdf 18588.pdf not found) INN (NITROGLYCERIN) NITROSTAT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018621 (pdf 18621.pdf not found) INN (NITROGLYCERIN) NITRO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018672 (pdf 18672.pdf not found) INN (NITROGLYCERIN) NITRONAL (POHL BOSKAMP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018705 (label 18705.pdf) INN (NITROGLYCERIN) NITROLINGUAL (POHL BOSKAMP) APPROVAL= AP YEAR= 1985 , NDA 018774 (pdf 18774.pdf not found) INN (NITROGLYCERIN) NITROL (RORER) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 019970 (label 19970.pdf) INN (NITROGLYCERIN) NITROGLYCERIN IN DEXTROSE 5% (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1989 , NDA 020144 (pdf 20144.pdf not found) INN (NITROGLYCERIN) TRANSDERM-NITRO (NOVARTIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 020145 (label 20145.pdf) INN (NITROGLYCERIN) NITRO-DUR (USPHARMA) APPROVAL= AP YEAR= 1985 , NDA 021134 (label 21134.pdf) INN (NITROGLYCERIN) NITROSTAT (VIATRIS) APPROVAL= AP YEAR= 2000 , NDA 021780 (label 21780.pdf) INN (NITROGLYCERIN) NITROMIST (EVUS) APPROVAL= AP YEAR= 2006 , NDA 040047 (pdf 40047.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (NOVEN) APPROVAL= TA YEAR= 1996 , NDA 040048 (pdf 40048.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (NOVEN) APPROVAL= TA YEAR= 1996 , NDA 040049 (pdf 40049.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (NOVEN) APPROVAL= TA YEAR= 1996 , NDA 070026 (pdf 70026.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070077 (pdf 70077.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070633 (pdf 70633.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070634 (pdf 70634.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (SMITH AND NEPHEW) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070863 (pdf 70863.pdf not found) INN (NITROGLYCERIN) NITROSTAT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070871 (pdf 70871.pdf not found) INN (NITROGLYCERIN) NITROSTAT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070872 (pdf 70872.pdf not found) INN (NITROGLYCERIN) NITROSTAT (PARKE DAVIS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071094 (pdf 71094.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071095 (pdf 71095.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071159 (pdf 71159.pdf not found) INN (NITROGLYCERIN) NITRO-BID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 071203 (pdf 71203.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071492 (pdf 71492.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (LUITPOLD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071846 (pdf 71846.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 071847 (pdf 71847.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 071848 (pdf 71848.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072034 (pdf 72034.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (AM REGENT) APPROVAL= AP YEAR= 1988 , NDA 074083 (pdf 74083.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074559 (pdf 74559.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1996 , NDA 074607 (pdf 74607.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1996 DISCONTINUED OBSOLETE , NDA 074609 (pdf 74609.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1996 DISCONTINUED OBSOLETE , NDA 074992 (pdf 74992.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075033 (pdf 75033.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1998 DISCONTINUED OBSOLETE , NDA 075073 (pdf 75073.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075075 (pdf 75075.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075076 (pdf 75076.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075115 (pdf 75115.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (LANNETT CO INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 087355 (pdf 87355.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1981 , NDA 089771 (pdf 89771.pdf not found) INN (NITROGLYCERIN) MINITRAN (VALEANT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089772 (pdf 89772.pdf not found) INN (NITROGLYCERIN) MINITRAN (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089773 (pdf 89773.pdf not found) INN (NITROGLYCERIN) MINITRAN (BAUSCH) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089774 (pdf 89774.pdf not found) INN (NITROGLYCERIN) MINITRAN (VALEANT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089884 (label 89884.pdf) INN (NITROGLYCERIN) NITROGLYCERIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 1998 , NDA 089885 (label 89885.pdf) INN (NITROGLYCERIN) NITROGLYCERIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 1998 , NDA 089886 (label 89886.pdf) INN (NITROGLYCERIN) NITROGLYCERIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 1998 , NDA 021359 (label 21359.pdf) INN (NITROGLYCERIN) RECTIV (ABBVIE) APPROVAL= AP YEAR= 2011 , NDA 091496 (pdf 91496.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2013 , NDA 208424 (label 208424.pdf) INN (NITROGLYCERIN) GONITRO (POHL BOSKAMP) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208191 (pdf 208191.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 203693 (pdf 203693.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206391 (pdf 206391.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 207745 (pdf 207745.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211604 (pdf 211604.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (NATCO) APPROVAL= AP YEAR= 2019 , NDA 209779 (pdf 209779.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 210153 (pdf 210153.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217879 (pdf 217879.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217970 (pdf 217970.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216103 (pdf 216103.pdf not found) INN (NITROGLYCERIN) NITROGLYCERIN (COSETTE) APPROVAL= AP YEAR= 2024 , 516 ; KETOCONAZOLE ; 65277-42-1 ; 1981 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- OPICAL TREATMENT OF SEBORRHEIC DERMATITIS -- IMPAIRS BIOSYNTHESIS OF ERGOSTEROL , ; NDA 018533 (label 18533.pdf) INN (KETOCONAZOLE) NIZORAL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 019084 (pdf 19084.pdf not found) INN (KETOCONAZOLE) NIZORAL (JANSSEN PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019927 (label 19927.pdf) INN (KETOCONAZOLE) NIZORAL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020310 (label 20310.pdf) INN (KETOCONAZOLE) NIZORAL ANTI-DANDRUFF (KRAMER) APPROVAL= AP YEAR= 1997 , NDA 021738 (label 21738.pdf) INN (KETOCONAZOLE) EXTINA (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021946 (label 21946.pdf) INN (KETOCONAZOLE) XOLEGEL (ALMIRALL) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 070767 (pdf 70767.pdf not found) INN (KETOCONAZOLE) NIZORAL (JANSSEN PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074971 (label 74971.pdf) INN (KETOCONAZOLE) KETOCONAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075273 (label 75273.pdf) INN (KETOCONAZOLE) KETOCONAZOLE (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075314 (pdf 75314.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075319 (pdf 75319.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (TARO) APPROVAL= AP YEAR= 1999 , NDA 075341 (pdf 75341.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (AAIPHARMA LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075362 (pdf 75362.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075581 (label 75581.pdf) INN (KETOCONAZOLE) KETOCONAZOLE (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075597 (pdf 75597.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075638 (pdf 75638.pdf not found) INN (KETOCONAZOLE) KETOZOLE (TARO) APPROVAL= AP YEAR= 2002 , NDA 075912 (pdf 75912.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (SENORES PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076294 (pdf 76294.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076419 (pdf 76419.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076942 (pdf 76942.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (TOLMAR) APPROVAL= AP YEAR= 2005 , NDA 091550 (pdf 91550.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2011 , NDA 210457 (pdf 210457.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 212443 (pdf 212443.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 213601 (pdf 213601.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (XIROMED) APPROVAL= AP YEAR= 2021 , NDA 215185 (pdf 215185.pdf not found) INN (KETOCONAZOLE) KETOCONAZOLE (TASMAN PHARMA) APPROVAL= AP YEAR= 2021 , 517 ; INDAPAMIDE ; 26807-65-8 ; 1983 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- DECREASES SERUM POTASSIUM , ; NDA 018538 (label 18538.pdf) INN (INDAPAMIDE) LOZOL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 074299 (pdf 74299.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 , NDA 074461 (pdf 74461.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (RISING) APPROVAL= AP YEAR= 1996 , NDA 074498 (pdf 74498.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074585 (pdf 74585.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074594 (pdf 74594.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074665 (pdf 74665.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074722 (pdf 74722.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1996 , NDA 075105 (label 75105.pdf) INN (INDAPAMIDE) INDAPAMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075201 (pdf 75201.pdf not found) INN (INDAPAMIDE) INDAPAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , 518 ; CARPROFEN ; 53716-49-7 ; 1987 ; DISCONTINUED ; ; CLASS ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITOR , ; NDA 018550 (pdf 18550.pdf not found) INN (CARPROFEN) RIMADYL (ROCHE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , 519 ; FLUTAMIDE ; 13311-84-7 ; 1989 ; ; ; CLASS ANTINEOPLASTIC -- ANTIANDROGENIC , ; NDA 018554 (label 18554.pdf) INN (FLUTAMIDE) EULEXIN (SCHERING) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 075298 (pdf 75298.pdf not found) INN (FLUTAMIDE) FLUTAMIDE (WAYLIS THERAP) APPROVAL= AP YEAR= 2001 , NDA 075780 (pdf 75780.pdf not found) INN (FLUTAMIDE) FLUTAMIDE (CIPLA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075818 (pdf 75818.pdf not found) INN (FLUTAMIDE) FLUTAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075820 (pdf 75820.pdf not found) INN (FLUTAMIDE) FLUTAMIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076224 (pdf 76224.pdf not found) INN (FLUTAMIDE) FLUTAMIDE (MYLAN) APPROVAL= AP YEAR= 2003 DISCONTINUED , 520 ; RITODRINE ; 26652-09-5 ; 1980 ; DISCONTINUED ; ; CLASS GENITO -- MUSCLE RELAXANT -- USED TO STOP PREMATURE LABOR -- SELECTIVE ADRENERGIC BETA 2 AGONISTS -- TOCOLYTIC AGENTS , ; NDA 018555 (pdf 18555.pdf not found) INN (RITODRINE HYDROCHLORIDE) YUTOPAR (ASTRAZENECA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018580 (pdf 18580.pdf not found) INN (RITODRINE HYDROCHLORIDE) YUTOPAR (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070700 (pdf 70700.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070701 (pdf 70701.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071188 (pdf 71188.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071189 (pdf 71189.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HYDROCHLORIDE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071438 (pdf 71438.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071618 (pdf 71618.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071619 (pdf 71619.pdf not found) INN (RITODRINE HYDROCHLORIDE) RITODRINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , 521 ; SULFADOXINE ; 2447-57-6 ; 1981 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTIMALARIALS -- DIHYDROPTEROATE SYNTHASE INHIBITOR , ; NDA 018557 (label 18557.pdf) INN (PYRIMETHAMINE SULFADOXINE) FANSIDAR (ROCHE) APPROVAL= AP YEAR= 1981 DISCONTINUED , 522 ; GUANABENZ ; 5051-62-7 ; 1982 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA 2 AGONISTS -- SYMPATHOLYTICS , ; NDA 018587 (pdf 18587.pdf not found) INN (GUANABENZ ACETATE) WYTENSIN (WYETH AYERST) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 074025 (pdf 74025.pdf not found) INN (GUANABENZ ACETATE) GUANABENZ ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074149 (pdf 74149.pdf not found) INN (GUANABENZ ACETATE) GUANABENZ ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074267 (pdf 74267.pdf not found) INN (GUANABENZ ACETATE) GUANABENZ ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074517 (label 74517.pdf) INN (GUANABENZ ACETATE) GUANABENZ ACETATE (CHARTWELL RX) APPROVAL= AP YEAR= 1998 DISCONTINUED , 523 ; DILTIAZEM ; 42399-41-7 ; 1982 ; ; ; CLASS CARDIOVASCULAR -- CALCIUM ION CELLULAR INFLUX INHIBITOR -- CORONARY VASODILATOR -- ANTIHYPERTENSIVE AGENTS -- CALCIUM CHANNEL BLOCKERS , ; NDA 018602 (label 18602.pdf) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM (BAUSCH) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 019471 (pdf 19471.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM SR (BIOVAIL) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 020027 (pdf 20027.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM (BIOVAIL LABS INTL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020062 (label 20062.pdf) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM CD (BAUSCH) APPROVAL= AP YEAR= 1991 , NDA 020092 (label 20092.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILACOR XR (ALLERGAN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020401 (label 20401.pdf) INN (DILTIAZEM HYDROCHLORIDE) TIAZAC (BAUSCH) APPROVAL= AP YEAR= 1995 , NDA 020506 (pdf 20506.pdf not found) INN (DILTIAZEM MALATE) TIAMATE (MERCK) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020507 (pdf 20507.pdf not found) INN (DILTIAZEM MALATE ENALAPRIL MALEATE) TECZEM (BIOVAIL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020792 (pdf 20792.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM (BIOVAIL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020939 (label 20939.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (BIOVAIL) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021392 (label 21392.pdf) INN (DILTIAZEM HYDROCHLORIDE) CARDIZEM LA (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 072837 (pdf 72837.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 072838 (pdf 72838.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073185 (pdf 73185.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073186 (pdf 73186.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 074051 (pdf 74051.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074067 (pdf 74067.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074079 (pdf 74079.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074084 (pdf 74084.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074093 (pdf 74093.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074168 (pdf 74168.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074185 (pdf 74185.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074617 (pdf 74617.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SAGENT) APPROVAL= AP YEAR= 1996 , NDA 074752 (label 74752.pdf) INN (DILTIAZEM HYDROCHLORIDE) CARTIA XT (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1998 , NDA 074845 (label 74845.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (BIOVAIL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074852 (pdf 74852.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074894 (pdf 74894.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074910 (pdf 74910.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1997 , NDA 074941 (label 74941.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1998 , NDA 074943 (label 74943.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 1998 , NDA 074984 (pdf 74984.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1999 , NDA 075004 (pdf 75004.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075086 (label 75086.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1998 , NDA 075106 (pdf 75106.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075116 (pdf 75116.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1999 , NDA 075124 (label 75124.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075375 (pdf 75375.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075401 (pdf 75401.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) TAZTIA XT (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 , NDA 075749 (pdf 75749.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075853 (pdf 75853.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2002 , NDA 076151 (pdf 76151.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILT-CD (APOTEX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076395 (pdf 76395.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTZAC (APOTEX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076563 (pdf 76563.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077686 (pdf 77686.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2010 , NDA 078538 (pdf 78538.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 090421 (pdf 90421.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 090492 (pdf 90492.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091022 (pdf 91022.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 202463 (pdf 202463.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 202651 (pdf 202651.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2012 , NDA 203023 (pdf 203023.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 206534 (pdf 206534.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206641 (pdf 206641.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209766 (pdf 209766.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205231 (pdf 205231.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208783 (pdf 208783.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 211596 (pdf 211596.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206997 (pdf 206997.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 212317 (pdf 212317.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 215252 (label 215252.pdf) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (EXELA PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215775 (pdf 215775.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 , NDA 216304 (pdf 216304.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (AMTA) APPROVAL= AP YEAR= 2022 , NDA 216521 (pdf 216521.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 216327 (pdf 216327.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 216439 (pdf 216439.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (AMTA) APPROVAL= AP YEAR= 2023 , NDA 216552 (pdf 216552.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217377 (pdf 217377.pdf not found) INN (DILTIAZEM HYDROCHLORIDE) DILTIAZEM HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2023 , 524 ; BUPROPION ; 34911-55-2 ; 1985 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- NON-NICOTINE AID TO SMOKING CESSATION -- WEAK DOPAMINE AND NOREPINEPHRINE UPTAKE INHIBITORS -- AMINOKETONE CLASS , ; NDA 018644 (label 18644.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 020358 (label 20358.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN SR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1996 , NDA 020711 (label 20711.pdf) INN (BUPROPION HYDROCHLORIDE) ZYBAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021515 (label 21515.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN XL (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 022108 (label 22108.pdf) INN (BUPROPION HYDROBROMIDE) APLENZIN (BAUSCH) APPROVAL= AP YEAR= 2008 , NDA 075310 (pdf 75310.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075491 (pdf 75491.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2000 , NDA 075584 (pdf 75584.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 2000 , NDA 075613 (pdf 75613.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075913 (pdf 75913.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 075914 (pdf 75914.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 075932 (pdf 75932.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2003 , NDA 076143 (pdf 76143.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 076711 (pdf 76711.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076834 (pdf 76834.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076845 (pdf 76845.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077284 (label 77284.pdf) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077285 (pdf 77285.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2008 , NDA 077415 (pdf 77415.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077455 (pdf 77455.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077475 (pdf 77475.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 077715 (pdf 77715.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2007 , NDA 078866 (pdf 78866.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 079094 (pdf 79094.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 079095 (pdf 79095.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 090325 (pdf 90325.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090941 (pdf 90941.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090942 (pdf 90942.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091459 (pdf 91459.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091520 (pdf 91520.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022497 (label 22497.pdf) INN (BUPROPION HYDROCHLORIDE) FORFIVO XL (TWI PHARMS) APPROVAL= AP YEAR= 2011 , NDA 201331 (pdf 201331.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202189 (pdf 202189.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 , NDA 200835 (pdf 200835.pdf not found) INN (BUPROPION HYDROBROMIDE) BUPROPION HYDROBROMIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2013 , NDA 202774 (pdf 202774.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202775 (pdf 202775.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200063 (label 200063.pdf) INN (BUPROPION HYDROCHLORIDE NALTREXONE HYDROCHLORIDE) CONTRAVE (NALPROPION) APPROVAL= AP YEAR= 2014 , NDA 200695 (pdf 200695.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201567 (pdf 201567.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203969 (pdf 203969.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202304 (pdf 202304.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 205794 (pdf 205794.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 206674 (pdf 206674.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206122 (pdf 206122.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 206556 (pdf 206556.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206975 (pdf 206975.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2016 , NDA 090693 (pdf 90693.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 207224 (pdf 207224.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ANBISON LAB) APPROVAL= AP YEAR= 2017 , NDA 207459 (pdf 207459.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207479 (pdf 207479.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207389 (pdf 207389.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208652 (pdf 208652.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2017 , NDA 210081 (pdf 210081.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203013 (pdf 203013.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 210015 (pdf 210015.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 210497 (pdf 210497.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 211347 (pdf 211347.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 211020 (pdf 211020.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211200 (pdf 211200.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ZHEJIANG JUTAI PHARM) APPROVAL= AP YEAR= 2019 , NDA 207403 (pdf 207403.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 208606 (pdf 208606.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 200216 (pdf 200216.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 203650 (pdf 203650.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 215568 (pdf 215568.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 , NDA 208043 (pdf 208043.pdf not found) INN (NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2022 , NDA 215430 (label 215430.pdf) INN (BUPROPION HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE) AUVELITY (AXSOME) APPROVAL= AP YEAR= 2022 , NDA 216766 (pdf 216766.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2023 , NDA 216800 (pdf 216800.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , 525 ; ACYCLOVIR ; 59277-89-3 ; 1982 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGAINST HERPES SIMPLEX VIRUS TYPES 1 (HSV-1), TYPES 2 (HSV-2) AND VARICELLA-ZOSTER VIRUS (VZV) , ; NDA 018603 (label 18603.pdf) INN (ACYCLOVIR SODIUM) ZOVIRAX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018604 (label 18604.pdf) INN (ACYCLOVIR) ZOVIRAX (BAUSCH) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 018828 (label 18828.pdf) INN (ACYCLOVIR) ZOVIRAX (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019909 (label 19909.pdf) INN (ACYCLOVIR) ZOVIRAX (MYLAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 020089 (label 20089.pdf) INN (ACYCLOVIR) ZOVIRAX (MYLAN) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 021478 (label 21478.pdf) INN (ACYCLOVIR) ZOVIRAX (BAUSCH) APPROVAL= AP YEAR= 2002 , NDA 074556 (pdf 74556.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TEVA) APPROVAL= AP YEAR= 1997 , NDA 074570 (pdf 74570.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ROXANE) APPROVAL= TA YEAR= 1996 , NDA 074578 (pdf 74578.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TEVA) APPROVAL= AP YEAR= 1997 , NDA 074596 (pdf 74596.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074658 (pdf 74658.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (LEK PHARM) APPROVAL= TA YEAR= 1997 , NDA 074663 (pdf 74663.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074674 (pdf 74674.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074720 (pdf 74720.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074727 (pdf 74727.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074738 (pdf 74738.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1997 , NDA 074750 (pdf 74750.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (LEK PHARM) APPROVAL= TA YEAR= 1997 , NDA 074758 (pdf 74758.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074828 (pdf 74828.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074833 (pdf 74833.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074834 (pdf 74834.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074836 (pdf 74836.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074870 (pdf 74870.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074872 (pdf 74872.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074885 (pdf 74885.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE (EUROHLTH INTL SARL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074889 (pdf 74889.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (HERITAGE PHARMS) APPROVAL= AP YEAR= 1997 , NDA 074891 (pdf 74891.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (HERITAGE PHARMS) APPROVAL= AP YEAR= 1997 , NDA 074897 (pdf 74897.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (APOTHECON) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074906 (pdf 74906.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074913 (pdf 74913.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (EUROHLTH INTL SARL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074914 (label 74914.pdf) INN (ACYCLOVIR) ACYCLOVIR (TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074930 (pdf 74930.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 , NDA 074946 (pdf 74946.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 , NDA 074969 (pdf 74969.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (TEVA PARENTERAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074975 (pdf 74975.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (RANBAXY) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074976 (label 74976.pdf) INN (ACYCLOVIR) ACYCLOVIR (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074977 (pdf 74977.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074980 (pdf 74980.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075015 (pdf 75015.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075021 (pdf 75021.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075065 (pdf 75065.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075090 (pdf 75090.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (INDOCO) APPROVAL= AP YEAR= 1999 , NDA 075101 (pdf 75101.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075114 (pdf 75114.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR (ABBVIE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075211 (pdf 75211.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075382 (pdf 75382.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CARLSBAD) APPROVAL= AP YEAR= 1999 , NDA 075627 (pdf 75627.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (TEVA PARENTERAL) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075677 (pdf 75677.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (APOTEX) APPROVAL= AP YEAR= 2005 , NDA 077026 (pdf 77026.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (HIKMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077309 (pdf 77309.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (APOTEX INC) APPROVAL= AP YEAR= 2005 , NDA 022436 (label 22436.pdf) INN (ACYCLOVIR HYDROCORTISONE) XERESE (BAUSCH) APPROVAL= AP YEAR= 2009 , NDA 202168 (pdf 202168.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202459 (pdf 202459.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 203701 (pdf 203701.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 203791 (label 203791.pdf) INN (ACYCLOVIR) SITAVIG (LNHC) APPROVAL= AP YEAR= 2013 , NDA 203834 (pdf 203834.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (HETERO LABS LTD V) APPROVAL= AP YEAR= 2013 , NDA 201445 (pdf 201445.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 204314 (pdf 204314.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204605 (pdf 204605.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204313 (pdf 204313.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CADILA) APPROVAL= AP YEAR= 2016 , NDA 205771 (pdf 205771.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HIKMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206633 (pdf 206633.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 205469 (pdf 205469.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TARO) APPROVAL= AP YEAR= 2016 , NDA 203927 (pdf 203927.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205510 (pdf 205510.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 206437 (pdf 206437.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ANDA REPOSITORY) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206606 (pdf 206606.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205591 (pdf 205591.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (COSETTE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206261 (pdf 206261.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CARLSBAD TECHNOLOGY) APPROVAL= AP YEAR= 2017 , NDA 209000 (pdf 209000.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 210401 (pdf 210401.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (YILING) APPROVAL= AP YEAR= 2018 , NDA 206535 (pdf 206535.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 202408 (label 202408.pdf) INN (ACYCLOVIR) AVACLYR (FERA PHARMS LLC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205659 (pdf 205659.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205974 (pdf 205974.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2019 , NDA 208702 (pdf 208702.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 , NDA 209971 (pdf 209971.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TORRENT) APPROVAL= AP YEAR= 2019 , NDA 211794 (pdf 211794.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 209366 (pdf 209366.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (SQUARE PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210774 (pdf 210774.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 201501 (pdf 201501.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 207919 (pdf 207919.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (DR REDDYS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212252 (pdf 212252.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212495 (pdf 212495.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 212718 (pdf 212718.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 208766 (pdf 208766.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 212173 (pdf 212173.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (YILING) APPROVAL= AP YEAR= 2020 , NDA 212444 (pdf 212444.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 213951 (pdf 213951.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (VISTAPHARM LLC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212202 (pdf 212202.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (PRINSTON INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215669 (pdf 215669.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 216331 (pdf 216331.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215724 (pdf 215724.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 206770 (pdf 206770.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217393 (pdf 217393.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (MSN) APPROVAL= AP YEAR= 2023 , NDA 212361 (pdf 212361.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 205470 (pdf 205470.pdf not found) INN (ACYCLOVIR) ACYCLOVIR (TARO) APPROVAL= AP YEAR= 2024 , NDA 218111 (pdf 218111.pdf not found) INN (ACYCLOVIR SODIUM) ACYCLOVIR SODIUM (HAINAN POLY) APPROVAL= AP YEAR= 2024 , 526 ; TIOCONAZOLE ; 65899-73-2 ; 1983 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- LOCAL TREATMENT OF VULVOVAGINAL CANDIDIASIS (MONILIASIS) , ; NDA 018682 (pdf 18682.pdf not found) INN (TIOCONAZOLE) TZ-3 (PFIZER) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 020676 (label 20676.pdf) INN (TIOCONAZOLE) VAGISTAT-1 (COMBE) APPROVAL= AP YEAR= 1997 , NDA 075915 (pdf 75915.pdf not found) INN (TIOCONAZOLE) TIOCONAZOLE (PERRIGO) APPROVAL= AP YEAR= 2001 , 527 ; PENTOXIFYLLINE ; 6493-05-6 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- HEMORRHEOLOGIC AGENTS AFFECT BLOOD VISCOSITY -- TREATMENT OF PATIENTS WITH INTERMITTENT CLAUDICATION ON THE BASIS OF CHRONIC OCCLUSIVE ARTERIAL DISEASE OF THE LIMBS -- PHOSPHODIESTERASE INHIBITORS -- ANTIMALARIALS , ; NDA 018631 (label 18631.pdf) INN (PENTOXIFYLLINE) TRENTAL (VALIDUS PHARMS) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 074425 (pdf 74425.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (RISING) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074874 (pdf 74874.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (PLIVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074877 (pdf 74877.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074878 (pdf 74878.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (ANI PHARMS) APPROVAL= AP YEAR= 1997 , NDA 074962 (label 74962.pdf) INN (PENTOXIFYLLINE) PENTOXIL (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075028 (pdf 75028.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (VALEANT PHARMS) APPROVAL= AP YEAR= 1998 , NDA 075093 (pdf 75093.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (IMPAX LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075107 (pdf 75107.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (ANI PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075191 (pdf 75191.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (APOTEX) APPROVAL= AP YEAR= 1999 , NDA 075199 (pdf 75199.pdf not found) INN (PENTOXIFYLLINE) PENTOXIFYLLINE (ANI PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , 528 ; BUPROPION ; 34911-55-2 ; 1985 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- NON-NICOTINE AID TO SMOKING CESSATION -- WEAK DOPAMINE AND NOREPINEPHRINE UPTAKE INHIBITORS -- AMINOKETONE CLASS , ; NDA 018644 (label 18644.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 020358 (label 20358.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN SR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1996 , NDA 020711 (label 20711.pdf) INN (BUPROPION HYDROCHLORIDE) ZYBAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021515 (label 21515.pdf) INN (BUPROPION HYDROCHLORIDE) WELLBUTRIN XL (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 022108 (label 22108.pdf) INN (BUPROPION HYDROBROMIDE) APLENZIN (BAUSCH) APPROVAL= AP YEAR= 2008 , NDA 075310 (pdf 75310.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075491 (pdf 75491.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2000 , NDA 075584 (pdf 75584.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 2000 , NDA 075613 (pdf 75613.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075913 (pdf 75913.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 075914 (pdf 75914.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 , NDA 075932 (pdf 75932.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2003 , NDA 076143 (pdf 76143.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 076711 (pdf 76711.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076834 (pdf 76834.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076845 (pdf 76845.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077284 (label 77284.pdf) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077285 (pdf 77285.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2008 , NDA 077415 (pdf 77415.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077455 (pdf 77455.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077475 (pdf 77475.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 077715 (pdf 77715.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2007 , NDA 078866 (pdf 78866.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 079094 (pdf 79094.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 079095 (pdf 79095.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 , NDA 090325 (pdf 90325.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090941 (pdf 90941.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090942 (pdf 90942.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091459 (pdf 91459.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091520 (pdf 91520.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022497 (label 22497.pdf) INN (BUPROPION HYDROCHLORIDE) FORFIVO XL (TWI PHARMS) APPROVAL= AP YEAR= 2011 , NDA 201331 (pdf 201331.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202189 (pdf 202189.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 , NDA 200835 (pdf 200835.pdf not found) INN (BUPROPION HYDROBROMIDE) BUPROPION HYDROBROMIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2013 , NDA 202774 (pdf 202774.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202775 (pdf 202775.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200063 (label 200063.pdf) INN (BUPROPION HYDROCHLORIDE NALTREXONE HYDROCHLORIDE) CONTRAVE (NALPROPION) APPROVAL= AP YEAR= 2014 , NDA 200695 (pdf 200695.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201567 (pdf 201567.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203969 (pdf 203969.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202304 (pdf 202304.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 205794 (pdf 205794.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 206674 (pdf 206674.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206122 (pdf 206122.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 206556 (pdf 206556.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206975 (pdf 206975.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2016 , NDA 090693 (pdf 90693.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 207224 (pdf 207224.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ANBISON LAB) APPROVAL= AP YEAR= 2017 , NDA 207459 (pdf 207459.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207479 (pdf 207479.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207389 (pdf 207389.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208652 (pdf 208652.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2017 , NDA 210081 (pdf 210081.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203013 (pdf 203013.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 210015 (pdf 210015.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 210497 (pdf 210497.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 211347 (pdf 211347.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 211020 (pdf 211020.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211200 (pdf 211200.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ZHEJIANG JUTAI PHARM) APPROVAL= AP YEAR= 2019 , NDA 207403 (pdf 207403.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 208606 (pdf 208606.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 200216 (pdf 200216.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 203650 (pdf 203650.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 215568 (pdf 215568.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 , NDA 208043 (pdf 208043.pdf not found) INN (NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2022 , NDA 215430 (label 215430.pdf) INN (BUPROPION HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE) AUVELITY (AXSOME) APPROVAL= AP YEAR= 2022 , NDA 216766 (pdf 216766.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2023 , NDA 216800 (pdf 216800.pdf not found) INN (BUPROPION HYDROCHLORIDE) BUPROPION HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , 529 ; MIDAZOLAM ; 59467-70-8 ; 1985 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- ANTI-ANXIETY AGENTS -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES -- BENZODIAZEPINE -- TREATMENT OF CONVULSIVE SEIZURES (EPILEPSY) , ; NDA 018654 (pdf 18654.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) VERSED (HLR) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 020942 (pdf 20942.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) VERSED (ROCHE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075154 (pdf 75154.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 , NDA 075243 (pdf 75243.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075247 (pdf 75247.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075249 (pdf 75249.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (BEDFORD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075263 (pdf 75263.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (IGI LABS INC) APPROVAL= TA YEAR= 1999 , NDA 075293 (pdf 75293.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 , NDA 075324 (pdf 75324.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075396 (pdf 75396.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075409 (pdf 75409.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075421 (pdf 75421.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075455 (pdf 75455.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (BEN VENUE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075481 (pdf 75481.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075484 (pdf 75484.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075494 (pdf 75494.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 075620 (pdf 75620.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075637 (pdf 75637.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075641 (pdf 75641.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075856 (pdf 75856.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075857 (pdf 75857.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 2002 , NDA 075873 (pdf 75873.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 075958 (pdf 75958.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076020 (pdf 76020.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (INTL MEDICATION) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076058 (pdf 76058.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076144 (pdf 76144.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (INTL MEDICATED) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076379 (pdf 76379.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2005 , NDA 077115 (pdf 77115.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078141 (pdf 78141.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (PAI HOLDINGS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078511 (pdf 78511.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (PAI HOLDINGS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090315 (pdf 90315.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE (STERISCIENCE) APPROVAL= AP YEAR= 2010 , NDA 090316 (pdf 90316.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDOZALAM HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2011 , NDA 090850 (pdf 90850.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090696 (pdf 90696.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 203460 (pdf 203460.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2014 , NDA 208878 (label 208878.pdf) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209566 (label 209566.pdf) INN (MIDAZOLAM HYDROCHLORIDE) SEIZALAM (MMT) APPROVAL= AP YEAR= 2018 NEWAPPLICATION , NDA 211321 (label 211321.pdf) INN (MIDAZOLAM) NAYZILAM (UCB INC) APPROVAL= AP YEAR= 2019 , NDA 212847 (pdf 212847.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 211844 (label 211844.pdf) INN (MIDAZOLAM) MIDAZOLAM IN 0.9% SODIUM CHLORIDE (INFORLIFE) APPROVAL= AP YEAR= 2021 , NDA 215868 (label 215868.pdf) INN (MIDAZOLAM) MIDAZOLAM IN 0.8% SODIUM CHLORIDE (EXELA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216048 (pdf 216048.pdf not found) INN (MIDAZOLAM) MIDAZOLAM (CIPLA LTD) APPROVAL= TA YEAR= 2022 , NDA 216359 (label 216359.pdf) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE AUTOINJECTOR (RAFA LABS LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216159 (pdf 216159.pdf not found) INN (MIDAZOLAM) MIDAZOLAM IN 0.9% SODIUM CHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 217504 (pdf 217504.pdf not found) INN (MIDAZOLAM HYDROCHLORIDE) MIDAZOLAM HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , 530 ; ISOTRETINOIN ; 4759-48-2 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- KERATOLYTIC -- ANTI-ACNE AGENTS , ; NDA 018662 (label 18662.pdf) INN (ISOTRETINOIN) ACCUTANE (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 075945 (pdf 75945.pdf not found) INN (ISOTRETINOIN) AMNESTEEM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 , NDA 076041 (label 76041.pdf) INN (ISOTRETINOIN) SOTRET (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076135 (pdf 76135.pdf not found) INN (ISOTRETINOIN) CLARAVIS (TEVA PHARMS USA) APPROVAL= AP YEAR= 2003 , NDA 076356 (pdf 76356.pdf not found) INN (ISOTRETINOIN) CLARAVIS (TEVA PHARMS USA) APPROVAL= AP YEAR= 2003 , NDA 076503 (pdf 76503.pdf not found) INN (ISOTRETINOIN) SOTRET (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076485 (pdf 76485.pdf not found) INN (ISOTRETINOIN) MYORISAN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2012 , NDA 021951 (label 21951.pdf) INN (ISOTRETINOIN) ABSORICA (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2012 , NDA 202099 (pdf 202099.pdf not found) INN (ISOTRETINOIN) ZENATANE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 207792 (pdf 207792.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2017 , NDA 211913 (label 211913.pdf) INN (ISOTRETINOIN) ABSORICA LD (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 205063 (pdf 205063.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2021 , NDA 213571 (pdf 213571.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2021 , NDA 212333 (pdf 212333.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2021 , NDA 211568 (pdf 211568.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 218194 (pdf 218194.pdf not found) INN (ISOTRETINOIN) ISOTRETINOIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , 531 ; LEVONORGESTREL ; 797-63-7 ; 1979 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVES , ; NDA 018668 (label 18668.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) NORDETTE-21 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018782 (label 18782.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) NORDETTE-28 (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 019190 (label 19190.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIPHASIL-28 (WYETH PHARMS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019192 (label 19192.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIPHASIL-21 (WYETH PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019897 (pdf 19897.pdf not found) INN (LEVONORGESTREL) NORPLANT (POPULATION COUNCIL) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020088 (pdf 20088.pdf not found) INN (LEVONORGESTREL) NORPLANT SYSTEM IN PLASTIC CONTAINER (WYETH PHARMS INC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020544 (label 20544.pdf) INN (LEVONORGESTREL) JADELLE (POPULATION COUNCIL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020627 (pdf 20627.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020683 (label 20683.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ALESSE (CADENCE HEALTH) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020860 (pdf 20860.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVLITE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020946 (label 20946.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) PREVEN EMERGENCY CONTRACEPTIVE KIT (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021045 (label 21045.pdf) INN (LEVONORGESTREL) PLAN B (FDN CONSUMER) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021225 (label 21225.pdf) INN (LEVONORGESTREL) MIRENA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2000 , NDA 021258 (label 21258.pdf) INN (ESTRADIOL LEVONORGESTREL) CLIMARA PRO (BAYER HLTHCARE) APPROVAL= AP YEAR= 2003 , NDA 021544 (label 21544.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SEASONALE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2003 , NDA 021840 (label 21840.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SEASONIQUE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2006 , NDA 021864 (label 21864.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LYBREL (WYETH PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021885 (label 21885.pdf) INN (ESTRADIOL LEVONORGESTREL) CLIMARA PRO (BERLEX LABS) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 073592 (pdf 73592.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVORA 0.15/30-21 (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073594 (pdf 73594.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVORA 0.15/30-28 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1993 , NDA 074538 (label 74538.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TRIVORA-21 (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1997 , NDA 075796 (label 75796.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AVIANE-28 (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 075803 (label 75803.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LESSINA-21 (BARR) APPROVAL= AP YEAR= 2002 , NDA 075809 (pdf 75809.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ENPRESSE-21 (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2001 , NDA 075862 (pdf 75862.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075866 (pdf 75866.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) PORTIA-21 (BARR) APPROVAL= AP YEAR= 2002 , NDA 076625 (label 76625.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2004 , NDA 077101 (pdf 77101.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) QUASENSE (WATSON LABS) APPROVAL= AP YEAR= 2006 , NDA 077681 (label 77681.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2006 , NDA 021998 (label 21998.pdf) INN (LEVONORGESTREL) PLAN B ONE-STEP (FDN CONSUMER) APPROVAL= AP YEAR= 2009 , NDA 022262 (label 22262.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LOSEASONIQUE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2008 , NDA 078665 (pdf 78665.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (FDN CONSUMER) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078666 (pdf 78666.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (WATSON LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078834 (pdf 78834.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 , NDA 079064 (pdf 79064.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) INTROVALE (XIROMED) APPROVAL= AP YEAR= 2010 , NDA 079102 (pdf 79102.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ALTAVERA (XIROMED) APPROVAL= AP YEAR= 2010 , NDA 090719 (pdf 90719.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONEST (NOVAST LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 090740 (pdf 90740.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (L PERRIGO CO) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077099 (pdf 77099.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ORSYTHIA (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079218 (pdf 79218.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 077502 (pdf 77502.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MYZILRA (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2011 , NDA 091674 (pdf 91674.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 200407 (pdf 200407.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090721 (pdf 90721.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) FALMINA (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091408 (pdf 91408.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) KURVELO (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 091440 (pdf 91440.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 091452 (pdf 91452.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MARLISSA (GLENMARK GENERICS) APPROVAL= AP YEAR= 2012 , NDA 091663 (pdf 91663.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 200670 (pdf 200670.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (FDN CONSUMER) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091328 (pdf 91328.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 091425 (pdf 91425.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 091467 (pdf 91467.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) DAYSEE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 200245 (pdf 200245.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202508 (pdf 202508.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (NOVEL LABS INC) APPROVAL= AP YEAR= 2013 , NDA 203159 (label 203159.pdf) INN (LEVONORGESTREL) SKYLA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 204061 (label 204061.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) QUARTETTE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2013 , NDA 090716 (pdf 90716.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SETLAKIN (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 201095 (pdf 201095.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201108 (pdf 201108.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201446 (pdf 201446.pdf not found) INN (LEVONORGESTREL) FALLBACK SOLO (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202247 (pdf 202247.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202334 (pdf 202334.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (PERRIGO R AND D) APPROVAL= AP YEAR= 2014 , NDA 202635 (pdf 202635.pdf not found) INN (LEVONORGESTREL) OPCICON ONE-STEP (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 202739 (pdf 202739.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (XIROMED) APPROVAL= AP YEAR= 2014 , NDA 200490 (pdf 200490.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 200492 (pdf 200492.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 200493 (pdf 200493.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 201088 (pdf 201088.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) VIENVA (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202246 (pdf 202246.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (ALVOGEN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202380 (pdf 202380.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (NAARI PTE LTD) APPROVAL= AP YEAR= 2015 , NDA 202791 (pdf 202791.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (GLENMARK GENERICS) APPROVAL= AP YEAR= 2015 , NDA 203163 (pdf 203163.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ASHLYNA (GLENMARK GENERICS) APPROVAL= AP YEAR= 2015 , NDA 203164 (pdf 203164.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 206229 (label 206229.pdf) INN (LEVONORGESTREL) LILETTA (MEDICINES360) APPROVAL= AP YEAR= 2015 , NDA 091690 (pdf 91690.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ETHINYL ESTRADIOL AND LEVONORGESTREL (NOVAST LABS) APPROVAL= TA YEAR= 2015 , NDA 200248 (pdf 200248.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202507 (pdf 202507.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ELIFEMME (XIROMED) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203871 (pdf 203871.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203872 (pdf 203872.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206867 (pdf 206867.pdf not found) INN (LEVONORGESTREL) ATHENTIA NEXT (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 205943 (pdf 205943.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) FAYOSIM (LUPIN LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207044 (pdf 207044.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207976 (pdf 207976.pdf not found) INN (LEVONORGESTREL) HER STYLE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 018206 (label 18206.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL FERROUS FUMARATE) LO/OVRAL FE (CADENCE HEALTH) APPROVAL= AP YEAR= 1979 , NDA 202684 (pdf 202684.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202740 (pdf 202740.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (XIROMED) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206866 (pdf 206866.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AYUNA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206886 (pdf 206886.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) AFIRMELLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 208224 (label 208224.pdf) INN (LEVONORGESTREL) KYLEENA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 206053 (pdf 206053.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 206201 (pdf 206201.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ETHINYL ESTRADIOL LEVONORGESTREL (MAYNE PHARMA INC) APPROVAL= TA YEAR= 2017 , NDA 206851 (pdf 206851.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SIMPESSE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206852 (pdf 206852.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LO SIMPESSE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203770 (pdf 203770.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) JAIMIESS (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 205131 (pdf 205131.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (XIROMED) APPROVAL= AP YEAR= 2017 , NDA 202970 (pdf 202970.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208612 (label 208612.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) BALCOLTRA (AVION PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204044 (pdf 204044.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (LABORATOIRE HRA) APPROVAL= AP YEAR= 2018 , NDA 205329 (pdf 205329.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 206850 (pdf 206850.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) ICLEVIA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 202817 (pdf 202817.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) CERINTA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 202988 (pdf 202988.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) SYLEVIA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207660 (pdf 207660.pdf not found) INN (LEVONORGESTREL) LEVONORGESTREL (NAARI PTE LTD) APPROVAL= AP YEAR= 2019 , NDA 204017 (label 204017.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TWIRLA (AGILE) APPROVAL= AP YEAR= 2020 , NDA 209405 (label 209405.pdf) INN (ETHINYL ESTRADIOL LEVONORGESTREL) TYBLUME (EXELTIS USA INC) APPROVAL= AP YEAR= 2020 , NDA 091692 (pdf 91692.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) DOLISHALE (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 207033 (pdf 207033.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2020 , NDA 207065 (pdf 207065.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2020 , NDA 212298 (pdf 212298.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2023 , NDA 214640 (pdf 214640.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (XIROMED) APPROVAL= AP YEAR= 2023 , NDA 217087 (pdf 217087.pdf not found) INN (ETHINYL ESTRADIOL LEVONORGESTREL) MINZOYA (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 532 ; NICLOSAMIDE ; 50-65-7 ; 0 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TENIACIDE -- INHIBITS OXIDATIVE PHOSPHORYLATION IN MITOCHONDRIA OF THE WORMS RESULTING IN ENERGY DEPLETION , ; NDA 018669 (pdf 18669.pdf not found) INN (NICLOSAMIDE) NICLOCIDE (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 533 ; NABILONE ; 51022-71-0 ; 1985 ; ; ; CLASS METABOLISM -- ANXIOLYTIC -- ANTIEMETIC -- CANNABINOID RECEPTOR 1 AGONIST -- TREATMENT OF NAUSEA AND VOMITING INDUCED BY CANCER CHEMOTHERAPY -- SIMILAR TO THE ACTIVE INGREDIENT FOUND IN NATURALLY OCCURRING CANNABIS SATIVA L. , ; NDA 018677 (label 18677.pdf) INN (NABILONE) CESAMET (BAUSCH) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , 534 ; TIOCONAZOLE ; 65899-73-2 ; 1983 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- LOCAL TREATMENT OF VULVOVAGINAL CANDIDIASIS (MONILIASIS) , ; NDA 018682 (pdf 18682.pdf not found) INN (TIOCONAZOLE) TZ-3 (PFIZER) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 020676 (label 20676.pdf) INN (TIOCONAZOLE) VAGISTAT-1 (COMBE) APPROVAL= AP YEAR= 1997 , NDA 075915 (pdf 75915.pdf not found) INN (TIOCONAZOLE) TIOCONAZOLE (PERRIGO) APPROVAL= AP YEAR= 2001 , 535 ; LABETALOL ; 36894-69-6 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- SYMPATHOLYTICS , ; NDA 018686 (pdf 18686.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 018687 (pdf 18687.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018716 (label 18716.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (ALVOGEN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019046 (pdf 19046.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) NORMOZIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019174 (pdf 19174.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) TRANDATE HCT (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019425 (label 19425.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 074787 (label 74787.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1998 , NDA 074989 (pdf 74989.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075113 (pdf 75113.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075133 (pdf 75133.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 , NDA 075215 (pdf 75215.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1999 , NDA 075223 (pdf 75223.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075239 (label 75239.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075240 (pdf 75240.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075242 (pdf 75242.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075303 (pdf 75303.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 075355 (pdf 75355.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= TA YEAR= 1999 , NDA 075431 (pdf 75431.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 , NDA 075524 (pdf 75524.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076051 (pdf 76051.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2002 , NDA 079134 (pdf 79134.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090699 (pdf 90699.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 200908 (pdf 200908.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 207743 (pdf 207743.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209603 (pdf 209603.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207863 (pdf 207863.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 , NDA 211325 (pdf 211325.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212990 (pdf 212990.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213330 (label 213330.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE IN DEXTROSE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 211953 (pdf 211953.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 214533 (pdf 214533.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 212719 (pdf 212719.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , 536 ; PRAZIQUANTEL ; 55268-74-1 ; 1982 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF OF SCHISTOSOME INFECTIONS AND INFECTIONS DUE TO LIVER FLUKE -- ANTIMALARIALS , ; NDA 018714 (label 18714.pdf) INN (PRAZIQUANTEL) BILTRICIDE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 208820 (pdf 208820.pdf not found) INN (PRAZIQUANTEL) PRAZIQUANTEL (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , 537 ; RANITIDINE ; 66357-35-5 ; 1983 ; ; ; CLASS METABOLISM -- HISTAMINE H2 RECEPTOR BLOCKER -- ANTI-ULCER AGENTS , ; NDA 018703 (label 18703.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 150 (GLAXO GRP LTD) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 019090 (label 19090.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019593 (label 19593.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC IN PLASTIC CONTAINER (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019675 (label 19675.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC (GLAXO GRP LTD) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 020095 (pdf 20095.pdf not found) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 150 (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020251 (label 20251.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 150 (GLAXO GRP LTD) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020520 (label 20520.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 75 (CHATTEM SANOFI) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020559 (label 20559.pdf) INN (RANITIDINE BISMUTH CITRATE) TRITEC (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020745 (pdf 20745.pdf not found) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 75 (CHATTEM SANOFI) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021698 (label 21698.pdf) INN (RANITIDINE HYDROCHLORIDE) ZANTAC 150 (CHATTEM SANOFI) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074023 (pdf 74023.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074104 (pdf 74104.pdf not found) INN (RANITIDINE) RANITIDINE (TEVA) APPROVAL= TA YEAR= 1994 OBSOLETE , NDA 074467 (pdf 74467.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074488 (pdf 74488.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074552 (pdf 74552.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074655 (pdf 74655.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074662 (pdf 74662.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074680 (pdf 74680.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 1997 , NDA 074764 (pdf 74764.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (BEDFORD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074777 (pdf 74777.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 074794 (pdf 74794.pdf not found) INN (RANITIDINE) RANITIDINE (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 1997 , NDA 074864 (pdf 74864.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075000 (pdf 75000.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (RANBAXY) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075094 (pdf 75094.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075132 (pdf 75132.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075165 (pdf 75165.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075167 (pdf 75167.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075180 (pdf 75180.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075208 (pdf 75208.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT LTD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075212 (pdf 75212.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075254 (pdf 75254.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (RANBAXY) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075294 (pdf 75294.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2000 , NDA 075296 (pdf 75296.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075439 (pdf 75439.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075497 (pdf 75497.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075519 (pdf 75519.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075557 (pdf 75557.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075564 (pdf 75564.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075742 (pdf 75742.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2000 , NDA 076124 (pdf 76124.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076195 (pdf 76195.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076705 (pdf 76705.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2005 , NDA 076760 (pdf 76760.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077405 (pdf 77405.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077426 (pdf 77426.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077458 (pdf 77458.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077476 (pdf 77476.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077602 (pdf 77602.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077824 (pdf 77824.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078192 (pdf 78192.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 078312 (pdf 78312.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078448 (pdf 78448.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (RANBAXY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078653 (pdf 78653.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078884 (pdf 78884.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078542 (pdf 78542.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 078684 (pdf 78684.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078701 (pdf 78701.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079211 (pdf 79211.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079212 (pdf 79212.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090102 (pdf 90102.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078890 (pdf 78890.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090054 (pdf 90054.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (TOLMAR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090623 (pdf 90623.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091288 (pdf 91288.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091078 (pdf 91078.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091429 (pdf 91429.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091091 (pdf 91091.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200536 (pdf 200536.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200172 (pdf 200172.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201745 (pdf 201745.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091534 (pdf 91534.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 079076 (pdf 79076.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205512 (pdf 205512.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203694 (pdf 203694.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207578 (pdf 207578.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207579 (pdf 207579.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209160 (pdf 209160.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209161 (pdf 209161.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209859 (pdf 209859.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210010 (pdf 210010.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210243 (pdf 210243.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210681 (pdf 210681.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211058 (pdf 211058.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211289 (pdf 211289.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (VKT PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211893 (pdf 211893.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210228 (pdf 210228.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210250 (pdf 210250.pdf not found) INN (RANITIDINE HYDROCHLORIDE) RANITIDINE HYDROCHLORIDE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2019 DISCONTINUED , 538 ; QUAZEPAM ; 36735-22-5 ; 1985 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- BENZODIAZEPINES -- GABA MODULATORS -- SEDATIVES , ; NDA 018708 (label 18708.pdf) INN (QUAZEPAM) DORAL (GALT PHARMS) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , 539 ; PRAZIQUANTEL ; 55268-74-1 ; 1982 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF OF SCHISTOSOME INFECTIONS AND INFECTIONS DUE TO LIVER FLUKE , ; NDA 018714 (label 18714.pdf) INN (PRAZIQUANTEL) BILTRICIDE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 208820 (pdf 208820.pdf not found) INN (PRAZIQUANTEL) PRAZIQUANTEL (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , 540 ; TRILOSTANE ; 13647-35-3 ; 1984 ; DISCONTINUED ; ; CLASS HORMONE -- ANTINEOPLASTIC -- ANTIADRENAL -- 3-BETA-HYDROXYSTEROID DEHYDROGENASE INHIBITOR (PMID12209583) , ; NDA 018719 (pdf 18719.pdf not found) INN (TRILOSTANE) MODRASTANE (BIOENVISION) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , 541 ; MILNACIPRAN ; 92623-85-3 ; 2009 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER -- SEROTONIN (KI=11 NANOMOLAR) AND NOREPINEPHRINE (KI=91 NANOMOLAR) REUPTAKE INHIBITOR (SNRI) -- MANAGEMENT OF FIBROMYALGIA , ; NDA 022256 (label 22256.pdf) INN (MILNACIPRAN HYDROCHLORIDE) SAVELLA (ABBVIE) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 205081 (pdf 205081.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205367 (pdf 205367.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2020 , NDA 205062 (pdf 205062.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (PAR PHARM INC) APPROVAL= TA YEAR= 2015 , NDA 205286 (pdf 205286.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (LUPIN LTD) APPROVAL= TA YEAR= 2015 , NDA 205071 (pdf 205071.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (USPHARMA WINDLAS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205267 (pdf 205267.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2017 , NDA 210944 (pdf 210944.pdf not found) INN (MILNACIPRAN HYDROCHLORIDE) MILNACIPRAN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2022 , 542 ; BUSPIRONE ; 36505-84-7 ; 1986 ; ; ; CLASS NERVOUS SYSTEM -- 5HT1A RECEPTOR AGONIST -- ANXIOLYTIC -- SEROTONIN AGONISTS , ; NDA 018731 (label 18731.pdf) INN (BUSPIRONE HYDROCHLORIDE) BUSPAR (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 021190 (pdf 21190.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPAR (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074253 (pdf 74253.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2001 , NDA 074684 (pdf 74684.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HCL (NOVOPHARM LIMITED) APPROVAL= TA YEAR= 1998 OBSOLETE , NDA 075022 (pdf 75022.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075119 (pdf 75119.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (EGIS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075272 (pdf 75272.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1998 OBSOLETE , NDA 075385 (pdf 75385.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075388 (pdf 75388.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2002 , NDA 075413 (pdf 75413.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075467 (pdf 75467.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075521 (pdf 75521.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2002 , NDA 075572 (pdf 75572.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076008 (pdf 76008.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2001 , NDA 078302 (pdf 78302.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2007 , NDA 078246 (pdf 78246.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2009 , NDA 078888 (pdf 78888.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 202330 (pdf 202330.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 202557 (pdf 202557.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 202087 (pdf 202087.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (AIPING PHARM INC) APPROVAL= AP YEAR= 2015 , NDA 204582 (pdf 204582.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2015 , NDA 208829 (pdf 208829.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209696 (pdf 209696.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 208972 (pdf 208972.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 210907 (pdf 210907.pdf not found) INN (BUSPIRONE HYDROCHLORIDE) BUSPIRONE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2019 , 543 ; SULCONAZOLE ; 61318-90-9 ; 1985 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- CYTOCHROME P450 INHIBITOR , ; NDA 018737 (label 18737.pdf) INN (SULCONAZOLE NITRATE) EXELDERM (JOURNEY) APPROVAL= AP YEAR= 1989 , NDA 018738 (label 18738.pdf) INN (SULCONAZOLE NITRATE) EXELDERM (JOURNEY) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , 544 ; ANTAZOLINE ; 91-75-8 ; 1990 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTI-ALLERGIC , ; NDA 018746 (pdf 18746.pdf not found) INN (ANTAZOLINE PHOSPHATE NAPHAZOLINE HYDROCHLORIDE) VASOCON-A (NOVARTIS) APPROVAL= AP YEAR= 1990 NEWAPPLICATION DISCONTINUED , 545 ; NAPHAZOLINE ; 835-31-4 ; 1971 ; ; ; CLASS RESPIRATORY SYSTEM -- ALPHA ADRENERGIC RECEPTOR AGONIST -- ANTIALLERGIC , ; NDA 018746 (pdf 18746.pdf not found) INN (ANTAZOLINE PHOSPHATE NAPHAZOLINE HYDROCHLORIDE) VASOCON-A (NOVARTIS) APPROVAL= AP YEAR= 1990 NEWAPPLICATION DISCONTINUED , NDA 020065 (label 20065.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) OPCON-A (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 020226 (label 20226.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHCON-A (ALCON) APPROVAL= AP YEAR= 1994 , NDA 020485 (label 20485.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) VISINE (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1996 , NDA 040073 (pdf 40073.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) NAFAZAIR (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 080229 (pdf 80229.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) NAPHCON FORTE (ALCON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080235 (pdf 80235.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) VASOCON (NOVARTIS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080248 (pdf 80248.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) ALBALON (ALLERGAN) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083590 (pdf 83590.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) NAPHAZOLINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 087506 (pdf 87506.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) OPCON (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088101 (pdf 88101.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE) NAFAZAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 078208 (pdf 78208.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 202795 (pdf 202795.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (RISING) APPROVAL= AP YEAR= 2013 , 546 ; CICLOPIROX ; 29342-05-0 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- CHELATION OF POLYVALENT CATIONS RESULTING IN THE INHIBITION OF THE METAL-DEPENDENT ENZYMES THAT ARE RESPONSIBLE FOR THE DEGRADATION OF PEROXIDES WITHIN THE FUNGAL CELL , ; NDA 018748 (label 18748.pdf) INN (CICLOPIROX) LOPROX (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , NDA 019824 (label 19824.pdf) INN (CICLOPIROX) LOPROX (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1988 , NDA 020519 (label 20519.pdf) INN (CICLOPIROX) CICLOPIROX (ALVOGEN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021022 (label 21022.pdf) INN (CICLOPIROX) PENLAC (VALEANT BERMUDA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021159 (label 21159.pdf) INN (CICLOPIROX) LOPROX (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 076422 (pdf 76422.pdf not found) INN (CICLOPIROX) CICLOPIROX (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076435 (pdf 76435.pdf not found) INN (CICLOPIROX) CICLOPIROX (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076790 (pdf 76790.pdf not found) INN (CICLOPIROX) CICLOPIROX (TARO) APPROVAL= AP YEAR= 2005 , NDA 077092 (pdf 77092.pdf not found) INN (CICLOPIROX) CICLOPIROX (TARO) APPROVAL= AP YEAR= 2005 , NDA 077364 (pdf 77364.pdf not found) INN (CICLOPIROX) CICLOPIROX (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2006 , NDA 077623 (pdf 77623.pdf not found) INN (CICLOPIROX) CICLOPIROX (PADAGIS US) APPROVAL= AP YEAR= 2007 , NDA 077676 (pdf 77676.pdf not found) INN (CICLOPIROX) CICLOPIROX (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2006 , NDA 077687 (pdf 77687.pdf not found) INN (CICLOPIROX) CICLOPIROX (ENCUBE) APPROVAL= AP YEAR= 2007 , NDA 077896 (pdf 77896.pdf not found) INN (CICLOPIROX) CICLOPIROX (FOUGERA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078046 (pdf 78046.pdf not found) INN (CICLOPIROX) CICLOPIROX (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 078079 (pdf 78079.pdf not found) INN (CICLOPIROX) CICLOPIROX (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078124 (pdf 78124.pdf not found) INN (CICLOPIROX) CICLOPIROX (RISING) APPROVAL= AP YEAR= 2007 , NDA 078144 (pdf 78144.pdf not found) INN (CICLOPIROX) CICLOPIROX (TARO PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 078172 (pdf 78172.pdf not found) INN (CICLOPIROX) CICLOPIROX (ACELLA) APPROVAL= AP YEAR= 2007 , NDA 078233 (pdf 78233.pdf not found) INN (CICLOPIROX) CICLOPIROX (COSETTE) APPROVAL= AP YEAR= 2007 , NDA 078270 (pdf 78270.pdf not found) INN (CICLOPIROX) CICLOPIROX (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078567 (pdf 78567.pdf not found) INN (CICLOPIROX) CICLOPIROX (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078266 (pdf 78266.pdf not found) INN (CICLOPIROX) CICLOPIROX (PADAGIS US) APPROVAL= AP YEAR= 2009 , NDA 078594 (pdf 78594.pdf not found) INN (CICLOPIROX) CICLOPIROX (PADAGIS US) APPROVAL= AP YEAR= 2010 , NDA 078975 (pdf 78975.pdf not found) INN (CICLOPIROX) CICLOPIROX (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090273 (pdf 90273.pdf not found) INN (CICLOPIROX) CICLOPIROX (GLENMARK PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090490 (pdf 90490.pdf not found) INN (CICLOPIROX) CICLOPIROX (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2009 , NDA 090146 (pdf 90146.pdf not found) INN (CICLOPIROX) CICLOPIROX (FOUGERA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078463 (pdf 78463.pdf not found) INN (CICLOPIROX) CICLOPIROX (COSETTE) APPROVAL= AP YEAR= 2010 , NDA 090269 (pdf 90269.pdf not found) INN (CICLOPIROX) CICLOPIROX (TARO) APPROVAL= AP YEAR= 2011 , NDA 091595 (pdf 91595.pdf not found) INN (CICLOPIROX) CICLOPIROX (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 209975 (pdf 209975.pdf not found) INN (CICLOPIROX) CICLOPIROX (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , 547 ; ACETOHYDROXAMIC ACID ; 546-88-3 ; 1983 ; ; ; CLASS GENITO -- UREASE INHIBITOR -- TREATMENT OF INFETION-INDUCED URINARY STONES , ; NDA 018749 (pdf 18749.pdf not found) INN (ACETOHYDROXAMIC ACID) LITHOSTAT (MISSION PHARMA) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY , 548 ; ECONAZOLE ; 27220-47-9 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- INHIBITORS , ; NDA 018751 (label 18751.pdf) INN (ECONAZOLE NITRATE) SPECTAZOLE (ALVOGEN) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 076005 (label 76005.pdf) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (TARO) APPROVAL= AP YEAR= 2002 , NDA 076075 (label 76075.pdf) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076479 (pdf 76479.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076574 (pdf 76574.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (ENCUBE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 205175 (label 205175.pdf) INN (ECONAZOLE NITRATE) ECOZA (RESILIA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 210364 (pdf 210364.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , 549 ; KETOPROFEN ; 22071-15-4 ; 1986 ; ; ; CLASS MUSCULO-SKELETEL SYSTEM -- NSAID -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- CYCLOOXYGENASE INHIBITORS -- ANTIRHEUMATIC -- ANTIPYRETIC -- ANALGESIC -- INHIBITORY EFFECTS ON PROSTAGLANDIN AND LEUKOTRIENE SYNTHESIS AND ANTIBRADYKININ ACTIVITY , ; NDA 018754 (label 18754.pdf) INN (KETOPROFEN) ORUDIS (WYETH AYERST) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 019816 (label 19816.pdf) INN (KETOPROFEN) ORUVAIL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020429 (pdf 20429.pdf not found) INN (KETOPROFEN) ORUDIS KT (WYETH CONS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020499 (pdf 20499.pdf not found) INN (KETOPROFEN) ACTRON (BAYER) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073515 (pdf 73515.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073516 (pdf 73516.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073517 (pdf 73517.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074014 (pdf 74014.pdf not found) INN (KETOPROFEN) KETOPROFEN (MISEMER) APPROVAL= AP YEAR= 1993 , NDA 074024 (pdf 74024.pdf not found) INN (KETOPROFEN) KETOPROFEN (RISING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074035 (pdf 74035.pdf not found) INN (KETOPROFEN) KETOPROFEN (RISING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074879 (pdf 74879.pdf not found) INN (KETOPROFEN) KETOPROFEN (ALKERMES GAINESVILLE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075270 (pdf 75270.pdf not found) INN (KETOPROFEN) KETOPROFEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075364 (pdf 75364.pdf not found) INN (KETOPROFEN) KETOPROFEN (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075679 (pdf 75679.pdf not found) INN (KETOPROFEN) KETOPROFEN (MYLAN) APPROVAL= AP YEAR= 2002 , NDA 022470 (pdf 22470.pdf not found) INN (KETOPROFEN) NEXCEDE (NOVARTIS) APPROVAL= AP YEAR= 2009 DISCONTINUED , 550 ; FLURBIPROFEN ; 5104-49-4 ; 1986 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANALGESICS -- NSAID -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- CYCLOOXYGENASE INHIBITORS , ; NDA 018766 (label 18766.pdf) INN (FLURBIPROFEN) ANSAID (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019404 (label 19404.pdf) INN (FLURBIPROFEN SODIUM) OCUFEN (ALLERGAN) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 074358 (pdf 74358.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074405 (pdf 74405.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074411 (pdf 74411.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074431 (pdf 74431.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074447 (pdf 74447.pdf not found) INN (FLURBIPROFEN SODIUM) FLURBIPROFEN SODIUM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 074448 (pdf 74448.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (RISING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074560 (pdf 74560.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (THERAGEN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074647 (pdf 74647.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075058 (pdf 75058.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , 551 ; ETOPOSIDE ; 33419-42-0 ; 1983 ; ; ; CLASS ANTINEOPLASTIC -- NUCLEIC ACID SYNTHESIS INHIBITORS -- INDUCTION OF DNA STRAND BREAKS BY AN INTERACTION WITH DNA-TOPOISOMERASE II OR THE FORMATION OF FREE RADICALS , ; NDA 018768 (label 18768.pdf) INN (ETOPOSIDE) VEPESID (CORDEN PHARMA) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 019557 (label 19557.pdf) INN (ETOPOSIDE) VEPESID (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 074166 (pdf 74166.pdf not found) INN (ETOPOSIDE) TOPOSAR (TEVA PARENTERAL) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074227 (pdf 74227.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (PHARMACHEMIE BV) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074228 (pdf 74228.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074284 (pdf 74284.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074290 (pdf 74290.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 074320 (pdf 74320.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074351 (pdf 74351.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074510 (pdf 74510.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074513 (pdf 74513.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1996 , NDA 074529 (pdf 74529.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (MEITHEAL) APPROVAL= AP YEAR= 1996 , NDA 074813 (pdf 74813.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (PIERRE FABRE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074968 (pdf 74968.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074983 (pdf 74983.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 , NDA 075635 (pdf 75635.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (MYLAN) APPROVAL= AP YEAR= 2001 , NDA 203507 (pdf 203507.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (DASH PHARMS NATCO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204927 (pdf 204927.pdf not found) INN (ETOPOSIDE) ETOPOSIDE (DASH PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , 552 ; VECURONIUM ; 50700-72-6 ; 1984 ; ; ; CLASS MUSCULO-SKELETAL -- NEUROMUSCULAR BLOCKER -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- CURARIFORM -- ANTAGONISM TO ACETYLCHOLINE , ; NDA 018776 (pdf 18776.pdf not found) INN (VECURONIUM BROMIDE) NORCURON (ORGANON USA INC) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 074334 (pdf 74334.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074688 (pdf 74688.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (MEITHEAL) APPROVAL= AP YEAR= 1999 , NDA 075164 (pdf 75164.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075218 (pdf 75218.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075549 (label 75549.pdf) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075558 (pdf 75558.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (HOSPIRA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 078274 (pdf 78274.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 079001 (pdf 79001.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 090243 (pdf 90243.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 205390 (pdf 205390.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (GLAND) APPROVAL= AP YEAR= 2016 , NDA 206670 (pdf 206670.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 203725 (pdf 203725.pdf not found) INN (VECURONIUM BROMIDE) VECURONIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2019 , 553 ; FLECAINIDE ; 54143-55-4 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- CARDIAC DEPRESSANT , ; NDA 018830 (label 18830.pdf) INN (FLECAINIDE ACETATE) TAMBOCOR (ALVOGEN) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 075442 (pdf 75442.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (AMNEAL PHARM) APPROVAL= AP YEAR= 2001 , NDA 075882 (pdf 75882.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076030 (pdf 76030.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076278 (pdf 76278.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076421 (pdf 76421.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 , NDA 079164 (pdf 79164.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (CHARTWELL) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 202821 (pdf 202821.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 210683 (pdf 210683.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 215599 (pdf 215599.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2022 , 554 ; OXAPROZIN ; 21256-18-8 ; 1992 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- NSAID -- ANALGESIC -- ANTIPYRETIC -- MAY BE RELATED TO PROSTAGLANDIN SYNTHETASE INHIBITION , ; NDA 018841 (label 18841.pdf) INN (OXAPROZIN) DAYPRO (PFIZER) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020776 (label 20776.pdf) INN (OXAPROZIN POTASSIUM) DAYPRO ALTA (PFIZER) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075842 (pdf 75842.pdf not found) INN (OXAPROZIN) OXAPROZIN (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075843 (pdf 75843.pdf not found) INN (OXAPROZIN) OXAPROZIN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075844 (pdf 75844.pdf not found) INN (OXAPROZIN) OXAPROZIN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075845 (pdf 75845.pdf not found) INN (OXAPROZIN) OXAPROZIN (SANDOZ) APPROVAL= AP YEAR= 2001 , NDA 075846 (pdf 75846.pdf not found) INN (OXAPROZIN) OXAPROZIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075847 (pdf 75847.pdf not found) INN (OXAPROZIN) OXAPROZIN (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075848 (pdf 75848.pdf not found) INN (OXAPROZIN) OXAPROZIN (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075849 (pdf 75849.pdf not found) INN (OXAPROZIN) OXAPROZIN (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075850 (pdf 75850.pdf not found) INN (OXAPROZIN) OXAPROZIN (SANDOZ) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075851 (label 75851.pdf) INN (OXAPROZIN) OXAPROZIN (MYLAN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075855 (pdf 75855.pdf not found) INN (OXAPROZIN) OXAPROZIN (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2001 , NDA 075987 (pdf 75987.pdf not found) INN (OXAPROZIN) OXAPROZIN (CHARTWELL) APPROVAL= AP YEAR= 2004 , NDA 208633 (pdf 208633.pdf not found) INN (OXAPROZIN) OXAPROZIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 217927 (pdf 217927.pdf not found) INN (OXAPROZIN) COXANTO (SOLUBIOMIX) APPROVAL= AP YEAR= 2023 , 555 ; RIBAVIRIN ; 36791-04-5 ; 1985 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTIMETABOLITES -- TREATMENT OF CHRONIC HEPATITIS C , ; NDA 018859 (pdf 18859.pdf not found) INN (RIBAVIRIN) VIRAZOLE (BAUSCH) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 020903 (label 20903.pdf) INN (RIBAVIRIN) REBETOL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021511 (label 21511.pdf) INN (RIBAVIRIN) COPEGUS (ROCHE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021546 (label 21546.pdf) INN (RIBAVIRIN) REBETOL (SCHERING) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076192 (label 76192.pdf) INN (RIBAVIRIN) RIBAVIRIN (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076203 (label 76203.pdf) INN (RIBAVIRIN) RIBASPHERE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076277 (pdf 76277.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077053 (pdf 77053.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077094 (pdf 77094.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 077224 (pdf 77224.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 077456 (pdf 77456.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077743 (pdf 77743.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 125083 (pdf 125083.pdf not found) INN (RIBAVIRIN) PEGINTERFERON (HOFFMAN-LA ROCHE) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 125196 (label 125196.pdf) INN (RIBAVIRIN) PEGINTRON/REBETOL COMBO PACK (SCHERING) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 079111 (pdf 79111.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 079117 (pdf 79117.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 077611 (pdf 77611.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (TEVA PHARMS) APPROVAL= TA YEAR= 2011 , NDA 202546 (pdf 202546.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 207366 (pdf 207366.pdf not found) INN (RIBAVIRIN) RIBAVIRIN (NAVINTA LLC) APPROVAL= AP YEAR= 2016 , 556 ; NIMODIPINE ; 66085-59-4 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- CALCIUM CHANNEL ANTAGONIST -- ANTIHYPERTENSIVE AGENTS , ; NDA 018869 (label 18869.pdf) INN (NIMODIPINE) NIMOTOP (BAYER PHARMS) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 076740 (pdf 76740.pdf not found) INN (NIMODIPINE) NIMODIPINE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 077067 (pdf 77067.pdf not found) INN (NIMODIPINE) NIMODIPINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077811 (pdf 77811.pdf not found) INN (NIMODIPINE) NIMODIPINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2007 , NDA 203340 (label 203340.pdf) INN (NIMODIPINE) NYMALIZE (AZURITY) APPROVAL= AP YEAR= 2013 , NDA 090103 (pdf 90103.pdf not found) INN (NIMODIPINE) NIMODIPINE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2014 , NDA 201832 (pdf 201832.pdf not found) INN (NIMODIPINE) NIMODIPINE (SOFGEN PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 213409 (pdf 213409.pdf not found) INN (NIMODIPINE) NIMODIPINE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2023 , 557 ; MEXILETINE ; 31828-71-4 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- LOCAL ANESTHETIC -- ANTIARRYTHMIC -- SODIUM CHANNEL BLOCKER , ; NDA 018873 (pdf 18873.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXITIL (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 074377 (pdf 74377.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074450 (pdf 74450.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 , NDA 074711 (pdf 74711.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074865 (label 74865.pdf) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 213500 (pdf 213500.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2020 , NDA 214352 (pdf 214352.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2021 , NDA 214089 (pdf 214089.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215315 (pdf 215315.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ZENARA) APPROVAL= AP YEAR= 2022 , NDA 216463 (pdf 216463.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215876 (pdf 215876.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2023 , 558 ; ACEBUTOLOL ; 37517-30-9 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ANTIARRHYTHMIC -- ADRENERGIC (BETA) BLOCKER , ; NDA 018917 (label 18917.pdf) INN (ACEBUTOLOL HYDROCHLORIDE) SECTRAL (PROMIUS PHARMA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 074007 (pdf 74007.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 , NDA 074288 (pdf 74288.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075047 (pdf 75047.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 1999 , 559 ; ETODOLAC ; 41340-25-4 ; 1991 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- NSAID -- ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITORS , ; NDA 018922 (label 18922.pdf) INN (ETODOLAC) LODINE (WYETH PHARMS INC) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020584 (label 20584.pdf) INN (ETODOLAC) LODINE XL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074819 (pdf 74819.pdf not found) INN (ETODOLAC) ETODOLAC (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074839 (pdf 74839.pdf not found) INN (ETODOLAC) ETODOLAC (SHREE HARI INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074840 (pdf 74840.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074841 (pdf 74841.pdf not found) INN (ETODOLAC) ETODOLAC (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074842 (pdf 74842.pdf not found) INN (ETODOLAC) ETODOLAC (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074844 (pdf 74844.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074846 (pdf 74846.pdf not found) INN (ETODOLAC) ETODOLAC (SHREE HARI INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074847 (pdf 74847.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074883 (pdf 74883.pdf not found) INN (ETODOLAC) ETODOLAC (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074892 (pdf 74892.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074899 (pdf 74899.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074903 (pdf 74903.pdf not found) INN (ETODOLAC) ETODOLAC (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074927 (pdf 74927.pdf not found) INN (ETODOLAC) ETODOLAC (BIOPHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074929 (label 74929.pdf) INN (ETODOLAC) ETODOLAC (BIOPHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074932 (pdf 74932.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074942 (pdf 74942.pdf not found) INN (ETODOLAC) ETODOLAC (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075009 (pdf 75009.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075012 (pdf 75012.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075069 (pdf 75069.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075071 (pdf 75071.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075074 (pdf 75074.pdf not found) INN (ETODOLAC) ETODOLAC (TARO PHARM INDS) APPROVAL= AP YEAR= 1998 , NDA 075078 (pdf 75078.pdf not found) INN (ETODOLAC) ETODOLAC (TARO) APPROVAL= AP YEAR= 1998 , NDA 075104 (pdf 75104.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075126 (pdf 75126.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075226 (pdf 75226.pdf not found) INN (ETODOLAC) ETODOLAC (RANBAXY LABS LTD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075419 (pdf 75419.pdf not found) INN (ETODOLAC) ETODOLAC (APOTEX) APPROVAL= AP YEAR= 2000 , NDA 075665 (pdf 75665.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075696 (pdf 75696.pdf not found) INN (ETODOLAC) ETODOLAC (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075829 (pdf 75829.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075943 (pdf 75943.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076004 (pdf 76004.pdf not found) INN (ETODOLAC) ETODOLAC (APOTEX INC) APPROVAL= AP YEAR= 2002 , NDA 076174 (pdf 76174.pdf not found) INN (ETODOLAC) ETODOLAC (TARO) APPROVAL= AP YEAR= 2003 , NDA 091134 (pdf 91134.pdf not found) INN (ETODOLAC) ETODOLAC (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 208834 (pdf 208834.pdf not found) INN (ETODOLAC) ETODOLAC (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209888 (pdf 209888.pdf not found) INN (ETODOLAC) ETODOLAC (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210704 (pdf 210704.pdf not found) INN (ETODOLAC) ETODOLAC (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 212263 (pdf 212263.pdf not found) INN (ETODOLAC) ETODOLAC (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 204729 (pdf 204729.pdf not found) INN (ETODOLAC) ETODOLAC (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 560 ; NALTREXONE ; 16590-41-3 ; 1984 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTIC ANTAGONIST -- OPIATE ANTAGONISTS -- TREATMENT OF ALCOHOL DEPENDENCE , ; NDA 018932 (label 18932.pdf) INN (NALTREXONE HYDROCHLORIDE) REVIA (TEVA WOMENS) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 021897 (label 21897.pdf) INN (NALTREXONE) VIVITROL (ALKERMES) APPROVAL= AP YEAR= 2006 , NDA 074918 (pdf 74918.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 1998 , NDA 075274 (pdf 75274.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (ELITE LABS) APPROVAL= AP YEAR= 1999 , NDA 075434 (label 75434.pdf) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076264 (pdf 76264.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 , NDA 022321 (label 22321.pdf) INN (MORPHINE SULFATE NALTREXONE HYDROCHLORIDE) EMBEDA (ALPHARMA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091205 (pdf 91205.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 090356 (pdf 90356.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 200063 (label 200063.pdf) INN (BUPROPION HYDROCHLORIDE NALTREXONE HYDROCHLORIDE) CONTRAVE (NALPROPION) APPROVAL= AP YEAR= 2014 , NDA 207621 (label 207621.pdf) INN (NALTREXONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE) TROXYCA ER (PFIZER) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207905 (pdf 207905.pdf not found) INN (NALTREXONE HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2017 , NDA 208043 (pdf 208043.pdf not found) INN (NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE) NALTREXONE HYDROCHLORIDE BUPROPION HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2022 , NDA 213195 (pdf 213195.pdf not found) INN (NALTREXONE) NALTREXONE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2023 DISCONTINUED , 561 ; FLUOXETINE ; 54910-89-3 ; 1987 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) -- INHIBITION OF CNS NEURONAL UPTAKE OF SEROTONIN , ; NDA 018936 (label 18936.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (ELI LILLY AND CO) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 020101 (label 20101.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (LILLY) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020974 (label 20974.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (LILLY) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021235 (label 21235.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC WEEKLY (LILLY) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021520 (label 21520.pdf) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) SYMBYAX (LILLY) APPROVAL= AP YEAR= 2003 , NDA 021860 (label 21860.pdf) INN (FLUOXETINE HYDROCHLORIDE) SARAFEM (APIL) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 074803 (label 74803.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075049 (label 75049.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 2001 , NDA 075207 (pdf 75207.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075245 (pdf 75245.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 , NDA 075292 (pdf 75292.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2002 , NDA 075452 (pdf 75452.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075464 (pdf 75464.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LANDELA PHARM) APPROVAL= AP YEAR= 2002 , NDA 075465 (label 75465.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2002 , NDA 075506 (pdf 75506.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2001 , NDA 075514 (pdf 75514.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075525 (pdf 75525.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075577 (pdf 75577.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075658 (pdf 75658.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075662 (pdf 75662.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075690 (pdf 75690.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075755 (label 75755.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075787 (pdf 75787.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075807 (pdf 75807.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075810 (pdf 75810.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075865 (pdf 75865.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075872 (pdf 75872.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075920 (pdf 75920.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BAJAJ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076001 (pdf 76001.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 , NDA 076006 (pdf 76006.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2002 , NDA 076015 (pdf 76015.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2002 , NDA 076016 (pdf 76016.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (ESI LEDERLE) APPROVAL= TA YEAR= 2001 OBSOLETE , NDA 076022 (pdf 76022.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CARLSBAD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076024 (pdf 76024.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076165 (pdf 76165.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CR DOUBLE CRANE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076251 (pdf 76251.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076287 (pdf 76287.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076458 (pdf 76458.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076922 (pdf 76922.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076990 (pdf 76990.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077469 (pdf 77469.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077528 (pdf 77528.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 077849 (pdf 77849.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2007 , NDA 078045 (pdf 78045.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078143 (pdf 78143.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078619 (pdf 78619.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 076237 (pdf 76237.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078572 (pdf 78572.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 079209 (pdf 79209.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090223 (pdf 90223.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 202133 (label 202133.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2011 , NDA 077742 (pdf 77742.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 078901 (pdf 78901.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 201336 (pdf 201336.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202074 (pdf 202074.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 200151 (pdf 200151.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) SELFEMRA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204597 (pdf 204597.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 203836 (pdf 203836.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 206937 (pdf 206937.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 208698 (pdf 208698.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209419 (pdf 209419.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209695 (pdf 209695.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 211051 (pdf 211051.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211477 (pdf 211477.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 206993 (pdf 206993.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 210935 (pdf 210935.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211282 (pdf 211282.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211632 (pdf 211632.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211653 (pdf 211653.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211696 (pdf 211696.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2019 , NDA 211721 (pdf 211721.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 212191 (pdf 212191.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (G AND W LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213265 (pdf 213265.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213286 (pdf 213286.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 202729 (pdf 202729.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 216232 (pdf 216232.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 211444 (pdf 211444.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216448 (pdf 216448.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216953 (pdf 216953.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (APTAPHARMA INC) APPROVAL= AP YEAR= 2022 , NDA 212684 (pdf 212684.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2024 , 562 ; LEVOCARNITINE ; 541-15-1 ; 1985 ; ; ; CLASS METABOLISM -- CARNITINE REPLENISHER -- FACILITATE LONG-CHAIN FATTY ACID ENTRY INTO CELLULAR MITOCHONDRIA -- LEVOCARNITINE CLEARS ACYLCOA COMPOUND , ; NDA 018948 (label 18948.pdf) INN (LEVOCARNITINE) CARNITOR (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 019257 (label 19257.pdf) INN (LEVOCARNITINE) CARNITOR (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1986 , NDA 020182 (label 20182.pdf) INN (LEVOCARNITINE) CARNITOR (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1992 , NDA 075567 (label 75567.pdf) INN (LEVOCARNITINE) LEVOCARNITINE (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 075861 (pdf 75861.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (AM REGENT) APPROVAL= AP YEAR= 2001 , NDA 075881 (label 75881.pdf) INN (LEVOCARNITINE) LEVOCARNITINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076851 (pdf 76851.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (LYNE) APPROVAL= AP YEAR= 2004 , NDA 076858 (pdf 76858.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (RISING) APPROVAL= AP YEAR= 2004 , NDA 077399 (pdf 77399.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 211676 (pdf 211676.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212533 (pdf 212533.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 216384 (pdf 216384.pdf not found) INN (LEVOCARNITINE) LEVOCARNITINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 563 ; AMIODARONE ; 1951-25-3 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC CLASS III , ; NDA 018972 (label 18972.pdf) INN (AMIODARONE HYDROCHLORIDE) CORDARONE (WYETH PHARMS) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 020377 (pdf 20377.pdf not found) INN (AMIODARONE HYDROCHLORIDE) CORDARONE (WYETH PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 021594 (pdf 21594.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074739 (label 74739.pdf) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1998 , NDA 074895 (pdf 74895.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075135 (label 75135.pdf) INN (AMIODARONE HYDROCHLORIDE) PACERONE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1998 , NDA 075188 (label 75188.pdf) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075315 (pdf 75315.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075389 (pdf 75389.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 , NDA 075424 (pdf 75424.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2001 , NDA 075761 (pdf 75761.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 075955 (label 75955.pdf) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076018 (label 76018.pdf) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (BEDFORD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076088 (pdf 76088.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (BEN VENUE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076108 (pdf 76108.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076163 (pdf 76163.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076217 (pdf 76217.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2002 , NDA 076232 (pdf 76232.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076299 (pdf 76299.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (BEDFORD LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076362 (pdf 76362.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2002 , NDA 076394 (label 76394.pdf) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (PAR STERILE PRODUCTS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077069 (pdf 77069.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 077161 (pdf 77161.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2005 , NDA 077234 (pdf 77234.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 , NDA 079029 (pdf 79029.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2008 , NDA 022325 (label 22325.pdf) INN (AMIODARONE HYDROCHLORIDE) NEXTERONE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 077610 (pdf 77610.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (ACELLA) APPROVAL= AP YEAR= 2008 , NDA 077834 (pdf 77834.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (ACELLA) APPROVAL= AP YEAR= 2008 , NDA 078578 (pdf 78578.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2008 , NDA 203884 (pdf 203884.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203885 (pdf 203885.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204742 (pdf 204742.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204550 (pdf 204550.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 213446 (pdf 213446.pdf not found) INN (AMIODARONE HYDROCHLORIDE) AMIODARONE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2020 , 564 ; ENALAPRIL ; 75847-73-3 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS , ; NDA 018998 (label 18998.pdf) INN (ENALAPRIL MALEATE) VASOTEC (BAUSCH) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 019221 (label 19221.pdf) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) VASERETIC (BAUSCH) APPROVAL= AP YEAR= 1986 , NDA 020507 (pdf 20507.pdf not found) INN (DILTIAZEM MALATE ENALAPRIL MALEATE) TECZEM (BIOVAIL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020668 (label 20668.pdf) INN (ENALAPRIL MALEATE FELODIPINE) LEXXEL (ASTRAZENECA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075048 (pdf 75048.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075178 (pdf 75178.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (AIPING PHARM INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075369 (pdf 75369.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (KRKA DD NOVO MESTO) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075370 (pdf 75370.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (KRKA DD NOVO MESTO) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075459 (pdf 75459.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (SANDOZ INC) APPROVAL= AP YEAR= 2000 , NDA 075472 (pdf 75472.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075479 (pdf 75479.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2000 , NDA 075480 (pdf 75480.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075482 (pdf 75482.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075483 (pdf 75483.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2000 , NDA 075496 (pdf 75496.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (SANDOZ INC) APPROVAL= AP YEAR= 2000 , NDA 075501 (pdf 75501.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075556 (pdf 75556.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075583 (pdf 75583.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075621 (pdf 75621.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075624 (pdf 75624.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075657 (pdf 75657.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (TARO) APPROVAL= AP YEAR= 2001 , NDA 075727 (pdf 75727.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (COSETTE) APPROVAL= AP YEAR= 2001 , NDA 075736 (pdf 75736.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075788 (pdf 75788.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (TARO PHARM INDS) APPROVAL= AP YEAR= 2001 , NDA 075909 (label 75909.pdf) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2001 , NDA 076116 (pdf 76116.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076486 (pdf 76486.pdf not found) INN (ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE) ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 204308 (label 204308.pdf) INN (ENALAPRIL MALEATE) EPANED KIT (AZURITY) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 208686 (label 208686.pdf) INN (ENALAPRIL MALEATE) EPANED (AZURITY) APPROVAL= AP YEAR= 2016 , NDA 214467 (pdf 214467.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 212408 (pdf 212408.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (BIONPHARMA) APPROVAL= AP YEAR= 2021 , NDA 212894 (pdf 212894.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 213273 (pdf 213273.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 213714 (pdf 213714.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 216458 (pdf 216458.pdf not found) INN (ENALAPRIL MALEATE) ENALAPRIL MALEATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , 565 ; BEPRIDIL ; 64706-54-3 ; 1990 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- VASODILATOR -- ANTIANGINAL -- CALCIUM CHANNEL BLOCKERS , ; NDA 019001 (pdf 19001.pdf not found) INN (BEPRIDIL HYDROCHLORIDE) BEPADIN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019002 (pdf 19002.pdf not found) INN (BEPRIDIL HYDROCHLORIDE) VASCOR (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 566 ; LEUPROLIDE ; 53714-56-0 ; 1985 ; ; ; CLASS ANTINEOPLASTIC -- ANTI-ESTROGEN AGENTS , ; NDA 019010 (label 19010.pdf) INN (LEUPROLIDE ACETATE) LUPRON (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 019732 (label 19732.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1989 , NDA 019943 (label 19943.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1995 , NDA 020011 (label 20011.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1990 , NDA 020263 (label 20263.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT-PED KIT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1993 , NDA 020517 (label 20517.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1995 , NDA 020708 (label 20708.pdf) INN (LEUPROLIDE ACETATE) LUPRON DEPOT (ABBVIE ENDOCRINE INC) APPROVAL= AP YEAR= 1997 , NDA 021088 (label 21088.pdf) INN (LEUPROLIDE ACETATE) VIADUR (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021343 (label 21343.pdf) INN (LEUPROLIDE ACETATE) ELIGARD KIT (TOLMAR) APPROVAL= AP YEAR= 2002 , NDA 021379 (label 21379.pdf) INN (LEUPROLIDE ACETATE) ELIGARD KIT (TOLMAR) APPROVAL= AP YEAR= 2002 , NDA 021488 (label 21488.pdf) INN (LEUPROLIDE ACETATE) ELIGARD KIT (TOLMAR) APPROVAL= AP YEAR= 2003 , NDA 021731 (label 21731.pdf) INN (LEUPROLIDE ACETATE) ELIGARD KIT (TOLMAR) APPROVAL= AP YEAR= 2004 , NDA 074728 (label 74728.pdf) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075471 (pdf 75471.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (MEITHEAL) APPROVAL= AP YEAR= 2000 , NDA 075721 (pdf 75721.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (GENZYME) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 078885 (pdf 78885.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 203696 (label 203696.pdf) INN (LEUPROLIDE ACETATE NORETHINDRONE ACETATE) LUPANETA PACK (ABBVIE ENDOCRINE) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 205054 (label 205054.pdf) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (INVAGEN PHARMS) APPROVAL= AP YEAR= 2018 , NDA 213150 (label 213150.pdf) INN (LEUPROLIDE ACETATE) FENSOLVI KIT (TOLMAR) APPROVAL= AP YEAR= 2020 NEWAPPLICATION , NDA 211488 (label 211488.pdf) INN (LEUPROLIDE MESYLATE) CAMCEVI KIT (ACCORD) APPROVAL= AP YEAR= 2021 , NDA 213829 (pdf 213829.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (RK PHARMA) APPROVAL= AP YEAR= 2021 , NDA 212963 (pdf 212963.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215336 (pdf 215336.pdf not found) INN (LEUPROLIDE ACETATE) LEUPROLIDE ACETATE (AMNEAL) APPROVAL= AP YEAR= 2022 , 567 ; GUANFACINE ; 29110-47-2 ; 1986 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC ALPHA 2 AGONIST -- SYMPATHOLYTICS -- TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) , ; NDA 019032 (label 19032.pdf) INN (GUANFACINE HYDROCHLORIDE) TENEX (PROMIUS PHARMA) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 074145 (pdf 74145.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1995 , NDA 074673 (pdf 74673.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 , NDA 074762 (pdf 74762.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074796 (pdf 74796.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1997 , NDA 075109 (pdf 75109.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 1998 , NDA 022037 (label 22037.pdf) INN (GUANFACINE HYDROCHLORIDE) INTUNIV (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 , NDA 200881 (pdf 200881.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 201382 (pdf 201382.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 201408 (pdf 201408.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2015 , NDA 202568 (pdf 202568.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 202578 (pdf 202578.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202238 (pdf 202238.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205689 (pdf 205689.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 205430 (pdf 205430.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2018 , NDA 213428 (pdf 213428.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2020 , NDA 214689 (pdf 214689.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2021 , NDA 216399 (pdf 216399.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 217293 (pdf 217293.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216762 (pdf 216762.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 216828 (pdf 216828.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (I 3 PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217269 (pdf 217269.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217638 (pdf 217638.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (WANBANG BIOPHARMS) APPROVAL= AP YEAR= 2024 , NDA 218326 (pdf 218326.pdf not found) INN (GUANFACINE HYDROCHLORIDE) GUANFACINE HYDROCHLORIDE (XIROMED) APPROVAL= AP YEAR= 2024 , 568 ; HYDROMORPHONE ; 466-99-9 ; 1984 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- NARCOTICS , ; NDA 019034 (label 19034.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) DILAUDID-HP (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1984 , NDA 019891 (label 19891.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) DILAUDID (RHODES PHARMS) APPROVAL= AP YEAR= 1992 , NDA 019892 (label 19892.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) DILAUDID (RHODES PHARMS) APPROVAL= AP YEAR= 1992 , NDA 021044 (label 21044.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) PALLADONE (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074317 (pdf 74317.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074597 (pdf 74597.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074598 (pdf 74598.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074653 (pdf 74653.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 076444 (pdf 76444.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076723 (pdf 76723.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076855 (pdf 76855.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 077311 (pdf 77311.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078273 (pdf 78273.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078591 (pdf 78591.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2008 , NDA 021217 (label 21217.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) EXALGO (SPECGX LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077471 (pdf 77471.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078228 (pdf 78228.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 , NDA 078261 (pdf 78261.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 , NDA 078439 (pdf 78439.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 2009 , NDA 200403 (label 200403.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2011 , NDA 202144 (label 202144.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204278 (label 204278.pdf) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2015 , NDA 205814 (pdf 205814.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 205629 (pdf 205629.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2016 , NDA 210176 (pdf 210176.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 202159 (pdf 202159.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2018 , NDA 210506 (pdf 210506.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 207108 (pdf 207108.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212133 (pdf 212133.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 217812 (pdf 217812.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 216899 (pdf 216899.pdf not found) INN (HYDROMORPHONE HYDROCHLORIDE) HYDROMORPHONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2024 , 569 ; TERAZOSIN ; 63590-64-7 ; 1987 ; ; ; CLASS GENITO -- BENIGN PROSTATIC HYPERPLASIA -- ANTIHYPERTENSIVE -- ALPHA-1-SELECTIVE ADRENOCEPTOR BLOCKING AGENT , ; NDA 019057 (label 19057.pdf) INN (TERAZOSIN HYDROCHLORIDE) HYTRIN (ABBOTT) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 020347 (pdf 20347.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) HYTRIN (ABBOTT) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074315 (label 74315.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074446 (label 74446.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074530 (label 74530.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074651 (pdf 74651.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (LEMMON CO) APPROVAL= TA YEAR= 1997 OBSOLETE , NDA 074657 (label 74657.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074823 (pdf 74823.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 1998 , NDA 075140 (label 75140.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075317 (pdf 75317.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2004 , NDA 075384 (pdf 75384.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075498 (pdf 75498.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075614 (pdf 75614.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2001 , NDA 075667 (pdf 75667.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2000 , NDA 076021 (pdf 76021.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , 570 ; ESTAZOLAM ; 29975-16-4 ; 1990 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- MANAGEMENT OF INSOMNIA -- GABA MODULATORS -- BENZODIAZEPINE , ; NDA 019080 (pdf 19080.pdf not found) INN (ESTAZOLAM) PROSOM (ABBOTT) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 074818 (pdf 74818.pdf not found) INN (ESTAZOLAM) ESTAZOLAM (WATSON LABS) APPROVAL= AP YEAR= 1997 , NDA 074826 (pdf 74826.pdf not found) INN (ESTAZOLAM) ESTAZOLAM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1997 , NDA 074921 (pdf 74921.pdf not found) INN (ESTAZOLAM) ESTAZOLAM (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1997 , 571 ; DEZOCINE ; 53648-55-8 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- NARCOTIC ANTAGONIST -- ANALGESIC OPIOD , ; NDA 019082 (pdf 19082.pdf not found) INN (DEZOCINE) DALGAN (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , 572 ; IPRATROPIUM ; 60205-81-4 ; 1986 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- ANTICHOLINERGIC (PARASYMPATHOLYTIC) -- CHOLINERGIC ANTAGONISTS , ; NDA 019085 (pdf 19085.pdf not found) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 020228 (pdf 20228.pdf not found) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020291 (label 20291.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020393 (label 20393.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020394 (label 20394.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020950 (label 20950.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) DUONEB (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021527 (label 21527.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT HFA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2004 , NDA 074755 (label 74755.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075111 (label 75111.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075313 (label 75313.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075441 (pdf 75441.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075507 (pdf 75507.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ZENNOVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075552 (pdf 75552.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075553 (pdf 75553.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075562 (pdf 75562.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (NEPHRON) APPROVAL= AP YEAR= 2001 , NDA 075693 (pdf 75693.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2001 , NDA 075835 (pdf 75835.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075867 (pdf 75867.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ROXANE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076025 (pdf 76025.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 076103 (label 76103.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 076155 (pdf 76155.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2003 , NDA 076156 (pdf 76156.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2003 , NDA 076291 (pdf 76291.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (WATSON LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076598 (pdf 76598.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076664 (pdf 76664.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076724 (pdf 76724.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076749 (pdf 76749.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (NEPHRON) APPROVAL= AP YEAR= 2007 , NDA 076867 (label 76867.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077063 (pdf 77063.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077072 (pdf 77072.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (LANDELA PHARM) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077117 (pdf 77117.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077559 (pdf 77559.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 021747 (label 21747.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2011 , NDA 202496 (pdf 202496.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2012 , NDA 206543 (pdf 206543.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2016 , NDA 207875 (pdf 207875.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 207903 (pdf 207903.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 206532 (pdf 206532.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215104 (label 215104.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215105 (pdf 215105.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , 573 ; PROPAFENONE ; 54063-53-5 ; 1989 ; ; ; CLASS CARDIOVASCULAR -- CLASS 1C ANTIARRHYTHMIC -- CHANNEL BLOCKER , ; NDA 019151 (label 19151.pdf) INN (PROPAFENONE HYDROCHLORIDE) RYTHMOL (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 021416 (label 21416.pdf) INN (PROPAFENONE HYDROCHLORIDE) RYTHMOL SR (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075203 (label 75203.pdf) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 , NDA 075938 (pdf 75938.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2002 , NDA 075998 (pdf 75998.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2001 , NDA 076193 (pdf 76193.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076550 (pdf 76550.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 , NDA 078540 (pdf 78540.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 202688 (label 202688.pdf) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 202445 (pdf 202445.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203803 (pdf 203803.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205268 (pdf 205268.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205956 (pdf 205956.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 , NDA 210339 (pdf 210339.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2019 , NDA 212744 (pdf 212744.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2020 , NDA 212928 (pdf 212928.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214184 (pdf 214184.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 213096 (pdf 213096.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 574 ; METHACHOLINE ; 55-92-5 ; 1986 ; ; ; CLASS RESPIRATORY SYSTEM -- DIAGNOSIS OF BRONCHIAL AIRWAY HYPERREACTIVITY -- PARASYMPATHOMIMETIC (CH0IINERGIC) BRONCHOCONSTRICTOR AGENT -- ACETYLCHOLINE ANALOG THAT INDUCES BRONCHOCONSTRICTION , ; NDA 019193 (label 19193.pdf) INN (METHACHOLINE CHLORIDE) PROVOCHOLINE (METHAPHARM) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , 575 ; TRIENTINE ; 112-24-3 ; 1985 ; ; ; CLASS ANTI-WILSON'S DISEASE (HEPATOLENTICULAR DEGENERATION) AUTOSOMAL INHERITED METABOLIC DEFECT RESULTING IN AN INABILITY TO MAINTAIN A NEARZERO BALANCE OF COPPER -- CHELATING AGENT , ; NDA 019194 (pdf 19194.pdf not found) INN (TRIENTINE HYDROCHLORIDE) SYPRINE (BAUSCH) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 207567 (pdf 207567.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2018 , NDA 210619 (pdf 210619.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211134 (pdf 211134.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2019 , NDA 211251 (pdf 211251.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (NAVINTA LLC) APPROVAL= AP YEAR= 2019 , NDA 211554 (pdf 211554.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209415 (pdf 209415.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209731 (pdf 209731.pdf not found) INN (TRIENTINE HYDROCHLORIDE) CLOVIQUE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210096 (pdf 210096.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 211076 (pdf 211076.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 211637 (pdf 211637.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212238 (pdf 212238.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2020 , NDA 209945 (pdf 209945.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2021 , NDA 212929 (pdf 212929.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215760 (label 215760.pdf) INN (TRIENTINE TETRAHYDROCHLORIDE) CUVRIOR (ORPHALAN) APPROVAL= AP YEAR= 2022 , NDA 216356 (pdf 216356.pdf not found) INN (TRIENTINE HYDROCHLORIDE) TRIENTINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , 576 ; DICLOFENAC ; 15307-86-5 ; 1988 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITORS -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS (NSAIDS) -- ANALGESIC -- ANTIPYRETIC , ; NDA 019201 (label 19201.pdf) INN (DICLOFENAC SODIUM) VOLTAREN (NOVARTIS) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 020037 (label 20037.pdf) INN (DICLOFENAC SODIUM) VOLTAREN (NOVARTIS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020142 (label 20142.pdf) INN (DICLOFENAC POTASSIUM) CATAFLAM (NOVARTIS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020254 (label 20254.pdf) INN (DICLOFENAC SODIUM) VOLTAREN-XR (NOVARTIS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020607 (label 20607.pdf) INN (DICLOFENAC SODIUM MISOPROSTOL) ARTHROTEC (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 020809 (label 20809.pdf) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (FALCON PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021005 (label 21005.pdf) INN (DICLOFENAC SODIUM) SOLARAZE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021234 (label 21234.pdf) INN (DICLOFENAC EPOLAMINE) FLECTOR (IBSA) APPROVAL= AP YEAR= 2007 , NDA 022122 (label 22122.pdf) INN (DICLOFENAC SODIUM) VOLTAREN ARTHRITIS PAIN (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2007 , NDA 074376 (pdf 74376.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074390 (pdf 74390.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074391 (pdf 74391.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074394 (pdf 74394.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074432 (pdf 74432.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (PLIVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074459 (pdf 74459.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074514 (pdf 74514.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1996 , NDA 074723 (pdf 74723.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074986 (label 74986.pdf) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (MICRO LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075152 (pdf 75152.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075185 (pdf 75185.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (CARLSBAD) APPROVAL= AP YEAR= 1998 , NDA 075219 (pdf 75219.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (TEVA) APPROVAL= AP YEAR= 1998 , NDA 075229 (pdf 75229.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (RUBICON) APPROVAL= AP YEAR= 1998 , NDA 075281 (pdf 75281.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075463 (pdf 75463.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (RK PHARMA) APPROVAL= AP YEAR= 1999 , NDA 075470 (pdf 75470.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075492 (pdf 75492.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (VPNA) APPROVAL= AP YEAR= 2000 , NDA 075582 (pdf 75582.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075910 (pdf 75910.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076152 (pdf 76152.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076201 (pdf 76201.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (DEXCEL LTD) APPROVAL= AP YEAR= 2002 , NDA 076561 (pdf 76561.pdf not found) INN (DICLOFENAC POTASSIUM) CATAFLAM (AMICI) APPROVAL= AP YEAR= 2004 , NDA 077600 (pdf 77600.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RUBICON) APPROVAL= AP YEAR= 2008 , NDA 077845 (pdf 77845.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077863 (pdf 77863.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (UNIQUE) APPROVAL= AP YEAR= 2007 , NDA 078031 (pdf 78031.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078553 (pdf 78553.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RISING) APPROVAL= AP YEAR= 2007 , NDA 078792 (pdf 78792.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2007 , NDA 020947 (label 20947.pdf) INN (DICLOFENAC SODIUM) PENNSAID (NUVO PHARMS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022165 (label 22165.pdf) INN (DICLOFENAC POTASSIUM) CAMBIA (ASSERTIO) APPROVAL= AP YEAR= 2009 , NDA 022202 (label 22202.pdf) INN (DICLOFENAC POTASSIUM) ZIPSOR (ASSERTIO) APPROVAL= AP YEAR= 2009 , NDA 090066 (pdf 90066.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (UNIQUE) APPROVAL= AP YEAR= 2010 , NDA 201089 (pdf 201089.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2012 , NDA 200158 (pdf 200158.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 200936 (label 200936.pdf) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AMNEAL) APPROVAL= AP YEAR= 2013 , NDA 202393 (pdf 202393.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TWI PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204592 (label 204592.pdf) INN (DICLOFENAC) ZORVOLEX (ZYLA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 022396 (label 22396.pdf) INN (DICLOFENAC SODIUM) DYLOJECT (JAVELIN PHARMS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 200540 (pdf 200540.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (EXELA HOLDINGS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202027 (pdf 202027.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202769 (pdf 202769.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202852 (pdf 202852.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2014 , NDA 203818 (pdf 203818.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TARO) APPROVAL= AP YEAR= 2014 , NDA 204623 (label 204623.pdf) INN (DICLOFENAC SODIUM) PENNSAID (HORIZON) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203383 (pdf 203383.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 204132 (pdf 204132.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 205878 (pdf 205878.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 206493 (pdf 206493.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 , NDA 208068 (pdf 208068.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (PADDOCK LABS) APPROVAL= TA YEAR= 2015 , NDA 202964 (label 202964.pdf) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 204648 (pdf 204648.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (BIONPHARMA) APPROVAL= AP YEAR= 2016 , NDA 206298 (pdf 206298.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TARO) APPROVAL= AP YEAR= 2016 , NDA 208021 (pdf 208021.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (LUPIN PHARMS) APPROVAL= AP YEAR= 2022 , NDA 208077 (pdf 208077.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 208098 (pdf 208098.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (TARO) APPROVAL= AP YEAR= 2022 , NDA 208198 (pdf 208198.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 203786 (pdf 203786.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (VERSAPHARM INC) APPROVAL= TA YEAR= 2016 , NDA 203995 (pdf 203995.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206116 (pdf 206116.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207393 (pdf 207393.pdf not found) INN (DICLOFENAC) DICLOFENAC (LUPIN LTD) APPROVAL= TA YEAR= 2016 , NDA 208301 (pdf 208301.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206715 (pdf 206715.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207238 (label 207238.pdf) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2017 , NDA 206411 (pdf 206411.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 206976 (label 206976.pdf) INN (DICLOFENAC EPOLAMINE) LICART (IBSA INST BIO) APPROVAL= AP YEAR= 2018 , NDA 209484 (pdf 209484.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209903 (pdf 209903.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 210893 (pdf 210893.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2018 , NDA 204306 (pdf 204306.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 211253 (pdf 211253.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2019 , NDA 208786 (pdf 208786.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210078 (pdf 210078.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 205143 (pdf 205143.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 , NDA 210986 (pdf 210986.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ENCUBE) APPROVAL= AP YEAR= 2020 , NDA 206655 (pdf 206655.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2021 , NDA 204355 (pdf 204355.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 213875 (pdf 213875.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 215585 (pdf 215585.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (NOVAST LABS) APPROVAL= AP YEAR= 2021 , NDA 207714 (pdf 207714.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 215375 (pdf 215375.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215750 (pdf 215750.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (UMEDICA) APPROVAL= AP YEAR= 2022 , NDA 212351 (pdf 212351.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 212506 (pdf 212506.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216275 (pdf 216275.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RICONPHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 216635 (pdf 216635.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 206771 (pdf 206771.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213040 (pdf 213040.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 215787 (pdf 215787.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (SENORES PHARMS) APPROVAL= AP YEAR= 2023 , NDA 216548 (pdf 216548.pdf not found) INN (DICLOFENAC SODIUM) DICLOFENAC SODIUM (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 218011 (pdf 218011.pdf not found) INN (DICLOFENAC POTASSIUM) DICLOFENAC POTASSIUM (TARO) APPROVAL= AP YEAR= 2024 , 577 ; MISOPROSTOL ; 59122-46-2 ; 1988 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- PROSTAGLANDINS -- SYNTHETIC PROSTAGLANDIN E1 ANALOG , ; NDA 019268 (label 19268.pdf) INN (MISOPROSTOL) CYTOTEC (PFIZER) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 020607 (label 20607.pdf) INN (DICLOFENAC SODIUM MISOPROSTOL) ARTHROTEC (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 076095 (pdf 76095.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (ANI PHARMS) APPROVAL= AP YEAR= 2002 , NDA 091667 (pdf 91667.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (NOVEL LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201089 (pdf 201089.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2012 , NDA 200158 (pdf 200158.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 200540 (pdf 200540.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (EXELA HOLDINGS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203995 (pdf 203995.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 210201 (pdf 210201.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (ACQ PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205143 (pdf 205143.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 , NDA 204355 (pdf 204355.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 216872 (pdf 216872.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 206771 (pdf 206771.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , 578 ; CARTEOLOL ; 51781-06-7 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC (BETA) BLOCKER -- ANTI-ARRHYTHMIA AGENTS -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS -- LOWERING INTRAOCULAR PRESSURE AND MAY BE USED IN PATIENTS WITH CHRONIC OPEN-ANGLE GLAUCOMA AND INTRAOCULAR HYPERTENSION. , ; NDA 019204 (pdf 19204.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTROL (ABBVIE) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 019972 (pdf 19972.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) OCUPRESS (NOVARTIS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 075476 (pdf 75476.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 075546 (pdf 75546.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076097 (pdf 76097.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , 579 ; LEVOBUNOLOL ; 47141-42-4 ; 1985 ; ; ; CLASS SENSORY -- BETA-ADRENERGIC BLOCKER -- ANTIGLAUCOMA -- EENT DRUGS -- SYMPATHOLYTICS -- LOWERING INTRAOCULAR PRESSURE , ; NDA 019219 (label 19219.pdf) INN (LEVOBUNOLOL HYDROCHLORIDE) BETAGAN (ALLERGAN) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 019814 (label 19814.pdf) INN (LEVOBUNOLOL HYDROCHLORIDE) BETAGAN (ALLERGAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 074307 (pdf 74307.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074326 (pdf 74326.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 074779 (pdf 74779.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) AKBETA (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074780 (pdf 74780.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) AKBETA (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074850 (pdf 74850.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074851 (pdf 74851.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (ALCON LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075473 (pdf 75473.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075475 (pdf 75475.pdf not found) INN (LEVOBUNOLOL HYDROCHLORIDE) LEVOBUNOLOL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , 580 ; MISOPROSTOL ; 59122-46-2 ; 1988 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- PROSTAGLANDINS -- SYNTHETIC PROSTAGLANDIN E1 ANALOG , ; NDA 019268 (label 19268.pdf) INN (MISOPROSTOL) CYTOTEC (PFIZER) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 020607 (label 20607.pdf) INN (DICLOFENAC SODIUM MISOPROSTOL) ARTHROTEC (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 076095 (pdf 76095.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (ANI PHARMS) APPROVAL= AP YEAR= 2002 , NDA 091667 (pdf 91667.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (NOVEL LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201089 (pdf 201089.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2012 , NDA 200158 (pdf 200158.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 200540 (pdf 200540.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (EXELA HOLDINGS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203995 (pdf 203995.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 210201 (pdf 210201.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (ACQ PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205143 (pdf 205143.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 , NDA 204355 (pdf 204355.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 216872 (pdf 216872.pdf not found) INN (MISOPROSTOL) MISOPROSTOL (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 206771 (pdf 206771.pdf not found) INN (DICLOFENAC SODIUM MISOPROSTOL) DICLOFENAC SODIUM AND MISOPROSTOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , 581 ; LEVOBETAXOLOL ; 63659-18-7 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC BETA ANTAGONISTS -- EENT DRUGS -- SYMPATHOLYTICS -- INTRAOCULAR PRESSURE AND IS INDICATED IN THE TREATMENT OF OCULAR HYPERTENSION AND CHRONIC OPEN-ANGLE GLAUCOMA. , ; NDA 019270 (label 19270.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETOPTIC (ALCON) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 019507 (label 19507.pdf) INN (BETAXOLOL HYDROCHLORIDE) KERLONE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019807 (label 19807.pdf) INN (BETAXOLOL HYDROCHLORIDE) KERLEDEX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019845 (label 19845.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETOPTIC S (ALCON) APPROVAL= AP YEAR= 1989 , NDA 020619 (pdf 20619.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETOPTIC PILO (ALCON) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075386 (pdf 75386.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2000 , NDA 075446 (pdf 75446.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (NOVEX) APPROVAL= AP YEAR= 2000 , NDA 075541 (label 75541.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (EPIC PHARMA) APPROVAL= AP YEAR= 1999 , NDA 075630 (pdf 75630.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2000 , NDA 078962 (pdf 78962.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 021114 (label 21114.pdf) INN (LEVOBETAXOLOL HYDROCHLORIDE) BETAXON (ALCON PHARMS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 078694 (pdf 78694.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 , 582 ; TRANEXAMIC ACID ; 1197-18-8 ; 1986 ; ; ; CLASS BLOOD -- HEMOSTATIC -- ANTIFIBRINOLYTIC -- TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING -- COMPETITIVE INHIBITOR OF PLASMINOGEN ACTIVATION , ; NDA 019280 (pdf 19280.pdf not found) INN (TRANEXAMIC ACID) CYKLOKAPRON (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 019281 (label 19281.pdf) INN (TRANEXAMIC ACID) CYKLOKAPRON (PFIZER) APPROVAL= AP YEAR= 1986 , NDA 022430 (label 22430.pdf) INN (TRANEXAMIC ACID) LYSTEDA (AMRING PHARMS) APPROVAL= AP YEAR= 2009 , NDA 091657 (pdf 91657.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2011 , NDA 201885 (pdf 201885.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (AM REGENT) APPROVAL= AP YEAR= 2011 , NDA 202373 (pdf 202373.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2011 , NDA 091596 (pdf 91596.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2012 , NDA 202093 (pdf 202093.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2012 , NDA 202286 (pdf 202286.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201580 (pdf 201580.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (XGEN PHARMS) APPROVAL= AP YEAR= 2013 , NDA 202436 (pdf 202436.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (ACIC PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203521 (pdf 203521.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 , NDA 205133 (pdf 205133.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2015 , NDA 202755 (pdf 202755.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205035 (pdf 205035.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206634 (pdf 206634.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203256 (pdf 203256.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (ANI PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205228 (pdf 205228.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206713 (pdf 206713.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 207239 (pdf 207239.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (GLAND) APPROVAL= AP YEAR= 2017 , NDA 208840 (pdf 208840.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 206594 (pdf 206594.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209326 (pdf 209326.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (ACIC PHARMS) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 212020 (label 212020.pdf) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (EXELA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212360 (pdf 212360.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (CAPLIN) APPROVAL= AP YEAR= 2019 , NDA 212676 (pdf 212676.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (PROVEPHARM SAS) APPROVAL= AP YEAR= 2019 , NDA 209860 (pdf 209860.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 217155 (pdf 217155.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 216877 (pdf 216877.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (NEXUS) APPROVAL= AP YEAR= 2024 , NDA 218320 (pdf 218320.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (RUBICON) APPROVAL= AP YEAR= 2024 , NDA 218599 (pdf 218599.pdf not found) INN (TRANEXAMIC ACID) TRANEXAMIC ACID (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 583 ; MITOXANTRONE ; 65271-80-9 ; 1987 ; ; ; CLASS ANTINEOPLASTIC -- INTERCALATING AGENT , ; NDA 019297 (label 19297.pdf) INN (MITOXANTRONE HYDROCHLORIDE) NOVANTRONE (EMD SERONO) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 021120 (label 21120.pdf) INN (MITOXANTRONE HYDROCHLORIDE) NOVANTRONE (SERONO INC) APPROVAL= AP YEAR= 2000 NEWAPPLICATION DISCONTINUED , NDA 076611 (pdf 76611.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076871 (pdf 76871.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 077356 (pdf 77356.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2006 , NDA 077496 (pdf 77496.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 078606 (pdf 78606.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (FRESENIUS KABI ONCOL) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078980 (pdf 78980.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 201014 (pdf 201014.pdf not found) INN (MITOXANTRONE HYDROCHLORIDE) MITOXANTRONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , 584 ; FENOFIBRATE ; 49562-28-9 ; 1993 ; ; ; CLASS CARDIOVASCULAR -- HYPOCHOLESTEROLEMIC -- HYPOLIPIDEMIC -- RAPIDLY HYDROLIZED BY ESTERASES , ; NDA 019304 (label 19304.pdf) INN (FENOFIBRATE) LIPIDIL (ABBVIE) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 021203 (label 21203.pdf) INN (FENOFIBRATE) TRICOR (ABBVIE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021350 (label 21350.pdf) INN (FENOFIBRATE) TRIGLIDE (SKYEPHARMA AG) APPROVAL= AP YEAR= 2005 , NDA 021612 (label 21612.pdf) INN (FENOFIBRATE) LIPOFEN (CIPHER PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 021656 (label 21656.pdf) INN (FENOFIBRATE) TRICOR (ABBVIE) APPROVAL= AP YEAR= 2004 , NDA 021695 (label 21695.pdf) INN (FENOFIBRATE) ANTARA MICRONIZED (LUPIN) APPROVAL= AP YEAR= 2004 , NDA 022118 (label 22118.pdf) INN (FENOFIBRATE) FENOGLIDE (SALIX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 075753 (label 75753.pdf) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (RHODES PHARMS) APPROVAL= AP YEAR= 2002 , NDA 075868 (pdf 75868.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (IMPAX LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076433 (pdf 76433.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (RHODES PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076509 (pdf 76509.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (IMPAX LABS) APPROVAL= AP YEAR= 2008 , NDA 076520 (pdf 76520.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 076635 (pdf 76635.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005 , NDA 090856 (pdf 90856.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 090715 (pdf 90715.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2012 , NDA 090859 (pdf 90859.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2012 , NDA 200579 (pdf 200579.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2012 OBSOLETE , NDA 202579 (pdf 202579.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202676 (pdf 202676.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202856 (pdf 202856.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202252 (pdf 202252.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 201748 (pdf 201748.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2014 , NDA 204019 (pdf 204019.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 204475 (label 204475.pdf) INN (FENOFIBRATE) FENOFIBRATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 205118 (pdf 205118.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204598 (pdf 204598.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2016 , NDA 208709 (pdf 208709.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 205566 (pdf 205566.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207378 (pdf 207378.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 200884 (pdf 200884.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 207803 (pdf 207803.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AUSTARPHARMA) APPROVAL= AP YEAR= 2017 , NDA 207805 (pdf 207805.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (REYOUNG) APPROVAL= AP YEAR= 2017 , NDA 209504 (pdf 209504.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (ANI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209950 (pdf 209950.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 209951 (pdf 209951.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210138 (pdf 210138.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210606 (pdf 210606.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210705 (pdf 210705.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210782 (pdf 210782.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 211080 (pdf 211080.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 207564 (pdf 207564.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209660 (pdf 209660.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 210476 (pdf 210476.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 210670 (pdf 210670.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 211122 (pdf 211122.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213252 (pdf 213252.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (ALEMBIC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213864 (pdf 213864.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213842 (pdf 213842.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 208476 (pdf 208476.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AUSTARPHARMA) APPROVAL= AP YEAR= 2021 , NDA 212232 (pdf 212232.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 216798 (pdf 216798.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 217732 (pdf 217732.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 2023 , NDA 211407 (pdf 211407.pdf not found) INN (FENOFIBRATE) FENOFIBRATE MICRONIZED (CHARTWELL) APPROVAL= AP YEAR= 2024 , NDA 218548 (pdf 218548.pdf not found) INN (FENOFIBRATE) FENOFIBRATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2024 , 585 ; CLOBETASOL PROPIONATE ; 25122-46-7 ; 1985 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- ANTIPRURITIC -- CORTICOSTEROIDS , ; NDA 019322 (label 19322.pdf) INN (CLOBETASOL PROPIONATE) TEMOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 019323 (label 19323.pdf) INN (CLOBETASOL PROPIONATE) TEMOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019966 (label 19966.pdf) INN (CLOBETASOL PROPIONATE) TEMOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020337 (label 20337.pdf) INN (CLOBETASOL PROPIONATE) TEMOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020340 (label 20340.pdf) INN (CLOBETASOL PROPIONATE) TEMOVATE E (FOUGERA PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 021142 (label 21142.pdf) INN (CLOBETASOL PROPIONATE) OLUX (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021535 (label 21535.pdf) INN (CLOBETASOL PROPIONATE) CLOBEX (GALDERMA LABS LP) APPROVAL= AP YEAR= 2003 , NDA 021644 (label 21644.pdf) INN (CLOBETASOL PROPIONATE) CLOBEX (GALDERMA LABS) APPROVAL= AP YEAR= 2004 , NDA 021835 (label 21835.pdf) INN (CLOBETASOL PROPIONATE) CLOBEX (GALDERMA LABS LP) APPROVAL= AP YEAR= 2005 , NDA 022013 (label 22013.pdf) INN (CLOBETASOL PROPIONATE) OLUX E (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 074087 (pdf 74087.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074089 (pdf 74089.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 1994 , NDA 074128 (pdf 74128.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074139 (pdf 74139.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074220 (pdf 74220.pdf not found) INN (CLOBETASOL PROPIONATE) CORMAX (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074221 (pdf 74221.pdf not found) INN (CLOBETASOL PROPIONATE) EMBELINE (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074222 (pdf 74222.pdf not found) INN (CLOBETASOL PROPIONATE) EMBELINE (HIKMA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074248 (pdf 74248.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 1996 , NDA 074249 (pdf 74249.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 1996 , NDA 074331 (pdf 74331.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074392 (pdf 74392.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1996 , NDA 074407 (pdf 74407.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1996 , NDA 075027 (pdf 75027.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PADAGIS US) APPROVAL= AP YEAR= 1997 , NDA 075057 (pdf 75057.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1998 , NDA 075205 (pdf 75205.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075224 (pdf 75224.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 1998 , NDA 075279 (pdf 75279.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 1999 , NDA 075325 (pdf 75325.pdf not found) INN (CLOBETASOL PROPIONATE) EMBELINE E (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075338 (pdf 75338.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2001 , NDA 075363 (pdf 75363.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2000 , NDA 075368 (pdf 75368.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2000 , NDA 075391 (pdf 75391.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075430 (pdf 75430.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE EMOLLIENT (FOUGERA PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075633 (pdf 75633.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE EMOLLIENT (TARO) APPROVAL= AP YEAR= 2000 , NDA 075733 (label 75733.pdf) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE EMOLLIENT (ANI PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076141 (pdf 76141.pdf not found) INN (CLOBETASOL PROPIONATE) EMBELINE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076977 (pdf 76977.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2005 , NDA 077763 (pdf 77763.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2008 , NDA 078223 (pdf 78223.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2008 , NDA 090898 (pdf 90898.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PADAGIS US) APPROVAL= AP YEAR= 2011 , NDA 078854 (pdf 78854.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200302 (pdf 200302.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2012 , NDA 090974 (pdf 90974.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , NDA 201402 (pdf 201402.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , NDA 206075 (pdf 206075.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 208667 (pdf 208667.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206378 (pdf 206378.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206805 (pdf 206805.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (NOVAST LABS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207218 (pdf 207218.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208842 (pdf 208842.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2018 , NDA 208881 (pdf 208881.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208933 (pdf 208933.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 209147 (pdf 209147.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 209361 (pdf 209361.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 209411 (pdf 209411.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE EMOLLIENT (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209483 (label 209483.pdf) INN (CLOBETASOL PROPIONATE) IMPOYZ (PRIMUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209871 (pdf 209871.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210199 (pdf 210199.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208125 (pdf 208125.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 208841 (pdf 208841.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2018 , NDA 209004 (pdf 209004.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 209095 (pdf 209095.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 209701 (pdf 209701.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 209974 (pdf 209974.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210190 (pdf 210190.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 210208 (pdf 210208.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 210446 (pdf 210446.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208779 (pdf 208779.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2018 , NDA 210034 (pdf 210034.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (XIROMED) APPROVAL= AP YEAR= 2018 , NDA 210551 (pdf 210551.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (AMNEAL) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211074 (pdf 211074.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211256 (pdf 211256.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211348 (pdf 211348.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208589 (pdf 208589.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210809 (pdf 210809.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 211401 (pdf 211401.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (RISING) APPROVAL= AP YEAR= 2019 , NDA 211800 (pdf 211800.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 205249 (pdf 205249.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2019 , NDA 211191 (pdf 211191.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 211295 (pdf 211295.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2019 , NDA 211450 (pdf 211450.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 211494 (pdf 211494.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211836 (pdf 211836.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TORRENT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212881 (pdf 212881.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 212926 (pdf 212926.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TORRENT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213290 (pdf 213290.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 213291 (pdf 213291.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 213691 (label 213691.pdf) INN (CLOBETASOL PROPIONATE) IMPEKLO (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212982 (pdf 212982.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2020 , NDA 211207 (pdf 211207.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213139 (pdf 213139.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (PRINSTON INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214867 (pdf 214867.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2021 , NDA 214895 (pdf 214895.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 211240 (pdf 211240.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (QUAGEN) APPROVAL= AP YEAR= 2022 , NDA 215838 (pdf 215838.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 215990 (pdf 215990.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 208563 (pdf 208563.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2024 , NDA 218158 (pdf 218158.pdf not found) INN (CLOBETASOL PROPIONATE) CLOBETASOL PROPIONATE (EYENOVIA) APPROVAL= AP YEAR= 2024 , 586 ; SELEGILINE ; 14611-51-9 ; 1989 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ENZYME INHIBITOR MAO -- ANTIDYSKINETICS -- CENTRAL NERVOUS SYSTEM AGENTS -- COVALENT BINDING -- ALSO INCREASE DOPAMINERGIC ACTIVITY , ; NDA 019334 (label 19334.pdf) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (SOMERSET) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 020647 (label 20647.pdf) INN (SELEGILINE HYDROCHLORIDE) ELDEPRYL (SOMERSET) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 021336 (label 21336.pdf) INN (SELEGILINE) EMSAM (SOMERSET) APPROVAL= AP YEAR= 2006 , NDA 021479 (label 21479.pdf) INN (SELEGILINE HYDROCHLORIDE) ZELAPAR (BAUSCH) APPROVAL= AP YEAR= 2006 , NDA 021708 (label 21708.pdf) INN (SELEGILINE) EMSAM (SOMERSET) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 074537 (pdf 74537.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (G AND W LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074565 (pdf 74565.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074641 (pdf 74641.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074672 (pdf 74672.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (I3 PHARMS) APPROVAL= AP YEAR= 1997 , NDA 074744 (pdf 74744.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074756 (pdf 74756.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074866 (pdf 74866.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (DASH PHARMS NATCO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074871 (pdf 74871.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 1997 , NDA 074912 (label 74912.pdf) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (KENTON) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075145 (pdf 75145.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075321 (pdf 75321.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 1998 , NDA 075352 (pdf 75352.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1998 , NDA 206803 (pdf 206803.pdf not found) INN (SELEGILINE HYDROCHLORIDE) SELEGILINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2019 , 587 ; ALFENTANIL ; 71195-58-9 ; 1986 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- ANESTHETICS -- NARCOTICS -- OPIATE AGONISTS , ; NDA 019353 (label 19353.pdf) INN (ALFENTANIL HYDROCHLORIDE) ALFENTA (RISING) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , NDA 075221 (pdf 75221.pdf not found) INN (ALFENTANIL HYDROCHLORIDE) ALFENTANIL (HOSPIRA) APPROVAL= AP YEAR= 1999 , 588 ; NAFTIFINE ; 65472-88-0 ; 1988 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- ANTI-INFLAMMATORY , ; NDA 019356 (label 19356.pdf) INN (NAFTIFINE HYDROCHLORIDE) NAFTIN (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1990 , NDA 019599 (label 19599.pdf) INN (NAFTIFINE HYDROCHLORIDE) NAFTIN (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 204286 (label 204286.pdf) INN (NAFTIFINE HYDROCHLORIDE) NAFTIN (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2013 , NDA 206901 (pdf 206901.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2016 , NDA 205975 (pdf 205975.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2016 , NDA 206960 (pdf 206960.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 206165 (pdf 206165.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 208201 (pdf 208201.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2019 , NDA 210038 (pdf 210038.pdf not found) INN (NAFTIFINE HYDROCHLORIDE) NAFTIFINE HYDROCHLORIDE (XIROMED) APPROVAL= AP YEAR= 2020 , 589 ; ETHANOLAMINE OLEATE ; 3282-75-5 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- SCLEROTIC AGENT -- TREATMENT OF ESOPHAGEAL VARICES , ; NDA 019357 (pdf 19357.pdf not found) INN (ETHANOLAMINE OLEATE) ETHAMOLIN (QOL MEDCL) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , 590 ; ETRETINATE ; 54350-48-0 ; 1986 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIPSORIATIC -- KERATOLYTIC AGENTS , ; NDA 019369 (pdf 19369.pdf not found) INN (ETRETINATE) TEGISON (ROCHE) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , 591 ; NORFLOXACIN ; 70458-96-7 ; 1986 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- NUCLEIC ACID SYNTHESIS INHIBITORS -- QUINOLONES , ; NDA 019384 (label 19384.pdf) INN (NORFLOXACIN) NOROXIN (MERCK) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 019757 (label 19757.pdf) INN (NORFLOXACIN) CHIBROXIN (MERCK) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 074690 (pdf 74690.pdf not found) INN (NORFLOXACIN) NORFLOXACIN (NOVOPHARM LIMITED) APPROVAL= TA YEAR= 2000 OBSOLETE , 592 ; PERGOLIDE ; 66104-22-1 ; 1988 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- DOPAMINE RECEPTOR AGONIST -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- NEUROPROTECTIVE AGENTS -- ERGOT DERIVATIVE , ; NDA 019385 (label 19385.pdf) INN (PERGOLIDE MESYLATE) PERMAX (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 076061 (pdf 76061.pdf not found) INN (PERGOLIDE MESYLATE) PERGOLIDE MESYLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076094 (pdf 76094.pdf not found) INN (PERGOLIDE MESYLATE) PERGOLIDE MESYLATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , 593 ; ESMOLOL ; 81147-92-4 ; 1986 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC (BETA-1) SELECTIVE BLOCKER -- ADRENERGIC BETA-ANTAGONISTS , ; NDA 019386 (label 19386.pdf) INN (ESMOLOL HYDROCHLORIDE) BREVIBLOC (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , NDA 073323 (pdf 73323.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 073326 (pdf 73326.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076323 (pdf 76323.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076326 (pdf 76326.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076456 (pdf 76456.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (PHARMAFORCE) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076474 (pdf 76474.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2005 , NDA 076573 (pdf 76573.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 205703 (label 205703.pdf) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2016 , NDA 201126 (pdf 201126.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205520 (pdf 205520.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 208538 (pdf 208538.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 206608 (pdf 206608.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 207107 (pdf 207107.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 216244 (pdf 216244.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214172 (pdf 214172.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216603 (pdf 216603.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , 594 ; SUPROFEN ; 40828-46-4 ; 1988 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS , ; NDA 019387 (pdf 19387.pdf not found) INN (SUPROFEN) PROFENAL (ALCON) APPROVAL= AP YEAR= 1988 DISCONTINUED , 595 ; PINACIDIL ; 60560-33-0 ; 1989 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ATP-DEPENDENT POTASSIUM CHANNEL AGONIST -- ANTIHYPERTENSIVE , ; NDA 019456 (pdf 19456.pdf not found) INN (PINACIDIL) PINDAC (LEO PHARM) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , 596 ; M MISOPROSTOL ; 259218-80-9 ; 0 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- PROSTAGLANDINS -- SYNTHETIC PROSTAGLANDIN E1 ANALOG , ; 597 ; ISRADIPINE ; 75695-93-1 ; 1990 ; ; ; CLASS CARDIOVASCULAR -- CA CHANNEL ANTAGONIST -- ANTIHYPERTENSIVE -- VASODILATOR AGENTS , ; NDA 019546 (pdf 19546.pdf not found) INN (ISRADIPINE) DYNACIRC (SMITHKLINE BEECHAM) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 020336 (pdf 20336.pdf not found) INN (ISRADIPINE) DYNACIRC CR (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 077169 (pdf 77169.pdf not found) INN (ISRADIPINE) ISRADIPINE (ELITE LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077317 (pdf 77317.pdf not found) INN (ISRADIPINE) ISRADIPINE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2006 , NDA 201067 (pdf 201067.pdf not found) INN (ISRADIPINE) ISRADIPINE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , 598 ; PINACIDIL ; 60560-33-0 ; 1989 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ATP-DEPENDENT POTASSIUM CHANNEL AGONIST -- ANTIHYPERTENSIVE , ; NDA 019456 (pdf 19456.pdf not found) INN (PINACIDIL) PINDAC (LEO PHARM) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , 599 ; FAMOTIDINE ; 76824-35-6 ; 1986 ; ; ; CLASS METABOLISM -- HISTAMINE H2 RECEPTOR ANTAGONIST -- ANTIHISTAMINE -- TREATMENT OF ACTIVE DUODENAL ULCER, GASTRIC ULCER AND GASTROESOPHAGEAL REFLUX DISEASE , ; NDA 019462 (label 19462.pdf) INN (FAMOTIDINE) PEPCID (BAUSCH) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 019510 (label 19510.pdf) INN (FAMOTIDINE) PEPCID (MERCK) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019527 (label 19527.pdf) INN (FAMOTIDINE) PEPCID (SALIX PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 020249 (label 20249.pdf) INN (FAMOTIDINE) PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020325 (label 20325.pdf) INN (FAMOTIDINE) PEPCID AC (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1995 , NDA 020752 (label 20752.pdf) INN (FAMOTIDINE) PEPCID RPD (MERCK) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020801 (label 20801.pdf) INN (FAMOTIDINE) PEPCID AC (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1998 , NDA 020902 (label 20902.pdf) INN (FAMOTIDINE) PEPCID AC (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1999 , NDA 020958 (label 20958.pdf) INN (CALCIUM CARBONATE FAMOTIDINE MAGNESIUM HYDROXIDE) PEPCID COMPLETE (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2000 , NDA 021712 (label 21712.pdf) INN (FAMOTIDINE) FLUXID (UCB INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074687 (pdf 74687.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (NOVOPHARM LIMITED) APPROVAL= TA YEAR= 1998 OBSOLETE , NDA 075062 (pdf 75062.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075192 (pdf 75192.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MARSAM PHARMS LLC) APPROVAL= TA YEAR= 1998 , NDA 075193 (pdf 75193.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MARSAM PHARMS LLC) APPROVAL= TA YEAR= 1998 , NDA 075194 (pdf 75194.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MARSAM PHARMS LLC) APPROVAL= TA YEAR= 1998 , NDA 075302 (pdf 75302.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MANKIND PHARMA) APPROVAL= AP YEAR= 2001 , NDA 075311 (label 75311.pdf) INN (FAMOTIDINE) FAMOTIDINE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075312 (pdf 75312.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075400 (pdf 75400.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (PERRIGO) APPROVAL= AP YEAR= 2005 , NDA 075404 (pdf 75404.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075457 (pdf 75457.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075486 (pdf 75486.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 075488 (pdf 75488.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 075511 (pdf 75511.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2001 , NDA 075512 (pdf 75512.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (P AND L) APPROVAL= AP YEAR= 2001 , NDA 075591 (pdf 75591.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2001 , NDA 075607 (pdf 75607.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SANDOZ) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075610 (pdf 75610.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (APOTEX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075611 (label 75611.pdf) INN (FAMOTIDINE) FAMOTIDINE (APOTEX) APPROVAL= AP YEAR= 2001 , NDA 075622 (pdf 75622.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (SAGENT) APPROVAL= AP YEAR= 2001 , NDA 075639 (pdf 75639.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075650 (pdf 75650.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075651 (pdf 75651.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SAGENT) APPROVAL= AP YEAR= 2001 , NDA 075669 (pdf 75669.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075674 (pdf 75674.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MYLAN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075684 (pdf 75684.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SAGENT) APPROVAL= AP YEAR= 2001 , NDA 075704 (pdf 75704.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (RISING) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075705 (pdf 75705.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (HOSPIRA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075707 (pdf 75707.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (APOTHECON) APPROVAL= TA YEAR= 2001 , NDA 075708 (pdf 75708.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (APOTHECON) APPROVAL= TA YEAR= 2001 , NDA 075709 (pdf 75709.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 075715 (pdf 75715.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (PERRIGO) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075718 (pdf 75718.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2001 , NDA 075729 (pdf 75729.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER (ABBVIE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075758 (pdf 75758.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2001 OBSOLETE , NDA 075786 (pdf 75786.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CHARTWELL RX) APPROVAL= AP YEAR= 2001 , NDA 075789 (pdf 75789.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075793 (pdf 75793.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SANDOZ) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075799 (pdf 75799.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075805 (pdf 75805.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CARLSBAD) APPROVAL= AP YEAR= 2001 , NDA 075813 (pdf 75813.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 075821 (pdf 75821.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (TEVA) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 075825 (pdf 75825.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (SAGENT) APPROVAL= AP YEAR= 2001 , NDA 075870 (pdf 75870.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (HOSPIRA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075905 (pdf 75905.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (HOSPIRA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075942 (pdf 75942.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (APOTEX INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076101 (pdf 76101.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076322 (pdf 76322.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE PHARMACY BULK (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076324 (pdf 76324.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 077146 (pdf 77146.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2005 , NDA 077351 (pdf 77351.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (PERRIGO R AND D) APPROVAL= AP YEAR= 2006 , NDA 077352 (pdf 77352.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (PERRIGO R AND D) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077355 (pdf 77355.pdf not found) INN (CALCIUM CARBONATE FAMOTIDINE MAGNESIUM HYDROXIDE) FAMOTIDINE , CALCIUM CARBONATE , AND MAGNESIUM HYDROXIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 077367 (pdf 77367.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 078641 (pdf 78641.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078642 (pdf 78642.pdf not found) INN (FAMOTIDINE) FAMOTIDINE PRESERVATIVE FREE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078916 (pdf 78916.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 090283 (pdf 90283.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090440 (pdf 90440.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 090837 (pdf 90837.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 091020 (pdf 91020.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (NAVINTA LLC) APPROVAL= AP YEAR= 2010 , NDA 022519 (label 22519.pdf) INN (FAMOTIDINE IBUPROFEN) DUEXIS (HORIZON) APPROVAL= AP YEAR= 2011 , NDA 201695 (pdf 201695.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (NOVEL LABS INC) APPROVAL= AP YEAR= 2012 , NDA 201995 (pdf 201995.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (AKORN) APPROVAL= AP YEAR= 2014 , NDA 206530 (pdf 206530.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 206531 (pdf 206531.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204782 (pdf 204782.pdf not found) INN (CALCIUM CARBONATE FAMOTIDINE MAGNESIUM HYDROXIDE) FAMOTIDINE , CALCIUM CARBONATE , AND MAGNESIUM HYDROXIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 211890 (pdf 211890.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 215043 (pdf 215043.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 211278 (pdf 211278.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215689 (pdf 215689.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215766 (pdf 215766.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215767 (pdf 215767.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216030 (pdf 216030.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215630 (pdf 215630.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 215822 (pdf 215822.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (VKT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216441 (pdf 216441.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215828 (pdf 215828.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216427 (pdf 216427.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (AMNEALS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216400 (pdf 216400.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 216814 (pdf 216814.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217375 (pdf 217375.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217543 (pdf 217543.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217655 (pdf 217655.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2023 , NDA 217137 (pdf 217137.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CARNEGIE) APPROVAL= AP YEAR= 2023 , NDA 217330 (pdf 217330.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217529 (pdf 217529.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217669 (pdf 217669.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2023 , NDA 217842 (pdf 217842.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 218181 (pdf 218181.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 203658 (pdf 203658.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2024 , NDA 215925 (pdf 215925.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE AND IBUPROFEN (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 217605 (pdf 217605.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CEROVENE INC) APPROVAL= AP YEAR= 2024 , NDA 218003 (pdf 218003.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2024 , NDA 218461 (pdf 218461.pdf not found) INN (FAMOTIDINE) FAMOTIDINE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2024 , 600 ; GLUCONOLACTONE ; 90-80-2 ; 1990 ; ; ; CLASS FOOD ADDITIVE E575 USED AS A SEQUESTRANT -- IN VITRO GLYCATING AGENT , ; NDA 019481 (label 19481.pdf) INN (CITRIC ACID GLUCONOLACTONE MAGNESIUM CARBONATE) RENACIDIN (UNITED GUARDIAN) APPROVAL= AP YEAR= 1990 , 601 ; NICARDIPINE ; 55985-32-5 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ANTIARRHYTHMIC AGENTS -- ANTIHYPERTENSIVE AGENTS -- CALCIUM CHANNEL BLOCKERS -- DIHYDROPYRIDINES , ; NDA 019488 (label 19488.pdf) INN (NICARDIPINE HYDROCHLORIDE) CARDENE (CHIESI) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 019734 (label 19734.pdf) INN (NICARDIPINE HYDROCHLORIDE) CARDENE (CHIESI) APPROVAL= AP YEAR= 1992 , NDA 020005 (label 20005.pdf) INN (NICARDIPINE HYDROCHLORIDE) CARDENE SR (CHIESI) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 022276 (label 22276.pdf) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2008 , NDA 074439 (pdf 74439.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074540 (pdf 74540.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074642 (pdf 74642.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074670 (pdf 74670.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 , NDA 074928 (label 74928.pdf) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 , NDA 078405 (pdf 78405.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078714 (pdf 78714.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090125 (pdf 90125.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (NAVINTA LLC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090534 (pdf 90534.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2009 , NDA 090664 (pdf 90664.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (RK PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090671 (pdf 90671.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 211121 (pdf 211121.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216357 (pdf 216357.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 217555 (pdf 217555.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 215377 (pdf 215377.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (SENORES PHARMS) APPROVAL= AP YEAR= 2023 , NDA 216420 (pdf 216420.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 203978 (pdf 203978.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE (INFORLIFE) APPROVAL= AP YEAR= 2024 , NDA 218202 (pdf 218202.pdf not found) INN (NICARDIPINE HYDROCHLORIDE) NICARDIPINE HYDROCHLORIDE (SKG PHARMA) APPROVAL= AP YEAR= 2024 , 602 ; CLOFAZIMINE ; 2030-63-9 ; 1986 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIMYCOBACTERIALS -- LEPROSTATIC AGENTS -- ANTI-INFLAMMATORY -- TREATMENT OF LEPROMATOUS LEPROSY , ; NDA 019500 (label 19500.pdf) INN (CLOFAZIMINE) LAMPRENE (NOVARTIS) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , 603 ; NIZATIDINE ; 76963-41-2 ; 1988 ; ; ; CLASS METABOLISM -- HISTAMINE H2 RECEPTOR ANTAGONIST -- ANTIHISTAMINE -- ANTI-ULCER AGENTS , ; NDA 019508 (label 19508.pdf) INN (NIZATIDINE) AXID (SMITHKLINE BEECHAM) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 020555 (label 20555.pdf) INN (NIZATIDINE) AXID AR (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1996 , NDA 021494 (label 21494.pdf) INN (NIZATIDINE) AXID (BRAINTREE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075461 (pdf 75461.pdf not found) INN (NIZATIDINE) NIZATIDINE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075616 (pdf 75616.pdf not found) INN (NIZATIDINE) NIZATIDINE (WATSON LABS) APPROVAL= AP YEAR= 2002 , NDA 075668 (pdf 75668.pdf not found) INN (NIZATIDINE) NIZATIDINE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075806 (pdf 75806.pdf not found) INN (NIZATIDINE) NIZATIDINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075934 (pdf 75934.pdf not found) INN (NIZATIDINE) NIZATIDINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076178 (pdf 76178.pdf not found) INN (NIZATIDINE) NIZATIDINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 076383 (pdf 76383.pdf not found) INN (NIZATIDINE) NIZATIDINE (APOTEX INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077314 (pdf 77314.pdf not found) INN (NIZATIDINE) NIZATIDINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2005 , NDA 090576 (label 90576.pdf) INN (NIZATIDINE) NIZATIDINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090618 (pdf 90618.pdf not found) INN (NIZATIDINE) NIZATIDINE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2011 , 604 ; CIPROFLOXACIN ; 85721-33-1 ; 1987 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- NUCLEIC ACID SYNTHESIS INHIBITORS -- QUINOLONES , ; NDA 019537 (label 19537.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPRO (BAYER HLTHCARE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 019847 (label 19847.pdf) INN (CIPROFLOXACIN) CIPRO (BAYER HLTHCARE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019857 (label 19857.pdf) INN (CIPROFLOXACIN) CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER (BAYER HLTHCARE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019858 (label 19858.pdf) INN (CIPROFLOXACIN) CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (BAYER PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019992 (label 19992.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE) CILOXAN (SANDOZ) APPROVAL= AP YEAR= 1990 , NDA 020369 (label 20369.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE) CILOXAN (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 020780 (label 20780.pdf) INN (CIPROFLOXACIN) CIPRO (BAYER HLTHCARE) APPROVAL= AP YEAR= 1997 , NDA 020805 (label 20805.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE HYDROCORTISONE) CIPRO HC (NOVARTIS) APPROVAL= AP YEAR= 1998 , NDA 021473 (label 21473.pdf) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPRO XR (BAYER HLTHCARE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021537 (label 21537.pdf) INN (CIPROFLOXACIN DEXAMETHASONE) CIPRODEX (NOVARTIS) APPROVAL= AP YEAR= 2003 , NDA 021554 (label 21554.pdf) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPRO XR (BAYER PHARMS) APPROVAL= AP YEAR= 2003 NEWAPPLICATION , NDA 021744 (label 21744.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE) PROQUIN XR (DEPOMED INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 074124 (pdf 74124.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074876 (pdf 74876.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (NOVOPHARM LIMITED) APPROVAL= TA YEAR= 1999 OBSOLETE , NDA 075593 (pdf 75593.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2004 , NDA 075685 (pdf 75685.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075747 (pdf 75747.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075817 (pdf 75817.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2004 , NDA 075928 (pdf 75928.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2004 , NDA 075939 (pdf 75939.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2004 , NDA 076089 (pdf 76089.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076126 (pdf 76126.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (CARLSBAD) APPROVAL= AP YEAR= 2004 , NDA 076136 (pdf 76136.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (TEVA) APPROVAL= TA YEAR= 2001 , NDA 076138 (pdf 76138.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (NOSTRUM LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076426 (pdf 76426.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076484 (pdf 76484.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076558 (pdf 76558.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076593 (pdf 76593.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (AIPING PHARM INC) APPROVAL= AP YEAR= 2004 , NDA 076639 (pdf 76639.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2004 , NDA 076673 (pdf 76673.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2005 , NDA 076754 (pdf 76754.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076757 (pdf 76757.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076794 (pdf 76794.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2004 , NDA 076896 (pdf 76896.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2004 , NDA 076912 (pdf 76912.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076992 (pdf 76992.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (BEDFORD LABS) APPROVAL= TA YEAR= 2004 , NDA 076993 (pdf 76993.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (BEDFORD LABS) APPROVAL= TA YEAR= 2005 , NDA 077138 (pdf 77138.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (TEVA PHARMS) APPROVAL= TA YEAR= 2005 , NDA 077245 (pdf 77245.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (HOSPIRA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077568 (pdf 77568.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (FDC LTD) APPROVAL= AP YEAR= 2008 , NDA 077689 (pdf 77689.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2006 , NDA 077701 (pdf 77701.pdf not found) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 077753 (pdf 77753.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 077782 (pdf 77782.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (DR REDDYS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077859 (pdf 77859.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077888 (pdf 77888.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077902 (pdf 77902.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN EXTENDED RELEASE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078024 (pdf 78024.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2008 , NDA 078062 (pdf 78062.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2008 , NDA 078114 (pdf 78114.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BEDFORD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078166 (pdf 78166.pdf not found) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078183 (pdf 78183.pdf not found) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078252 (pdf 78252.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (INFORLIFE) APPROVAL= AP YEAR= 2008 , NDA 078598 (pdf 78598.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (AMRING PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078712 (pdf 78712.pdf not found) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (FOSUN PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021918 (label 21918.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE) CETRAXAL (KEY THERAP) APPROVAL= AP YEAR= 2009 , NDA 076555 (pdf 76555.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076717 (pdf 76717.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 078431 (pdf 78431.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 077417 (pdf 77417.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (ANI PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED OBSOLETE , NDA 077809 (pdf 77809.pdf not found) INN (CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN EXTENDED RELEASE (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200563 (pdf 200563.pdf not found) INN (CIPROFLOXACIN) CIPROFLOXACIN (CHARTWELL) APPROVAL= AP YEAR= 2014 , NDA 207986 (label 207986.pdf) INN (CIPROFLOXACIN) OTIPRIO (ALK ABELLO) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208251 (label 208251.pdf) INN (CIPROFLOXACIN HYDROCHLORIDE FLUOCINOLONE ACETONIDE) OTOVEL (LABORATORIOS SALVAT) APPROVAL= AP YEAR= 2016 , NDA 204613 (pdf 204613.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 208921 (pdf 208921.pdf not found) INN (CIPROFLOXACIN HYDROCHLORIDE) CIPROFLOXACIN HYDROCHLORIDE (YILING) APPROVAL= AP YEAR= 2018 , NDA 205548 (pdf 205548.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 210470 (pdf 210470.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (SUN PHARM) APPROVAL= AP YEAR= 2022 , NDA 215768 (pdf 215768.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN AND DEXAMETHASONE (AKORN) APPROVAL= AP YEAR= 2023 , NDA 216501 (pdf 216501.pdf not found) INN (CIPROFLOXACIN DEXAMETHASONE) CIPROFLOXACIN DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2024 , 605 ; MOMETASONE ; 105102-22-5 ; 0 ; ; ; CLASS RESPIRATORY -- ANTI-ALLERGIC AGENTS -- ANTI-INFLAMMATORY AGENTS , ; 606 ; ISRADIPINE ; 75695-93-1 ; 1990 ; ; ; CLASS CARDIOVASCULAR -- CA CHANNEL ANTAGONIST -- ANTIHYPERTENSIVE -- VASODILATOR AGENTS , ; NDA 019546 (pdf 19546.pdf not found) INN (ISRADIPINE) DYNACIRC (SMITHKLINE BEECHAM) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 020336 (pdf 20336.pdf not found) INN (ISRADIPINE) DYNACIRC CR (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 077169 (pdf 77169.pdf not found) INN (ISRADIPINE) ISRADIPINE (ELITE LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077317 (pdf 77317.pdf not found) INN (ISRADIPINE) ISRADIPINE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2006 , NDA 201067 (pdf 201067.pdf not found) INN (ISRADIPINE) ISRADIPINE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , 607 ; LISINOPRIL ; 76547-98-3 ; 1987 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN-CONVERTING ENZYME INHIBITOR (ACE) -- ANTIHYPERTENSIVE -- CARDIOTONIC AGENTS , ; NDA 019558 (label 19558.pdf) INN (LISINOPRIL) PRINIVIL (MERCK) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 019777 (label 19777.pdf) INN (LISINOPRIL) ZESTRIL (TWI PHARMS) APPROVAL= AP YEAR= 1988 , NDA 019778 (label 19778.pdf) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) PRINZIDE (MERCK) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019888 (label 19888.pdf) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) ZESTORETIC (ALMATICA) APPROVAL= AP YEAR= 1989 , NDA 075743 (pdf 75743.pdf not found) INN (LISINOPRIL) LISINOPRIL (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 075752 (pdf 75752.pdf not found) INN (LISINOPRIL) LISINOPRIL (HERITAGE PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075776 (pdf 75776.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075783 (pdf 75783.pdf not found) INN (LISINOPRIL) LISINOPRIL (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075869 (pdf 75869.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075903 (pdf 75903.pdf not found) INN (LISINOPRIL) LISINOPRIL (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2002 , NDA 075926 (pdf 75926.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075944 (pdf 75944.pdf not found) INN (LISINOPRIL) LISINOPRIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 , NDA 075994 (pdf 75994.pdf not found) INN (LISINOPRIL) LISINOPRIL (CHARTWELL RX) APPROVAL= AP YEAR= 2002 , NDA 075999 (pdf 75999.pdf not found) INN (LISINOPRIL) LISINOPRIL (RISING) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076007 (pdf 76007.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 , NDA 076059 (pdf 76059.pdf not found) INN (LISINOPRIL) LISINOPRIL (WATSON LABS) APPROVAL= AP YEAR= 2002 , NDA 076063 (pdf 76063.pdf not found) INN (LISINOPRIL) LISINOPRIL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076071 (pdf 76071.pdf not found) INN (LISINOPRIL) LISINOPRIL (STRIDES PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076102 (pdf 76102.pdf not found) INN (LISINOPRIL) LISINOPRIL (COREPHARMA) APPROVAL= AP YEAR= 2002 , NDA 076113 (pdf 76113.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076164 (pdf 76164.pdf not found) INN (LISINOPRIL) LISINOPRIL (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 076180 (pdf 76180.pdf not found) INN (LISINOPRIL) LISINOPRIL (PRINSTON INC) APPROVAL= AP YEAR= 2002 OBSOLETE , NDA 076194 (pdf 76194.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 , NDA 076230 (pdf 76230.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2002 , NDA 076262 (pdf 76262.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 076265 (pdf 76265.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076674 (pdf 76674.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (COREPHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077321 (pdf 77321.pdf not found) INN (LISINOPRIL) LISINOPRIL (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 077606 (pdf 77606.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (AUROBINDO) APPROVAL= AP YEAR= 2006 , NDA 077622 (pdf 77622.pdf not found) INN (LISINOPRIL) LISINOPRIL (AUROBINDO) APPROVAL= AP YEAR= 2006 , NDA 077912 (pdf 77912.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 078402 (pdf 78402.pdf not found) INN (LISINOPRIL) LISINOPRIL (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2007 , NDA 202554 (pdf 202554.pdf not found) INN (LISINOPRIL) LISINOPRIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203508 (pdf 203508.pdf not found) INN (LISINOPRIL) LISINOPRIL (INVAGEN PHARMS) APPROVAL= AP YEAR= 2013 , NDA 208401 (label 208401.pdf) INN (LISINOPRIL) QBRELIS (AZURITY) APPROVAL= AP YEAR= 2016 , NDA 204058 (pdf 204058.pdf not found) INN (HYDROCHLOROTHIAZIDE LISINOPRIL) LISINOPRIL AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 , NDA 212041 (pdf 212041.pdf not found) INN (LISINOPRIL) LISINOPRIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 208920 (pdf 208920.pdf not found) INN (LISINOPRIL) LISINOPRIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , 608 ; PREDNICARBATE ; 73771-04-7 ; 1991 ; ; ; CLASS DERMATOLOGICAL -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- CORTICOSTEROID -- STEROIDAL -- ANTI-PRURITIC , ; NDA 019568 (label 19568.pdf) INN (PREDNICARBATE) DERMATOP (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020279 (label 20279.pdf) INN (PREDNICARBATE) DERMATOP E EMOLLIENT (VALEANT BERMUDA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 077236 (pdf 77236.pdf not found) INN (PREDNICARBATE) PREDNICARBATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077287 (pdf 77287.pdf not found) INN (PREDNICARBATE) PREDNICARBATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , 609 ; MEFLOQUINE ; 53230-10-7 ; 1989 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- STRUCTURAL ANALOG OF QUININE , ; NDA 019578 (pdf 19578.pdf not found) INN (MEFLOQUINE HYDROCHLORIDE) MEFLOQUINE HYDROCHLORIDE (US ARMY WALTER REED) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 019591 (label 19591.pdf) INN (MEFLOQUINE HYDROCHLORIDE) LARIAM (ROCHE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 076175 (label 76175.pdf) INN (MEFLOQUINE HYDROCHLORIDE) MEFLOQUINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076392 (label 76392.pdf) INN (MEFLOQUINE HYDROCHLORIDE) MEFLOQUINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2003 , NDA 076523 (label 76523.pdf) INN (MEFLOQUINE HYDROCHLORIDE) MEFLOQUINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 077699 (pdf 77699.pdf not found) INN (MEFLOQUINE HYDROCHLORIDE) MEFLOQUINE HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , 610 ; TERCONAZOLE ; 67915-31-5 ; 1987 ; ; ; CLASS GENITO -- ANTIFUNGAL (CANDIDA ALBICANS) -- TREATMENT OF VULVOVAGINAL CANDIDIASIS -- NHIBITION OF ERGOSTEROL SYNTHESIS AND DISRUPTION OF NORMAL FUNGAL CELL MEMBRANE PERMEABILITY , ; NDA 019579 (label 19579.pdf) INN (TERCONAZOLE) TERAZOL 7 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 019641 (label 19641.pdf) INN (TERCONAZOLE) TERAZOL 3 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019964 (label 19964.pdf) INN (TERCONAZOLE) TERAZOL 3 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 021735 (label 21735.pdf) INN (TERCONAZOLE) TERCONAZOLE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 2004 , NDA 075953 (pdf 75953.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076043 (pdf 76043.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (TARO) APPROVAL= AP YEAR= 2005 , NDA 076712 (pdf 76712.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076850 (pdf 76850.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077149 (pdf 77149.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2006 , NDA 077553 (pdf 77553.pdf not found) INN (TERCONAZOLE) TERCONAZOLE (TARO) APPROVAL= AP YEAR= 2007 , 611 ; NABUMETONE ; 42924-53-8 ; 1991 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- NSAID -- ANALGESIC -- ANTIPYRETIC , ; NDA 019583 (label 19583.pdf) INN (NABUMETONE) RELAFEN (SMITHKLINE BEECHAM) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 075179 (label 75179.pdf) INN (NABUMETONE) NABUMETONE (COPLEY PHARM) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075189 (label 75189.pdf) INN (NABUMETONE) NABUMETONE (IMPAX LABS INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075280 (pdf 75280.pdf not found) INN (NABUMETONE) NABUMETONE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 , NDA 075590 (pdf 75590.pdf not found) INN (NABUMETONE) NABUMETONE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076009 (pdf 76009.pdf not found) INN (NABUMETONE) NABUMETONE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2003 , NDA 078671 (pdf 78671.pdf not found) INN (NABUMETONE) NABUMETONE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078420 (pdf 78420.pdf not found) INN (NABUMETONE) NABUMETONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 079093 (pdf 79093.pdf not found) INN (NABUMETONE) NABUMETONE (OXFORD PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090516 (pdf 90516.pdf not found) INN (NABUMETONE) NABUMETONE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090445 (pdf 90445.pdf not found) INN (NABUMETONE) NABUMETONE (ANNORA PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091083 (pdf 91083.pdf not found) INN (NABUMETONE) NABUMETONE (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 090427 (pdf 90427.pdf not found) INN (NABUMETONE) NABUMETONE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203166 (pdf 203166.pdf not found) INN (NABUMETONE) NABUMETONE (LGM PHARMA) APPROVAL= AP YEAR= 2019 , 612 ; URSODIOL ; 128-13-2 ; 1987 ; ; NATURAL MOLECULE C00032464 ; CLASS METABOLISM -- STEROL -- CHOLERETIC -- CHOLAGOGUES -- ANTICHOLELITHOGENIC -- TREATMENT OF PRIMARY BILIARY CIRRHOSIS -- NATURALLY OCCURRING HYDROPHILIC BILE ACID -- IN THE LIVER, URSODIOL IS CONJUGATED WITH GLYCINE OR TAURINE THEN SECRETED INTO BILE , ; NDA 019594 (label 19594.pdf) INN (URSODIOL) ACTIGALL (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 020675 (label 20675.pdf) INN (URSODIOL) URSO 250 (ALLERGAN) APPROVAL= AP YEAR= 1997 , NDA 075517 (pdf 75517.pdf not found) INN (URSODIOL) URSODIOL (EPIC PHARMA) APPROVAL= AP YEAR= 2000 , NDA 075592 (pdf 75592.pdf not found) INN (URSODIOL) URSODIOL (TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077865 (pdf 77865.pdf not found) INN (URSODIOL) URSODIOL (COREPHARMA) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 077895 (pdf 77895.pdf not found) INN (URSODIOL) URSODIOL (IMPAX LABS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 079082 (pdf 79082.pdf not found) INN (URSODIOL) URSODIOL (LANNETT CO INC) APPROVAL= AP YEAR= 2008 , NDA 079184 (pdf 79184.pdf not found) INN (URSODIOL) URSODIOL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090530 (pdf 90530.pdf not found) INN (URSODIOL) URSODIOL (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090801 (pdf 90801.pdf not found) INN (URSODIOL) URSODIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200826 (pdf 200826.pdf not found) INN (URSODIOL) URSODIOL (IMPAX LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202540 (pdf 202540.pdf not found) INN (URSODIOL) URSODIOL (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 , NDA 210707 (pdf 210707.pdf not found) INN (URSODIOL) URSODIOL (ABHAI LLC) APPROVAL= AP YEAR= 2018 , NDA 211145 (pdf 211145.pdf not found) INN (URSODIOL) URSODIOL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 211301 (pdf 211301.pdf not found) INN (URSODIOL) URSODIOL (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 212452 (pdf 212452.pdf not found) INN (URSODIOL) URSODIOL (EYWA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 205789 (pdf 205789.pdf not found) INN (URSODIOL) URSODIOL (LGM PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213200 (pdf 213200.pdf not found) INN (URSODIOL) URSODIOL (RISING) APPROVAL= AP YEAR= 2020 , NDA 213504 (pdf 213504.pdf not found) INN (URSODIOL) URSODIOL (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213555 (pdf 213555.pdf not found) INN (URSODIOL) URSODIOL (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 214295 (pdf 214295.pdf not found) INN (URSODIOL) URSODIOL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 210344 (pdf 210344.pdf not found) INN (URSODIOL) URSODIOL (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214329 (pdf 214329.pdf not found) INN (URSODIOL) URSODIOL (RK PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214849 (pdf 214849.pdf not found) INN (URSODIOL) URSODIOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , 613 ; KETOROLAC ; 74103-06-3 ; 1989 ; ; ; CLASS MUSCULO-SKELETAL -- NONSTEROIDAL ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS , ; NDA 019645 (label 19645.pdf) INN (KETOROLAC TROMETHAMINE) TORADOL (ROCHE PALO) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019698 (pdf 19698.pdf not found) INN (KETOROLAC TROMETHAMINE) TORADOL (ROCHE PALO) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 019700 (label 19700.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR (ABBVIE) APPROVAL= AP YEAR= 1992 , NDA 020811 (label 20811.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR PRESERVATIVE FREE (ALLERGAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021528 (label 21528.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR LS (ABBVIE) APPROVAL= AP YEAR= 2003 , NDA 074754 (pdf 74754.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (TEVA) APPROVAL= AP YEAR= 1997 , NDA 074761 (pdf 74761.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (MYLAN) APPROVAL= AP YEAR= 1997 , NDA 074790 (pdf 74790.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074801 (pdf 74801.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074802 (label 74802.pdf) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1997 , NDA 074955 (pdf 74955.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074993 (pdf 74993.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075222 (pdf 75222.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075228 (pdf 75228.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075230 (pdf 75230.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BEDFORD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075284 (pdf 75284.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (PLIVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075299 (pdf 75299.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075348 (pdf 75348.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075626 (pdf 75626.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075631 (pdf 75631.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075772 (pdf 75772.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 075784 (pdf 75784.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 076109 (pdf 76109.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 076209 (pdf 76209.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (AMPHASTAR PHARM) APPROVAL= AP YEAR= 2004 , NDA 076271 (pdf 76271.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 076722 (pdf 76722.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2004 , NDA 077201 (pdf 77201.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077308 (pdf 77308.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 077942 (pdf 77942.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 077943 (pdf 77943.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078145 (pdf 78145.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (LUITPOLD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078299 (pdf 78299.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (STERISCIENCE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078721 (pdf 78721.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022427 (label 22427.pdf) INN (KETOROLAC TROMETHAMINE) ACUVAIL (ABBVIE) APPROVAL= AP YEAR= 2009 , NDA 076583 (pdf 76583.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078399 (pdf 78399.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078434 (pdf 78434.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078737 (pdf 78737.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SUN PHARM) APPROVAL= AP YEAR= 2008 , NDA 090017 (pdf 90017.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 022382 (label 22382.pdf) INN (KETOROLAC TROMETHAMINE) SPRIX (ZYLA) APPROVAL= AP YEAR= 2010 , NDA 091065 (pdf 91065.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 201155 (pdf 201155.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (STERISCIENCE) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203376 (pdf 203376.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205388 (label 205388.pdf) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) OMIDRIA (RAYNER SURGICAL) APPROVAL= AP YEAR= 2014 , NDA 203242 (pdf 203242.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204216 (pdf 204216.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (GLAND) APPROVAL= AP YEAR= 2016 , NDA 209900 (pdf 209900.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2017 , NDA 205191 (pdf 205191.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210616 (pdf 210616.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 203410 (pdf 203410.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2019 , NDA 210183 (pdf 210183.pdf not found) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 205190 (pdf 205190.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211445 (pdf 211445.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (NEPHRON) APPROVAL= AP YEAR= 2020 , NDA 212939 (pdf 212939.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215788 (pdf 215788.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SENORES PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214456 (pdf 214456.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216407 (pdf 216407.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ATNAHS PHARMA US) APPROVAL= AP YEAR= 2022 , NDA 216651 (pdf 216651.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 217038 (pdf 217038.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 215745 (pdf 215745.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (LEADING) APPROVAL= AP YEAR= 2023 , NDA 216759 (pdf 216759.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217166 (pdf 217166.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ASPIRO) APPROVAL= AP YEAR= 2023 , NDA 217789 (pdf 217789.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CAPLIN) APPROVAL= AP YEAR= 2023 , NDA 218204 (pdf 218204.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CAPLIN) APPROVAL= AP YEAR= 2024 , 614 ; ENOXACIN ; 74011-58-8 ; 1991 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- BROAD-SPECTRUM AZAFLUOROQUINOLONE ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 019616 (pdf 19616.pdf not found) INN (ENOXACIN) PENETREX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , 615 ; PROPOFOL ; 2078-54-8 ; 1989 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- ANTICONVULSANTS -- ANTIEMETICS -- FREE RADICAL SCAVENGERS -- HYPNOTICS -- SEDATIVES -- GABA-A AGONIST , ; NDA 019627 (label 19627.pdf) INN (PROPOFOL) DIPRIVAN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY , NDA 074704 (pdf 74704.pdf not found) INN (PROPOFOL) PROPOFOL (ABBOTT) APPROVAL= TA YEAR= 1997 OBSOLETE , NDA 074719 (pdf 74719.pdf not found) INN (PROPOFOL) PROPOFOL (BAXTER HLTHCARE) APPROVAL= TA YEAR= 1998 , NDA 074816 (pdf 74816.pdf not found) INN (PROPOFOL) PROPOFOL (GENSIA SICOR PHARMS) APPROVAL= TA YEAR= 1998 , NDA 074848 (pdf 74848.pdf not found) INN (PROPOFOL) PROPOFOL (HIKMA) APPROVAL= AP YEAR= 2005 , NDA 075040 (pdf 75040.pdf not found) INN (PROPOFOL) PROPOFOL (ESI LEDERLE) APPROVAL= TA YEAR= 1999 , NDA 075102 (pdf 75102.pdf not found) INN (PROPOFOL) PROPOFOL (SAGENT PHARMS INC) APPROVAL= AP YEAR= 1999 , NDA 075392 (label 75392.pdf) INN (PROPOFOL) PROPOFOL (TEVA PARENTERAL) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077908 (pdf 77908.pdf not found) INN (PROPOFOL) PROPOFOL (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 205307 (pdf 205307.pdf not found) INN (PROPOFOL) PROPOFOL (WATSON LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205067 (pdf 205067.pdf not found) INN (PROPOFOL) PROPOFOL (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 205576 (pdf 205576.pdf not found) INN (PROPOFOL) PROPOFOL (INNOPHARMA) APPROVAL= AP YEAR= 2020 , NDA 206408 (pdf 206408.pdf not found) INN (PROPOFOL) PROPOFOL (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 217013 (pdf 217013.pdf not found) INN (PROPOFOL) PROPOFOL (ASPIRO) APPROVAL= AP YEAR= 2024 , 616 ; LOVASTATIN ; 75330-75-5 ; 1987 ; ; NATURAL MOLECULE C00000547 ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- HYDROXYMETHYLGLUTARYL-COA (HMG-COA) REDUCTASE INHIBITORS , ; NDA 019643 (label 19643.pdf) INN (LOVASTATIN) MEVACOR (MERCK) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 021249 (label 21249.pdf) INN (LOVASTATIN) ADVICOR (ABBVIE) APPROVAL= AP YEAR= 2001 OBSOLETE , NDA 021316 (label 21316.pdf) INN (LOVASTATIN) ALTOPREV (COVIS) APPROVAL= AP YEAR= 2002 , NDA 075300 (pdf 75300.pdf not found) INN (LOVASTATIN) LOVASTATIN (CHARTWELL RX) APPROVAL= AP YEAR= 2001 , NDA 075451 (pdf 75451.pdf not found) INN (LOVASTATIN) LOVASTATIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075551 (pdf 75551.pdf not found) INN (LOVASTATIN) LOVASTATIN (TEVA) APPROVAL= AP YEAR= 2001 , NDA 075636 (pdf 75636.pdf not found) INN (LOVASTATIN) LOVASTATIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2001 , NDA 075828 (pdf 75828.pdf not found) INN (LOVASTATIN) LOVASTATIN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2001 , NDA 075935 (pdf 75935.pdf not found) INN (LOVASTATIN) LOVASTATIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075991 (pdf 75991.pdf not found) INN (LOVASTATIN) LOVASTATIN (CARLSBAD) APPROVAL= AP YEAR= 2002 , NDA 077520 (pdf 77520.pdf not found) INN (LOVASTATIN) LOVASTATIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077748 (pdf 77748.pdf not found) INN (LOVASTATIN) LOVASTATIN (COREPHARMA) APPROVAL= AP YEAR= 2007 , NDA 078296 (pdf 78296.pdf not found) INN (LOVASTATIN) LOVASTATIN (LUPIN) APPROVAL= AP YEAR= 2007 , 617 ; KETOROLAC ; 74103-06-3 ; 1989 ; ; ; CLASS MUSCULO-SKELETAL -- NONSTEROIDAL ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS , ; NDA 019645 (label 19645.pdf) INN (KETOROLAC TROMETHAMINE) TORADOL (ROCHE PALO) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019698 (pdf 19698.pdf not found) INN (KETOROLAC TROMETHAMINE) TORADOL (ROCHE PALO) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 019700 (label 19700.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR (ABBVIE) APPROVAL= AP YEAR= 1992 , NDA 020811 (label 20811.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR PRESERVATIVE FREE (ALLERGAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021528 (label 21528.pdf) INN (KETOROLAC TROMETHAMINE) ACULAR LS (ABBVIE) APPROVAL= AP YEAR= 2003 , NDA 074754 (pdf 74754.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (TEVA) APPROVAL= AP YEAR= 1997 , NDA 074761 (pdf 74761.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (MYLAN) APPROVAL= AP YEAR= 1997 , NDA 074790 (pdf 74790.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074801 (pdf 74801.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074802 (label 74802.pdf) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1997 , NDA 074955 (pdf 74955.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074993 (pdf 74993.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075222 (pdf 75222.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075228 (pdf 75228.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075230 (pdf 75230.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BEDFORD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075284 (pdf 75284.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (PLIVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075299 (pdf 75299.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075348 (pdf 75348.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075626 (pdf 75626.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075631 (pdf 75631.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075772 (pdf 75772.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 075784 (pdf 75784.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 076109 (pdf 76109.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 076209 (pdf 76209.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (AMPHASTAR PHARM) APPROVAL= AP YEAR= 2004 , NDA 076271 (pdf 76271.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 076722 (pdf 76722.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2004 , NDA 077201 (pdf 77201.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077308 (pdf 77308.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 077942 (pdf 77942.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 077943 (pdf 77943.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078145 (pdf 78145.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (LUITPOLD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078299 (pdf 78299.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (STERISCIENCE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078721 (pdf 78721.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022427 (label 22427.pdf) INN (KETOROLAC TROMETHAMINE) ACUVAIL (ABBVIE) APPROVAL= AP YEAR= 2009 , NDA 076583 (pdf 76583.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078399 (pdf 78399.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078434 (pdf 78434.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078737 (pdf 78737.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SUN PHARM) APPROVAL= AP YEAR= 2008 , NDA 090017 (pdf 90017.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 022382 (label 22382.pdf) INN (KETOROLAC TROMETHAMINE) SPRIX (ZYLA) APPROVAL= AP YEAR= 2010 , NDA 091065 (pdf 91065.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 201155 (pdf 201155.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (STERISCIENCE) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203376 (pdf 203376.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205388 (label 205388.pdf) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) OMIDRIA (RAYNER SURGICAL) APPROVAL= AP YEAR= 2014 , NDA 203242 (pdf 203242.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204216 (pdf 204216.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (GLAND) APPROVAL= AP YEAR= 2016 , NDA 209900 (pdf 209900.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2017 , NDA 205191 (pdf 205191.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210616 (pdf 210616.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 203410 (pdf 203410.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2019 , NDA 210183 (pdf 210183.pdf not found) INN (KETOROLAC TROMETHAMINE PHENYLEPHRINE HYDROCHLORIDE) KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 205190 (pdf 205190.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211445 (pdf 211445.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (NEPHRON) APPROVAL= AP YEAR= 2020 , NDA 212939 (pdf 212939.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215788 (pdf 215788.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (SENORES PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214456 (pdf 214456.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216407 (pdf 216407.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ATNAHS PHARMA US) APPROVAL= AP YEAR= 2022 , NDA 216651 (pdf 216651.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 217038 (pdf 217038.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 215745 (pdf 215745.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (LEADING) APPROVAL= AP YEAR= 2023 , NDA 216759 (pdf 216759.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217166 (pdf 217166.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (ASPIRO) APPROVAL= AP YEAR= 2023 , NDA 217789 (pdf 217789.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CAPLIN) APPROVAL= AP YEAR= 2023 , NDA 218204 (pdf 218204.pdf not found) INN (KETOROLAC TROMETHAMINE) KETOROLAC TROMETHAMINE (CAPLIN) APPROVAL= AP YEAR= 2024 , 618 ; RIMANTADINE ; 13392-28-4 ; 1993 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI INFLUENZA A -- RESISTANCE OBSERVED -- CHANNEL BLOCKER , ; NDA 019649 (label 19649.pdf) INN (RIMANTADINE HYDROCHLORIDE) FLUMADINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 019650 (label 19650.pdf) INN (RIMANTADINE HYDROCHLORIDE) FLUMADINE (FOREST LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 075916 (pdf 75916.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076132 (pdf 76132.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2002 , NDA 076375 (pdf 76375.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 DISCONTINUED , 619 ; NORGESTIMATE ; 35189-28-7 ; 1989 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVES , ; NDA 019653 (label 19653.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO CYCLEN-21 (JANSSEN PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019697 (label 19697.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 021040 (label 21040.pdf) INN (ESTRADIOL NORGESTIMATE) PREFEST (TEVA WOMENS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021241 (label 21241.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN LO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021690 (label 21690.pdf) INN (ETHINYL ESTRADIOL NORGESTIMATE) ORTHO TRI-CYCLEN 21 (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 075804 (pdf 75804.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) SPRINTEC (BARR) APPROVAL= AP YEAR= 2002 , NDA 075808 (pdf 75808.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-SPRINTEC (BARR) APPROVAL= AP YEAR= 2003 , NDA 076334 (pdf 76334.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) PREVIFEM (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2004 , NDA 076335 (pdf 76335.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-PREVIFEM (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076626 (pdf 76626.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076627 (pdf 76627.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076812 (pdf 76812.pdf not found) INN (ESTRADIOL NORGESTIMATE) ESTRADIOL AND NORGESTIMATE (BARR) APPROVAL= AP YEAR= 2005 , NDA 076784 (pdf 76784.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI LO SPRINTEC (BARR LABS INC) APPROVAL= AP YEAR= 2009 , NDA 090479 (pdf 90479.pdf not found) INN (NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 200494 (pdf 200494.pdf not found) INN (NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK GENERICS) APPROVAL= AP YEAR= 2011 , NDA 200538 (pdf 200538.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK GENERICS) APPROVAL= AP YEAR= 2012 , NDA 090523 (pdf 90523.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) MONO-LINYAH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 090524 (pdf 90524.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LINYAH (NOVAST LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 090541 (pdf 90541.pdf not found) INN (NORGESTIMATE ETHINYL ESTRADIOL) TRI-LO-LINYAH (NOVAST LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 200541 (pdf 200541.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 090793 (pdf 90793.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 090794 (pdf 90794.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2013 , NDA 091232 (pdf 91232.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LO-ESTARYLLA (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 200383 (pdf 200383.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2015 , NDA 200384 (pdf 200384.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2015 , NDA 202132 (pdf 202132.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203865 (pdf 203865.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203870 (pdf 203870.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201896 (pdf 201896.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 201897 (pdf 201897.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203873 (pdf 203873.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204057 (pdf 204057.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (GLENMARK PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205588 (pdf 205588.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 205441 (pdf 205441.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-MILI (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205449 (pdf 205449.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) MILI (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205630 (pdf 205630.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) NORGESTIMATE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 205762 (pdf 205762.pdf not found) INN (ETHINYL ESTRADIOL NORGESTIMATE) TRI-LO-MILI (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , 620 ; ZIDOVUDINE ; 30516-87-1 ; 1987 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV -- ANTIMETABOLITES -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE (GAG-POL POLYPROTEIN) INHIBITORS , ; NDA 019655 (label 19655.pdf) INN (ZIDOVUDINE) RETROVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 019910 (label 19910.pdf) INN (ZIDOVUDINE) RETROVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1989 , NDA 019951 (label 19951.pdf) INN (ZIDOVUDINE) RETROVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1990 , NDA 020518 (label 20518.pdf) INN (ZIDOVUDINE) RETROVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020857 (label 20857.pdf) INN (LAMIVUDINE ZIDOVUDINE) COMBIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021205 (label 21205.pdf) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) TRIZIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021841 (pdf 21841.pdf not found) INN (ZIDOVUDINE) LAMIVUDINE/ZIDOVUDINE TABLETS CO-PACKAGED WITH NEVIRAPINE TABLETS (PHARMACARE LTD) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 021939 (pdf 21939.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE , NEVIRAPINE TABS 150MG/300MG/200MG (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021943 (pdf 21943.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021944 (pdf 21944.pdf not found) INN (LAMIVUDINE ZIDOVUDINE ABACAVIR) LAMIVUDINE ZIDOVUDINE ABACAVIR (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021971 (pdf 21971.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE ZIDOVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 021988 (pdf 21988.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE/ZIDOVUDINE 150 MG/300 MG TABLETS CO-PACKAGED WITH NEVIRAPINE 200 MG TABLETS (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022018 (label 22018.pdf) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (PHARMACARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 022096 (pdf 22096.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 074047 (pdf 74047.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (BARR) APPROVAL= TA YEAR= 1995 , NDA 076844 (pdf 76844.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (HIKMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077267 (pdf 77267.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (AUROBINDO) APPROVAL= AP YEAR= 2005 , NDA 077268 (pdf 77268.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (AUROBINDO) APPROVAL= AP YEAR= 2005 , NDA 077327 (pdf 77327.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (RANBAXY LABS LTD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077411 (pdf 77411.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 077558 (pdf 77558.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 077981 (pdf 77981.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (CIPLA LTD) APPROVAL= AP YEAR= 2008 , NDA 078128 (pdf 78128.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2006 , NDA 078349 (pdf 78349.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (CIPLA LTD) APPROVAL= AP YEAR= 2007 , NDA 078922 (pdf 78922.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078929 (pdf 78929.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2007 , NDA 079079 (pdf 79079.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 079124 (pdf 79124.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2015 , NDA 090092 (pdf 90092.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2008 , NDA 022061 (pdf 22061.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MATRIX LABS) APPROVAL= TA YEAR= 2008 , NDA 022294 (label 22294.pdf) INN (ZIDOVUDINE) ZIDOVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022296 (pdf 22296.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2009 , NDA 022356 (pdf 22356.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009 , NDA 022464 (label 22464.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2009 , NDA 079081 (pdf 79081.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090309 (pdf 90309.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (MYLAN PHARMA) APPROVAL= TA YEAR= 2009 , NDA 090679 (pdf 90679.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 079128 (pdf 79128.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 090561 (pdf 90561.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (CIPLA) APPROVAL= AP YEAR= 2010 , NDA 091457 (pdf 91457.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (AM REGENT) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200793 (pdf 200793.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS (MATRIX LABS) APPROVAL= TA YEAR= 2010 , NDA 200732 (label 200732.pdf) INN (ZIDOVUDINE) ZIDOVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200748 (pdf 200748.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 090246 (pdf 90246.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 201151 (pdf 201151.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 202058 (pdf 202058.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (HEC PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202157 (pdf 202157.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (HETERO LABS UNIT III) APPROVAL= TA YEAR= 2011 , NDA 202589 (pdf 202589.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 202418 (pdf 202418.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202685 (pdf 202685.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2012 , NDA 202814 (pdf 202814.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 203076 (pdf 203076.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (CIPLA LTD) APPROVAL= TA YEAR= 2012 , NDA 202912 (pdf 202912.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 204538 (pdf 204538.pdf not found) INN (ZIDOVUDINE) ZIDOVUDINE (LIAONING CHENGDA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203259 (pdf 203259.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 204005 (pdf 204005.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (NATCO) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204914 (pdf 204914.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (MYLAN LABS) APPROVAL= TA YEAR= 2014 , NDA 206040 (pdf 206040.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206041 (pdf 206041.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR LAMIVUDINE ZIDOVUDINE) ATAZANAVIR SULFATERITONAVIRLAMIVUDINEZIDOVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206375 (pdf 206375.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2018 , NDA 205626 (label 205626.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE , NEVIRAPINE AND ZIDOVUDINE (MICRO LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , 621 ; LORATADINE ; 79794-75-5 ; 1993 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTI-ALLERGIC AGENTS -- ANTIPRURITICS -- HISTAMINE H1 ANTAGONISTS, NON-SEDATING , ; NDA 019658 (label 19658.pdf) INN (LORATADINE) CLARITIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , NDA 019670 (label 19670.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) CLARITIN-D (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1994 , NDA 020470 (label 20470.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) CLARITIN-D 24 HOUR (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 , NDA 020641 (label 20641.pdf) INN (LORATADINE) CLARITIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 , NDA 020704 (label 20704.pdf) INN (LORATADINE) CLARITIN REDITABS (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996 , NDA 021375 (label 21375.pdf) INN (LORATADINE) ALAVERT (FDN CONSUMER) APPROVAL= AP YEAR= 2002 , NDA 021512 (label 21512.pdf) INN (LORATADINE) LORATADINE (PERRIGO) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021734 (label 21734.pdf) INN (LORATADINE) LORATADINE (TARO) APPROVAL= AP YEAR= 2005 , NDA 021891 (label 21891.pdf) INN (LORATADINE) CHILDREN'S CLARITIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 2006 , NDA 021952 (label 21952.pdf) INN (LORATADINE) CLARITIN (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 2008 , NDA 021993 (label 21993.pdf) INN (LORATADINE) CLARITIN REDITABS (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 2006 , NDA 075209 (pdf 75209.pdf not found) INN (LORATADINE) LORATADINE (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 2003 , NDA 075505 (pdf 75505.pdf not found) INN (LORATADINE) LORATADINE (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075565 (pdf 75565.pdf not found) INN (LORATADINE) LORATADINE (PHARM ASSOC) APPROVAL= AP YEAR= 2004 , NDA 075706 (label 75706.pdf) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (P AND L) APPROVAL= AP YEAR= 2003 , NDA 075728 (pdf 75728.pdf not found) INN (LORATADINE) LORATADINE (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 075790 (pdf 75790.pdf not found) INN (LORATADINE) LORATADINE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 075815 (pdf 75815.pdf not found) INN (LORATADINE) LORATADINE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2004 , NDA 075822 (pdf 75822.pdf not found) INN (LORATADINE) LORATADINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075989 (pdf 75989.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2004 , NDA 075990 (pdf 75990.pdf not found) INN (LORATADINE) LORATADINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076011 (pdf 76011.pdf not found) INN (LORATADINE) LORATADINE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2003 , NDA 076050 (pdf 76050.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2003 , NDA 076127 (pdf 76127.pdf not found) INN (LORATADINE) LORATADINE (TARO) APPROVAL= TA YEAR= 2002 OBSOLETE , NDA 076134 (pdf 76134.pdf not found) INN (LORATADINE) LORATADINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 , NDA 076154 (pdf 76154.pdf not found) INN (LORATADINE) LORATADINE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 076208 (pdf 76208.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076301 (pdf 76301.pdf not found) INN (LORATADINE) LORATADINE (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076471 (pdf 76471.pdf not found) INN (LORATADINE) LORATADINE (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 076529 (pdf 76529.pdf not found) INN (LORATADINE) LORATADINE (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076557 (pdf 76557.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 , NDA 076805 (pdf 76805.pdf not found) INN (LORATADINE) LORATADINE (TARO) APPROVAL= AP YEAR= 2004 , NDA 077153 (pdf 77153.pdf not found) INN (LORATADINE) LORATADINE REDIDOSE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 , NDA 077421 (pdf 77421.pdf not found) INN (LORATADINE) LORATADINE (LANNETT CO INC) APPROVAL= AP YEAR= 2006 , NDA 078447 (pdf 78447.pdf not found) INN (LORATADINE) LORATADINE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201865 (pdf 201865.pdf not found) INN (LORATADINE) LORATADINE (TARO) APPROVAL= AP YEAR= 2015 , NDA 206214 (label 206214.pdf) INN (LORATADINE) LORATADINE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2016 , NDA 208314 (pdf 208314.pdf not found) INN (LORATADINE) LORATADINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 208477 (label 208477.pdf) INN (LORATADINE) LORATADINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210088 (pdf 210088.pdf not found) INN (LORATADINE) LORATADINE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 202538 (pdf 202538.pdf not found) INN (LORATADINE) LORATADINE (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 208931 (pdf 208931.pdf not found) INN (LORATADINE) LORATADINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207569 (pdf 207569.pdf not found) INN (LORATADINE) LORATADINE (GUARDIAN DRUG) APPROVAL= AP YEAR= 2019 , NDA 210033 (pdf 210033.pdf not found) INN (LORATADINE) LORATADINE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2019 , NDA 210722 (pdf 210722.pdf not found) INN (LORATADINE) LORATADINE (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 211926 (pdf 211926.pdf not found) INN (LORATADINE) LORATADINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212795 (pdf 212795.pdf not found) INN (LORATADINE) LORATADINE (TENSHI) APPROVAL= AP YEAR= 2020 , NDA 213294 (pdf 213294.pdf not found) INN (LORATADINE) LORATADINE (TENSHI) APPROVAL= AP YEAR= 2020 , NDA 214280 (pdf 214280.pdf not found) INN (LORATADINE) LORATADINE (RUBICON) APPROVAL= AP YEAR= 2020 , NDA 210409 (pdf 210409.pdf not found) INN (LORATADINE) LORATADINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 214684 (pdf 214684.pdf not found) INN (LORATADINE) LORATADINE (UNIQUE PHARM) APPROVAL= AP YEAR= 2021 , NDA 211900 (pdf 211900.pdf not found) INN (LORATADINE) LORATADINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 211718 (pdf 211718.pdf not found) INN (LORATADINE) LORATADINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 218017 (pdf 218017.pdf not found) INN (LORATADINE PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (BIONPHARMA) APPROVAL= AP YEAR= 2024 , 622 ; NEDOCROMIL ; 69049-73-6 ; 1992 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- ANTIALLERGIC -- ANTI-ASTHMATIC AGENTS -- ANTI-INFLAMMATORY AGENTS -- MAST CELL STABILIZER -- TREATMENT OF ALLERGIC CONJUNCTIVITIS , ; NDA 019660 (pdf 19660.pdf not found) INN (NEDOCROMIL SODIUM) TILADE (KING PHARMS LLC) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 020750 (pdf 20750.pdf not found) INN (NEDOCROMIL SODIUM) TILADE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021009 (label 21009.pdf) INN (NEDOCROMIL SODIUM) ALOCRIL (ALLERGAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 090638 (pdf 90638.pdf not found) INN (NEDOCROMIL SODIUM) NEDOCROMIL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 DISCONTINUED , 623 ; GANCICLOVIR ; 82410-32-0 ; 1989 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- CYTOMEGALOVIRUS (CMV) -- HERPES SIMPLEX VIRUS (HSV) -- ACYCLIC NUCLEOSIDE ANALOGUE OF 2'-DEOXYGUANOSINE , ; NDA 019661 (label 19661.pdf) INN (GANCICLOVIR SODIUM) CYTOVENE (CHEPLAPHARM) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 020460 (pdf 20460.pdf not found) INN (GANCICLOVIR) CYTOVENE (ROCHE PALO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020569 (pdf 20569.pdf not found) INN (GANCICLOVIR) VITRASERT (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 076222 (pdf 76222.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076457 (pdf 76457.pdf not found) INN (GANCICLOVIR) GANCICLOVIR (RANBAXY LABS LTD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 022211 (label 22211.pdf) INN (GANCICLOVIR) ZIRGAN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2009 , NDA 090658 (pdf 90658.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 202624 (pdf 202624.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (AM REGENT) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204950 (pdf 204950.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 209347 (label 209347.pdf) INN (GANCICLOVIR) GANZYK-RTU (EXELA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 204560 (pdf 204560.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (STERISCIENCE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207645 (pdf 207645.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (PHARMASCIENCE INC) APPROVAL= AP YEAR= 2017 , NDA 204204 (pdf 204204.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 212001 (pdf 212001.pdf not found) INN (GANCICLOVIR SODIUM) GANCICLOVIR SODIUM (CUSTOPHARM INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , 624 ; INDECAINIDE ; 74517-78-5 ; 1989 ; DISCONTINUED ; ; CLASS ANTIARRHYTHMIC -- ANTIDYSRHYTHMIC AGENTS -- SODIUM CHANNEL BLOCKERS , ; NDA 019693 (pdf 19693.pdf not found) INN (INDECAINIDE HYDROCHLORIDE) DECABID (LILLY) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , 625 ; OLSALAZINE ; 15722-48-2 ; 1990 ; ; ; CLASS METABOLISM -- ANTIINFLAMMATORY -- GASTROINTESTINAL AGENTS -- TREATMENT OF ULCERATIVE COLITIS , ; NDA 019715 (label 19715.pdf) INN (OLSALAZINE SODIUM) DIPENTUM (MYLAN SPCLT VIATRIS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY , 626 ; OFLOXACIN ; 82419-36-1 ; 1990 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- DNA TOPOISOMERASE IV INHIBITOR -- DNA GYRASE INHIBITOR -- QUINOLONES , ; NDA 019735 (label 19735.pdf) INN (OFLOXACIN) FLOXIN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 019921 (label 19921.pdf) INN (OFLOXACIN) OCUFLOX (ALLERGAN) APPROVAL= AP YEAR= 1993 , NDA 020087 (pdf 20087.pdf not found) INN (OFLOXACIN) FLOXIN IN DEXTROSE 5% (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020799 (label 20799.pdf) INN (OFLOXACIN) FLOXIN OTIC (DAIICHI) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075762 (pdf 75762.pdf not found) INN (OFLOXACIN) OFLOXACIN (BEDFORD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076093 (pdf 76093.pdf not found) INN (OFLOXACIN) OFLOXACIN (LARKEN LABS) APPROVAL= AP YEAR= 2003 , NDA 076128 (pdf 76128.pdf not found) INN (OFLOXACIN) OFLOXACIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2008 , NDA 076182 (label 76182.pdf) INN (OFLOXACIN) OFLOXACIN (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076220 (pdf 76220.pdf not found) INN (OFLOXACIN) OFLOXACIN (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2003 , NDA 076231 (pdf 76231.pdf not found) INN (OFLOXACIN) OFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076407 (pdf 76407.pdf not found) INN (OFLOXACIN) OFLOXACIN (SENTISS) APPROVAL= AP YEAR= 2008 , NDA 076513 (pdf 76513.pdf not found) INN (OFLOXACIN) OFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2004 , NDA 076527 (pdf 76527.pdf not found) INN (OFLOXACIN) OFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 076615 (pdf 76615.pdf not found) INN (OFLOXACIN) OFLOXACIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076616 (pdf 76616.pdf not found) INN (OFLOXACIN) OFLOXACIN (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076622 (pdf 76622.pdf not found) INN (OFLOXACIN) OFLOXACIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2004 , NDA 076830 (pdf 76830.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALVOGEN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077098 (pdf 77098.pdf not found) INN (OFLOXACIN) OFLOXACIN (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 078222 (pdf 78222.pdf not found) INN (OFLOXACIN) OFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076848 (pdf 76848.pdf not found) INN (OFLOXACIN) OFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078559 (pdf 78559.pdf not found) INN (OFLOXACIN) OFLOXACIN (FDC LTD) APPROVAL= AP YEAR= 2009 , NDA 090395 (pdf 90395.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALVOGEN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 202692 (pdf 202692.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 091656 (pdf 91656.pdf not found) INN (OFLOXACIN) OFLOXACIN (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 211525 (pdf 211525.pdf not found) INN (OFLOXACIN) OFLOXACIN (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 215038 (pdf 215038.pdf not found) INN (OFLOXACIN) OFLOXACIN (FDC LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215886 (pdf 215886.pdf not found) INN (OFLOXACIN) OFLOXACIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216130 (pdf 216130.pdf not found) INN (OFLOXACIN) OFLOXACIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 211524 (pdf 211524.pdf not found) INN (OFLOXACIN) OFLOXACIN (AMNEAL) APPROVAL= AP YEAR= 2024 , NDA 217903 (pdf 217903.pdf not found) INN (OFLOXACIN) OFLOXACIN (CAPLIN) APPROVAL= AP YEAR= 2024 , NDA 217904 (pdf 217904.pdf not found) INN (OFLOXACIN) OFLOXACIN (CAPLIN) APPROVAL= AP YEAR= 2024 , 627 ; MORICIZINE ; 31883-05-3 ; 1990 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC , ; NDA 019753 (pdf 19753.pdf not found) INN (MORICIZINE HYDROCHLORIDE) ETHMOZINE (SHIRE) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 628 ; CLOZAPINE ; 5786-21-0 ; 1989 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTIPSYCHOTIC -- DOPAMINE RECEPTOR ANTAGONIST -- ADRENERGIC, CHOLINERGIC, HISTAMINERGIC AND SEROTONERGIC RECEPTORS ANTAGONIST , ; NDA 019758 (label 19758.pdf) INN (CLOZAPINE) CLOZARIL (HERITAGE LIFE) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY , NDA 021590 (label 21590.pdf) INN (CLOZAPINE) FAZACLO ODT (JAZZ) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 074546 (pdf 74546.pdf not found) INN (CLOZAPINE) CLOZAPINE (SANDOZ) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074949 (pdf 74949.pdf not found) INN (CLOZAPINE) CLOZAPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1997 , NDA 075162 (pdf 75162.pdf not found) INN (CLOZAPINE) CLOZAPINE (PAR PHARM) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075417 (pdf 75417.pdf not found) INN (CLOZAPINE) CLOZAPINE (MYLAN) APPROVAL= AP YEAR= 1999 , NDA 075713 (pdf 75713.pdf not found) INN (CLOZAPINE) CLOZAPINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 , NDA 076809 (pdf 76809.pdf not found) INN (CLOZAPINE) CLOZAPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 203479 (label 203479.pdf) INN (CLOZAPINE) VERSACLOZ (TASMAN PHARMA) APPROVAL= AP YEAR= 2013 , NDA 090308 (pdf 90308.pdf not found) INN (CLOZAPINE) CLOZAPINE (BARR LABS INC) APPROVAL= AP YEAR= 2015 , NDA 201824 (pdf 201824.pdf not found) INN (CLOZAPINE) CLOZAPINE (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 202873 (pdf 202873.pdf not found) INN (CLOZAPINE) CLOZAPINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 , NDA 203039 (label 203039.pdf) INN (CLOZAPINE) CLOZAPINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 OBSOLETE , NDA 203807 (pdf 203807.pdf not found) INN (CLOZAPINE) CLOZAPINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206433 (pdf 206433.pdf not found) INN (CLOZAPINE) CLOZAPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 209480 (pdf 209480.pdf not found) INN (CLOZAPINE) CLOZAPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , 629 ; IFOSFAMIDE ; 3778-73-2 ; 1987 ; ; ; CLASS ANTINEOPLASTIC AGENTS, ALKYLATING -- ALKYLATED METABOLITES OF IFOSFAMIDE HAVE BEEN SHOWN TO INTERACT WITH DNA , ; NDA 019763 (label 19763.pdf) INN (IFOSFAMIDE) IFEX (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 075874 (pdf 75874.pdf not found) INN (IFOSFAMIDE MESNA) IFOSFAMIDE/MESNA KIT (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076078 (pdf 76078.pdf not found) INN (IFOSFAMIDE) IFOSFAMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 076657 (label 76657.pdf) INN (IFOSFAMIDE) IFOSFAMIDE (MEITHEAL) APPROVAL= AP YEAR= 2007 , NDA 090181 (pdf 90181.pdf not found) INN (IFOSFAMIDE) IFOSFAMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076619 (pdf 76619.pdf not found) INN (IFOSFAMIDE) IFOSFAMIDE (HIKMA) APPROVAL= AP YEAR= 2011 , NDA 201689 (pdf 201689.pdf not found) INN (IFOSFAMIDE) IFOSFAMIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , 630 ; MESNA ; 19767-45-4 ; 1987 ; ; NATURAL MOLECULE C00000761 ; CLASS VARIOUS -- DETOXIFYING AGENT -- DETOXIFYING AGENT TO INHIBIT THE HEMORRHAGIC CYSTITIS INDUCED BY IFOSFAMIDE -- MESNA REACTS CHEMICALLY WITH THE UROTOXIC IFOSFAMIDE METABOLITES ACROLEIN AND 4-HYDROXY-IFOSFAMIDE , ; NDA 019763 (label 19763.pdf) INN (MESNA) IFEX/MESNEX KIT (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 019884 (label 19884.pdf) INN (MESNA) MESNEX (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 020855 (label 20855.pdf) INN (MESNA) MESNEX (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2002 , NDA 075739 (pdf 75739.pdf not found) INN (MESNA) MESNA (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 075764 (pdf 75764.pdf not found) INN (MESNA) MESNA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075811 (label 75811.pdf) INN (MESNA) MESNA (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 075874 (pdf 75874.pdf not found) INN (IFOSFAMIDE MESNA) IFOSFAMIDE/MESNA KIT (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076488 (pdf 76488.pdf not found) INN (MESNA) MESNA (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090913 (pdf 90913.pdf not found) INN (MESNA) MESNA (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 203364 (pdf 203364.pdf not found) INN (MESNA) MESNA (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 206992 (pdf 206992.pdf not found) INN (MESNA) MESNA (GLAND) APPROVAL= AP YEAR= 2017 , 631 ; SIMVASTATIN ; 79902-63-9 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- HYPOCHOLESTEROLEMIC -- ANTILIPEMIC AGENTS -- HYDROXYMETHYLGLUTARYL-COA (HMG-COA) REDUCTASE INHIBITORS -- STATIN , ; NDA 019766 (label 19766.pdf) INN (SIMVASTATIN) ZOCOR (ORGANON) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 021687 (label 21687.pdf) INN (EZETIMIBE SIMVASTATIN) VYTORIN (ORGANON) APPROVAL= AP YEAR= 2004 , NDA 021961 (label 21961.pdf) INN (SIMVASTATIN) SIMVASTATIN (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022078 (label 22078.pdf) INN (SIMVASTATIN) SIMCOR (ABBVIE) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 076052 (pdf 76052.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076285 (pdf 76285.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076532 (pdf 76532.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (TEVA PHARMS) APPROVAL= TA YEAR= 2005 , NDA 076685 (pdf 76685.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (WATSON LABS TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077691 (pdf 77691.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 077752 (pdf 77752.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077766 (pdf 77766.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077837 (pdf 77837.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 078034 (pdf 78034.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (BIOCON PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078103 (pdf 78103.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 078155 (pdf 78155.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 078425 (pdf 78425.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078735 (pdf 78735.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (OXFORD PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090868 (pdf 90868.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090383 (pdf 90383.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (MICRO LABS) APPROVAL= AP YEAR= 2011 , NDA 200082 (pdf 200082.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2020 , NDA 202343 (label 202343.pdf) INN (SIMVASTATIN SITAGLIPTIN PHOSPHATE) JUVISYNC (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200895 (pdf 200895.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2014 , NDA 201890 (pdf 201890.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206679 (label 206679.pdf) INN (SIMVASTATIN) FLOLIPID (SALERNO PHARMS) APPROVAL= AP YEAR= 2016 , NDA 200909 (pdf 200909.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 202968 (pdf 202968.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (WATSON LABS INC) APPROVAL= AP YEAR= 2017 , NDA 206557 (pdf 206557.pdf not found) INN (SIMVASTATIN) SIMVASTATIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208831 (pdf 208831.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 209222 (pdf 209222.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 208699 (pdf 208699.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , 632 ; APRACLONIDINE ; 66711-21-5 ; 1987 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ALPHA ADRENERGIC ANTAGONIST , ; NDA 019779 (label 19779.pdf) INN (APRACLONIDINE HYDROCHLORIDE) IOPIDINE (HARROW EYE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 020258 (label 20258.pdf) INN (APRACLONIDINE HYDROCHLORIDE) IOPIDINE (HARROW EYE) APPROVAL= AP YEAR= 1993 , NDA 077764 (pdf 77764.pdf not found) INN (APRACLONIDINE HYDROCHLORIDE) APRACLONIDINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2009 , 633 ; LEVAMLODIPINE ; 103129-82-4 ; 1992 ; ; ; CLASS CARDIVASCULAR -- CALCIUM CHANNEL BLOCKER -- ANTIANGINALS -- ANTIHYPERTENSIVE AGENTS -- VASODILATOR AGENTS -- PYRIDINE CALCIUM ANTAGONIST (CALCIUM ION ANTAGONIST OR SLOW-CHANNEL BLOCKER) , ; NDA 019787 (label 19787.pdf) INN (AMLODIPINE BESYLATE) NORVASC (PFIZER) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020364 (label 20364.pdf) INN (AMLODIPINE BESYLATE) LOTREL (NOVARTIS) APPROVAL= AP YEAR= 1995 , NDA 021435 (pdf 21435.pdf not found) INN (AMLODIPINE MALEATE) AMVAZ (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021540 (label 21540.pdf) INN (AMLODIPINE BESYLATE) CADUET (PFIZER) APPROVAL= AP YEAR= 2004 , NDA 021714 (pdf 21714.pdf not found) INN (AMLODIPINE MALEATE) AMLODIPINE MALEATE BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2006 , NDA 021990 (label 21990.pdf) INN (AMLODIPINE BESYLATE) EXFORGE (NOVARTIS) APPROVAL= AP YEAR= 2007 , NDA 022026 (label 22026.pdf) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022100 (label 22100.pdf) INN (AMLODIPINE BESYLATE) AZOR (DAIICHI SANKYO) APPROVAL= AP YEAR= 2007 , NDA 076418 (pdf 76418.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 076692 (pdf 76692.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (HEBEI CHANGSHAN) APPROVAL= AP YEAR= 2007 , NDA 076719 (pdf 76719.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (APOTEX) APPROVAL= AP YEAR= 2007 , NDA 076846 (pdf 76846.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (TEVA) APPROVAL= AP YEAR= 2007 , NDA 076859 (pdf 76859.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (YAOPHARMA CO LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077073 (pdf 77073.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 077080 (pdf 77080.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077179 (pdf 77179.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077215 (pdf 77215.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 077262 (pdf 77262.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2007 , NDA 077333 (pdf 77333.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (GEDEON RICHTER USA) APPROVAL= TA YEAR= 2007 , NDA 077362 (pdf 77362.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (GENPHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077375 (pdf 77375.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077516 (pdf 77516.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077671 (pdf 77671.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (WATSON LABS) APPROVAL= AP YEAR= 2007 , NDA 077759 (pdf 77759.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2007 , NDA 077955 (pdf 77955.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077974 (pdf 77974.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 , NDA 078021 (pdf 78021.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078043 (pdf 78043.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 078081 (pdf 78081.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078131 (pdf 78131.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (PURACAP PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078224 (pdf 78224.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078226 (pdf 78226.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 078231 (pdf 78231.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 , NDA 078381 (pdf 78381.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 2010 , NDA 078477 (pdf 78477.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078500 (pdf 78500.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 078573 (pdf 78573.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2008 , NDA 022314 (label 22314.pdf) INN (AMLODIPINE BESYLATE) EXFORGE HCT (NOVARTIS) APPROVAL= AP YEAR= 2009 , NDA 022401 (label 22401.pdf) INN (AMLODIPINE BESYLATE) TWYNSTA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2009 , NDA 077183 (pdf 77183.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2010 , NDA 078414 (pdf 78414.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (OXFORD PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078453 (pdf 78453.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 078466 (pdf 78466.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (LUPIN PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078552 (pdf 78552.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 , NDA 078925 (pdf 78925.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ALKEM) APPROVAL= AP YEAR= 2009 , NDA 079047 (pdf 79047.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090011 (pdf 90011.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (PAR PHARM INC) APPROVAL= AP YEAR= 2013 , NDA 090144 (pdf 90144.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (PAR PHARM INC) APPROVAL= AP YEAR= 2010 OBSOLETE , NDA 090364 (pdf 90364.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2011 , NDA 090483 (pdf 90483.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 022545 (label 22545.pdf) INN (AMLODIPINE BESYLATE) TEKAMLO (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077890 (pdf 77890.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 200175 (label 200175.pdf) INN (AMLODIPINE BESYLATE) TRIBENZOR (DAIICHI SANKYO) APPROVAL= AP YEAR= 2010 , NDA 200045 (label 200045.pdf) INN (AMLODIPINE BESYLATE) AMTURNIDE (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077771 (pdf 77771.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090149 (pdf 90149.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2011 , NDA 090398 (pdf 90398.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 090752 (pdf 90752.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CHINA RESOURCES) APPROVAL= AP YEAR= 2011 , NDA 200435 (pdf 200435.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 201380 (pdf 201380.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202239 (pdf 202239.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 078652 (pdf 78652.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2013 , NDA 090245 (pdf 90245.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (LUPIN) APPROVAL= AP YEAR= 2015 , NDA 091431 (pdf 91431.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2013 , NDA 200465 (pdf 200465.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (MYLAN) APPROVAL= AP YEAR= 2013 , NDA 200797 (pdf 200797.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201087 (pdf 201087.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 2015 , NDA 201586 (pdf 201586.pdf not found) INN (AMLODIPINE BESYLATE) TELMISARTAN AND AMLODIPINE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202553 (pdf 202553.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 203245 (pdf 203245.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (UNICHEM LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 091235 (pdf 91235.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 201593 (pdf 201593.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2015 , NDA 202377 (pdf 202377.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (TORRENT) APPROVAL= AP YEAR= 2015 , NDA 202516 (pdf 202516.pdf not found) INN (AMLODIPINE BESYLATE) TELMISARTAN AND AMLODIPINE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202517 (pdf 202517.pdf not found) INN (AMLODIPINE BESYLATE) TELMISARTAN AND AMLODIPINE (TORRENT) APPROVAL= AP YEAR= 2014 , NDA 203874 (pdf 203874.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 202713 (pdf 202713.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 202829 (pdf 202829.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 202933 (pdf 202933.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 204900 (pdf 204900.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205003 (label 205003.pdf) INN (AMLODIPINE BESYLATE) PRESTALIA (ADHERA) APPROVAL= AP YEAR= 2015 , NDA 091154 (pdf 91154.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206367 (pdf 206367.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206884 (pdf 206884.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 202491 (pdf 202491.pdf not found) INN (AMLODIPINE BESYLATE) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206512 (pdf 206512.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 203580 (pdf 203580.pdf not found) INN (AMLODIPINE BESYLATE) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 205137 (pdf 205137.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205234 (pdf 205234.pdf not found) INN (AMLODIPINE BESYLATE) TELMISARTAN AND AMLODIPINE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206137 (label 206137.pdf) INN (AMLODIPINE BESYLATE) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (PAR PHARM INC) APPROVAL= AP YEAR= 2016 , NDA 207216 (pdf 207216.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207821 (pdf 207821.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (POLYGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206906 (pdf 206906.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 207073 (pdf 207073.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207450 (pdf 207450.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 , NDA 207807 (pdf 207807.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 209042 (pdf 209042.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 206180 (pdf 206180.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 207435 (pdf 207435.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 207771 (pdf 207771.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206524 (pdf 206524.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUNSHINE LAKE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210045 (label 210045.pdf) INN (AMLODIPINE BESYLATE) CONSENSI (COEPTIS) APPROVAL= AP YEAR= 2018 , NDA 209010 (pdf 209010.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 209600 (pdf 209600.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ACCORD HLTHCARE INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207762 (pdf 207762.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212895 (label 212895.pdf) INN (LEVAMLODIPINE MALEATE) CONJUPRI (CSPC OUYI) APPROVAL= AP YEAR= 2019 , NDA 205199 (pdf 205199.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 211340 (label 211340.pdf) INN (AMLODIPINE BENZOATE) KATERZIA (AZURITY) APPROVAL= AP YEAR= 2019 , NDA 214439 (label 214439.pdf) INN (AMLODIPINE BESYLATE) NORLIQVA (CMP DEV LLC) APPROVAL= AP YEAR= 2022 , NDA 215035 (pdf 215035.pdf not found) INN (AMLODIPINE BENZOATE) AMLODIPINE BENZOATE (AMNEAL) APPROVAL= AP YEAR= 2023 , 634 ; PODOFILOX ; 518-28-5 ; 1990 ; ; NATURAL MOLECULE NPA009289 ; CLASS DERMATOLOGICALS -- ANTIMITOTIC AGENT -- TREATMENT OF PERIANAL OR MUCOUS MEMBRANE WARTS , ; NDA 019795 (pdf 19795.pdf not found) INN (PODOFILOX) CONDYLOX (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1990 , NDA 020529 (label 20529.pdf) INN (PODOFILOX) CONDYLOX (ALLERGAN) APPROVAL= AP YEAR= 1997 , NDA 075600 (pdf 75600.pdf not found) INN (PODOFILOX) PODOFILOX (PADAGIS US) APPROVAL= AP YEAR= 2002 , NDA 090184 (pdf 90184.pdf not found) INN (PODOFILOX) PODOFILOX (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 211871 (pdf 211871.pdf not found) INN (PODOFILOX) PODOFILOX (PADAGIS US) APPROVAL= AP YEAR= 2023 , 635 ; OMEPRAZOLE ; 73590-58-6 ; 1989 ; ; ; CLASS METABOLISM -- ANTISECRETORY (GASTRIC ACID) -- PROTON-PUMP INHIBITORS -- ANTI-ULCER AGENTS , ; NDA 019810 (label 19810.pdf) INN (OMEPRAZOLE) PRILOSEC (ASTRAZENECA) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 021229 (label 21229.pdf) INN (OMEPRAZOLE MAGNESIUM) PRILOSEC OTC (ASTRAZENECA) APPROVAL= AP YEAR= 2003 , NDA 021636 (label 21636.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) ZEGERID (SALIX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021706 (label 21706.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) ZEGERID (SANTARUS) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED , NDA 021849 (label 21849.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) ZEGERID (SALIX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021850 (label 21850.pdf) INN (MAGNESIUM HYDROXIDE OMEPRAZOLE SODIUM BICARBONATE) ZEGERID (SANTARUS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 022032 (label 22032.pdf) INN (OMEPRAZOLE) OMEPRAZOLE (DEXCEL PHARMA) APPROVAL= AP YEAR= 2007 , NDA 022056 (label 22056.pdf) INN (OMEPRAZOLE MAGNESIUM) PRILOSEC (COVIS) APPROVAL= AP YEAR= 2008 , NDA 075268 (pdf 75268.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (GENPHARM) APPROVAL= TA YEAR= 2002 OBSOLETE , NDA 075347 (pdf 75347.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2002 , NDA 075410 (pdf 75410.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2002 , NDA 075576 (pdf 75576.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 075757 (pdf 75757.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 075785 (pdf 75785.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (IMPAX LABS) APPROVAL= AP YEAR= 2007 , NDA 075791 (pdf 75791.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075876 (pdf 75876.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076048 (pdf 76048.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2007 , NDA 076515 (pdf 76515.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078490 (pdf 78490.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 022281 (label 22281.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) ZEGERID OTC (RILEY CONSUMER) APPROVAL= AP YEAR= 2009 , NDA 022456 (label 22456.pdf) INN (MAGNESIUM HYDROXIDE OMEPRAZOLE SODIUM BICARBONATE) MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE (SANTARUS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078693 (pdf 78693.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 OBSOLETE , NDA 078878 (pdf 78878.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 078966 (pdf 78966.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 050824 (label 50824.pdf) INN (AMOXICILLIN CLARITHROMYCIN OMEPRAZOLE) OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN (CUMBERLAND) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 021153 (label 21153.pdf) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2001 , NDA 021689 (label 21689.pdf) INN (ESOMEPRAZOLE SODIUM) NEXIUM IV (ASTRAZENECA) APPROVAL= AP YEAR= 2005 , NDA 021957 (label 21957.pdf) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 022101 (label 22101.pdf) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2008 , NDA 077830 (pdf 77830.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (RANBAXY) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022511 (label 22511.pdf) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) VIMOVO (HORIZON) APPROVAL= AP YEAR= 2010 , NDA 091352 (pdf 91352.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 201361 (label 201361.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2016 , NDA 201946 (pdf 201946.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 022283 (label 22283.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) ZEGERID OTC (RILEY CONSUMER) APPROVAL= AP YEAR= 2013 , NDA 079182 (pdf 79182.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2013 , NDA 091672 (pdf 91672.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 204152 (pdf 204152.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200882 (pdf 200882.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202342 (label 202342.pdf) INN (ESOMEPRAZOLE STRONTIUM) ESOMEPRAZOLE STRONTIUM (BELCHER) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202461 (pdf 202461.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2018 , NDA 204655 (label 204655.pdf) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM 24HR (ASTRAZENECA LP) APPROVAL= AP YEAR= 2014 , NDA 078003 (label 78003.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2015 , NDA 078936 (label 78936.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 202384 (pdf 202384.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203270 (pdf 203270.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204228 (pdf 204228.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 206877 (pdf 206877.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 078279 (label 78279.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2015 , NDA 202784 (label 202784.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203636 (pdf 203636.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205379 (label 205379.pdf) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207920 (label 207920.pdf) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM 24HR (ASTRAZENECA LP) APPROVAL= AP YEAR= 2015 , NDA 205606 (pdf 205606.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204068 (pdf 204068.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 204137 (label 204137.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204922 (pdf 204922.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 204923 (pdf 204923.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205103 (label 205103.pdf) INN (ASPIRIN OMEPRAZOLE) YOSPRALA (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205545 (pdf 205545.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207476 (pdf 207476.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 203481 (pdf 203481.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (BRECKENRIDGE) APPROVAL= AP YEAR= 2017 , NDA 204661 (pdf 204661.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 209400 (label 209400.pdf) INN (OMEPRAZOLE) OMEPRAZOLE (DEXCEL) APPROVAL= AP YEAR= 2017 , NDA 204657 (pdf 204657.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207193 (label 207193.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2017 , NDA 202686 (pdf 202686.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (MYLAN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207181 (pdf 207181.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2017 , NDA 209339 (pdf 209339.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203290 (pdf 203290.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 203345 (pdf 203345.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ZYDUS) APPROVAL= AP YEAR= 2018 , NDA 205563 (pdf 205563.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2017 , NDA 208333 (pdf 208333.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207265 (pdf 207265.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HEC PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207673 (pdf 207673.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 209735 (pdf 209735.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 205070 (pdf 205070.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207740 (pdf 207740.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 207891 (pdf 207891.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 210593 (pdf 210593.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (SPIL) APPROVAL= AP YEAR= 2018 , NDA 210070 (pdf 210070.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 204206 (pdf 204206.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 206296 (pdf 206296.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209202 (pdf 209202.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (P AND L) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209495 (pdf 209495.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 , NDA 209647 (pdf 209647.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209716 (pdf 209716.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2019 , NDA 204012 (pdf 204012.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 213004 (label 213004.pdf) INN (AMOXICILLIN OMEPRAZOLE MAGNESIUM RIFABUTIN) TALICIA (REDHILL) APPROVAL= AP YEAR= 2019 , NDA 206582 (pdf 206582.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (P AND L) APPROVAL= AP YEAR= 2020 , NDA 211732 (pdf 211732.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 212587 (pdf 212587.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2020 , NDA 212376 (pdf 212376.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 203349 (pdf 203349.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 208939 (pdf 208939.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211571 (pdf 211571.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 211751 (pdf 211751.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 211752 (pdf 211752.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 211977 (pdf 211977.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 212088 (pdf 212088.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 212507 (pdf 212507.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 212866 (pdf 212866.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 212977 (pdf 212977.pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 212949 (pdf 212949.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CSPC OUYI) APPROVAL= AP YEAR= 2020 , NDA 213158 (pdf 213158.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CISEN) APPROVAL= AP YEAR= 2020 , NDA 213859 (pdf 213859.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GUANGZHOU NOVAKEN) APPROVAL= AP YEAR= 2020 , NDA 214278 (label 214278.pdf) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DEXCEL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 090841 (pdf 90841.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ETHYPHARM) APPROVAL= AP YEAR= 2021 , NDA 210559 (pdf 210559.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (INDCHEMIE HEALTH) APPROVAL= AP YEAR= 2021 , NDA 213486 (pdf 213486.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2021 , NDA 216096 (pdf 216096.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (L PERRIGO CO) APPROVAL= AP YEAR= 2022 , NDA 204920 (pdf 204920.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2021 , NDA 215732 (pdf 215732.pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (HAINAN POLY) APPROVAL= AP YEAR= 2022 , NDA 216349 (pdf 216349.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 213593 (label 213593.pdf) INN (OMEPRAZOLE SODIUM BICARBONATE) KONVOMEP (AZURITY) APPROVAL= AP YEAR= 2022 , NDA 209791 (pdf 209791.pdf not found) INN (ASPIRIN OMEPRAZOLE) ASPIRIN OMEPRAZOLE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2023 , NDA 213201 (pdf 213201.pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204470 (pdf 204470.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213699 (pdf 213699.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 206055 (pdf 206055.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 214920 (pdf 214920.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 216149 (pdf 216149.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GUARDIAN DRUG) APPROVAL= AP YEAR= 2023 , NDA 217784 (pdf 217784.pdf not found) INN (OMEPRAZOLE SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 214473 (pdf 214473.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217022 (pdf 217022.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZHEJIANG YONGTAI) APPROVAL= AP YEAR= 2023 , NDA 217264 (pdf 217264.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) 0 (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217427 (pdf 217427.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217738 (pdf 217738.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 207198 (pdf 207198.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 218092 (pdf 218092.pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GLENMARK SPECLT) APPROVAL= AP YEAR= 2024 , 636 ; MIDODRINE ; 42794-76-3 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- VASOCONSTRICTOR -- ADRENERGIC ALPHA-AGONISTS -- SYMPATHOMIMETICS , ; NDA 019815 (label 19815.pdf) INN (MIDODRINE HYDROCHLORIDE) PROAMATINE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 076449 (pdf 76449.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076514 (pdf 76514.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076577 (pdf 76577.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2003 , NDA 076725 (pdf 76725.pdf not found) INN (MIDODRINE HYDROCHLORIDE) ORVATEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2004 , NDA 077746 (pdf 77746.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2006 , NDA 207169 (pdf 207169.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 , NDA 207613 (pdf 207613.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2018 , NDA 212543 (pdf 212543.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 207849 (pdf 207849.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 212774 (pdf 212774.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213055 (pdf 213055.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 214734 (pdf 214734.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 211973 (pdf 211973.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (NOVUGEN) APPROVAL= AP YEAR= 2023 , NDA 217271 (pdf 217271.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , 637 ; ACITRETIN ; 55079-83-9 ; 1996 ; ; ; CLASS DERMATOLOGICALS -- ANTIPSORIATIC -- KERATOLYTIC AGENTS , ; NDA 019821 (label 19821.pdf) INN (ACITRETIN) SORIATANE (STIEFEL LABS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 091455 (pdf 91455.pdf not found) INN (ACITRETIN) ACITRETIN (BARR LABS INC) APPROVAL= AP YEAR= 2013 , NDA 202897 (pdf 202897.pdf not found) INN (ACITRETIN) ACITRETIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 204633 (pdf 204633.pdf not found) INN (ACITRETIN) ACITRETIN (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2015 , NDA 202148 (pdf 202148.pdf not found) INN (ACITRETIN) ACITRETIN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 202552 (pdf 202552.pdf not found) INN (ACITRETIN) ACITRETIN (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203707 (pdf 203707.pdf not found) INN (ACITRETIN) ACITRETIN (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , 638 ; OXICONAZOLE ; 64211-45-6 ; 1988 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- INHIBITION OF ERGOSTEROL BIOSYNTHESIS , ; NDA 019828 (label 19828.pdf) INN (OXICONAZOLE NITRATE) OXISTAT (FOUGERA PHARMS) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 020209 (label 20209.pdf) INN (OXICONAZOLE NITRATE) OXISTAT (ANI PHARMS) APPROVAL= AP YEAR= 1992 , NDA 205076 (label 205076.pdf) INN (OXICONAZOLE NITRATE) OXICONAZOLE NITRATE (TARO) APPROVAL= AP YEAR= 2016 , 639 ; FELODIPINE ; 72509-76-3 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ANTIHYPERTENSIVE -- ANTI-ARRHYTHMIA AGENTS -- CALCIUM CHANNEL BLOCKERS -- DIHYDROPYRIDINES -- S ENANTIOMER MORE ACTIVE , ; NDA 019834 (label 19834.pdf) INN (FELODIPINE) PLENDIL (ASTRAZENECA) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020668 (label 20668.pdf) INN (ENALAPRIL MALEATE FELODIPINE) LEXXEL (ASTRAZENECA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075896 (pdf 75896.pdf not found) INN (FELODIPINE) FELODIPINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 078855 (pdf 78855.pdf not found) INN (FELODIPINE) FELODIPINE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090365 (pdf 90365.pdf not found) INN (FELODIPINE) FELODIPINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 200815 (pdf 200815.pdf not found) INN (FELODIPINE) FELODIPINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 , NDA 202170 (pdf 202170.pdf not found) INN (FELODIPINE) FELODIPINE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 091484 (pdf 91484.pdf not found) INN (FELODIPINE) FELODIPINE (WOCKHARDT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091200 (pdf 91200.pdf not found) INN (FELODIPINE) FELODIPINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 201964 (pdf 201964.pdf not found) INN (FELODIPINE) FELODIPINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2013 , NDA 203417 (pdf 203417.pdf not found) INN (FELODIPINE) FELODIPINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203032 (pdf 203032.pdf not found) INN (FELODIPINE) FELODIPINE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203983 (pdf 203983.pdf not found) INN (FELODIPINE) FELODIPINE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 210847 (pdf 210847.pdf not found) INN (FELODIPINE) FELODIPINE (YILING) APPROVAL= AP YEAR= 2018 , NDA 204800 (pdf 204800.pdf not found) INN (FELODIPINE) FELODIPINE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2019 , 640 ; CETIRIZINE ; 83881-52-1 ; 1995 ; ; ; CLASS RESPIRATORY -- H1 HISTAMINE ANTAGONIST -- ANTIHISTAMINE -- ANTIALLERGIC -- SEASONAL ALLERGIC RHINITIS , ; NDA 019835 (label 19835.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC ALLERGY (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 020346 (label 20346.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 021150 (label 21150.pdf) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ZYRTEC-D 12 HOUR (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2001 , NDA 021621 (label 21621.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S ZYRTEC ALLERGY (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2004 , NDA 022155 (label 22155.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S ZYRTEC HIVES RELIEF (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2007 , NDA 076047 (label 76047.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2007 , NDA 076581 (pdf 76581.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TEVA) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076601 (pdf 76601.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2008 , NDA 076677 (label 76677.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (MYLAN) APPROVAL= AP YEAR= 2007 , NDA 077170 (label 77170.pdf) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077279 (pdf 77279.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077318 (pdf 77318.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CIPLA LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 077472 (pdf 77472.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2006 , NDA 077498 (label 77498.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 , NDA 077499 (label 77499.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077631 (label 77631.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES RELIEF (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077946 (label 77946.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (PLD ACQUISITIONS) APPROVAL= AP YEAR= 2007 , NDA 077991 (pdf 77991.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS) APPROVAL= AP YEAR= 2008 , NDA 078317 (label 78317.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 078336 (label 78336.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (PERRIGO R AND D) APPROVAL= AP YEAR= 2007 , NDA 078343 (label 78343.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078398 (pdf 78398.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2008 , NDA 078412 (pdf 78412.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2008 , NDA 078427 (label 78427.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2007 , NDA 078615 (label 78615.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (HERITAGE PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078692 (pdf 78692.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 090182 (pdf 90182.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (TARO) APPROVAL= AP YEAR= 2008 , NDA 090183 (pdf 90183.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090188 (pdf 90188.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (PHARM ASSOC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090254 (pdf 90254.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 090378 (pdf 90378.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022429 (label 22429.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (BIONPHARMA) APPROVAL= AP YEAR= 2009 , NDA 077829 (pdf 77829.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (UNIQUE) APPROVAL= AP YEAR= 2009 , NDA 078072 (pdf 78072.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2009 , NDA 078488 (pdf 78488.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 078496 (pdf 78496.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078617 (pdf 78617.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078680 (pdf 78680.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (UNICHEM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078757 (pdf 78757.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078780 (pdf 78780.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2010 , NDA 078862 (pdf 78862.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (ORBION PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078870 (pdf 78870.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079191 (pdf 79191.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (TORRENT PHARMS LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090191 (pdf 90191.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (BAJAJ) APPROVAL= AP YEAR= 2009 , NDA 090300 (pdf 90300.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (CYPRESS PHARM) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090474 (pdf 90474.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (APOZEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090750 (pdf 90750.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090751 (pdf 90751.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090765 (pdf 90765.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090766 (pdf 90766.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 022578 (label 22578.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC ALLERGY (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2010 , NDA 078933 (pdf 78933.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (MARKSANS PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091130 (pdf 91130.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 201546 (pdf 201546.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2011 , NDA 090142 (pdf 90142.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091327 (pdf 91327.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (BAJAJ) APPROVAL= AP YEAR= 2011 , NDA 078876 (pdf 78876.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 , NDA 090572 (pdf 90572.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090922 (pdf 90922.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012 , NDA 204226 (pdf 204226.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (PERRIGO R AND D) APPROVAL= AP YEAR= 2013 , NDA 202277 (pdf 202277.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (IPCA LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 091116 (pdf 91116.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 , NDA 090760 (pdf 90760.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 205490 (label 205490.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (PERRIGO R AND D) APPROVAL= AP YEAR= 2015 , NDA 206793 (pdf 206793.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 207235 (pdf 207235.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (APOTEX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205291 (pdf 205291.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208694 (label 208694.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZERVIATE (HARROW EYE) APPROVAL= AP YEAR= 2017 , NDA 209274 (pdf 209274.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (GRANULES) APPROVAL= AP YEAR= 2017 , NDA 209107 (pdf 209107.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210719 (pdf 210719.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 210622 (pdf 210622.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 212266 (label 212266.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (QUAGEN) APPROVAL= AP YEAR= 2019 , NDA 211415 (label 211415.pdf) INN (CETIRIZINE HYDROCHLORIDE) QUZYTTIR (JDP) APPROVAL= AP YEAR= 2019 , NDA 213105 (pdf 213105.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CATALENT) APPROVAL= AP YEAR= 2020 , NDA 213557 (pdf 213557.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212409 (pdf 212409.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 641 ; SERTRALINE ; 79617-96-2 ; 1991 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) , ; NDA 019839 (label 19839.pdf) INN (SERTRALINE HYDROCHLORIDE) ZOLOFT (VIATRIS) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 020990 (label 20990.pdf) INN (SERTRALINE HYDROCHLORIDE) ZOLOFT (VIATRIS) APPROVAL= AP YEAR= 1999 , NDA 075719 (pdf 75719.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076442 (pdf 76442.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2007 , NDA 076465 (pdf 76465.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2006 , NDA 076540 (pdf 76540.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2004 , NDA 076671 (pdf 76671.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076881 (pdf 76881.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2007 , NDA 076882 (pdf 76882.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (VIWIT PHARM) APPROVAL= AP YEAR= 2007 , NDA 076934 (pdf 76934.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2006 , NDA 076944 (pdf 76944.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ANDRX PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 077106 (pdf 77106.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ZYDUS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077162 (pdf 77162.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077206 (pdf 77206.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077299 (pdf 77299.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077345 (pdf 77345.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077397 (pdf 77397.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077663 (pdf 77663.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077670 (pdf 77670.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 077713 (pdf 77713.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077765 (pdf 77765.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077818 (pdf 77818.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077977 (pdf 77977.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078053 (pdf 78053.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2006 , NDA 078108 (pdf 78108.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078403 (pdf 78403.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2008 , NDA 078626 (pdf 78626.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077864 (pdf 77864.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078677 (pdf 78677.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (REYOUNG) APPROVAL= AP YEAR= 2009 , NDA 078861 (pdf 78861.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 078175 (pdf 78175.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2010 , NDA 202825 (pdf 202825.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 214790 (pdf 214790.pdf not found) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215133 (label 215133.pdf) INN (SERTRALINE HYDROCHLORIDE) SERTRALINE HYDROCHLORIDE (ALMATICA) APPROVAL= AP YEAR= 2021 , 642 ; DAPIPRAZOLE ; 72822-12-9 ; 1990 ; DISCONTINUED ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ADRENERGIC ALPHA ANTAGONISTS -- ANTIMYDRIATICS -- ANTIPSYCHOTIC AGENTS -- OPHTHALMOLOGICALS , ; NDA 019849 (pdf 19849.pdf not found) INN (DAPIPRAZOLE HYDROCHLORIDE) DAPIPRAZOLE HYDROCHLORIDE (FERA PHARMS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 204902 (pdf 204902.pdf not found) INN (DAPIPRAZOLE HYDROCHLORIDE) DAPIPRAZOLE HYDROCHLORIDE (WOODWARD) APPROVAL= AP YEAR= 2019 DISCONTINUED , 643 ; BENAZEPRIL ; 86541-75-5 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS , ; NDA 019851 (label 19851.pdf) INN (BENAZEPRIL HYDROCHLORIDE) LOTENSIN (VALIDUS PHARMS) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 020033 (label 20033.pdf) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) LOTENSIN HCT (VALIDUS PHARMS) APPROVAL= AP YEAR= 1992 , NDA 020364 (label 20364.pdf) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) LOTREL (NOVARTIS) APPROVAL= AP YEAR= 1995 , NDA 021714 (pdf 21714.pdf not found) INN (AMLODIPINE MALEATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE MALEATE BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2006 , NDA 076118 (pdf 76118.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2004 , NDA 076211 (pdf 76211.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2004 , NDA 076267 (pdf 76267.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2004 , NDA 076333 (pdf 76333.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076342 (pdf 76342.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076344 (pdf 76344.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 , NDA 076348 (pdf 76348.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076402 (pdf 76402.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 , NDA 076430 (pdf 76430.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076476 (pdf 76476.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (GENPHARM) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076612 (pdf 76612.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076631 (pdf 76631.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 076688 (pdf 76688.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076820 (pdf 76820.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2006 , NDA 077128 (pdf 77128.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2006 , NDA 077179 (pdf 77179.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077215 (pdf 77215.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 077375 (pdf 77375.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077483 (pdf 77483.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078212 (pdf 78212.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 078381 (pdf 78381.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078848 (pdf 78848.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE) BENAZEPRIL HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2008 , NDA 077183 (pdf 77183.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2010 , NDA 078466 (pdf 78466.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (LUPIN PHARMS) APPROVAL= AP YEAR= 2010 , NDA 079047 (pdf 79047.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090364 (pdf 90364.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2011 , NDA 077890 (pdf 77890.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 090149 (pdf 90149.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2011 , NDA 202239 (pdf 202239.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 078652 (pdf 78652.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2013 , NDA 091431 (pdf 91431.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 078794 (pdf 78794.pdf not found) INN (BENAZEPRIL HYDROCHLORIDE HYDROCHLOROTHIAZIDE) BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2014 , 644 ; PENICILLAMINE ; 52-67-5 ; 1970 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIDOTES -- ANTIRHEUMATIC AGENTS -- CHELATING AGENTS -- TREATMENT OF WILSON'S DISEASE -- REDUCE CYSTINE EXCRETION IN CYSTINURIA , ; NDA 019853 (label 19853.pdf) INN (PENICILLAMINE) CUPRIMINE (VALEANT PHARMS INTL) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY , NDA 019854 (pdf 19854.pdf not found) INN (PENICILLAMINE) DEPEN (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1978 , NDA 209921 (pdf 209921.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (ANI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210976 (pdf 210976.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 211196 (pdf 211196.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 211231 (pdf 211231.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 211497 (pdf 211497.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213310 (pdf 213310.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 211735 (pdf 211735.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 211867 (pdf 211867.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 212933 (pdf 212933.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (LUPIN LTD) APPROVAL= AP YEAR= 2020 , NDA 213293 (pdf 213293.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214363 (pdf 214363.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (NAVINTA LLC) APPROVAL= AP YEAR= 2021 , NDA 215409 (pdf 215409.pdf not found) INN (PENICILLAMINE) PENICILLAMINE (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 , 645 ; SOTALOL ; 3930-20-9 ; 1992 ; ; ; CLASS CARDIOVASCULAR -- ADRENERGIC BETA RECEPTOR ANTAGONISTS -- ANTI-ARRHYTHMIA AGENTS -- SYMPATHOLYTICS -- TREATMENT OF DOCUMENTED VENTRICULAR ARRHYTHMIAS , ; NDA 019865 (label 19865.pdf) INN (SOTALOL HYDROCHLORIDE) BETAPACE (LEGACY PHARMA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 021151 (label 21151.pdf) INN (SOTALOL HYDROCHLORIDE) BETAPACE AF (LEGACY PHARMA) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 075237 (label 75237.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075238 (pdf 75238.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075366 (label 75366.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075429 (label 75429.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075500 (pdf 75500.pdf not found) INN (SOTALOL HYDROCHLORIDE) SORINE (AIPING PHARM INC) APPROVAL= AP YEAR= 2001 , NDA 075515 (pdf 75515.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075563 (pdf 75563.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2003 , NDA 075663 (pdf 75663.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075725 (pdf 75725.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076140 (pdf 76140.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 076214 (pdf 76214.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2003 , NDA 076576 (pdf 76576.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076883 (pdf 76883.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077070 (pdf 77070.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 , NDA 077616 (pdf 77616.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2007 , NDA 022306 (label 22306.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (ALTATHERA PHARMS LLC) APPROVAL= AP YEAR= 2009 , NDA 205108 (label 205108.pdf) INN (SOTALOL HYDROCHLORIDE) SOTYLIZE (AZURITY) APPROVAL= AP YEAR= 2014 , NDA 207428 (pdf 207428.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 207429 (pdf 207429.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2018 , 646 ; SOTALOL ; 3930-20-9 ; 1992 ; ; ; CLASS CARDIOVASCULAR -- ADRENERGIC BETA RECEPTOR ANTAGONISTS -- ANTI-ARRHYTHMIA AGENTS -- SYMPATHOLYTICS -- TREATMENT OF DOCUMENTED VENTRICULAR ARRHYTHMIAS , ; NDA 019865 (label 19865.pdf) INN (SOTALOL HYDROCHLORIDE) BETAPACE (LEGACY PHARMA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 021151 (label 21151.pdf) INN (SOTALOL HYDROCHLORIDE) BETAPACE AF (LEGACY PHARMA) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 075237 (label 75237.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075238 (pdf 75238.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075366 (label 75366.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075429 (label 75429.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075500 (pdf 75500.pdf not found) INN (SOTALOL HYDROCHLORIDE) SORINE (AIPING PHARM INC) APPROVAL= AP YEAR= 2001 , NDA 075515 (pdf 75515.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075563 (pdf 75563.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2003 , NDA 075663 (pdf 75663.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075725 (pdf 75725.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076140 (pdf 76140.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 076214 (pdf 76214.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2003 , NDA 076576 (pdf 76576.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076883 (pdf 76883.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077070 (pdf 77070.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 , NDA 077616 (pdf 77616.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2007 , NDA 022306 (label 22306.pdf) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (ALTATHERA PHARMS LLC) APPROVAL= AP YEAR= 2009 , NDA 205108 (label 205108.pdf) INN (SOTALOL HYDROCHLORIDE) SOTYLIZE (AZURITY) APPROVAL= AP YEAR= 2014 , NDA 207428 (pdf 207428.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 207429 (pdf 207429.pdf not found) INN (SOTALOL HYDROCHLORIDE) SOTALOL HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2018 , 647 ; QUINAPRIL ; 85441-61-8 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR , ; NDA 019885 (label 19885.pdf) INN (QUINAPRIL HYDROCHLORIDE) ACCUPRIL (PFIZER PHARMS) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020125 (label 20125.pdf) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) ACCURETIC (PFIZER PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075504 (pdf 75504.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076036 (pdf 76036.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (MYLAN) APPROVAL= TA YEAR= 2002 , NDA 076049 (pdf 76049.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076240 (pdf 76240.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076374 (pdf 76374.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076459 (pdf 76459.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076607 (pdf 76607.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076651 (pdf 76651.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (MUTUAL PHARMA) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076694 (pdf 76694.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076803 (pdf 76803.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077093 (pdf 77093.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077690 (pdf 77690.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 078450 (pdf 78450.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078457 (pdf 78457.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078211 (pdf 78211.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090800 (pdf 90800.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 201356 (pdf 201356.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091524 (pdf 91524.pdf not found) INN (HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 202725 (pdf 202725.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 205823 (pdf 205823.pdf not found) INN (QUINAPRIL HYDROCHLORIDE) QUINAPRIL HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2016 , 648 ; PRAVASTATIN ; 81093-37-0 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERLIPIDEMIC -- HMG-COA REDUCTASE INHIBITOR -- ANTICHOLESTEREMIC AGENTS , ; NDA 019898 (label 19898.pdf) INN (PRAVASTATIN SODIUM) PRAVACHOL (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 021387 (label 21387.pdf) INN (ASPIRIN PRAVASTATIN SODIUM) PRAVIGARD PAC COPACKAGED (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076056 (pdf 76056.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (TEVA) APPROVAL= AP YEAR= 2006 , NDA 076199 (pdf 76199.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (IVAX PHARMS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076279 (pdf 76279.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (GENEVA PHARMS TECH) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076341 (pdf 76341.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (APOTEX) APPROVAL= AP YEAR= 2006 , NDA 076397 (pdf 76397.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 076445 (pdf 76445.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2003 , NDA 076714 (pdf 76714.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 076939 (pdf 76939.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (WATSON LABS) APPROVAL= AP YEAR= 2006 , NDA 077013 (pdf 77013.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077491 (pdf 77491.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (APNAR PHARMA LP) APPROVAL= AP YEAR= 2008 , NDA 077730 (pdf 77730.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (PLIVA HRVATSKA DOO) APPROVAL= TA YEAR= 2006 , NDA 077751 (pdf 77751.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2008 , NDA 077793 (pdf 77793.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077904 (pdf 77904.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (CIPLA) APPROVAL= AP YEAR= 2006 , NDA 077917 (pdf 77917.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 077987 (pdf 77987.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 079187 (pdf 79187.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 207068 (pdf 207068.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 203367 (pdf 203367.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209869 (pdf 209869.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2018 , NDA 206061 (pdf 206061.pdf not found) INN (PRAVASTATIN SODIUM) PRAVASTATIN SODIUM (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2018 DISCONTINUED , 649 ; RAMIPRIL ; 87333-19-5 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS -- ANTIHYPERTENSIVE AGENTS , ; NDA 019901 (label 19901.pdf) INN (RAMIPRIL) ALTACE (KING PHARMS LLC) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 022021 (label 22021.pdf) INN (RAMIPRIL) ALTACE (KING PFIZER) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076549 (pdf 76549.pdf not found) INN (RAMIPRIL) RAMIPRIL (WATSON LABS) APPROVAL= AP YEAR= 2005 , NDA 077004 (pdf 77004.pdf not found) INN (RAMIPRIL) RAMIPRIL (CIPLA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077470 (pdf 77470.pdf not found) INN (RAMIPRIL) RAMIPRIL (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077513 (pdf 77513.pdf not found) INN (RAMIPRIL) RAMIPRIL (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077514 (pdf 77514.pdf not found) INN (RAMIPRIL) RAMIPRIL (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077626 (pdf 77626.pdf not found) INN (RAMIPRIL) RAMIPRIL (LUPIN) APPROVAL= AP YEAR= 2008 , NDA 077900 (pdf 77900.pdf not found) INN (RAMIPRIL) RAMIPRIL (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 078191 (pdf 78191.pdf not found) INN (RAMIPRIL) RAMIPRIL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078745 (pdf 78745.pdf not found) INN (RAMIPRIL) RAMIPRIL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2008 , NDA 078832 (pdf 78832.pdf not found) INN (RAMIPRIL) RAMIPRIL (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2008 , NDA 079116 (pdf 79116.pdf not found) INN (RAMIPRIL) RAMIPRIL (COREPHARMA) APPROVAL= AP YEAR= 2008 , NDA 078849 (pdf 78849.pdf not found) INN (RAMIPRIL) RAMIPRIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090697 (pdf 90697.pdf not found) INN (RAMIPRIL) RAMIPRIL (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091604 (pdf 91604.pdf not found) INN (RAMIPRIL) RAMIPRIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 090650 (pdf 90650.pdf not found) INN (RAMIPRIL) RAMIPRIL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202392 (pdf 202392.pdf not found) INN (RAMIPRIL) RAMIPRIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 091069 (pdf 91069.pdf not found) INN (RAMIPRIL) RAMIPRIL (APOTEX) APPROVAL= AP YEAR= 2015 DISCONTINUED , 650 ; CLOMIPRAMINE ; 303-49-1 ; 1989 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTIOBSESSIONAL -- SEROTONIN UPTAKE INHIBITORS , ; NDA 019906 (label 19906.pdf) INN (CLOMIPRAMINE HYDROCHLORIDE) ANAFRANIL (SPECGX LLC) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY , NDA 074364 (pdf 74364.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1996 , NDA 074600 (pdf 74600.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074694 (pdf 74694.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 1996 , NDA 074751 (pdf 74751.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074849 (pdf 74849.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074947 (pdf 74947.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074953 (pdf 74953.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074958 (pdf 74958.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 208961 (pdf 208961.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208632 (pdf 208632.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209294 (pdf 209294.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 211767 (pdf 211767.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212218 (pdf 212218.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2019 , NDA 210653 (pdf 210653.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (TULEX PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 211364 (pdf 211364.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2020 , NDA 213219 (pdf 213219.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 213221 (pdf 213221.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (RK PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212285 (pdf 212285.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2020 , NDA 213897 (pdf 213897.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211822 (pdf 211822.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 216440 (pdf 216440.pdf not found) INN (CLOMIPRAMINE HYDROCHLORIDE) CLOMIPRAMINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 651 ; METIPRANOLOL ; 22664-55-7 ; 1989 ; DISCONTINUED ; ; CLASS SENSORY -- NON-SELECTIVE BETA-ADRENERGIC RECEPTOR ANTAGONIST -- ANTIHYPERTENSIVE AGENTS -- GLAUCOMA , ; NDA 019907 (pdf 19907.pdf not found) INN (METIPRANOLOL HYDROCHLORIDE) OPTIPRANOLOL (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 075720 (pdf 75720.pdf not found) INN (METIPRANOLOL HYDROCHLORIDE) METIPRANOLOL (SANDOZ) APPROVAL= AP YEAR= 2001 DISCONTINUED , 652 ; ZOLPIDEM ; 82626-48-0 ; 1992 ; ; ; CLASS NERVOUS SYSTEM -- GABA AGONISTS -- HYPNOTICS AND SEDATIVES -- ANXIOLYTIC -- SHORT-TERM TREATMENT OF INSOMNIA , ; NDA 019908 (label 19908.pdf) INN (ZOLPIDEM TARTRATE) AMBIEN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 021412 (label 21412.pdf) INN (ZOLPIDEM TARTRATE) TOVALT ODT (BIOVAIL LABS INTL) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021774 (label 21774.pdf) INN (ZOLPIDEM TARTRATE) AMBIEN CR (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2005 , NDA 076062 (label 76062.pdf) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076410 (pdf 76410.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (TEVA) APPROVAL= AP YEAR= 2007 , NDA 076578 (pdf 76578.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077214 (pdf 77214.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ACME LABS) APPROVAL= AP YEAR= 2007 , NDA 077288 (pdf 77288.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077300 (pdf 77300.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM (PLIVA) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 077322 (label 77322.pdf) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077359 (pdf 77359.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077388 (pdf 77388.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 , NDA 077540 (pdf 77540.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SYNTHON PHARMS) APPROVAL= TA YEAR= 2006 , NDA 077773 (pdf 77773.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077884 (pdf 77884.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 077903 (pdf 77903.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077985 (pdf 77985.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077990 (pdf 77990.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078016 (pdf 78016.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2006 , NDA 078055 (pdf 78055.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078129 (pdf 78129.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078184 (pdf 78184.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078413 (pdf 78413.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078426 (pdf 78426.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021997 (label 21997.pdf) INN (ZOLPIDEM TARTRATE) EDLUAR (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2009 , NDA 022196 (label 22196.pdf) INN (ZOLPIDEM TARTRATE) ZOLPIMIST (AYTU) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078616 (pdf 78616.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078179 (pdf 78179.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078483 (pdf 78483.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078148 (pdf 78148.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022328 (label 22328.pdf) INN (ZOLPIDEM TARTRATE) INTERMEZZO (PURDUE PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090107 (pdf 90107.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 078970 (pdf 78970.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 090153 (pdf 90153.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200266 (pdf 200266.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 204299 (pdf 204299.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 201509 (pdf 201509.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 202657 (pdf 202657.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204503 (pdf 204503.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 204170 (pdf 204170.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 204229 (pdf 204229.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 213592 (pdf 213592.pdf not found) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215721 (label 215721.pdf) INN (ZOLPIDEM TARTRATE) ZOLPIDEM TARTRATE (ALMATICA) APPROVAL= AP YEAR= 2023 , 653 ; FOSINOPRIL ; 98048-97-6 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS -- ANTIHYPERTENSIVE AGENTS , ; NDA 019915 (label 19915.pdf) INN (FOSINOPRIL SODIUM) MONOPRIL (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020286 (pdf 20286.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) MONOPRIL-HCT (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 076139 (pdf 76139.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076188 (pdf 76188.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076483 (pdf 76483.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2004 , NDA 076580 (pdf 76580.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076608 (pdf 76608.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076620 (pdf 76620.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076739 (pdf 76739.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076906 (pdf 76906.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2005 , NDA 076945 (pdf 76945.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076961 (pdf 76961.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 076987 (pdf 76987.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077144 (pdf 77144.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077222 (pdf 77222.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (INVAGEN PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077531 (pdf 77531.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077705 (pdf 77705.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 079245 (pdf 79245.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090228 (pdf 90228.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 079025 (pdf 79025.pdf not found) INN (FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE) FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091163 (pdf 91163.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 205670 (pdf 205670.pdf not found) INN (FOSINOPRIL SODIUM) FOSINOPRIL SODIUM (PRINSTON INC) APPROVAL= AP YEAR= 2016 , 654 ; ALTRETAMINE ; 645-05-6 ; 1990 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- ALKYLATING , ; NDA 019926 (pdf 19926.pdf not found) INN (ALTRETAMINE) HEXALEN (EISAI INC) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 655 ; ADENOSINE ; 58-61-7 ; 1989 ; ; NATURAL MOLECULE C00007444 ; CLASS CARDIOVASCULAR -- ANTI-ARRHYTHMIA AGENTS -- VASODILATOR AGENTS -- ADENOSINE PRODUCES A DIRECT NEGATIVE CHRONOTROPIC, DROMOTROPIC AND INOTROPIC EFFECT ON THE HEART , ; NDA 019937 (label 19937.pdf) INN (ADENOSINE) ADENOCARD (ASTELLAS) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 020059 (label 20059.pdf) INN (ADENOSINE) ADENOSCAN (ASTELLAS) APPROVAL= AP YEAR= 1995 NEWAPPLICATION DISCONTINUED , NDA 076404 (pdf 76404.pdf not found) INN (ADENOSINE) ADENOSINE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076500 (pdf 76500.pdf not found) INN (ADENOSINE) ADENOSINE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076501 (pdf 76501.pdf not found) INN (ADENOSINE) ADENOSINE (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076564 (pdf 76564.pdf not found) INN (ADENOSINE) ADENOSINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077133 (pdf 77133.pdf not found) INN (ADENOSINE) ADENOSINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 , NDA 077283 (pdf 77283.pdf not found) INN (ADENOSINE) ADENOSINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2007 , NDA 077425 (label 77425.pdf) INN (ADENOSINE) ADENOSINE (MEITHEAL) APPROVAL= AP YEAR= 2013 , NDA 077897 (pdf 77897.pdf not found) INN (ADENOSINE) ADENOSINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 , NDA 078618 (pdf 78618.pdf not found) INN (ADENOSINE) ADENOSINE (BEDFORD LABS) APPROVAL= TA YEAR= 2008 , NDA 078676 (pdf 78676.pdf not found) INN (ADENOSINE) ADENOSINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078076 (pdf 78076.pdf not found) INN (ADENOSINE) ADENOSINE (RISING) APPROVAL= AP YEAR= 2008 , NDA 078686 (pdf 78686.pdf not found) INN (ADENOSINE) ADENOSINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 079147 (pdf 79147.pdf not found) INN (ADENOSINE) ADENOSINE (WOCKHARDT) APPROVAL= TA YEAR= 2009 , NDA 090010 (pdf 90010.pdf not found) INN (ADENOSINE) ADENOSINE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090212 (pdf 90212.pdf not found) INN (ADENOSINE) ADENOSINE (MYLAN ASI) APPROVAL= AP YEAR= 2014 , NDA 090220 (pdf 90220.pdf not found) INN (ADENOSINE) ADENOSINE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090450 (pdf 90450.pdf not found) INN (ADENOSINE) ADENOSINE (RISING) APPROVAL= AP YEAR= 2014 , NDA 202313 (pdf 202313.pdf not found) INN (ADENOSINE) ADENOSINE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 , NDA 078640 (pdf 78640.pdf not found) INN (ADENOSINE) ADENOSINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203883 (pdf 203883.pdf not found) INN (ADENOSINE) ADENOSINE (HOSPIRA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205331 (pdf 205331.pdf not found) INN (ADENOSINE) ADENOSINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205568 (pdf 205568.pdf not found) INN (ADENOSINE) ADENOSINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 206778 (pdf 206778.pdf not found) INN (ADENOSINE) ADENOSINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , 656 ; MASOPROCOL ; 27686-84-6 ; 1992 ; DISCONTINUED ; NATURAL MOLECULE C00000693 ; CLASS ANTINEOPLASTIC -- LIPOXYGENASE INHIBITORS , ; NDA 019940 (pdf 19940.pdf not found) INN (MASOPROCOL) ACTINEX (UNIV AZ CANCER CTR) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 657 ; DOXACURIUM ; 106819-53-8 ; 1991 ; DISCONTINUED ; ; CLASS MUSCLE RELAXANT (SKELETAL) -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST , ; NDA 019946 (label 19946.pdf) INN (DOXACURIUM CHLORIDE) NUROMAX (ABBVIE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , 658 ; FLUCONAZOLE ; 86386-73-4 ; 1990 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- FUNGAL CYTOCHROME P450 DEPENDENT ENZYME LANOSTEROL 14-ALPHA-DEMETHYLASE , ; NDA 019949 (label 19949.pdf) INN (FLUCONAZOLE) DIFLUCAN (PFIZER) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY , NDA 019950 (label 19950.pdf) INN (FLUCONAZOLE) DIFLUCAN IN SODIUM CHLORIDE 0.9% (PFIZER) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020090 (label 20090.pdf) INN (FLUCONAZOLE) DIFLUCAN (PFIZER) APPROVAL= AP YEAR= 1993 , NDA 074681 (pdf 74681.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076042 (pdf 76042.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2003 , NDA 076077 (pdf 76077.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076086 (pdf 76086.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076087 (pdf 76087.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076145 (pdf 76145.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 076213 (pdf 76213.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (ROXANE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076246 (pdf 76246.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076303 (pdf 76303.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 076304 (pdf 76304.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076332 (pdf 76332.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076351 (pdf 76351.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076386 (pdf 76386.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2003 , NDA 076424 (pdf 76424.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (PLIVA) APPROVAL= TA YEAR= 2003 , NDA 076432 (pdf 76432.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (GEDEON RICHTER USA) APPROVAL= TA YEAR= 2003 , NDA 076507 (pdf 76507.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076617 (pdf 76617.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= TA YEAR= 2003 , NDA 076653 (pdf 76653.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% (DR REDDYS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076658 (pdf 76658.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2004 , NDA 076665 (pdf 76665.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (CHARTWELL) APPROVAL= AP YEAR= 2004 , NDA 076736 (pdf 76736.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2005 , NDA 076766 (pdf 76766.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2004 , NDA 076837 (pdf 76837.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (DR REDDYS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076888 (pdf 76888.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER (MYLAN LABS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076889 (pdf 76889.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (MYLAN LABS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076918 (pdf 76918.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (TARO PHARM INDS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076957 (pdf 76957.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2005 , NDA 077253 (pdf 77253.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2006 , NDA 077523 (pdf 77523.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078107 (pdf 78107.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 , NDA 077731 (pdf 77731.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 079104 (pdf 79104.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (INFORLIFE) APPROVAL= AP YEAR= 2009 , NDA 079150 (pdf 79150.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 077909 (pdf 77909.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (WOODWARD) APPROVAL= AP YEAR= 2010 , NDA 077947 (pdf 77947.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077988 (pdf 77988.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER (WOODWARD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078423 (pdf 78423.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (ANI PHARMS) APPROVAL= AP YEAR= 2011 , NDA 078698 (pdf 78698.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2012 , NDA 078764 (pdf 78764.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 208963 (pdf 208963.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209146 (pdf 209146.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215738 (pdf 215738.pdf not found) INN (FLUCONAZOLE) FLUCONAZOLE (HAINAN POLY) APPROVAL= AP YEAR= 2023 , 659 ; FLUTICASONE PROPIONATE ; 80474-14-2 ; 1990 ; ; ; CLASS DERMATOLOGICALS -- ANTI-ALLERGIC AGENTS -- ANTI-INFLAMMATORY AGENTS -- CORTICOIDS -- ANTIPRURITIC -- VASOCONSTRICTIVE PROPERTIES , ; NDA 019957 (label 19957.pdf) INN (FLUTICASONE PROPIONATE) CUTIVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 019958 (label 19958.pdf) INN (FLUTICASONE PROPIONATE) CUTIVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020121 (label 20121.pdf) INN (FLUTICASONE PROPIONATE) FLONASE (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020548 (label 20548.pdf) INN (FLUTICASONE PROPIONATE) FLOVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020549 (label 20549.pdf) INN (FLUTICASONE PROPIONATE) FLOVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020833 (label 20833.pdf) INN (FLUTICASONE PROPIONATE) FLOVENT DISKUS 50 (GLAXO GRP LTD) APPROVAL= AP YEAR= 2000 , NDA 021077 (label 21077.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR DISKUS 100/50 (GLAXO GRP LTD) APPROVAL= AP YEAR= 2000 , NDA 021152 (label 21152.pdf) INN (FLUTICASONE PROPIONATE) CUTIVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021254 (label 21254.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR HFA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2006 , NDA 021433 (label 21433.pdf) INN (FLUTICASONE PROPIONATE) FLOVENT HFA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2004 , NDA 076300 (pdf 76300.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076451 (pdf 76451.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076504 (pdf 76504.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076633 (pdf 76633.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076668 (pdf 76668.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076793 (pdf 76793.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076865 (pdf 76865.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (NESHER PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077055 (pdf 77055.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (COSETTE) APPROVAL= AP YEAR= 2006 , NDA 077145 (pdf 77145.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (TARO PHARM INDS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077168 (pdf 77168.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (COSETTE) APPROVAL= AP YEAR= 2006 , NDA 077538 (pdf 77538.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 077570 (pdf 77570.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090759 (pdf 90759.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 078492 (pdf 78492.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 202236 (label 202236.pdf) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) DYMISTA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2012 , NDA 091553 (pdf 91553.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2013 , NDA 205434 (label 205434.pdf) INN (FLUTICASONE PROPIONATE) FLONASE ALLERGY RELIEF (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2014 , NDA 207957 (pdf 207957.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 208150 (pdf 208150.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2016 , NDA 207712 (pdf 207712.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 208798 (label 208798.pdf) INN (FLUTICASONE PROPIONATE) ARMONAIR RESPICLICK (TEVA PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208799 (label 208799.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) AIRDUO RESPICLICK (TEVA PHARM) APPROVAL= AP YEAR= 2017 , NDA 209022 (label 209022.pdf) INN (FLUTICASONE PROPIONATE) XHANCE (OPTINOSE US INC) APPROVAL= AP YEAR= 2017 , NDA 208024 (pdf 208024.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (HIKMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208891 (label 208891.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) WIXELA INHUB (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 203433 (pdf 203433.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 208111 (pdf 208111.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 213948 (pdf 213948.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215343 (pdf 215343.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (BRIGHT) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217088 (pdf 217088.pdf not found) INN (FLUTICASONE PROPIONATE) FLUTICASONE PROPIONATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 660 ; HALOBETASOL PROPIONATE ; 66852-54-8 ; 1990 ; ; ; CLASS DERMATOLOGICAL -- ANTI-INFLAMMATORY AGENTS -- VASOCONSTRICTOR AGENTS -- CORTICOSTEROIDS -- ANTIPRURITIC , ; NDA 019967 (label 19967.pdf) INN (HALOBETASOL PROPIONATE) ULTRAVATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019968 (label 19968.pdf) INN (HALOBETASOL PROPIONATE) ULTRAVATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 076872 (pdf 76872.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076903 (pdf 76903.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076994 (pdf 76994.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 077001 (pdf 77001.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 077109 (pdf 77109.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 2005 , NDA 077123 (pdf 77123.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 077227 (pdf 77227.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (TARO) APPROVAL= AP YEAR= 2005 , NDA 077721 (pdf 77721.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078162 (pdf 78162.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (COSETTE) APPROVAL= AP YEAR= 2007 , NDA 208183 (label 208183.pdf) INN (HALOBETASOL PROPIONATE) ULTRAVATE (MICAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 209978 (pdf 209978.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210566 (label 210566.pdf) INN (HALOBETASOL PROPIONATE) LEXETTE (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209355 (label 209355.pdf) INN (HALOBETASOL PROPIONATE) BRYHALI (BAUSCH) APPROVAL= AP YEAR= 2018 , NDA 209354 (label 209354.pdf) INN (HALOBETASOL PROPIONATE TAZAROTENE) DUOBRII (BAUSCH) APPROVAL= AP YEAR= 2019 , NDA 211464 (pdf 211464.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213560 (pdf 213560.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 215266 (pdf 215266.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 , NDA 214285 (pdf 214285.pdf not found) INN (HALOBETASOL PROPIONATE) HALOBETASOL PROPIONATE (PERRIGO ISRAEL) APPROVAL= TA YEAR= 2023 , NDA 217190 (pdf 217190.pdf not found) INN (HALOBETASOL PROPIONATE TAZAROTENE) HALOBETASOL PROPIONATE TAZAROTENE (TARO PHARMS) APPROVAL= TA YEAR= 2023 , 661 ; TICLOPIDINE ; 55142-85-3 ; 1991 ; ; ; CLASS BLOOD -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- FIBRINOLYTIC AGENTS -- P2Y PURINOCEPTOR 12 ANTAGONIST , ; NDA 019979 (label 19979.pdf) INN (TICLOPIDINE HYDROCHLORIDE) TICLID (ROCHE PALO) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 074994 (pdf 74994.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (NOVOPHARM LIMITED) APPROVAL= TA YEAR= 1999 OBSOLETE , NDA 075089 (pdf 75089.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 1999 , NDA 075149 (pdf 75149.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075161 (label 75161.pdf) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075253 (label 75253.pdf) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075309 (pdf 75309.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075316 (pdf 75316.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075318 (label 75318.pdf) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075326 (label 75326.pdf) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075526 (pdf 75526.pdf not found) INN (TICLOPIDINE HYDROCHLORIDE) TICLOPIDINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , 662 ; BISOPROLOL ; 66722-44-9 ; 1992 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC BETA-1 ANTAGONIST -- SYMPATHOLYTICS -- ADRENERGIC BETA-2 INVERSE AGONIST , ; NDA 019982 (label 19982.pdf) INN (BISOPROLOL FUMARATE) ZEBETA (TEVA WOMENS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 020186 (label 20186.pdf) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) ZIAC (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1993 , NDA 075469 (pdf 75469.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075474 (pdf 75474.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (UNITED RES LABS) APPROVAL= AP YEAR= 2002 , NDA 075527 (pdf 75527.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075579 (pdf 75579.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 075632 (pdf 75632.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075642 (pdf 75642.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075643 (pdf 75643.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (RUBICON) APPROVAL= AP YEAR= 2000 , NDA 075644 (pdf 75644.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (TEVA PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075672 (pdf 75672.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075686 (pdf 75686.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075768 (pdf 75768.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2000 , NDA 075831 (pdf 75831.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (DASH PHARMS NATCO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077910 (pdf 77910.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078635 (pdf 78635.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (UNICHEM) APPROVAL= AP YEAR= 2009 , NDA 079106 (pdf 79106.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2010 , NDA 204891 (pdf 204891.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 212678 (pdf 212678.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 215562 (pdf 215562.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215563 (pdf 215563.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215995 (pdf 215995.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 215666 (pdf 215666.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2022 , NDA 215680 (pdf 215680.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 217368 (pdf 217368.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 217617 (pdf 217617.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (HARMAN FINOCHEM) APPROVAL= AP YEAR= 2024 , 663 ; SUCCIMER ; 304-55-2 ; 1991 ; ; ; CLASS VARIOUS -- ANTIDOTE (HEAVY METAL POISONING) -- LEAD CHELATING AGENTS -- IT FORMS WATER SOLUBLE CHELATES , ; NDA 019998 (label 19998.pdf) INN (SUCCIMER) CHEMET (RECORDATI RARE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , 664 ; ONDANSETRON ; 99614-02-5 ; 1991 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- 5-HT3 ANTAGONIST , ; NDA 020007 (label 20007.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020103 (label 20103.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020403 (label 20403.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020605 (label 20605.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020781 (label 20781.pdf) INN (ONDANSETRON) ZOFRAN ODT (SANDOZ) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021915 (label 21915.pdf) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 076183 (pdf 76183.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 076252 (pdf 76252.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076506 (pdf 76506.pdf not found) INN (ONDANSETRON) ONDANSETRON (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 076559 (pdf 76559.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 076693 (pdf 76693.pdf not found) INN (ONDANSETRON) ONDANSETRON (BARR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076695 (pdf 76695.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= TA YEAR= 2004 , NDA 076696 (pdf 76696.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= TA YEAR= 2004 , NDA 076759 (pdf 76759.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076780 (pdf 76780.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076781 (pdf 76781.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2006 , NDA 076810 (pdf 76810.pdf not found) INN (ONDANSETRON) ONDANSETRON (TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076876 (pdf 76876.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076930 (pdf 76930.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076960 (pdf 76960.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076967 (pdf 76967.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076972 (pdf 76972.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 076974 (pdf 76974.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 076978 (pdf 76978.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077009 (pdf 77009.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077011 (pdf 77011.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077050 (pdf 77050.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2007 , NDA 077112 (pdf 77112.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077172 (pdf 77172.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077173 (pdf 77173.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077303 (pdf 77303.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2007 , NDA 077306 (pdf 77306.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2007 , NDA 077343 (pdf 77343.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077348 (pdf 77348.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 077365 (pdf 77365.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077368 (pdf 77368.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077387 (pdf 77387.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (AM REGENT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077406 (pdf 77406.pdf not found) INN (ONDANSETRON) ONDANSETRON (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2006 , NDA 077430 (pdf 77430.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077473 (pdf 77473.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 077480 (pdf 77480.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (TEVA PHARMS) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 077517 (pdf 77517.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077535 (pdf 77535.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 077541 (pdf 77541.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077544 (pdf 77544.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077545 (pdf 77545.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077548 (pdf 77548.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 077551 (pdf 77551.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077557 (pdf 77557.pdf not found) INN (ONDANSETRON) ONDANSETRON (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 077577 (pdf 77577.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2006 , NDA 077582 (pdf 77582.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077716 (pdf 77716.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (WOCKHARDT) APPROVAL= AP YEAR= 2006 , NDA 077717 (pdf 77717.pdf not found) INN (ONDANSETRON) ONDANSETRON (NESHER PHARMS) APPROVAL= TA YEAR= 2007 , NDA 077729 (pdf 77729.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077840 (pdf 77840.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077851 (pdf 77851.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2007 , NDA 078014 (pdf 78014.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (TARO PHARMS IRELAND) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078050 (pdf 78050.pdf not found) INN (ONDANSETRON) ONDANSETRON (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 078127 (pdf 78127.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078139 (pdf 78139.pdf not found) INN (ONDANSETRON) ONDANSETRON (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078152 (pdf 78152.pdf not found) INN (ONDANSETRON) ONDANSETRON (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078180 (pdf 78180.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078244 (pdf 78244.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (STERISCIENCE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078257 (pdf 78257.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078308 (pdf 78308.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (CLARIS LIFESCIENCES) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 078539 (pdf 78539.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078776 (pdf 78776.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078291 (pdf 78291.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (BEDFORD LABS) APPROVAL= AP YEAR= 2009 OBSOLETE , NDA 079032 (pdf 79032.pdf not found) INN (ONDANSETRON) ONDANSETRON (AM REGENT) APPROVAL= AP YEAR= 2008 , NDA 079039 (pdf 79039.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079224 (pdf 79224.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2009 , NDA 090116 (pdf 90116.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090424 (pdf 90424.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090469 (pdf 90469.pdf not found) INN (ONDANSETRON) ONDANSETRON (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 022524 (label 22524.pdf) INN (ONDANSETRON) ZUPLENZ (AQUESTIVE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090883 (pdf 90883.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078602 (pdf 78602.pdf not found) INN (ONDANSETRON) ONDANSETRON (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091342 (pdf 91342.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 091483 (pdf 91483.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090224 (pdf 90224.pdf not found) INN (ONDANSETRON) ONDANSETRON (ZENOTECH LABS LTD) APPROVAL= AP YEAR= 2011 OBSOLETE , NDA 090648 (pdf 90648.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202599 (pdf 202599.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202600 (pdf 202600.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078287 (pdf 78287.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 , NDA 078288 (pdf 78288.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078945 (pdf 78945.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202253 (pdf 202253.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 203711 (label 203711.pdf) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2014 , NDA 203761 (pdf 203761.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 206846 (pdf 206846.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 , NDA 206845 (pdf 206845.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204906 (pdf 204906.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209389 (pdf 209389.pdf not found) INN (ONDANSETRON) ONDANSETRON (IPCA LABS LTD) APPROVAL= AP YEAR= 2023 , 665 ; LOMEFLOXACIN ; 98079-51-7 ; 1992 ; DISCONTINUED ; ; CLASS ANTIBACTERIAL -- ANTIINFECTIVE -- INHIBITOR , ; NDA 020013 (label 20013.pdf) INN (LOMEFLOXACIN HYDROCHLORIDE) MAXAQUIN (PHARMACIA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 666 ; PAROXETINE ; 61869-08-7 ; 1992 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANTS -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) , ; NDA 020031 (label 20031.pdf) INN (PAROXETINE HYDROCHLORIDE) PAXIL (APOTEX) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020710 (label 20710.pdf) INN (PAROXETINE HYDROCHLORIDE) PAXIL (APOTEX) APPROVAL= AP YEAR= 1997 , NDA 020885 (pdf 20885.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAXIL (APOTEX) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020936 (label 20936.pdf) INN (PAROXETINE HYDROCHLORIDE) PAXIL CR (APOTEX) APPROVAL= AP YEAR= 1999 , NDA 021299 (label 21299.pdf) INN (PAROXETINE MESYLATE) PEXEVA (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075356 (pdf 75356.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2003 , NDA 075566 (pdf 75566.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075716 (pdf 75716.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076618 (pdf 76618.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 077082 (pdf 77082.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077395 (pdf 77395.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077584 (pdf 77584.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 077873 (pdf 77873.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2007 , NDA 078026 (pdf 78026.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078194 (pdf 78194.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078406 (pdf 78406.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078902 (pdf 78902.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2008 , NDA 076968 (pdf 76968.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091427 (pdf 91427.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 , NDA 204516 (label 204516.pdf) INN (PAROXETINE MESYLATE) BRISDELLE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2013 , NDA 203854 (pdf 203854.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE (PRINSTON INC) APPROVAL= AP YEAR= 2014 , NDA 205528 (pdf 205528.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204744 (pdf 204744.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 204134 (pdf 204134.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 207139 (label 207139.pdf) INN (PAROXETINE MESYLATE) PAROXETINE MESYLATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 207188 (pdf 207188.pdf not found) INN (PAROXETINE MESYLATE) PAROXETINE MESYLATE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 209293 (pdf 209293.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (SCIECURE PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 213485 (pdf 213485.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (CSPC OUYI) APPROVAL= AP YEAR= 2021 , NDA 211248 (pdf 211248.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (YILING) APPROVAL= AP YEAR= 2021 , NDA 212645 (pdf 212645.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 213612 (pdf 213612.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215003 (pdf 215003.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 209748 (pdf 209748.pdf not found) INN (PAROXETINE HYDROCHLORIDE) PAROXETINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2024 , 667 ; PHENIRAMINE ; 86-21-5 ; 1994 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITIC AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 020065 (label 20065.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) OPCON-A (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 020226 (label 20226.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHCON-A (ALCON) APPROVAL= AP YEAR= 1994 , NDA 020485 (label 20485.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) VISINE (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1996 , NDA 078208 (pdf 78208.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 202795 (pdf 202795.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (AKORN) APPROVAL= AP YEAR= 2013 , 668 ; LEVAMISOLE ; 14769-73-4 ; 1990 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- SELECTIVELY ACTIVATE NEMATODE ACETYLCHOLINE ION CHANNEL RECEPTORS , ; NDA 020035 (pdf 20035.pdf not found) INN (LEVAMISOLE HYDROCHLORIDE) ERGAMISOL (JANSSEN PHARMA) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 669 ; FLUDARABINE PHOSPHATE ; 75607-67-9 ; 1991 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- IMMUNOSUPPRESSIVE AGENTS -- RAPIDLY DEPHOSPHORYLATED INTO FLUDARABINE AND THEN PHOSPHORYLATED BY DEOXYCYTIDINE KINASE TO THE ACTIVE TRIPHOSPHATE , ; NDA 020038 (label 20038.pdf) INN (FLUDARABINE PHOSPHATE) FLUDARA (GENZYME CORP) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 022137 (label 22137.pdf) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SANDOZ) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076349 (pdf 76349.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076661 (pdf 76661.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2004 , NDA 077790 (pdf 77790.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078393 (pdf 78393.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 078544 (pdf 78544.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 022273 (label 22273.pdf) INN (FLUDARABINE PHOSPHATE) OFORTA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078610 (pdf 78610.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2009 , NDA 090724 (pdf 90724.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (AREVA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 200647 (pdf 200647.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200648 (pdf 200648.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203738 (pdf 203738.pdf not found) INN (FLUDARABINE PHOSPHATE) FLUDARABINE PHOSPHATE (ACTAVIS LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 670 ; TYLOXAPOL ; 140-66-9 ; 1990 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- DETERGENTS -- SURFACE-ACTIVE AGENTS -- EXPECTORANT -- PREVENTS THE CATABOLISM OF TRIGLYCERIDES-RICH LIPOPROTEINS BY SERUM LIPASES AND ALLOWS A TIME-DEPENDENT AND LINEAR INCREASE IN PLASMA TRIGLYCERIDES LEVELS , ; NDA 020044 (pdf 20044.pdf not found) INN (CETYL ALCOHOL COLFOSCERIL PALMITATE TYLOXAPOL) EXOSURF NEONATAL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1990 DISCONTINUED , 671 ; ITRACONAZOLE ; 84625-61-6 ; 1992 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- ANTIPROTOZOALS -- CYTOCHROME P450-DEPENDENT SYNTHESIS OF ERGOSTEROL , ; NDA 020083 (label 20083.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020657 (label 20657.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1997 , NDA 020966 (label 20966.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076104 (pdf 76104.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 020694 (pdf 20694.pdf not found) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMA) APPROVAL= AP YEAR= 1996 NEWAPPLICATION , NDA 022484 (label 22484.pdf) INN (ITRACONAZOLE) ONMEL (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200463 (pdf 200463.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 205991 (pdf 205991.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205573 (pdf 205573.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205080 (pdf 205080.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205724 (pdf 205724.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206741 (pdf 206741.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2016 , NDA 203445 (pdf 203445.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208591 (pdf 208591.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 204672 (pdf 204672.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208901 (label 208901.pdf) INN (ITRACONAZOLE) TOLSURA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209460 (pdf 209460.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 206410 (pdf 206410.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208481 (pdf 208481.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (APOTEX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212239 (pdf 212239.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ANNORA PHARMA) APPROVAL= AP YEAR= 2020 , 672 ; AZELASTINE ; 58581-89-8 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- H1 ANTIHISTAMINE ANTAGONIST -- PHTHALAZINONE DERIVATIVE , ; NDA 020114 (label 20114.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTELIN (MYLAN SPCLT VIATRIS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 021127 (label 21127.pdf) INN (AZELASTINE HYDROCHLORIDE) OPTIVAR (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077954 (pdf 77954.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 022203 (label 22203.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022371 (label 22371.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (MEDA PHARMS) APPROVAL= AP YEAR= 2009 NEWAPPLICATION , NDA 078621 (pdf 78621.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 078738 (pdf 78738.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 090423 (pdf 90423.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 201846 (pdf 201846.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202236 (label 202236.pdf) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) DYMISTA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2012 , NDA 202305 (pdf 202305.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 091444 (pdf 91444.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202743 (pdf 202743.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090176 (pdf 90176.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2015 , NDA 203660 (pdf 203660.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207243 (pdf 207243.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208199 (pdf 208199.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 091409 (pdf 91409.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 202609 (pdf 202609.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2017 , NDA 207712 (pdf 207712.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 204660 (pdf 204660.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 208156 (pdf 208156.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207411 (pdf 207411.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 207610 (pdf 207610.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 209620 (pdf 209620.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 210032 (pdf 210032.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210092 (pdf 210092.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212289 (pdf 212289.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212775 (pdf 212775.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208111 (pdf 208111.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 213872 (label 213872.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO ALLERGY (BAYER HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 216561 (pdf 216561.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2023 , NDA 216576 (pdf 216576.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2024 , NDA 216421 (pdf 216421.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE ALLERGY (APOTEX) APPROVAL= AP YEAR= 2024 , NDA 216801 (pdf 216801.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2024 DISCONTINUED , 673 ; PHENIRAMINE ; 86-21-5 ; 1994 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITIC AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 020065 (label 20065.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) OPCON-A (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 020226 (label 20226.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHCON-A (ALCON) APPROVAL= AP YEAR= 1994 , NDA 020485 (label 20485.pdf) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) VISINE (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1996 , NDA 078208 (pdf 78208.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 202795 (pdf 202795.pdf not found) INN (NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE) NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (AKORN) APPROVAL= AP YEAR= 2013 , 674 ; FOSCARNET ; 4428-95-9 ; 1991 ; ; NATURAL MOLECULE C00000800 ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- CHELATE DIVALENT METAL IONS -- INHIBITS REPLICATION OF HERPES VIRUSES CMV, HSV-1 AND HSV-2 , ; NDA 020068 (label 20068.pdf) INN (FOSCARNET SODIUM) FOSCAVIR (CLINIGEN HLTHCARE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 077174 (pdf 77174.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 212483 (pdf 212483.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2021 , NDA 213001 (pdf 213001.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 213807 (pdf 213807.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 213987 (pdf 213987.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (BEIJING) APPROVAL= AP YEAR= 2023 , NDA 216602 (pdf 216602.pdf not found) INN (FOSCARNET SODIUM) FOSCARNET SODIUM (AMNEAL) APPROVAL= AP YEAR= 2024 , 675 ; TACRINE ; 321-64-2 ; 1993 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICHOLINESTERASE -- CHOLINESTERASE INHIBITOR -- , ; NDA 020070 (pdf 20070.pdf not found) INN (TACRINE HYDROCHLORIDE) COGNEX (SHIONOGI INC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , 676 ; DESOGESTREL ; 54024-22-5 ; 1992 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVES , ; NDA 020071 (label 20071.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGEN (ORGANON USA INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020301 (label 20301.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) ORTHO-CEPT (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020713 (label 20713.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) MIRCETTE (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021090 (label 21090.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) CYCLESSA (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 2000 , NDA 075256 (label 75256.pdf) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 , NDA 075863 (pdf 75863.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KARIVA (BARR) APPROVAL= AP YEAR= 2002 , NDA 076455 (pdf 76455.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VELIVET (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 2004 , NDA 076915 (pdf 76915.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2005 , NDA 076916 (pdf 76916.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077182 (pdf 77182.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2006 , NDA 076675 (pdf 76675.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) EMOQUETTE (VINTAGE PHARMS LLC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091346 (pdf 91346.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VIORELE (GLENMARK GENERICS) APPROVAL= AP YEAR= 2012 , NDA 091234 (pdf 91234.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 091247 (pdf 91247.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) PIMTREA (NOVAST LABS) APPROVAL= AP YEAR= 2013 , NDA 201887 (pdf 201887.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) ENSKYCE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 202296 (pdf 202296.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 076681 (pdf 76681.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KIMIDESS (VINTAGE PHARMS) APPROVAL= AP YEAR= 2015 , NDA 202085 (pdf 202085.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202226 (pdf 202226.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) BEKYREE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202789 (pdf 202789.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) ISIBLOOM (XIROMED) APPROVAL= AP YEAR= 2015 , NDA 202689 (pdf 202689.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) VOLNEA (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 206853 (pdf 206853.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) SIMLIYA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207081 (pdf 207081.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) KALLIGA (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209170 (pdf 209170.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2017 , NDA 207067 (pdf 207067.pdf not found) INN (DESOGESTREL ETHINYL ESTRADIOL) DESOGESTREL AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , 677 ; FLUMAZENIL ; 78755-81-4 ; 1991 ; ; ; CLASS VARIOUS -- BENZODIAZEPINE ANTAGONIST -- ANTIDOTES -- GABA ANATAGONIST , ; NDA 020073 (label 20073.pdf) INN (FLUMAZENIL) ROMAZICON (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 076256 (pdf 76256.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076589 (pdf 76589.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (DR REDDYS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076755 (pdf 76755.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2004 , NDA 076787 (pdf 76787.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076955 (pdf 76955.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 077071 (pdf 77071.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 078595 (pdf 78595.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (RISING) APPROVAL= AP YEAR= 2008 , NDA 078527 (pdf 78527.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 090584 (pdf 90584.pdf not found) INN (FLUMAZENIL) FLUMAZENIL (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , 678 ; ITRACONAZOLE ; 84625-61-6 ; 1992 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- ANTIPROTOZOALS -- CYTOCHROME P450-DEPENDENT SYNTHESIS OF ERGOSTEROL , ; NDA 020083 (label 20083.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020657 (label 20657.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1997 , NDA 020966 (label 20966.pdf) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076104 (pdf 76104.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 020694 (pdf 20694.pdf not found) INN (ITRACONAZOLE) SPORANOX (JANSSEN PHARMA) APPROVAL= AP YEAR= 1996 NEWAPPLICATION , NDA 022484 (label 22484.pdf) INN (ITRACONAZOLE) ONMEL (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200463 (pdf 200463.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 205991 (pdf 205991.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205573 (pdf 205573.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205080 (pdf 205080.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205724 (pdf 205724.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206741 (pdf 206741.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2016 , NDA 203445 (pdf 203445.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208591 (pdf 208591.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 204672 (pdf 204672.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208901 (label 208901.pdf) INN (ITRACONAZOLE) TOLSURA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209460 (pdf 209460.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 206410 (pdf 206410.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208481 (pdf 208481.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (APOTEX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212239 (pdf 212239.pdf not found) INN (ITRACONAZOLE) ITRACONAZOLE (ANNORA PHARMA) APPROVAL= AP YEAR= 2020 , 679 ; MIVACURIUM ; 133814-19-4 ; 1992 ; ; ; CLASS MUSCULO-SKELETAL -- NEUROMUSCULAR NONDEPOLARIZING MUSCLE RELAXANT AGENTS -- ANESTHETIC -- CHOLINERGIC RECEPTOR ANTAGONIST , ; NDA 020098 (label 20098.pdf) INN (MIVACURIUM CHLORIDE) MIVACRON (ABBVIE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 078562 (label 78562.pdf) INN (MIVACURIUM CHLORIDE) MIVACURIUM CHLORIDE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 209708 (pdf 209708.pdf not found) INN (MIVACURIUM CHLORIDE) MIVACURIUM CHLORIDE (WOODWARD) APPROVAL= AP YEAR= 2021 , 680 ; AZELASTINE ; 58581-89-8 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- H1 ANTIHISTAMINE ANTAGONIST -- PHTHALAZINONE DERIVATIVE , ; NDA 020114 (label 20114.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTELIN (MYLAN SPCLT VIATRIS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 021127 (label 21127.pdf) INN (AZELASTINE HYDROCHLORIDE) OPTIVAR (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077954 (pdf 77954.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 022203 (label 22203.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022371 (label 22371.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO (MEDA PHARMS) APPROVAL= AP YEAR= 2009 NEWAPPLICATION , NDA 078621 (pdf 78621.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2009 , NDA 078738 (pdf 78738.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 090423 (pdf 90423.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 201846 (pdf 201846.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202236 (label 202236.pdf) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) DYMISTA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2012 , NDA 202305 (pdf 202305.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 091444 (pdf 91444.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202743 (pdf 202743.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090176 (pdf 90176.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2015 , NDA 203660 (pdf 203660.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207243 (pdf 207243.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208199 (pdf 208199.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 091409 (pdf 91409.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 202609 (pdf 202609.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2017 , NDA 207712 (pdf 207712.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 204660 (pdf 204660.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 208156 (pdf 208156.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207411 (pdf 207411.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 207610 (pdf 207610.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 209620 (pdf 209620.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 210032 (pdf 210032.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210092 (pdf 210092.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212289 (pdf 212289.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212775 (pdf 212775.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208111 (pdf 208111.pdf not found) INN (AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE) AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 213872 (label 213872.pdf) INN (AZELASTINE HYDROCHLORIDE) ASTEPRO ALLERGY (BAYER HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 216561 (pdf 216561.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2023 , NDA 216576 (pdf 216576.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2024 , NDA 216421 (pdf 216421.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE ALLERGY (APOTEX) APPROVAL= AP YEAR= 2024 , NDA 216801 (pdf 216801.pdf not found) INN (AZELASTINE HYDROCHLORIDE) AZELASTINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2024 DISCONTINUED , 681 ; DESFLURANE ; 57041-67-5 ; 1992 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 020118 (label 20118.pdf) INN (DESFLURANE) SUPRANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 208234 (pdf 208234.pdf not found) INN (DESFLURANE) DESFLURANE (SHANGHAI HENGRUI) APPROVAL= AP YEAR= 2018 , 682 ; TENIPOSIDE ; 29767-20-2 ; 1992 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- CYTOTOXIC -- NUCLEIC ACID SYNTHESIS INHIBITORS , ; NDA 020119 (label 20119.pdf) INN (TENIPOSIDE) VUMON (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 683 ; PENTOSTATIN ; 53910-25-1 ; 1991 ; ; ; CLASS ANTINEOPLASTIC -- IMMUNOSUPPRESSIVE AGENTS -- TREATMENT OF LEUKAEMIA , ; NDA 020122 (label 20122.pdf) INN (PENTOSTATIN) NIPENT (HOSPIRA INC) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY , NDA 077841 (pdf 77841.pdf not found) INN (PENTOSTATIN) PENTOSTATIN (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2007 , NDA 203554 (pdf 203554.pdf not found) INN (PENTOSTATIN) PENTOSTATIN (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , 684 ; BUDESONIDE ; 51333-22-3 ; 1994 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIINFLAMMATORY -- BRONCHODILATOR AGENTS -- CORTICOSTEROIDS -- GLUCOCORTICOIDS , ; NDA 020233 (pdf 20233.pdf not found) INN (BUDESONIDE) RHINOCORT (ASTRAZENECA) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020441 (label 20441.pdf) INN (BUDESONIDE) PULMICORT (ASTRAZENECA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020746 (label 20746.pdf) INN (BUDESONIDE) RHINOCORT (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1999 , NDA 020929 (label 20929.pdf) INN (BUDESONIDE) PULMICORT RESPULES (ASTRAZENECA) APPROVAL= AP YEAR= 2000 , NDA 021324 (label 21324.pdf) INN (BUDESONIDE) ENTOCORT EC (PADAGIS US) APPROVAL= AP YEAR= 2001 , NDA 021929 (label 21929.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) SYMBICORT (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 021949 (label 21949.pdf) INN (BUDESONIDE) PULMICORT FLEXHALER (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 077519 (pdf 77519.pdf not found) INN (BUDESONIDE) BUDESONIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078202 (pdf 78202.pdf not found) INN (BUDESONIDE) BUDESONIDE (NEPHRON) APPROVAL= AP YEAR= 2009 , NDA 090410 (pdf 90410.pdf not found) INN (BUDESONIDE) BUDESONIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 , NDA 078404 (pdf 78404.pdf not found) INN (BUDESONIDE) BUDESONIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2012 , NDA 201966 (pdf 201966.pdf not found) INN (BUDESONIDE) BUDESONIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 203634 (label 203634.pdf) INN (BUDESONIDE) UCERIS (SALIX) APPROVAL= AP YEAR= 2013 , NDA 078949 (pdf 78949.pdf not found) INN (BUDESONIDE) BUDESONIDE (APOTEX INC) APPROVAL= AP YEAR= 2014 , NDA 090379 (pdf 90379.pdf not found) INN (BUDESONIDE) BUDESONIDE (BARR LABS DIV TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205613 (label 205613.pdf) INN (BUDESONIDE) UCERIS (SALIX) APPROVAL= AP YEAR= 2014 , NDA 204548 (pdf 204548.pdf not found) INN (BUDESONIDE) BUDESONIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206623 (pdf 206623.pdf not found) INN (BUDESONIDE) BUDESONIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2016 , NDA 206724 (pdf 206724.pdf not found) INN (BUDESONIDE) BUDESONIDE (NATCO) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206134 (pdf 206134.pdf not found) INN (BUDESONIDE) BUDESONIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206200 (pdf 206200.pdf not found) INN (BUDESONIDE) BUDESONIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207367 (pdf 207367.pdf not found) INN (BUDESONIDE) BUDESONIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 205710 (pdf 205710.pdf not found) INN (BUDESONIDE) BUDESONIDE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 209041 (pdf 209041.pdf not found) INN (BUDESONIDE) BUDESONIDE (SCIECURE PHARMA INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205457 (pdf 205457.pdf not found) INN (BUDESONIDE) BUDESONIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2018 , NDA 210897 (pdf 210897.pdf not found) INN (BUDESONIDE) BUDESONIDE (LUPIN) APPROVAL= AP YEAR= 2018 , NDA 211929 (label 211929.pdf) INN (BUDESONIDE) ORTIKOS (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208851 (pdf 208851.pdf not found) INN (BUDESONIDE) BUDESONIDE (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 212122 (label 212122.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE GLYCOPYRROLATE) BREZTRI AEROSPHERE (ASTRAZENECA AB) APPROVAL= AP YEAR= 2020 , NDA 211699 (pdf 211699.pdf not found) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) BREYNA (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 211922 (pdf 211922.pdf not found) INN (BUDESONIDE) BUDESONIDE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 215935 (label 215935.pdf) INN (BUDESONIDE) TARPEYO (CALLIDITAS) APPROVAL= AP YEAR= 2021 , NDA 214070 (label 214070.pdf) INN (ALBUTEROL SULFATE BUDESONIDE) AIRSUPRA (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , NDA 215328 (pdf 215328.pdf not found) INN (BUDESONIDE) BUDESONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 , NDA 216579 (label 216579.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE) SYMBICORT AEROSPHERE (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , NDA 216667 (pdf 216667.pdf not found) INN (BUDESONIDE) BUDESONIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213976 (pdf 213976.pdf not found) INN (BUDESONIDE) EOHILIA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2024 , 685 ; VENLAFAXINE ; 93413-69-5 ; 1993 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANALGESIC -- SEROTONIN REUPTAKE INHIBITORS , ; NDA 020151 (label 20151.pdf) INN (VENLAFAXINE HYDROCHLORIDE) EFFEXOR (WYETH PHARMS INC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 020699 (label 20699.pdf) INN (VENLAFAXINE HYDROCHLORIDE) EFFEXOR XR (UPJOHN) APPROVAL= AP YEAR= 1997 , NDA 022104 (label 22104.pdf) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2008 , NDA 076690 (label 76690.pdf) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2006 , NDA 077166 (pdf 77166.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077515 (pdf 77515.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077653 (pdf 77653.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2008 , NDA 078057 (pdf 78057.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= TA YEAR= 2007 , NDA 078301 (pdf 78301.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078517 (pdf 78517.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= TA YEAR= 2007 , NDA 078627 (pdf 78627.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 , NDA 078554 (pdf 78554.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078789 (pdf 78789.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090555 (pdf 90555.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 076565 (pdf 76565.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2010 , NDA 079098 (pdf 79098.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090027 (pdf 90027.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091272 (pdf 91272.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 078421 (pdf 78421.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 078932 (pdf 78932.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 078865 (pdf 78865.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2011 , NDA 090071 (pdf 90071.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2011 , NDA 090174 (pdf 90174.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 090899 (pdf 90899.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200834 (pdf 200834.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091123 (pdf 91123.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2011 , NDA 078087 (pdf 78087.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ANCHEN PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202036 (pdf 202036.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (YAOPHARMA CO LTD) APPROVAL= AP YEAR= 2015 , NDA 205468 (pdf 205468.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204889 (pdf 204889.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 201272 (pdf 201272.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2018 , NDA 206250 (pdf 206250.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 209193 (pdf 209193.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2019 , NDA 211323 (pdf 211323.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212277 (pdf 212277.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 203332 (pdf 203332.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214419 (pdf 214419.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 213927 (pdf 213927.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 214127 (pdf 214127.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214609 (pdf 214609.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 214654 (pdf 214654.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2021 , NDA 214423 (pdf 214423.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUNNY) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215429 (label 215429.pdf) INN (VENLAFAXINE BESYLATE) VENLAFAXINE BESYLATE (ALMATICA) APPROVAL= AP YEAR= 2022 , NDA 215622 (pdf 215622.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216044 (pdf 216044.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2022 , NDA 200430 (pdf 200430.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214691 (pdf 214691.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217390 (pdf 217390.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217767 (pdf 217767.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2024 , 686 ; VENLAFAXINE ; 93413-69-5 ; 1993 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANALGESIC -- SEROTONIN REUPTAKE INHIBITORS , ; NDA 020151 (label 20151.pdf) INN (VENLAFAXINE HYDROCHLORIDE) EFFEXOR (WYETH PHARMS INC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 020699 (label 20699.pdf) INN (VENLAFAXINE HYDROCHLORIDE) EFFEXOR XR (UPJOHN) APPROVAL= AP YEAR= 1997 , NDA 022104 (label 22104.pdf) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2008 , NDA 076690 (label 76690.pdf) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2006 , NDA 077166 (pdf 77166.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077515 (pdf 77515.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077653 (pdf 77653.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2008 , NDA 078057 (pdf 78057.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= TA YEAR= 2007 , NDA 078301 (pdf 78301.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078517 (pdf 78517.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= TA YEAR= 2007 , NDA 078627 (pdf 78627.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 , NDA 078554 (pdf 78554.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078789 (pdf 78789.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090555 (pdf 90555.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 076565 (pdf 76565.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2010 , NDA 079098 (pdf 79098.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090027 (pdf 90027.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091272 (pdf 91272.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 078421 (pdf 78421.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 078932 (pdf 78932.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 078865 (pdf 78865.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2011 , NDA 090071 (pdf 90071.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 2011 , NDA 090174 (pdf 90174.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 090899 (pdf 90899.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200834 (pdf 200834.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091123 (pdf 91123.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2011 , NDA 078087 (pdf 78087.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ANCHEN PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202036 (pdf 202036.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (YAOPHARMA CO LTD) APPROVAL= AP YEAR= 2015 , NDA 205468 (pdf 205468.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204889 (pdf 204889.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 201272 (pdf 201272.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2018 , NDA 206250 (pdf 206250.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 209193 (pdf 209193.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2019 , NDA 211323 (pdf 211323.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212277 (pdf 212277.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 203332 (pdf 203332.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214419 (pdf 214419.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 213927 (pdf 213927.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 214127 (pdf 214127.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214609 (pdf 214609.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 214654 (pdf 214654.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2021 , NDA 214423 (pdf 214423.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (SUNNY) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215429 (label 215429.pdf) INN (VENLAFAXINE BESYLATE) VENLAFAXINE BESYLATE (ALMATICA) APPROVAL= AP YEAR= 2022 , NDA 215622 (pdf 215622.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 216044 (pdf 216044.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (UNIQUE) APPROVAL= AP YEAR= 2022 , NDA 200430 (pdf 200430.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214691 (pdf 214691.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217390 (pdf 217390.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217767 (pdf 217767.pdf not found) INN (VENLAFAXINE HYDROCHLORIDE) VENLAFAXINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2024 , 687 ; NEFAZODONE ; 83366-66-9 ; 1994 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANALGESICS -- SEROTONIN AGENTS -- 5-HYDROXYTRYPTAMINE 2A RECEPTOR ANTAGONIST , ; NDA 020152 (label 20152.pdf) INN (NEFAZODONE HYDROCHLORIDE) SERZONE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 075763 (pdf 75763.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= TA YEAR= 2003 , NDA 076037 (label 76037.pdf) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076072 (pdf 76072.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076073 (pdf 76073.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076129 (pdf 76129.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076196 (pdf 76196.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (ROXANE) APPROVAL= TA YEAR= 2003 , NDA 076302 (pdf 76302.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076309 (pdf 76309.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076409 (pdf 76409.pdf not found) INN (NEFAZODONE HYDROCHLORIDE) NEFAZODONE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , 688 ; DIDANOSINE ; 69655-05-6 ; 1991 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV AGENTS -- ANTIMETABOLITES -- REVERSE TRANSCRIPTASE INHIBITORS , ; NDA 020154 (label 20154.pdf) INN (DIDANOSINE) VIDEX (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020155 (label 20155.pdf) INN (DIDANOSINE) VIDEX (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020156 (label 20156.pdf) INN (DIDANOSINE) VIDEX (BRISTOL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 021183 (label 21183.pdf) INN (DIDANOSINE) VIDEX EC (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 077167 (pdf 77167.pdf not found) INN (DIDANOSINE) DIDANOSINE (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077275 (pdf 77275.pdf not found) INN (DIDANOSINE) DIDANOSINE (AUROBINDO) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078112 (pdf 78112.pdf not found) INN (DIDANOSINE) DIDANOSINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 090094 (pdf 90094.pdf not found) INN (DIDANOSINE) DIDANOSINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090788 (pdf 90788.pdf not found) INN (DIDANOSINE) DIDANOSINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , 689 ; ALATROFLOXACIN ; 146961-76-4 ; 1997 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- FLUOROQUINOLONE , ; NDA 020760 (pdf 20760.pdf not found) INN (ALATROFLOXACIN MESYLATE) TROVAN PRESERVATIVE FREE (PFIZER) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 690 ; NILUTAMIDE ; 63612-50-0 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- ANTIANDROGENIC -- ANDROGEN RECEPTOR ANTAGONIST , ; NDA 020169 (label 20169.pdf) INN (NILUTAMIDE) NILANDRON (CONCORDIA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 207631 (label 207631.pdf) INN (NILUTAMIDE) NILUTAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2016 , 691 ; FINASTERIDE ; 98319-26-7 ; 1992 ; ; ; CLASS DERMATOLOGICALS -- ANTI-BALDNESS AGENTS -- 5 ALPHA REDUCTASE INHIBITORS , ; NDA 020180 (label 20180.pdf) INN (FINASTERIDE) PROSCAR (ORGANON) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020788 (label 20788.pdf) INN (FINASTERIDE) PROPECIA (ORGANON) APPROVAL= AP YEAR= 1997 , NDA 076340 (pdf 76340.pdf not found) INN (FINASTERIDE) FINASTERIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076436 (pdf 76436.pdf not found) INN (FINASTERIDE) FINASTERIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 076437 (pdf 76437.pdf not found) INN (FINASTERIDE) FINASTERIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 076511 (pdf 76511.pdf not found) INN (FINASTERIDE) FINASTERIDE (TEVA) APPROVAL= AP YEAR= 2006 , NDA 076905 (pdf 76905.pdf not found) INN (FINASTERIDE) FINASTERIDE (TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 077251 (pdf 77251.pdf not found) INN (FINASTERIDE) FINASTERIDE (GEDEON RICHTER USA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077335 (pdf 77335.pdf not found) INN (FINASTERIDE) FINASTERIDE (CIPLA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 077578 (pdf 77578.pdf not found) INN (FINASTERIDE) FINASTERIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077914 (pdf 77914.pdf not found) INN (FINASTERIDE) FINASTERIDE (ACTAVIS TOTOWA TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078341 (pdf 78341.pdf not found) INN (FINASTERIDE) FINASTERIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078371 (pdf 78371.pdf not found) INN (FINASTERIDE) FINASTERIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078900 (pdf 78900.pdf not found) INN (FINASTERIDE) FINASTERIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 090121 (pdf 90121.pdf not found) INN (FINASTERIDE) FINASTERIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 090060 (pdf 90060.pdf not found) INN (FINASTERIDE) FINASTERIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2013 , NDA 090061 (pdf 90061.pdf not found) INN (FINASTERIDE) FINASTERIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2010 , NDA 091643 (pdf 91643.pdf not found) INN (FINASTERIDE) FINASTERIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 090507 (pdf 90507.pdf not found) INN (FINASTERIDE) FINASTERIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 090508 (pdf 90508.pdf not found) INN (FINASTERIDE) FINASTERIDE (SUN PHARM) APPROVAL= AP YEAR= 2013 , NDA 203687 (pdf 203687.pdf not found) INN (FINASTERIDE) FINASTERIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 078161 (pdf 78161.pdf not found) INN (FINASTERIDE) FINASTERIDE (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204304 (pdf 204304.pdf not found) INN (FINASTERIDE) FINASTERIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207750 (pdf 207750.pdf not found) INN (FINASTERIDE) FINASTERIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 215423 (label 215423.pdf) INN (FINASTERIDE TADALAFIL) ENTADFI (BLUE WATER BIOTECH) APPROVAL= AP YEAR= 2021 , NDA 218232 (pdf 218232.pdf not found) INN (FINASTERIDE TADALAFIL) FINASTERIDE AND TADALAFIL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 692 ; PERINDOPRIL ; 82834-16-0 ; 1993 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ACE INHIBITOR , ; NDA 020184 (label 20184.pdf) INN (PERINDOPRIL ERBUMINE) ACEON (SYMPLMED PHARMS LLC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 078138 (pdf 78138.pdf not found) INN (PERINDOPRIL ERBUMINE) PERINDOPRIL ERBUMINE (ANI PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078263 (pdf 78263.pdf not found) INN (PERINDOPRIL ERBUMINE) PERINDOPRIL ERBUMINE (LUPIN LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079070 (pdf 79070.pdf not found) INN (PERINDOPRIL ERBUMINE) PERINDOPRIL ERBUMINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090072 (pdf 90072.pdf not found) INN (PERINDOPRIL ERBUMINE) PERINDOPRIL ERBUMINE (HIKMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090463 (pdf 90463.pdf not found) INN (PERINDOPRIL ERBUMINE) PERINDOPRIL ERBUMINE (APOTEX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 205003 (label 205003.pdf) INN (AMLODIPINE BESYLATE PERINDOPRIL ARGININE) PRESTALIA (ADHERA) APPROVAL= AP YEAR= 2015 , 693 ; FELBAMATE ; 25451-15-4 ; 1993 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC AGENTS -- NEUROPROTECTIVE AGENTS , ; NDA 020189 (label 20189.pdf) INN (FELBAMATE) FELBATOL (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , NDA 201680 (pdf 201680.pdf not found) INN (FELBAMATE) FELBAMATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 202385 (pdf 202385.pdf not found) INN (FELBAMATE) FELBAMATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 202284 (pdf 202284.pdf not found) INN (FELBAMATE) FELBAMATE (ANI PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204595 (pdf 204595.pdf not found) INN (FELBAMATE) FELBAMATE (ALVOGEN) APPROVAL= AP YEAR= 2016 , NDA 206314 (pdf 206314.pdf not found) INN (FELBAMATE) FELBAMATE (TARO) APPROVAL= AP YEAR= 2017 , NDA 207093 (pdf 207093.pdf not found) INN (FELBAMATE) FELBAMATE (TARO) APPROVAL= AP YEAR= 2017 , NDA 208970 (pdf 208970.pdf not found) INN (FELBAMATE) FELBAMATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 211333 (pdf 211333.pdf not found) INN (FELBAMATE) FELBAMATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , 694 ; TERBINAFINE ; 91161-71-6 ; 1992 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- ALLYLAMINES -- INHIBITS BIOSYNTHESIS OF ERGOSTEROL , ; NDA 020192 (pdf 20192.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL (NOVARTIS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 020539 (label 20539.pdf) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL (NOVARTIS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020749 (label 20749.pdf) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL (KARO HLTHCARE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020846 (label 20846.pdf) INN (TERBINAFINE) LAMISIL (KARO HLTHCARE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020980 (label 20980.pdf) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL (KARO HLTHCARE) APPROVAL= AP YEAR= 1999 , NDA 021124 (label 21124.pdf) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL AT (KARO HLTHCARE) APPROVAL= AP YEAR= 2000 , NDA 021958 (label 21958.pdf) INN (TERBINAFINE) LAMISIL AT (KARO HLTHCARE) APPROVAL= AP YEAR= 2006 , NDA 022071 (label 22071.pdf) INN (TERBINAFINE HYDROCHLORIDE) LAMISIL (NOVARTIS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076377 (pdf 76377.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076390 (pdf 76390.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2007 , NDA 076713 (pdf 76713.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (ANDRX PHARM) APPROVAL= TA YEAR= 2004 , NDA 077065 (pdf 77065.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (GEDEON RICHTER USA) APPROVAL= TA YEAR= 2005 , NDA 077136 (pdf 77136.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (MYLAN) APPROVAL= TA YEAR= 2005 , NDA 077137 (pdf 77137.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077195 (pdf 77195.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077223 (pdf 77223.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (ROXANE) APPROVAL= TA YEAR= 2005 , NDA 077444 (pdf 77444.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 077511 (pdf 77511.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2007 , NDA 077533 (pdf 77533.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077919 (pdf 77919.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (EMED MEDCL) APPROVAL= AP YEAR= 2007 , NDA 078157 (pdf 78157.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078163 (pdf 78163.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2007 , NDA 078199 (pdf 78199.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2007 , NDA 078229 (pdf 78229.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078297 (pdf 78297.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077714 (pdf 77714.pdf not found) INN (TERBINAFINE HYDROCHLORIDE) TERBINAFINE HYDROCHLORIDE (BRECKENRIDGE PHARM) APPROVAL= AP YEAR= 2010 , 695 ; ZALCITABINE ; 7481-89-2 ; 1992 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTI-HIV AGENTS -- ANTIMETABOLITES -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS , ; NDA 020199 (label 20199.pdf) INN (ZALCITABINE) HIVID (ROCHE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 696 ; CISAPRIDE ; 81098-60-4 ; 1993 ; DISCONTINUED ; ; CLASS METABOLISM -- GASTROINTESTINAL AGENTS -- TREATMENT OF NOCTURNAL HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE -- SEROTONIN RECEPTOR 5-HT4 AGONIST , ; NDA 020210 (label 20210.pdf) INN (CISAPRIDE MONOHYDRATE) PROPULSID (JANSSEN PHARMS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 020398 (pdf 20398.pdf not found) INN (CISAPRIDE MONOHYDRATE) PROPULSID (JANSSEN PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020767 (pdf 20767.pdf not found) INN (CISAPRIDE MONOHYDRATE) PROPULSID QUICKSOLV (JANSSEN PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , 697 ; DEXRAZOXANE ; 24584-09-6 ; 1995 ; ; ; CLASS VARIOUS -- CARDIOPROTECTIVE -- CHELATING AGENTS -- CYCLIC DERIVATIVE OF EDTA -- EXTRAVASATION OF ANTHRACYCLINE DRUGS -- CATALYTIC TOPOISOMERASE II INHIBITOR (PMID25521189) , ; NDA 020212 (label 20212.pdf) INN (DEXRAZOXANE HYDROCHLORIDE) ZINECARD (PFIZER) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 022025 (label 22025.pdf) INN (DEXRAZOXANE HYDROCHLORIDE) TOTECT (CLINIGEN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076068 (pdf 76068.pdf not found) INN (DEXRAZOXANE HYDROCHLORIDE) DEXRAZOXANE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 200752 (pdf 200752.pdf not found) INN (DEXRAZOXANE HYDROCHLORIDE) DEXRAZOXANE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2011 , NDA 207321 (pdf 207321.pdf not found) INN (DEXRAZOXANE HYDROCHLORIDE) DEXRAZOXANE HYDROCHLORIDE (GLAND) APPROVAL= AP YEAR= 2016 , 698 ; LEVOCABASTINE ; 79516-68-0 ; 1993 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- HISTAMINE H1 ANTAGONISTS , ; NDA 020219 (pdf 20219.pdf not found) INN (LEVOCABASTINE HYDROCHLORIDE) LIVOSTIN (NOVARTIS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , 699 ; AMIFOSTINE ; 20537-88-6 ; 1995 ; ; ; CLASS VARIOUS -- RADIATION-PROTECTIVE AGENTS -- PRODRUG -- REDUCTION OF THE CUMULATIVE RENAL TOXICITY OF CISPLATIN AND FOR THE REDUCTION OF THE TOXIC EFFECTS OF RADIATION ON NORMAL ORAL TISSUES -- INTESTINAL-TYPE ALKALINE PHOSPHATASE (IAP) IS A MAJOR ISOENZYME INVOLVED IN THE HYDROLYSIS OF AMIFOSTINE (PMID12577238) , ; NDA 020221 (label 20221.pdf) INN (AMIFOSTINE) ETHYOL (CLINIGEN) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 077126 (pdf 77126.pdf not found) INN (AMIFOSTINE) AMIFOSTINE (SUN PHARM) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 204363 (pdf 204363.pdf not found) INN (AMIFOSTINE) AMIFOSTINE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2017 DISCONTINUED , 700 ; CANDESARTAN CILEXETIL ; 145040-37-5 ; 1998 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- HYDROLYZED TO CANDESARTAN DURING ABSORPTION FROM THE GASTROINTESTINAL TRACT -- CANDESARTAN IS A SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR ANTAGONIST -- CANDESARTAN BLOCKS THE VASOCONSTRICTOR AND ALDOSTERONE-SECRETING EFFECTS OF ANGIOTENSIN II , ; NDA 020838 (label 20838.pdf) INN (CANDESARTAN CILEXETIL) ATACAND (ANI PHARMS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021093 (label 21093.pdf) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) ATACAND HCT (ANI PHARMS) APPROVAL= AP YEAR= 2000 , NDA 078702 (pdf 78702.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MYLAN) APPROVAL= AP YEAR= 2013 , NDA 090434 (pdf 90434.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 OBSOLETE , NDA 090704 (pdf 90704.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2012 , NDA 200887 (pdf 200887.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2012 , NDA 202884 (pdf 202884.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202079 (pdf 202079.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202965 (pdf 202965.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 204100 (pdf 204100.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203813 (pdf 203813.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 209119 (pdf 209119.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 091390 (pdf 91390.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 203466 (pdf 203466.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 207455 (pdf 207455.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 210302 (pdf 210302.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 206233 (pdf 206233.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (PRINSTON INC) APPROVAL= AP YEAR= 2023 , 701 ; CLADRIBINE ; 4291-63-8 ; 1993 ; ; ; CLASS ANTINEOPLASTIC -- IMMUNOSUPPRESSIVE AGENTS -- TREATMENT OF HAIRY CELL LEUKEMIA , ; NDA 020229 (label 20229.pdf) INN (CLADRIBINE) LEUSTATIN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 075405 (pdf 75405.pdf not found) INN (CLADRIBINE) CLADRIBINE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 076571 (pdf 76571.pdf not found) INN (CLADRIBINE) CLADRIBINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 200510 (pdf 200510.pdf not found) INN (CLADRIBINE) CLADRIBINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022561 (label 22561.pdf) INN (CLADRIBINE) MAVENCLAD (EMD SERONO INC) APPROVAL= AP YEAR= 2019 , NDA 210856 (pdf 210856.pdf not found) INN (CLADRIBINE) CLADRIBINE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 , 702 ; TRICLOSAN ; 3380-34-5 ; 1997 ; DISCONTINUED ; NATURAL MOLECULE NPA011823 ; CLASS DERMATOLOGICALS -- ANTIINFECTIVE , ; NDA 020231 (label 20231.pdf) INN (SODIUM FLUORIDE TRICLOSAN) COLGATE TOTAL (COLGATE PALMOLIVE) APPROVAL= AP YEAR= 1997 DISCONTINUED , 703 ; BUDESONIDE ; 51333-22-3 ; 1994 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIINFLAMMATORY -- BRONCHODILATOR AGENTS -- CORTICOSTEROIDS -- GLUCOCORTICOIDS , ; NDA 020233 (pdf 20233.pdf not found) INN (BUDESONIDE) RHINOCORT (ASTRAZENECA) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020441 (label 20441.pdf) INN (BUDESONIDE) PULMICORT (ASTRAZENECA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020746 (label 20746.pdf) INN (BUDESONIDE) RHINOCORT (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1999 , NDA 020929 (label 20929.pdf) INN (BUDESONIDE) PULMICORT RESPULES (ASTRAZENECA) APPROVAL= AP YEAR= 2000 , NDA 021324 (label 21324.pdf) INN (BUDESONIDE) ENTOCORT EC (PADAGIS US) APPROVAL= AP YEAR= 2001 , NDA 021929 (label 21929.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) SYMBICORT (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 021949 (label 21949.pdf) INN (BUDESONIDE) PULMICORT FLEXHALER (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 077519 (pdf 77519.pdf not found) INN (BUDESONIDE) BUDESONIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078202 (pdf 78202.pdf not found) INN (BUDESONIDE) BUDESONIDE (NEPHRON) APPROVAL= AP YEAR= 2009 , NDA 090410 (pdf 90410.pdf not found) INN (BUDESONIDE) BUDESONIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 , NDA 078404 (pdf 78404.pdf not found) INN (BUDESONIDE) BUDESONIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2012 , NDA 201966 (pdf 201966.pdf not found) INN (BUDESONIDE) BUDESONIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 203634 (label 203634.pdf) INN (BUDESONIDE) UCERIS (SALIX) APPROVAL= AP YEAR= 2013 , NDA 078949 (pdf 78949.pdf not found) INN (BUDESONIDE) BUDESONIDE (APOTEX INC) APPROVAL= AP YEAR= 2014 , NDA 090379 (pdf 90379.pdf not found) INN (BUDESONIDE) BUDESONIDE (BARR LABS DIV TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205613 (label 205613.pdf) INN (BUDESONIDE) UCERIS (SALIX) APPROVAL= AP YEAR= 2014 , NDA 204548 (pdf 204548.pdf not found) INN (BUDESONIDE) BUDESONIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206623 (pdf 206623.pdf not found) INN (BUDESONIDE) BUDESONIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2016 , NDA 206724 (pdf 206724.pdf not found) INN (BUDESONIDE) BUDESONIDE (NATCO) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206134 (pdf 206134.pdf not found) INN (BUDESONIDE) BUDESONIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206200 (pdf 206200.pdf not found) INN (BUDESONIDE) BUDESONIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207367 (pdf 207367.pdf not found) INN (BUDESONIDE) BUDESONIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 205710 (pdf 205710.pdf not found) INN (BUDESONIDE) BUDESONIDE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 209041 (pdf 209041.pdf not found) INN (BUDESONIDE) BUDESONIDE (SCIECURE PHARMA INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205457 (pdf 205457.pdf not found) INN (BUDESONIDE) BUDESONIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2018 , NDA 210897 (pdf 210897.pdf not found) INN (BUDESONIDE) BUDESONIDE (LUPIN) APPROVAL= AP YEAR= 2018 , NDA 211929 (label 211929.pdf) INN (BUDESONIDE) ORTIKOS (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208851 (pdf 208851.pdf not found) INN (BUDESONIDE) BUDESONIDE (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 212122 (label 212122.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE GLYCOPYRROLATE) BREZTRI AEROSPHERE (ASTRAZENECA AB) APPROVAL= AP YEAR= 2020 , NDA 211699 (pdf 211699.pdf not found) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) BREYNA (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 211922 (pdf 211922.pdf not found) INN (BUDESONIDE) BUDESONIDE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 215935 (label 215935.pdf) INN (BUDESONIDE) TARPEYO (CALLIDITAS) APPROVAL= AP YEAR= 2021 , NDA 214070 (label 214070.pdf) INN (ALBUTEROL SULFATE BUDESONIDE) AIRSUPRA (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , NDA 215328 (pdf 215328.pdf not found) INN (BUDESONIDE) BUDESONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 , NDA 216579 (label 216579.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE) SYMBICORT AEROSPHERE (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , NDA 216667 (pdf 216667.pdf not found) INN (BUDESONIDE) BUDESONIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213976 (pdf 213976.pdf not found) INN (BUDESONIDE) EOHILIA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2024 , 704 ; GABAPENTIN ; 60142-96-3 ; 1993 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- MODERATE-TO-SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS) IN ADULTS -- ANTIEPILEPTIC -- POSTHERPETIC NEURALGIA (PHN) -- GABA RECEPTOR AGONIST , ; NDA 020235 (label 20235.pdf) INN (GABAPENTIN) NEURONTIN (VIATRIS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , NDA 020882 (label 20882.pdf) INN (GABAPENTIN) NEURONTIN (VIATRIS) APPROVAL= AP YEAR= 1998 , NDA 021129 (label 21129.pdf) INN (GABAPENTIN) NEURONTIN (VIATRIS) APPROVAL= AP YEAR= 2000 , NDA 021216 (label 21216.pdf) INN (GABAPENTIN) NEURONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 2000 NEWAPPLICATION , NDA 021397 (label 21397.pdf) INN (GABAPENTIN) NEURONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021423 (label 21423.pdf) INN (GABAPENTIN) NEURONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021424 (label 21424.pdf) INN (GABAPENTIN) NEURONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 075350 (pdf 75350.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 , NDA 075360 (pdf 75360.pdf not found) INN (GABAPENTIN) GABAPENTIN (GRANULES) APPROVAL= AP YEAR= 2005 , NDA 075428 (pdf 75428.pdf not found) INN (GABAPENTIN) GABAPENTIN (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 075435 (pdf 75435.pdf not found) INN (GABAPENTIN) GABAPENTIN (TEVA PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 075477 (pdf 75477.pdf not found) INN (GABAPENTIN) GABAPENTIN (CSPC OUYI) APPROVAL= AP YEAR= 2005 , NDA 075485 (pdf 75485.pdf not found) INN (GABAPENTIN) GABAPENTIN (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 075539 (pdf 75539.pdf not found) INN (GABAPENTIN) GABAPENTIN (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075694 (pdf 75694.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 , NDA 075827 (pdf 75827.pdf not found) INN (GABAPENTIN) GABAPENTIN (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076017 (pdf 76017.pdf not found) INN (GABAPENTIN) GABAPENTIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076120 (pdf 76120.pdf not found) INN (GABAPENTIN) GABAPENTIN (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076537 (pdf 76537.pdf not found) INN (GABAPENTIN) GABAPENTIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076605 (pdf 76605.pdf not found) INN (GABAPENTIN) GABAPENTIN (RANBAXY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076606 (pdf 76606.pdf not found) INN (GABAPENTIN) GABAPENTIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076672 (pdf 76672.pdf not found) INN (GABAPENTIN) GABAPENTIN (TARO) APPROVAL= AP YEAR= 2013 , NDA 076877 (pdf 76877.pdf not found) INN (GABAPENTIN) GABAPENTIN (INVATECH) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077242 (pdf 77242.pdf not found) INN (GABAPENTIN) GABAPENTIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077261 (pdf 77261.pdf not found) INN (GABAPENTIN) GABAPENTIN (TARO) APPROVAL= AP YEAR= 2013 , NDA 077525 (pdf 77525.pdf not found) INN (GABAPENTIN) GABAPENTIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 , NDA 077661 (pdf 77661.pdf not found) INN (GABAPENTIN) GABAPENTIN (RUBICON) APPROVAL= AP YEAR= 2006 , NDA 077662 (pdf 77662.pdf not found) INN (GABAPENTIN) GABAPENTIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2006 , NDA 077894 (pdf 77894.pdf not found) INN (GABAPENTIN) GABAPENTIN (APOTEX) APPROVAL= AP YEAR= 2006 , NDA 078150 (pdf 78150.pdf not found) INN (GABAPENTIN) GABAPENTIN (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078428 (pdf 78428.pdf not found) INN (GABAPENTIN) GABAPENTIN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 078787 (pdf 78787.pdf not found) INN (GABAPENTIN) GABAPENTIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 078926 (pdf 78926.pdf not found) INN (GABAPENTIN) GABAPENTIN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 090705 (pdf 90705.pdf not found) INN (GABAPENTIN) GABAPENTIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090335 (pdf 90335.pdf not found) INN (GABAPENTIN) GABAPENTIN (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090858 (pdf 90858.pdf not found) INN (GABAPENTIN) GABAPENTIN (ALKEM) APPROVAL= AP YEAR= 2010 , NDA 022544 (label 22544.pdf) INN (GABAPENTIN) GRALISE (ALMATICA) APPROVAL= AP YEAR= 2011 , NDA 078974 (pdf 78974.pdf not found) INN (GABAPENTIN) GABAPENTIN (MISSION PHARMACAL) APPROVAL= AP YEAR= 2011 , NDA 090158 (pdf 90158.pdf not found) INN (GABAPENTIN) GABAPENTIN (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078782 (pdf 78782.pdf not found) INN (GABAPENTIN) GABAPENTIN (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090007 (pdf 90007.pdf not found) INN (GABAPENTIN) GABAPENTIN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 200651 (pdf 200651.pdf not found) INN (GABAPENTIN) GABAPENTIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 076403 (pdf 76403.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACELLA PHARMS LLC) APPROVAL= AP YEAR= 2012 , NDA 202024 (pdf 202024.pdf not found) INN (GABAPENTIN) GABAPENTIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202764 (pdf 202764.pdf not found) INN (GABAPENTIN) GABAPENTIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091008 (pdf 91008.pdf not found) INN (GABAPENTIN) GABAPENTIN (CHARTWELL RX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203244 (pdf 203244.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACI) APPROVAL= AP YEAR= 2013 , NDA 203611 (pdf 203611.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 2013 , NDA 206402 (pdf 206402.pdf not found) INN (GABAPENTIN) GABAPENTIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 091286 (pdf 91286.pdf not found) INN (GABAPENTIN) GABAPENTIN (BELCHER) APPROVAL= AP YEAR= 2016 , NDA 204989 (pdf 204989.pdf not found) INN (GABAPENTIN) GABAPENTIN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 205101 (pdf 205101.pdf not found) INN (GABAPENTIN) GABAPENTIN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 205807 (pdf 205807.pdf not found) INN (GABAPENTIN) GABAPENTIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207057 (pdf 207057.pdf not found) INN (GABAPENTIN) GABAPENTIN (CSPC OUYI) APPROVAL= AP YEAR= 2017 , NDA 207099 (pdf 207099.pdf not found) INN (GABAPENTIN) GABAPENTIN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206943 (pdf 206943.pdf not found) INN (GABAPENTIN) GABAPENTIN (ACI) APPROVAL= AP YEAR= 2018 , NDA 209306 (pdf 209306.pdf not found) INN (GABAPENTIN) GABAPENTIN (LUPIN LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211314 (pdf 211314.pdf not found) INN (GABAPENTIN) GABAPENTIN (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211330 (pdf 211330.pdf not found) INN (GABAPENTIN) GABAPENTIN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213603 (pdf 213603.pdf not found) INN (GABAPENTIN) GABAPENTIN (ZHEJIANG YONGTAI) APPROVAL= AP YEAR= 2020 , NDA 214956 (pdf 214956.pdf not found) INN (GABAPENTIN) GABAPENTIN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214957 (pdf 214957.pdf not found) INN (GABAPENTIN) GABAPENTIN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 203934 (pdf 203934.pdf not found) INN (GABAPENTIN) GABAPENTIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2024 , NDA 216492 (pdf 216492.pdf not found) INN (GABAPENTIN) GABAPENTIN (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 217116 (pdf 217116.pdf not found) INN (GABAPENTIN) GABAPENTIN (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217546 (pdf 217546.pdf not found) INN (GABAPENTIN) GABAPENTIN (LAURUS) APPROVAL= AP YEAR= 2023 , NDA 208928 (pdf 208928.pdf not found) INN (GABAPENTIN) GABAPENTIN (IPCA LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217995 (pdf 217995.pdf not found) INN (GABAPENTIN) GABAPENTIN (RISING) APPROVAL= AP YEAR= 2023 , NDA 209855 (pdf 209855.pdf not found) INN (GABAPENTIN) GABAPENTIN (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , NDA 211313 (pdf 211313.pdf not found) INN (GABAPENTIN) GABAPENTIN (STRIDES PHARMA) APPROVAL= AP YEAR= 2024 , NDA 216252 (pdf 216252.pdf not found) INN (GABAPENTIN) GABAPENTIN (HUMANWELL) APPROVAL= AP YEAR= 2024 , NDA 217682 (pdf 217682.pdf not found) INN (GABAPENTIN) GABAPENTIN (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , NDA 217965 (pdf 217965.pdf not found) INN (GABAPENTIN) GABAPENTIN (LAURUS) APPROVAL= AP YEAR= 2024 , NDA 218075 (pdf 218075.pdf not found) INN (GABAPENTIN) GABAPENTIN (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , 705 ; GRANISETRON ; 109889-09-0 ; 1993 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- SEROTONIN (5HT3) ANTAGONISTS , ; NDA 020239 (label 20239.pdf) INN (GRANISETRON HYDROCHLORIDE) KYTRIL (ROCHE) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 020305 (label 20305.pdf) INN (GRANISETRON HYDROCHLORIDE) KYTRIL (ROCHE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 021238 (label 21238.pdf) INN (GRANISETRON HYDROCHLORIDE) KYTRIL (ROCHE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 022198 (label 22198.pdf) INN (GRANISETRON) SANCUSO (CUMBERLAND) APPROVAL= AP YEAR= 2008 , NDA 077165 (pdf 77165.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE (DR REDDYS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077177 (pdf 77177.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 077186 (pdf 77186.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 077187 (pdf 77187.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 077297 (pdf 77297.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2008 , NDA 077842 (pdf 77842.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077913 (pdf 77913.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 077963 (pdf 77963.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078037 (pdf 78037.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2008 , NDA 078080 (label 78080.pdf) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078090 (label 78090.pdf) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 078096 (label 78096.pdf) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 078197 (pdf 78197.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078198 (pdf 78198.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078221 (pdf 78221.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078258 (pdf 78258.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2008 , NDA 078260 (pdf 78260.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078262 (pdf 78262.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2007 , NDA 078334 (pdf 78334.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISOL (INTRA SANA LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078392 (pdf 78392.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2007 , NDA 078522 (label 78522.pdf) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 078564 (pdf 78564.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (WOCKHARDT USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078565 (pdf 78565.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (WOCKHARDT USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078566 (pdf 78566.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (WOCKHARDT USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078678 (pdf 78678.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2008 , NDA 078725 (pdf 78725.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078808 (pdf 78808.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078835 (pdf 78835.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (SANDOZ INC) APPROVAL= AP YEAR= 2008 , NDA 078843 (pdf 78843.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 078863 (pdf 78863.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 078880 (pdf 78880.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 078531 (pdf 78531.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078534 (pdf 78534.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078629 (pdf 78629.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 078846 (pdf 78846.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 078969 (pdf 78969.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (NATCO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 079078 (pdf 79078.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2009 , NDA 079119 (pdf 79119.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091136 (pdf 91136.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (MYLAN ASI) APPROVAL= AP YEAR= 2010 , NDA 091137 (pdf 91137.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (MYLAN ASI) APPROVAL= AP YEAR= 2010 , NDA 090817 (pdf 90817.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2010 , NDA 091274 (pdf 91274.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022445 (label 22445.pdf) INN (GRANISETRON) SUSTOL (HERON THERAPS INC) APPROVAL= AP YEAR= 2016 , NDA 204238 (pdf 204238.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203453 (pdf 203453.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203454 (pdf 203454.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 202647 (pdf 202647.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 202648 (pdf 202648.pdf not found) INN (GRANISETRON HYDROCHLORIDE) GRANISETRON HYDROCHLORIDE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 DISCONTINUED , 706 ; SPIRAPRIL ; 83647-97-6 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS , ; NDA 020240 (label 20240.pdf) INN (SPIRAPRIL HYDROCHLORIDE) RENORMAX (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , 707 ; LAMOTRIGINE ; 84057-84-1 ; 1994 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC -- PHENYLTRIAZINE CLASS -- TREATMENT OF BIPOLAR I DISORDER -- SODIUM CHANNEL BLOCKER , ; NDA 020241 (label 20241.pdf) INN (LAMOTRIGINE) LAMICTAL (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY , NDA 020764 (label 20764.pdf) INN (LAMOTRIGINE) LAMICTAL CD (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1998 , NDA 076388 (pdf 76388.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076420 (pdf 76420.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076630 (pdf 76630.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076701 (pdf 76701.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 076708 (pdf 76708.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 076928 (pdf 76928.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (WATSON LABS) APPROVAL= AP YEAR= 2009 , NDA 077392 (pdf 77392.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ROXANE) APPROVAL= TA YEAR= 2006 , NDA 077420 (pdf 77420.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077428 (pdf 77428.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077633 (pdf 77633.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2009 , NDA 077757 (pdf 77757.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (CARACO) APPROVAL= TA YEAR= 2007 , NDA 077783 (pdf 77783.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078009 (pdf 78009.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 078409 (pdf 78409.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078443 (pdf 78443.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078525 (pdf 78525.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TARO PHARM INDS) APPROVAL= AP YEAR= 2009 , NDA 078645 (pdf 78645.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022115 (label 22115.pdf) INN (LAMOTRIGINE) LAMICTAL XR (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 2009 , NDA 022251 (label 22251.pdf) INN (LAMOTRIGINE) LAMICTAL ODT (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 2009 , NDA 022509 (label 22509.pdf) INN (LAMOTRIGINE) LAMICTAL XR (SMITHKLINE BEECHAM) APPROVAL= AP YEAR= 2010 , NDA 078310 (pdf 78310.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ZENNOVA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078625 (pdf 78625.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (RUBICON) APPROVAL= AP YEAR= 2009 , NDA 078947 (pdf 78947.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TORRENT PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078956 (pdf 78956.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078982 (pdf 78982.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (GRANULES) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079099 (pdf 79099.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 079132 (pdf 79132.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2009 , NDA 079204 (pdf 79204.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TARO) APPROVAL= AP YEAR= 2009 , NDA 090401 (label 90401.pdf) INN (LAMOTRIGINE) LAMOTRIGINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078691 (pdf 78691.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 078134 (pdf 78134.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078669 (pdf 78669.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090607 (pdf 90607.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200220 (pdf 200220.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090170 (label 90170.pdf) INN (LAMOTRIGINE) LAMOTRIGINE (UNICHEM LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 090169 (pdf 90169.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201374 (pdf 201374.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200672 (pdf 200672.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 200694 (pdf 200694.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 200828 (pdf 200828.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (IMPAX LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201791 (pdf 201791.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 , NDA 202383 (pdf 202383.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202498 (pdf 202498.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2013 , NDA 202887 (pdf 202887.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (RUBICON) APPROVAL= AP YEAR= 2013 , NDA 203370 (pdf 203370.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (TORRENT) APPROVAL= AP YEAR= 2013 , NDA 203733 (pdf 203733.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 OBSOLETE , NDA 201168 (pdf 201168.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ALEMBIC) APPROVAL= AP YEAR= 2014 , NDA 204158 (pdf 204158.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 , NDA 206382 (pdf 206382.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 207497 (pdf 207497.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207763 (pdf 207763.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213271 (pdf 213271.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 213949 (pdf 213949.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (YILING) APPROVAL= AP YEAR= 2021 , NDA 214124 (pdf 214124.pdf not found) INN (LAMOTRIGINE) LAMOTRIGINE (AMRING PHARMS) APPROVAL= AP YEAR= 2022 , 708 ; FLUVOXAMINE ; 54739-18-3 ; 1994 ; ; ; CLASS NERVOUS SYSTEM -- ANTIOBSESSIONAL AGENT -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) , ; NDA 020243 (pdf 20243.pdf not found) INN (FLUVOXAMINE MALEATE) LUVOX (SOLVAY) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 021519 (label 21519.pdf) INN (FLUVOXAMINE MALEATE) LUVOX (ANI PHARMS) APPROVAL= AP YEAR= 2007 , NDA 022033 (label 22033.pdf) INN (FLUVOXAMINE MALEATE) LUVOX CR (JAZZ PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022235 (label 22235.pdf) INN (FLUVOXAMINE MALEATE) LUVOX (JAZZ) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 075887 (pdf 75887.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075888 (pdf 75888.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2000 , NDA 075889 (pdf 75889.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075893 (pdf 75893.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075894 (pdf 75894.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075897 (pdf 75897.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075898 (pdf 75898.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075899 (pdf 75899.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075900 (pdf 75900.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 075901 (label 75901.pdf) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075902 (pdf 75902.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (APOTEX) APPROVAL= AP YEAR= 2001 , NDA 075950 (pdf 75950.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (MYLAN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076125 (pdf 76125.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 091476 (pdf 91476.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 , NDA 091482 (pdf 91482.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 203240 (pdf 203240.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 212182 (pdf 212182.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (BIONPHARMA) APPROVAL= AP YEAR= 2020 , NDA 217917 (pdf 217917.pdf not found) INN (FLUVOXAMINE MALEATE) FLUVOXAMINE MALEATE (BIONPHARMA) APPROVAL= AP YEAR= 2024 , 709 ; HALOFANTRINE ; 69756-53-2 ; 1992 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- SCHIZONTICIDAL ANTIMALARIAL AGENT , ; NDA 020250 (label 20250.pdf) INN (HALOFANTRINE HYDROCHLORIDE) HALFAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 710 ; ATOVAQUONE ; 95233-18-4 ; 1992 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- ANTIPNEUMOCYSTIS -- ANTIINFECTIVE -- ANTIPROTOZOAL -- ANALOG OF UBIQUINONE -- MITOCHONDRIAL ELECTRON TRANSPORT , ; NDA 020259 (pdf 20259.pdf not found) INN (ATOVAQUONE) MEPRON (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 020500 (label 20500.pdf) INN (ATOVAQUONE) MEPRON (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1995 , NDA 021078 (label 21078.pdf) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) MALARONE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2000 , NDA 091211 (pdf 91211.pdf not found) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 202362 (pdf 202362.pdf not found) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202960 (pdf 202960.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 207833 (pdf 207833.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 209750 (pdf 209750.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 209105 (pdf 209105.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 209685 (pdf 209685.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 210692 (pdf 210692.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 210510 (pdf 210510.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (ABHAI LLC) APPROVAL= AP YEAR= 2019 , NDA 212918 (pdf 212918.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (BIONPHARMA) APPROVAL= AP YEAR= 2021 , NDA 214272 (pdf 214272.pdf not found) INN (ATOVAQUONE) ATOVAQUONE (ABON PHARMS LLC) APPROVAL= AP YEAR= 2021 , 711 ; FLUVASTATIN ; 93957-54-1 ; 1993 ; ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- HYPOCHOLESTEROLEMIC -- HMG-COA REDUCTASE INHIBITORS , ; NDA 020261 (label 20261.pdf) INN (FLUVASTATIN SODIUM) LESCOL (NOVARTIS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 021192 (label 21192.pdf) INN (FLUVASTATIN SODIUM) LESCOL XL (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 078407 (pdf 78407.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078872 (pdf 78872.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (PAR PHARM) APPROVAL= TA YEAR= 2009 , NDA 090595 (pdf 90595.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202458 (pdf 202458.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 079011 (pdf 79011.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 209397 (pdf 209397.pdf not found) INN (FLUVASTATIN SODIUM) FLUVASTATIN SODIUM (BEIJING) APPROVAL= AP YEAR= 2021 , 712 ; PACLITAXEL ; 33069-62-4 ; 1992 ; ; NATURAL MOLECULE NPA016690 ; CLASS ANTINEOPLASTIC -- TUBULIN MODULATORS -- STABILIZES MICROTUBULES BY PREVENTING DEPOLYMERIZATION , ; NDA 020262 (label 20262.pdf) INN (PACLITAXEL) TAXOL (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 021660 (label 21660.pdf) INN (PACLITAXEL) ABRAXANE (BRISTOL-MYERS) APPROVAL= AP YEAR= 2005 , NDA 075184 (label 75184.pdf) INN (PACLITAXEL) PACLITAXEL (TEVA PHARMS) APPROVAL= AP YEAR= 2002 , NDA 075190 (pdf 75190.pdf not found) INN (PACLITAXEL) PACLITAXEL (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 075278 (pdf 75278.pdf not found) INN (PACLITAXEL) PACLITAXEL (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075297 (label 75297.pdf) INN (PACLITAXEL) PACLITAXEL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075436 (pdf 75436.pdf not found) INN (PACLITAXEL) PACLITAXEL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076131 (label 76131.pdf) INN (PACLITAXEL) PACLITAXEL (HOSPIRA) APPROVAL= AP YEAR= 2002 , NDA 076233 (pdf 76233.pdf not found) INN (PACLITAXEL) PACLITAXEL (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 077413 (pdf 77413.pdf not found) INN (PACLITAXEL) PACLITAXEL (PLIVA LACHEMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077574 (pdf 77574.pdf not found) INN (PACLITAXEL) PACLITAXEL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 078167 (pdf 78167.pdf not found) INN (PACLITAXEL) PACLITAXEL (SANDOZ) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 090130 (pdf 90130.pdf not found) INN (PACLITAXEL) PACLITAXEL (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2009 , NDA 091540 (pdf 91540.pdf not found) INN (PACLITAXEL) PACLITAXEL (DASH PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 207326 (pdf 207326.pdf not found) INN (PACLITAXEL) PACLITAXEL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205720 (pdf 205720.pdf not found) INN (PACLITAXEL) PACLITAXEL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 213434 (pdf 213434.pdf not found) INN (PACLITAXEL) PACLITAXEL (MSN) APPROVAL= AP YEAR= 2020 , NDA 211875 (label 211875.pdf) INN (PACLITAXEL) PACLITAXEL (AM REGENT) APPROVAL= AP YEAR= 2022 , NDA 216874 (pdf 216874.pdf not found) INN (PACLITAXEL) PACLITAXEL (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216338 (label 216338.pdf) INN (PACLITAXEL) PACLITAXEL (TEVA PHARMS INC) APPROVAL= AP YEAR= 2023 , 713 ; RISPERIDONE ; 106266-06-2 ; 1993 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- DOPAMINE ANTAGONISTS -- SEROTONIN ANTAGONISTS , ; NDA 020272 (label 20272.pdf) INN (RISPERIDONE) RISPERDAL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , NDA 020588 (label 20588.pdf) INN (RISPERIDONE) RISPERDAL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1996 , NDA 021346 (label 21346.pdf) INN (RISPERIDONE) RISPERDAL CONSTA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2003 , NDA 021444 (label 21444.pdf) INN (RISPERIDONE) RISPERDAL (JANSSEN PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076228 (label 76228.pdf) INN (RISPERIDONE) RISPERIDONE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076288 (pdf 76288.pdf not found) INN (RISPERIDONE) RISPERIDONE (DASH PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076440 (pdf 76440.pdf not found) INN (RISPERIDONE) RISPERIDONE (ANI PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076797 (pdf 76797.pdf not found) INN (RISPERIDONE) RISPERIDONE (PRECISION DOSE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076904 (pdf 76904.pdf not found) INN (RISPERIDONE) RISPERIDONE (HIKMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077416 (pdf 77416.pdf not found) INN (RISPERIDONE) RISPERIDONE (RANBAXY) APPROVAL= TA YEAR= 2006 , NDA 077769 (pdf 77769.pdf not found) INN (RISPERIDONE) RISPERIDONE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077953 (pdf 77953.pdf not found) INN (RISPERIDONE) RISPERIDONE (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 076879 (pdf 76879.pdf not found) INN (RISPERIDONE) RISPERIDONE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 077328 (label 77328.pdf) INN (RISPERIDONE) RISPERIDONE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 077494 (pdf 77494.pdf not found) INN (RISPERIDONE) RISPERIDONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 , NDA 077719 (pdf 77719.pdf not found) INN (RISPERIDONE) RISPERIDONE (PHARM ASSOC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077860 (pdf 77860.pdf not found) INN (RISPERIDONE) RISPERIDONE (WATSON LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078040 (pdf 78040.pdf not found) INN (RISPERIDONE) RISPERIDONE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2008 , NDA 078071 (pdf 78071.pdf not found) INN (RISPERIDONE) RISPERIDONE (AMNEAL) APPROVAL= AP YEAR= 2009 , NDA 078116 (pdf 78116.pdf not found) INN (RISPERIDONE) RISPERIDONE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078187 (pdf 78187.pdf not found) INN (RISPERIDONE) RISPERIDONE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078269 (pdf 78269.pdf not found) INN (RISPERIDONE) RISPERIDONE (RISING) APPROVAL= AP YEAR= 2008 , NDA 078452 (pdf 78452.pdf not found) INN (RISPERIDONE) RISPERIDONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2009 , NDA 078516 (pdf 78516.pdf not found) INN (RISPERIDONE) RISPERIDONE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2009 , NDA 078528 (pdf 78528.pdf not found) INN (RISPERIDONE) RISPERIDONE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 078707 (pdf 78707.pdf not found) INN (RISPERIDONE) RISPERIDONE (RENATA) APPROVAL= AP YEAR= 2008 , NDA 078740 (pdf 78740.pdf not found) INN (RISPERIDONE) RISPERIDONE (WEST WARD PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078744 (pdf 78744.pdf not found) INN (RISPERIDONE) RISPERIDONE (WOCKHARDT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078828 (pdf 78828.pdf not found) INN (RISPERIDONE) RISPERIDONE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078871 (pdf 78871.pdf not found) INN (RISPERIDONE) RISPERIDONE (CELLTRION) APPROVAL= AP YEAR= 2008 , NDA 078909 (pdf 78909.pdf not found) INN (RISPERIDONE) RISPERIDONE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079088 (pdf 79088.pdf not found) INN (RISPERIDONE) RISPERIDONE (TORRENT PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077542 (pdf 77542.pdf not found) INN (RISPERIDONE) RISPERIDONE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 , NDA 077784 (pdf 77784.pdf not found) INN (RISPERIDONE) RISPERIDONE (RATIOPHARM) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078474 (pdf 78474.pdf not found) INN (RISPERIDONE) RISPERIDONE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 , NDA 079158 (pdf 79158.pdf not found) INN (RISPERIDONE) RISPERIDONE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 , NDA 076996 (pdf 76996.pdf not found) INN (RISPERIDONE) RISPERIDONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077543 (pdf 77543.pdf not found) INN (RISPERIDONE) RISPERIDONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 090347 (pdf 90347.pdf not found) INN (RISPERIDONE) RISPERIDONE (TARO) APPROVAL= AP YEAR= 2011 , NDA 091384 (pdf 91384.pdf not found) INN (RISPERIDONE) RISPERIDONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091537 (pdf 91537.pdf not found) INN (RISPERIDONE) RISPERIDONE (DASH PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077493 (pdf 77493.pdf not found) INN (RISPERIDONE) RISPERIDONE (PRINSTON INC) APPROVAL= AP YEAR= 2011 , NDA 090839 (pdf 90839.pdf not found) INN (RISPERIDONE) RISPERIDONE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2011 , NDA 201003 (pdf 201003.pdf not found) INN (RISPERIDONE) RISPERIDONE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 076908 (pdf 76908.pdf not found) INN (RISPERIDONE) RISPERIDONE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 079059 (pdf 79059.pdf not found) INN (RISPERIDONE) RISPERIDONE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 078464 (pdf 78464.pdf not found) INN (RISPERIDONE) RISPERIDONE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 078036 (pdf 78036.pdf not found) INN (RISPERIDONE) RISPERIDONE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202386 (pdf 202386.pdf not found) INN (RISPERIDONE) RISPERIDONE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2015 , NDA 210655 (label 210655.pdf) INN (RISPERIDONE) PERSERIS KIT (INDIVIOR) APPROVAL= AP YEAR= 2018 , NDA 212849 (label 212849.pdf) INN (RISPERIDONE) RYKINDO (SHANDONG LUYE) APPROVAL= AP YEAR= 2023 , NDA 213586 (label 213586.pdf) INN (RISPERIDONE) UZEDY (TEVA) APPROVAL= AP YEAR= 2023 , NDA 214068 (pdf 214068.pdf not found) INN (RISPERIDONE) RISPERIDONE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2023 , NDA 214835 (pdf 214835.pdf not found) INN (RISPERIDONE) RISVAN (LABS FARMS ROVI SA) APPROVAL= AP YEAR= 2024 , 714 ; TRAMADOL ; 181289-59-8 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; NDA 020281 (label 20281.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM (JANSSEN PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 021123 (label 21123.pdf) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) ULTRACET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021692 (label 21692.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM ER (VALEANT PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021693 (label 21693.pdf) INN (TRAMADOL HYDROCHLORIDE) RYBIX ODT (SHIONOGI INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075960 (label 75960.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075962 (label 75962.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075963 (pdf 75963.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075964 (label 75964.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 , NDA 075968 (label 75968.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075974 (label 75974.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ASTA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075977 (label 75977.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075980 (pdf 75980.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075981 (pdf 75981.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075982 (pdf 75982.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075983 (label 75983.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075986 (label 75986.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076003 (label 76003.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076100 (label 76100.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076475 (pdf 76475.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076914 (pdf 76914.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077184 (pdf 77184.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2005 , NDA 077858 (pdf 77858.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2008 , NDA 021745 (label 21745.pdf) INN (TRAMADOL HYDROCHLORIDE) RYZOLT (PURDUE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022370 (label 22370.pdf) INN (TRAMADOL HYDROCHLORIDE) CONZIP (CIPHER PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 078783 (pdf 78783.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090485 (pdf 90485.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078935 (pdf 78935.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090404 (pdf 90404.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 091607 (pdf 91607.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200503 (pdf 200503.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 201384 (pdf 201384.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 202075 (pdf 202075.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 090460 (pdf 90460.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 091609 (pdf 91609.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200491 (pdf 200491.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201952 (pdf 201952.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2012 , NDA 201973 (pdf 201973.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202076 (pdf 202076.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091498 (pdf 91498.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (CSPC OUYI PHARM CO) APPROVAL= AP YEAR= 2013 , NDA 202390 (pdf 202390.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078778 (pdf 78778.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203494 (pdf 203494.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 205702 (pdf 205702.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204421 (label 204421.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205257 (pdf 205257.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206885 (pdf 206885.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207152 (pdf 207152.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206706 (pdf 206706.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MERRO PHARM USA) APPROVAL= AP YEAR= 2019 , NDA 208708 (pdf 208708.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 211825 (pdf 211825.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 214044 (label 214044.pdf) INN (TRAMADOL HYDROCHLORIDE) QDOLO (ATHENA) APPROVAL= AP YEAR= 2020 , NDA 213426 (label 213426.pdf) INN (CELECOXIB TRAMADOL HYDROCHLORIDE) SEGLENTIS (KOWA PHARMS) APPROVAL= AP YEAR= 2021 , 715 ; CARVEDILOL ; 72956-09-3 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- VASODILATOR AGENTS , ; NDA 020297 (label 20297.pdf) INN (CARVEDILOL) COREG (WAYLIS THERAP) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 022012 (label 22012.pdf) INN (CARVEDILOL PHOSPHATE) COREG CR (WAYLIS THERAP) APPROVAL= AP YEAR= 2006 , NDA 076373 (pdf 76373.pdf not found) INN (CARVEDILOL) CARVEDILOL (TEVA) APPROVAL= AP YEAR= 2007 , NDA 076649 (pdf 76649.pdf not found) INN (CARVEDILOL) CARVEDILOL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 076989 (pdf 76989.pdf not found) INN (CARVEDILOL) CARVEDILOL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077316 (pdf 77316.pdf not found) INN (CARVEDILOL) CARVEDILOL (MYLAN) APPROVAL= AP YEAR= 2007 , NDA 077346 (label 77346.pdf) INN (CARVEDILOL) CARVEDILOL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077474 (pdf 77474.pdf not found) INN (CARVEDILOL) CARVEDILOL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 , NDA 077614 (pdf 77614.pdf not found) INN (CARVEDILOL) CARVEDILOL (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2007 , NDA 077780 (pdf 77780.pdf not found) INN (CARVEDILOL) CARVEDILOL (TARO) APPROVAL= AP YEAR= 2007 , NDA 077887 (pdf 77887.pdf not found) INN (CARVEDILOL) CARVEDILOL (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078165 (pdf 78165.pdf not found) INN (CARVEDILOL) CARVEDILOL (RUBICON) APPROVAL= AP YEAR= 2007 , NDA 078217 (pdf 78217.pdf not found) INN (CARVEDILOL) CARVEDILOL (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 078227 (pdf 78227.pdf not found) INN (CARVEDILOL) CARVEDILOL (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 078240 (pdf 78240.pdf not found) INN (CARVEDILOL) CARVEDILOL (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078251 (pdf 78251.pdf not found) INN (CARVEDILOL) CARVEDILOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078332 (pdf 78332.pdf not found) INN (CARVEDILOL) CARVEDILOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078384 (pdf 78384.pdf not found) INN (CARVEDILOL) CARVEDILOL (BEXIMCO USA) APPROVAL= AP YEAR= 2007 , NDA 078786 (pdf 78786.pdf not found) INN (CARVEDILOL) CARVEDILOL (ACI) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090132 (pdf 90132.pdf not found) INN (CARVEDILOL PHOSPHATE) CARVEDILOL PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2017 , NDA 204717 (pdf 204717.pdf not found) INN (CARVEDILOL PHOSPHATE) CARVEDILOL PHOSPHATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2018 , 716 ; MOEXIPRIL ; 103775-10-6 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN CONVERTING ENZYME INHIBITORS , ; NDA 020312 (label 20312.pdf) INN (MOEXIPRIL HYDROCHLORIDE) UNIVASC (UCB INC) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 020729 (label 20729.pdf) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) UNIRETIC (UCB INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 076204 (pdf 76204.pdf not found) INN (MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076980 (pdf 76980.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2007 , NDA 077536 (pdf 77536.pdf not found) INN (MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2006 , NDA 078454 (pdf 78454.pdf not found) INN (MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 090096 (pdf 90096.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090416 (pdf 90416.pdf not found) INN (MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090718 (pdf 90718.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS) APPROVAL= AP YEAR= 2010 , NDA 202150 (pdf 202150.pdf not found) INN (HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE) MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , 717 ; ANAGRELIDE ; 68475-42-3 ; 1997 ; ; ; CLASS ANTINEOPLASTIC -- REDUCES BLOOD PLATELET COUNT -- TREATMENT OF ESSENTIAL-THROMBOCYTHAEMIA (ET) , ; NDA 020333 (label 20333.pdf) INN (ANAGRELIDE HYDROCHLORIDE) AGRYLIN (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 076417 (pdf 76417.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076468 (pdf 76468.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076489 (pdf 76489.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076530 (pdf 76530.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076683 (pdf 76683.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076811 (pdf 76811.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076910 (pdf 76910.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2005 , NDA 077613 (pdf 77613.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 209151 (pdf 209151.pdf not found) INN (ANAGRELIDE HYDROCHLORIDE) ANAGRELIDE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2017 , 718 ; ADAPALENE ; 106685-40-9 ; 1996 ; ; ; CLASS DERMATOLOGICALS -- ANTI-ACNE -- RETINOIDS -- RETINOIC ACID RECEPTOR AGONIST , ; NDA 020338 (pdf 20338.pdf not found) INN (ADAPALENE) DIFFERIN (GALDERMA LABS LP) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020380 (label 20380.pdf) INN (ADAPALENE) DIFFERIN (GALDERMA LABS LP) APPROVAL= AP YEAR= 1996 , NDA 020748 (label 20748.pdf) INN (ADAPALENE) DIFFERIN (GALDERMA LABS LP) APPROVAL= AP YEAR= 2000 , NDA 021753 (label 21753.pdf) INN (ADAPALENE) DIFFERIN (GALDERMA LABS LP) APPROVAL= AP YEAR= 2007 , NDA 022320 (label 22320.pdf) INN (ADAPALENE BENZOYL PEROXIDE) EPIDUO (GALDERMA LABS LP) APPROVAL= AP YEAR= 2008 , NDA 022502 (label 22502.pdf) INN (ADAPALENE) DIFFERIN (GALDERMA LABS LP) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090824 (pdf 90824.pdf not found) INN (ADAPALENE) ADAPALENE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090962 (pdf 90962.pdf not found) INN (ADAPALENE) ADAPALENE (P AND L) APPROVAL= AP YEAR= 2010 , NDA 091314 (pdf 91314.pdf not found) INN (ADAPALENE) ADAPALENE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 200298 (pdf 200298.pdf not found) INN (ADAPALENE) ADAPALENE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2012 , NDA 201000 (pdf 201000.pdf not found) INN (ADAPALENE) ADAPALENE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2014 , NDA 203790 (pdf 203790.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207917 (label 207917.pdf) INN (ADAPALENE BENZOYL PEROXIDE) EPIDUO FORTE (GALDERMA LABS) APPROVAL= AP YEAR= 2015 , NDA 204593 (pdf 204593.pdf not found) INN (ADAPALENE) ADAPALENE (CALL INC) APPROVAL= AP YEAR= 2016 , NDA 208108 (pdf 208108.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 208322 (pdf 208322.pdf not found) INN (ADAPALENE) ADAPALENE (TARO) APPROVAL= AP YEAR= 2016 , NDA 203981 (pdf 203981.pdf not found) INN (ADAPALENE) ADAPALENE (CALL INC) APPROVAL= AP YEAR= 2016 , NDA 205033 (pdf 205033.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2018 , NDA 206959 (pdf 206959.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 206164 (pdf 206164.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2018 , NDA 209148 (pdf 209148.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 212464 (pdf 212464.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2022 , NDA 213508 (pdf 213508.pdf not found) INN (ADAPALENE) ADAPALENE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 209641 (pdf 209641.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2022 , NDA 214553 (pdf 214553.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215940 (pdf 215940.pdf not found) INN (ADAPALENE) ADAPALENE (TARO) APPROVAL= AP YEAR= 2022 , NDA 214185 (pdf 214185.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216632 (pdf 216632.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CABTREO (BAUSCH) APPROVAL= AP YEAR= 2023 , 719 ; MIRTAZAPINE ; 61337-67-5 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC ALPHA ANTAGONISTS -- HISTAMINE H1 ANTAGONISTS -- 5-HYDROXYTRYPTAMINE RECEPTOR ANTAGONIST , ; NDA 020415 (label 20415.pdf) INN (MIRTAZAPINE) REMERON (ORGANON) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021208 (label 21208.pdf) INN (MIRTAZAPINE) REMERON SOLTAB (ORGANON USA ORGANON) APPROVAL= AP YEAR= 2001 , NDA 076119 (pdf 76119.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076122 (pdf 76122.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 076176 (pdf 76176.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076189 (pdf 76189.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076219 (pdf 76219.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 , NDA 076241 (pdf 76241.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076244 (pdf 76244.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076270 (pdf 76270.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ROXANE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076307 (pdf 76307.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076308 (pdf 76308.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076312 (pdf 76312.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (WATSON LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076336 (pdf 76336.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076541 (pdf 76541.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2004 , NDA 076689 (pdf 76689.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076901 (pdf 76901.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (IMPAX LABS INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076921 (pdf 76921.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (AUROBINDO) APPROVAL= AP YEAR= 2004 , NDA 077376 (pdf 77376.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2005 , NDA 077666 (pdf 77666.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 077959 (pdf 77959.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 205798 (pdf 205798.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (SQUARE PHARMS) APPROVAL= AP YEAR= 2017 , NDA 216751 (pdf 216751.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (PRASCO) APPROVAL= AP YEAR= 2023 , 720 ; NISOLDIPINE ; 63675-72-9 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- CORONARY VASODILATOR -- ANTIANGINAL -- ANTIHYPERTENSIVE AGENTS -- CALCIUM CHANNEL BLOCKERS , ; NDA 020356 (label 20356.pdf) INN (NISOLDIPINE) SULAR (COVIS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 079051 (pdf 79051.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (MYLAN) APPROVAL= AP YEAR= 2008 , NDA 091001 (pdf 91001.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (MYLAN) APPROVAL= AP YEAR= 2011 , NDA 216606 (pdf 216606.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (AMTA) APPROVAL= AP YEAR= 2023 , 721 ; METFORMIN ; 657-24-9 ; 1995 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- MITOCHONDRIAL ACTIVITY -- INHIBITOR OF CHLORIDE INTRACELLULAR CHANNEL-1 (CLIC1) (PMID25361004) , ; NDA 020357 (label 20357.pdf) INN (METFORMIN HYDROCHLORIDE) GLUCOPHAGE (EMD SERONO INC) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 021178 (label 21178.pdf) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLUCOVANCE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021202 (label 21202.pdf) INN (METFORMIN HYDROCHLORIDE) GLUCOPHAGE XR (EMD SERONO INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021410 (label 21410.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) AVANDAMET (SB PHARMCO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021460 (label 21460.pdf) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) METAGLIP (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021574 (label 21574.pdf) INN (METFORMIN HYDROCHLORIDE) FORTAMET (ANDRX LABS LLC) APPROVAL= AP YEAR= 2004 , NDA 021591 (label 21591.pdf) INN (METFORMIN HYDROCHLORIDE) RIOMET (RANBAXY) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021748 (label 21748.pdf) INN (METFORMIN HYDROCHLORIDE) GLUMETZA (SANTARUS INC) APPROVAL= AP YEAR= 2005 , NDA 021842 (label 21842.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 022044 (label 22044.pdf) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) JANUMET (MSD SUB MERCK) APPROVAL= AP YEAR= 2007 , NDA 022386 (label 22386.pdf) INN (METFORMIN HYDROCHLORIDE REPAGLINIDE) PRANDIMET (NOVO NORDISK INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 075961 (pdf 75961.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075965 (pdf 75965.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 075967 (pdf 75967.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075969 (pdf 75969.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075971 (pdf 75971.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075972 (pdf 75972.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2002 , NDA 075973 (pdf 75973.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 , NDA 075975 (pdf 75975.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075976 (pdf 75976.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075978 (pdf 75978.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075979 (pdf 75979.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075984 (pdf 75984.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075985 (pdf 75985.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076033 (pdf 76033.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ATLAS PHARMS LLC) APPROVAL= AP YEAR= 2002 , NDA 076038 (pdf 76038.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076172 (pdf 76172.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076223 (pdf 76223.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076249 (pdf 76249.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076269 (pdf 76269.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2004 , NDA 076328 (pdf 76328.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076345 (pdf 76345.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2004 , NDA 076413 (pdf 76413.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2003 , NDA 076450 (pdf 76450.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076496 (pdf 76496.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076545 (pdf 76545.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076650 (pdf 76650.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076706 (pdf 76706.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076716 (pdf 76716.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2005 , NDA 076731 (pdf 76731.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076756 (pdf 76756.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (NOSTRUM PHARMS LLC) APPROVAL= AP YEAR= 2006 , NDA 076818 (pdf 76818.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076821 (pdf 76821.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076863 (pdf 76863.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076864 (pdf 76864.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2005 , NDA 076869 (pdf 76869.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2005 , NDA 076873 (pdf 76873.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2004 , NDA 076878 (pdf 76878.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076985 (pdf 76985.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077060 (pdf 77060.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2005 , NDA 077064 (pdf 77064.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 077078 (pdf 77078.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2005 , NDA 077095 (pdf 77095.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AUROBINDO) APPROVAL= AP YEAR= 2005 , NDA 077113 (pdf 77113.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077124 (pdf 77124.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077211 (pdf 77211.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077270 (pdf 77270.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077336 (pdf 77336.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2006 , NDA 077337 (label 77337.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 077507 (pdf 77507.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 , NDA 077620 (pdf 77620.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077711 (pdf 77711.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077787 (pdf 77787.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077853 (pdf 77853.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (PROVIDENT PHARM) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077870 (pdf 77870.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077880 (pdf 77880.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 078083 (pdf 78083.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (DASH PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078170 (pdf 78170.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2008 , NDA 078321 (pdf 78321.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (CSPC OUYI) APPROVAL= AP YEAR= 2008 , NDA 078422 (pdf 78422.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078596 (pdf 78596.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 , NDA 022024 (label 22024.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET XR (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079009 (pdf 79009.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079148 (pdf 79148.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (INDICUS PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079226 (pdf 79226.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090014 (pdf 90014.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090564 (pdf 90564.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (GRANULES INDIA) APPROVAL= AP YEAR= 2010 , NDA 078728 (pdf 78728.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091184 (pdf 91184.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ALKEM) APPROVAL= AP YEAR= 2010 , NDA 200678 (label 200678.pdf) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) KOMBIGLYZE XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078905 (pdf 78905.pdf not found) INN (GLIPIZIDE METFORMIN HYDROCHLORIDE) GLIPIZIDE AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 090406 (pdf 90406.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090692 (pdf 90692.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 090666 (pdf 90666.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 200690 (pdf 200690.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 091664 (label 91664.pdf) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 201281 (label 201281.pdf) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) JENTADUETO (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2012 , NDA 201991 (pdf 201991.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (INVENTIA) APPROVAL= AP YEAR= 2012 , NDA 202270 (label 202270.pdf) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) JANUMET XR (MSD SUB MERCK) APPROVAL= AP YEAR= 2012 , NDA 091155 (pdf 91155.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 079118 (pdf 79118.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090888 (pdf 90888.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2012 , NDA 200624 (pdf 200624.pdf not found) INN (METFORMIN HYDROCHLORIDE REPAGLINIDE) REPAGLINIDE AND METFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200823 (pdf 200823.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 202001 (pdf 202001.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091273 (pdf 91273.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202388 (pdf 202388.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN METFORMIN HYDROCHLORIDE (SANDOZ INC) APPROVAL= TA YEAR= 2013 , NDA 202917 (pdf 202917.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 203414 (label 203414.pdf) INN (ALOGLIPTIN BENZOATE METFORMIN HYDROCHLORIDE) KAZANO (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 203769 (pdf 203769.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 202426 (pdf 202426.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN METFORMIN HYDROCHLORIDE (APOTEX INC) APPROVAL= TA YEAR= 2014 , NDA 203686 (pdf 203686.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ZYDUS HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 204353 (label 204353.pdf) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) INVOKAMET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2014 , NDA 205649 (label 205649.pdf) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE) XIGDUO XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2014 , NDA 204144 (pdf 204144.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE (ANCHEN PHARMS) APPROVAL= TA YEAR= 2015 , NDA 202365 (pdf 202365.pdf not found) INN (SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE) SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2015 , NDA 204591 (pdf 204591.pdf not found) INN (SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE) SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2015 , NDA 204802 (pdf 204802.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 206111 (label 206111.pdf) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) SYNJARDY (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , NDA 090295 (pdf 90295.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205942 (pdf 205942.pdf not found) INN (SAXAGLIPTIN METFORMIN HYDROCHLORIDE) SAXAGLIPTINMETFORMIN HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= TA YEAR= 2016 , NDA 206748 (pdf 206748.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 208026 (label 208026.pdf) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) JENTADUETO XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2016 , NDA 203755 (pdf 203755.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 205096 (pdf 205096.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (CSPC OUYI) APPROVAL= AP YEAR= 2016 , NDA 205879 (label 205879.pdf) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) INVOKAMET XR (JANSSEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206955 (pdf 206955.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207427 (pdf 207427.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 208658 (label 208658.pdf) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) SYNJARDY XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2016 , NDA 202306 (pdf 202306.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2017 , NDA 203832 (pdf 203832.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 205330 (pdf 205330.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208535 (pdf 208535.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2017 , NDA 209806 (label 209806.pdf) INN (ERTUGLIFLOZIN METFORMIN HYDROCHLORIDE) SEGLUROMET (MSD SUB MERCK) APPROVAL= AP YEAR= 2017 , NDA 209303 (pdf 209303.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ALIGNSCIENCE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209313 (pdf 209313.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 206145 (pdf 206145.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 208430 (pdf 208430.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN METFORMIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2018 , NDA 208449 (pdf 208449.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 208880 (pdf 208880.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 208999 (pdf 208999.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209674 (pdf 209674.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 209882 (pdf 209882.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (LAURUS) APPROVAL= AP YEAR= 2018 , NDA 209993 (pdf 209993.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (QINGDAO BAHEAL PHARM) APPROVAL= AP YEAR= 2018 , NDA 210160 (pdf 210160.pdf not found) INN (ALOGLIPTIN METFORMIN HYDROCHLORIDE) ALOGLIPTIN METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2018 , NDA 211052 (pdf 211052.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 210874 (label 210874.pdf) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) QTERNMET XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210212 (pdf 210212.pdf not found) INN (ALOGLIPTIN METFORMIN HYDROCHLORIDE) ALOGLIPTIN AND METFORMIN HYDROCHLORIDE (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2019 , NDA 212595 (label 212595.pdf) INN (METFORMIN HYDROCHLORIDE) RIOMET ER (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212969 (pdf 212969.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 208454 (pdf 208454.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2020 , NDA 211309 (pdf 211309.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 212614 (label 212614.pdf) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) TRIJARDY XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2020 , NDA 213651 (pdf 213651.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211479 (pdf 211479.pdf not found) INN (METFORMIN HYDROCHLORIDE) DAPAGLIFLOZIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 212198 (pdf 212198.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 208427 (pdf 208427.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 213334 (pdf 213334.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 213344 (pdf 213344.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 213654 (pdf 213654.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZINMETFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= TA YEAR= 2021 , NDA 213962 (pdf 213962.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 208336 (pdf 208336.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUNSHINE) APPROVAL= AP YEAR= 2021 , NDA 213247 (pdf 213247.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213320 (pdf 213320.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (HARMAN FINOCHEM) APPROVAL= AP YEAR= 2021 , NDA 213356 (pdf 213356.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 213359 (pdf 213359.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2021 , NDA 213394 (pdf 213394.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (AMTA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 208473 (pdf 208473.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , NDA 212681 (pdf 212681.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 214629 (pdf 214629.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 215220 (pdf 215220.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= TA YEAR= 2022 , NDA 211583 (pdf 211583.pdf not found) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE) DAPAGLIFLOZINMETFORMIN HYDROCHLORIDE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2022 , NDA 212677 (pdf 212677.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (VISTAPHARM) APPROVAL= AP YEAR= 2022 , NDA 210542 (pdf 210542.pdf not found) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) CANAGLIFLOZIN METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2023 , NDA 212362 (pdf 212362.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , NDA 212448 (pdf 212448.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 215629 (pdf 215629.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (RK PHARMA) APPROVAL= AP YEAR= 2023 , NDA 205981 (pdf 205981.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2023 , NDA 206081 (pdf 206081.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 207678 (pdf 207678.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2023 , NDA 216743 (pdf 216743.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN) ZITUVIMET (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 217631 (pdf 217631.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (LAURUS) APPROVAL= AP YEAR= 2023 , NDA 211163 (pdf 211163.pdf not found) INN (METFORMIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 217049 (pdf 217049.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2024 , 722 ; FAMCICLOVIR ; 104227-87-4 ; 1994 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- DNA POLYMERASE INHIBITOR -- PRODRUG OF PENCICLOVIR -- TREATMENT OF HERPES VIRUS HSV-1 AND HSV-2 , ; NDA 020363 (label 20363.pdf) INN (FAMCICLOVIR) FAMVIR (NOVARTIS) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 077487 (pdf 77487.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (TEVA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 090128 (pdf 90128.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078278 (pdf 78278.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (CIPLA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091114 (pdf 91114.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 201333 (pdf 201333.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091480 (pdf 91480.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 201022 (pdf 201022.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202438 (pdf 202438.pdf not found) INN (FAMCICLOVIR) FAMCICLOVIR (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , 723 ; LOSARTAN ; 114798-26-4 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE-- ANGIOTENSIN II RECEPTOR ANTAGONIST -- ANTI-ARRHYTHMIA AGENTS , ; NDA 020386 (label 20386.pdf) INN (LOSARTAN POTASSIUM) COZAAR (ORGANON) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 020387 (label 20387.pdf) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) HYZAAR (ORGANON) APPROVAL= AP YEAR= 1995 , NDA 076958 (pdf 76958.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (TEVA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077157 (pdf 77157.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 077424 (pdf 77424.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2010 , NDA 077459 (pdf 77459.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077732 (pdf 77732.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077948 (pdf 77948.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 078243 (pdf 78243.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 078385 (pdf 78385.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 090083 (pdf 90083.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090150 (pdf 90150.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (APOTEX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090467 (pdf 90467.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (TORRENT PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090528 (pdf 90528.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090544 (pdf 90544.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (AIPING PHARM INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091652 (pdf 91652.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078232 (pdf 78232.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 078245 (pdf 78245.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 090382 (pdf 90382.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090428 (pdf 90428.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090790 (pdf 90790.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (APOTEX CORP) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091129 (pdf 91129.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 091590 (pdf 91590.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091629 (pdf 91629.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 091497 (pdf 91497.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (PRINSTON INC) APPROVAL= AP YEAR= 2011 , NDA 200180 (label 200180.pdf) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091541 (pdf 91541.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (MICRO LABS) APPROVAL= AP YEAR= 2012 , NDA 091617 (pdf 91617.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201170 (pdf 201170.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (JUBILANT CADISTA) APPROVAL= AP YEAR= 2012 , NDA 201845 (pdf 201845.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2012 , NDA 202230 (pdf 202230.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202289 (pdf 202289.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 200290 (pdf 200290.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (IPCA LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 201682 (pdf 201682.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 203030 (pdf 203030.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (UNICHEM) APPROVAL= AP YEAR= 2015 , NDA 203835 (pdf 203835.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 204832 (pdf 204832.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2017 , NDA 204901 (pdf 204901.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 204795 (pdf 204795.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 215959 (pdf 215959.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217396 (pdf 217396.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (MSN) APPROVAL= AP YEAR= 2023 , NDA 218015 (pdf 218015.pdf not found) INN (HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM) LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (GRANULES) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 218551 (pdf 218551.pdf not found) INN (LOSARTAN POTASSIUM) LOSARTAN POTASSIUM (APOTEX) APPROVAL= AP YEAR= 2024 , 724 ; VINORELBINE ; 71486-22-1 ; 1994 ; ; ; CLASS ANTINEOPLASTIC -- INTERFERES WITH MICROTUBULE ASSEMBLY , ; NDA 020388 (label 20388.pdf) INN (VINORELBINE TARTRATE) NAVELBINE (PIERRE FABRE) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 075992 (pdf 75992.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076028 (pdf 76028.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076461 (pdf 76461.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076827 (pdf 76827.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076849 (pdf 76849.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078408 (pdf 78408.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (EBEWE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078011 (pdf 78011.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2009 , NDA 091106 (pdf 91106.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2012 , NDA 200148 (pdf 200148.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202017 (pdf 202017.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 208997 (pdf 208997.pdf not found) INN (VINORELBINE TARTRATE) VINORELBINE TARTRATE (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , 725 ; TIZANIDINE ; 51322-75-9 ; 1996 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ADRENERGIC ALPHA-AGONISTS -- ANTIHYPERTENSIVE , ; NDA 020397 (label 20397.pdf) INN (TIZANIDINE HYDROCHLORIDE) ZANAFLEX (LEGACY PHARMA USA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021447 (label 21447.pdf) INN (TIZANIDINE HYDROCHLORIDE) ZANAFLEX (LEGACY PHARMA USA) APPROVAL= AP YEAR= 2002 , NDA 076280 (pdf 76280.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076281 (pdf 76281.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2003 , NDA 076282 (pdf 76282.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076283 (pdf 76283.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076284 (pdf 76284.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076286 (pdf 76286.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2002 , NDA 076321 (pdf 76321.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076347 (pdf 76347.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 076354 (pdf 76354.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076371 (pdf 76371.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076399 (pdf 76399.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2002 OBSOLETE , NDA 076416 (pdf 76416.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2003 , NDA 076533 (pdf 76533.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2004 , NDA 078868 (pdf 78868.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 091283 (pdf 91283.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (UNICHEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091502 (pdf 91502.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 207170 (pdf 207170.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207199 (pdf 207199.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208622 (pdf 208622.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209605 (pdf 209605.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 , NDA 208187 (pdf 208187.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (CADILA) APPROVAL= AP YEAR= 2018 , NDA 210021 (pdf 210021.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 210267 (pdf 210267.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 211798 (pdf 211798.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 212196 (pdf 212196.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 213223 (pdf 213223.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 213544 (pdf 213544.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213798 (pdf 213798.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2020 , NDA 213365 (pdf 213365.pdf not found) INN (TIZANIDINE HYDROCHLORIDE) TIZANIDINE HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2024 , 726 ; LANSOPRAZOLE ; 103577-45-3 ; 1995 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- GASTRIC ACID PROTON-PUMP INHIBITORS , ; NDA 020406 (label 20406.pdf) INN (LANSOPRAZOLE) PREVACID (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 021281 (label 21281.pdf) INN (LANSOPRAZOLE) PREVACID (TAKEDA PHARMS NA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021428 (label 21428.pdf) INN (LANSOPRAZOLE) PREVACID (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2002 , NDA 021507 (label 21507.pdf) INN (LANSOPRAZOLE NAPROXEN) PREVACID NAPRAPAC 250 COPACKAGED (TAKEDA PHARMS NA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021566 (label 21566.pdf) INN (LANSOPRAZOLE) PREVACID IV (TAKEDA PHARMS NA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 050757 (label 50757.pdf) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) PREVPAC COPACKAGED (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 077255 (pdf 77255.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (TEVA PHARMS) APPROVAL= AP YEAR= 2009 , NDA 022327 (label 22327.pdf) INN (LANSOPRAZOLE) PREVACID 24 HR (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2009 , NDA 090331 (pdf 90331.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 090763 (pdf 90763.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2009 , NDA 078730 (pdf 78730.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091269 (pdf 91269.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 022287 (label 22287.pdf) INN (DEXLANSOPRAZOLE) DEXILANT (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 , NDA 091212 (pdf 91212.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (KRKA TOVARNA ZDRAVIL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201921 (pdf 201921.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202176 (pdf 202176.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (WOCKHARDT) APPROVAL= AP YEAR= 2012 , NDA 202194 (pdf 202194.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202319 (pdf 202319.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (PERRIGO R AND D) APPROVAL= AP YEAR= 2012 , NDA 202727 (pdf 202727.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 091509 (pdf 91509.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200218 (pdf 200218.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (ANI PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202366 (pdf 202366.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (ZYDUS HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 202637 (pdf 202637.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202588 (pdf 202588.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 202294 (label 202294.pdf) INN (DEXLANSOPRAZOLE) DEXLANSOPRAZOLE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 203187 (pdf 203187.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203306 (pdf 203306.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (NATCO) APPROVAL= AP YEAR= 2016 , NDA 208025 (label 208025.pdf) INN (LANSOPRAZOLE) LANSOPRAZOLE (DEXCEL) APPROVAL= AP YEAR= 2016 , NDA 208056 (label 208056.pdf) INN (DEXLANSOPRAZOLE) DEXILANT SOLUTAB (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203203 (pdf 203203.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (XIROMED) APPROVAL= AP YEAR= 2016 , NDA 203957 (pdf 203957.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206006 (pdf 206006.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (RISING) APPROVAL= AP YEAR= 2016 , NDA 205868 (pdf 205868.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (INVENTIA) APPROVAL= AP YEAR= 2017 , NDA 207156 (pdf 207156.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2017 , NDA 207157 (pdf 207157.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208784 (pdf 208784.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 200816 (pdf 200816.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 202396 (pdf 202396.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 203964 (pdf 203964.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207394 (pdf 207394.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 203083 (pdf 203083.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 210465 (pdf 210465.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 207167 (pdf 207167.pdf not found) INN (LANSOPRAZOLE) LANSOPRAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 202666 (pdf 202666.pdf not found) INN (DEXLANSOPRAZOLE) DEXLANSOPRAZOLE (TWI PHARMS) APPROVAL= AP YEAR= 2022 , NDA 205205 (pdf 205205.pdf not found) INN (DEXLANSOPRAZOLE) DEXLANSOPRAZOLE (MYLAN) APPROVAL= AP YEAR= 2024 , 727 ; DORZOLAMIDE ; 120279-96-1 ; 1994 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ANTIHYPERTENSIVE AGENTS -- CARBONIC ANHYDRASE INHIBITORS , ; NDA 020408 (label 20408.pdf) INN (DORZOLAMIDE HYDROCHLORIDE) TRUSOPT (MSD SUB MERCK) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020869 (label 20869.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) COSOPT (THEA PHARMA) APPROVAL= AP YEAR= 1998 , NDA 077847 (pdf 77847.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (AKORN) APPROVAL= AP YEAR= 2008 , NDA 078201 (pdf 78201.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (RUBICON) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078395 (pdf 78395.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2008 , NDA 077846 (pdf 77846.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078704 (pdf 78704.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (TEVA PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078748 (pdf 78748.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078749 (pdf 78749.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078756 (pdf 78756.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078981 (pdf 78981.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 079186 (pdf 79186.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090037 (pdf 90037.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2009 , NDA 090143 (pdf 90143.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2009 , NDA 090604 (pdf 90604.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 202667 (label 202667.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) COSOPT PF (THEA PHARMA) APPROVAL= AP YEAR= 2012 , NDA 091034 (pdf 91034.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (ZAMBON SPA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091180 (pdf 91180.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (ZAMBON SPA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201998 (pdf 201998.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202053 (label 202053.pdf) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (INDOCO) APPROVAL= AP YEAR= 2014 , NDA 202054 (pdf 202054.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (INDOCO) APPROVAL= AP YEAR= 2014 , NDA 203058 (label 203058.pdf) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (AKORN) APPROVAL= AP YEAR= 2014 , NDA 207630 (pdf 207630.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 205294 (pdf 205294.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (FDC LTD) APPROVAL= AP YEAR= 2019 , NDA 204778 (pdf 204778.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 205295 (pdf 205295.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (FDC LTD) APPROVAL= AP YEAR= 2019 , NDA 207523 (pdf 207523.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (SOMERSET) APPROVAL= AP YEAR= 2019 , NDA 212639 (pdf 212639.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 204777 (pdf 204777.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 207629 (pdf 207629.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213099 (pdf 213099.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 215660 (pdf 215660.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE) DORZOLAMIDE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215936 (pdf 215936.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 215520 (pdf 215520.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 217260 (pdf 217260.pdf not found) INN (DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE) DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2023 , 728 ; STAVUDINE ; 3056-17-5 ; 1994 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV AGENTS -- ANTIMETABOLITES -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS , ; NDA 020412 (label 20412.pdf) INN (STAVUDINE) ZERIT (BRISTOL) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020413 (label 20413.pdf) INN (STAVUDINE) ZERIT (BRISTOL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 021453 (label 21453.pdf) INN (STAVUDINE) ZERIT XR (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021837 (pdf 21837.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ARCOLAB) APPROVAL= TA YEAR= 2008 , NDA 021838 (pdf 21838.pdf not found) INN (STAVUDINE LAMIVUDINE) STAVUDINE LAMIVUDINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 021969 (pdf 21969.pdf not found) INN (LAMIVUDINE STAVUDINE NEVIRAPINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2006 , NDA 021972 (pdf 21972.pdf not found) INN (STAVUDINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 OBSOLETE , NDA 021974 (pdf 21974.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE STAVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 022085 (pdf 22085.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE STAVUDINE (MATRIX LABS) APPROVAL= TA YEAR= 2007 , NDA 022097 (pdf 22097.pdf not found) INN (STAVUDINE LAMIVUDINE EFAVIRENZ) STAVUDINE LAMIVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022167 (pdf 22167.pdf not found) INN (STAVUDINE) LAMIVUDINE STAVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022177 (pdf 22177.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2008 , NDA 077672 (label 77672.pdf) INN (STAVUDINE) STAVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077774 (pdf 77774.pdf not found) INN (STAVUDINE) STAVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078030 (pdf 78030.pdf not found) INN (STAVUDINE) STAVUDINE (CIPLA LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078256 (pdf 78256.pdf not found) INN (STAVUDINE) STAVUDINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2006 , NDA 078587 (pdf 78587.pdf not found) INN (STAVUDINE) STAVUDINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2007 , NDA 078775 (pdf 78775.pdf not found) INN (STAVUDINE) STAVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078957 (pdf 78957.pdf not found) INN (STAVUDINE) STAVUDINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 021854 (pdf 21854.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE W/NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022342 (pdf 22342.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2009 , NDA 022346 (pdf 22346.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (PHARMACARE LTD) APPROVAL= TA YEAR= 2009 , NDA 022347 (pdf 22347.pdf not found) INN (STAVUDINE LAMIVUDINE) STAVUDINE LAMIVUDINE (PHARMACARE LTD) APPROVAL= TA YEAR= 2009 , NDA 079069 (pdf 79069.pdf not found) INN (STAVUDINE) STAVUDINE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022479 (pdf 22479.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE AND STAVUDINE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2010 , NDA 022537 (pdf 22537.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (MACLEODS PHARMA) APPROVAL= TA YEAR= 2010 , NDA 022541 (pdf 22541.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE AND STAVUDINE (MACLEODS PHARMA) APPROVAL= TA YEAR= 2010 , NDA 200244 (pdf 200244.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2010 , 729 ; MIRTAZAPINE ; 61337-67-5 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC ALPHA ANTAGONISTS -- HISTAMINE H1 ANTAGONISTS -- 5-HYDROXYTRYPTAMINE RECEPTOR ANTAGONIST , ; NDA 020415 (label 20415.pdf) INN (MIRTAZAPINE) REMERON (ORGANON) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021208 (label 21208.pdf) INN (MIRTAZAPINE) REMERON SOLTAB (ORGANON USA ORGANON) APPROVAL= AP YEAR= 2001 , NDA 076119 (pdf 76119.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (TEVA) APPROVAL= AP YEAR= 2003 , NDA 076122 (pdf 76122.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 076176 (pdf 76176.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076189 (pdf 76189.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076219 (pdf 76219.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 , NDA 076241 (pdf 76241.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076244 (pdf 76244.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076270 (pdf 76270.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ROXANE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076307 (pdf 76307.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076308 (pdf 76308.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076312 (pdf 76312.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (WATSON LABS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076336 (pdf 76336.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076541 (pdf 76541.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2004 , NDA 076689 (pdf 76689.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076901 (pdf 76901.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (IMPAX LABS INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076921 (pdf 76921.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (AUROBINDO) APPROVAL= AP YEAR= 2004 , NDA 077376 (pdf 77376.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2005 , NDA 077666 (pdf 77666.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 077959 (pdf 77959.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 205798 (pdf 205798.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (SQUARE PHARMS) APPROVAL= AP YEAR= 2017 , NDA 216751 (pdf 216751.pdf not found) INN (MIRTAZAPINE) MIRTAZAPINE (PRASCO) APPROVAL= AP YEAR= 2023 , 730 ; ARBUTAMINE ; 128470-16-6 ; 1997 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ADRENERGIC BETA AGONIST -- CARDIOTONIC AGENTS -- AGENT FOR CARDIAC STRESS TESTING , ; NDA 020420 (pdf 20420.pdf not found) INN (ARBUTAMINE HYDROCHLORIDE) GENESA (GENSIA AUTOMEDICS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 731 ; AZELAIC ACID ; 123-99-9 ; 1995 ; ; ; CLASS DERMATOLOGICALS -- ANTIMICROBIAL -- INHIBITION OF MICROBIAL CELLULAR PROTEIN SYNTHESIS , ; NDA 020428 (label 20428.pdf) INN (AZELAIC ACID) AZELEX (ALMIRALL) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 021470 (label 21470.pdf) INN (AZELAIC ACID) FINACEA (LEO PHARMA AS) APPROVAL= AP YEAR= 2002 , NDA 207071 (label 207071.pdf) INN (AZELAIC ACID) FINACEA (LEO PHARMA AS) APPROVAL= AP YEAR= 2015 , NDA 204637 (pdf 204637.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 208011 (pdf 208011.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2018 , NDA 208724 (pdf 208724.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (ENCUBE) APPROVAL= AP YEAR= 2018 , NDA 210549 (pdf 210549.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (TARO) APPROVAL= AP YEAR= 2019 , NDA 210928 (pdf 210928.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212581 (pdf 212581.pdf not found) INN (AZELAIC ACID) AZELAIC ACID (TARO PHARM INDS LTD) APPROVAL= TA YEAR= 2021 , 732 ; EPOPROSTENOL ; 35121-78-9 ; 1995 ; ; ; CLASS BLOOD -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- ANTIHYPERTENSIVE -- PROSTANOID VASODILATATOR , ; NDA 020444 (label 20444.pdf) INN (EPOPROSTENOL SODIUM) FLOLAN (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 022260 (label 22260.pdf) INN (EPOPROSTENOL SODIUM) VELETRI (ACTELION) APPROVAL= AP YEAR= 2008 , NDA 078396 (pdf 78396.pdf not found) INN (EPOPROSTENOL SODIUM) EPOPROSTENOL SODIUM (MEITHEAL) APPROVAL= AP YEAR= 2008 , NDA 210473 (pdf 210473.pdf not found) INN (EPOPROSTENOL SODIUM) EPOPROSTENOL SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 213913 (pdf 213913.pdf not found) INN (EPOPROSTENOL SODIUM) EPOPROSTENOL SODIUM (MYLAN) APPROVAL= AP YEAR= 2024 , 733 ; DOCETAXEL ; 114977-28-5 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- STABILIZES MICROTUBULES , ; NDA 020449 (label 20449.pdf) INN (DOCETAXEL) TAXOTERE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 022234 (label 22234.pdf) INN (DOCETAXEL) DOCETAXEL (HOSPIRA INC) APPROVAL= AP YEAR= 2011 , NDA 022534 (label 22534.pdf) INN (DOCETAXEL) DOCEFREZ (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 201195 (label 201195.pdf) INN (DOCETAXEL) DOCETAXEL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 201525 (label 201525.pdf) INN (DOCETAXEL) DOCETAXEL (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 022312 (label 22312.pdf) INN (DOCETAXEL) DOCETAXEL (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203551 (label 203551.pdf) INN (DOCETAXEL) DOCETAXEL (ACTAVIS) APPROVAL= AP YEAR= 2013 , NDA 202356 (label 202356.pdf) INN (DOCETAXEL) DOCETAXEL (PFIZER LABS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204193 (pdf 204193.pdf not found) INN (DOCETAXEL) DOCETAXEL (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 203877 (pdf 203877.pdf not found) INN (DOCETAXEL) DOCETAXEL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205934 (label 205934.pdf) INN (DOCETAXEL) DOCETAXEL (SHILPA) APPROVAL= AP YEAR= 2015 , NDA 203170 (pdf 203170.pdf not found) INN (DOCETAXEL) DOCETAXEL (HENGRUI PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206177 (pdf 206177.pdf not found) INN (DOCETAXEL) DOCETAXEL (DFB ONCOLOGY LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207252 (pdf 207252.pdf not found) INN (DOCETAXEL) DOCETAXEL (HENGRUI PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207563 (pdf 207563.pdf not found) INN (DOCETAXEL) DOCETAXEL (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 208859 (pdf 208859.pdf not found) INN (DOCETAXEL) DOCETAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 209640 (pdf 209640.pdf not found) INN (DOCETAXEL) DOCETAXEL (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 209634 (pdf 209634.pdf not found) INN (DOCETAXEL) DOCETAXEL (MEITHEAL) APPROVAL= AP YEAR= 2018 , NDA 210072 (pdf 210072.pdf not found) INN (DOCETAXEL) DOCETAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 210848 (pdf 210848.pdf not found) INN (DOCETAXEL) DOCETAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 208137 (pdf 208137.pdf not found) INN (DOCETAXEL) DOCETAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210327 (pdf 210327.pdf not found) INN (DOCETAXEL) DOCETAXEL (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 204490 (pdf 204490.pdf not found) INN (DOCETAXEL) DOCETAXEL (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 213510 (pdf 213510.pdf not found) INN (DOCETAXEL) DOCETAXEL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214575 (pdf 214575.pdf not found) INN (DOCETAXEL) DOCETAXEL (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215813 (label 215813.pdf) INN (DOCETAXEL) DOCIVYX (AVYXA HOLDINGS) APPROVAL= AP YEAR= 2022 , NDA 203892 (pdf 203892.pdf not found) INN (DOCETAXEL) DOCETAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215744 (pdf 215744.pdf not found) INN (DOCETAXEL) DOCETAXEL (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 216677 (pdf 216677.pdf not found) INN (DOCETAXEL) DOCETAXEL (ACIC PHARMS) APPROVAL= AP YEAR= 2024 , 734 ; FOSPHENYTOIN ; 93390-81-9 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTIC -- ANTICONVULSANTS , ; NDA 020450 (label 20450.pdf) INN (FOSPHENYTOIN SODIUM) CEREBYX (PARKE DAVIS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 076886 (label 76886.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (DR REDDYS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077481 (label 77481.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 077989 (label 77989.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 078052 (label 78052.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 078126 (label 78126.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078137 (label 78137.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 078158 (label 78158.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078277 (label 78277.pdf) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (AM REGENT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078417 (pdf 78417.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2008 , NDA 078476 (pdf 78476.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (AMNEAL) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078765 (pdf 78765.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 078736 (pdf 78736.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090099 (pdf 90099.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (AM REGENT) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 210864 (label 210864.pdf) INN (FOSPHENYTOIN SODIUM) SESQUIENT (LUPIN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214926 (pdf 214926.pdf not found) INN (FOSPHENYTOIN SODIUM) FOSPHENYTOIN SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 735 ; ZILEUTON ; 111406-87-2 ; 1996 ; ; ; CLASS ANTIINFLAMMATORY -- INHIBITS LEUKOTRIENE SYNTHESIS -- 5-LIPOXYGENASE INHIBITORS , ; NDA 020471 (label 20471.pdf) INN (ZILEUTON) ZYFLO (CHIESI) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 022052 (label 22052.pdf) INN (ZILEUTON) ZYFLO CR (CHIESI) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 204929 (pdf 204929.pdf not found) INN (ZILEUTON) ZILEUTON (RISING) APPROVAL= AP YEAR= 2017 , NDA 211972 (pdf 211972.pdf not found) INN (ZILEUTON) ZILEUTON (LUPIN LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212670 (pdf 212670.pdf not found) INN (ZILEUTON) ZILEUTON (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211390 (pdf 211390.pdf not found) INN (ZILEUTON) ZILEUTON (AIZANT) APPROVAL= AP YEAR= 2020 , NDA 211043 (pdf 211043.pdf not found) INN (ZILEUTON) ZILEUTON (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215742 (pdf 215742.pdf not found) INN (ZILEUTON) ZILEUTON (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , 736 ; ZILEUTON ; 111406-87-2 ; 1996 ; ; ; CLASS ANTIINFLAMMATORY -- INHIBITS LEUKOTRIENE SYNTHESIS -- 5-LIPOXYGENASE INHIBITORS , ; NDA 020471 (label 20471.pdf) INN (ZILEUTON) ZYFLO (CHIESI) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 022052 (label 22052.pdf) INN (ZILEUTON) ZYFLO CR (CHIESI) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 204929 (pdf 204929.pdf not found) INN (ZILEUTON) ZILEUTON (RISING) APPROVAL= AP YEAR= 2017 , NDA 211972 (pdf 211972.pdf not found) INN (ZILEUTON) ZILEUTON (LUPIN LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212670 (pdf 212670.pdf not found) INN (ZILEUTON) ZILEUTON (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211390 (pdf 211390.pdf not found) INN (ZILEUTON) ZILEUTON (AIZANT) APPROVAL= AP YEAR= 2020 , NDA 211043 (pdf 211043.pdf not found) INN (ZILEUTON) ZILEUTON (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215742 (pdf 215742.pdf not found) INN (ZILEUTON) ZILEUTON (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , 737 ; RIMEXOLONE ; 49697-38-3 ; 1994 ; DISCONTINUED ; ; CLASS SENSORY -- ANTIINFLAMMATORY -- CORTICOSTEROIDS , ; NDA 020474 (label 20474.pdf) INN (RIMEXOLONE) VEXOL (HARROW EYE) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , 738 ; SEVOFLURANE ; 28523-86-6 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETICS , ; NDA 020478 (label 20478.pdf) INN (SEVOFLURANE) ULTANE (ABBVIE) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 075895 (pdf 75895.pdf not found) INN (SEVOFLURANE) SEVOFLURANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2002 , NDA 077867 (pdf 77867.pdf not found) INN (SEVOFLURANE) SOJOURN (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2007 , NDA 078650 (pdf 78650.pdf not found) INN (SEVOFLURANE) SEVOFLURANE (HALOCARBON PRODS) APPROVAL= AP YEAR= 2007 , NDA 203793 (pdf 203793.pdf not found) INN (SEVOFLURANE) SEVOFLURANE (SHANGHAI HENGRUI) APPROVAL= AP YEAR= 2015 , NDA 214382 (pdf 214382.pdf not found) INN (SEVOFLURANE) SEVOFLURANE (SHANDONG) APPROVAL= AP YEAR= 2023 , 739 ; ACARBOSE ; 56180-94-0 ; 1995 ; ; ; CLASS METABOLISM -- MEMBRANE-BOUND INTESTINAL ALPHA-GLUCOSIDE HYDROLASE INHIBITOR -- HYPOGLYCEMIC AGENTS -- DELAYS THE DIGESTION OF INGESTED CARBOHYDRATES -- PANCREATIC ALPHA-AMYLASE INHIBITOR , ; NDA 020482 (label 20482.pdf) INN (ACARBOSE) PRECOSE (BAYER HLTHCARE) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 077532 (pdf 77532.pdf not found) INN (ACARBOSE) ACARBOSE (WATSON LABS) APPROVAL= AP YEAR= 2008 , NDA 078470 (pdf 78470.pdf not found) INN (ACARBOSE) ACARBOSE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 078441 (pdf 78441.pdf not found) INN (ACARBOSE) ACARBOSE (IMPAX LABS) APPROVAL= AP YEAR= 2009 , NDA 091053 (pdf 91053.pdf not found) INN (ACARBOSE) ACARBOSE (DASH PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090912 (pdf 90912.pdf not found) INN (ACARBOSE) ACARBOSE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 202271 (pdf 202271.pdf not found) INN (ACARBOSE) ACARBOSE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 091343 (pdf 91343.pdf not found) INN (ACARBOSE) ACARBOSE (VIRTUS PHARM) APPROVAL= AP YEAR= 2013 , NDA 213821 (pdf 213821.pdf not found) INN (ACARBOSE) ACARBOSE (HANGZHOU ZHONGMEI) APPROVAL= AP YEAR= 2020 DISCONTINUED , 740 ; VALACYCLOVIR ; 124832-26-4 ; 1995 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGAINST HERPES SIMPLEX VIRUS TYPES 1 (HSV-1), TYPES 2 (HSV-2) AND VARICELLA-ZOSTER VIRUS (VZV) , ; NDA 020487 (label 20487.pdf) INN (VALACYCLOVIR HYDROCHLORIDE) VALTREX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 , NDA 020550 (label 20550.pdf) INN (VALACYCLOVIR HYDROCHLORIDE) VALTREX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 NEWAPPLICATION , NDA 076588 (pdf 76588.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 , NDA 077135 (pdf 77135.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077478 (pdf 77478.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 077655 (pdf 77655.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078070 (pdf 78070.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078518 (pdf 78518.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 079012 (pdf 79012.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (ADAPTIS) APPROVAL= AP YEAR= 2010 , NDA 078656 (pdf 78656.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090216 (pdf 90216.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 , NDA 090682 (pdf 90682.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090370 (pdf 90370.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201506 (pdf 201506.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2012 , NDA 090500 (pdf 90500.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 203047 (pdf 203047.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 079137 (pdf 79137.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 209553 (pdf 209553.pdf not found) INN (VALACYCLOVIR HYDROCHLORIDE) VALACYCLOVIR HYDROCHLORIDE (YILING) APPROVAL= AP YEAR= 2020 , 741 ; BRIMONIDINE ; 59803-98-4 ; 1996 ; ; ; CLASS SENSORY -- ADRENERGIC ALPHA 2 AGONISTS -- ANTIHYPERTENSIVE AGENTS , ; NDA 020490 (label 20490.pdf) INN (BRIMONIDINE TARTRATE) ALPHAGAN (ALLERGAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020613 (label 20613.pdf) INN (BRIMONIDINE TARTRATE) ALPHAGAN (ALLERGAN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 021262 (label 21262.pdf) INN (BRIMONIDINE TARTRATE) ALPHAGAN P (ABBVIE) APPROVAL= AP YEAR= 2001 , NDA 021398 (label 21398.pdf) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) COMBIGAN (ABBVIE) APPROVAL= AP YEAR= 2007 , NDA 021764 (label 21764.pdf) INN (BRIMONIDINE TARTRATE) QOLIANA (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 021770 (label 21770.pdf) INN (BRIMONIDINE TARTRATE) ALPHAGAN P (ABBVIE) APPROVAL= AP YEAR= 2005 , NDA 076254 (pdf 76254.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076260 (pdf 76260.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2003 , NDA 076372 (pdf 76372.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076439 (pdf 76439.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (RISING) APPROVAL= AP YEAR= 2006 , NDA 078075 (pdf 78075.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 091574 (pdf 91574.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE TIMOLOL MALEATE (ALCON) APPROVAL= TA YEAR= 2010 , NDA 091086 (pdf 91086.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE TIMOLOL MALEATE (HITECH PHARMA) APPROVAL= TA YEAR= 2011 , NDA 091087 (pdf 91087.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 078480 (pdf 78480.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 204251 (label 204251.pdf) INN (BRIMONIDINE TARTRATE BRINZOLAMIDE) SIMBRINZA (ALCON LABS INC) APPROVAL= AP YEAR= 2013 , NDA 204708 (label 204708.pdf) INN (BRIMONIDINE TARTRATE) MIRVASO (GALDERMA LABS LP) APPROVAL= AP YEAR= 2013 , NDA 091691 (pdf 91691.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (INDOCO) APPROVAL= AP YEAR= 2014 , NDA 078479 (pdf 78479.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 208144 (label 208144.pdf) INN (BRIMONIDINE TARTRATE) LUMIFY (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2017 , NDA 209158 (pdf 209158.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 208992 (pdf 208992.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 091442 (pdf 91442.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 201949 (pdf 201949.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2022 , NDA 215598 (pdf 215598.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2022 , NDA 215225 (pdf 215225.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 216361 (pdf 216361.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2024 , NDA 212137 (pdf 212137.pdf not found) INN (BRINZOLAMIDE BRIMONIDINE TARTRATE) BRINZOLAMIDE BRIMONIDINE TARTRATE (PERRIGO PHARMA INTERNATIONAL DAC) APPROVAL= TA YEAR= 2023 , NDA 215230 (pdf 215230.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 216909 (pdf 216909.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217846 (pdf 217846.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 203172 (pdf 203172.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (SANDOZ) APPROVAL= AP YEAR= 2024 , NDA 214987 (pdf 214987.pdf not found) INN (BRIMONIDINE TARTRATE TIMOLOL MALEATE) BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 216772 (pdf 216772.pdf not found) INN (BRIMONIDINE TARTRATE) BRIMONIDINE TARTRATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2024 , NDA 218424 (pdf 218424.pdf not found) INN (BRIMONIDINE TARTRATE) LUMIFY PRESERVATIVE FREE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2024 , 742 ; GLIMEPIRIDE ; 93479-97-1 ; 1995 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- TREATMENT OF TYPE 2 DIABETES MELLITUS -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS , ; NDA 020496 (label 20496.pdf) INN (GLIMEPIRIDE) AMARYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 021700 (label 21700.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) AVANDARYL (SB PHARMCO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021925 (label 21925.pdf) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) DUETACT (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 076802 (pdf 76802.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076875 (pdf 76875.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2005 , NDA 076995 (pdf 76995.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077091 (pdf 77091.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2005 , NDA 077274 (pdf 77274.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077280 (pdf 77280.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (WATSON LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077295 (pdf 77295.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2005 , NDA 077366 (pdf 77366.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (RANBAXY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077370 (pdf 77370.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 , NDA 077486 (pdf 77486.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077624 (pdf 77624.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078181 (pdf 78181.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2007 , NDA 077911 (pdf 77911.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (CARLSBAD) APPROVAL= AP YEAR= 2009 , NDA 078709 (label 78709.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 091220 (pdf 91220.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (MICRO LABS) APPROVAL= AP YEAR= 2012 , NDA 202759 (pdf 202759.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 078952 (pdf 78952.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201049 (pdf 201049.pdf not found) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 202112 (pdf 202112.pdf not found) INN (GLIMEPIRIDE) GLIMEPIRIDE (INDOCO REMEDIES) APPROVAL= AP YEAR= 2013 , 743 ; BICALUTAMIDE ; 90357-06-5 ; 1995 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR ANTAGONISTS -- R ENANTIOMER IS ACTIVE -- TREATMENT OF METASTATIC CARCINOMA OF THE PROSTATE -- REMOVE SOURCE OF ANDROGENS , ; NDA 020498 (label 20498.pdf) INN (BICALUTAMIDE) CASODEX (ANI PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 078575 (label 78575.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 022310 (label 22310.pdf) INN (BICALUTAMIDE) CASODEX (ASTRAZENECA) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 076932 (label 76932.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (TEVA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077973 (label 77973.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077995 (label 77995.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (KUDCO IRELAND) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078634 (pdf 78634.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2009 , NDA 078917 (label 78917.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 079089 (label 79089.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (ADAPTIS) APPROVAL= AP YEAR= 2009 , NDA 079110 (label 79110.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 079185 (label 79185.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079045 (pdf 79045.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078285 (pdf 78285.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (ROXANE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091011 (pdf 91011.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2015 , NDA 200274 (pdf 200274.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (APOTEX) APPROVAL= AP YEAR= 2015 , 744 ; TOPIRAMATE ; 97240-79-4 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- MIGRAINE -- EPILEPSY , ; NDA 020505 (label 20505.pdf) INN (TOPIRAMATE) TOPAMAX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 020844 (label 20844.pdf) INN (TOPIRAMATE) TOPAMAX (JANSSEN PHARMS) APPROVAL= AP YEAR= 1998 , NDA 076306 (pdf 76306.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ROXANE) APPROVAL= TA YEAR= 2003 , NDA 076311 (pdf 76311.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 076314 (pdf 76314.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076315 (pdf 76315.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (BARR) APPROVAL= TA YEAR= 2004 , NDA 076317 (pdf 76317.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (TEVA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076327 (pdf 76327.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076343 (pdf 76343.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (CIPLA LTD) APPROVAL= AP YEAR= 2009 , NDA 076448 (pdf 76448.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (BARR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076575 (pdf 76575.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (TEVA) APPROVAL= AP YEAR= 2009 , NDA 077627 (pdf 77627.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 077643 (pdf 77643.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (WATSON LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077733 (pdf 77733.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (VIWIT PHARM) APPROVAL= AP YEAR= 2009 , NDA 077868 (pdf 77868.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (WATSON LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078235 (pdf 78235.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 078410 (pdf 78410.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (CHARTWELL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078418 (pdf 78418.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078462 (pdf 78462.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 077905 (pdf 77905.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078499 (pdf 78499.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (AIPING PHARM INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078877 (pdf 78877.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 079153 (pdf 79153.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079162 (pdf 79162.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 079206 (pdf 79206.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (FOSUN PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090162 (pdf 90162.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (UNICHEM LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090278 (pdf 90278.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 090353 (pdf 90353.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (WOCKHARDT) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022580 (label 22580.pdf) INN (PHENTERMINE HYDROCHLORIDE TOPIRAMATE) QSYMIA (VIVUS) APPROVAL= AP YEAR= 2012 , NDA 201635 (label 201635.pdf) INN (TOPIRAMATE) TROKENDI XR (SUPERNUS PHARMS) APPROVAL= AP YEAR= 2013 , NDA 078637 (pdf 78637.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091185 (pdf 91185.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 205122 (label 205122.pdf) INN (TOPIRAMATE) QUDEXY XR (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2014 , NDA 207382 (pdf 207382.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ZYDUS) APPROVAL= AP YEAR= 2017 , NDA 210278 (pdf 210278.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214679 (label 214679.pdf) INN (TOPIRAMATE) EPRONTIA (AZURITY) APPROVAL= AP YEAR= 2021 , NDA 215414 (pdf 215414.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215663 (pdf 215663.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 208949 (pdf 208949.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ZYDUS) APPROVAL= AP YEAR= 2022 , NDA 215638 (pdf 215638.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (XIAMEN LP PHARM CO) APPROVAL= TA YEAR= 2024 , NDA 205976 (pdf 205976.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , NDA 206210 (pdf 206210.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2023 , NDA 216167 (pdf 216167.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217231 (pdf 217231.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 217248 (pdf 217248.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 215449 (pdf 215449.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217694 (pdf 217694.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (TWI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 218482 (pdf 218482.pdf not found) INN (TOPIRAMATE) TOPIRAMATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2024 , 745 ; GEMCITABINE ; 95058-81-4 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES , ; NDA 020509 (label 20509.pdf) INN (GEMCITABINE HYDROCHLORIDE) GEMZAR (LILLY) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 077983 (pdf 77983.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078339 (pdf 78339.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2011 , NDA 078433 (pdf 78433.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 078460 (pdf 78460.pdf not found) INN (GEMCITABINE) GEMCITABINE (EUROHLTH INTL) APPROVAL= TA YEAR= 2010 , NDA 078759 (pdf 78759.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (TEYRO LABS) APPROVAL= AP YEAR= 2011 , NDA 079160 (pdf 79160.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079183 (pdf 79183.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2010 , NDA 090242 (pdf 90242.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2011 , NDA 090644 (pdf 90644.pdf not found) INN (GEMCITABINE) GEMCITABINE (TEVA PARENTERAL) APPROVAL= TA YEAR= 2009 , NDA 090799 (pdf 90799.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2011 , NDA 090663 (pdf 90663.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HAMELN RDS GMBH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091365 (pdf 91365.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 091594 (pdf 91594.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200145 (pdf 200145.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200795 (label 200795.pdf) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2011 , NDA 202063 (pdf 202063.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (EMCURE PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202485 (pdf 202485.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2013 , NDA 091597 (pdf 91597.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202031 (pdf 202031.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202997 (pdf 202997.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 204520 (pdf 204520.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204549 (pdf 204549.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (ACTAVIS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206776 (pdf 206776.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209604 (label 209604.pdf) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 205242 (pdf 205242.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 208313 (label 208313.pdf) INN (GEMCITABINE HYDROCHLORIDE) INFUGEM (SUN PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209077 (pdf 209077.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 207575 (pdf 207575.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 210383 (pdf 210383.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 210991 (pdf 210991.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 212129 (pdf 212129.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2020 , NDA 206617 (pdf 206617.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213175 (pdf 213175.pdf not found) INN (GEMCITABINE HYDROCHLORIDE) GEMCITABINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , 746 ; AMLEXANOX ; 68302-57-8 ; 1996 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTI-ALLERGIC -- ANTI-INFLAMMATORY -- TREATMENT OF APHTHOUS ULCER , ; NDA 020511 (label 20511.pdf) INN (AMLEXANOX) APHTHASOL (ULURU) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 021727 (label 21727.pdf) INN (AMLEXANOX) AMLEXANOX (ULURU) APPROVAL= AP YEAR= 2004 DISCONTINUED , 747 ; BUTENAFINE ; 101828-21-1 ; 1996 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- INHIBITING THE EPOXIDATION OF SQUALENE THUS BLOCKING THE BIOSYNTHESIS OF ERGOSTEROL , ; NDA 020524 (label 20524.pdf) INN (BUTENAFINE HYDROCHLORIDE) MENTAX (MYLAN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 021307 (label 21307.pdf) INN (BUTENAFINE HYDROCHLORIDE) LOTRIMIN ULTRA (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 2001 , NDA 021408 (label 21408.pdf) INN (BUTENAFINE HYDROCHLORIDE) MENTAX-TC (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 020663 (pdf 20663.pdf not found) INN (BUTENAFINE HYDROCHLORIDE) MENTAX (MYLAN BERTEK) APPROVAL= AP YEAR= 1996 NEWAPPLICATION , NDA 205181 (pdf 205181.pdf not found) INN (BUTENAFINE HYDROCHLORIDE) BUTENAFINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2017 , 748 ; TRANDOLAPRIL ; 87679-37-6 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS , ; NDA 020528 (label 20528.pdf) INN (TRANDOLAPRIL) MAVIK (ABBVIE) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020591 (label 20591.pdf) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TARKA (ABBVIE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 077256 (pdf 77256.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077307 (pdf 77307.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077489 (pdf 77489.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (TEVA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077522 (pdf 77522.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 077805 (pdf 77805.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078320 (pdf 78320.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078346 (pdf 78346.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078438 (pdf 78438.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078493 (pdf 78493.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078508 (pdf 78508.pdf not found) INN (TRANDOLAPRIL) TRANDOLAPRIL (EPIC PHARMA) APPROVAL= AP YEAR= 2008 , NDA 079135 (pdf 79135.pdf not found) INN (TRANDOLAPRIL VERAPAMIL HYDROCHLORIDE) TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (GLENMARK GENERICS) APPROVAL= AP YEAR= 2010 , 749 ; FEXOFENADINE ; 138452-21-8 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- NON-SEDATING H1 HISTAMINE ANTAGONIST -- ANTI-ALLERGIC AGENTS , ; NDA 020625 (label 20625.pdf) INN (FEXOFENADINE HYDROCHLORIDE) ALLEGRA (CHATTEM SANOFI) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020786 (label 20786.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 1997 , NDA 020872 (label 20872.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2000 , NDA 021704 (label 21704.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 2004 , NDA 021909 (label 21909.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021963 (label 21963.pdf) INN (FEXOFENADINE HYDROCHLORIDE) ALLEGRA (CHATTEM SANOFI) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076169 (pdf 76169.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076236 (pdf 76236.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076298 (pdf 76298.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076447 (pdf 76447.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2005 , NDA 076502 (pdf 76502.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 076538 (pdf 76538.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HCL PSEUDOEPHEDRINE HCL (MYLAN) APPROVAL= TA YEAR= 2004 , NDA 076970 (pdf 76970.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2007 , NDA 077081 (pdf 77081.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 , NDA 076667 (pdf 76667.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 076707 (pdf 76707.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2009 , NDA 077999 (pdf 77999.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS LLC) APPROVAL= TA YEAR= 2010 , NDA 079043 (pdf 79043.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 076191 (pdf 76191.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 079115 (pdf 79115.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= TA YEAR= 2010 , NDA 201373 (label 201373.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2011 , NDA 079112 (pdf 79112.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (WOCKHARDT) APPROVAL= AP YEAR= 2012 , NDA 091567 (pdf 91567.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 , NDA 201311 (pdf 201311.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (P AND L) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202978 (label 202978.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202039 (pdf 202039.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 203330 (pdf 203330.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (P AND L) APPROVAL= AP YEAR= 2014 , NDA 090818 (pdf 90818.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015 , NDA 204507 (pdf 204507.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 204097 (pdf 204097.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 208123 (pdf 208123.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2017 , NDA 209116 (pdf 209116.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 210137 (pdf 210137.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (UNIQUE) APPROVAL= AP YEAR= 2018 , NDA 211075 (pdf 211075.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 212971 (pdf 212971.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2020 , NDA 215434 (pdf 215434.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 213466 (pdf 213466.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 750 ; ANASTROZOLE ; 120511-73-1 ; 1995 ; ; ; CLASS ANTINEOPLASTIC -- AROMATASE INHIBITORS -- HORMONE RECEPTOR-POSITIVE EARLY BREAST CANCER , ; NDA 020541 (label 20541.pdf) INN (ANASTROZOLE) ARIMIDEX (ANI PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 078058 (pdf 78058.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (TEVA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078322 (pdf 78322.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (SYNTHON PHARMS) APPROVAL= TA YEAR= 2007 , NDA 078485 (pdf 78485.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078921 (pdf 78921.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 078984 (pdf 78984.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079007 (pdf 79007.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (SANDOZ) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022214 (pdf 22214.pdf not found) INN (ANASTROZOLE) ARIMIDEX (ASTRAZENECA) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 078944 (pdf 78944.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (KENTON) APPROVAL= AP YEAR= 2010 , NDA 079220 (pdf 79220.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2010 , NDA 090088 (pdf 90088.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090568 (pdf 90568.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 090732 (pdf 90732.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091051 (pdf 91051.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091164 (pdf 91164.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (CIPLA) APPROVAL= AP YEAR= 2010 , NDA 091331 (pdf 91331.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091177 (pdf 91177.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091242 (pdf 91242.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (IMPAX LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200654 (pdf 200654.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 206037 (pdf 206037.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (BEIJING YILING) APPROVAL= AP YEAR= 2018 , NDA 212434 (pdf 212434.pdf not found) INN (ANASTROZOLE) ANASTROZOLE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , 751 ; ZAFIRLUKAST ; 107753-78-6 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- PEPTIDE LEUKOTRIENE RECEPTOR ANTAGONIST (LTRA) -- ANTIASTHMATIC , ; NDA 020547 (label 20547.pdf) INN (ZAFIRLUKAST) ACCOLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 090372 (pdf 90372.pdf not found) INN (ZAFIRLUKAST) ZAFIRLUKAST (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 212475 (pdf 212475.pdf not found) INN (ZAFIRLUKAST) ZAFIRLUKAST (ANNORA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 204928 (pdf 204928.pdf not found) INN (ZAFIRLUKAST) ZAFIRLUKAST (RISING PHARMS) APPROVAL= AP YEAR= 2022 , NDA 213163 (pdf 213163.pdf not found) INN (ZAFIRLUKAST) ZAFIRLUKAST (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 752 ; CISATRACURIUM ; 96946-41-7 ; 1983 ; ; ; CLASS METABOLISM -- NEUROMUSCULAR BLOCKER -- NONDEPOLARIZING SKELETAL MUSCLE RELAXANT -- CHOLINERGIC RECEPTORS ANTAGONISTS , ; NDA 020551 (label 20551.pdf) INN (CISATRACURIUM BESYLATE) NIMBEX (ABBVIE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 018831 (pdf 18831.pdf not found) INN (ATRACURIUM BESYLATE) TRACRIUM PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 074632 (pdf 74632.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074633 (pdf 74633.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074639 (pdf 74639.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074740 (pdf 74740.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074741 (pdf 74741.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074753 (pdf 74753.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074768 (pdf 74768.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074784 (pdf 74784.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074824 (pdf 74824.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074825 (pdf 74825.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074900 (pdf 74900.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 1997 , NDA 074901 (pdf 74901.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (HIKMA) APPROVAL= AP YEAR= 1997 , NDA 074944 (pdf 74944.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074945 (pdf 74945.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 200154 (pdf 200154.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 200159 (pdf 200159.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 090761 (pdf 90761.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (HOSPIRA INC) APPROVAL= AP YEAR= 2012 , NDA 090782 (pdf 90782.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (HOSPIRA INC) APPROVAL= AP YEAR= 2012 , NDA 091488 (pdf 91488.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (MEITHEAL) APPROVAL= AP YEAR= 2012 , NDA 091489 (pdf 91489.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (MEITHEAL) APPROVAL= AP YEAR= 2012 , NDA 206010 (pdf 206010.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 206011 (pdf 206011.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 203182 (pdf 203182.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 203183 (pdf 203183.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 206001 (pdf 206001.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE PRESERVATIVE FREE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206096 (pdf 206096.pdf not found) INN (ATRACURIUM BESYLATE) ATRACURIUM BESYLATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204960 (pdf 204960.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205872 (pdf 205872.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205873 (pdf 205873.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209334 (pdf 209334.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203236 (pdf 203236.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HOSPIRA) APPROVAL= AP YEAR= 2018 , NDA 203238 (pdf 203238.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HOSPIRA) APPROVAL= AP YEAR= 2018 , NDA 206791 (pdf 206791.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 209132 (pdf 209132.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (SOMERSET) APPROVAL= AP YEAR= 2019 , NDA 211668 (pdf 211668.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (MEITHEAL) APPROVAL= AP YEAR= 2019 , NDA 211669 (pdf 211669.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (MEITHEAL) APPROVAL= AP YEAR= 2019 , NDA 212171 (pdf 212171.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209144 (pdf 209144.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212190 (pdf 212190.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 201836 (pdf 201836.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 201851 (pdf 201851.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 209665 (pdf 209665.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213527 (pdf 213527.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 203078 (pdf 203078.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 212432 (pdf 212432.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215516 (pdf 215516.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2022 , NDA 215517 (pdf 215517.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2022 OBSOLETE , NDA 203079 (pdf 203079.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 217725 (pdf 217725.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (CAPLIN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216538 (pdf 216538.pdf not found) INN (CISATRACURIUM BESYLATE) CISATRACURIUM BESYLATE (HAINAN POLY) APPROVAL= AP YEAR= 2024 , 753 ; ALENDRONATE ; 129318-43-0 ; 1995 ; ; ; CLASS METABOLISM -- BONE RESORPTION INHIBITOR -- BISPHOSPHONATE -- ANTIHYPOCALCEMIC AGENTS -- ANTIRESORPTIVES , ; NDA 020560 (label 20560.pdf) INN (ALENDRONATE SODIUM) FOSAMAX (ORGANON) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 021575 (label 21575.pdf) INN (ALENDRONATE SODIUM) FOSAMAX (MERCK) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021762 (label 21762.pdf) INN (ALENDRONATE SODIUM CHOLECALCIFEROL) FOSAMAX PLUS D (ORGANON LLC) APPROVAL= AP YEAR= 2005 , NDA 075710 (pdf 75710.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (IMPAX LABS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 075711 (pdf 75711.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (IVAX PHARMS) APPROVAL= TA YEAR= 2002 OBSOLETE , NDA 076184 (pdf 76184.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076584 (pdf 76584.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (RISING) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076768 (pdf 76768.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (CIPLA) APPROVAL= AP YEAR= 2008 , NDA 076984 (pdf 76984.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (WATSON LABS) APPROVAL= AP YEAR= 2008 , NDA 077982 (pdf 77982.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (APOTEX) APPROVAL= AP YEAR= 2008 , NDA 078638 (pdf 78638.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079049 (pdf 79049.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079109 (pdf 79109.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 090022 (pdf 90022.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2008 , NDA 090124 (pdf 90124.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 075871 (pdf 75871.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090258 (pdf 90258.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (HANGZHOU BINJIANG) APPROVAL= AP YEAR= 2009 , NDA 090557 (pdf 90557.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (JUBILANT CADISTA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202344 (label 202344.pdf) INN (ALENDRONATE SODIUM) BINOSTO (RADIUS) APPROVAL= AP YEAR= 2012 , NDA 090520 (pdf 90520.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 214512 (pdf 214512.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 206387 (pdf 206387.pdf not found) INN (ALENDRONATE SODIUM) ALENDRONATE SODIUM (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 754 ; LAMIVUDINE ; 134678-17-4 ; 1995 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV AGENTS -- ANTI-HBV AGENTS -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS) , ; NDA 020564 (label 20564.pdf) INN (LAMIVUDINE) EPIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 020596 (label 20596.pdf) INN (LAMIVUDINE) EPIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1995 , NDA 020857 (label 20857.pdf) INN (LAMIVUDINE ZIDOVUDINE) COMBIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1997 , NDA 021003 (label 21003.pdf) INN (LAMIVUDINE) EPIVIR-HBV (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021004 (label 21004.pdf) INN (LAMIVUDINE) EPIVIR-HBV (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021205 (label 21205.pdf) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) TRIZIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 2000 , NDA 021652 (label 21652.pdf) INN (ABACAVIR SULFATE LAMIVUDINE) EPZICOM (VIIV HLTHCARE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021837 (pdf 21837.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ARCOLAB) APPROVAL= TA YEAR= 2008 , NDA 021838 (pdf 21838.pdf not found) INN (STAVUDINE LAMIVUDINE) STAVUDINE LAMIVUDINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 021841 (pdf 21841.pdf not found) INN (LAMIVUDINE) LAMIVUDINE/ZIDOVUDINE TABLETS CO-PACKAGED WITH NEVIRAPINE TABLETS (PHARMACARE LTD) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 021854 (pdf 21854.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE W/NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 021939 (pdf 21939.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE , NEVIRAPINE TABS 150MG/300MG/200MG (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021943 (pdf 21943.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021944 (pdf 21944.pdf not found) INN (LAMIVUDINE ZIDOVUDINE ABACAVIR) LAMIVUDINE ZIDOVUDINE ABACAVIR (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021969 (pdf 21969.pdf not found) INN (LAMIVUDINE STAVUDINE NEVIRAPINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2006 , NDA 021971 (pdf 21971.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE ZIDOVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 021972 (pdf 21972.pdf not found) INN (LAMIVUDINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 OBSOLETE , NDA 021974 (pdf 21974.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE STAVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 021988 (pdf 21988.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE/ZIDOVUDINE 150 MG/300 MG TABLETS CO-PACKAGED WITH NEVIRAPINE 200 MG TABLETS (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022018 (label 22018.pdf) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (PHARMACARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 022085 (pdf 22085.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE STAVUDINE (MATRIX LABS) APPROVAL= TA YEAR= 2007 , NDA 022096 (pdf 22096.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022097 (pdf 22097.pdf not found) INN (STAVUDINE LAMIVUDINE EFAVIRENZ) STAVUDINE LAMIVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022141 (label 22141.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) CIMDUO (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 022167 (pdf 22167.pdf not found) INN (LAMIVUDINE) LAMIVUDINE STAVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022177 (pdf 22177.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2008 , NDA 077357 (pdf 77357.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (RANBAXY) APPROVAL= TA YEAR= 2005 , NDA 077411 (pdf 77411.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 077464 (pdf 77464.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 077558 (pdf 77558.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 077695 (pdf 77695.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 077980 (pdf 77980.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2006 , NDA 078545 (pdf 78545.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 078850 (pdf 78850.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (INVAGEN PHARMS) APPROVAL= TA YEAR= 2008 , NDA 078929 (pdf 78929.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2007 , NDA 079079 (pdf 79079.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 079124 (pdf 79124.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2015 , NDA 090159 (pdf 90159.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 022061 (pdf 22061.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MATRIX LABS) APPROVAL= TA YEAR= 2008 , NDA 022142 (label 22142.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 022295 (pdf 22295.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2008 , NDA 022296 (pdf 22296.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2009 , NDA 022342 (pdf 22342.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2009 , NDA 022346 (pdf 22346.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (PHARMACARE LTD) APPROVAL= TA YEAR= 2009 , NDA 022347 (pdf 22347.pdf not found) INN (STAVUDINE LAMIVUDINE) STAVUDINE LAMIVUDINE (PHARMACARE LTD) APPROVAL= TA YEAR= 2009 , NDA 022356 (pdf 22356.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009 , NDA 022459 (pdf 22459.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009 , NDA 022464 (label 22464.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2009 , NDA 079081 (pdf 79081.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079246 (label 79246.pdf) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 090198 (pdf 90198.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 090309 (pdf 90309.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (MYLAN PHARMA) APPROVAL= TA YEAR= 2009 , NDA 090433 (pdf 90433.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090457 (pdf 90457.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 090519 (pdf 90519.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090679 (pdf 90679.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 022479 (pdf 22479.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE AND STAVUDINE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2010 , NDA 022537 (pdf 22537.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (MACLEODS PHARMA) APPROVAL= TA YEAR= 2010 , NDA 022541 (pdf 22541.pdf not found) INN (LAMIVUDINE STAVUDINE) LAMIVUDINE AND STAVUDINE (MACLEODS PHARMA) APPROVAL= TA YEAR= 2010 , NDA 079128 (pdf 79128.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 200244 (pdf 200244.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2010 , NDA 200793 (pdf 200793.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS (MATRIX LABS) APPROVAL= TA YEAR= 2010 , NDA 022344 (label 22344.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 078636 (pdf 78636.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (TEVA PHARMS) APPROVAL= TA YEAR= 2011 , NDA 200623 (pdf 200623.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 200748 (pdf 200748.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 202007 (pdf 202007.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 090246 (pdf 90246.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 091606 (pdf 91606.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 201151 (pdf 201151.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 202032 (pdf 202032.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202157 (pdf 202157.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (HETERO LABS UNIT III) APPROVAL= TA YEAR= 2011 , NDA 202171 (pdf 202171.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091144 (pdf 91144.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 202381 (pdf 202381.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (MYLAN LABS) APPROVAL= TA YEAR= 2012 , NDA 202589 (pdf 202589.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 091475 (pdf 91475.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , NDA 200406 (pdf 200406.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (MICRO LABS LTD) APPROVAL= TA YEAR= 2012 , NDA 202418 (pdf 202418.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202685 (pdf 202685.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2012 , NDA 202814 (pdf 202814.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 203076 (pdf 203076.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (CIPLA LTD) APPROVAL= TA YEAR= 2012 , NDA 203283 (pdf 203283.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 204119 (pdf 204119.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2017 , NDA 022343 (label 22343.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 202529 (pdf 202529.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2013 , NDA 202912 (pdf 202912.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 204505 (pdf 204505.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2013 , NDA 204568 (pdf 204568.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= TA YEAR= 2013 , NDA 202941 (label 202941.pdf) INN (LAMIVUDINE) LAMIVUDINE (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 203259 (pdf 203259.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 203260 (label 203260.pdf) INN (LAMIVUDINE) LAMIVUDINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 203277 (pdf 203277.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 203564 (pdf 203564.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2014 , NDA 204002 (pdf 204002.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204005 (pdf 204005.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204311 (label 204311.pdf) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204914 (pdf 204914.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE ZIDOVUDINE (MYLAN LABS) APPROVAL= TA YEAR= 2014 , NDA 204915 (pdf 204915.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR AND LAMIVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 205217 (pdf 205217.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 205355 (pdf 205355.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014 , NDA 205412 (pdf 205412.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (HETERO LABS LTD V) APPROVAL= TA YEAR= 2014 , NDA 205551 (label 205551.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ (VIIV HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 205861 (pdf 205861.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2014 , NDA 206040 (pdf 206040.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206041 (pdf 206041.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR LAMIVUDINE ZIDOVUDINE) ATAZANAVIR SULFATERITONAVIRLAMIVUDINEZIDOVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 203586 (pdf 203586.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (BRECKENRIDGE) APPROVAL= AP YEAR= 2016 , NDA 206510 (label 206510.pdf) INN (LAMIVUDINE RALTEGRAVIR POTASSIUM) DUTREBIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207369 (pdf 207369.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR LAMIVUDINE (HETERO LABS LTD V) APPROVAL= TA YEAR= 2015 , NDA 204004 (pdf 204004.pdf not found) INN (ABACAVIR LAMIVUDINE) EPZICOM (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2016 , NDA 204528 (pdf 204528.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (NATCO) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206974 (pdf 206974.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2016 , NDA 077221 (pdf 77221.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 204990 (pdf 204990.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 206151 (pdf 206151.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207315 (pdf 207315.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2017 , NDA 208255 (label 208255.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI LO (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 208775 (pdf 208775.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR AND LAMIVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2017 , NDA 208990 (pdf 208990.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209670 (pdf 209670.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 206375 (pdf 206375.pdf not found) INN (LAMIVUDINE ZIDOVUDINE) LAMIVUDINE AND ZIDOVUDINE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2018 , NDA 205626 (label 205626.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE , NEVIRAPINE AND ZIDOVUDINE (MICRO LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210807 (label 210807.pdf) INN (DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DELSTRIGO (MSD MERCK CO) APPROVAL= AP YEAR= 2018 , NDA 211284 (label 211284.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) TEMIXYS (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210649 (label 210649.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210787 (pdf 210787.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 211306 (pdf 211306.pdf not found) INN (LAMIVUDINE) LAMIVUDINE (ANNORA) APPROVAL= AP YEAR= 2019 , NDA 211994 (label 211994.pdf) INN (DOLUTEGRAVIR SODIUM LAMIVUDINE) DOVATO (VIIV HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 212786 (pdf 212786.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213038 (pdf 213038.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213556 (pdf 213556.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD) APPROVAL= TA YEAR= 2020 , NDA 212303 (pdf 212303.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN PHARMS) APPROVAL= TA YEAR= 2021 , NDA 210796 (pdf 210796.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2019 , NDA 212527 (pdf 212527.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE (CIPLA USA INC.) APPROVAL= TA YEAR= 2022 , NDA 215413 (label 215413.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ PD (VIIV HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 216223 (pdf 216223.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 216332 (pdf 216332.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (LAURUS) APPROVAL= AP YEAR= 2022 , NDA 211868 (pdf 211868.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 215187 (pdf 215187.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIRLAMIVUDINETENOFOVIR ALAFENAMIDE (LUPIN PHARMS) APPROVAL= TA YEAR= 2023 , NDA 217016 (pdf 217016.pdf not found) INN (DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE) DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE (STRIDES PHARMA) APPROVAL= TA YEAR= 2023 , NDA 217070 (pdf 217070.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , 755 ; IRINOTECAN ; 97682-44-5 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- TOPOISOMERASE I INHIBITOR -- CAMPTOTHECIN DERIVATIVES , ; NDA 020571 (label 20571.pdf) INN (IRINOTECAN HYDROCHLORIDE) CAMPTOSAR (PFIZER INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 077219 (pdf 77219.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (CIPLA LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077260 (pdf 77260.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2008 , NDA 077776 (pdf 77776.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 077915 (pdf 77915.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 077994 (pdf 77994.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078188 (pdf 78188.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078589 (pdf 78589.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2008 , NDA 078796 (pdf 78796.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 078805 (pdf 78805.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078122 (pdf 78122.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (PLIVA LACHEMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078753 (pdf 78753.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 , NDA 078953 (pdf 78953.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079068 (pdf 79068.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 090016 (pdf 90016.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2009 , NDA 090101 (pdf 90101.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2008 , NDA 090137 (pdf 90137.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090726 (pdf 90726.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 , NDA 078839 (pdf 78839.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (APOTEX CORP) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 091032 (pdf 91032.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 090393 (pdf 90393.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (ZENNOVA) APPROVAL= AP YEAR= 2011 , NDA 090675 (pdf 90675.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2011 , NDA 200771 (pdf 200771.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (EMCURE PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 207793 (label 207793.pdf) INN (IRINOTECAN HYDROCHLORIDE) ONIVYDE (IPSEN) APPROVAL= AP YEAR= 2015 , NDA 203380 (pdf 203380.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2016 , NDA 206935 (pdf 206935.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 203054 (pdf 203054.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (INTAS PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 208718 (pdf 208718.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (SHILPA) APPROVAL= AP YEAR= 2018 , NDA 212993 (pdf 212993.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 213278 (pdf 213278.pdf not found) INN (IRINOTECAN HYDROCHLORIDE) IRINOTECAN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , 756 ; BETAINE ; 107-43-7 ; 1996 ; ; ; CLASS METABOLISM -- NUTRIENT -- ANTIARTERIOSCLEROTIC -- HYPOLIPAEMIC -- HEPATOPROTECTANT -- TREATMENT OF HOMOCYSTINURIA TO DECREASE ELEVATED HOMOCYSTEINE -- ACTS AS A METHYL GROUP DONOR IN THE REMETHYLATION OF HOMOCYSTEINE TO METHIONINE IN PATIENTS WITH HOMOCYSTINURIA BLOOD LEVELS , ; NDA 020576 (label 20576.pdf) INN (BETAINE) CYSTADANE (RECORDATI RARE) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 214864 (pdf 214864.pdf not found) INN (BETAINE) BETAINE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 210508 (pdf 210508.pdf not found) INN (BETAINE) BETAINE (ETON) APPROVAL= AP YEAR= 2022 , 757 ; TAMSULOSIN ; 106133-20-4 ; 1997 ; ; ; CLASS GENITO -- BENIGN PROSTATIC HYPERPLASIA (BPH) RELATED TO BLADDER OUTLET OBSTRUCTION -- ADRENERGIC (ALPHA-1) BLOCKER , ; NDA 020579 (label 20579.pdf) INN (TAMSULOSIN HYDROCHLORIDE) FLOMAX (SANOFI) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 077451 (pdf 77451.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2007 OBSOLETE , NDA 077630 (pdf 77630.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078015 (pdf 78015.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 078225 (pdf 78225.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 022460 (label 22460.pdf) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) JALYN (WAYLIS THERAP) APPROVAL= AP YEAR= 2010 , NDA 078801 (pdf 78801.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078938 (pdf 78938.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2010 , NDA 090377 (pdf 90377.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2010 , NDA 090408 (pdf 90408.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090931 (pdf 90931.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 , NDA 202010 (pdf 202010.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202433 (pdf 202433.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 202509 (pdf 202509.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 202975 (pdf 202975.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204645 (pdf 204645.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207405 (pdf 207405.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207769 (pdf 207769.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211885 (pdf 211885.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 214730 (pdf 214730.pdf not found) INN (TAMSULOSIN HYDROCHLORIDE) TAMSULOSIN HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , 758 ; LOTEPREDNOL ETABONATE ; 82034-46-6 ; 1998 ; ; ; CLASS SENSORY -- ANTIINFLAMMATORY -- ANTIALLERGIC -- CORTICOSTEROIDS , ; NDA 020583 (label 20583.pdf) INN (LOTEPREDNOL ETABONATE) LOTEMAX (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 020803 (label 20803.pdf) INN (LOTEPREDNOL ETABONATE) ALREX (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 020841 (label 20841.pdf) INN (LOTEPREDNOL ETABONATE) LOTEMAX (PHARMOS) APPROVAL= AP YEAR= 1998 NEWAPPLICATION DISCONTINUED , NDA 050804 (label 50804.pdf) INN (LOTEPREDNOL ETABONATE TOBRAMYCIN) ZYLET (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2004 , NDA 200738 (label 200738.pdf) INN (LOTEPREDNOL ETABONATE) LOTEMAX (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2011 , NDA 202872 (label 202872.pdf) INN (LOTEPREDNOL ETABONATE) LOTEMAX (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2012 , NDA 210565 (label 210565.pdf) INN (LOTEPREDNOL ETABONATE) INVELTYS (ALCON LABS INC) APPROVAL= AP YEAR= 2018 , NDA 207609 (pdf 207609.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (SENTISS) APPROVAL= AP YEAR= 2019 , NDA 208219 (label 208219.pdf) INN (LOTEPREDNOL ETABONATE) LOTEMAX SM (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2019 , NDA 210933 (label 210933.pdf) INN (LOTEPREDNOL ETABONATE) EYSUVIS (ALCON LABS INC) APPROVAL= AP YEAR= 2020 NEWAPPLICATION , NDA 212080 (pdf 212080.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (SENTISS) APPROVAL= AP YEAR= 2021 , NDA 212450 (pdf 212450.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 215933 (pdf 215933.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (SENTISS) APPROVAL= AP YEAR= 2023 , NDA 213956 (pdf 213956.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215384 (pdf 215384.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 215550 (pdf 215550.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 215719 (pdf 215719.pdf not found) INN (LOTEPREDNOL ETABONATE) LOTEPREDNOL ETABONATE (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 759 ; OLANZAPINE ; 132539-06-1 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- SEROTONIN 5HT-2A (KI=4 NANOMOLAR), 5HT-2C (KI=11 NANOMOLAR), 5HT-6 (KI=11 NANOMOLAR) ANTAGONIST -- D(2) DOPAMINE RECEPTOR ANTAGONIST -- DOPAMINE D1-4 (KI=11-31 NANOMOLAR) -- HISTAMINE H1 (KI=7 NANOMOLAR) -- ADRENERGIC ALPHA-1 RECEPTOR (KI=19 NANOMOLAR) -- SEROTONIN 5HT-3 (KI=57 NANOMOLAR) -- MUSCARINIC M1-5 (KI=32-132 NANOMOLAR) , ; NDA 020592 (label 20592.pdf) INN (OLANZAPINE) ZYPREXA (CHEPLAPHARM) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021086 (label 21086.pdf) INN (OLANZAPINE) ZYPREXA ZYDIS (CHEPLAPHARM) APPROVAL= AP YEAR= 2000 , NDA 021253 (label 21253.pdf) INN (OLANZAPINE) ZYPREXA (CHEPLAPHARM) APPROVAL= AP YEAR= 2004 , NDA 021520 (label 21520.pdf) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) SYMBYAX (LILLY) APPROVAL= AP YEAR= 2003 , NDA 076415 (pdf 76415.pdf not found) INN (OLANZAPINE) OLANZAPINE (TEVA PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 076866 (pdf 76866.pdf not found) INN (OLANZAPINE) OLANZAPINE (MYLAN) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077158 (pdf 77158.pdf not found) INN (OLANZAPINE) OLANZAPINE (SANDOZ) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 077243 (pdf 77243.pdf not found) INN (OLANZAPINE) OLANZAPINE (BARR LABS INC) APPROVAL= AP YEAR= 2012 , NDA 077528 (pdf 77528.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 077993 (pdf 77993.pdf not found) INN (OLANZAPINE) OLANZAPINE (ROXANE) APPROVAL= TA YEAR= 2006 , NDA 022173 (label 22173.pdf) INN (OLANZAPINE PAMOATE) ZYPREXA RELPREVV (CHEPLAPHARM) APPROVAL= AP YEAR= 2009 , NDA 076133 (pdf 76133.pdf not found) INN (OLANZAPINE) OLANZAPINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 076255 (pdf 76255.pdf not found) INN (OLANZAPINE) OLANZAPINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 076000 (pdf 76000.pdf not found) INN (OLANZAPINE) OLANZAPINE (TEVA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 076534 (pdf 76534.pdf not found) INN (OLANZAPINE) OLANZAPINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 078109 (pdf 78109.pdf not found) INN (OLANZAPINE) OLANZAPINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091265 (pdf 91265.pdf not found) INN (OLANZAPINE) OLANZAPINE (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 091415 (pdf 91415.pdf not found) INN (OLANZAPINE) OLANZAPINE (TORRENT) APPROVAL= AP YEAR= 2011 , NDA 201588 (pdf 201588.pdf not found) INN (OLANZAPINE) OLANZAPINE (SANDOZ INC) APPROVAL= AP YEAR= 2011 , NDA 077742 (pdf 77742.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 2012 , NDA 078901 (pdf 78901.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 090798 (pdf 90798.pdf not found) INN (OLANZAPINE) OLANZAPINE (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 090881 (pdf 90881.pdf not found) INN (OLANZAPINE) OLANZAPINE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091038 (pdf 91038.pdf not found) INN (OLANZAPINE) OLANZAPINE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091434 (pdf 91434.pdf not found) INN (OLANZAPINE) OLANZAPINE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200221 (pdf 200221.pdf not found) INN (OLANZAPINE) OLANZAPINE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2012 , NDA 201741 (pdf 201741.pdf not found) INN (OLANZAPINE) OLANZAPINE (AM REGENT) APPROVAL= AP YEAR= 2012 , NDA 202050 (pdf 202050.pdf not found) INN (OLANZAPINE) OLANZAPINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202287 (pdf 202287.pdf not found) INN (OLANZAPINE) OLANZAPINE (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202074 (pdf 202074.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 202285 (pdf 202285.pdf not found) INN (OLANZAPINE) OLANZAPINE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202862 (pdf 202862.pdf not found) INN (OLANZAPINE) OLANZAPINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203708 (pdf 203708.pdf not found) INN (OLANZAPINE) OLANZAPINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 077301 (pdf 77301.pdf not found) INN (OLANZAPINE) OLANZAPINE (IVAX PHARMS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202937 (pdf 202937.pdf not found) INN (OLANZAPINE) OLANZAPINE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203044 (pdf 203044.pdf not found) INN (OLANZAPINE) OLANZAPINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 202295 (pdf 202295.pdf not found) INN (OLANZAPINE) OLANZAPINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 203333 (pdf 203333.pdf not found) INN (OLANZAPINE) OLANZAPINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2016 , NDA 203456 (pdf 203456.pdf not found) INN (OLANZAPINE) OLANZAPINE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2016 , NDA 204319 (pdf 204319.pdf not found) INN (OLANZAPINE) OLANZAPINE (QILU) APPROVAL= AP YEAR= 2016 , NDA 206711 (pdf 206711.pdf not found) INN (OLANZAPINE) OLANZAPINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204320 (pdf 204320.pdf not found) INN (OLANZAPINE) OLANZAPINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204866 (pdf 204866.pdf not found) INN (OLANZAPINE) OLANZAPINE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 090459 (pdf 90459.pdf not found) INN (OLANZAPINE) OLANZAPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 206238 (pdf 206238.pdf not found) INN (OLANZAPINE) OLANZAPINE (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208146 (pdf 208146.pdf not found) INN (OLANZAPINE) OLANZAPINE (HEC PHARM) APPROVAL= AP YEAR= 2018 , NDA 209399 (pdf 209399.pdf not found) INN (OLANZAPINE) OLANZAPINE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206155 (pdf 206155.pdf not found) INN (OLANZAPINE) OLANZAPINE (INDOCO) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206892 (pdf 206892.pdf not found) INN (OLANZAPINE) OLANZAPINE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2020 , NDA 206924 (pdf 206924.pdf not found) INN (OLANZAPINE) OLANZAPINE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210968 (pdf 210968.pdf not found) INN (OLANZAPINE) OLANZAPINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213378 (label 213378.pdf) INN (OLANZAPINE SAMIDORPHAN L-MALATE) LYBALVI (ALKERMES INC) APPROVAL= AP YEAR= 2021 , NDA 202889 (pdf 202889.pdf not found) INN (OLANZAPINE) OLANZAPINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 210022 (pdf 210022.pdf not found) INN (OLANZAPINE) OLANZAPINE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 217466 (pdf 217466.pdf not found) INN (OLANZAPINE) OLANZAPINE (ASPIRO) APPROVAL= AP YEAR= 2023 , 760 ; FEBUXOSTAT ; 144060-53-7 ; 2009 ; ; ; CLASS METABOLISM -- ANTIGOUT -- CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT -- XANTHINE OXIDASE INHIBITOR -- DECREASES SERUM URIC ACID , ; NDA 021856 (label 21856.pdf) INN (FEBUXOSTAT) ULORIC (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 205385 (pdf 205385.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205421 (pdf 205421.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 205414 (pdf 205414.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (HIKMA) APPROVAL= AP YEAR= 2019 , NDA 205406 (pdf 205406.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (LUPIN LTD) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 207293 (pdf 207293.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 205443 (pdf 205443.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 211339 (pdf 211339.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (BEIJING SL PHARMA CO LTD) APPROVAL= TA YEAR= 2018 , NDA 210461 (pdf 210461.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (MSN) APPROVAL= AP YEAR= 2019 , NDA 211837 (pdf 211837.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 205467 (pdf 205467.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 210292 (pdf 210292.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (INDOCO) APPROVAL= AP YEAR= 2019 , NDA 213069 (pdf 213069.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 205374 (pdf 205374.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 212924 (pdf 212924.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 206266 (pdf 206266.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 210741 (pdf 210741.pdf not found) INN (FEBUXOSTAT) FEBUXOSTAT (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 761 ; LATANOPROST ; 130209-82-4 ; 1996 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ANTIHYPERTENSIVE AGENTS -- PROSTANOID , ; NDA 020597 (label 20597.pdf) INN (LATANOPROST) XALATAN (UPJOHN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 076218 (pdf 76218.pdf not found) INN (LATANOPROST) LATANOPROST (PAR PHARM) APPROVAL= TA YEAR= 2007 , NDA 077697 (pdf 77697.pdf not found) INN (LATANOPROST) LATANOPROST (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091449 (pdf 91449.pdf not found) INN (LATANOPROST) LATANOPROST (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 200925 (pdf 200925.pdf not found) INN (LATANOPROST) LATANOPROST (AMRING PHARMS) APPROVAL= AP YEAR= 2011 , NDA 201006 (pdf 201006.pdf not found) INN (LATANOPROST) LATANOPROST (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2011 , NDA 201786 (pdf 201786.pdf not found) INN (LATANOPROST) LATANOPROST (SOMERSET) APPROVAL= AP YEAR= 2011 , NDA 090887 (pdf 90887.pdf not found) INN (LATANOPROST) LATANOPROST (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202077 (pdf 202077.pdf not found) INN (LATANOPROST) LATANOPROST (CARNEGIE) APPROVAL= AP YEAR= 2013 , NDA 202442 (pdf 202442.pdf not found) INN (LATANOPROST) LATANOPROST (FDC LTD) APPROVAL= AP YEAR= 2016 , NDA 206185 (label 206185.pdf) INN (LATANOPROST) XELPROS (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 208259 (label 208259.pdf) INN (LATANOPROST NETARSUDIL DIMESYLATE) ROCKLATAN (ALCON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 206519 (pdf 206519.pdf not found) INN (LATANOPROST) LATANOPROST (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 216472 (label 216472.pdf) INN (LATANOPROST) IYUZEH (THEA PHARMA) APPROVAL= AP YEAR= 2022 , 762 ; RILUZOLE ; 1744-22-5 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NEUROPROTECTIVE -- INHIBITORY EFFECT ON GLUTAMATE RELEASE -- PARTIAL INACTIVATION OF VOLTAGE-DEPENDENT SODIUM CHANNELS (PMID25548669) -- SEDATIVES -- MYORELAXANT -- TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) -- ACTIVATES SK CHANNELS BUT NOT BK CHANNELS , ; NDA 020599 (label 20599.pdf) INN (RILUZOLE) RILUTEK (COVIS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 076173 (pdf 76173.pdf not found) INN (RILUZOLE) RILUZOLE (IMPAX LABS) APPROVAL= AP YEAR= 2003 , NDA 091394 (pdf 91394.pdf not found) INN (RILUZOLE) RILUZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 091417 (pdf 91417.pdf not found) INN (RILUZOLE) RILUZOLE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 091300 (pdf 91300.pdf not found) INN (RILUZOLE) RILUZOLE (APOTEX CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203042 (pdf 203042.pdf not found) INN (RILUZOLE) RILUZOLE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 204048 (pdf 204048.pdf not found) INN (RILUZOLE) RILUZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 204430 (pdf 204430.pdf not found) INN (RILUZOLE) RILUZOLE (DAITO PHARMS CO LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209080 (label 209080.pdf) INN (RILUZOLE) TIGLUTIK KIT (ITALFARMACO SA) APPROVAL= AP YEAR= 2018 , NDA 206045 (pdf 206045.pdf not found) INN (RILUZOLE) RILUZOLE (KENTON) APPROVAL= AP YEAR= 2019 , NDA 212640 (label 212640.pdf) INN (RILUZOLE) EXSERVAN (AQUESTIVE) APPROVAL= AP YEAR= 2019 , 763 ; TAZAROTENE ; 118292-40-3 ; 1997 ; ; ; CLASS DERMATOLOGIC AGENTS -- KERATOLYTIC AGENTS -- PRODRUGS -- TERATOGENS -- RETINOIDS -- TREATMENT OF PSORIASIS AND ACNE -- RAPIDLY HYDROLYSED IN TAZAROTENIC ACID , ; NDA 020600 (label 20600.pdf) INN (TAZAROTENE) TAZORAC (ALLERGAN) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 021184 (label 21184.pdf) INN (TAZAROTENE) TAZORAC (ALLERGAN) APPROVAL= AP YEAR= 2000 , NDA 202428 (label 202428.pdf) INN (TAZAROTENE) FABIOR (MAYNE PHARMA) APPROVAL= AP YEAR= 2012 , NDA 208258 (label 208258.pdf) INN (TAZAROTENE) TAZAROTENE (TARO) APPROVAL= AP YEAR= 2017 , NDA 208662 (pdf 208662.pdf not found) INN (TAZAROTENE) TAZAROTENE (COSETTE) APPROVAL= AP YEAR= 2017 , NDA 209354 (label 209354.pdf) INN (HALOBETASOL PROPIONATE TAZAROTENE) DUOBRII (BAUSCH) APPROVAL= AP YEAR= 2019 , NDA 211175 (pdf 211175.pdf not found) INN (TAZAROTENE) TAZAROTENE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211882 (label 211882.pdf) INN (TAZAROTENE) ARAZLO (BAUSCH) APPROVAL= AP YEAR= 2019 , NDA 214136 (pdf 214136.pdf not found) INN (TAZAROTENE) TAZAROTENE (COSETTE) APPROVAL= AP YEAR= 2022 , NDA 215433 (pdf 215433.pdf not found) INN (TAZAROTENE) TAZAROTENE (COSETTE) APPROVAL= AP YEAR= 2022 , NDA 213079 (pdf 213079.pdf not found) INN (TAZAROTENE) TAZAROTENE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 , NDA 213644 (pdf 213644.pdf not found) INN (TAZAROTENE) TAZAROTENE (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2023 , NDA 217190 (pdf 217190.pdf not found) INN (HALOBETASOL PROPIONATE TAZAROTENE) HALOBETASOL PROPIONATE TAZAROTENE (TARO PHARMS) APPROVAL= TA YEAR= 2023 , 764 ; SIBUTRAMINE ; 106650-56-0 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; NDA 020632 (label 20632.pdf) INN (SIBUTRAMINE HYDROCHLORIDE) MERIDIA (ABBOTT) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 765 ; FEXOFENADINE ; 138452-21-8 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- NON-SEDATING H1 HISTAMINE ANTAGONIST -- ANTI-ALLERGIC AGENTS , ; NDA 020625 (label 20625.pdf) INN (FEXOFENADINE HYDROCHLORIDE) ALLEGRA (CHATTEM SANOFI) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020786 (label 20786.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 1997 , NDA 020872 (label 20872.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2000 , NDA 021704 (label 21704.pdf) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 2004 , NDA 021909 (label 21909.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 021963 (label 21963.pdf) INN (FEXOFENADINE HYDROCHLORIDE) ALLEGRA (CHATTEM SANOFI) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076169 (pdf 76169.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076236 (pdf 76236.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076298 (pdf 76298.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076447 (pdf 76447.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2005 , NDA 076502 (pdf 76502.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 076538 (pdf 76538.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HCL PSEUDOEPHEDRINE HCL (MYLAN) APPROVAL= TA YEAR= 2004 , NDA 076970 (pdf 76970.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2007 , NDA 077081 (pdf 77081.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 , NDA 076667 (pdf 76667.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 076707 (pdf 76707.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2009 , NDA 077999 (pdf 77999.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS LLC) APPROVAL= TA YEAR= 2010 , NDA 079043 (pdf 79043.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 076191 (pdf 76191.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 079115 (pdf 79115.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= TA YEAR= 2010 , NDA 201373 (label 201373.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S ALLEGRA ALLERGY (CHATTEM SANOFI) APPROVAL= AP YEAR= 2011 , NDA 079112 (pdf 79112.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (WOCKHARDT) APPROVAL= AP YEAR= 2012 , NDA 091567 (pdf 91567.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 , NDA 201311 (pdf 201311.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (P AND L) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202978 (label 202978.pdf) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202039 (pdf 202039.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 203330 (pdf 203330.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (P AND L) APPROVAL= AP YEAR= 2014 , NDA 090818 (pdf 90818.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015 , NDA 204507 (pdf 204507.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 204097 (pdf 204097.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 208123 (pdf 208123.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2017 , NDA 209116 (pdf 209116.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 210137 (pdf 210137.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (UNIQUE) APPROVAL= AP YEAR= 2018 , NDA 211075 (pdf 211075.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE ALLERGY (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 212971 (pdf 212971.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2020 , NDA 215434 (pdf 215434.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 213466 (pdf 213466.pdf not found) INN (FEXOFENADINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 766 ; PENCICLOVIR ; 39809-25-1 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- TREATMENT OF HERPES VIRUS HSV-1 AND HSV-2 , ; NDA 020629 (label 20629.pdf) INN (PENCICLOVIR) DENAVIR (MYLAN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 212710 (pdf 212710.pdf not found) INN (PENCICLOVIR) PENCICLOVIR (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 216981 (pdf 216981.pdf not found) INN (PENCICLOVIR) PENCICLOVIR (TORRENT) APPROVAL= AP YEAR= 2023 , 767 ; REMIFENTANIL ; 132875-61-7 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS, OPIOID , ; NDA 020630 (label 20630.pdf) INN (REMIFENTANIL HYDROCHLORIDE) ULTIVA (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 206223 (pdf 206223.pdf not found) INN (REMIFENTANIL HYDROCHLORIDE) REMIFENTANIL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210594 (pdf 210594.pdf not found) INN (REMIFENTANIL HYDROCHLORIDE) REMIFENTANIL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , 768 ; SIBUTRAMINE ; 106650-56-0 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; NDA 020632 (label 20632.pdf) INN (SIBUTRAMINE HYDROCHLORIDE) MERIDIA (ABBOTT) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 769 ; LEVOFLOXACIN ; 100986-85-4 ; 1990 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- NUCLEIC ACID SYNTHESIS INHIBITORS -- QUINOLONES , ; NDA 020634 (label 20634.pdf) INN (LEVOFLOXACIN) LEVAQUIN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020635 (label 20635.pdf) INN (LEVOFLOXACIN) LEVAQUIN (JANSSEN PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 021199 (label 21199.pdf) INN (LEVOFLOXACIN) QUIXIN (SANTEN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021571 (label 21571.pdf) INN (LEVOFLOXACIN) IQUIX (SANTEN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021721 (label 21721.pdf) INN (LEVOFLOXACIN) LEVAQUIN (JANSSEN PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021832 (pdf 21832.pdf not found) INN (LEVOFLOXACIN SODIUM CHLORIDE) LEVOFLOXACIN (SICOR PHARMS) APPROVAL= TA YEAR= 2005 , NDA 076276 (pdf 76276.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 076361 (pdf 76361.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (TEVA) APPROVAL= AP YEAR= 2011 , NDA 076599 (pdf 76599.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (BEDFORD LABS) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076614 (pdf 76614.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (BEDFORD LABS) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076710 (pdf 76710.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2011 , NDA 076826 (pdf 76826.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (WATSON LABS TEVA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 076839 (pdf 76839.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (SICOR PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 076854 (pdf 76854.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (SICOR PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 076874 (pdf 76874.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (RANBAXY) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076890 (pdf 76890.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 , NDA 077097 (pdf 77097.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077652 (pdf 77652.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 019735 (label 19735.pdf) INN (OFLOXACIN) FLOXIN (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 019921 (label 19921.pdf) INN (OFLOXACIN) OCUFLOX (ALLERGAN) APPROVAL= AP YEAR= 1993 , NDA 020087 (pdf 20087.pdf not found) INN (OFLOXACIN) FLOXIN IN DEXTROSE 5% (ORTHO MCNEIL PHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020799 (label 20799.pdf) INN (OFLOXACIN) FLOXIN OTIC (DAIICHI) APPROVAL= AP YEAR= 1997 , NDA 075762 (pdf 75762.pdf not found) INN (OFLOXACIN) OFLOXACIN (BEDFORD) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076093 (pdf 76093.pdf not found) INN (OFLOXACIN) OFLOXACIN (LARKEN LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076128 (pdf 76128.pdf not found) INN (OFLOXACIN) OFLOXACIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2003 , NDA 076182 (label 76182.pdf) INN (OFLOXACIN) OFLOXACIN (TEVA) APPROVAL= AP YEAR= 2001 , NDA 076220 (pdf 76220.pdf not found) INN (OFLOXACIN) OFLOXACIN (RANBAXY) APPROVAL= AP YEAR= 2003 , NDA 076231 (pdf 76231.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALCON) APPROVAL= AP YEAR= 2002 , NDA 076407 (pdf 76407.pdf not found) INN (OFLOXACIN) OFLOXACIN (AKORN) APPROVAL= AP YEAR= 2008 , NDA 076513 (pdf 76513.pdf not found) INN (OFLOXACIN) OFLOXACIN (NOVEX) APPROVAL= AP YEAR= 2003 , NDA 076527 (pdf 76527.pdf not found) INN (OFLOXACIN) OFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 076615 (pdf 76615.pdf not found) INN (OFLOXACIN) OFLOXACIN (HI TECH PHARMA) APPROVAL= AP YEAR= 2004 , NDA 076616 (pdf 76616.pdf not found) INN (OFLOXACIN) OFLOXACIN (HI TECH PHARMA) APPROVAL= AP YEAR= 2005 , NDA 076622 (pdf 76622.pdf not found) INN (OFLOXACIN) OFLOXACIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2004 , NDA 076830 (pdf 76830.pdf not found) INN (OFLOXACIN) OFLOXACIN (PHARMAFORCE) APPROVAL= AP YEAR= 2004 , NDA 077098 (pdf 77098.pdf not found) INN (OFLOXACIN) OFLOXACIN (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 078222 (pdf 78222.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALCON) APPROVAL= AP YEAR= 2007 , NDA 076848 (pdf 76848.pdf not found) INN (OFLOXACIN) OFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078559 (pdf 78559.pdf not found) INN (OFLOXACIN) OFLOXACIN (FDC LTD) APPROVAL= AP YEAR= 2009 , NDA 090395 (pdf 90395.pdf not found) INN (OFLOXACIN) OFLOXACIN (PHARMAFORCE) APPROVAL= AP YEAR= 2009 , NDA 077438 (pdf 77438.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 078282 (pdf 78282.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (RUBICON) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078424 (pdf 78424.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (LUPIN) APPROVAL= AP YEAR= 2011 , NDA 078577 (pdf 78577.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 078579 (pdf 78579.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2015 , NDA 090063 (pdf 90063.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MYLAN PHARMA) APPROVAL= TA YEAR= 2009 , NDA 090268 (pdf 90268.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090367 (pdf 90367.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (CELLTRION) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090722 (pdf 90722.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077700 (pdf 77700.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (RISING) APPROVAL= AP YEAR= 2010 , NDA 090305 (pdf 90305.pdf not found) INN (LEVOFLOXACIN DEXTROSE) LEVOFLOXACIN DEXTROSE (BEDFORD LABS) APPROVAL= TA YEAR= 2010 , NDA 078767 (pdf 78767.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (HIKMA PHARMS) APPROVAL= TA YEAR= 2011 , NDA 091644 (pdf 91644.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (RISING) APPROVAL= AP YEAR= 2011 , NDA 091678 (pdf 91678.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2011 , NDA 201043 (pdf 201043.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 202200 (pdf 202200.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 090343 (pdf 90343.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (INFORLIFE) APPROVAL= AP YEAR= 2011 , NDA 090787 (pdf 90787.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 091375 (pdf 91375.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2011 , NDA 200250 (pdf 200250.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 200560 (pdf 200560.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MYLAN ASI) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202692 (pdf 202692.pdf not found) INN (OFLOXACIN) OFLOXACIN (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 091656 (pdf 91656.pdf not found) INN (OFLOXACIN) OFLOXACIN (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 200839 (pdf 200839.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091397 (pdf 91397.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 , NDA 091436 (pdf 91436.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200674 (pdf 200674.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 201484 (pdf 201484.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (WATSON LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202328 (pdf 202328.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202590 (pdf 202590.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202801 (pdf 202801.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 203613 (pdf 203613.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206919 (pdf 206919.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205968 (pdf 205968.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204899 (pdf 204899.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205222 (pdf 205222.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (LANNETT CO INC) APPROVAL= AP YEAR= 2018 , NDA 204968 (pdf 204968.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (HEC PHARM) APPROVAL= AP YEAR= 2019 , NDA 205600 (pdf 205600.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2019 , NDA 211525 (pdf 211525.pdf not found) INN (OFLOXACIN) OFLOXACIN (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 205540 (pdf 205540.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 206908 (pdf 206908.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 215038 (pdf 215038.pdf not found) INN (OFLOXACIN) OFLOXACIN (FDC LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215886 (pdf 215886.pdf not found) INN (OFLOXACIN) OFLOXACIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216130 (pdf 216130.pdf not found) INN (OFLOXACIN) OFLOXACIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 211524 (pdf 211524.pdf not found) INN (OFLOXACIN) OFLOXACIN (AMNEAL) APPROVAL= AP YEAR= 2024 , NDA 217903 (pdf 217903.pdf not found) INN (OFLOXACIN) OFLOXACIN (CAPLIN) APPROVAL= AP YEAR= 2024 , NDA 217904 (pdf 217904.pdf not found) INN (OFLOXACIN) OFLOXACIN (CAPLIN) APPROVAL= AP YEAR= 2024 , NDA 216164 (pdf 216164.pdf not found) INN (LEVOFLOXACIN) LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (KNACK) APPROVAL= AP YEAR= 2024 , 770 ; NEVIRAPINE ; 129618-40-2 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTI-HIV AGENTS -- NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS , ; NDA 020636 (label 20636.pdf) INN (NEVIRAPINE) VIRAMUNE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020933 (label 20933.pdf) INN (NEVIRAPINE) VIRAMUNE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1998 , NDA 021837 (pdf 21837.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ARCOLAB) APPROVAL= TA YEAR= 2008 , NDA 021841 (pdf 21841.pdf not found) INN (NEVIRAPINE) LAMIVUDINE/ZIDOVUDINE TABLETS CO-PACKAGED WITH NEVIRAPINE TABLETS (PHARMACARE LTD) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 021939 (pdf 21939.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE , NEVIRAPINE TABS 150MG/300MG/200MG (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 021969 (pdf 21969.pdf not found) INN (LAMIVUDINE STAVUDINE NEVIRAPINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2006 , NDA 021971 (pdf 21971.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE ZIDOVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 021972 (pdf 21972.pdf not found) INN (NEVIRAPINE) LAMIVUDINE STAVUDINE NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 OBSOLETE , NDA 022177 (pdf 22177.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2008 , NDA 077429 (pdf 77429.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (RANBAXY) APPROVAL= TA YEAR= 2005 , NDA 077521 (pdf 77521.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (AUROBINDO) APPROVAL= AP YEAR= 2012 , NDA 077702 (pdf 77702.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (AUROBINDO) APPROVAL= AP YEAR= 2012 , NDA 077956 (pdf 77956.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (CIPLA) APPROVAL= AP YEAR= 2012 , NDA 078195 (pdf 78195.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 , NDA 078584 (pdf 78584.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2012 , NDA 078644 (pdf 78644.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (PRINSTON INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078864 (pdf 78864.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MYLAN LABS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078887 (pdf 78887.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2007 , NDA 021854 (pdf 21854.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE W/NEVIRAPINE (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 021988 (pdf 21988.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE/ZIDOVUDINE 150 MG/300 MG TABLETS CO-PACKAGED WITH NEVIRAPINE 200 MG TABLETS (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022061 (pdf 22061.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MATRIX LABS) APPROVAL= TA YEAR= 2008 , NDA 022299 (pdf 22299.pdf not found) INN (NEVIRAPINE) NEVIRAPINE TABLETS FOR ORAL SUSPENSION (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2010 , NDA 022342 (pdf 22342.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (EMCURE PHARMA) APPROVAL= TA YEAR= 2009 , NDA 022346 (pdf 22346.pdf not found) INN (STAVUDINE LAMIVUDINE NEVIRAPINE) STAVUDINE LAMIVUDINE NEVIRAPINE (PHARMACARE LTD) APPROVAL= TA YEAR= 2009 , NDA 022356 (pdf 22356.pdf not found) INN (LAMIVUDINE ZIDOVUDINE NEVIRAPINE) LAMIVUDINE , ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009 , NDA 022464 (label 22464.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2009 , NDA 090688 (pdf 90688.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 022537 (pdf 22537.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (MACLEODS PHARMA) APPROVAL= TA YEAR= 2010 , NDA 200244 (pdf 200244.pdf not found) INN (LAMIVUDINE NEVIRAPINE STAVUDINE) LAMIVUDINE , NEVIRAPINE , AND STAVUDINE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2010 , NDA 200793 (pdf 200793.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS (MATRIX LABS) APPROVAL= TA YEAR= 2010 , NDA 201152 (label 201152.pdf) INN (NEVIRAPINE) VIRAMUNE XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2011 , NDA 202157 (pdf 202157.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (HETERO LABS UNIT III) APPROVAL= TA YEAR= 2011 , NDA 202171 (pdf 202171.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 202523 (pdf 202523.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202589 (pdf 202589.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 202212 (pdf 202212.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 202685 (pdf 202685.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2012 , NDA 203021 (pdf 203021.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203076 (pdf 203076.pdf not found) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE NEVIRAPINE ZIDOVUDINE (CIPLA LTD) APPROVAL= TA YEAR= 2012 , NDA 203080 (pdf 203080.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MICRO LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 203176 (pdf 203176.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (TECH ORGANIZED) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 204505 (pdf 204505.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2013 , NDA 203411 (pdf 203411.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 205258 (pdf 205258.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205355 (pdf 205355.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014 , NDA 205651 (pdf 205651.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 205921 (pdf 205921.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206042 (pdf 206042.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) EMTRICITABINETENOFOVIR DISOPROXIL FUMARATENEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 204621 (pdf 204621.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (ALVOGEN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207064 (pdf 207064.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2015 , NDA 206271 (label 206271.pdf) INN (NEVIRAPINE) NEVIRAPINE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206448 (label 206448.pdf) INN (NEVIRAPINE) NEVIRAPINE (CIPLA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208616 (pdf 208616.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207467 (pdf 207467.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (TECH ORGANIZED) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207684 (pdf 207684.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 207698 (pdf 207698.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206879 (pdf 206879.pdf not found) INN (NEVIRAPINE) NEVIRAPINE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205626 (label 205626.pdf) INN (LAMIVUDINE NEVIRAPINE ZIDOVUDINE) LAMIVUDINE , NEVIRAPINE AND ZIDOVUDINE (MICRO LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , 771 ; CIDOFOVIR ; 113852-37-2 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- SUPPRESS CYTOMEGALOVIRUS (CMV) REPLICATION -- CMV DNA POLYMERASE INHIBITOR , ; NDA 020638 (label 20638.pdf) INN (CIDOFOVIR) VISTIDE (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 201276 (pdf 201276.pdf not found) INN (CIDOFOVIR) CIDOFOVIR (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2012 , NDA 202501 (pdf 202501.pdf not found) INN (CIDOFOVIR) CIDOFOVIR (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2012 , 772 ; TIAGABINE ; 115103-54-3 ; 1997 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ENHANCE THE ACTIVITY OF GABA -- NEUROPROTECTIVE AGENTS , ; NDA 020646 (label 20646.pdf) INN (TIAGABINE HYDROCHLORIDE) GABITRIL (CEPHALON) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 077555 (pdf 77555.pdf not found) INN (TIAGABINE HYDROCHLORIDE) TIAGABINE HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2011 , NDA 206857 (pdf 206857.pdf not found) INN (TIAGABINE HYDROCHLORIDE) TIAGABINE HYDROCHLORIDE (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208181 (pdf 208181.pdf not found) INN (TIAGABINE HYDROCHLORIDE) TIAGABINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 214816 (pdf 214816.pdf not found) INN (TIAGABINE HYDROCHLORIDE) TIAGABINE HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2021 , 773 ; ROPINIROLE ; 91374-21-9 ; 1997 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- NON-ERGOLINE DOPAMINE AGONISTS , ; NDA 020658 (label 20658.pdf) INN (ROPINIROLE HYDROCHLORIDE) REQUIP (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 022008 (label 22008.pdf) INN (ROPINIROLE HYDROCHLORIDE) REQUIP XL (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077460 (label 77460.pdf) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077852 (pdf 77852.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078110 (pdf 78110.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2008 , NDA 078230 (pdf 78230.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078881 (pdf 78881.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079050 (pdf 79050.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 090135 (pdf 90135.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 090411 (pdf 90411.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2009 , NDA 090429 (pdf 90429.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ALEMBIC LTD) APPROVAL= AP YEAR= 2010 , NDA 079165 (pdf 79165.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (MLV) APPROVAL= AP YEAR= 2012 , NDA 201576 (pdf 201576.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091395 (pdf 91395.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 202786 (pdf 202786.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 079229 (pdf 79229.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 090869 (pdf 90869.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 200431 (pdf 200431.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200462 (pdf 200462.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201047 (pdf 201047.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 204022 (pdf 204022.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 204413 (pdf 204413.pdf not found) INN (ROPINIROLE HYDROCHLORIDE) ROPINIROLE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , 774 ; RITONAVIR ; 155213-67-5 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV -- HIV PROTEASE INHIBITORS , ; NDA 020659 (label 20659.pdf) INN (RITONAVIR) NORVIR (ABBVIE) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020680 (pdf 20680.pdf not found) INN (RITONAVIR) NORVIR (ABBOTT) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020945 (label 20945.pdf) INN (RITONAVIR) NORVIR (ABBVIE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021226 (label 21226.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021251 (label 21251.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2000 , NDA 021906 (label 21906.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2005 , NDA 022417 (label 22417.pdf) INN (RITONAVIR) NORVIR (ABBVIE) APPROVAL= AP YEAR= 2010 , NDA 079074 (pdf 79074.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (MYLAN LABS LTD) APPROVAL= AP YEAR= 2024 , NDA 090371 (pdf 90371.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (CIPLA LIMITED) APPROVAL= TA YEAR= 2009 , NDA 090471 (pdf 90471.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2009 , NDA 091202 (label 91202.pdf) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (MYLAN PHARMA) APPROVAL= TA YEAR= 2011 , NDA 022282 (pdf 22282.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR) ATAZANAVIR SULFATE AND RITONAVIR (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091203 (pdf 91203.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 091677 (pdf 91677.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 202573 (label 202573.pdf) INN (RITONAVIR) RITONAVIR (CIPLA) APPROVAL= AP YEAR= 2015 , NDA 205508 (pdf 205508.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR) ATAZANAVIR SULFATE RITONAVIR (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2014 , NDA 206041 (pdf 206041.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR LAMIVUDINE ZIDOVUDINE) ATAZANAVIR SULFATERITONAVIRLAMIVUDINEZIDOVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206619 (label 206619.pdf) INN (DASABUVIR SODIUM OMBITASVIR PARITAPREVIR RITONAVIR) VIEKIRA PAK COPACKAGED (ABBVIE) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203759 (pdf 203759.pdf not found) INN (RITONAVIR) RITONAVIR (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 205040 (pdf 205040.pdf not found) INN (RITONAVIR) RITONAVIR (CIPLA LIMITED) APPROVAL= TA YEAR= 2015 , NDA 205425 (pdf 205425.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (CIPLA LTD) APPROVAL= TA YEAR= 2015 , NDA 207931 (label 207931.pdf) INN (OMBITASVIR PARITAPREVIR RITONAVIR) TECHNIVIE (ABBVIE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202738 (pdf 202738.pdf not found) INN (RITONAVIR) RITONAVIR (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2016 , NDA 204739 (pdf 204739.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 206614 (pdf 206614.pdf not found) INN (RITONAVIR) RITONAVIR (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207407 (label 207407.pdf) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 208624 (label 208624.pdf) INN (DASABUVIR SODIUM OMBITASVIR PARITAPREVIR RITONAVIR) VIEKIRA XR (ABBVIE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204587 (pdf 204587.pdf not found) INN (RITONAVIR) RITONAVIR (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 209512 (label 209512.pdf) INN (RITONAVIR) NORVIR (ABBVIE) APPROVAL= AP YEAR= 2017 , NDA 208890 (pdf 208890.pdf not found) INN (RITONAVIR) RITONAVIR (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 205801 (pdf 205801.pdf not found) INN (RITONAVIR) RITONAVIR (HIKMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213857 (pdf 213857.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (LAURUS) APPROVAL= AP YEAR= 2022 , NDA 217188 (label 217188.pdf) INN (NIRMATRELVIR RITONAVIR) PAXLOVID COPACKAGED (PFIZER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , NDA 209847 (pdf 209847.pdf not found) INN (DARUNAVIR RITONAVIR) DARUNAVIR AND RITONAVIR (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2023 , NDA 205024 (pdf 205024.pdf not found) INN (RITONAVIR) RITONAVIR (MYLAN) APPROVAL= AP YEAR= 2024 , 775 ; CABERGOLINE ; 81409-90-7 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- PROLACTIN SECRETION INHIBITOR -- ANTIPARKINSON AGENTS -- DOPAMINE AGONISTS , ; NDA 020664 (label 20664.pdf) INN (CABERGOLINE) DOSTINEX (PFIZER) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 076310 (pdf 76310.pdf not found) INN (CABERGOLINE) CABERGOLINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2005 , NDA 077750 (pdf 77750.pdf not found) INN (CABERGOLINE) CABERGOLINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077843 (pdf 77843.pdf not found) INN (CABERGOLINE) CABERGOLINE (IMPAX LABS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078035 (pdf 78035.pdf not found) INN (CABERGOLINE) CABERGOLINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201503 (pdf 201503.pdf not found) INN (CABERGOLINE) CABERGOLINE (APOTEX CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202947 (pdf 202947.pdf not found) INN (CABERGOLINE) CABERGOLINE (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204735 (pdf 204735.pdf not found) INN (CABERGOLINE) CABERGOLINE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2018 , 776 ; VALSARTAN ; 137862-53-4 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II ANTAGONIST , ; NDA 020665 (label 20665.pdf) INN (VALSARTAN) DIOVAN (NOVARTIS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 020818 (label 20818.pdf) INN (HYDROCHLOROTHIAZIDE VALSARTAN) DIOVAN HCT (NOVARTIS) APPROVAL= AP YEAR= 1998 , NDA 021283 (label 21283.pdf) INN (VALSARTAN) DIOVAN (NOVARTIS) APPROVAL= AP YEAR= 2001 , NDA 021990 (label 21990.pdf) INN (AMLODIPINE BESYLATE VALSARTAN) EXFORGE (NOVARTIS) APPROVAL= AP YEAR= 2007 , NDA 077492 (label 77492.pdf) INN (VALSARTAN) VALSARTAN (OHM LABS INC) APPROVAL= AP YEAR= 2014 , NDA 077530 (pdf 77530.pdf not found) INN (VALSARTAN) VALSARTAN (IVAX PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 078020 (pdf 78020.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 022217 (label 22217.pdf) INN (ALISKIREN HEMIFUMARATE VALSARTAN) VALTURNA (NOVARTIS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022314 (label 22314.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) EXFORGE HCT (NOVARTIS) APPROVAL= AP YEAR= 2009 , NDA 090011 (pdf 90011.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (STRIDES PHARMA) APPROVAL= AP YEAR= 2013 , NDA 090144 (pdf 90144.pdf not found) INN (VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (PAR PHARM INC) APPROVAL= AP YEAR= 2010 OBSOLETE , NDA 090483 (pdf 90483.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 090866 (pdf 90866.pdf not found) INN (VALSARTAN) VALSARTAN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 091519 (pdf 91519.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091654 (pdf 91654.pdf not found) INN (VALSARTAN HYDROCHLOROTHIAZIDE) VALSARTAN HYDROCHLOROTHIAZIDE (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 200435 (pdf 200435.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078946 (pdf 78946.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 090245 (pdf 90245.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (LUPIN) APPROVAL= AP YEAR= 2015 , NDA 090642 (pdf 90642.pdf not found) INN (VALSARTAN) VALSARTAN (WATSON LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091367 (pdf 91367.pdf not found) INN (VALSARTAN) VALSARTAN (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 200797 (pdf 200797.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201087 (pdf 201087.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 201618 (label 201618.pdf) INN (VALSARTAN) VALSARTAN (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 201662 (pdf 201662.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 201677 (pdf 201677.pdf not found) INN (VALSARTAN) VALSARTAN (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202223 (pdf 202223.pdf not found) INN (VALSARTAN) VALSARTAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 202519 (pdf 202519.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203026 (pdf 203026.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203145 (pdf 203145.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 091235 (pdf 91235.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201593 (pdf 201593.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202377 (pdf 202377.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202713 (pdf 202713.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 202728 (pdf 202728.pdf not found) INN (VALSARTAN) VALSARTAN (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202829 (pdf 202829.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203311 (pdf 203311.pdf not found) INN (VALSARTAN) VALSARTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 203536 (pdf 203536.pdf not found) INN (VALSARTAN) VALSARTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 , NDA 204821 (pdf 204821.pdf not found) INN (VALSARTAN) VALSARTAN (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 207620 (label 207620.pdf) INN (SACUBITRIL VALSARTAN) ENTRESTO (NOVARTIS PHARMS CORP) APPROVAL= AP YEAR= 2015 , NDA 204011 (pdf 204011.pdf not found) INN (VALSARTAN) VALSARTAN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206083 (pdf 206083.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2016 , NDA 206302 (label 206302.pdf) INN (NEBIVOLOL HYDROCHLORIDE VALSARTAN) BYVALSON (ABBVIE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206512 (pdf 206512.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 202696 (pdf 202696.pdf not found) INN (VALSARTAN) VALSARTAN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 205137 (pdf 205137.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (HETERO LABS) APPROVAL= AP YEAR= 2016 , NDA 205357 (pdf 205357.pdf not found) INN (VALSARTAN) VALSARTAN (HUAREN PHARMACEUTICAL CO LTD) APPROVAL= TA YEAR= 2016 , NDA 205439 (pdf 205439.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) HYDROCHLOROTHIAZIDE VALSARTAN (HUAREN PHARMACEUTICAL CO LTD) APPROVAL= TA YEAR= 2017 , NDA 206180 (pdf 206180.pdf not found) INN (VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 209139 (label 209139.pdf) INN (VALSARTAN) PREXXARTAN (CARMEL BIOSCIENCES) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205347 (pdf 205347.pdf not found) INN (VALSARTAN) VALSARTAN (SQUARE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209261 (pdf 209261.pdf not found) INN (VALSARTAN) VALSARTAN (UNICHEM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 203000 (pdf 203000.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205536 (pdf 205536.pdf not found) INN (VALSARTAN) VALSARTAN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 204038 (pdf 204038.pdf not found) INN (VALSARTAN) VALSARTAN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214102 (pdf 214102.pdf not found) INN (VALSARTAN) VALSARTAN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 210596 (pdf 210596.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE VALSARTAN) VYDUO (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 204382 (pdf 204382.pdf not found) INN (HYDROCHLOROTHIAZIDE VALSARTAN) VALSARTAN AND HYDROCHLOROTHIAZIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2023 , NDA 213605 (pdf 213605.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (CRYSTAL) APPROVAL= AP YEAR= 2024 , NDA 213676 (pdf 213676.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (LAURUS) APPROVAL= AP YEAR= 2024 , NDA 213682 (pdf 213682.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (ALEMBIC) APPROVAL= AP YEAR= 2024 , NDA 218591 (pdf 218591.pdf not found) INN (SACUBITRIL VALSARTAN) ENTRESTO SPRINKLE (NOVARTIS) APPROVAL= AP YEAR= 2024 , 777 ; ALBENDAZOLE ; 54965-21-8 ; 1996 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- ANTIPROTOZOAL AGENTS -- TUBULIN MODULATORS -- INHIBITORY EFFECT ON TUBULIN POLYMERIZATION -- ANTIMALARIALS , ; NDA 020666 (label 20666.pdf) INN (ALBENDAZOLE) ALBENZA (IMPAX LABS INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 207844 (label 207844.pdf) INN (ALBENDAZOLE) ALBENZA (AMEDRA PHARMS LLC) APPROVAL= AP YEAR= 2015 DISCONTINUED OBSOLETE , NDA 208979 (pdf 208979.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210011 (pdf 210011.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210434 (pdf 210434.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (CIPLA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208094 (pdf 208094.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2019 , NDA 211117 (pdf 211117.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211636 (pdf 211636.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211034 (pdf 211034.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 213435 (pdf 213435.pdf not found) INN (ALBENDAZOLE) ALBENDAZOLE (MSN) APPROVAL= AP YEAR= 2021 , 778 ; TOPOTECAN ; 123948-87-8 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- TOPOISOMERASE INHIBITOR -- TREATMENT OF METASTATIC CARCINOMA OF THE OVARY, SMALL CELL LUNG CANCER -- DERIVATIVE OF CAMPTOTHECIN , ; NDA 020671 (label 20671.pdf) INN (TOPOTECAN HYDROCHLORIDE) HYCAMTIN (SANDOZ) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 020981 (label 20981.pdf) INN (TOPOTECAN HYDROCHLORIDE) HYCAMTIN (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 091089 (pdf 91089.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 091376 (pdf 91376.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090620 (pdf 90620.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2010 , NDA 091199 (pdf 91199.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (TEYRO LABS) APPROVAL= AP YEAR= 2010 , NDA 091284 (pdf 91284.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200199 (label 200199.pdf) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN (SANDOZ INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200582 (label 200582.pdf) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2011 , NDA 201191 (pdf 201191.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 022453 (label 22453.pdf) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2012 , NDA 091542 (pdf 91542.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201166 (pdf 201166.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202203 (pdf 202203.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202351 (pdf 202351.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 206962 (pdf 206962.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 204406 (pdf 204406.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 206074 (pdf 206074.pdf not found) INN (TOPOTECAN HYDROCHLORIDE) TOPOTECAN HYDROCHLORIDE (DASH PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , 779 ; SPARFLOXACIN ; 110871-86-8 ; 1996 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL AGENTS -- DNA GYRASE (A BACTERIAL TOPOISOMERASE) INHIBITOR , ; NDA 020677 (label 20677.pdf) INN (SPARFLOXACIN) ZAGAM (MYLAN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , 780 ; MIGLITOL ; 72432-03-2 ; 1996 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- MEMBRANE-BOUND INTESTINAL ALPHA-GLUCOSIDE HYDROLASE INHIBITOR -- MANAGEMENT OF ON-INSULIN-DEPENDENT DIABETES MELLITUS (NIDDM) , ; NDA 020682 (label 20682.pdf) INN (MIGLITOL) GLYSET (PFIZER) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 203965 (pdf 203965.pdf not found) INN (MIGLITOL) MIGLITOL (WESTMINSTER PHARMS) APPROVAL= AP YEAR= 2015 , 781 ; MIFEPRISTONE ; 84371-65-3 ; 2000 ; ; ; CLASS GENITO -- CONTRACEPTIVE -- ANTIPROGESTERONE -- USED TO END AN EARLY PREGNANCY , ; NDA 020687 (label 20687.pdf) INN (MIFEPRISTONE) MIFEPREX (DANCO LABS LLC) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 202107 (label 202107.pdf) INN (MIFEPRISTONE) KORLYM (CORCEPT THERAP) APPROVAL= AP YEAR= 2012 , NDA 091178 (pdf 91178.pdf not found) INN (MIFEPRISTONE) MIFEPRISTONE (GENBIOPRO) APPROVAL= AP YEAR= 2019 , NDA 211436 (pdf 211436.pdf not found) INN (MIFEPRISTONE) MIFEPRISTONE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 , 782 ; OLOPATADINE ; 113806-05-6 ; 1996 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTIALLERGIC -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- HISTAMINE H1 ANTAGONISTS -- NON-SEDATING , ; NDA 020688 (label 20688.pdf) INN (OLOPATADINE HYDROCHLORIDE) PATADAY TWICE DAILY RELIEF (ALCON LABS INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021545 (label 21545.pdf) INN (OLOPATADINE HYDROCHLORIDE) PATADAY ONCE DAILY RELIEF (ALCON LABS INC) APPROVAL= AP YEAR= 2004 , NDA 021861 (label 21861.pdf) INN (OLOPATADINE HYDROCHLORIDE) PATANASE (NOVARTIS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078350 (pdf 78350.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 090972 (pdf 90972.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2010 , NDA 090848 (label 90848.pdf) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2015 , NDA 090918 (pdf 90918.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 200810 (pdf 200810.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 091572 (pdf 91572.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2014 , NDA 202526 (pdf 202526.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2014 , NDA 203416 (pdf 203416.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (WATSON LABS) APPROVAL= TA YEAR= 2015 , NDA 206276 (label 206276.pdf) INN (OLOPATADINE HYDROCHLORIDE) PATADAY ONCE DAILY RELIEF (ALCON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203152 (label 203152.pdf) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (USV) APPROVAL= AP YEAR= 2015 , NDA 204706 (pdf 204706.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (ZAMBON SPA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204812 (pdf 204812.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 206306 (pdf 206306.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2015 , NDA 204723 (pdf 204723.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 202853 (pdf 202853.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 204532 (pdf 204532.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206046 (pdf 206046.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206087 (pdf 206087.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204392 (pdf 204392.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209919 (pdf 209919.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 209015 (pdf 209015.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (APOTEX INC) APPROVAL= TA YEAR= 2019 , NDA 209420 (pdf 209420.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 209995 (pdf 209995.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 209282 (pdf 209282.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (FDC LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209619 (pdf 209619.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 204620 (pdf 204620.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208637 (pdf 208637.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (FLORIDA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209752 (pdf 209752.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 210901 (pdf 210901.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 213757 (pdf 213757.pdf not found) INN (OLOPATADINE HYDROCHLORIDE) OLOPATADINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211746 (label 211746.pdf) INN (MOMETASONE FUROATE OLOPATADINE HYDROCHLORIDE) RYALTRIS (GLENMARK SPECIALTY) APPROVAL= AP YEAR= 2022 , 783 ; DONEPEZIL ; 120014-06-4 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ACETYLCHOLINESTERASE INHIBITOR (REVERSIBLE) -- COGNITIVE ENHANCER -- ANTI-ALZHEIMER'S DISEASE -- CHOLINESTERASE INHIBITORS -- INCREASES CONCENTRATION OF ACETYLCHOLINE , ; NDA 020690 (label 20690.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021719 (label 21719.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021720 (label 21720.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT ODT (EISAI INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076786 (pdf 76786.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076893 (pdf 76893.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (PAR PHARM) APPROVAL= TA YEAR= 2007 , NDA 077344 (pdf 77344.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078662 (pdf 78662.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 077975 (label 77975.pdf) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078388 (pdf 78388.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078841 (pdf 78841.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090056 (pdf 90056.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (AUROBINDO) APPROVAL= AP YEAR= 2011 , NDA 090100 (pdf 90100.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 090686 (pdf 90686.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 022568 (label 22568.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 2010 , NDA 090175 (pdf 90175.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090247 (pdf 90247.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090290 (pdf 90290.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090425 (pdf 90425.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 , NDA 090493 (pdf 90493.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077518 (pdf 77518.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CIPLA LTD) APPROVAL= AP YEAR= 2011 , NDA 090521 (pdf 90521.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090551 (pdf 90551.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 090768 (pdf 90768.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2011 , NDA 091198 (pdf 91198.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091267 (pdf 91267.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200292 (pdf 200292.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2011 , NDA 201001 (pdf 201001.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 201335 (pdf 201335.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201634 (pdf 201634.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (INDICUS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 201146 (pdf 201146.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201787 (pdf 201787.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201724 (pdf 201724.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202114 (pdf 202114.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2013 , NDA 202542 (pdf 202542.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202631 (pdf 202631.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 202723 (label 202723.pdf) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 203104 (pdf 203104.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203907 (pdf 203907.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 206439 (label 206439.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) NAMZARIC (ABBVIE) APPROVAL= AP YEAR= 2014 , NDA 203034 (pdf 203034.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 204293 (pdf 204293.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203114 (pdf 203114.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202415 (pdf 202415.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202656 (pdf 202656.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202782 (pdf 202782.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 203419 (pdf 203419.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203656 (pdf 203656.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203713 (pdf 203713.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2016 , NDA 204831 (pdf 204831.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202410 (pdf 202410.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208328 (label 208328.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203162 (pdf 203162.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204609 (pdf 204609.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 208672 (pdf 208672.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2017 , NDA 205269 (pdf 205269.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2018 , NDA 212304 (label 212304.pdf) INN (DONEPEZIL HYDROCHLORIDE) ADLARITY (CORIUM) APPROVAL= AP YEAR= 2022 , NDA 216901 (pdf 216901.pdf not found) INN (MEMANTINE DONEPEZIL HYDROCHLORIDES) MEMANTINEDONEPEZIL HYDROCHLORIDES (XIAMEN LP PHARM CO) APPROVAL= TA YEAR= 2024 , NDA 208237 (pdf 208237.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2023 , 784 ; GREPAFLOXACIN ; 119914-60-2 ; 1997 ; DISCONTINUED ; ; CLASS ANTIBIOTIC -- ANTIBACTERIAL -- ANTIINFECTIVES -- INHIBITOR , ; NDA 020695 (pdf 20695.pdf not found) INN (GREPAFLOXACIN HYDROCHLORIDE) RAXAR (OTSUKA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 785 ; FOMEPIZOLE ; 7554-65-6 ; 1997 ; ; ; CLASS VARIOUS -- ANTIDOTE -- OMPETITIVE INHIBITOR OF ALCOHOL DEHYDROGENASE , ; NDA 020696 (label 20696.pdf) INN (FOMEPIZOLE) ANTIZOL (PAR PHARM INC) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 078368 (pdf 78368.pdf not found) INN (FOMEPIZOLE) FOMEPIZOLE (AM REGENT) APPROVAL= AP YEAR= 2007 , NDA 078537 (pdf 78537.pdf not found) INN (FOMEPIZOLE) FOMEPIZOLE (NAVINTA LLC) APPROVAL= AP YEAR= 2008 , NDA 078639 (pdf 78639.pdf not found) INN (FOMEPIZOLE) FOMEPIZOLE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2008 , NDA 079033 (pdf 79033.pdf not found) INN (FOMEPIZOLE) FOMEPIZOLE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 216791 (pdf 216791.pdf not found) INN (FOMEPIZOLE) FOMEPIZOLE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 786 ; TOLCAPONE ; 134308-13-7 ; 1998 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- CATECHOL O-METHYLTRANSFERASE (COMT) INHIBITOR -- DRUG IS METHYLATED BY COMT TO 3-O-METHYL-TOLCAPON , ; NDA 020697 (label 20697.pdf) INN (TOLCAPONE) TASMAR (BAUSCH) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 204584 (pdf 204584.pdf not found) INN (TOLCAPONE) TOLCAPONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208937 (pdf 208937.pdf not found) INN (TOLCAPONE) TOLCAPONE (NOVAST LABS) APPROVAL= AP YEAR= 2018 , NDA 210095 (pdf 210095.pdf not found) INN (TOLCAPONE) TOLCAPONE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207729 (pdf 207729.pdf not found) INN (TOLCAPONE) TOLCAPONE (ALVOGEN) APPROVAL= AP YEAR= 2020 DISCONTINUED , 787 ; ATORVASTATIN ; 134523-00-5 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERLIPIDEMIC -- HMG-COA REDUCTASE INHIBITOR -- ANTICHOLESTEREMIC AGENTS , ; NDA 020702 (label 20702.pdf) INN (ATORVASTATIN CALCIUM) LIPITOR (UPJOHN) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021540 (label 21540.pdf) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) CADUET (PHARMACIA) APPROVAL= AP YEAR= 2004 , NDA 076477 (pdf 76477.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 , NDA 078773 (pdf 78773.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091226 (pdf 91226.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 077575 (pdf 77575.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 090548 (pdf 90548.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 091650 (pdf 91650.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202357 (pdf 202357.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091624 (pdf 91624.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 200153 (label 200153.pdf) INN (ATORVASTATIN CALCIUM EZETIMIBE) LIPTRUZET (ORGANON) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200465 (pdf 200465.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (MYLAN) APPROVAL= AP YEAR= 2013 , NDA 203874 (pdf 203874.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 205519 (pdf 205519.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 204846 (pdf 204846.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (INVAGEN PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205300 (pdf 205300.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 206084 (pdf 206084.pdf not found) INN (ATORVASTATIN CALCIUM EZETIMIBE) LYPQOZET (ALTHERA PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207687 (pdf 207687.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 206536 (pdf 206536.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209288 (pdf 209288.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 209912 (pdf 209912.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204991 (pdf 204991.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 207762 (pdf 207762.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211933 (pdf 211933.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (MSN) APPROVAL= AP YEAR= 2019 , NDA 205199 (pdf 205199.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 205945 (pdf 205945.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2019 , NDA 208478 (pdf 208478.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213853 (pdf 213853.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (UMEDICA) APPROVAL= AP YEAR= 2020 , NDA 214659 (pdf 214659.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 214969 (pdf 214969.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (AGNITIO) APPROVAL= AP YEAR= 2021 , NDA 216436 (pdf 216436.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216848 (pdf 216848.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (LEPU PHARM) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213260 (label 213260.pdf) INN (ATORVASTATIN CALCIUM) ATORVALIQ (CMP DEV LLC) APPROVAL= AP YEAR= 2023 , NDA 212103 (pdf 212103.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214344 (pdf 214344.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 217634 (pdf 217634.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (ACI) APPROVAL= AP YEAR= 2023 , NDA 208480 (pdf 208480.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 211886 (pdf 211886.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (SHANDONG XINHUA) APPROVAL= AP YEAR= 2024 , NDA 214513 (pdf 214513.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (LAURUS) APPROVAL= AP YEAR= 2024 , NDA 217081 (pdf 217081.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , NDA 217118 (pdf 217118.pdf not found) INN (ATORVASTATIN CALCIUM) ATORVASTATIN CALCIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 788 ; MODAFINIL ; 68693-11-8 ; 1998 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- TARGETS UNKNOWN -- ANOREXIGENIC AGENTS -- MODAFINIL HAS WAKE-PROMOTING ACTIONS SIMILAR TO SYMPATHOMIMETIC AGENTS LIKE AMPHETAMINE -- RACEMIC L-ISOMER AND D-ISOMER DO NOT INTERCONVERT , ; NDA 020717 (label 20717.pdf) INN (MODAFINIL) PROVIGIL (CEPHALON) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 076594 (pdf 76594.pdf not found) INN (MODAFINIL) MODAFINIL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 076596 (pdf 76596.pdf not found) INN (MODAFINIL) MODAFINIL (TEVA PHARMS) APPROVAL= TA YEAR= 2005 , NDA 076597 (pdf 76597.pdf not found) INN (MODAFINIL) MODAFINIL (BARR) APPROVAL= TA YEAR= 2004 , NDA 076715 (pdf 76715.pdf not found) INN (MODAFINIL) MODAFINIL (WATSON LABS INC) APPROVAL= AP YEAR= 2012 , NDA 076935 (pdf 76935.pdf not found) INN (MODAFINIL) MODAFINIL (SANDOZ) APPROVAL= TA YEAR= 2006 , NDA 077667 (pdf 77667.pdf not found) INN (MODAFINIL) MODAFINIL (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 077892 (pdf 77892.pdf not found) INN (MODAFINIL) MODAFINIL (CARACO) APPROVAL= TA YEAR= 2007 , NDA 021875 (label 21875.pdf) INN (ARMODAFINIL) NUVIGIL (CEPHALON) APPROVAL= AP YEAR= 2007 , NDA 078963 (pdf 78963.pdf not found) INN (MODAFINIL) MODAFINIL (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 076595 (pdf 76595.pdf not found) INN (MODAFINIL) MODAFINIL (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 200043 (pdf 200043.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 090543 (pdf 90543.pdf not found) INN (MODAFINIL) MODAFINIL (HIKMA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202566 (pdf 202566.pdf not found) INN (MODAFINIL) MODAFINIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202700 (pdf 202700.pdf not found) INN (MODAFINIL) MODAFINIL (ALEMBIC) APPROVAL= AP YEAR= 2012 , NDA 200156 (pdf 200156.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200751 (pdf 200751.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 200152 (pdf 200152.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2014 , NDA 201514 (pdf 201514.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (COREPHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 202768 (pdf 202768.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207196 (pdf 207196.pdf not found) INN (MODAFINIL) MODAFINIL (APPCO) APPROVAL= AP YEAR= 2017 , NDA 209966 (pdf 209966.pdf not found) INN (MODAFINIL) MODAFINIL (CADILA) APPROVAL= AP YEAR= 2017 , NDA 206069 (pdf 206069.pdf not found) INN (ARMODAFINIL) ARMODAFINIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , 789 ; EPTIFIBATIDE ; 148031-34-9 ; 1998 ; ; ; CLASS BLOOD -- ANTICOAGULANTS -- ANTIPLATELET AGENTS -- PLATELET AGGREGATION INHIBITORS , ; NDA 020718 (label 20718.pdf) INN (EPTIFIBATIDE) INTEGRILIN (MSD SUB MERCK) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY DISCONTINUED , NDA 090854 (pdf 90854.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 091555 (pdf 91555.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206127 (pdf 206127.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 205581 (pdf 205581.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204589 (pdf 204589.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205557 (pdf 205557.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204693 (pdf 204693.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 203258 (pdf 203258.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 208554 (pdf 208554.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2018 , NDA 204361 (pdf 204361.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (USV) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 204362 (pdf 204362.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (USV) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209864 (pdf 209864.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2019 , NDA 207864 (pdf 207864.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (HYBIO) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213081 (pdf 213081.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (SHUANGCHENG) APPROVAL= AP YEAR= 2021 , NDA 213599 (pdf 213599.pdf not found) INN (EPTIFIBATIDE) EPTIFIBATIDE (HONG KONG) APPROVAL= AP YEAR= 2024 , 790 ; TROGLITAZONE ; 97322-87-7 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- PPAR AGONIST , ; NDA 020719 (label 20719.pdf) INN (TROGLITAZONE) PRELAY (SANKYO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020720 (label 20720.pdf) INN (TROGLITAZONE) REZULIN (PFIZER PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 791 ; IMIQUIMOD ; 99011-02-6 ; 1997 ; ; ; CLASS DERMATOLOGICALS -- IMMUNOMODULATOR -- ANTIVIRAL -- ADJUVANTS, IMMUNOLOGIC -- ANTINEOPLASTIC AGENTS -- INTERFERON INDUCERS -- TREATMENT OF ACTINIC KERATOSIS, UPERFICIAL BASAL CELL CARCINOMA AND EXTERNAL GENITAL WARTS -- TOLL-LIKE RECEPTOR 7 AGONIST THAT ACTIVATES IMMUNE CELLS , ; NDA 020723 (label 20723.pdf) INN (IMIQUIMOD) ALDARA (BAUSCH) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 022483 (label 22483.pdf) INN (IMIQUIMOD) ZYCLARA (BAUSCH) APPROVAL= AP YEAR= 2010 , NDA 078548 (pdf 78548.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (FOUGERA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078837 (pdf 78837.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2010 , NDA 091044 (pdf 91044.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (ENCUBE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200173 (pdf 200173.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (TARO) APPROVAL= AP YEAR= 2011 , NDA 200481 (pdf 200481.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (COSETTE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201153 (label 201153.pdf) INN (IMIQUIMOD) ZYCLARA (GRACEWAY) APPROVAL= AP YEAR= 2011 NEWAPPLICATION , NDA 091308 (pdf 91308.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 201994 (pdf 201994.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202002 (label 202002.pdf) INN (IMIQUIMOD) IMIQUIMOD (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205971 (pdf 205971.pdf not found) INN (IMIQUIMOD) IMIQUIMOD (TARO) APPROVAL= AP YEAR= 2021 , 792 ; LETROZOLE ; 112809-51-5 ; 1997 ; ; ; CLASS ANTINEOPLASTIC -- AROMATASE INHIBITORS -- TREATMENT OF POSTMENOPAUSAL WOMEN WITH EARLY BREAST CANCER (INHIBITOR OF ESTROGEN SYNTHESIS) , ; NDA 020726 (label 20726.pdf) INN (LETROZOLE) FEMARA (NOVARTIS PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 078190 (pdf 78190.pdf not found) INN (LETROZOLE) LETROZOLE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090289 (pdf 90289.pdf not found) INN (LETROZOLE) LETROZOLE (TEVA PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090405 (pdf 90405.pdf not found) INN (LETROZOLE) LETROZOLE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2010 , NDA 090838 (pdf 90838.pdf not found) INN (LETROZOLE) LETROZOLE (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090196 (pdf 90196.pdf not found) INN (LETROZOLE) LETROZOLE (SYNTHON PHARMS) APPROVAL= TA YEAR= 2010 , NDA 090491 (pdf 90491.pdf not found) INN (LETROZOLE) LETROZOLE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090934 (pdf 90934.pdf not found) INN (LETROZOLE) LETROZOLE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 090789 (pdf 90789.pdf not found) INN (LETROZOLE) LETROZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091098 (pdf 91098.pdf not found) INN (LETROZOLE) LETROZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091191 (pdf 91191.pdf not found) INN (LETROZOLE) LETROZOLE (CARNEGIE) APPROVAL= AP YEAR= 2011 , NDA 091466 (pdf 91466.pdf not found) INN (LETROZOLE) LETROZOLE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091638 (pdf 91638.pdf not found) INN (LETROZOLE) LETROZOLE (IMPAX LABS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200161 (pdf 200161.pdf not found) INN (LETROZOLE) LETROZOLE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 201804 (pdf 201804.pdf not found) INN (LETROZOLE) LETROZOLE (INDICUS PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090292 (pdf 90292.pdf not found) INN (LETROZOLE) LETROZOLE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091303 (pdf 91303.pdf not found) INN (LETROZOLE) LETROZOLE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202716 (pdf 202716.pdf not found) INN (LETROZOLE) LETROZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202048 (pdf 202048.pdf not found) INN (LETROZOLE) LETROZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203796 (pdf 203796.pdf not found) INN (LETROZOLE) LETROZOLE (HIKMA PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 209935 (label 209935.pdf) INN (LETROZOLE RIBOCICLIB SUCCINATE) KISQALI FEMARA CO-PACK COPACKAGED (NOVARTIS) APPROVAL= AP YEAR= 2017 , NDA 205869 (pdf 205869.pdf not found) INN (LETROZOLE) LETROZOLE (BEIJING YILING) APPROVAL= AP YEAR= 2018 , NDA 211717 (pdf 211717.pdf not found) INN (LETROZOLE) LETROZOLE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 215975 (pdf 215975.pdf not found) INN (LETROZOLE RIBOCICLIB SUCCINATE) LETROZOLEVRIBOCICLIB SUCCINATE (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , 793 ; CERIVASTATIN ; 145599-86-6 ; 1997 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- HYPOCHOLESTEROLEMIC -- 3-HYDROXY-3-METHYLGLUTARYL-COENZYME A REDUCTASE (HMG-COA) INHIBITOR -- ANTI-LIPIDEMIC AGENTS , ; NDA 020740 (label 20740.pdf) INN (CERIVASTATIN SODIUM) BAYCOL (BAYER PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 794 ; REPAGLINIDE ; 135062-02-1 ; 1997 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- MEGLITINIDE CLASS -- MANAGEMENT OF TYPE 2 DIABETES MELLITUS , ; NDA 020741 (label 20741.pdf) INN (REPAGLINIDE) PRANDIN (GEMINI LABS LLC) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 022386 (label 22386.pdf) INN (METFORMIN HYDROCHLORIDE REPAGLINIDE) PRANDIMET (NOVO NORDISK INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077571 (label 77571.pdf) INN (REPAGLINIDE) REPAGLINIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 , NDA 090008 (pdf 90008.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 200624 (pdf 200624.pdf not found) INN (METFORMIN HYDROCHLORIDE REPAGLINIDE) REPAGLINIDE AND METFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 078555 (pdf 78555.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 090252 (pdf 90252.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201189 (pdf 201189.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (PADAGIS US) APPROVAL= AP YEAR= 2013 , NDA 203820 (pdf 203820.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 091517 (label 91517.pdf) INN (REPAGLINIDE) REPAGLINIDE (KENTON) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207209 (pdf 207209.pdf not found) INN (REPAGLINIDE) REPAGLINIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , 795 ; EXEMESTANE ; 107868-30-4 ; 1999 ; ; ; CLASS ANTINEOPLASTIC -- STEROIDAL AROMATASE INHIBITOR (PRINCIPAL ENZYME THAT CONVERTS ANDROGENS TO ESTROGENS) -- THE TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN , ; NDA 020753 (label 20753.pdf) INN (EXEMESTANE) AROMASIN (PFIZER) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 077431 (pdf 77431.pdf not found) INN (EXEMESTANE) EXEMESTANE (HIKMA) APPROVAL= AP YEAR= 2011 , NDA 200898 (pdf 200898.pdf not found) INN (EXEMESTANE) EXEMESTANE (ALVOGEN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203315 (pdf 203315.pdf not found) INN (EXEMESTANE) EXEMESTANE (RISING) APPROVAL= AP YEAR= 2017 , NDA 209208 (pdf 209208.pdf not found) INN (EXEMESTANE) EXEMESTANE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2017 , NDA 210323 (pdf 210323.pdf not found) INN (EXEMESTANE) EXEMESTANE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 202602 (pdf 202602.pdf not found) INN (EXEMESTANE) EXEMESTANE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 206421 (pdf 206421.pdf not found) INN (EXEMESTANE) EXEMESTANE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211031 (pdf 211031.pdf not found) INN (EXEMESTANE) EXEMESTANE (BRECKENRIDGE) APPROVAL= AP YEAR= 2019 , NDA 208764 (pdf 208764.pdf not found) INN (EXEMESTANE) EXEMESTANE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213547 (pdf 213547.pdf not found) INN (EXEMESTANE) EXEMESTANE (QILU) APPROVAL= AP YEAR= 2020 , NDA 216454 (pdf 216454.pdf not found) INN (EXEMESTANE) EXEMESTANE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , 796 ; IRBESARTAN ; 138402-11-6 ; 1997 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN II RECEPTOR ANTAGONIST -- ANTIHYPERTENSIVE AGENTS , ; NDA 020757 (label 20757.pdf) INN (IRBESARTAN) AVAPRO (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 020758 (label 20758.pdf) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) AVALIDE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 , NDA 077159 (pdf 77159.pdf not found) INN (IRBESARTAN) IRBESARTAN (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 077369 (pdf 77369.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2012 , NDA 077446 (pdf 77446.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 077466 (pdf 77466.pdf not found) INN (IRBESARTAN) IRBESARTAN (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 077969 (pdf 77969.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077205 (pdf 77205.pdf not found) INN (IRBESARTAN) IRBESARTAN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 , NDA 091236 (pdf 91236.pdf not found) INN (IRBESARTAN) IRBESARTAN (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 079213 (pdf 79213.pdf not found) INN (IRBESARTAN) IRBESARTAN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 090351 (pdf 90351.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HIKMA) APPROVAL= AP YEAR= 2012 , NDA 090815 (pdf 90815.pdf not found) INN (IRBESARTAN HYDROCHLOROTHIAZIDE) IRBESARTAN HYDROCHLOROTHIAZIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2011 , NDA 202414 (pdf 202414.pdf not found) INN (IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 200461 (pdf 200461.pdf not found) INN (IRBESARTAN) IRBESARTAN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201531 (pdf 201531.pdf not found) INN (IRBESARTAN) IRBESARTAN (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 202254 (pdf 202254.pdf not found) INN (IRBESARTAN) IRBESARTAN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091370 (pdf 91370.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2012 , NDA 200832 (pdf 200832.pdf not found) INN (IRBESARTAN) IRBESARTAN (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090201 (pdf 90201.pdf not found) INN (IRBESARTAN) IRBESARTAN (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090720 (pdf 90720.pdf not found) INN (IRBESARTAN) IRBESARTAN (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091539 (pdf 91539.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201505 (pdf 201505.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201616 (pdf 201616.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) HYDROCHLOROTHIAZIDE IRBESARTAN (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 202910 (pdf 202910.pdf not found) INN (IRBESARTAN) IRBESARTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2012 , NDA 203020 (pdf 203020.pdf not found) INN (IRBESARTAN) IRBESARTAN (UNICHEM) APPROVAL= AP YEAR= 2015 , NDA 203071 (pdf 203071.pdf not found) INN (IRBESARTAN) IRBESARTAN (PRINSTON INC) APPROVAL= AP YEAR= 2012 , NDA 203081 (pdf 203081.pdf not found) INN (IRBESARTAN) IRBESARTAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 203161 (pdf 203161.pdf not found) INN (IRBESARTAN) IRBESARTAN (CHARTWELL RX) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203500 (pdf 203500.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 201524 (pdf 201524.pdf not found) INN (IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 203630 (pdf 203630.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203072 (pdf 203072.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2014 , NDA 203534 (pdf 203534.pdf not found) INN (IRBESARTAN) IRBESARTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 , NDA 203685 (pdf 203685.pdf not found) INN (IRBESARTAN) IRBESARTAN (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204774 (pdf 204774.pdf not found) INN (IRBESARTAN) IRBESARTAN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 203036 (pdf 203036.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ATLAS PHARMS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206194 (pdf 206194.pdf not found) INN (IRBESARTAN) IRBESARTAN (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2016 , NDA 207896 (pdf 207896.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2016 , NDA 207018 (pdf 207018.pdf not found) INN (HYDROCHLOROTHIAZIDE IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204740 (pdf 204740.pdf not found) INN (IRBESARTAN) IRBESARTAN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211056 (pdf 211056.pdf not found) INN (IRBESARTAN) IRBESARTAN (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 797 ; NARATRIPTAN ; 121679-13-8 ; 1998 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- SELECTIVE SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS , ; NDA 020763 (label 20763.pdf) INN (NARATRIPTAN HYDROCHLORIDE) AMERGE (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY DISCONTINUED , NDA 090288 (pdf 90288.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090381 (pdf 90381.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (HIKMA) APPROVAL= AP YEAR= 2010 , NDA 078751 (pdf 78751.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091326 (pdf 91326.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (PADAGIS US) APPROVAL= AP YEAR= 2010 , NDA 091373 (pdf 91373.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (APOTEX CORP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091552 (pdf 91552.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200502 (pdf 200502.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (HERITAGE PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091441 (pdf 91441.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202431 (pdf 202431.pdf not found) INN (NARATRIPTAN HYDROCHLORIDE) NARATRIPTAN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , 798 ; ORLISTAT ; 96829-58-2 ; 1999 ; ; ; CLASS METABOLISM -- ANTIOBESITY -- HYPOLIPIDEMIC -- COVALENT INHIBITOR OF GASTROINTESTINAL LIPASES -- TREATMENT OF OBESITY , ; NDA 020766 (label 20766.pdf) INN (ORLISTAT) XENICAL (CHEPLAPHARM) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021887 (label 21887.pdf) INN (ORLISTAT) ALLI (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2007 , 799 ; ZOLMITRIPTAN ; 139264-17-8 ; 1997 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- ANTI-INFLAMMATORY AGENTS -- SELECTIVE SEROTONIN 5-HYDROXYTRYPTAMINE 1B/1D RECEPTOR AGONISTS -- VASOCONSTRICTOR AGENTS , ; NDA 020768 (label 20768.pdf) INN (ZOLMITRIPTAN) ZOMIG (IPR) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 021231 (label 21231.pdf) INN (ZOLMITRIPTAN) ZOMIG-ZMT (ASTRAZENECA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021450 (label 21450.pdf) INN (ZOLMITRIPTAN) ZOMIG (AMNEAL) APPROVAL= AP YEAR= 2003 , NDA 090861 (pdf 90861.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ANI PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201779 (pdf 201779.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202078 (pdf 202078.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202476 (pdf 202476.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202560 (pdf 202560.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202890 (pdf 202890.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2013 , NDA 203186 (pdf 203186.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (NATCO PHARMA USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202279 (pdf 202279.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2014 , NDA 203476 (pdf 203476.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204284 (pdf 204284.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202956 (pdf 202956.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 , NDA 203772 (pdf 203772.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204232 (pdf 204232.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 204336 (pdf 204336.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204041 (pdf 204041.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207021 (pdf 207021.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205074 (pdf 205074.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ALEMBIC) APPROVAL= AP YEAR= 2016 , NDA 206973 (pdf 206973.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (APPCO) APPROVAL= AP YEAR= 2017 , NDA 207867 (pdf 207867.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 2017 , NDA 203019 (pdf 203019.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 202855 (pdf 202855.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 203726 (pdf 203726.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (ORBION PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212469 (pdf 212469.pdf not found) INN (ZOLMITRIPTAN) ZOLMITRIPTAN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , 800 ; TOLTERODINE ; 124937-51-5 ; 1998 ; ; ; CLASS GENITO -- ANTICHOLINERGIC -- ANTI-INCONTINENCE AGENTS -- ANTISPASMODICS -- GENITOURINARY SMOOTH MUSCLE RELAXANTS -- MUSCARINIC RECEPTOR ANTAGONISTS , ; NDA 020771 (label 20771.pdf) INN (TOLTERODINE TARTRATE) DETROL (UPJOHN) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021228 (label 21228.pdf) INN (TOLTERODINE TARTRATE) DETROL LA (UPJOHN) APPROVAL= AP YEAR= 2000 , NDA 076953 (pdf 76953.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE (RANBAXY) APPROVAL= TA YEAR= 2005 , NDA 078419 (pdf 78419.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (SANDOZ) APPROVAL= TA YEAR= 2011 , NDA 200164 (pdf 200164.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (APOTEX CORP) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202641 (pdf 202641.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201486 (pdf 201486.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 077006 (pdf 77006.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203016 (pdf 203016.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (TORRENT) APPROVAL= AP YEAR= 2015 , NDA 203409 (pdf 203409.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 079141 (pdf 79141.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206419 (pdf 206419.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2017 , NDA 204562 (pdf 204562.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 210775 (pdf 210775.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (ELYSIUM) APPROVAL= AP YEAR= 2019 , NDA 204721 (pdf 204721.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (UNIQUE) APPROVAL= AP YEAR= 2020 , NDA 213397 (pdf 213397.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 205399 (pdf 205399.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 213858 (pdf 213858.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (AMTA) APPROVAL= AP YEAR= 2021 , NDA 204397 (pdf 204397.pdf not found) INN (TOLTERODINE TARTRATE) TOLTERODINE TARTRATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , 801 ; THALIDOMIDE ; 50-35-1 ; 1998 ; ; ; CLASS ANTINEOPLASTIC -- MULTIPLE MYELOMA (MM) -- HYPNOTIC -- ANXIOLYTIC -- ANGIOGENESIS INHIBITORS -- IMMUNOSUPPRESSIVE AGENTS -- LEPROSTATIC AGENTS -- TERATOGENS -- ERYTHEMA NODOSUM LEPROSUM -- POSSESSES IMMUNOMODULATORY, ANTIINFLAMMATORY AND ANTIANGIOGENIC PROPERTIES , ; NDA 020785 (label 20785.pdf) INN (THALIDOMIDE) THALOMID (BRISTOL-MYERS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021430 (label 21430.pdf) INN (THALIDOMIDE) THALOMID (CELGENE) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 213267 (pdf 213267.pdf not found) INN (THALIDOMIDE) THALIDOMIDE (NATCO) APPROVAL= AP YEAR= 2023 , 802 ; ZONISAMIDE ; 68291-97-4 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- CARBONIC ANHYDRASE INHIBITOR , ; NDA 020789 (label 20789.pdf) INN (ZONISAMIDE) ZONEGRAN (CONCORDIA) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 077625 (pdf 77625.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2006 , NDA 077634 (pdf 77634.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2006 , NDA 077635 (pdf 77635.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077636 (pdf 77636.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (GRANULES) APPROVAL= AP YEAR= 2005 , NDA 077637 (pdf 77637.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (RISING) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077639 (pdf 77639.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077641 (pdf 77641.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077642 (pdf 77642.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (APOTEX INC) APPROVAL= AP YEAR= 2005 , NDA 077644 (pdf 77644.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077645 (pdf 77645.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2005 , NDA 077647 (pdf 77647.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077648 (pdf 77648.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (ROXANE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077650 (pdf 77650.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077651 (pdf 77651.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 077813 (pdf 77813.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2006 , NDA 077869 (pdf 77869.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 077876 (pdf 77876.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077891 (pdf 77891.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 214492 (pdf 214492.pdf not found) INN (ZONISAMIDE) ZONISAMIDE (UNICHEM) APPROVAL= AP YEAR= 2021 , NDA 214273 (label 214273.pdf) INN (ZONISAMIDE) ZONISADE (AZURITY) APPROVAL= AP YEAR= 2022 , 803 ; ENTACAPONE ; 130929-57-6 ; 1999 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- TREATMENT OF PARKINSON’S DISEASE , ; NDA 020796 (label 20796.pdf) INN (ENTACAPONE) COMTAN (ORION PHARMA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021485 (label 21485.pdf) INN (CARBIDOPA ENTACAPONE LEVODOPA) STALEVO 50 (ORION PHARMA) APPROVAL= AP YEAR= 2003 , NDA 079085 (pdf 79085.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 078941 (pdf 78941.pdf not found) INN (ENTACAPONE) ENTACAPONE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2012 , NDA 090690 (pdf 90690.pdf not found) INN (ENTACAPONE) ENTACAPONE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 090786 (pdf 90786.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090833 (pdf 90833.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (WOCKHARDT LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202394 (pdf 202394.pdf not found) INN (ENTACAPONE) ENTACAPONE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203437 (pdf 203437.pdf not found) INN (ENTACAPONE) ENTACAPONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 207210 (pdf 207210.pdf not found) INN (ENTACAPONE) ENTACAPONE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205792 (pdf 205792.pdf not found) INN (ENTACAPONE) ENTACAPONE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 206669 (pdf 206669.pdf not found) INN (ENTACAPONE) ENTACAPONE (SUNSHINE) APPROVAL= AP YEAR= 2018 , NDA 203424 (pdf 203424.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212601 (pdf 212601.pdf not found) INN (ENTACAPONE) ENTACAPONE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 213212 (pdf 213212.pdf not found) INN (CARBIDOPA ENTACAPONE LEVODOPA) CARBIDOPA , LEVODOPA AND ENTACAPONE (RISING) APPROVAL= AP YEAR= 2022 , 804 ; RALOXIFENE ; 84449-90-1 ; 1997 ; ; ; CLASS GENITO -- TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN -- ANTINEOPLASTIC -- ANTIHYPOCALCEMIC AGENTS -- BONE DENSITY CONSERVATION AGENTS -- ESTROGEN RECEPTOR AGONIST/ANTAGONIST , ; NDA 020815 (label 20815.pdf) INN (RALOXIFENE HYDROCHLORIDE) EVISTA (LILLY) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 022042 (label 22042.pdf) INN (RALOXIFENE HYDROCHLORIDE) EVISTA (LILLY) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 078193 (pdf 78193.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 090842 (pdf 90842.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2014 , NDA 200825 (pdf 200825.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 204310 (pdf 204310.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204491 (pdf 204491.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 208206 (pdf 208206.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206384 (pdf 206384.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 211324 (pdf 211324.pdf not found) INN (RALOXIFENE HYDROCHLORIDE) RALOXIFENE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2020 , 805 ; BRINZOLAMIDE ; 138890-62-7 ; 1998 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- CARBONIC ANHYDRASE INHIBITORS -- OPHTHALMICS , ; NDA 020816 (label 20816.pdf) INN (BRINZOLAMIDE) AZOPT (SANDOZ) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 204251 (label 204251.pdf) INN (BRIMONIDINE TARTRATE BRINZOLAMIDE) SIMBRINZA (ALCON LABS INC) APPROVAL= AP YEAR= 2013 , NDA 209406 (pdf 209406.pdf not found) INN (BRINZOLAMIDE) BRINZOLAMIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2020 , NDA 204884 (pdf 204884.pdf not found) INN (BRINZOLAMIDE) BRINZOLAMIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2021 , NDA 211914 (pdf 211914.pdf not found) INN (BRINZOLAMIDE) BRINZOLAMIDE (PADAGIS US) APPROVAL= AP YEAR= 2023 , NDA 212137 (pdf 212137.pdf not found) INN (BRINZOLAMIDE BRIMONIDINE TARTRATE) BRINZOLAMIDE BRIMONIDINE TARTRATE (PERRIGO PHARMA INTERNATIONAL DAC) APPROVAL= TA YEAR= 2023 , 806 ; PARICALCITOL ; 131918-61-1 ; 1998 ; ; ; CLASS METABOLISM -- PARATHYROID HORMONE REGULATOR -- VITAMIN D3 RECEPTOR (VDR) AGONIST -- CALCITRIOL ANALOG -- TREATMENT OF SECONDARY HYPERPARATHYROIDISM , ; NDA 020819 (label 20819.pdf) INN (PARICALCITOL) ZEMPLAR (ABBVIE) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021606 (label 21606.pdf) INN (PARICALCITOL) ZEMPLAR (ABBVIE) APPROVAL= AP YEAR= 2005 , NDA 090829 (pdf 90829.pdf not found) INN (PARICALCITOL) PARICALCITOL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 091108 (pdf 91108.pdf not found) INN (PARICALCITOL) PARICALCITOL (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 091412 (pdf 91412.pdf not found) INN (PARICALCITOL) PARICALCITOL (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 091583 (pdf 91583.pdf not found) INN (PARICALCITOL) PARICALCITOL (TEVA PHARMS USA) APPROVAL= TA YEAR= 2013 , NDA 201657 (label 201657.pdf) INN (PARICALCITOL) PARICALCITOL (HOSPIRA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202124 (pdf 202124.pdf not found) INN (PARICALCITOL) PARICALCITOL (RISING) APPROVAL= AP YEAR= 2014 , NDA 202539 (pdf 202539.pdf not found) INN (PARICALCITOL) PARICALCITOL (BIONPHARMA) APPROVAL= AP YEAR= 2014 , NDA 205917 (label 205917.pdf) INN (PARICALCITOL) PARICALCITOL (HIKMA PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204910 (pdf 204910.pdf not found) INN (PARICALCITOL) PARICALCITOL (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 206710 (pdf 206710.pdf not found) INN (PARICALCITOL) PARICALCITOL (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204327 (pdf 204327.pdf not found) INN (PARICALCITOL) PARICALCITOL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207174 (label 207174.pdf) INN (PARICALCITOL) PARICALCITOL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 207672 (pdf 207672.pdf not found) INN (PARICALCITOL) PARICALCITOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204948 (pdf 204948.pdf not found) INN (PARICALCITOL) PARICALCITOL (MARKSANS PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206699 (pdf 206699.pdf not found) INN (PARICALCITOL) PARICALCITOL (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 203897 (pdf 203897.pdf not found) INN (PARICALCITOL) PARICALCITOL (RISING) APPROVAL= AP YEAR= 2017 , NDA 207692 (pdf 207692.pdf not found) INN (PARICALCITOL) PARICALCITOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205982 (pdf 205982.pdf not found) INN (PARICALCITOL) PARICALCITOL (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , 807 ; RIVASTIGMINE ; 123441-03-2 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINERGIC AGENTS -- CHOLINESTERASE INHIBITORS -- NEUROPROTECTIVE AGENTS -- ALZHEIMER -- PARKINSON’S DISEASE , ; NDA 020823 (label 20823.pdf) INN (RIVASTIGMINE TARTRATE) EXELON (NOVARTIS) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , NDA 021025 (label 21025.pdf) INN (RIVASTIGMINE TARTRATE) EXELON (NOVARTIS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 022083 (label 22083.pdf) INN (RIVASTIGMINE) EXELON (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077129 (pdf 77129.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (WATSON LABS) APPROVAL= AP YEAR= 2008 , NDA 077130 (pdf 77130.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2007 , NDA 077131 (pdf 77131.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (SUN PHARM) APPROVAL= AP YEAR= 2007 , NDA 077363 (pdf 77363.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE (RANBAXY) APPROVAL= TA YEAR= 2005 , NDA 090879 (pdf 90879.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 , NDA 091689 (pdf 91689.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091072 (pdf 91072.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203148 (pdf 203148.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 204403 (pdf 204403.pdf not found) INN (RIVASTIGMINE) RIVASTIGMINE (ALVOGEN) APPROVAL= AP YEAR= 2015 , NDA 204572 (pdf 204572.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203844 (pdf 203844.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207797 (pdf 207797.pdf not found) INN (RIVASTIGMINE TARTRATE) RIVASTIGMINE TARTRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 205622 (pdf 205622.pdf not found) INN (RIVASTIGMINE) RIVASTIGMINE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2018 , NDA 206318 (pdf 206318.pdf not found) INN (RIVASTIGMINE) RIVASTIGMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 207308 (pdf 207308.pdf not found) INN (RIVASTIGMINE) RIVASTIGMINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209063 (pdf 209063.pdf not found) INN (RIVASTIGMINE) RIVASTIGMINE (BRECKENRIDGE) APPROVAL= AP YEAR= 2019 , 808 ; ZIPRASIDONE ; 146939-27-7 ; 2001 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF BIPOLAR DISORDER -- ANTIPSYCHOTIC -- DOPAMINE D2 (KI = 4.8 NANOMOLAR) AND D3 (KI = 7.2 NANOMOLAR) ANTAGONISTS -- SEROTONIN 5HT2A (KI = 0.4 NANOMOLAR) 5HT2C (KI = 1.3 NANOMOLAR) 5HT1D (KI = 2 NANOMOLAR) ANTAGONISTS -- ALPHA 1 ADRENERGIC RECEPTOR (KI = 10 NANOMOLAR) ANTAGONISTS -- 5HT1A RECEPTOR AGONIST (KI = 3.4 NANOMOLAR) , ; NDA 020825 (label 20825.pdf) INN (ZIPRASIDONE HYDROCHLORIDE) GEODON (VIATRIS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 020919 (label 20919.pdf) INN (ZIPRASIDONE MESYLATE) GEODON (VIATRIS) APPROVAL= AP YEAR= 2002 , NDA 021483 (label 21483.pdf) INN (ZIPRASIDONE HYDROCHLORIDE) GEODON (PFIZER INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077560 (pdf 77560.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (LUPIN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 077562 (pdf 77562.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 077565 (pdf 77565.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2012 , NDA 077561 (pdf 77561.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2012 , NDA 090348 (pdf 90348.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 202395 (pdf 202395.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204117 (pdf 204117.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204375 (pdf 204375.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 208988 (pdf 208988.pdf not found) INN (ZIPRASIDONE HYDROCHLORIDE) ZIPRASIDONE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 211908 (pdf 211908.pdf not found) INN (ZIPRASIDONE MESYLATE) ZIPRASIDONE MESYLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 216091 (pdf 216091.pdf not found) INN (ZIPRASIDONE MESYLATE) ZIPRASIDONE MESYLATE (MSN) APPROVAL= AP YEAR= 2022 , 809 ; MONTELUKAST ; 158966-92-8 ; 1998 ; ; ; CLASS RESPIRATORY SYSTEM -- LEUKOTRIENE RECEPTOR ANTAGONIST -- ANTIASTHMATIC -- CHRONIC TREATMENT OF ASTHMA , ; NDA 020829 (label 20829.pdf) INN (MONTELUKAST SODIUM) SINGULAIR (ORGANON) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 020830 (label 20830.pdf) INN (MONTELUKAST SODIUM) SINGULAIR (ORGANON) APPROVAL= AP YEAR= 1998 , NDA 021409 (label 21409.pdf) INN (MONTELUKAST SODIUM) SINGULAIR (ORGANON) APPROVAL= AP YEAR= 2002 , NDA 078605 (pdf 78605.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078723 (pdf 78723.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079103 (pdf 79103.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 079142 (pdf 79142.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090655 (pdf 90655.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091128 (pdf 91128.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090984 (pdf 90984.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 090926 (pdf 90926.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091414 (pdf 91414.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 091576 (pdf 91576.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091588 (pdf 91588.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203328 (pdf 203328.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203432 (pdf 203432.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203438 (pdf 203438.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 090955 (pdf 90955.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200405 (pdf 200405.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2012 , NDA 200889 (pdf 200889.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 201294 (pdf 201294.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (APOTEX CORP) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201508 (pdf 201508.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201515 (pdf 201515.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201522 (pdf 201522.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012 , NDA 201581 (pdf 201581.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 201582 (pdf 201582.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202096 (pdf 202096.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202468 (pdf 202468.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202717 (pdf 202717.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2012 , NDA 202776 (pdf 202776.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202906 (pdf 202906.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202843 (pdf 202843.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 202859 (pdf 202859.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (UNIMARK REMEDIES LTD) APPROVAL= AP YEAR= 2014 , NDA 203037 (pdf 203037.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (UNIMARK REMEDIES LTD) APPROVAL= AP YEAR= 2014 , NDA 203366 (pdf 203366.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203582 (pdf 203582.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203795 (pdf 203795.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204093 (pdf 204093.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 204290 (pdf 204290.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (UNICHEM) APPROVAL= AP YEAR= 2015 , NDA 204604 (pdf 204604.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205695 (pdf 205695.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (ANBISON LAB) APPROVAL= AP YEAR= 2015 , NDA 205683 (pdf 205683.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (ANBISON LAB) APPROVAL= AP YEAR= 2016 , NDA 207463 (pdf 207463.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 206112 (pdf 206112.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (L PERRIGO CO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209011 (pdf 209011.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (RISING) APPROVAL= AP YEAR= 2017 , NDA 209012 (pdf 209012.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207464 (pdf 207464.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2018 , NDA 208621 (pdf 208621.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (UNICHEM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210431 (pdf 210431.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 213471 (pdf 213471.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 205107 (pdf 205107.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2020 , NDA 205319 (pdf 205319.pdf not found) INN (MONTELUKAST SODIUM) MONTELUKAST SODIUM (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 DISCONTINUED , 810 ; FORMOTEROL ; 73573-87-2 ; 2001 ; ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- LONG-ACTING SELECTIVE BETA-2 ADRENERGIC RECEPTOR AGONIST -- SYMPATHOMIMETIC , ; NDA 020831 (label 20831.pdf) INN (FORMOTEROL FUMARATE) FORADIL (NOVARTIS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 021279 (label 21279.pdf) INN (FORMOTEROL FUMARATE) FORADIL (NOVARTIS) APPROVAL= AP YEAR= 2001 NEWAPPLICATION DISCONTINUED , NDA 021592 (label 21592.pdf) INN (FORMOTEROL FUMARATE) FORADIL CERTIHALER (NOVARTIS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021929 (label 21929.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) SYMBICORT (ASTRAZENECA) APPROVAL= AP YEAR= 2006 , NDA 022007 (label 22007.pdf) INN (FORMOTEROL FUMARATE) PERFOROMIST (MYLAN SPECLT) APPROVAL= AP YEAR= 2007 , NDA 022518 (label 22518.pdf) INN (FORMOTEROL FUMARATE MOMETASONE FUROATE) DULERA (ORGANON LLC) APPROVAL= AP YEAR= 2010 , NDA 091141 (pdf 91141.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 208294 (label 208294.pdf) INN (FORMOTEROL FUMARATE GLYCOPYRROLATE) BEVESPI AEROSPHERE (ASTRAZENECA) APPROVAL= AP YEAR= 2016 , NDA 210595 (label 210595.pdf) INN (ACLIDINIUM BROMIDE FORMOTEROL FUMARATE) DUAKLIR PRESSAIR (COVIS) APPROVAL= AP YEAR= 2019 , NDA 212122 (label 212122.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE GLYCOPYRROLATE) BREZTRI AEROSPHERE (ASTRAZENECA AB) APPROVAL= AP YEAR= 2020 , NDA 211699 (pdf 211699.pdf not found) INN (BUDESONIDE FORMOTEROL FUMARATE DIHYDRATE) BREYNA (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 215078 (pdf 215078.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 215053 (pdf 215053.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (LUPIN) APPROVAL= AP YEAR= 2022 , NDA 215621 (pdf 215621.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 216486 (pdf 216486.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (RITEDOSE CORP) APPROVAL= AP YEAR= 2022 , NDA 215883 (pdf 215883.pdf not found) INN (FORMOTEROL FUMARATE) FORMOTEROL FUMARATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216579 (label 216579.pdf) INN (BUDESONIDE FORMOTEROL FUMARATE) SYMBICORT AEROSPHERE (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , 811 ; ARGATROBAN ; 74863-84-6 ; 2000 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC -- ANTICOAGULANTS -- PLATELET AGGREGATION INHIBITORS -- THROMBIN INHIBITOR (KI = 0.04 MICROMOLAR) , ; NDA 020883 (label 20883.pdf) INN (ARGATROBAN) ARGATROBAN (SANDOZ) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , NDA 079238 (pdf 79238.pdf not found) INN (ARGATROBAN) ARGATROBAN (PLIVA HRVATSKA DOO) APPROVAL= TA YEAR= 2010 , NDA 022359 (pdf 22359.pdf not found) INN (ARGATROBAN) ARGATROBAN (BAXTER HLTHCARE CORP) APPROVAL= TA YEAR= 2010 , NDA 022485 (label 22485.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 201743 (label 201743.pdf) INN (ARGATROBAN) ARGATROBAN IN DEXTROSE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022434 (label 22434.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (CIPLA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203049 (label 203049.pdf) INN (ARGATROBAN) ARGATROBAN (HIKMA PHARM CO LTD) APPROVAL= AP YEAR= 2012 , NDA 091665 (pdf 91665.pdf not found) INN (ARGATROBAN) ARGATROBAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 202626 (pdf 202626.pdf not found) INN (ARGATROBAN) ARGATROBAN (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 , NDA 206769 (label 206769.pdf) INN (ARGATROBAN) ARGATROBAN IN 0.9% SODIUM CHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201811 (label 201811.pdf) INN (ARGATROBAN) ARGATROBAN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204120 (pdf 204120.pdf not found) INN (ARGATROBAN) ARGATROBAN (HOSPIRA) APPROVAL= AP YEAR= 2016 , NDA 205570 (pdf 205570.pdf not found) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 206698 (pdf 206698.pdf not found) INN (ARGATROBAN) ARGATROBAN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209552 (pdf 209552.pdf not found) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2018 , NDA 212035 (label 212035.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 214235 (pdf 214235.pdf not found) INN (ARGATROBAN) ARGATROBAN (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 217848 (pdf 217848.pdf not found) INN (ARGATROBAN) ARGATROBAN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 812 ; RISEDRONATE ; 105462-24-6 ; 1998 ; ; ; CLASS MUSCULO-SKELETAL -- OSTEOPOROSIS -- OSTEOCLASTIC RESORPTION INHIBITOR -- BISPHOSPHONATES -- HAS AN AFFINITY FOR HYDROXYAPATITE CRYSTALS IN BONE AND ACTS AS AN ANTIRESORPTIVE AGENT , ; NDA 020835 (label 20835.pdf) INN (RISEDRONATE SODIUM) ACTONEL (APIL) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021823 (label 21823.pdf) INN (CALCIUM CARBONATE RISEDRONATE SODIUM) ACTONEL WITH CALCIUM COPACKAGED (WARNER CHILCOTT) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077132 (label 77132.pdf) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 022560 (label 22560.pdf) INN (RISEDRONATE SODIUM) ATELVIA (APIL) APPROVAL= AP YEAR= 2010 , NDA 079215 (pdf 79215.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 200296 (pdf 200296.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 200477 (pdf 200477.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090877 (pdf 90877.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 090886 (pdf 90886.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 203217 (pdf 203217.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 203533 (pdf 203533.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 205280 (pdf 205280.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (ORBION PHARMS) APPROVAL= AP YEAR= 2019 , NDA 206768 (pdf 206768.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203822 (pdf 203822.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205066 (pdf 205066.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (IMPAX LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207516 (pdf 207516.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (HANGZHOU BINJIANG) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 203925 (pdf 203925.pdf not found) INN (RISEDRONATE SODIUM) RISEDRONATE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2019 , 813 ; LEVALBUTEROL ; 34391-04-3 ; 1999 ; ; ; CLASS RESPIRATORY SYSTEM -- BETA2-ADRENERGIC BRONCHODILATOR -- AGONIST -- BETA-BLOCKERS , ; NDA 020837 (label 20837.pdf) INN (LEVALBUTEROL HYDROCHLORIDE) XOPENEX (HIKMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021730 (label 21730.pdf) INN (LEVALBUTEROL TARTRATE) XOPENEX HFA (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 077756 (pdf 77756.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2008 , NDA 077800 (pdf 77800.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078309 (pdf 78309.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2009 , NDA 078171 (pdf 78171.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2013 , NDA 090297 (pdf 90297.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 200875 (pdf 200875.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2014 , NDA 203653 (pdf 203653.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2016 , NDA 207625 (pdf 207625.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2016 , NDA 207628 (pdf 207628.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2017 , NDA 207820 (pdf 207820.pdf not found) INN (LEVALBUTEROL HYDROCHLORIDE) LEVALBUTEROL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , 814 ; TELMISARTAN ; 144701-48-4 ; 1998 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II RECEPTOR ANTAGONIST , ; NDA 020850 (label 20850.pdf) INN (TELMISARTAN) MICARDIS (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021162 (label 21162.pdf) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) MICARDIS HCT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2000 , NDA 078710 (pdf 78710.pdf not found) INN (TELMISARTAN) TELMISARTAN (CHARTWELL RX) APPROVAL= AP YEAR= 2014 , NDA 022401 (label 22401.pdf) INN (AMLODIPINE BESYLATE TELMISARTAN) TWYNSTA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091084 (pdf 91084.pdf not found) INN (TELMISARTAN HYDROCHLOROTHIAZIDE) TELMISARTAN HYDROCHLOROTHIAZIDE (WATSON LABS FLORIDA) APPROVAL= TA YEAR= 2011 , NDA 091351 (pdf 91351.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 090032 (pdf 90032.pdf not found) INN (TELMISARTAN) TELMISARTAN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 201586 (pdf 201586.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202130 (pdf 202130.pdf not found) INN (TELMISARTAN) TELMISARTAN (ALEMBIC) APPROVAL= AP YEAR= 2014 , NDA 091648 (pdf 91648.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201192 (pdf 201192.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202397 (pdf 202397.pdf not found) INN (TELMISARTAN) TELMISARTAN (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202516 (pdf 202516.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202517 (pdf 202517.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203010 (pdf 203010.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2014 , NDA 203171 (pdf 203171.pdf not found) INN (TELMISARTAN) TELMISARTAN (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203325 (pdf 203325.pdf not found) INN (TELMISARTAN) TELMISARTAN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203867 (pdf 203867.pdf not found) INN (TELMISARTAN) TELMISARTAN (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 204169 (pdf 204169.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204415 (pdf 204415.pdf not found) INN (TELMISARTAN) TELMISARTAN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205150 (pdf 205150.pdf not found) INN (TELMISARTAN) TELMISARTAN (INVENTIA) APPROVAL= AP YEAR= 2015 , NDA 206511 (pdf 206511.pdf not found) INN (TELMISARTAN) TELMISARTAN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 205901 (label 205901.pdf) INN (TELMISARTAN) TELMISARTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 204164 (pdf 204164.pdf not found) INN (TELMISARTAN) TELMISARTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205234 (pdf 205234.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (ALEMBIC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208727 (pdf 208727.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207882 (pdf 207882.pdf not found) INN (TELMISARTAN) TELMISARTAN (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 208605 (pdf 208605.pdf not found) INN (TELMISARTAN) TELMISARTAN (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 204221 (pdf 204221.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207016 (pdf 207016.pdf not found) INN (TELMISARTAN) TELMISARTAN (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 209028 (pdf 209028.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 202544 (pdf 202544.pdf not found) INN (HYDROCHLOROTHIAZIDE TELMISARTAN) TELMISARTAN AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 207843 (pdf 207843.pdf not found) INN (TELMISARTAN) TELMISARTAN (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 DISCONTINUED , 815 ; ZALEPLON ; 151319-34-5 ; 1999 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- ANTICONVULSANTS -- MUSCLE RELAXANT -- SEDATIVE -- A NONBENZODIAZEPINE HYPNOTIC FROM THE PYRAZOLOPYRIMIDINE CLASS , ; NDA 020859 (label 20859.pdf) INN (ZALEPLON) SONATA (PFIZER) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 077237 (pdf 77237.pdf not found) INN (ZALEPLON) ZALEPLON (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 077238 (pdf 77238.pdf not found) INN (ZALEPLON) ZALEPLON (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077239 (label 77239.pdf) INN (ZALEPLON) ZALEPLON (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077505 (pdf 77505.pdf not found) INN (ZALEPLON) ZALEPLON (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2008 , NDA 078095 (pdf 78095.pdf not found) INN (ZALEPLON) ZALEPLON (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078706 (pdf 78706.pdf not found) INN (ZALEPLON) ZALEPLON (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078829 (pdf 78829.pdf not found) INN (ZALEPLON) ZALEPLON (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 078989 (pdf 78989.pdf not found) INN (ZALEPLON) ZALEPLON (UNICHEM) APPROVAL= AP YEAR= 2008 , NDA 078147 (pdf 78147.pdf not found) INN (ZALEPLON) ZALEPLON (HIKMA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090374 (pdf 90374.pdf not found) INN (ZALEPLON) ZALEPLON (ORBION PHARMS) APPROVAL= AP YEAR= 2009 , 816 ; CILOSTAZOL ; 73963-72-1 ; 1999 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC -- A QUINOLINONE DERIVATIVE -- VASODILATOR AGENTS -- PHOSPHODIESTERASE III INHIBITORS , ; NDA 020863 (label 20863.pdf) INN (CILOSTAZOL) PLETAL (OTSUKA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 077019 (pdf 77019.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077020 (pdf 77020.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077021 (pdf 77021.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (CHARTWELL RX) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077022 (pdf 77022.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 , NDA 077024 (pdf 77024.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (HIKMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077027 (pdf 77027.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (TEVA) APPROVAL= AP YEAR= 2004 , NDA 077028 (pdf 77028.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 , NDA 077030 (pdf 77030.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (APOTEX INC) APPROVAL= AP YEAR= 2004 , NDA 077150 (pdf 77150.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 DISCONTINUED OBSOLETE , NDA 077208 (pdf 77208.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2006 , NDA 077310 (pdf 77310.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077323 (pdf 77323.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (RISING) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077898 (pdf 77898.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077708 (pdf 77708.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077722 (pdf 77722.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 077831 (pdf 77831.pdf not found) INN (CILOSTAZOL) CILOSTAZOL (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , 817 ; CYCLOPENTOLATE ; 204990-63-6 ; 1974 ; ; ; CLASS SENSORY -- MYDRIATIC -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTIMUSCARINIC EYE PREPARATIONS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 040075 (pdf 40075.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040164 (pdf 40164.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AKPENTOLATE (RISING) APPROVAL= AP YEAR= 1997 , NDA 040165 (pdf 40165.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AKPENTOLATE (RISING) APPROVAL= AP YEAR= 1997 , NDA 084108 (pdf 84108.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084109 (pdf 84109.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084110 (pdf 84110.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084150 (pdf 84150.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084300 (pdf 84300.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE) CYCLOMYDRIL (ALCON LABS INC) APPROVAL= AP YEAR= 1975 , NDA 084863 (pdf 84863.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085555 (pdf 85555.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AK-PENTOLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 088150 (pdf 88150.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088643 (pdf 88643.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089162 (pdf 89162.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 205937 (pdf 205937.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 818 ; ARGATROBAN ; 74863-84-6 ; 2000 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC -- ANTICOAGULANTS -- PLATELET AGGREGATION INHIBITORS -- THROMBIN INHIBITOR (KI = 0.04 MICROMOLAR) , ; NDA 020883 (label 20883.pdf) INN (ARGATROBAN) ARGATROBAN (SANDOZ) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , NDA 079238 (pdf 79238.pdf not found) INN (ARGATROBAN) ARGATROBAN (PLIVA HRVATSKA DOO) APPROVAL= TA YEAR= 2010 , NDA 022359 (pdf 22359.pdf not found) INN (ARGATROBAN) ARGATROBAN (BAXTER HLTHCARE CORP) APPROVAL= TA YEAR= 2010 , NDA 022485 (label 22485.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 , NDA 201743 (label 201743.pdf) INN (ARGATROBAN) ARGATROBAN IN DEXTROSE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 022434 (label 22434.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (CIPLA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203049 (label 203049.pdf) INN (ARGATROBAN) ARGATROBAN (HIKMA PHARM CO LTD) APPROVAL= AP YEAR= 2012 , NDA 091665 (pdf 91665.pdf not found) INN (ARGATROBAN) ARGATROBAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 202626 (pdf 202626.pdf not found) INN (ARGATROBAN) ARGATROBAN (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 , NDA 206769 (label 206769.pdf) INN (ARGATROBAN) ARGATROBAN IN 0.9% SODIUM CHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201811 (label 201811.pdf) INN (ARGATROBAN) ARGATROBAN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204120 (pdf 204120.pdf not found) INN (ARGATROBAN) ARGATROBAN (HOSPIRA) APPROVAL= AP YEAR= 2016 , NDA 205570 (pdf 205570.pdf not found) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 206698 (pdf 206698.pdf not found) INN (ARGATROBAN) ARGATROBAN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209552 (pdf 209552.pdf not found) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2018 , NDA 212035 (label 212035.pdf) INN (ARGATROBAN) ARGATROBAN IN SODIUM CHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 214235 (pdf 214235.pdf not found) INN (ARGATROBAN) ARGATROBAN (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 217848 (pdf 217848.pdf not found) INN (ARGATROBAN) ARGATROBAN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 819 ; ALITRETINOIN ; 5300-03-8 ; 1999 ; ; ; CLASS ANTINEOPLASTIC -- TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S SARCOMA -- KERATOLYTIC AGENTS -- RETINOIC ACID RECEPTOR AGONIST -- RETINOIC X RECEPTOR AGONIST , ; NDA 020886 (label 20886.pdf) INN (ALITRETINOIN) PANRETIN (CONCORDIA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , 820 ; VALRUBICIN ; 56124-62-0 ; 1998 ; ; ; CLASS ANTINEOPLASTIC -- BLADDER CANCER -- ANTHRACYCLINE -- INHIBITS THE INCORPORATION OF NUCLEOSIDES INTO NUCLEIC ACIDS , ; NDA 020892 (label 20892.pdf) INN (VALRUBICIN) VALSTAR PRESERVATIVE FREE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 206430 (pdf 206430.pdf not found) INN (VALRUBICIN) VALRUBICIN (HIKMA) APPROVAL= AP YEAR= 2019 , 821 ; CAPECITABINE ; 154361-50-9 ; 1998 ; ; ; CLASS ANTINEOPLASTIC -- BREAST CANCER -- COLORECTAL CANCER -- COLON CANCER -- ANTIMETABOLITES -- NUCLEOSIDE METABOLIC INHIBITOR -- METABOLIZED ENZYMATICALLY TO 5-FU , ; NDA 020896 (label 20896.pdf) INN (CAPECITABINE) XELODA (CHEPLAPHARM) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 091649 (label 91649.pdf) INN (CAPECITABINE) CAPECITABINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 090943 (pdf 90943.pdf not found) INN (CAPECITABINE) CAPECITABINE (RISING) APPROVAL= AP YEAR= 2014 , NDA 202593 (pdf 202593.pdf not found) INN (CAPECITABINE) CAPECITABINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 , NDA 200483 (pdf 200483.pdf not found) INN (CAPECITABINE) CAPECITABINE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 207456 (pdf 207456.pdf not found) INN (CAPECITABINE) CAPECITABINE (SHILPA) APPROVAL= AP YEAR= 2016 , NDA 204741 (pdf 204741.pdf not found) INN (CAPECITABINE) CAPECITABINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207652 (pdf 207652.pdf not found) INN (CAPECITABINE) CAPECITABINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 210604 (pdf 210604.pdf not found) INN (CAPECITABINE) CAPECITABINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209365 (pdf 209365.pdf not found) INN (CAPECITABINE) CAPECITABINE (MSN) APPROVAL= AP YEAR= 2018 , NDA 204668 (pdf 204668.pdf not found) INN (CAPECITABINE) CAPECITABINE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 211724 (pdf 211724.pdf not found) INN (CAPECITABINE) CAPECITABINE (RELIANCE LIFE) APPROVAL= AP YEAR= 2020 , NDA 204345 (pdf 204345.pdf not found) INN (CAPECITABINE) CAPECITABINE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 217237 (pdf 217237.pdf not found) INN (CAPECITABINE) CAPECITABINE (TEYRO LABS) APPROVAL= AP YEAR= 2023 , NDA 210203 (pdf 210203.pdf not found) INN (CAPECITABINE) CAPECITABINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 822 ; LEFLUNOMIDE ; 75706-12-6 ; 1998 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATIONG AGENT -- PYRIMIDINE SYNTHESIS INHIBITOR -- TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS -- ANTIINFLAMMATORY , ; NDA 020905 (label 20905.pdf) INN (LEFLUNOMIDE) ARAVA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 077083 (pdf 77083.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077084 (pdf 77084.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077085 (pdf 77085.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077086 (pdf 77086.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2005 , NDA 077087 (pdf 77087.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (WANBANG BIOPHARMS) APPROVAL= AP YEAR= 2005 , NDA 077090 (pdf 77090.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (APOTEX INC) APPROVAL= AP YEAR= 2005 , NDA 091369 (pdf 91369.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 212308 (pdf 212308.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2019 , NDA 212453 (pdf 212453.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (ABHAI LLC) APPROVAL= AP YEAR= 2019 , NDA 211863 (pdf 211863.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2020 , NDA 213497 (pdf 213497.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (AET PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213652 (pdf 213652.pdf not found) INN (LEFLUNOMIDE) LEFLUNOMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2021 , 823 ; TIROFIBAN ; 144494-65-5 ; 1998 ; ; ; CLASS BLOOD -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- ANTIANGINAL -- FIBRINOLYTIC AGENTS , ; NDA 020912 (label 20912.pdf) INN (TIROFIBAN HYDROCHLORIDE) AGGRASTAT (MEDICURE) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 020913 (label 20913.pdf) INN (TIROFIBAN HYDROCHLORIDE) AGGRASTAT (MEDICURE) APPROVAL= AP YEAR= 1998 , NDA 206888 (pdf 206888.pdf not found) INN (TIROFIBAN HYDROCHLORIDE) TIROFIBAN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 216379 (pdf 216379.pdf not found) INN (TIROFIBAN HYDROCHLORIDE) TIROFIBAN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 213947 (pdf 213947.pdf not found) INN (TIROFIBAN HYDROCHLORIDE) TIROFIBAN HYDROCHLORIDE (NEXUS) APPROVAL= AP YEAR= 2023 , 824 ; CHOLECALCIFEROL ; 67-97-0 ; 2000 ; ; ; CLASS METABOLISM -- VITAMIN D3 -- ANTIARTHRITIC -- ANTIHYPOCALCEMIC AGENTS -- ANTIHYPOPARATHYROID AGENTS -- BONE DENSITY CONSERVATION AGENTS -- SECOSTEROL , ; NDA 021163 (label 21163.pdf) INN (CHOLECALCIFEROL) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (CHOLECALCIFEROL) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (CHOLECALCIFEROL) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021646 (label 21646.pdf) INN (CHOLECALCIFEROL) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 021762 (label 21762.pdf) INN (ALENDRONATE SODIUM CHOLECALCIFEROL) FOSAMAX PLUS D (ORGANON LLC) APPROVAL= AP YEAR= 2005 , 825 ; PIOGLITAZONE ; 111025-46-8 ; 1999 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- THAZOLIDINEDIONES -- PPAR GAMMA AGONIST , ; NDA 021073 (label 21073.pdf) INN (PIOGLITAZONE HYDROCHLORIDE) ACTOS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021842 (label 21842.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 021925 (label 21925.pdf) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) DUETACT (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 076798 (pdf 76798.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 076799 (pdf 76799.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE (ALPHAPHARM) APPROVAL= TA YEAR= 2005 , NDA 076801 (pdf 76801.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077210 (pdf 77210.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 022024 (label 22024.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET XR (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090406 (pdf 90406.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091155 (pdf 91155.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 078472 (pdf 78472.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200823 (pdf 200823.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 202001 (pdf 202001.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202467 (pdf 202467.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 022426 (label 22426.pdf) INN (ALOGLIPTIN BENZOATE PIOGLITAZONE HYDROCHLORIDE) OSENI (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 078383 (pdf 78383.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078670 (pdf 78670.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 091273 (pdf 91273.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091298 (pdf 91298.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200044 (pdf 200044.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 200268 (pdf 200268.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 201049 (pdf 201049.pdf not found) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 202456 (pdf 202456.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2013 , NDA 204133 (pdf 204133.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2014 , NDA 204802 (pdf 204802.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 206738 (pdf 206738.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2017 , NDA 207806 (pdf 207806.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 210165 (pdf 210165.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (SHUANGCHENG) APPROVAL= AP YEAR= 2021 , 826 ; DOFETILIDE ; 115256-11-6 ; 1999 ; ; ; CLASS CARDIOVASCULAR -- K CHANNEL BLOCKER -- ANTIARRHYTHMIC , ; NDA 020931 (label 20931.pdf) INN (DOFETILIDE) TIKOSYN (PFIZER) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 207058 (label 207058.pdf) INN (DOFETILIDE) DOFETILIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2016 , NDA 207746 (pdf 207746.pdf not found) INN (DOFETILIDE) DOFETILIDE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2018 , NDA 208625 (pdf 208625.pdf not found) INN (DOFETILIDE) DOFETILIDE (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 208519 (pdf 208519.pdf not found) INN (DOFETILIDE) DOFETILIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210466 (pdf 210466.pdf not found) INN (DOFETILIDE) DOFETILIDE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 210740 (pdf 210740.pdf not found) INN (DOFETILIDE) DOFETILDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211223 (pdf 211223.pdf not found) INN (DOFETILIDE) DOFETILIDE (PRINSTON INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212410 (pdf 212410.pdf not found) INN (DOFETILIDE) DOFETILIDE (NOVAST LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213220 (pdf 213220.pdf not found) INN (DOFETILIDE) DOFETILIDE (MSN) APPROVAL= AP YEAR= 2020 , NDA 213338 (pdf 213338.pdf not found) INN (DOFETILIDE) DOFETILIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 212750 (pdf 212750.pdf not found) INN (DOFETILIDE) DOFETILIDE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 210018 (pdf 210018.pdf not found) INN (DOFETILIDE) DOFETILIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215323 (pdf 215323.pdf not found) INN (DOFETILIDE) DOFETILIDE (RK PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , 827 ; GEMIFLOXACIN ; 175463-14-6 ; 2003 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- FLUOROQUINOLONE CLASS OF ANTIBIOTICS , ; NDA 021158 (label 21158.pdf) INN (GEMIFLOXACIN MESYLATE) FACTIVE (LG CHEM LTD) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 090466 (pdf 90466.pdf not found) INN (GEMIFLOXACIN MESYLATE) GEMIFLOXACIN MESYLATE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 828 ; MELOXICAM ; 71125-38-7 ; 2000 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY -- ANALGESICS -- ANTIPYRETIC -- CYCLOOXYGENASE INHIBITORS -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS (NSAIDS) , ; NDA 020938 (label 20938.pdf) INN (MELOXICAM) MOBIC (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , NDA 021530 (label 21530.pdf) INN (MELOXICAM) MELOXICAM (AVONDALE PHARMS) APPROVAL= AP YEAR= 2004 , NDA 077882 (pdf 77882.pdf not found) INN (MELOXICAM) MELOXICAM (COREPHARMA) APPROVAL= AP YEAR= 2006 , NDA 077918 (pdf 77918.pdf not found) INN (MELOXICAM) MELOXICAM (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2006 , NDA 077920 (pdf 77920.pdf not found) INN (MELOXICAM) MELOXICAM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 077921 (pdf 77921.pdf not found) INN (MELOXICAM) MELOXICAM (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 077923 (pdf 77923.pdf not found) INN (MELOXICAM) MELOXICAM (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077925 (pdf 77925.pdf not found) INN (MELOXICAM) MELOXICAM (ROXANE) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077927 (pdf 77927.pdf not found) INN (MELOXICAM) MELOXICAM (UNICHEM) APPROVAL= AP YEAR= 2006 , NDA 077929 (pdf 77929.pdf not found) INN (MELOXICAM) MELOXICAM (CIPLA) APPROVAL= AP YEAR= 2006 , NDA 077930 (pdf 77930.pdf not found) INN (MELOXICAM) MELOXICAM (IMPAX LABS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077931 (pdf 77931.pdf not found) INN (MELOXICAM) MELOXICAM (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077932 (pdf 77932.pdf not found) INN (MELOXICAM) MELOXICAM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2006 , NDA 077933 (pdf 77933.pdf not found) INN (MELOXICAM) MELOXICAM (YABAO PHARM) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077934 (pdf 77934.pdf not found) INN (MELOXICAM) MELOXICAM (MYLAN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077935 (pdf 77935.pdf not found) INN (MELOXICAM) MELOXICAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077936 (pdf 77936.pdf not found) INN (MELOXICAM) MELOXICAM (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077937 (pdf 77937.pdf not found) INN (MELOXICAM) MELOXICAM (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077938 (pdf 77938.pdf not found) INN (MELOXICAM) MELOXICAM (PURACAP PHARM) APPROVAL= AP YEAR= 2006 , NDA 077944 (pdf 77944.pdf not found) INN (MELOXICAM) MELOXICAM (LUPIN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078008 (pdf 78008.pdf not found) INN (MELOXICAM) MELOXICAM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078039 (pdf 78039.pdf not found) INN (MELOXICAM) MELOXICAM (CR DOUBLE CRANE) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078102 (pdf 78102.pdf not found) INN (MELOXICAM) MELOXICAM (TARO) APPROVAL= AP YEAR= 2006 , NDA 077928 (pdf 77928.pdf not found) INN (MELOXICAM) MELOXICAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 , NDA 207233 (label 207233.pdf) INN (MELOXICAM) VIVLODEX (ICEUTICA OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 211210 (label 211210.pdf) INN (MELOXICAM) QMIIZ ODT (TERSERA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211398 (pdf 211398.pdf not found) INN (MELOXICAM) MELOXICAM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 209487 (pdf 209487.pdf not found) INN (MELOXICAM) MELOXICAM (LUPIN LTD) APPROVAL= AP YEAR= 2020 , NDA 210583 (label 210583.pdf) INN (MELOXICAM) ANJESO (BAUDAX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211988 (label 211988.pdf) INN (BUPIVACAINE MELOXICAM) ZYNRELEF KIT (HERON THERAPS INC) APPROVAL= AP YEAR= 2021 , NDA 217579 (pdf 217579.pdf not found) INN (MELOXICAM) MELOXICAM (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , 829 ; DOCOSANOL ; 661-19-8 ; 2000 ; ; NATURAL MOLECULE C00030805 ; CLASS DERMATOLOGICALS -- ANTIVIRAL -- BLOCK THE VIRUS FROM ENTERING THE HEALTHY SKIN CELLS , ; NDA 020941 (label 20941.pdf) INN (DOCOSANOL) ABREVA (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 208754 (pdf 208754.pdf not found) INN (DOCOSANOL) DOCOSANOL (P AND L) APPROVAL= AP YEAR= 2018 , NDA 215839 (pdf 215839.pdf not found) INN (DOCOSANOL) DOCOSANOL (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 212385 (pdf 212385.pdf not found) INN (DOCOSANOL) DOCOSANOL (P AND L DEVELOPMENT) APPROVAL= AP YEAR= 2022 , NDA 214454 (pdf 214454.pdf not found) INN (DOCOSANOL) DOCOSANOL (TARO) APPROVAL= AP YEAR= 2023 , NDA 217090 (pdf 217090.pdf not found) INN (DOCOSANOL) DOCOSANOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 830 ; AMINOLEVULINIC ACID ; 106-60-5 ; 1999 ; ; ; CLASS ANTINEOPLASTIC -- DERMATOLOGIC -- CHEMOPHOTODYNAMIC -- PHOTOSENSITIZING AGENTS -- A PORPHYRIN PRECURSOR -- TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSES OF THE FACE OR SCALP -- MALIGNANT GLIOMA (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 020965 (label 20965.pdf) INN (AMINOLEVULINIC ACID HYDROCHLORIDE) LEVULAN (DUSA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 208081 (label 208081.pdf) INN (AMINOLEVULINIC ACID HYDROCHLORIDE) AMELUZ (BIOFRONTERA) APPROVAL= AP YEAR= 2016 , NDA 208630 (label 208630.pdf) INN (AMINOLEVULINIC ACID HYDROCHLORIDE) GLEOLAN (NXDC) APPROVAL= AP YEAR= 2017 , 831 ; EFAVIRENZ ; 154598-52-4 ; 1998 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV -- HIV-1 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR , ; NDA 020972 (label 20972.pdf) INN (EFAVIRENZ) SUSTIVA (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY DISCONTINUED , NDA 021360 (label 21360.pdf) INN (EFAVIRENZ) SUSTIVA (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021937 (label 21937.pdf) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) ATRIPLA (GILEAD SCIENCES) APPROVAL= AP YEAR= 2006 , NDA 021943 (pdf 21943.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 022096 (pdf 22096.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 022097 (pdf 22097.pdf not found) INN (STAVUDINE LAMIVUDINE EFAVIRENZ) STAVUDINE LAMIVUDINE EFAVIRENZ (STRIDES ACROLAB) APPROVAL= TA YEAR= 2007 , NDA 077673 (pdf 77673.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 077916 (pdf 77916.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (CIPLA LIMITED) APPROVAL= TA YEAR= 2006 , NDA 078064 (pdf 78064.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 078509 (pdf 78509.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 078883 (pdf 78883.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (MATRIX LABS) APPROVAL= TA YEAR= 2008 , NDA 078886 (pdf 78886.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 078958 (pdf 78958.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (EMCURE PHARMA) APPROVAL= TA YEAR= 2007 , NDA 022142 (label 22142.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 022297 (pdf 22297.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022420 (pdf 22420.pdf not found) INN (EFAVIRENZ) EFAVIRENZ 200MG SCORED TABLETS (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2010 , NDA 022461 (label 22461.pdf) INN (EFAVIRENZ) EFAVIRENZ (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090155 (pdf 90155.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (CIPLA LIMITED) APPROVAL= TA YEAR= 2009 , NDA 090437 (pdf 90437.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 091471 (label 91471.pdf) INN (EFAVIRENZ) EFAVIRENZ (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 091215 (pdf 91215.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 091579 (pdf 91579.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 202042 (pdf 202042.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (MICRO LABS LTD) APPROVAL= TA YEAR= 2012 , NDA 091593 (pdf 91593.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 202301 (pdf 202301.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (MICRO LABS LTD) APPROVAL= TA YEAR= 2012 , NDA 202990 (pdf 202990.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (PAR FORMULATIONS PRIVATE LTD) APPROVAL= TA YEAR= 2012 , NDA 204119 (pdf 204119.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2017 , NDA 022343 (label 22343.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 203041 (pdf 203041.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 203053 (pdf 203053.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 204568 (pdf 204568.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= TA YEAR= 2013 , NDA 204287 (pdf 204287.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 205861 (pdf 205861.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2014 , NDA 206040 (pdf 206040.pdf not found) INN (LAMIVUDINE ZIDOVUDINE EFAVIRENZ) LAMIVUDINE ZIDOVUDINE EFAVIRENZ (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206584 (pdf 206584.pdf not found) INN (EFAVIRENZ) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2015 OBSOLETE , NDA 204869 (pdf 204869.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 205322 (pdf 205322.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206894 (pdf 206894.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 091175 (pdf 91175.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (TEVA PHARMS USA) APPROVAL= TA YEAR= 2015 , NDA 204766 (pdf 204766.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 207895 (pdf 207895.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (PHARMACARE LTD) APPROVAL= TA YEAR= 2017 , NDA 208255 (label 208255.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI LO (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 205389 (pdf 205389.pdf not found) INN (EFAVIRENZ) EFAVIRENZ (MICRO LABS LTD INDIA) APPROVAL= TA YEAR= 2018 , NDA 210649 (label 210649.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212786 (pdf 212786.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213038 (pdf 213038.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213541 (pdf 213541.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2021 , NDA 201802 (pdf 201802.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 , NDA 213509 (pdf 213509.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR ALAFENAMIDE) EFAVIRENZ , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (MYLAN) APPROVAL= TA YEAR= 2024 , 832 ; RABEPRAZOLE ; 117976-89-3 ; 1999 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- ANTISECRETORY (GASTRIC ACID) -- PROTON-PUMP INHIBITOR (PPI) -- H+, K+ ATPASE INHIBITOR , ; NDA 020973 (label 20973.pdf) INN (RABEPRAZOLE SODIUM) ACIPHEX (WAYLIS THERAP) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021456 (label 21456.pdf) INN (RABEPRAZOLE SODIUM) ACIPHEX (EISAI MEDCL RES) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 076822 (label 76822.pdf) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 076885 (label 76885.pdf) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (MYLAN) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 076824 (pdf 76824.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 078964 (label 78964.pdf) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 090678 (label 90678.pdf) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 202376 (pdf 202376.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (TORRENT) APPROVAL= AP YEAR= 2013 , NDA 204736 (label 204736.pdf) INN (RABEPRAZOLE SODIUM) ACIPHEX SPRINKLE (AYTU) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204179 (pdf 204179.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204237 (pdf 204237.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (RUBICON) APPROVAL= AP YEAR= 2015 , NDA 205761 (pdf 205761.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208644 (pdf 208644.pdf not found) INN (RABEPRAZOLE SODIUM) RABEPRAZOLE SODIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2018 , 833 ; PANTOPRAZOLE ; 102625-70-7 ; 2000 ; ; ; CLASS METABOLISM -- ANTISECRETORY (GASTRIC ACID) -- PROTON-PUMP INHIBITORS -- ANTI-ULCER AGENTS -- (H+, K+)-ATPASE INHIBITOR , ; NDA 020987 (label 20987.pdf) INN (PANTOPRAZOLE SODIUM) PROTONIX (WYETH PHARMS) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 020988 (label 20988.pdf) INN (PANTOPRAZOLE SODIUM) PROTONIX IV (WYETH PHARMS) APPROVAL= AP YEAR= 2001 , NDA 022020 (label 22020.pdf) INN (PANTOPRAZOLE SODIUM) PROTONIX (WYETH PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077056 (pdf 77056.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077057 (pdf 77057.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE (SANDOZ) APPROVAL= TA YEAR= 2006 OBSOLETE , NDA 077058 (pdf 77058.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077619 (pdf 77619.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 022226 (pdf 22226.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (TEVA PARENTERAL) APPROVAL= TA YEAR= 2008 , NDA 078281 (pdf 78281.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 090074 (pdf 90074.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090970 (pdf 90970.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 090797 (pdf 90797.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2011 , NDA 091231 (pdf 91231.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2011 , NDA 090901 (pdf 90901.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (JUBILANT GENERICS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079197 (pdf 79197.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 090807 (pdf 90807.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (RUBICON) APPROVAL= AP YEAR= 2012 , NDA 200794 (pdf 200794.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200821 (pdf 200821.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202038 (pdf 202038.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202052 (pdf 202052.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (ORBION PHARMS) APPROVAL= AP YEAR= 2014 , NDA 202882 (pdf 202882.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 203024 (pdf 203024.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (L PERRIGO CO) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090296 (pdf 90296.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 205119 (pdf 205119.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205675 (pdf 205675.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204400 (pdf 204400.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 209463 (label 209463.pdf) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (HIKMA) APPROVAL= AP YEAR= 2017 , NDA 208580 (pdf 208580.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211368 (pdf 211368.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2019 , NDA 077674 (pdf 77674.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213725 (pdf 213725.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 209524 (pdf 209524.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (HANGZHOU ZHONGMEI) APPROVAL= AP YEAR= 2021 , NDA 213778 (pdf 213778.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 214680 (pdf 214680.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (KNACK) APPROVAL= AP YEAR= 2022 , NDA 216171 (pdf 216171.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (BE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215860 (pdf 215860.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215880 (pdf 215880.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216247 (pdf 216247.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (DEXCEL) APPROVAL= AP YEAR= 2023 , NDA 217416 (pdf 217416.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216139 (pdf 216139.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217282 (pdf 217282.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 217512 (pdf 217512.pdf not found) INN (PANTOPRAZOLE SODIUM) PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2024 , 834 ; CEVIMELINE ; 107233-08-9 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- MUSCARINIC AGONIST -- CHOLINERGIC AGONIST -- ANTI-ALZHEIMER'S DISEASE -- PARASYMPATHOMIMETICS , ; NDA 020989 (label 20989.pdf) INN (CEVIMELINE HYDROCHLORIDE) EVOXAC (COSETTE) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 091260 (pdf 91260.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091591 (pdf 91591.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 203775 (pdf 203775.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 , NDA 204746 (pdf 204746.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 215056 (pdf 215056.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216682 (pdf 216682.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 218290 (pdf 218290.pdf not found) INN (CEVIMELINE HYDROCHLORIDE) CEVIMELINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , 835 ; LEVOBUPIVACAINE ; 27262-47-1 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC (LOCAL) -- ACETYLCHOLINE RECEPTOR ION CHANNEL BLOCKER , ; NDA 020997 (label 20997.pdf) INN (LEVOBUPIVACAINE HYDROCHLORIDE) CHIROCAINE (PURDUE PHARMA LP) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 016964 (label 16964.pdf) INN (BUPIVACAINE HYDROCHLORIDE) MARCAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 018053 (label 18053.pdf) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1978 , NDA 018304 (label 18304.pdf) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1981 , NDA 018692 (label 18692.pdf) INN (BUPIVACAINE HYDROCHLORIDE) MARCAINE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 019978 (pdf 19978.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE KIT (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 021496 (label 21496.pdf) INN (BUPIVACAINE HYDROCHLORIDE) DUOCAINE (AMPHASTAR) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 022046 (label 22046.pdf) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 070552 (pdf 70552.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1986 , NDA 070553 (pdf 70553.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1986 , NDA 070554 (pdf 70554.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1986 , NDA 070583 (pdf 70583.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070584 (pdf 70584.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070585 (pdf 70585.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070586 (pdf 70586.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070587 (pdf 70587.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070590 (pdf 70590.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070597 (pdf 70597.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070609 (pdf 70609.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070966 (pdf 70966.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1987 , NDA 070967 (pdf 70967.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1987 , NDA 070968 (pdf 70968.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1987 , NDA 071165 (label 71165.pdf) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071166 (pdf 71166.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071167 (pdf 71167.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071168 (label 71168.pdf) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071169 (pdf 71169.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071170 (pdf 71170.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071171 (pdf 71171.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071202 (label 71202.pdf) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (APP PHARMS) APPROVAL= AP YEAR= 1987 , NDA 071810 (pdf 71810.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 076012 (pdf 76012.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (INTL MEDICATED) APPROVAL= AP YEAR= 2002 , NDA 077250 (pdf 77250.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (SEPTODONT) APPROVAL= AP YEAR= 2006 , NDA 022496 (label 22496.pdf) INN (BUPIVACAINE) EXPAREL (PACIRA PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 091487 (pdf 91487.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (SAGENT STRIDES) APPROVAL= AP YEAR= 2011 , NDA 091503 (pdf 91503.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (SAGENT STRIDES) APPROVAL= AP YEAR= 2011 , NDA 203895 (pdf 203895.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 207183 (pdf 207183.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207266 (pdf 207266.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (CLARIS) APPROVAL= AP YEAR= 2016 , NDA 209087 (pdf 209087.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2019 , NDA 211096 (pdf 211096.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (NOVOCOL HEALTHCARE) APPROVAL= AP YEAR= 2019 , NDA 212822 (pdf 212822.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HUONS) APPROVAL= AP YEAR= 2019 , NDA 209511 (label 209511.pdf) INN (BUPIVACAINE HYDROCHLORIDE) XARACOLL (INNOCOLL PHARMS) APPROVAL= AP YEAR= 2020 , NDA 204803 (label 204803.pdf) INN (BUPIVACAINE) POSIMIR (DURECT) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 204842 (pdf 204842.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (HIKMA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 205141 (pdf 205141.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211988 (label 211988.pdf) INN (BUPIVACAINE MELOXICAM) ZYNRELEF KIT (HERON THERAPS INC) APPROVAL= AP YEAR= 2021 , NDA 216039 (pdf 216039.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 216040 (pdf 216040.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 217792 (pdf 217792.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (SOMERSET) APPROVAL= AP YEAR= 2023 , NDA 217821 (pdf 217821.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2024 , 836 ; CELECOXIB ; 169590-42-5 ; 1998 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIARTHRITIC -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL NSAID -- CYCLOOXYGENASE INHIBITORS , ; NDA 020998 (label 20998.pdf) INN (CELECOXIB) CELEBREX (UPJOHN) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021156 (label 21156.pdf) INN (CELECOXIB) CELEBREX (GD SEARLE LLC) APPROVAL= AP YEAR= 1999 NEWAPPLICATION , NDA 078857 (pdf 78857.pdf not found) INN (CELECOXIB) CELECOXIB (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 076898 (pdf 76898.pdf not found) INN (CELECOXIB) CELECOXIB (TEVA) APPROVAL= AP YEAR= 2014 , NDA 200562 (pdf 200562.pdf not found) INN (CELECOXIB) CELECOXIB (WATSON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 202240 (label 202240.pdf) INN (CELECOXIB) CELECOXIB (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 204197 (pdf 204197.pdf not found) INN (CELECOXIB) CELECOXIB (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 204519 (pdf 204519.pdf not found) INN (CELECOXIB) CELECOXIB (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 207446 (pdf 207446.pdf not found) INN (CELECOXIB) CELECOXIB (CIPLA) APPROVAL= AP YEAR= 2015 , NDA 207677 (pdf 207677.pdf not found) INN (CELECOXIB) CELECOXIB (TORRENT) APPROVAL= AP YEAR= 2015 , NDA 204590 (pdf 204590.pdf not found) INN (CELECOXIB) CELECOXIB (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206827 (label 206827.pdf) INN (CELECOXIB) CELECOXIB (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207061 (pdf 207061.pdf not found) INN (CELECOXIB) CELECOXIB (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204776 (pdf 204776.pdf not found) INN (CELECOXIB) CELECOXIB (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 208833 (pdf 208833.pdf not found) INN (CELECOXIB) CELECOXIB (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210045 (label 210045.pdf) INN (AMLODIPINE BESYLATE CELECOXIB) CONSENSI (PURPLE BIOTECH) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210071 (pdf 210071.pdf not found) INN (CELECOXIB) CELECOXIB (CSPC OUYI) APPROVAL= AP YEAR= 2018 , NDA 208701 (pdf 208701.pdf not found) INN (CELECOXIB) CELECOXIB (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 208856 (pdf 208856.pdf not found) INN (CELECOXIB) CELECOXIB (QINGDAO BAHEAL PHARM) APPROVAL= AP YEAR= 2019 , NDA 210628 (pdf 210628.pdf not found) INN (CELECOXIB) CELECOXIB (UMEDICA) APPROVAL= AP YEAR= 2019 , NDA 207872 (pdf 207872.pdf not found) INN (CELECOXIB) CELECOXIB (TIANJIN TIANYAO) APPROVAL= AP YEAR= 2020 , NDA 211412 (pdf 211412.pdf not found) INN (CELECOXIB) CELECOXIB (YILING) APPROVAL= AP YEAR= 2020 , NDA 212157 (label 212157.pdf) INN (CELECOXIB) ELYXYB (SCILEX PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213598 (pdf 213598.pdf not found) INN (CELECOXIB) CELECOXIB (NANJING) APPROVAL= AP YEAR= 2020 , NDA 205129 (pdf 205129.pdf not found) INN (CELECOXIB) CELECOXIB (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212925 (pdf 212925.pdf not found) INN (CELECOXIB) CELECOXIB (ACIC PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213301 (pdf 213301.pdf not found) INN (CELECOXIB) CELECOXIB (UNICHEM) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213426 (label 213426.pdf) INN (CELECOXIB TRAMADOL HYDROCHLORIDE) SEGLENTIS (KOWA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 212564 (pdf 212564.pdf not found) INN (CELECOXIB) CELECOXIB (YABAO PHARM) APPROVAL= AP YEAR= 2023 DISCONTINUED , 837 ; AMPRENAVIR ; 161814-49-9 ; 1999 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ENZYME INHIBITOR (HIV PROTEASE) -- ANTIVIRAL , ; NDA 021007 (label 21007.pdf) INN (AMPRENAVIR) AGENERASE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021039 (label 21039.pdf) INN (AMPRENAVIR) AGENERASE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1999 DISCONTINUED , 838 ; OXCARBAZEPINE ; 28721-07-5 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC , ; NDA 021014 (label 21014.pdf) INN (OXCARBAZEPINE) TRILEPTAL (NOVARTIS) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 021285 (label 21285.pdf) INN (OXCARBAZEPINE) TRILEPTAL (NOVARTIS) APPROVAL= AP YEAR= 2001 , NDA 077747 (pdf 77747.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (RUBICON) APPROVAL= AP YEAR= 2008 , NDA 077794 (label 77794.pdf) INN (OXCARBAZEPINE) OXCARBAZEPINE (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 077795 (label 77795.pdf) INN (OXCARBAZEPINE) OXCARBAZEPINE (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077801 (pdf 77801.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (TARO) APPROVAL= AP YEAR= 2007 , NDA 077802 (label 77802.pdf) INN (OXCARBAZEPINE) OXCARBAZEPINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078005 (pdf 78005.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (ANI PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078069 (pdf 78069.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (BRECKENRIDGE PHARM) APPROVAL= AP YEAR= 2008 , NDA 078734 (pdf 78734.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 , NDA 090239 (pdf 90239.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201193 (pdf 201193.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202810 (label 202810.pdf) INN (OXCARBAZEPINE) OXTELLAR XR (SUPERNUS PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202961 (pdf 202961.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2012 , NDA 206576 (pdf 206576.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (TWI PHARMS INC) APPROVAL= TA YEAR= 2018 , NDA 205444 (pdf 205444.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2018 , NDA 212428 (pdf 212428.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (CHARTWELL RX) APPROVAL= AP YEAR= 2021 , NDA 211420 (pdf 211420.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (RENEW PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215939 (pdf 215939.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 209652 (pdf 209652.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (BIONPHARMA) APPROVAL= AP YEAR= 2022 , NDA 215332 (pdf 215332.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (AUCTA) APPROVAL= AP YEAR= 2022 , NDA 215726 (pdf 215726.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 211747 (pdf 211747.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (ZYDUS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213369 (pdf 213369.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216749 (pdf 216749.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , NDA 207717 (pdf 207717.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (RUBICON) APPROVAL= AP YEAR= 2024 , NDA 213183 (pdf 213183.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2024 , NDA 217659 (pdf 217659.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217782 (pdf 217782.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (MEDLEY PHARMS) APPROVAL= AP YEAR= 2024 , NDA 218278 (pdf 218278.pdf not found) INN (OXCARBAZEPINE) OXCARBAZEPINE (BIOCON PHARMA) APPROVAL= AP YEAR= 2024 , 839 ; ELETRIPTAN ; 143322-58-1 ; 2002 ; ; ; CLASS NERVOUS SYSTEM -- ANTI-MIGRANE -- ANTI-INFLAMMATORY AGENTS -- SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS -- 5-HYDROXYTRYPTAMINE RECEPTOR AGONIST (5HT) , ; NDA 021016 (label 21016.pdf) INN (ELETRIPTAN HYDROBROMIDE) RELPAX (UPJOHN) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 201536 (pdf 201536.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (APOTEX INC) APPROVAL= TA YEAR= 2013 , NDA 202040 (pdf 202040.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 205186 (pdf 205186.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 205152 (pdf 205152.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 206409 (pdf 206409.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206787 (pdf 206787.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (STEVENS J) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210708 (pdf 210708.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 209680 (pdf 209680.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215467 (pdf 215467.pdf not found) INN (ELETRIPTAN HYDROBROMIDE) ELETRIPTAN HYDROBROMIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2022 , 840 ; CYCLOSPORINE ; 59865-13-3 ; 1983 ; ; NATURAL MOLECULE NPA017720 ; CLASS IMMUNOMODULATORY AGENT -- PRODUCED AS A METABOLITE BY THE FUNGUS SPECIES BEAUVERIA NIVEA , ; NDA 021023 (pdf 21023.pdf not found) INN (CYCLOSPORINE) RESTASIS (ALLERGAN) APPROVAL= AP YEAR= 2003 , NDA 050573 (label 50573.pdf) INN (CYCLOSPORINE) SANDIMMUNE (NOVARTIS) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY , NDA 050574 (label 50574.pdf) INN (CYCLOSPORINE) SANDIMMUNE (NOVARTIS) APPROVAL= AP YEAR= 1983 , NDA 050625 (label 50625.pdf) INN (CYCLOSPORINE) SANDIMMUNE (NOVARTIS) APPROVAL= AP YEAR= 1990 , NDA 050715 (label 50715.pdf) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1995 , NDA 050716 (label 50716.pdf) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1995 , NDA 050790 (label 50790.pdf) INN (CYCLOSPORINE) RESTASIS (ABBVIE) APPROVAL= AP YEAR= 2002 , NDA 064195 (label 64195.pdf) INN (CYCLOSPORINE) SANGCYA (SANGSTAT MEDCL) APPROVAL= AP YEAR= 1998 DISCONTINUED OBSOLETE , NDA 065003 (pdf 65003.pdf not found) INN (CYCLOSPORINE) GENGRAF (ABBVIE) APPROVAL= AP YEAR= 2000 , NDA 065004 (pdf 65004.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 065017 (label 65017.pdf) INN (CYCLOSPORINE) CYCLOSPORINE (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 065025 (pdf 65025.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (ABBVIE) APPROVAL= AP YEAR= 2000 , NDA 065040 (pdf 65040.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 065044 (pdf 65044.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2000 , NDA 065054 (pdf 65054.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065078 (pdf 65078.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 065110 (pdf 65110.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 065133 (pdf 65133.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065151 (pdf 65151.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (PADAGIS US) APPROVAL= AP YEAR= 2003 , NDA 065167 (pdf 65167.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 210913 (label 210913.pdf) INN (CYCLOSPORINE) CEQUA (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 210721 (pdf 210721.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 214965 (label 214965.pdf) INN (CYCLOSPORINE) VERKAZIA (HARROW EYE) APPROVAL= AP YEAR= 2021 , NDA 205894 (pdf 205894.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 216046 (pdf 216046.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 207606 (pdf 207606.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 217469 (label 217469.pdf) INN (CYCLOSPORINE) VEVYE (HARROW EYE) APPROVAL= AP YEAR= 2023 , NDA 050735 (pdf 50735.pdf not found) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1997 NEWAPPLICATION , NDA 050736 (pdf 50736.pdf not found) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1997 NEWAPPLICATION , NDA 050737 (pdf 50737.pdf not found) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1997 NEWAPPLICATION , NDA 050738 (pdf 50738.pdf not found) INN (CYCLOSPORINE) NEORAL (NOVARTIS) APPROVAL= AP YEAR= 1997 NEWAPPLICATION , NDA 203880 (pdf 203880.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2023 , NDA 209811 (pdf 209811.pdf not found) INN (CYCLOSPORINE) CYCLOSPORINE (DEVA HOLDING AS) APPROVAL= AP YEAR= 2024 , 841 ; RIFAPENTINE ; 61379-65-5 ; 1998 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIBIOTIC -- RIFAMYCIN ANTIMYCOBACTERIALS -- INHIBITS DNA-DEPENDENT RNA POLYMERASE , ; NDA 021024 (label 21024.pdf) INN (RIFAPENTINE) PRIFTIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , 842 ; TEMOZOLOMIDE ; 85622-93-1 ; 1999 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING DNA -- ALKYLATION (METHYLATION) OCCURS MAINLY AT THE O6 AND N7 POSITIONS OF GUANINE , ; NDA 021029 (label 21029.pdf) INN (TEMOZOLOMIDE) TEMODAR (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 022277 (label 22277.pdf) INN (TEMOZOLOMIDE) TEMODAR (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2009 , NDA 078879 (pdf 78879.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (HERITAGE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201742 (pdf 201742.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 203691 (pdf 203691.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 205227 (pdf 205227.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203898 (pdf 203898.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206309 (pdf 206309.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 206413 (pdf 206413.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (CHARTWELL) APPROVAL= AP YEAR= 2016 , NDA 203490 (pdf 203490.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (ANI PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204639 (pdf 204639.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (CHEMI SPA) APPROVAL= AP YEAR= 2016 , NDA 201528 (pdf 201528.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 203959 (pdf 203959.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206750 (pdf 206750.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207658 (pdf 207658.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (DEVA HOLDING AS) APPROVAL= AP YEAR= 2017 , NDA 204159 (pdf 204159.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (APOTEX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213328 (pdf 213328.pdf not found) INN (TEMOZOLOMIDE) TEMOZOLOMIDE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , 843 ; LEVETIRACETAM ; 102767-28-2 ; 1999 ; ; ; CLASS NERVOUS SYSTEM -- NOOTROPIC -- COGNITION ENHANCER -- ANTIEPILEPTIC -- ANTICONVULSANTS -- PARTIALLY INHIBITS N-TYPE CALCIUM CURRENTS IN NEURONAL CELLS , ; NDA 021035 (label 21035.pdf) INN (LEVETIRACETAM) KEPPRA (UCB INC) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021505 (label 21505.pdf) INN (LEVETIRACETAM) KEPPRA (UCB INC) APPROVAL= AP YEAR= 2003 , NDA 021872 (label 21872.pdf) INN (LEVETIRACETAM) KEPPRA (UCB INC) APPROVAL= AP YEAR= 2006 , NDA 022285 (label 22285.pdf) INN (LEVETIRACETAM) KEPPRA XR (UCB INC) APPROVAL= AP YEAR= 2008 , NDA 076919 (pdf 76919.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MYLAN) APPROVAL= AP YEAR= 2008 , NDA 076920 (pdf 76920.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 077319 (pdf 77319.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (OXFORD PHARMS) APPROVAL= AP YEAR= 2009 , NDA 077324 (pdf 77324.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (FOSUN PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077384 (pdf 77384.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (COBALT LABS INC) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 077408 (pdf 77408.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078042 (pdf 78042.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACI) APPROVAL= AP YEAR= 2009 , NDA 078101 (pdf 78101.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TEVA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078106 (pdf 78106.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PRINSTON INC) APPROVAL= AP YEAR= 2009 , NDA 078154 (pdf 78154.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LUPIN) APPROVAL= AP YEAR= 2009 , NDA 078234 (pdf 78234.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (INVAGEN PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078526 (pdf 78526.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ORBION PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078582 (pdf 78582.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACI) APPROVAL= AP YEAR= 2009 , NDA 078731 (pdf 78731.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078774 (pdf 78774.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TARO) APPROVAL= AP YEAR= 2009 , NDA 078797 (pdf 78797.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (WATSON LABS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078858 (pdf 78858.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TORRENT PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078869 (pdf 78869.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (VIWIT PHARM) APPROVAL= AP YEAR= 2009 , NDA 078904 (pdf 78904.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 078918 (pdf 78918.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 , NDA 078960 (pdf 78960.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TARO) APPROVAL= AP YEAR= 2010 , NDA 078976 (pdf 78976.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2009 , NDA 078993 (pdf 78993.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 079042 (pdf 79042.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (STALLION LABS) APPROVAL= AP YEAR= 2009 , NDA 079063 (pdf 79063.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 079107 (pdf 79107.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TOLMAR) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079120 (pdf 79120.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (BIONPHARMA) APPROVAL= AP YEAR= 2009 , NDA 090025 (pdf 90025.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LUPIN) APPROVAL= AP YEAR= 2009 , NDA 090028 (pdf 90028.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090261 (pdf 90261.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 090263 (pdf 90263.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2009 , NDA 090992 (pdf 90992.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090461 (pdf 90461.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (BELCHER) APPROVAL= AP YEAR= 2010 , NDA 090484 (pdf 90484.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ORBION PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090515 (pdf 90515.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2010 , NDA 090754 (pdf 90754.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090767 (pdf 90767.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (RISING) APPROVAL= AP YEAR= 2010 , NDA 090813 (pdf 90813.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090906 (pdf 90906.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091338 (pdf 91338.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201293 (pdf 201293.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (CHARTWELL RX) APPROVAL= AP YEAR= 2011 , NDA 091491 (pdf 91491.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ZHEJIANG JINGXIN) APPROVAL= AP YEAR= 2010 , NDA 090843 (pdf 90843.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091399 (pdf 91399.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 090187 (pdf 90187.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090511 (pdf 90511.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090893 (pdf 90893.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 090981 (pdf 90981.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2011 , NDA 091093 (pdf 91093.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2011 , NDA 091261 (pdf 91261.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 091285 (pdf 91285.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091291 (pdf 91291.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091360 (pdf 91360.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091430 (pdf 91430.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (TEVA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091485 (pdf 91485.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ADRASTEA PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091557 (pdf 91557.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200475 (pdf 200475.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202543 (label 202543.pdf) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2011 , NDA 202143 (pdf 202143.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AM REGENT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203067 (pdf 203067.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ALEMBIC) APPROVAL= AP YEAR= 2013 , NDA 090079 (pdf 90079.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (QUAGEN) APPROVAL= AP YEAR= 2012 , NDA 090601 (pdf 90601.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091668 (pdf 91668.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SANDOZ) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201464 (pdf 201464.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PHARMADAX INC) APPROVAL= AP YEAR= 2012 , NDA 202524 (pdf 202524.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ROUSES POINT PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202533 (pdf 202533.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PRINSTON INC) APPROVAL= AP YEAR= 2012 , NDA 202869 (pdf 202869.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HOSPIRA INC) APPROVAL= AP YEAR= 2012 , NDA 091627 (pdf 91627.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SAGENT PHARMS) APPROVAL= AP YEAR= 2013 , NDA 202958 (label 202958.pdf) INN (LEVETIRACETAM) LEVETIRACETAM (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 203052 (pdf 203052.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2013 , NDA 203059 (pdf 203059.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201157 (pdf 201157.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PHARM ASSOC) APPROVAL= AP YEAR= 2015 , NDA 203468 (pdf 203468.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 204417 (label 204417.pdf) INN (LEVETIRACETAM) ELEPSIA XR (TRIPOINT) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207958 (label 207958.pdf) INN (LEVETIRACETAM) SPRITAM (APRECIA PHARMS) APPROVAL= AP YEAR= 2015 , NDA 090876 (pdf 90876.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 202167 (pdf 202167.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (DEXCEL) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205102 (pdf 205102.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SECAN PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202095 (pdf 202095.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204312 (label 204312.pdf) INN (LEVETIRACETAM) LEVETIRACETAM (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204511 (pdf 204511.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 2016 , NDA 206838 (pdf 206838.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (JUBILANT GENERICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203308 (pdf 203308.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 204754 (pdf 204754.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (AIPING PHARM INC) APPROVAL= AP YEAR= 2016 , NDA 207160 (label 207160.pdf) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206880 (pdf 206880.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 207175 (pdf 207175.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2017 , NDA 209781 (pdf 209781.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (HAINAN POLY PHARM) APPROVAL= AP YEAR= 2018 , NDA 209934 (pdf 209934.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211954 (pdf 211954.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 212688 (pdf 212688.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (OVERSEAS) APPROVAL= AP YEAR= 2020 , NDA 213532 (pdf 213532.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (NEXUS) APPROVAL= AP YEAR= 2020 , NDA 205130 (pdf 205130.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 215069 (pdf 215069.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 209474 (pdf 209474.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 216375 (pdf 216375.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 214757 (pdf 214757.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MSN) APPROVAL= AP YEAR= 2022 , NDA 214815 (pdf 214815.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MSN) APPROVAL= AP YEAR= 2022 , NDA 215980 (pdf 215980.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (MSN) APPROVAL= AP YEAR= 2022 , NDA 208619 (pdf 208619.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217878 (pdf 217878.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (GRANULES) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214673 (pdf 214673.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217059 (pdf 217059.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 , NDA 209705 (pdf 209705.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2024 , NDA 211356 (pdf 211356.pdf not found) INN (LEVETIRACETAM) LEVETIRACETAM IN SODIUM CHLORIDE (HIKMA) APPROVAL= AP YEAR= 2024 , 844 ; ZANAMIVIR ; 139110-80-8 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTIINFLUENZA -- NEURAMINIDASE INHIBITOR , ; NDA 021036 (label 21036.pdf) INN (ZANAMIVIR) RELENZA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , 845 ; DEXMEDETOMIDINE ; 113775-47-6 ; 1999 ; ; ; CLASS NERVOUS SYSTEM -- ADRENERGIC ALPHA AGONISTS -- HYPNOTICS AND SEDATIVES , ; NDA 021038 (label 21038.pdf) INN (DEXMEDETOMIDINE HYDROCHLORIDE) PRECEDEX (HOSPIRA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 091465 (pdf 91465.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2016 , NDA 202126 (pdf 202126.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (GLAND) APPROVAL= AP YEAR= 2015 , NDA 202585 (pdf 202585.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 , NDA 202881 (pdf 202881.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 , NDA 203972 (pdf 203972.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 201072 (pdf 201072.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 206628 (label 206628.pdf) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204023 (pdf 204023.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 205867 (pdf 205867.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204686 (pdf 204686.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (ACTAVIS INC) APPROVAL= AP YEAR= 2016 , NDA 203773 (pdf 203773.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205046 (pdf 205046.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2017 , NDA 205272 (pdf 205272.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 209065 (pdf 209065.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206798 (pdf 206798.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207551 (pdf 207551.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2020 , NDA 208129 (pdf 208129.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 208532 (pdf 208532.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2018 , NDA 204843 (pdf 204843.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2019 , NDA 212791 (pdf 212791.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 206407 (pdf 206407.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 209307 (pdf 209307.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 208266 (pdf 208266.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2020 , NDA 210321 (pdf 210321.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212571 (pdf 212571.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212857 (pdf 212857.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (TAGI) APPROVAL= AP YEAR= 2020 , NDA 214794 (pdf 214794.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215390 (label 215390.pdf) INN (DEXMEDETOMIDINE HYDROCHLORIDE) IGALMI (BIOXCEL) APPROVAL= AP YEAR= 2022 , NDA 216604 (pdf 216604.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 217308 (pdf 217308.pdf not found) INN (DEXMEDETOMIDINE HYDROCHLORIDE) DEXMEDETOMIDINE HYDROCHLORIDE (MILLA PHARMS) APPROVAL= AP YEAR= 2023 , 846 ; ROFECOXIB ; 162011-90-7 ; 1999 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY NSAID -- ANALGESIC -- CYCLOOXYGENASE 2 INHIBITORS , ; NDA 021042 (label 21042.pdf) INN (ROFECOXIB) VIOXX (MERCK) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021052 (label 21052.pdf) INN (ROFECOXIB) VIOXX (MERCK) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021647 (label 21647.pdf) INN (ROFECOXIB) VIOXX (MERCK) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED , 847 ; BEXAROTENE ; 153559-49-0 ; 1999 ; ; ; CLASS ANTILEOPLASTIC -- RETINOID RECEPTOR RXRS AGONIST -- ANTINEOPLASTIC -- ANTICANCER -- ANTICARCINOGENIC AGENTS , ; NDA 021055 (label 21055.pdf) INN (BEXAROTENE) TARGRETIN (VALEANT LUXEMBOURG) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021056 (label 21056.pdf) INN (BEXAROTENE) TARGRETIN (BAUSCH) APPROVAL= AP YEAR= 2000 , NDA 203174 (pdf 203174.pdf not found) INN (BEXAROTENE) BEXAROTENE (BIONPHARMA) APPROVAL= AP YEAR= 2014 , NDA 209861 (pdf 209861.pdf not found) INN (BEXAROTENE) BEXAROTENE (ANI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209886 (pdf 209886.pdf not found) INN (BEXAROTENE) BEXAROTENE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 , NDA 210105 (pdf 210105.pdf not found) INN (BEXAROTENE) BEXAROTENE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2018 , NDA 203663 (pdf 203663.pdf not found) INN (BEXAROTENE) BEXAROTENE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 209931 (pdf 209931.pdf not found) INN (BEXAROTENE) BEXAROTENE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215398 (pdf 215398.pdf not found) INN (BEXAROTENE) BEXAROTENE (AMNEAL) APPROVAL= AP YEAR= 2022 , 848 ; GUAIFENESIN ; 93-14-1 ; 2002 ; ; ; CLASS RESPIRATORY SYSTEM -- MUCOLYTIC -- EXPECTORANTS , ; NDA 021282 (label 21282.pdf) INN (GUAIFENESIN) MUCINEX (RB HLTH) APPROVAL= AP YEAR= 2002 , NDA 021585 (label 21585.pdf) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) MUCINEX D (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 021620 (label 21620.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) MUCINEX DM (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 078912 (pdf 78912.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 , NDA 205474 (label 205474.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) OBREDON (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 022279 (label 22279.pdf) INN (GUAIFENESIN) HYCOFENIX (BKK PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 022424 (label 22424.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) FLOWTUSS (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091071 (pdf 91071.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 091009 (pdf 91009.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 091070 (pdf 91070.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 208369 (pdf 208369.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 206941 (pdf 206941.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209215 (pdf 209215.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2017 , NDA 209692 (pdf 209692.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207602 (pdf 207602.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 208085 (label 208085.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) XTRELUS (ECI PHARMS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207342 (pdf 207342.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209254 (pdf 209254.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (OHM LABS INC) APPROVAL= AP YEAR= 2018 , NDA 210453 (pdf 210453.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212542 (pdf 212542.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 213203 (pdf 213203.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213420 (pdf 213420.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 214781 (pdf 214781.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 214407 (pdf 214407.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2022 , NDA 215932 (pdf 215932.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 216082 (pdf 216082.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217340 (pdf 217340.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 217780 (pdf 217780.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , 849 ; KETOTIFEN ; 34580-13-7 ; 1999 ; ; ; CLASS RESPIRATORY -- ANTIASTHMATIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITICS -- HISTAMINE H1 ANTAGONISTS , ; NDA 021066 (label 21066.pdf) INN (KETOTIFEN FUMARATE) ZADITOR (ALCON PHARMA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021996 (label 21996.pdf) INN (KETOTIFEN FUMARATE) ALAWAY (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2006 , NDA 077200 (pdf 77200.pdf not found) INN (KETOTIFEN FUMARATE) ZADITOR (ALCON PHARMS LTD) APPROVAL= AP YEAR= 2008 , NDA 077354 (pdf 77354.pdf not found) INN (KETOTIFEN FUMARATE) KETOTIFEN FUMARATE (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 077958 (pdf 77958.pdf not found) INN (KETOTIFEN FUMARATE) KETOTIFEN FUMARATE (SENTISS) APPROVAL= AP YEAR= 2007 , NDA 204059 (pdf 204059.pdf not found) INN (KETOTIFEN FUMARATE) KETOTIFEN FUMARATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 208158 (pdf 208158.pdf not found) INN (KETOTIFEN FUMARATE) ALAWAY (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2020 , NDA 022388 (label 22388.pdf) INN (KETOTIFEN FUMARATE) ACUVUE THERAVISION WITH KETOTIFEN (JOHNSON JOHNSON VISN) APPROVAL= AP YEAR= 2022 DISCONTINUED , 850 ; PIOGLITAZONE ; 111025-46-8 ; 1999 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- THAZOLIDINEDIONES -- PPAR GAMMA AGONIST , ; NDA 021073 (label 21073.pdf) INN (PIOGLITAZONE HYDROCHLORIDE) ACTOS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021842 (label 21842.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 021925 (label 21925.pdf) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) DUETACT (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 076798 (pdf 76798.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 076799 (pdf 76799.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE (ALPHAPHARM) APPROVAL= TA YEAR= 2005 , NDA 076801 (pdf 76801.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077210 (pdf 77210.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 022024 (label 22024.pdf) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) ACTOPLUS MET XR (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090406 (pdf 90406.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091155 (pdf 91155.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 078472 (pdf 78472.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200823 (pdf 200823.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 202001 (pdf 202001.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202467 (pdf 202467.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 022426 (label 22426.pdf) INN (ALOGLIPTIN BENZOATE PIOGLITAZONE HYDROCHLORIDE) OSENI (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 078383 (pdf 78383.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078670 (pdf 78670.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 091273 (pdf 91273.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091298 (pdf 91298.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200044 (pdf 200044.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 200268 (pdf 200268.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 201049 (pdf 201049.pdf not found) INN (GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 202456 (pdf 202456.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2013 , NDA 204133 (pdf 204133.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2014 , NDA 204802 (pdf 204802.pdf not found) INN (METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 206738 (pdf 206738.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2017 , NDA 207806 (pdf 207806.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 210165 (pdf 210165.pdf not found) INN (PIOGLITAZONE HYDROCHLORIDE) PIOGLITAZONE HYDROCHLORIDE (SHUANGCHENG) APPROVAL= AP YEAR= 2021 , 851 ; PROGUANIL ; 500-92-5 ; 2000 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- ANTIMETABOLITES -- DIHYDROFOLATE REDUCTASE INHIBITOR , ; NDA 021078 (label 21078.pdf) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) MALARONE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2000 , NDA 091211 (pdf 91211.pdf not found) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (GLENMARK GENERICS) APPROVAL= AP YEAR= 2011 , NDA 202362 (pdf 202362.pdf not found) INN (ATOVAQUONE PROGUANIL HYDROCHLORIDE) ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2014 , 852 ; PEMIROLAST ; 69372-19-6 ; 1999 ; DISCONTINUED ; ; CLASS ANTIINFLAMMATORY -- ANTIALLERGIC -- ANTIPRURITICS -- PREVENT CALCIUM INFLUX INTO MAST CELLS UPON ANTIGEN STIMULATION , ; NDA 021079 (label 21079.pdf) INN (PEMIROLAST POTASSIUM) ALAMAST (SANTEN) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , 853 ; SIROLIMUS ; 53123-88-9 ; 1999 ; ; NATURAL MOLECULE C00018055 ; CLASS ANTINEOPLASTIC -- IMMUNOSUPPRESSIVE -- SIROLIMUS BINDS TO THE IMMUNOPHILIN FK BINDING PROTEIN-12 (FKBP-12) -- PROTEIN-PROTEIN INHIBITOR , ; NDA 021083 (label 21083.pdf) INN (SIROLIMUS) RAPAMUNE (PF PRISM CV) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021110 (label 21110.pdf) INN (SIROLIMUS) RAPAMUNE (PF PRISM CV) APPROVAL= AP YEAR= 2000 , NDA 201578 (pdf 201578.pdf not found) INN (SIROLIMUS) SIROLIMUS (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 201676 (pdf 201676.pdf not found) INN (SIROLIMUS) SIROLIMUS (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 211040 (pdf 211040.pdf not found) INN (SIROLIMUS) SIROLIMUS (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211212 (pdf 211212.pdf not found) INN (SIROLIMUS) SIROLIMUS (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 211406 (pdf 211406.pdf not found) INN (SIROLIMUS) SIROLIMUS (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 208691 (pdf 208691.pdf not found) INN (SIROLIMUS) SIROLIMUS (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 214753 (pdf 214753.pdf not found) INN (SIROLIMUS) SIROLIMUS (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 213312 (label 213312.pdf) INN (SIROLIMUS) FYARRO (AADI) APPROVAL= AP YEAR= 2021 , NDA 215016 (pdf 215016.pdf not found) INN (SIROLIMUS) SIROLIMUS (TORRENT) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213478 (label 213478.pdf) INN (SIROLIMUS) HYFTOR (NOBELPHARMA) APPROVAL= AP YEAR= 2022 , NDA 216728 (pdf 216728.pdf not found) INN (SIROLIMUS) SIROLIMUS (MSN) APPROVAL= AP YEAR= 2023 , 854 ; MOXIFLOXACIN ; 151096-09-2 ; 1999 ; ; ; CLASS ANTIINFECTIVE -- FLUOROQUINOLONE ANTIBACTERIAL -- ANTIBIOTIC -- QUINOLONES , ; NDA 021085 (label 21085.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) AVELOX (BAYER HLTHCARE) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021277 (label 21277.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (BAYER HLTHCARE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021334 (label 21334.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) AVELOX (BAYER PHARMS) APPROVAL= AP YEAR= 2001 NEWAPPLICATION , NDA 021598 (label 21598.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) VIGAMOX (HARROW EYE) APPROVAL= AP YEAR= 2003 , NDA 076938 (pdf 76938.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 077437 (pdf 77437.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 078073 (pdf 78073.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= TA YEAR= 2009 , NDA 022428 (label 22428.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXEZA (HARROW EYE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090080 (pdf 90080.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 200160 (pdf 200160.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202632 (pdf 202632.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 202916 (pdf 202916.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 202867 (pdf 202867.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202525 (pdf 202525.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (INDOCO) APPROVAL= AP YEAR= 2015 , NDA 204079 (pdf 204079.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 205572 (label 205572.pdf) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204635 (pdf 204635.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (NATCO) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205348 (pdf 205348.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2016 , NDA 205833 (pdf 205833.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207285 (pdf 207285.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 206242 (pdf 206242.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208682 (pdf 208682.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2017 , NDA 206295 (pdf 206295.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209469 (pdf 209469.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 206447 (pdf 206447.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 208778 (pdf 208778.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212616 (pdf 212616.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2021 , NDA 204836 (pdf 204836.pdf not found) INN (MOXIFLOXACIN HYDROCHLORIDE) MOXIFLOXACIN HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , 855 ; DROSPIRENONE ; 67392-87-4 ; 2001 ; ; ; CLASS GENITO -- CONTRACEPTIVE -- ALDOSTERONE ANTAGONIST , ; NDA 021098 (label 21098.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YASMIN (BAYER HLTHCARE) APPROVAL= AP YEAR= 2001 , NDA 021355 (label 21355.pdf) INN (DROSPIRENONE ESTRADIOL) ANGELIQ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2005 , NDA 021676 (label 21676.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2006 , NDA 021873 (label 21873.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 022045 (pdf 22045.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 077527 (pdf 77527.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2008 , NDA 078515 (label 78515.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (BARR) APPROVAL= AP YEAR= 2009 , NDA 090081 (pdf 90081.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2010 , NDA 022532 (label 22532.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) BEYAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 022574 (label 22574.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) SAFYRAL (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 079221 (pdf 79221.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) LORYNA (XIROMED) APPROVAL= AP YEAR= 2011 , NDA 090114 (pdf 90114.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) SYEDA (XIROMED) APPROVAL= AP YEAR= 2011 , NDA 078833 (pdf 78833.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 201663 (pdf 201663.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 201661 (pdf 201661.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) NIKKI (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202015 (pdf 202015.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) YAELA (NOVAST LABS) APPROVAL= AP YEAR= 2014 , NDA 202131 (pdf 202131.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 203593 (label 203593.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 203594 (label 203594.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 202016 (pdf 202016.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) MELAMISA (NOVAST LABS) APPROVAL= AP YEAR= 2016 , NDA 202594 (pdf 202594.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 204296 (pdf 204296.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 204848 (pdf 204848.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 205876 (pdf 205876.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (APOTEX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207245 (pdf 207245.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (NAARI PTE LTD) APPROVAL= AP YEAR= 2016 , NDA 203291 (pdf 203291.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 205948 (pdf 205948.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) TYDEMY (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 209423 (pdf 209423.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209407 (pdf 209407.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) ZUMANDIMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 209632 (pdf 209632.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) LO-ZUMANDIMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 205947 (pdf 205947.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 210017 (pdf 210017.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 202138 (pdf 202138.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) KEMEYA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211367 (label 211367.pdf) INN (DROSPIRENONE) SLYND (EXELTIS USA INC) APPROVAL= AP YEAR= 2019 , NDA 211944 (pdf 211944.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2019 , NDA 202318 (pdf 202318.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) KYRA (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213034 (pdf 213034.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL) DROSPIRENONE AND ETHINYL ESTRADIOL (HETERO LABS) APPROVAL= AP YEAR= 2020 , NDA 214154 (label 214154.pdf) INN (DROSPIRENONE ESTETROL) NEXTSTELLIS (MAYNE PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216285 (label 216285.pdf) INN (DROSPIRENONE) DROSPIRENONE (EXELTIS USA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216936 (pdf 216936.pdf not found) INN (DROSPIRENONE) DROSPIRENONE (LUPIN LTD) APPROVAL= TA YEAR= 2022 , 856 ; ALOSETRON ; 122852-42-0 ; 2000 ; ; ; CLASS METABOLISM -- IRRITABLE BOWEL SYNDROME (THERAPEUTIC) -- ANTIEMETIC -- 5-HT3 RECEPTOR ANTAGONIST -- GASTROINTESTINAL AGENTS -- SEROTONIN ANTAGONISTS , ; NDA 021107 (label 21107.pdf) INN (ALOSETRON HYDROCHLORIDE) LOTRONEX (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 200652 (label 200652.pdf) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206647 (pdf 206647.pdf not found) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206113 (pdf 206113.pdf not found) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209180 (pdf 209180.pdf not found) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2019 , NDA 211621 (pdf 211621.pdf not found) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (EYWA PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213614 (pdf 213614.pdf not found) INN (ALOSETRON HYDROCHLORIDE) ALOSETRON HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2020 , 857 ; HYDROQUINONE ; 123-31-9 ; 2002 ; ; NATURAL MOLECULE C00002656 ; CLASS DERMATOLOGICAL -- ANTIOXIDANT -- DEPIGMENTOR -- MAY INTERRUPT ONE OR MORE STEPS IN THE TYROSINE-TYROSINASE PATHWAY OF MELANIN SYNTHESIS , ; NDA 021112 (label 21112.pdf) INN (FLUOCINOLONE ACETONIDE HYDROQUINONE TRETINOIN) TRI-LUMA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2002 , 858 ; LEVOTHYROXINE ; 51-48-9 ; 2000 ; ; ; CLASS HORMONES -- THYROMIMETIC -- ANTICOAGULANTS -- SYNTHETIC L-THYROXINE T4 -- ANTITHYROID AGENTS -- HYPOTHYROIDISM , ; NDA 021116 (label 21116.pdf) INN (LEVOTHYROXINE SODIUM) THYRO-TABS (ALVOGEN) APPROVAL= AP YEAR= 2002 , NDA 021137 (label 21137.pdf) INN (LEVOTHYROXINE SODIUM) LEVOLET (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2003 , NDA 021210 (label 21210.pdf) INN (LEVOTHYROXINE SODIUM) UNITHROID (STEVENS J) APPROVAL= AP YEAR= 2000 , NDA 021292 (label 21292.pdf) INN (LEVOTHYROXINE SODIUM) EUTHYROX (PROVELL) APPROVAL= AP YEAR= 2002 , NDA 021301 (label 21301.pdf) INN (LEVOTHYROXINE SODIUM) LEVOXYL (KING PHARMS) APPROVAL= AP YEAR= 2001 , NDA 021342 (label 21342.pdf) INN (LEVOTHYROXINE SODIUM) LEVO-T (CEDIPROF INC) APPROVAL= AP YEAR= 2002 , NDA 021402 (label 21402.pdf) INN (LEVOTHYROXINE SODIUM) SYNTHROID (ABBVIE) APPROVAL= AP YEAR= 2002 , NDA 021924 (label 21924.pdf) INN (LEVOTHYROXINE SODIUM) TIROSINT (IBSA) APPROVAL= AP YEAR= 2006 , NDA 022121 (label 22121.pdf) INN (LEVOTHYROXINE SODIUM) TIROSINT (INSTITUT BIOCHIMIQUE) APPROVAL= AP YEAR= 2007 NEWAPPLICATION OBSOLETE , NDA 076187 (label 76187.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (MYLAN) APPROVAL= AP YEAR= 2002 , NDA 076752 (pdf 76752.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (MERCK KGAA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076764 (pdf 76764.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 202231 (label 202231.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2011 , NDA 205366 (label 205366.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206163 (label 206163.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2016 , NDA 206977 (label 206977.pdf) INN (LEVOTHYROXINE SODIUM) TIROSINT-SOL (IBSA) APPROVAL= AP YEAR= 2016 , NDA 208749 (pdf 208749.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (MAIA PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 209713 (pdf 209713.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (LUPIN) APPROVAL= AP YEAR= 2019 , NDA 210632 (label 210632.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 210831 (pdf 210831.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (AMNEAL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208837 (pdf 208837.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (DR REDDYS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211369 (pdf 211369.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212399 (pdf 212399.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 214047 (label 214047.pdf) INN (LEVOTHYROXINE SODIUM) THYQUIDITY (AZURITY) APPROVAL= AP YEAR= 2020 , NDA 213256 (pdf 213256.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214253 (label 214253.pdf) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 207588 (pdf 207588.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (WATSON LABS TEVA) APPROVAL= AP YEAR= 2022 , NDA 215809 (label 215809.pdf) INN (LEVOTHYROXINE SODIUM) ERMEZA (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 211417 (pdf 211417.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 215259 (pdf 215259.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217066 (pdf 217066.pdf not found) INN (LEVOTHYROXINE SODIUM) LEVOTHYROXINE SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , 859 ; ALFUZOSIN ; 81403-80-7 ; 2003 ; ; ; CLASS GENITO -- ANTIHYPERTENSIVE -- ALPHA ADRENERGIC ANTAGONISTS -- TREATMENT OF BENIGN PROSTATIC HYPERPLASIA , ; NDA 021287 (label 21287.pdf) INN (ALFUZOSIN HYDROCHLORIDE) UROXATRAL (CONCORDIA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 079013 (pdf 79013.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 079014 (pdf 79014.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079054 (pdf 79054.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079056 (pdf 79056.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079057 (pdf 79057.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 079060 (pdf 79060.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090221 (pdf 90221.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090284 (pdf 90284.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 203192 (pdf 203192.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 , 860 ; LINEZOLID ; 165800-03-3 ; 2000 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PROTEIN SYNTHESIS INHIBITORS -- OXAZOLIDINONE CLASS -- BINDS 23S RIBOSOMAL RNA OF THE 50S SUBUNIT , ; NDA 021130 (label 21130.pdf) INN (LINEZOLID) ZYVOX (PFIZER) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 021131 (label 21131.pdf) INN (LINEZOLID) ZYVOX (PFIZER) APPROVAL= AP YEAR= 2000 , NDA 021132 (label 21132.pdf) INN (LINEZOLID) ZYVOX (PFIZER) APPROVAL= AP YEAR= 2000 , NDA 078061 (pdf 78061.pdf not found) INN (LINEZOLID) LINEZOLID (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 078845 (pdf 78845.pdf not found) INN (LINEZOLID) LINEZOLID (RISING) APPROVAL= AP YEAR= 2015 , NDA 078987 (pdf 78987.pdf not found) INN (LINEZOLID) LINEZOLID (GLENMARK SPECLT) APPROVAL= AP YEAR= 2015 , NDA 091210 (pdf 91210.pdf not found) INN (LINEZOLID) LINEZOLID (GATE PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 200222 (pdf 200222.pdf not found) INN (LINEZOLID) LINEZOLID (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200068 (pdf 200068.pdf not found) INN (LINEZOLID) LINEZOLID (HIKMA) APPROVAL= AP YEAR= 2015 , NDA 200904 (pdf 200904.pdf not found) INN (LINEZOLID) LINEZOLID (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 206473 (label 206473.pdf) INN (LINEZOLID) LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2015 , NDA 204239 (pdf 204239.pdf not found) INN (LINEZOLID) LINEZOLID (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 204536 (pdf 204536.pdf not found) INN (LINEZOLID) LINEZOLID (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205442 (pdf 205442.pdf not found) INN (LINEZOLID) LINEZOLID (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205233 (pdf 205233.pdf not found) INN (LINEZOLID) LINEZOLID (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 205517 (pdf 205517.pdf not found) INN (LINEZOLID) LINEZOLID (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 204764 (pdf 204764.pdf not found) INN (LINEZOLID) LINEZOLID (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2016 , NDA 206917 (pdf 206917.pdf not found) INN (LINEZOLID) LINEZOLID (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207354 (pdf 207354.pdf not found) INN (LINEZOLID) LINEZOLID (NANG KUANG PHARM CO) APPROVAL= AP YEAR= 2016 , NDA 207526 (pdf 207526.pdf not found) INN (LINEZOLID) LINEZOLID (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 204696 (pdf 204696.pdf not found) INN (LINEZOLID) LINEZOLID (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 206097 (pdf 206097.pdf not found) INN (LINEZOLID) LINEZOLID (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207001 (pdf 207001.pdf not found) INN (LINEZOLID) LINEZOLID (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205154 (pdf 205154.pdf not found) INN (LINEZOLID) LINEZOLID (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 210702 (pdf 210702.pdf not found) INN (LINEZOLID) LINEZOLID (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 206454 (pdf 206454.pdf not found) INN (LINEZOLID) LINEZOLID (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 211813 (pdf 211813.pdf not found) INN (LINEZOLID) LINEZOLID (HETERO LABS) APPROVAL= AP YEAR= 2022 , 861 ; VALGANCICLOVIR ; 175865-60-8 ; 2001 ; ; ; CLASS ANTIINFECTIVE -- ANTIVIRAL -- CYTOMEGALOVIRUS (CMV) NUCLEOSIDE ANALOGUE DNA POLYMERASE INHIBITOR -- HERPES SIMPLEX VIRUS (HSV) , ; NDA 021304 (label 21304.pdf) INN (VALGANCICLOVIR HYDROCHLORIDE) VALCYTE (CHEPLAPHARM) APPROVAL= AP YEAR= 2001 , NDA 078078 (pdf 78078.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022257 (label 22257.pdf) INN (VALGANCICLOVIR HYDROCHLORIDE) VALCYTE (CHEPLAPHARM) APPROVAL= AP YEAR= 2009 , NDA 200790 (pdf 200790.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 203511 (pdf 203511.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 204750 (pdf 204750.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205166 (pdf 205166.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 205220 (pdf 205220.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 206876 (pdf 206876.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 209672 (pdf 209672.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 212234 (pdf 212234.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212890 (pdf 212890.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213306 (pdf 213306.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 205151 (pdf 205151.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 210169 (pdf 210169.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 211475 (pdf 211475.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 215124 (pdf 215124.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216317 (pdf 216317.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2023 , NDA 212876 (pdf 212876.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (GPP) APPROVAL= AP YEAR= 2024 , 862 ; TELITHROMYCIN ; 191114-48-4 ; 2004 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTI-BACTERIAL AGENTS -- KETOLIDE CLASS -- BINDING TO DOMAINS II AND V OF 23S RRNA OF THE 50S RIBOSOMAL SUBUNIT , ; NDA 021144 (label 21144.pdf) INN (TELITHROMYCIN) KETEK (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , 863 ; M TICAGRELOR ; 220347-05-7 ; 0 ; ; ; CLASS BLOOD -- P2Y12 PLATELET INHIBITOR -- ANTITHROMBOTIC AGENTS , ; 864 ; GEMIFLOXACIN ; 175463-14-6 ; 2003 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- FLUOROQUINOLONE CLASS OF ANTIBIOTICS , ; NDA 021158 (label 21158.pdf) INN (GEMIFLOXACIN MESYLATE) FACTIVE (LG CHEM LTD) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 090466 (pdf 90466.pdf not found) INN (GEMIFLOXACIN MESYLATE) GEMIFLOXACIN MESYLATE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 865 ; DESLORATADINE ; 100643-71-8 ; 2001 ; ; ; CLASS RESPIRATORY -- HISTAMINE H1 RECEPTOR ANTAGONIST -- ANTIHISTAMINE -- CHOLINERGIC ANTAGONISTS , ; NDA 021165 (label 21165.pdf) INN (DESLORATADINE) CLARINEX (ORGANON) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 021297 (label 21297.pdf) INN (DESLORATADINE) CLARINEX (SCHERING) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021300 (label 21300.pdf) INN (DESLORATADINE) CLARINEX (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021312 (label 21312.pdf) INN (DESLORATADINE) CLARINEX (ORGANON) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021313 (label 21313.pdf) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) CLARINEX-D 12 HOUR (ORGANON LLC) APPROVAL= AP YEAR= 2006 , NDA 021363 (label 21363.pdf) INN (DESLORATADINE) CLARINEX (SCHERING) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021563 (label 21563.pdf) INN (DESLORATADINE) CLARINEX (SCHERING) APPROVAL= AP YEAR= 2004 , NDA 021605 (label 21605.pdf) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) CLARINEX D 24 HOUR (ORGANON) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 078357 (pdf 78357.pdf not found) INN (DESLORATADINE) DESLORATADINE (ORBION PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078362 (pdf 78362.pdf not found) INN (DESLORATADINE) DESLORATADINE (GLENMARK GENERICS) APPROVAL= TA YEAR= 2009 , NDA 078352 (pdf 78352.pdf not found) INN (DESLORATADINE) DESLORATADINE (LUPIN PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078359 (pdf 78359.pdf not found) INN (DESLORATADINE) DESLORATADINE (SUN PHARM INDS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078367 (pdf 78367.pdf not found) INN (DESLORATADINE) DESLORATADINE (REDDYS) APPROVAL= AP YEAR= 2010 , NDA 078364 (pdf 78364.pdf not found) INN (DESLORATADINE) DESLORATADINE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078353 (pdf 78353.pdf not found) INN (DESLORATADINE) DESLORATADINE (ZYDUS PHARMS USA) APPROVAL= TA YEAR= 2011 , NDA 078365 (pdf 78365.pdf not found) INN (DESLORATADINE) DESLORATADINE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 078366 (pdf 78366.pdf not found) INN (DESLORATADINE PSEUDOEPHEDRINE SULFATE) DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 078361 (pdf 78361.pdf not found) INN (DESLORATADINE) DESLORATADINE (PERRIGO) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078351 (pdf 78351.pdf not found) INN (DESLORATADINE) DESLORATADINE (DASH PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078355 (pdf 78355.pdf not found) INN (DESLORATADINE) DESLORATADINE (BELCHER PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202592 (pdf 202592.pdf not found) INN (DESLORATADINE) DESLORATADINE (TARO) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202936 (pdf 202936.pdf not found) INN (DESLORATADINE) DESLORATADINE (TARO) APPROVAL= AP YEAR= 2016 DISCONTINUED , 866 ; ETONOGESTREL ; 54048-10-1 ; 2001 ; ; ; CLASS GENITO -- PROGESTIN -- CONTRACEPTIVES , ; NDA 021187 (label 21187.pdf) INN (ETHINYL ESTRADIOL ETONOGESTREL) NUVARING (ORGANON USA ORGANON) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 021529 (label 21529.pdf) INN (ETONOGESTREL) IMPLANON (ORGANON) APPROVAL= AP YEAR= 2006 , NDA 210830 (pdf 210830.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ELURYNG (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 204305 (pdf 204305.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ETHINYL ESTRADIOL ETONOGESTREL (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 207577 (pdf 207577.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) VERARING (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211328 (pdf 211328.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) HALOETTE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 , NDA 211157 (pdf 211157.pdf not found) INN (ETHINYL ESTRADIOL ETONOGESTREL) ENILLORING (XIROMED) APPROVAL= AP YEAR= 2023 , 867 ; CETRORELIX ; 120287-85-6 ; 2000 ; ; ; CLASS HORMONES -- GONADOTROPIN-RELEASING HORMONE RECEPTOR (GNRH) ANTAGONIST -- INFERTILITY AGENTS , ; NDA 021197 (label 21197.pdf) INN (CETRORELIX ACETATE) CETROTIDE (EMD SERONO INC) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 215737 (pdf 215737.pdf not found) INN (CETRORELIX ACETATE) CETRORELIX ACETATE (TEVA PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 214540 (pdf 214540.pdf not found) INN (CETRORELIX ACETATE) CETRORELIX ACETATE (LIVZON GRP) APPROVAL= AP YEAR= 2024 , NDA 217776 (pdf 217776.pdf not found) INN (CETRORELIX ACETATE) CETRORELIX ACETATE (QILU) APPROVAL= AP YEAR= 2024 , NDA 218150 (pdf 218150.pdf not found) INN (CETRORELIX ACETATE) CETRORELIX ACETATE (GLAND) APPROVAL= AP YEAR= 2024 , 868 ; TEGASEROD ; 145158-71-0 ; 2002 ; DISCONTINUED ; ; CLASS METABOLISM -- PERISTALTIC STIMULANT -- IRRITABLE BOWEL SYNDROME (THERAPEUTIC) -- SEROTONIN AGONISTS -- 5-HT4 RECEPTOR PARTIAL AGONIST , ; NDA 021200 (label 21200.pdf) INN (TEGASEROD MALEATE) ZELNORM (ALFASIGMA) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY DISCONTINUED , 869 ; NATEGLINIDE ; 105816-04-4 ; 2000 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- MEGLITINIDES -- BINDS ATP-SENSITIVE POTASSIUM (K+ATP) CHANNEL ON PANCREATIC BETA-CELLS , ; NDA 021204 (label 21204.pdf) INN (NATEGLINIDE) STARLIX (NOVARTIS) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , NDA 077462 (pdf 77462.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (WATSON LABS) APPROVAL= AP YEAR= 2011 , NDA 077463 (label 77463.pdf) INN (NATEGLINIDE) NATEGLINIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 , NDA 077467 (label 77467.pdf) INN (NATEGLINIDE) NATEGLINIDE (TEVA PHARMS) APPROVAL= TA YEAR= 2007 , NDA 077461 (pdf 77461.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 205055 (pdf 205055.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (ALVOGEN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205248 (pdf 205248.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205544 (pdf 205544.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (RISING) APPROVAL= AP YEAR= 2018 , NDA 206432 (pdf 206432.pdf not found) INN (NATEGLINIDE) NATEGLINIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , 870 ; LOPINAVIR ; 192725-17-0 ; 2000 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV -- HIV PROTEASE INHIBITORS , ; NDA 021226 (label 21226.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021251 (label 21251.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2000 , NDA 021906 (label 21906.pdf) INN (LOPINAVIR RITONAVIR) KALETRA (ABBVIE) APPROVAL= AP YEAR= 2005 , NDA 079074 (pdf 79074.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090371 (pdf 90371.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (CIPLA LIMITED) APPROVAL= TA YEAR= 2009 , NDA 090471 (pdf 90471.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2009 , NDA 091202 (label 91202.pdf) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (MYLAN PHARMA) APPROVAL= TA YEAR= 2011 , NDA 091203 (pdf 91203.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 091677 (pdf 91677.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 205425 (pdf 205425.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (CIPLA LTD) APPROVAL= TA YEAR= 2015 , NDA 204739 (pdf 204739.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR RITONAVIR (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 207407 (label 207407.pdf) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 213857 (pdf 213857.pdf not found) INN (LOPINAVIR RITONAVIR) LOPINAVIR AND RITONAVIR (LAURUS) APPROVAL= AP YEAR= 2022 , 871 ; NITISINONE ; 104206-65-7 ; 2002 ; ; ; CLASS METABOLISM -- HEREDITARY TYROSINEMIA TYPE 1 -- INHIBITOR OF 4-HYDROXYPHENYLPYRUVATE DIOXYGENASE -- TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) , ; NDA 021232 (label 21232.pdf) INN (NITISINONE) ORFADIN (SWEDISH ORPHAN) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 206356 (label 206356.pdf) INN (NITISINONE) ORFADIN (SWEDISH ORPHAN) APPROVAL= AP YEAR= 2016 , NDA 209449 (label 209449.pdf) INN (NITISINONE) NITYR (CYCLE) APPROVAL= AP YEAR= 2017 , NDA 211041 (pdf 211041.pdf not found) INN (NITISINONE) NITISINONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212390 (pdf 212390.pdf not found) INN (NITISINONE) NITISINONE (MEDUNIK) APPROVAL= AP YEAR= 2022 , NDA 215908 (pdf 215908.pdf not found) INN (NITISINONE) NITISINONE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216201 (pdf 216201.pdf not found) INN (NITISINONE) NITISINONE (ETON) APPROVAL= AP YEAR= 2023 , 872 ; TRAVOPROST ; 157283-68-6 ; 2001 ; ; ; CLASS SENSORY -- ANTIHYPERTENSIVE -- ANTIGLAUCOMA -- OPHTHALMOLOGICALS -- PROSTAGLANDIN ANALOGUES -- FP PROSTANOID RECEPTOR AGONIST -- HYDROLYZED TO THE ACTIVE FREE ACID , ; NDA 021257 (label 21257.pdf) INN (TRAVOPROST) TRAVATAN (ALCON PHARMS LTD) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 021994 (label 21994.pdf) INN (TRAVOPROST) TRAVATAN Z (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 091340 (pdf 91340.pdf not found) INN (TRAVOPROST) TRAVOPROST (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 091341 (pdf 91341.pdf not found) INN (TRAVOPROST) TRAVOPROST (PAR PHARM) APPROVAL= TA YEAR= 2011 , NDA 204822 (label 204822.pdf) INN (TRAVOPROST) IZBA (NOVARTIS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203431 (pdf 203431.pdf not found) INN (TRAVOPROST) TRAVOPROST (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 205050 (pdf 205050.pdf not found) INN (TRAVOPROST) TRAVOPROST (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 210458 (pdf 210458.pdf not found) INN (TRAVOPROST) TRAVOPROST (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 203767 (pdf 203767.pdf not found) INN (TRAVOPROST) TRAVOPROST (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 218010 (pdf 218010.pdf not found) INN (TRAVOPROST) IDOSE TR (GLAUKOS) APPROVAL= AP YEAR= 2023 , NDA 207040 (pdf 207040.pdf not found) INN (TRAVOPROST) TRAVOPROST (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 873 ; APOMORPHINE ; 58-00-4 ; 2004 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- NON-ERGOLINE DOPAMINE AGONIST D4 (KI = 4.4 NANOMOLAR) D2 (KI = 35 NANOMOLAR) D3 (KI = 26 NANOMOLAR) D5 (KI = 15 NANOMOLAR) , ; NDA 021264 (label 21264.pdf) INN (APOMORPHINE HYDROCHLORIDE) APOKYN (MDD US) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 210875 (label 210875.pdf) INN (APOMORPHINE HYDROCHLORIDE) KYNMOBI (SUMITOMO PHARMA AM) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212025 (pdf 212025.pdf not found) INN (APOMORPHINE HYDROCHLORIDE) APOMORPHINE HYDROCHLORIDE (SAGE CHEMS) APPROVAL= AP YEAR= 2022 , 874 ; VORICONAZOLE ; 137234-62-9 ; 2002 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- INHIBITION OF FUNGAL CYTOCHROME P-450-MEDIATED 14 ALPHA-LANOSTEROL DEMETHYLATION (CYP51) AN ESSENTIAL STEP IN FUNGAL ERGOSTEROL BIOSYNTHESIS , ; NDA 021266 (label 21266.pdf) INN (VORICONAZOLE) VFEND (PF PRISM CV) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 021267 (label 21267.pdf) INN (VORICONAZOLE) VFEND (PF PRISM CV) APPROVAL= AP YEAR= 2002 , NDA 021464 (label 21464.pdf) INN (VORICONAZOLE) VFEND (PFIZER) APPROVAL= AP YEAR= 2003 NEWAPPLICATION , NDA 021466 (label 21466.pdf) INN (VORICONAZOLE) VFEND (PFIZER) APPROVAL= AP YEAR= 2003 NEWAPPLICATION , NDA 021630 (label 21630.pdf) INN (VORICONAZOLE) VFEND (PF PRISM CV) APPROVAL= AP YEAR= 2003 , NDA 090547 (pdf 90547.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 090862 (pdf 90862.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 200265 (pdf 200265.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (SANDOZ INC) APPROVAL= AP YEAR= 2011 , NDA 091658 (pdf 91658.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202361 (pdf 202361.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (RISING) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203503 (pdf 203503.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 205034 (pdf 205034.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206181 (pdf 206181.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 206398 (pdf 206398.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (ALMAJECT) APPROVAL= AP YEAR= 2016 , NDA 206747 (pdf 206747.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (CADILA) APPROVAL= AP YEAR= 2016 , NDA 206762 (pdf 206762.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (RISING) APPROVAL= AP YEAR= 2016 , NDA 206799 (pdf 206799.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 206837 (pdf 206837.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207371 (pdf 207371.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 , NDA 208562 (label 208562.pdf) INN (VORICONAZOLE) VORICONAZOLE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2017 , NDA 206654 (pdf 206654.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (PRINSTON INC) APPROVAL= AP YEAR= 2016 , NDA 207049 (pdf 207049.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 208983 (pdf 208983.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211661 (pdf 211661.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211099 (pdf 211099.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 214516 (pdf 214516.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 210849 (pdf 210849.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211264 (pdf 211264.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (UBI) APPROVAL= AP YEAR= 2023 , NDA 212162 (pdf 212162.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216805 (pdf 216805.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (HAINAN POLY) APPROVAL= AP YEAR= 2024 , NDA 218533 (pdf 218533.pdf not found) INN (VORICONAZOLE) VORICONAZOLE (ASPIRO) APPROVAL= AP YEAR= 2024 , 875 ; TREPROSTINIL ; 81846-19-7 ; 2002 ; ; ; CLASS BLOOD -- ANTIHYPERTENSIVE AGENTS -- ANTITHROMBOTIC AGENTS -- PROSTACYCLIN ANALOGS -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) -- PROSTACYCLIN (IP) RECEPTOR AGONIST , ; NDA 021272 (label 21272.pdf) INN (TREPROSTINIL) REMODULIN (UNITED THERAP) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 022387 (label 22387.pdf) INN (TREPROSTINIL) TYVASO (UNITED THERAP) APPROVAL= AP YEAR= 2009 , NDA 203496 (label 203496.pdf) INN (TREPROSTINIL DIOLAMINE) ORENITRAM (UNITED THERAP) APPROVAL= AP YEAR= 2013 , NDA 203649 (label 203649.pdf) INN (TREPROSTINIL) TREPROSTINIL (SANDOZ) APPROVAL= AP YEAR= 2017 , NDA 208276 (label 208276.pdf) INN (TREPROSTINIL) REMODULIN (UNITED THERAP) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209382 (pdf 209382.pdf not found) INN (TREPROSTINIL) TREPROSTINIL (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 206648 (pdf 206648.pdf not found) INN (TREPROSTINIL) TREPROSTINIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 210214 (pdf 210214.pdf not found) INN (TREPROSTINIL) TREPROSTINIL (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 211574 (pdf 211574.pdf not found) INN (TREPROSTINIL) TREPROSTINIL (ALEMBIC GLOBAL) APPROVAL= AP YEAR= 2021 , NDA 214324 (label 214324.pdf) INN (TREPROSTINIL) TYVASO DPI (UNITED THERAP) APPROVAL= AP YEAR= 2022 , NDA 208906 (pdf 208906.pdf not found) INN (TREPROSTINIL) TREPROSTINIL (ACTAVIS LABS) APPROVAL= TA YEAR= 2023 , 876 ; BIMATOPROST ; 155206-00-1 ; 2001 ; ; ; CLASS SENSORY -- ANTIHYPERTENSIVE -- ANTIGLAUCOMA -- PROSTAGLANDIN ANALOG , ; NDA 021275 (label 21275.pdf) INN (BIMATOPROST) LUMIGAN (ABBVIE) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 022369 (label 22369.pdf) INN (BIMATOPROST) LATISSE (ABBVIE) APPROVAL= AP YEAR= 2008 , NDA 022184 (label 22184.pdf) INN (BIMATOPROST) LUMIGAN (ABBVIE) APPROVAL= AP YEAR= 2010 , NDA 090449 (label 90449.pdf) INN (BIMATOPROST) BIMATOPROST (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 200487 (pdf 200487.pdf not found) INN (BIMATOPROST) BIMATOPROST (SANDOZ) APPROVAL= TA YEAR= 2011 , NDA 201894 (pdf 201894.pdf not found) INN (BIMATOPROST) BIMATOPROST (APOTEX) APPROVAL= AP YEAR= 2014 , NDA 203056 (pdf 203056.pdf not found) INN (BIMATOPROST) BIMATOPROST (SANDOZ INC) APPROVAL= TA YEAR= 2014 , NDA 202565 (label 202565.pdf) INN (BIMATOPROST) BIMATOPROST (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 203404 (pdf 203404.pdf not found) INN (BIMATOPROST) BIMATOPROST (APOTEX INC) APPROVAL= TA YEAR= 2015 , NDA 203991 (pdf 203991.pdf not found) INN (BIMATOPROST) BIMATOPROST (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 202719 (pdf 202719.pdf not found) INN (BIMATOPROST) BIMATOPROST (SANDOZ) APPROVAL= AP YEAR= 2016 , NDA 203051 (pdf 203051.pdf not found) INN (BIMATOPROST) BIMATOPROST (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 203299 (pdf 203299.pdf not found) INN (BIMATOPROST) BIMATOPROST (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209797 (pdf 209797.pdf not found) INN (BIMATOPROST) BIMATOPROST (GLAND PHARMA LTD) APPROVAL= TA YEAR= 2019 , NDA 210126 (pdf 210126.pdf not found) INN (BIMATOPROST) BIMATOPROST (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 210263 (pdf 210263.pdf not found) INN (BIMATOPROST) BIMATOPROST (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 207601 (pdf 207601.pdf not found) INN (BIMATOPROST) BIMATOPROST (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 210515 (pdf 210515.pdf not found) INN (BIMATOPROST) BIMATOPROST (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 211911 (label 211911.pdf) INN (BIMATOPROST) DURYSTA (ABBVIE) APPROVAL= AP YEAR= 2020 , NDA 202505 (pdf 202505.pdf not found) INN (BIMATOPROST) BIMATOPROST (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 204638 (pdf 204638.pdf not found) INN (BIMATOPROST) BIMATOPROST (MICRO LABS LTD INDIA) APPROVAL= TA YEAR= 2021 , NDA 205537 (pdf 205537.pdf not found) INN (BIMATOPROST) BIMATOPROST (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , 877 ; GUAIFENESIN ; 93-14-1 ; 2002 ; ; ; CLASS RESPIRATORY SYSTEM -- MUCOLYTIC -- EXPECTORANTS , ; NDA 021282 (label 21282.pdf) INN (GUAIFENESIN) MUCINEX (RB HLTH) APPROVAL= AP YEAR= 2002 , NDA 021585 (label 21585.pdf) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) MUCINEX D (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 021620 (label 21620.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) MUCINEX DM (RB HLTH) APPROVAL= AP YEAR= 2004 , NDA 078912 (pdf 78912.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 , NDA 205474 (label 205474.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) OBREDON (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 022279 (label 22279.pdf) INN (GUAIFENESIN) HYCOFENIX (BKK PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 022424 (label 22424.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) FLOWTUSS (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091071 (pdf 91071.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 091009 (pdf 91009.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 091070 (pdf 91070.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015 , NDA 208369 (pdf 208369.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 206941 (pdf 206941.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209215 (pdf 209215.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2017 , NDA 209692 (pdf 209692.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 207602 (pdf 207602.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 208085 (label 208085.pdf) INN (GUAIFENESIN HYDROCODONE BITARTRATE) XTRELUS (ECI PHARMS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207342 (pdf 207342.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209254 (pdf 209254.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (OHM LABS INC) APPROVAL= AP YEAR= 2018 , NDA 210453 (pdf 210453.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212542 (pdf 212542.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 213203 (pdf 213203.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213420 (pdf 213420.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 214781 (pdf 214781.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 214407 (pdf 214407.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2022 , NDA 215932 (pdf 215932.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 216082 (pdf 216082.pdf not found) INN (GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217340 (pdf 217340.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 217780 (pdf 217780.pdf not found) INN (GUAIFENESIN) GUAIFENESIN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , 878 ; OLMESARTAN MEDOXOMIL ; 144689-63-4 ; 2002 ; ; ; CLASS CARDIOVASCULAR -- SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR INHIBITOR PRODRUG -- ANTIHYPERTENSIVE -- TREATMENT OF HYPERTENSION , ; NDA 021286 (label 21286.pdf) INN (OLMESARTAN MEDOXOMIL) BENICAR (COSETTE) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 021532 (label 21532.pdf) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) BENICAR HCT (COSETTE) APPROVAL= AP YEAR= 2003 , NDA 022100 (label 22100.pdf) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AZOR (COSETTE) APPROVAL= AP YEAR= 2007 , NDA 078276 (pdf 78276.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 078827 (pdf 78827.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 090237 (pdf 90237.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (SANDOZ) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 200175 (label 200175.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) TRIBENZOR (COSETTE) APPROVAL= AP YEAR= 2010 , NDA 090398 (pdf 90398.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091079 (pdf 91079.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 200532 (pdf 200532.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 202933 (pdf 202933.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TORRENT) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 091154 (pdf 91154.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202375 (pdf 202375.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (TORRENT) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204801 (pdf 204801.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 205482 (pdf 205482.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206884 (pdf 206884.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 202491 (pdf 202491.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 203012 (pdf 203012.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 203281 (pdf 203281.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 204798 (pdf 204798.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 204814 (pdf 204814.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205391 (pdf 205391.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206763 (pdf 206763.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207480 (pdf 207480.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 207804 (pdf 207804.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 208130 (pdf 208130.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 203580 (pdf 203580.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 206137 (label 206137.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (PAR PHARM INC) APPROVAL= AP YEAR= 2016 , NDA 207216 (pdf 207216.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 204233 (pdf 204233.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 205192 (pdf 205192.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206515 (pdf 206515.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2017 , NDA 206631 (pdf 206631.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (LUPIN LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206906 (pdf 206906.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207073 (pdf 207073.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 207450 (pdf 207450.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207662 (pdf 207662.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 207807 (pdf 207807.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 209042 (pdf 209042.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207435 (pdf 207435.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 207771 (pdf 207771.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209010 (pdf 209010.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209600 (pdf 209600.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ACCORD HLTHCARE INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209281 (pdf 209281.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 210552 (pdf 210552.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (QILU) APPROVAL= AP YEAR= 2019 , NDA 211049 (pdf 211049.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (SUNSHINE) APPROVAL= AP YEAR= 2019 , NDA 206372 (pdf 206372.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 207135 (pdf 207135.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (UMEDICA) APPROVAL= AP YEAR= 2019 , NDA 208847 (pdf 208847.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (UMEDICA LABS PVT LTD) APPROVAL= AP YEAR= 2019 , NDA 208659 (pdf 208659.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (INVENTIA) APPROVAL= AP YEAR= 2020 , NDA 206720 (pdf 206720.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 206377 (pdf 206377.pdf not found) INN (HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217399 (pdf 217399.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (MSN) APPROVAL= AP YEAR= 2023 , NDA 206227 (pdf 206227.pdf not found) INN (OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL (CHARTWELL RX) APPROVAL= AP YEAR= 2024 , 879 ; ALFUZOSIN ; 81403-80-7 ; 2003 ; ; ; CLASS GENITO -- ANTIHYPERTENSIVE -- ALPHA ADRENERGIC ANTAGONISTS -- TREATMENT OF BENIGN PROSTATIC HYPERPLASIA , ; NDA 021287 (label 21287.pdf) INN (ALFUZOSIN HYDROCHLORIDE) UROXATRAL (CONCORDIA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 079013 (pdf 79013.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2011 , NDA 079014 (pdf 79014.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079054 (pdf 79054.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079056 (pdf 79056.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079057 (pdf 79057.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 079060 (pdf 79060.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090221 (pdf 90221.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090284 (pdf 90284.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 203192 (pdf 203192.pdf not found) INN (ALFUZOSIN HYDROCHLORIDE) ALFUZOSIN HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 , 880 ; BOSENTAN ; 147536-97-8 ; 2001 ; ; ; CLASS CARDIOVASCULAR -- ENDOTHELIN RECEPTOR (ET-A AND ET-B) ANTAGONIST -- ANTIHYPERTENSIVE -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION , ; NDA 021290 (label 21290.pdf) INN (BOSENTAN) TRACLEER (ACTELION) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 209279 (label 209279.pdf) INN (BOSENTAN) TRACLEER (ACTELION) APPROVAL= AP YEAR= 2017 , NDA 205699 (pdf 205699.pdf not found) INN (BOSENTAN) BOSENTAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206002 (pdf 206002.pdf not found) INN (BOSENTAN) BOSENTAN (ALVOGEN PINE BROOK) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206987 (pdf 206987.pdf not found) INN (BOSENTAN) BOSENTAN (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207110 (pdf 207110.pdf not found) INN (BOSENTAN) BOSENTAN (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 207760 (pdf 207760.pdf not found) INN (BOSENTAN) BOSENTAN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 208695 (pdf 208695.pdf not found) INN (BOSENTAN) BOSENTAN (HIKMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209324 (pdf 209324.pdf not found) INN (BOSENTAN) BOSENTAN (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 209742 (pdf 209742.pdf not found) INN (BOSENTAN) BOSENTAN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205173 (pdf 205173.pdf not found) INN (BOSENTAN) BOSENTAN (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210342 (pdf 210342.pdf not found) INN (BOSENTAN) BOSENTAN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211461 (pdf 211461.pdf not found) INN (BOSENTAN) BOSENTAN (ALEMBIC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213154 (pdf 213154.pdf not found) INN (BOSENTAN) BOSENTAN (NATCO PHARMA LTD) APPROVAL= TA YEAR= 2021 , NDA 213981 (pdf 213981.pdf not found) INN (BOSENTAN) BOSENTAN (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2023 , 881 ; PIMECROLIMUS ; 137071-32-0 ; 2001 ; ; ; CLASS DERMATOLOGICALS -- IMMUNOSUPPRESSANT -- ANTIINFLAMMATORY -- TREATMENT OF ATOPIC DERMATITIS , ; NDA 021302 (label 21302.pdf) INN (PIMECROLIMUS) ELIDEL (BAUSCH) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 209345 (pdf 209345.pdf not found) INN (PIMECROLIMUS) PIMECROLIMUS (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2018 , NDA 211769 (pdf 211769.pdf not found) INN (PIMECROLIMUS) PIMECROLIMUS (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , 882 ; VALGANCICLOVIR ; 175865-60-8 ; 2001 ; ; ; CLASS ANTIINFECTIVE -- ANTIVIRAL -- CYTOMEGALOVIRUS (CMV) NUCLEOSIDE ANALOGUE DNA POLYMERASE INHIBITOR -- HERPES SIMPLEX VIRUS (HSV) , ; NDA 021304 (label 21304.pdf) INN (VALGANCICLOVIR HYDROCHLORIDE) VALCYTE (CHEPLAPHARM) APPROVAL= AP YEAR= 2001 , NDA 078078 (pdf 78078.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (RANBAXY) APPROVAL= TA YEAR= 2008 OBSOLETE , NDA 022257 (label 22257.pdf) INN (VALGANCICLOVIR HYDROCHLORIDE) VALCYTE (CHEPLAPHARM) APPROVAL= AP YEAR= 2009 , NDA 200790 (pdf 200790.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 203511 (pdf 203511.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 204750 (pdf 204750.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205166 (pdf 205166.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 205220 (pdf 205220.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 206876 (pdf 206876.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 209672 (pdf 209672.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 212234 (pdf 212234.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212890 (pdf 212890.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213306 (pdf 213306.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 205151 (pdf 205151.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 210169 (pdf 210169.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 211475 (pdf 211475.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 215124 (pdf 215124.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216317 (pdf 216317.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2023 , NDA 212876 (pdf 212876.pdf not found) INN (VALGANCICLOVIR HYDROCHLORIDE) VALGANCICLOVIR HYDROCHLORIDE (GPP) APPROVAL= AP YEAR= 2024 , 883 ; DUTASTERIDE ; 164656-23-9 ; 2001 ; ; ; CLASS GENITO -- 5-ALPHA-REDUCTASE INHIBITOR -- TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) , ; NDA 021319 (label 21319.pdf) INN (DUTASTERIDE) AVODART (WAYLIS THERAP) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 022460 (label 22460.pdf) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) JALYN (WOODWARD) APPROVAL= AP YEAR= 2010 , NDA 090095 (pdf 90095.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (BARR) APPROVAL= AP YEAR= 2010 , NDA 200899 (pdf 200899.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (CHARTWELL) APPROVAL= AP YEAR= 2015 , NDA 202204 (pdf 202204.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HIKMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202421 (pdf 202421.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (VINTAGE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202660 (pdf 202660.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 202509 (pdf 202509.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ANCHEN PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203118 (pdf 203118.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204292 (pdf 204292.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (APOTEX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202808 (pdf 202808.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202530 (pdf 202530.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (RISING) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202975 (pdf 202975.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204262 (pdf 204262.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204705 (pdf 204705.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203241 (pdf 203241.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206373 (pdf 206373.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ACELLA) APPROVAL= AP YEAR= 2016 , NDA 206574 (pdf 206574.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 204376 (pdf 204376.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ADAPTIS) APPROVAL= AP YEAR= 2017 , NDA 204373 (pdf 204373.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 207935 (pdf 207935.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209909 (pdf 209909.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2017 , NDA 207769 (pdf 207769.pdf not found) INN (DUTASTERIDE TAMSULOSIN HYDROCHLORIDE) DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208227 (pdf 208227.pdf not found) INN (DUTASTERIDE) DUTASTERIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , 884 ; ABARELIX ; 183552-38-7 ; 2003 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- ANTI-TESTOSTERONE AGENTS -- GONADOTROPIN-RELEASING HORMONE (GNRH) ANTAGONIST (KD = 0.1 NANOMOLAR) , ; NDA 021320 (label 21320.pdf) INN (ABARELIX) PLENAXIS (SPECIALITY EUROPEAN) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , 885 ; ERTAPENEM ; 153832-46-3 ; 2001 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- INHIBITION OF CELL WALL SYNTHESIS , ; NDA 021337 (label 21337.pdf) INN (ERTAPENEM SODIUM) INVANZ (MSD SUB MERCK) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 208790 (pdf 208790.pdf not found) INN (ERTAPENEM SODIUM) ERTAPENEM SODIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2018 , NDA 209133 (pdf 209133.pdf not found) INN (ERTAPENEM SODIUM) ERTAPENEM SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 207647 (pdf 207647.pdf not found) INN (ERTAPENEM SODIUM) ERTAPENEM SODIUM (SAVIOR LIFETEC CORP) APPROVAL= AP YEAR= 2019 , NDA 212040 (pdf 212040.pdf not found) INN (ERTAPENEM SODIUM) ERTAPENEM SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 209145 (pdf 209145.pdf not found) INN (ERTAPENEM SODIUM) ERTAPENEM SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2023 DISCONTINUED , 886 ; VALDECOXIB ; 181695-72-7 ; 2001 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ENZYME INHIBITOR (COX-2) -- ANTIINFLAMMATORY -- ANALGESIC -- NONSTEROIDAL ANTIINFLAMMATORY AGENTS (NSAIDS) -- ANALGESIC -- ANTIPYRETIC , ; NDA 021341 (label 21341.pdf) INN (VALDECOXIB) BEXTRA (GD SEARLE) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , 887 ; FULVESTRANT ; 129453-61-8 ; 2002 ; ; ; CLASS ANTINEOPLASTIC -- BREAST CANCER (THERAPEUTIC) -- ANTIESTROGENIC -- ESTROGEN ANTAGONISTS -- TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER , ; NDA 021344 (label 21344.pdf) INN (FULVESTRANT) FASLODEX (ASTRAZENECA) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 205935 (pdf 205935.pdf not found) INN (FULVESTRANT) FULVESTRANT (SANDOZ) APPROVAL= AP YEAR= 2019 , NDA 207754 (pdf 207754.pdf not found) INN (FULVESTRANT) FULVESTRANT (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210044 (pdf 210044.pdf not found) INN (FULVESTRANT) FULVESTRANT (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 205871 (pdf 205871.pdf not found) INN (FULVESTRANT) FULVESTRANT (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 208811 (pdf 208811.pdf not found) INN (FULVESTRANT) FULVESTRANT (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 209714 (pdf 209714.pdf not found) INN (FULVESTRANT) FULVESTRANT (HBT LABS INC) APPROVAL= AP YEAR= 2019 , NDA 210063 (label 210063.pdf) INN (FULVESTRANT) FULVESTRANT (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2019 , NDA 210326 (label 210326.pdf) INN (FULVESTRANT) FULVESTRANT (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 211422 (pdf 211422.pdf not found) INN (FULVESTRANT) FULVESTRANT (CHIA TAI TIANQING) APPROVAL= AP YEAR= 2020 , NDA 209246 (pdf 209246.pdf not found) INN (FULVESTRANT) FULVESTRANT (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 211689 (pdf 211689.pdf not found) INN (FULVESTRANT) FULVESTRANT (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 211730 (pdf 211730.pdf not found) INN (FULVESTRANT) FULVESTRANT (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213553 (pdf 213553.pdf not found) INN (FULVESTRANT) FULVESTRANT (XIROMED) APPROVAL= AP YEAR= 2021 , NDA 215234 (pdf 215234.pdf not found) INN (FULVESTRANT) FULVESTRANT (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214682 (pdf 214682.pdf not found) INN (FULVESTRANT) FULVESTRANT (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2022 , NDA 215077 (pdf 215077.pdf not found) INN (FULVESTRANT) FULVESTRANT (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 215169 (pdf 215169.pdf not found) INN (FULVESTRANT) FULVESTRANT (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , 888 ; FONDAPARINUX ; 104993-28-4 ; 2001 ; ; ; CLASS BLOOD -- ANTICOAGULANTS -- ANTITHROMBOTICS -- FACTOR XA INHIBITOR , ; NDA 021345 (label 21345.pdf) INN (FONDAPARINUX SODIUM) ARIXTRA (MYLAN IRELAND LTD) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 091316 (pdf 91316.pdf not found) INN (FONDAPARINUX SODIUM) FONDAPARINUX SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 206918 (pdf 206918.pdf not found) INN (FONDAPARINUX SODIUM) FONDAPARINUX SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206812 (pdf 206812.pdf not found) INN (FONDAPARINUX SODIUM) FONDAPARINUX SODIUM (HENGRUI PHARMA) APPROVAL= AP YEAR= 2018 , NDA 208615 (pdf 208615.pdf not found) INN (FONDAPARINUX SODIUM) FONDAPARINUX SODIUM (SCINOPHARM TAIWAN) APPROVAL= AP YEAR= 2018 , 889 ; MIGLUSTAT ; 72599-27-0 ; 2003 ; ; ; CLASS METABOLISM -- TYPE 1 GAUCHER DISEASE -- GLUCOSYLCERAMIDE SYNTHASE INHIBITOR -- SYNTHESIS OF MOST GLYCOSPHINGOLIPIDS -- TREATMENT OF NIEMANN-PICK TYPE C DISEASE (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 021348 (label 21348.pdf) INN (MIGLUSTAT) ZAVESCA (ACTELION) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 208342 (pdf 208342.pdf not found) INN (MIGLUSTAT) MIGLUSTAT (ANI PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209821 (pdf 209821.pdf not found) INN (MIGLUSTAT) YARGESA (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 209325 (pdf 209325.pdf not found) INN (MIGLUSTAT) MIGLUSTAT (BRECKENRIDGE) APPROVAL= AP YEAR= 2022 , NDA 215211 (pdf 215211.pdf not found) INN (MIGLUSTAT) OPFOLDA (AMICUS THERAP US) APPROVAL= AP YEAR= 2023 , 890 ; GATIFLOXACIN ; 112811-59-3 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- DNA GYRASE INHIBITOR -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 021493 (label 21493.pdf) INN (GATIFLOXACIN) ZYMAR (ALLERGAN) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 079084 (pdf 79084.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 021061 (label 21061.pdf) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , NDA 021062 (label 21062.pdf) INN (GATIFLOXACIN) TEQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1999 DISCONTINUED OBSOLETE , NDA 021404 (pdf 21404.pdf not found) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 NEWAPPLICATION DISCONTINUED OBSOLETE , NDA 021405 (pdf 21405.pdf not found) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 NEWAPPLICATION DISCONTINUED OBSOLETE , NDA 021678 (label 21678.pdf) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 022548 (label 22548.pdf) INN (GATIFLOXACIN) ZYMAXID (ABBVIE) APPROVAL= AP YEAR= 2010 , NDA 076948 (pdf 76948.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (ZYDUS PHARMS USA) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 076950 (pdf 76950.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (TEVA PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 202653 (pdf 202653.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 203189 (pdf 203189.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203190 (pdf 203190.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (HI-TECH PHARMACAL) APPROVAL= TA YEAR= 2014 , NDA 204227 (pdf 204227.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2016 , NDA 206446 (pdf 206446.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (RISING) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213542 (pdf 213542.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (TORRENT) APPROVAL= AP YEAR= 2021 DISCONTINUED , 891 ; RIFAXIMIN ; 80621-81-4 ; 2004 ; ; ; CLASS METABOLISM -- ANTIINFECTIVE AGENTS -- GASTROINTESTINAL AGENTS -- TREATMENT OF TRAVELERS’ DIARRHEA -- STRUCTURAL ANALOG OF RIFAMPIN -- INHIBITION OF BACTERIAL RNA SYNTHESIS , ; NDA 021361 (label 21361.pdf) INN (RIFAXIMIN) XIFAXAN (SALIX PHARMS) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 022554 (label 22554.pdf) INN (RIFAXIMIN) XIFAXAN (SALIX PHARMS) APPROVAL= AP YEAR= 2010 NEWAPPLICATION , NDA 214370 (pdf 214370.pdf not found) INN (RIFAXIMIN) RIFAXIMIN (NORWICH) APPROVAL= TA YEAR= 2022 , NDA 213713 (pdf 213713.pdf not found) INN (RIFAXIMIN) RIFAXIMIN (SANDOZ INC) APPROVAL= TA YEAR= 2024 , 892 ; ROSUVASTATIN ; 287714-41-4 ; 2003 ; ; ; CLASS CARDIOVASCULAR -- ANTICHOLESTEREMIC AGENTS -- HMG-COA REDUCTASE INHIBITORS , ; NDA 021366 (label 21366.pdf) INN (ROSUVASTATIN CALCIUM) CRESTOR (IPR) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 079161 (pdf 79161.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 079166 (pdf 79166.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 079167 (label 79167.pdf) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 079168 (pdf 79168.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2016 , NDA 079169 (pdf 79169.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 079170 (pdf 79170.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 079171 (pdf 79171.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (SANDOZ) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 079172 (pdf 79172.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (GLENMARK SPECLT) APPROVAL= AP YEAR= 2016 , NDA 202172 (pdf 202172.pdf not found) INN (ROSUVASTATIN ZINC) ROSUVASTATIN ZINC (WATSON LABS INC) APPROVAL= TA YEAR= 2016 , NDA 079145 (pdf 79145.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (APOTEX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 201619 (pdf 201619.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 206465 (pdf 206465.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 206434 (pdf 206434.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 207062 (pdf 207062.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (RENATA) APPROVAL= AP YEAR= 2016 , NDA 207408 (pdf 207408.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (CHANGZHOU PHARM) APPROVAL= AP YEAR= 2016 , NDA 207453 (pdf 207453.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207616 (pdf 207616.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 207752 (pdf 207752.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205587 (pdf 205587.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (LUPIN) APPROVAL= AP YEAR= 2017 , NDA 208898 (pdf 208898.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (MSN) APPROVAL= AP YEAR= 2017 , NDA 208647 (label 208647.pdf) INN (ROSUVASTATIN CALCIUM) EZALLOR SPRINKLE (SUN PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208850 (pdf 208850.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206381 (pdf 206381.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 206513 (pdf 206513.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (ZHEJIANG JINGXIN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207375 (pdf 207375.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (SHANDONG) APPROVAL= AP YEAR= 2019 , NDA 207626 (pdf 207626.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (UMEDICA) APPROVAL= AP YEAR= 2019 , NDA 212059 (pdf 212059.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (ZHEJIANG YONGTAI) APPROVAL= AP YEAR= 2019 , NDA 210667 (pdf 210667.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (SUNSHINE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 207653 (pdf 207653.pdf not found) INN (ROSUVASTATIN CALCIUM) ROSUVASTATIN CALCIUM (INVENTIA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213072 (label 213072.pdf) INN (EZETIMIBE ROSUVASTATIN CALCIUM) ROSZET (ALTHERA PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , 893 ; TADALAFIL ; 171596-29-5 ; 2003 ; ; ; CLASS GENITO -- ERECTILE DYSFUNCTION (THERAPEUTIC) -- (CGMP)-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITORS -- VASOCONSTRICTOR AGENTS -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) , ; NDA 021368 (label 21368.pdf) INN (TADALAFIL) CIALIS (LILLY) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 022332 (label 22332.pdf) INN (TADALAFIL) ADCIRCA (ELI LILLY CO) APPROVAL= AP YEAR= 2009 NEWAPPLICATION , NDA 200630 (pdf 200630.pdf not found) INN (TADALAFIL) TADALAFIL (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206286 (pdf 206286.pdf not found) INN (TADALAFIL) TADALAFIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 206285 (pdf 206285.pdf not found) INN (TADALAFIL) TADALAFIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 204809 (pdf 204809.pdf not found) INN (TADALAFIL) TADALAFIL (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 090141 (pdf 90141.pdf not found) INN (TADALAFIL) TADALAFIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 205885 (pdf 205885.pdf not found) INN (TADALAFIL) TADALAFIL (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 208934 (pdf 208934.pdf not found) INN (TADALAFIL) TADALAFIL (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 206693 (pdf 206693.pdf not found) INN (TADALAFIL) TADALAFIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 206956 (pdf 206956.pdf not found) INN (TADALAFIL) TADALAFIL (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206957 (pdf 206957.pdf not found) INN (TADALAFIL) TADALAFIL (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209167 (pdf 209167.pdf not found) INN (TADALAFIL) TADALAFIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 209250 (pdf 209250.pdf not found) INN (TADALAFIL) TADALAFIL (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 209539 (pdf 209539.pdf not found) INN (TADALAFIL) TADALAFIL (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 209654 (pdf 209654.pdf not found) INN (TADALAFIL) TADALAFIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 209744 (pdf 209744.pdf not found) INN (TADALAFIL) TADALAFIL (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 209907 (pdf 209907.pdf not found) INN (TADALAFIL) TADALAFIL (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 209908 (pdf 209908.pdf not found) INN (TADALAFIL) TADALAFIL (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 209942 (pdf 209942.pdf not found) INN (TADALAFIL) ALYQ (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 210069 (pdf 210069.pdf not found) INN (TADALAFIL) TADALAFIL (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 210145 (pdf 210145.pdf not found) INN (TADALAFIL) TADALAFIL (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 210255 (pdf 210255.pdf not found) INN (TADALAFIL) TADALAFIL (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 210392 (pdf 210392.pdf not found) INN (TADALAFIL) TADALAFIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 210420 (pdf 210420.pdf not found) INN (TADALAFIL) TADALAFIL (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2019 , NDA 210567 (pdf 210567.pdf not found) INN (TADALAFIL) TADALAFIL (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 210572 (pdf 210572.pdf not found) INN (TADALAFIL) TADALAFIL (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 211335 (pdf 211335.pdf not found) INN (TADALAFIL) TADALAFIL (SUNSHINE) APPROVAL= AP YEAR= 2019 , NDA 211839 (pdf 211839.pdf not found) INN (TADALAFIL) TADALAFIL (TORRENT) APPROVAL= AP YEAR= 2019 , NDA 212062 (pdf 212062.pdf not found) INN (TADALAFIL) TADALAFIL (TORRENT) APPROVAL= AP YEAR= 2019 , NDA 207244 (pdf 207244.pdf not found) INN (TADALAFIL) TADALAFIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 207290 (pdf 207290.pdf not found) INN (TADALAFIL) TADALAFIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 208824 (pdf 208824.pdf not found) INN (TADALAFIL) TADALAFIL (HANGZHOU BINJIANG) APPROVAL= AP YEAR= 2020 , NDA 210716 (pdf 210716.pdf not found) INN (TADALAFIL) TADALAFIL (CHARTWELL RX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211298 (pdf 211298.pdf not found) INN (TADALAFIL) TADALAFIL (UMEDICA) APPROVAL= AP YEAR= 2020 , NDA 213496 (pdf 213496.pdf not found) INN (TADALAFIL) TADALAFIL (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 215423 (label 215423.pdf) INN (FINASTERIDE TADALAFIL) ENTADFI (VERU) APPROVAL= AP YEAR= 2021 , NDA 215556 (pdf 215556.pdf not found) INN (TADALAFIL) TADALAFIL (VKT PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214522 (label 214522.pdf) INN (TADALAFIL) TADLIQ (CMP DEV LLC) APPROVAL= AP YEAR= 2022 , NDA 210608 (pdf 210608.pdf not found) INN (TADALAFIL) TADALAFIL (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 210609 (pdf 210609.pdf not found) INN (TADALAFIL) TADALAFIL (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 216932 (pdf 216932.pdf not found) INN (TADALAFIL) ALYQ (TEVA PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 212515 (pdf 212515.pdf not found) INN (TADALAFIL) TADALAFIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215949 (pdf 215949.pdf not found) INN (TADALAFIL) TADALAFIL (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216279 (pdf 216279.pdf not found) INN (TADALAFIL) TADALAFIL (SHANDONG) APPROVAL= AP YEAR= 2024 , NDA 218232 (pdf 218232.pdf not found) INN (FINASTERIDE TADALAFIL) FINASTERIDE AND TADALAFIL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , NDA 218490 (pdf 218490.pdf not found) INN (MACITENTAN TADALAFIL) OPSYNVI (ACTELION) APPROVAL= AP YEAR= 2024 , 894 ; PALONOSETRON ; 135729-61-2 ; 2003 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- SEROTONIN 5-HT3 RECEPTOR ANTAGONIST -- PREVENT NAUSEA AND VOMITING , ; NDA 021372 (label 21372.pdf) INN (PALONOSETRON HYDROCHLORIDE) ALOXI (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 022233 (label 22233.pdf) INN (PALONOSETRON HYDROCHLORIDE) ALOXI (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201533 (pdf 201533.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 090713 (pdf 90713.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 203050 (label 203050.pdf) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (AVYXA HOLDINGS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205718 (label 205718.pdf) INN (NETUPITANT PALONOSETRON HYDROCHLORIDE) AKYNZEO (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 202521 (pdf 202521.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 204702 (pdf 204702.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2018 , NDA 204731 (pdf 204731.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (AKORN INC) APPROVAL= TA YEAR= 2015 , NDA 207963 (label 207963.pdf) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208109 (label 208109.pdf) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210493 (label 210493.pdf) INN (FOSNETUPITANT CHLORIDE HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE) AKYNZEO (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 204289 (pdf 204289.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 205648 (pdf 205648.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2018 , NDA 205870 (pdf 205870.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 206396 (pdf 206396.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206416 (pdf 206416.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2018 , NDA 206801 (pdf 206801.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 206802 (pdf 206802.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 207005 (pdf 207005.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2018 , NDA 209287 (pdf 209287.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 208789 (pdf 208789.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 202951 (pdf 202951.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 204615 (pdf 204615.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 206916 (pdf 206916.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2021 , NDA 215861 (pdf 215861.pdf not found) INN (PALONOSETRON HYDROCHLORIDE) PALONOSETRON HYDROCHLORIDE (NANJING KING-FRIEND) APPROVAL= AP YEAR= 2023 , 895 ; GEFITINIB ; 184475-35-2 ; 2003 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE EGFR INHIBITORS , ; NDA 021399 (label 21399.pdf) INN (GEFITINIB) IRESSA (ASTRAZENECA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 206995 (label 206995.pdf) INN (GEFITINIB) IRESSA (ASTRAZENECA) APPROVAL= AP YEAR= 2015 , NDA 209532 (pdf 209532.pdf not found) INN (GEFITINIB) GEFITINIB (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 208913 (pdf 208913.pdf not found) INN (GEFITINIB) GEFITINIB (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023 , NDA 211591 (pdf 211591.pdf not found) INN (GEFITINIB) GEFITINIB (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2023 , NDA 212827 (pdf 212827.pdf not found) INN (GEFITINIB) GEFITINIB (NATCO) APPROVAL= AP YEAR= 2023 , 896 ; VARDENAFIL ; 224785-90-4 ; 2003 ; ; ; CLASS GENITO -- TREATMENT OF ERECTILE DYSFUNCTION -- CYCLIC GUANOSINE MONOPHOSPHATE (CGMP)-SPECIFIC PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITOR -- ANTI-IMPOTENCE AGENTS -- VASOCONSTRICTOR AGENTS , ; NDA 021400 (label 21400.pdf) INN (VARDENAFIL HYDROCHLORIDE) LEVITRA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 200179 (label 200179.pdf) INN (VARDENAFIL HYDROCHLORIDE) STAXYN (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091347 (pdf 91347.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 203689 (pdf 203689.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= TA YEAR= 2017 , NDA 204632 (pdf 204632.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 204786 (pdf 204786.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (PAR PHARM INC) APPROVAL= TA YEAR= 2016 , NDA 205988 (pdf 205988.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 208324 (pdf 208324.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 208960 (pdf 208960.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209057 (pdf 209057.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2018 , NDA 210738 (pdf 210738.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (STEVENS J) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 214031 (pdf 214031.pdf not found) INN (VARDENAFIL HYDROCHLORIDE) VARDENAFIL HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2020 , 897 ; ATOMOXETINE ; 83015-26-3 ; 2002 ; ; ; CLASS NERVOUS SYSTEM -- NOREPINEPHRINE REUPTAKE INHIBITOR -- TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER , ; NDA 021411 (label 21411.pdf) INN (ATOMOXETINE HYDROCHLORIDE) STRATTERA (LILLY) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 079016 (label 79016.pdf) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 079017 (pdf 79017.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 079018 (pdf 79018.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (SANDOZ INC) APPROVAL= TA YEAR= 2012 OBSOLETE , NDA 079019 (pdf 79019.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 079020 (pdf 79020.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (SUN PHARMA GLOBAL) APPROVAL= TA YEAR= 2012 , NDA 079021 (pdf 79021.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 079022 (pdf 79022.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 078940 (pdf 78940.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 2012 , NDA 090609 (pdf 90609.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 078983 (pdf 78983.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2017 , NDA 202682 (pdf 202682.pdf not found) INN (ATOMOXETINE HYDROCHLORIDE) ATOMOXETINE HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , 898 ; DULOXETINE ; 116539-59-4 ; 2004 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF CHRONIC MUSCULOSKELETAL PAIN -- TREATMENT OF GENERALIZED ANXIETY DISORDER -- SELECTIVE SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITOR (SSNRI) , ; NDA 021427 (label 21427.pdf) INN (DULOXETINE HYDROCHLORIDE) CYMBALTA (LILLY) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 021733 (label 21733.pdf) INN (DULOXETINE HYDROCHLORIDE) CYMBALTA (LILLY) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 022148 (label 22148.pdf) INN (DULOXETINE HYDROCHLORIDE) CYMBALTA (LILLY) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 022516 (label 22516.pdf) INN (DULOXETINE HYDROCHLORIDE) CYMBALTA (LILLY) APPROVAL= AP YEAR= 2010 NEWAPPLICATION , NDA 090669 (pdf 90669.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= TA YEAR= 2010 , NDA 090728 (pdf 90728.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 090739 (pdf 90739.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ZYDUS HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 090745 (pdf 90745.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2013 , NDA 090774 (pdf 90774.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2013 , NDA 090778 (pdf 90778.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 090775 (pdf 90775.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2011 , NDA 090694 (pdf 90694.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 090723 (pdf 90723.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090773 (pdf 90773.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= TA YEAR= 2011 , NDA 090783 (pdf 90783.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090776 (pdf 90776.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 202045 (pdf 202045.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202949 (pdf 202949.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2014 , NDA 203088 (pdf 203088.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2014 , NDA 203197 (pdf 203197.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 090780 (label 90780.pdf) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202336 (pdf 202336.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (INVENTIA) APPROVAL= AP YEAR= 2015 , NDA 204343 (pdf 204343.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2016 , NDA 204815 (pdf 204815.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 206653 (pdf 206653.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 208706 (pdf 208706.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 211310 (pdf 211310.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (CSPC OUYI) APPROVAL= AP YEAR= 2018 , NDA 210599 (pdf 210599.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (QINGDAO BAHEAL PHARM) APPROVAL= AP YEAR= 2019 , NDA 207219 (pdf 207219.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (YAOPHARMA CO LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212516 (label 212516.pdf) INN (DULOXETINE HYDROCHLORIDE) DRIZALMA SPRINKLE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 212328 (pdf 212328.pdf not found) INN (DULOXETINE HYDROCHLORIDE) DULOXETINE HYDROCHLORIDE (SUNSHINE) APPROVAL= AP YEAR= 2021 , 899 ; ACAMPROSATE ; 77337-76-9 ; 2004 ; ; ; CLASS NERVOUS SYSTEM -- MAINTENANCE OF ABSTINENCE OF ALCOHOL -- CHEMICAL STRUCTURE SIMILAR TO THAT OF THE ENDOGENOUS AMINO ACID HOMOTAURINE -- MAY INTERACT WITH GLUTAMATE AND GABA NEUROTRANSMITTER SYSTEMS CENTRALLY , ; NDA 021431 (label 21431.pdf) INN (ACAMPROSATE CALCIUM) CAMPRAL (FOREST LABS) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 200143 (pdf 200143.pdf not found) INN (ACAMPROSATE CALCIUM) ACAMPROSATE CALCIUM (BARR LABS DIV TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202229 (pdf 202229.pdf not found) INN (ACAMPROSATE CALCIUM) ACAMPROSATE CALCIUM (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 200142 (pdf 200142.pdf not found) INN (ACAMPROSATE CALCIUM) ACAMPROSATE CALCIUM (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 205995 (pdf 205995.pdf not found) INN (ACAMPROSATE CALCIUM) ACAMPROSATE CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , 900 ; ARIPIPRAZOLE ; 129722-12-9 ; 2002 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTICS -- TREATMENT OF BIPOLAR I DISORDER (SCHIZOPHRENIA) -- D2 DOPAMINE RECEPTOR AGONIST (KI=0.34 NANOMOLAR) -- 5HT1A AGONIST (KI=1.7 NANOMOLAR) -- 5HT2A ANTAGONIST (KI=3.4 NANOMOLAR) -- ADRENERGIC ALPHA1 RECEPTOR ANTAGONIST -- D3 DOPAMINE RECEPTOR PARTIAL AGONIST (KI=0.8 NANOMOLAR) , ; NDA 021436 (label 21436.pdf) INN (ARIPIPRAZOLE) ABILIFY (OTSUKA) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 021713 (label 21713.pdf) INN (ARIPIPRAZOLE) ABILIFY (OTSUKA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021729 (label 21729.pdf) INN (ARIPIPRAZOLE) ABILIFY (OTSUKA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 021866 (label 21866.pdf) INN (ARIPIPRAZOLE) ABILIFY (OTSUKA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078612 (pdf 78612.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (BARR LABS INC) APPROVAL= TA YEAR= 2012 , NDA 078613 (pdf 78613.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (BARR LABS INC) APPROVAL= TA YEAR= 2012 , NDA 090165 (pdf 90165.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (SQUARE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 078614 (pdf 78614.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (SUN PHARMA GLOBAL) APPROVAL= TA YEAR= 2013 , NDA 201519 (pdf 201519.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (TORRENT) APPROVAL= AP YEAR= 2015 , NDA 202101 (label 202101.pdf) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 202102 (label 202102.pdf) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 202971 (label 202971.pdf) INN (ARIPIPRAZOLE) ABILIFY MAINTENA KIT (OTSUKA PHARM CO LTD) APPROVAL= AP YEAR= 2013 , NDA 078583 (pdf 78583.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 078607 (pdf 78607.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 078608 (pdf 78608.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 078708 (pdf 78708.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203906 (pdf 203906.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204171 (pdf 204171.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2015 , NDA 205064 (pdf 205064.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 203908 (pdf 203908.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204094 (pdf 204094.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 204838 (pdf 204838.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204111 (pdf 204111.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206174 (pdf 206174.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 206251 (pdf 206251.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 206383 (pdf 206383.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 091279 (pdf 91279.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (BRECKENRIDGE) APPROVAL= AP YEAR= 2017 , NDA 202683 (pdf 202683.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ORBION PHARMS) APPROVAL= AP YEAR= 2017 , NDA 202547 (pdf 202547.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ORBION PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205363 (pdf 205363.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 207202 (label 207202.pdf) INN (ARIPIPRAZOLE) ABILIFY MYCITE KIT (OTSUKA) APPROVAL= AP YEAR= 2017 , NDA 207240 (pdf 207240.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 206240 (pdf 206240.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208260 (pdf 208260.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (PHARMTAK INC) APPROVAL= TA YEAR= 2018 , NDA 208438 (pdf 208438.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (PHARMTAK INC) APPROVAL= TA YEAR= 2018 , NDA 090472 (pdf 90472.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207105 (pdf 207105.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210479 (pdf 210479.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212870 (pdf 212870.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (VISTAPHARM) APPROVAL= AP YEAR= 2019 , NDA 203025 (pdf 203025.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (UNICHEM) APPROVAL= AP YEAR= 2021 , NDA 215595 (pdf 215595.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2022 , NDA 216351 (pdf 216351.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 217006 (label 217006.pdf) INN (ARIPIPRAZOLE) ABILIFY ASIMTUFII (OTSUKA) APPROVAL= AP YEAR= 2023 , NDA 213037 (pdf 213037.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (SUNSHINE) APPROVAL= AP YEAR= 2023 , NDA 216150 (pdf 216150.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , NDA 205589 (pdf 205589.pdf not found) INN (ARIPIPRAZOLE) ARIPIPRAZOLE (LUPIN) APPROVAL= AP YEAR= 2024 , 901 ; EPLERENONE ; 107724-20-9 ; 2002 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ALDOSTERONE ANTAGONIST , ; NDA 021437 (label 21437.pdf) INN (EPLERENONE) INSPRA (UPJOHN) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 078482 (pdf 78482.pdf not found) INN (EPLERENONE) EPLERENONE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 078510 (pdf 78510.pdf not found) INN (EPLERENONE) EPLERENONE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 203896 (pdf 203896.pdf not found) INN (EPLERENONE) EPLERENONE (PRASCO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206922 (pdf 206922.pdf not found) INN (EPLERENONE) EPLERENONE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 208283 (pdf 208283.pdf not found) INN (EPLERENONE) EPLERENONE (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 , NDA 212765 (pdf 212765.pdf not found) INN (EPLERENONE) EPLERENONE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2020 , NDA 207842 (pdf 207842.pdf not found) INN (EPLERENONE) EPLERENONE (WESTMINSTER PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214663 (pdf 214663.pdf not found) INN (EPLERENONE) EPLERENONE (RISING) APPROVAL= AP YEAR= 2022 , NDA 213812 (pdf 213812.pdf not found) INN (EPLERENONE) EPLERENONE (ANNORA PHARMA) APPROVAL= AP YEAR= 2023 , 902 ; EZETIMIBE ; 163222-33-1 ; 2002 ; ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- INHIBITOR OF INTESTINAL CHOLESTEROL ABSORPTION , ; NDA 021445 (label 21445.pdf) INN (EZETIMIBE) ZETIA (ORGANON) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 021687 (label 21687.pdf) INN (EZETIMIBE SIMVASTATIN) VYTORIN (ORGANON) APPROVAL= AP YEAR= 2004 , NDA 078560 (pdf 78560.pdf not found) INN (EZETIMIBE) EZETIMIBE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 200082 (pdf 200082.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 200153 (label 200153.pdf) INN (ATORVASTATIN CALCIUM EZETIMIBE) LIPTRUZET (ORGANON) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201790 (pdf 201790.pdf not found) INN (EZETIMIBE) EZETIMIBE (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 078724 (pdf 78724.pdf not found) INN (EZETIMIBE) EZETIMIBE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 200831 (pdf 200831.pdf not found) INN (EZETIMIBE) EZETIMIBE (WATSON LABS INC) APPROVAL= AP YEAR= 2017 , NDA 201890 (pdf 201890.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203931 (pdf 203931.pdf not found) INN (EZETIMIBE) EZETIMIBE (SANDOZ) APPROVAL= AP YEAR= 2017 , NDA 200909 (pdf 200909.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 202968 (pdf 202968.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (WATSON LABS INC) APPROVAL= AP YEAR= 2017 , NDA 204331 (pdf 204331.pdf not found) INN (EZETIMIBE) EZETIMIBE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206084 (pdf 206084.pdf not found) INN (ATORVASTATIN CALCIUM EZETIMIBE) EZETIMIBE AND ATORVASTATIN CALCIUM (SCOV3) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207311 (pdf 207311.pdf not found) INN (EZETIMIBE) EZETIMIBE (OHM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 208332 (pdf 208332.pdf not found) INN (EZETIMIBE) EZETIMIBE (APOTEX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208803 (pdf 208803.pdf not found) INN (EZETIMIBE) EZETIMIBE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 208831 (pdf 208831.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 209222 (pdf 209222.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 209234 (pdf 209234.pdf not found) INN (EZETIMIBE) EZETIMIBE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 209838 (pdf 209838.pdf not found) INN (EZETIMIBE) EZETIMIBE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 211550 (pdf 211550.pdf not found) INN (EZETIMIBE) EZETIMIBE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 208699 (pdf 208699.pdf not found) INN (EZETIMIBE SIMVASTATIN) EZETIMIBE AND SIMVASTATIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 211617 (label 211617.pdf) INN (BEMPEDOIC ACID EZETIMIBE) NEXLIZET (ESPERION THERAPS INC) APPROVAL= AP YEAR= 2020 , NDA 210673 (pdf 210673.pdf not found) INN (EZETIMIBE) EZETIMIBE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 213072 (label 213072.pdf) INN (EZETIMIBE ROSUVASTATIN CALCIUM) ROSZET (ALTHERA PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 210859 (pdf 210859.pdf not found) INN (EZETIMIBE) EZETIMIBE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 215693 (pdf 215693.pdf not found) INN (EZETIMIBE) EZETIMIBE (ORIENT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 211159 (pdf 211159.pdf not found) INN (EZETIMIBE) EZETIMIBE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , 903 ; PREGABALIN ; 148553-50-8 ; 2004 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- ANTICONVULSANTS -- NEUROPATHIC PAIN , ; NDA 021446 (label 21446.pdf) INN (PREGABALIN) LYRICA (UPJOHN) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 021723 (pdf 21723.pdf not found) INN (PREGABALIN) LYRICA (CP PHARMS) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021724 (pdf 21724.pdf not found) INN (PREGABALIN) LYRICA (CP PHARMS) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 022488 (label 22488.pdf) INN (PREGABALIN) LYRICA (UPJOHN) APPROVAL= AP YEAR= 2010 , NDA 091040 (pdf 91040.pdf not found) INN (PREGABALIN) PREGABALIN (LUPIN LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 091219 (pdf 91219.pdf not found) INN (PREGABALIN) PREGABALIN (TEVA PHARMS) APPROVAL= AP YEAR= 2019 , NDA 091224 (pdf 91224.pdf not found) INN (PREGABALIN) PREGABALIN (TEVA PHARMS) APPROVAL= AP YEAR= 2019 , NDA 091221 (pdf 91221.pdf not found) INN (PREGABALIN) PREGABALIN (WATSON LABS INC) APPROVAL= TA YEAR= 2015 , NDA 091222 (pdf 91222.pdf not found) INN (PREGABALIN) PREGABALIN (HEALTHCARE PHARMA LTD) APPROVAL= TA YEAR= 2012 , NDA 091229 (pdf 91229.pdf not found) INN (PREGABALIN) PREGABALIN (SANDOZ INC) APPROVAL= TA YEAR= 2012 , NDA 091228 (pdf 91228.pdf not found) INN (PREGABALIN) PREGABALIN (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 201989 (pdf 201989.pdf not found) INN (PREGABALIN) PREGABALIN (LUPIN LTD) APPROVAL= TA YEAR= 2013 , NDA 091025 (pdf 91025.pdf not found) INN (PREGABALIN) PREGABALIN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2020 , NDA 202269 (pdf 202269.pdf not found) INN (PREGABALIN) PREGABALIN (NOVEL LABS INC) APPROVAL= TA YEAR= 2014 , NDA 202998 (pdf 202998.pdf not found) INN (PREGABALIN) PREGABALIN (APOTEX INC) APPROVAL= TA YEAR= 2014 , NDA 203022 (pdf 203022.pdf not found) INN (PREGABALIN) PREGABALIN (APOTEX INC) APPROVAL= TA YEAR= 2014 , NDA 203459 (pdf 203459.pdf not found) INN (PREGABALIN) PREGABALIN (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 205321 (pdf 205321.pdf not found) INN (PREGABALIN) PREGABALIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 205924 (pdf 205924.pdf not found) INN (PREGABALIN) PREGABALIN (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 207799 (pdf 207799.pdf not found) INN (PREGABALIN) PREGABALIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 206452 (pdf 206452.pdf not found) INN (PREGABALIN) PREGABALIN (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 207883 (pdf 207883.pdf not found) INN (PREGABALIN) PREGABALIN (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 209501 (label 209501.pdf) INN (PREGABALIN) LYRICA CR (UPJOHN) APPROVAL= AP YEAR= 2017 , NDA 208677 (pdf 208677.pdf not found) INN (PREGABALIN) PREGABALIN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210432 (pdf 210432.pdf not found) INN (PREGABALIN) PREGABALIN (RISING) APPROVAL= AP YEAR= 2019 , NDA 211384 (pdf 211384.pdf not found) INN (PREGABALIN) PREGABALIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 206942 (pdf 206942.pdf not found) INN (PREGABALIN) PREGABALIN (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2019 , NDA 207623 (pdf 207623.pdf not found) INN (PREGABALIN) PREGABALIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 209357 (pdf 209357.pdf not found) INN (PREGABALIN) PREGABALIN (MSN) APPROVAL= AP YEAR= 2019 , NDA 091157 (pdf 91157.pdf not found) INN (PREGABALIN) PREGABALIN (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206912 (pdf 206912.pdf not found) INN (PREGABALIN) PREGABALIN (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 209664 (pdf 209664.pdf not found) INN (PREGABALIN) PREGABALIN (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 209743 (pdf 209743.pdf not found) INN (PREGABALIN) PREGABALIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 210585 (pdf 210585.pdf not found) INN (PREGABALIN) PREGABALIN (RENATA) APPROVAL= AP YEAR= 2019 , NDA 210891 (pdf 210891.pdf not found) INN (PREGABALIN) PREGABALIN (YILING) APPROVAL= AP YEAR= 2019 , NDA 211177 (pdf 211177.pdf not found) INN (PREGABALIN) PREGABALIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 212280 (pdf 212280.pdf not found) INN (PREGABALIN) PREGABALIN (CIPLA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212865 (pdf 212865.pdf not found) INN (PREGABALIN) PREGABALIN (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 213423 (pdf 213423.pdf not found) INN (PREGABALIN) PREGABALIN (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 2020 , NDA 211593 (pdf 211593.pdf not found) INN (PREGABALIN) PREGABALIN (ALVOGEN) APPROVAL= AP YEAR= 2021 , NDA 211889 (pdf 211889.pdf not found) INN (PREGABALIN) PREGABALIN (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 211948 (pdf 211948.pdf not found) INN (PREGABALIN) PREGABALIN (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213226 (pdf 213226.pdf not found) INN (PREGABALIN) PREGABALIN (MSN) APPROVAL= AP YEAR= 2021 , NDA 213313 (pdf 213313.pdf not found) INN (PREGABALIN) PREGABALIN (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 211431 (pdf 211431.pdf not found) INN (PREGABALIN) PREGABALIN (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211685 (pdf 211685.pdf not found) INN (PREGABALIN) PREGABALIN (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 211687 (pdf 211687.pdf not found) INN (PREGABALIN) PREGABALIN (ALVOGEN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211967 (pdf 211967.pdf not found) INN (PREGABALIN) PREGABALIN (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214322 (pdf 214322.pdf not found) INN (PREGABALIN) PREGABALIN (CHANGZHOU PHARM) APPROVAL= AP YEAR= 2021 , NDA 212604 (pdf 212604.pdf not found) INN (PREGABALIN) PREGABALIN (PATRIN) APPROVAL= AP YEAR= 2022 , NDA 212988 (pdf 212988.pdf not found) INN (PREGABALIN) PREGABALIN (ESKAYEF) APPROVAL= AP YEAR= 2022 , NDA 215249 (pdf 215249.pdf not found) INN (PREGABALIN) PREGABALIN (RUBICON) APPROVAL= AP YEAR= 2022 , NDA 206752 (pdf 206752.pdf not found) INN (PREGABALIN) PREGABALIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215577 (pdf 215577.pdf not found) INN (PREGABALIN) PREGABALIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215675 (pdf 215675.pdf not found) INN (PREGABALIN) PREGABALIN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216197 (pdf 216197.pdf not found) INN (PREGABALIN) PREGABALIN (ADAPTIS) APPROVAL= AP YEAR= 2022 , NDA 214496 (pdf 214496.pdf not found) INN (PREGABALIN) PREGABALIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 215755 (pdf 215755.pdf not found) INN (PREGABALIN) PREGABALIN (ACI) APPROVAL= AP YEAR= 2023 , NDA 208113 (pdf 208113.pdf not found) INN (PREGABALIN) PREGABALIN (INDOCO) APPROVAL= AP YEAR= 2024 , NDA 209883 (pdf 209883.pdf not found) INN (PREGABALIN) PREGABALIN (STRIDES PHARMA) APPROVAL= AP YEAR= 2024 , 904 ; ADEFOVIR DIPIVOXIL ; 142340-99-6 ; 2002 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGENTS -- REVERSE TRANSCRIPTASE INHIBITORS -- TREATMENT OF CHRONIC HEPATITIS B , ; NDA 021449 (label 21449.pdf) INN (ADEFOVIR DIPIVOXIL) HEPSERA (GILEAD) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 202051 (label 202051.pdf) INN (ADEFOVIR DIPIVOXIL) ADEFOVIR DIPIVOXIL (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2013 , NDA 205459 (pdf 205459.pdf not found) INN (ADEFOVIR DIPIVOXIL) ADEFOVIR DIPIVOXIL (APOTEX) APPROVAL= AP YEAR= 2018 , 905 ; IBANDRONATE ; 114084-78-5 ; 2003 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIHYPOCALCEMIC AGENTS -- ANTIRESORPTIVES -- BISPHOSPHONATES -- BONE DENSITY CONSERVATION AGENTS , ; NDA 021455 (label 21455.pdf) INN (IBANDRONATE SODIUM) BONIVA (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 021858 (label 21858.pdf) INN (IBANDRONATE SODIUM) BONIVA (ROCHE) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078995 (pdf 78995.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078998 (pdf 78998.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (ORBION PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079002 (pdf 79002.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (COBALT LABS INC) APPROVAL= TA YEAR= 2011 , NDA 079003 (pdf 79003.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (WATSON LABS TEVA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 079194 (pdf 79194.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (TEVA PARENTERAL) APPROVAL= TA YEAR= 2009 , NDA 090853 (label 90853.pdf) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 078996 (pdf 78996.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078948 (pdf 78948.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 078997 (pdf 78997.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202235 (pdf 202235.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 202671 (pdf 202671.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 203987 (pdf 203987.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204222 (pdf 204222.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 205332 (pdf 205332.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 204502 (pdf 204502.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206058 (pdf 206058.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 206887 (pdf 206887.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 204329 (pdf 204329.pdf not found) INN (IBANDRONATE SODIUM) IBANDRONATE SODIUM (NANG KUANG PHARM CO) APPROVAL= AP YEAR= 2021 DISCONTINUED , 906 ; ESZOPICLONE ; 138729-47-2 ; 2004 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS AND SEDATIVES -- GABA RECEPTOR AGONIST , ; NDA 021476 (label 21476.pdf) INN (ESZOPICLONE) LUNESTA (WAYLIS THERAP) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 091124 (pdf 91124.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 091151 (pdf 91151.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 091166 (pdf 91166.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 091113 (pdf 91113.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (ORBION PHARMS) APPROVAL= AP YEAR= 2014 , NDA 091169 (pdf 91169.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (TEVA) APPROVAL= AP YEAR= 2011 , NDA 091165 (pdf 91165.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091103 (pdf 91103.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (SUN PHARM) APPROVAL= AP YEAR= 2013 , NDA 091024 (pdf 91024.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 091153 (pdf 91153.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202929 (pdf 202929.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 208451 (pdf 208451.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203087 (pdf 203087.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206222 (pdf 206222.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (IPCA LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 205504 (pdf 205504.pdf not found) INN (ESZOPICLONE) ESZOPICLONE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 907 ; MEMANTINE ; 19982-08-2 ; 2003 ; ; ; CLASS NERVOUS SYSTEM -- MUSCLE RELAXANT (SKELETAL) -- NMDA RECEPTOR ANTAGONIST (OPEN CHANNEL) -- ANTI-ALZHEIMER'S DISEASE , ; NDA 021487 (label 21487.pdf) INN (MEMANTINE HYDROCHLORIDE) NAMENDA (ABBVIE) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 021627 (label 21627.pdf) INN (MEMANTINE HYDROCHLORIDE) NAMENDA (ALLERGAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 079225 (pdf 79225.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090041 (pdf 90041.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 090043 (pdf 90043.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2015 , NDA 090044 (pdf 90044.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ORBION PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090048 (pdf 90048.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 090051 (pdf 90051.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 090052 (pdf 90052.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090058 (pdf 90058.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2010 , NDA 090073 (pdf 90073.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (CELLTRION) APPROVAL= AP YEAR= 2015 , NDA 022525 (label 22525.pdf) INN (MEMANTINE HYDROCHLORIDE) NAMENDA XR (ABBVIE) APPROVAL= AP YEAR= 2010 , NDA 200155 (pdf 200155.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090244 (pdf 90244.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (CHARTWELL) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 200022 (pdf 200022.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2015 , NDA 091585 (pdf 91585.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 200891 (pdf 200891.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 202840 (pdf 202840.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203175 (pdf 203175.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 204033 (pdf 204033.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2015 , NDA 206439 (label 206439.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) NAMZARIC (ABBVIE) APPROVAL= AP YEAR= 2014 , NDA 090961 (pdf 90961.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 202790 (pdf 202790.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 205446 (pdf 205446.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206032 (pdf 206032.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206528 (pdf 206528.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 206855 (pdf 206855.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2015 , NDA 205825 (pdf 205825.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205905 (label 205905.pdf) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206028 (label 206028.pdf) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2016 , NDA 206135 (pdf 206135.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2016 , NDA 206310 (pdf 206310.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 207236 (pdf 207236.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202350 (pdf 202350.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203293 (pdf 203293.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205784 (pdf 205784.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208328 (label 208328.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208672 (pdf 208672.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2017 , NDA 209527 (pdf 209527.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (RENATA) APPROVAL= AP YEAR= 2018 , NDA 209955 (pdf 209955.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2018 , NDA 205365 (pdf 205365.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208173 (pdf 208173.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212947 (pdf 212947.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (YILING) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210319 (pdf 210319.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (SETON PHARMS) APPROVAL= AP YEAR= 2020 , NDA 210587 (pdf 210587.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (POLYGEN PHARMS) APPROVAL= AP YEAR= 2020 , NDA 211100 (pdf 211100.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2021 , NDA 214651 (pdf 214651.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 204389 (pdf 204389.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 213985 (pdf 213985.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (XIAMEN LP PHARM CO) APPROVAL= AP YEAR= 2022 , NDA 214731 (pdf 214731.pdf not found) INN (MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE (NOVAST LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 216901 (pdf 216901.pdf not found) INN (MEMANTINE DONEPEZIL HYDROCHLORIDES) MEMANTINEDONEPEZIL HYDROCHLORIDES (XIAMEN LP PHARM CO) APPROVAL= TA YEAR= 2023 , NDA 208237 (pdf 208237.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2023 , 908 ; RANOLAZINE ; 95635-55-5 ; 2006 ; ; ; CLASS ANTIANGINALCLASS CARDIOVASCULAR -- ANTIANGINAL -- TREATMENT OF CHRONIC ANGINA -- INHIBIT THE CARDIAC LATE SODIUM CURRENT -- VOLTAGE-GATED NA(+) CHANNELS (NAV) INHIBITOR -- ALPHA1-ADRENERGIC RECEPTOR ANTAGONIST (PMID26655634) , ; NDA 021526 (label 21526.pdf) INN (RANOLAZINE) RANEXA (MENARINI INTL) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY DISCONTINUED , NDA 201046 (pdf 201046.pdf not found) INN (RANOLAZINE) RANOLAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 208174 (pdf 208174.pdf not found) INN (RANOLAZINE) RANOLAZINE (TEVA PHARMS) APPROVAL= TA YEAR= 2016 , NDA 208862 (pdf 208862.pdf not found) INN (RANOLAZINE) RANOLAZINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2019 , NDA 209081 (pdf 209081.pdf not found) INN (RANOLAZINE) RANOLAZINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210054 (pdf 210054.pdf not found) INN (RANOLAZINE) RANOLAZINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211291 (pdf 211291.pdf not found) INN (RANOLAZINE) RANOLAZINE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211707 (pdf 211707.pdf not found) INN (RANOLAZINE) RANOLAZINE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 211829 (pdf 211829.pdf not found) INN (RANOLAZINE) RANOLAZINE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210188 (pdf 210188.pdf not found) INN (RANOLAZINE) RANOLAZINE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 210482 (pdf 210482.pdf not found) INN (RANOLAZINE) RANOLAZINE (ANI PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211082 (pdf 211082.pdf not found) INN (RANOLAZINE) RANOLAZINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 211745 (pdf 211745.pdf not found) INN (RANOLAZINE) RANOLAZINE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 211865 (pdf 211865.pdf not found) INN (RANOLAZINE) RANOLAZINE (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 212284 (pdf 212284.pdf not found) INN (RANOLAZINE) RANOLAZINE (MANKIND PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212781 (pdf 212781.pdf not found) INN (RANOLAZINE) RANOLAZINE (PRAXGEN) APPROVAL= AP YEAR= 2020 , NDA 209953 (pdf 209953.pdf not found) INN (RANOLAZINE) RANOLAZINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 207690 (pdf 207690.pdf not found) INN (RANOLAZINE) RANOLAZINE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212889 (pdf 212889.pdf not found) INN (RANOLAZINE) RANOLAZINE (RISING) APPROVAL= AP YEAR= 2021 , NDA 212930 (pdf 212930.pdf not found) INN (RANOLAZINE) RANOLAZINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212788 (pdf 212788.pdf not found) INN (RANOLAZINE) RANOLAZINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 213517 (pdf 213517.pdf not found) INN (RANOLAZINE) RANOLAZINE (I3 PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214035 (pdf 214035.pdf not found) INN (RANOLAZINE) RANOLAZINE (VKT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216018 (label 216018.pdf) INN (RANOLAZINE) ASPRUZYO SPRINKLE (SPIL) APPROVAL= AP YEAR= 2022 , NDA 213083 (pdf 213083.pdf not found) INN (RANOLAZINE) RANOLAZINE (UNICHEM) APPROVAL= AP YEAR= 2023 , NDA 210668 (pdf 210668.pdf not found) INN (RANOLAZINE) RANOLAZINE (NOVAST LABS) APPROVAL= AP YEAR= 2023 , NDA 213085 (pdf 213085.pdf not found) INN (RANOLAZINE) RANOLAZINE (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2023 DISCONTINUED , 909 ; GATIFLOXACIN ; 112811-59-3 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- DNA GYRASE INHIBITOR -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 021493 (label 21493.pdf) INN (GATIFLOXACIN) ZYMAR (ALLERGAN) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 079084 (pdf 79084.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 021061 (label 21061.pdf) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , NDA 021062 (label 21062.pdf) INN (GATIFLOXACIN) TEQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1999 DISCONTINUED OBSOLETE , NDA 021404 (pdf 21404.pdf not found) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 NEWAPPLICATION DISCONTINUED OBSOLETE , NDA 021405 (pdf 21405.pdf not found) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2002 NEWAPPLICATION DISCONTINUED OBSOLETE , NDA 021678 (label 21678.pdf) INN (GATIFLOXACIN) TEQUIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 022548 (label 22548.pdf) INN (GATIFLOXACIN) ZYMAXID (ABBVIE) APPROVAL= AP YEAR= 2010 , NDA 076948 (pdf 76948.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (ZYDUS PHARMS USA) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 076950 (pdf 76950.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (TEVA PHARMS) APPROVAL= TA YEAR= 2005 OBSOLETE , NDA 202653 (pdf 202653.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 203189 (pdf 203189.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203190 (pdf 203190.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (HI-TECH PHARMACAL) APPROVAL= TA YEAR= 2014 , NDA 204227 (pdf 204227.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (SANDOZ) APPROVAL= AP YEAR= 2016 , NDA 206446 (pdf 206446.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (RISING) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213542 (pdf 213542.pdf not found) INN (GATIFLOXACIN) GATIFLOXACIN (TORRENT) APPROVAL= AP YEAR= 2021 DISCONTINUED , 910 ; NITAZOXANIDE ; 55981-09-4 ; 2002 ; ; ; CLASS ANTIPARASITIC-- ANTHELMINTIC -- ANTIPROTOZOAL -- INTERFERENCE WITH PYRUVATE:FERREDOXIN OXIDOREDUCTASE (PFOR) ENZYME DEPENDENT ELECTRON TRANSFER REACTION WHICH IS ESSENTIAL TO ANAEROBIC ENERGY METABOLISM -- RAPIDLY HYDROLYSED IN TIZOXANIDE , ; NDA 021497 (label 21497.pdf) INN (NITAZOXANIDE) ALINIA (ROMARK) APPROVAL= AP YEAR= 2004 , NDA 021498 (label 21498.pdf) INN (NITAZOXANIDE) ALINIA (ROMARK) APPROVAL= AP YEAR= 2002 NEWMOLECULARENTITY , NDA 021818 (label 21818.pdf) INN (NITAZOXANIDE) ALINIA (ROMARK) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 213820 (pdf 213820.pdf not found) INN (NITAZOXANIDE) NITAZOXANIDE (RISING) APPROVAL= AP YEAR= 2020 , 911 ; EMTRICITABINE ; 143491-57-0 ; 2003 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- HIV-1 REVERSE TRANSCRIPTASE INHIBITOR , ; NDA 021500 (label 21500.pdf) INN (EMTRICITABINE) EMTRIVA (GILEAD) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 021752 (label 21752.pdf) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) TRUVADA (GILEAD) APPROVAL= AP YEAR= 2004 , NDA 021896 (label 21896.pdf) INN (EMTRICITABINE) EMTRIVA (GILEAD) APPROVAL= AP YEAR= 2005 , NDA 021937 (label 21937.pdf) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) ATRIPLA (GILEAD SCIENCES) APPROVAL= AP YEAR= 2006 , NDA 079188 (pdf 79188.pdf not found) INN (EMTRICITABINE) EMTRICITABINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 090049 (pdf 90049.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090437 (pdf 90437.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090488 (pdf 90488.pdf not found) INN (EMTRICITABINE) EMTRICITABINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2008 , NDA 090513 (pdf 90513.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 091168 (pdf 91168.pdf not found) INN (EMTRICITABINE) EMTRICITABINE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 090894 (pdf 90894.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 091215 (pdf 91215.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 201806 (pdf 201806.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 202123 (label 202123.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR DISOPROXIL FUMARATE) COMPLERA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2011 , NDA 091593 (pdf 91593.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 203100 (label 203100.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012 , NDA 091055 (pdf 91055.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 , NDA 203041 (pdf 203041.pdf not found) INN (EMTRICITABINE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 203053 (pdf 203053.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 090958 (pdf 90958.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2021 , NDA 204287 (pdf 204287.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 206042 (pdf 206042.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) EMTRICITABINETENOFOVIR DISOPROXIL FUMARATENEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206584 (pdf 206584.pdf not found) INN (EMTRICITABINE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2015 OBSOLETE , NDA 207561 (label 207561.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) GENVOYA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2015 , NDA 206894 (pdf 206894.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 208215 (label 208215.pdf) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) DESCOVY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 208351 (label 208351.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR ALAFENAMIDE FUMARATE) ODEFSEY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 208452 (pdf 208452.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINERILPIVIRINETENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 206436 (pdf 206436.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 210251 (label 210251.pdf) INN (BICTEGRAVIR SODIUM EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) BIKTARVY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2018 , NDA 209721 (pdf 209721.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210455 (label 210455.pdf) INN (COBICISTAT DARUNAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) SYMTUZA (JANSSEN PRODS) APPROVAL= AP YEAR= 2018 , NDA 212114 (pdf 212114.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2019 , NDA 203442 (pdf 203442.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 212689 (pdf 212689.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 204131 (pdf 204131.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN LTD) APPROVAL= AP YEAR= 2021 , NDA 208740 (pdf 208740.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213541 (pdf 213541.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2021 , NDA 214058 (pdf 214058.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE (CIPLA LIMITED) APPROVAL= TA YEAR= 2022 , NDA 216875 (pdf 216875.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE TENOFOVIR ALAFENAMIDE (AUROBINDO PHARMA) APPROVAL= TA YEAR= 2022 , NDA 211640 (pdf 211640.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 214544 (pdf 214544.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE (LUPIN LTD) APPROVAL= TA YEAR= 2023 , NDA 215448 (pdf 215448.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , NDA 201802 (pdf 201802.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 , NDA 211148 (pdf 211148.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2024 , NDA 213509 (pdf 213509.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR ALAFENAMIDE) EFAVIRENZ , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (MYLAN) APPROVAL= TA YEAR= 2024 , NDA 214053 (pdf 214053.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (APOTEX) APPROVAL= AP YEAR= 2024 , 912 ; MICAFUNGIN ; 235114-32-6 ; 2005 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGALS -- MEMBER OF THE ECHINOCANDIN CLASS OF ANTIFUNGAL AGENTS , ; NDA 021506 (label 21506.pdf) INN (MICAFUNGIN SODIUM) MYCAMINE (ASTELLAS) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 021754 (label 21754.pdf) INN (MICAFUNGIN SODIUM) MYCAMINE (FUJISAWA HLTHCARE) APPROVAL= AP YEAR= 2005 NEWAPPLICATION , NDA 207344 (pdf 207344.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 208366 (pdf 208366.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 212125 (label 212125.pdf) INN (MICAFUNGIN SODIUM) MICAFUNGIN (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213363 (pdf 213363.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2021 , NDA 211713 (pdf 211713.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2021 , NDA 212156 (label 212156.pdf) INN (MICAFUNGIN SODIUM) MICAFUNGIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 213261 (pdf 213261.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (HIKMA) APPROVAL= AP YEAR= 2021 , NDA 215241 (pdf 215241.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215381 (pdf 215381.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 216142 (pdf 216142.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN IN SODIUM CHLORIDE 0.9% (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 , NDA 216438 (pdf 216438.pdf not found) INN (MICAFUNGIN SODIUM) MICAFUNGIN SODIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2024 , 913 ; RANOLAZINE ; 95635-55-5 ; 2006 ; ; ; CLASS CARDIOVASCULAR -- ANTIANGINAL -- TREATMENT OF CHRONIC ANGINA -- INHIBIT THE CARDIAC LATE SODIUM CURRENT -- VOLTAGE-GATED NA(+) CHANNELS (NAV) INHIBITOR -- ALPHA1-ADRENERGIC RECEPTOR ANTAGONIST (PMID26655634) , ; NDA 021526 (label 21526.pdf) INN (RANOLAZINE) RANEXA (MENARINI INTL) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY DISCONTINUED , NDA 201046 (pdf 201046.pdf not found) INN (RANOLAZINE) RANOLAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 208174 (pdf 208174.pdf not found) INN (RANOLAZINE) RANOLAZINE (TEVA PHARMS) APPROVAL= TA YEAR= 2016 , NDA 208862 (pdf 208862.pdf not found) INN (RANOLAZINE) RANOLAZINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2019 , NDA 209081 (pdf 209081.pdf not found) INN (RANOLAZINE) RANOLAZINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210054 (pdf 210054.pdf not found) INN (RANOLAZINE) RANOLAZINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211291 (pdf 211291.pdf not found) INN (RANOLAZINE) RANOLAZINE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211707 (pdf 211707.pdf not found) INN (RANOLAZINE) RANOLAZINE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 211829 (pdf 211829.pdf not found) INN (RANOLAZINE) RANOLAZINE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210188 (pdf 210188.pdf not found) INN (RANOLAZINE) RANOLAZINE (CADILA) APPROVAL= AP YEAR= 2019 , NDA 210482 (pdf 210482.pdf not found) INN (RANOLAZINE) RANOLAZINE (ANI PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211082 (pdf 211082.pdf not found) INN (RANOLAZINE) RANOLAZINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 211745 (pdf 211745.pdf not found) INN (RANOLAZINE) RANOLAZINE (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 211865 (pdf 211865.pdf not found) INN (RANOLAZINE) RANOLAZINE (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 212284 (pdf 212284.pdf not found) INN (RANOLAZINE) RANOLAZINE (MANKIND PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212781 (pdf 212781.pdf not found) INN (RANOLAZINE) RANOLAZINE (PRAXGEN) APPROVAL= AP YEAR= 2020 , NDA 209953 (pdf 209953.pdf not found) INN (RANOLAZINE) RANOLAZINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 207690 (pdf 207690.pdf not found) INN (RANOLAZINE) RANOLAZINE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212889 (pdf 212889.pdf not found) INN (RANOLAZINE) RANOLAZINE (RISING) APPROVAL= AP YEAR= 2021 , NDA 212930 (pdf 212930.pdf not found) INN (RANOLAZINE) RANOLAZINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212788 (pdf 212788.pdf not found) INN (RANOLAZINE) RANOLAZINE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 213517 (pdf 213517.pdf not found) INN (RANOLAZINE) RANOLAZINE (I3 PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214035 (pdf 214035.pdf not found) INN (RANOLAZINE) RANOLAZINE (VKT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216018 (label 216018.pdf) INN (RANOLAZINE) ASPRUZYO SPRINKLE (SPIL) APPROVAL= AP YEAR= 2022 , NDA 213083 (pdf 213083.pdf not found) INN (RANOLAZINE) RANOLAZINE (UNICHEM) APPROVAL= AP YEAR= 2023 , NDA 210668 (pdf 210668.pdf not found) INN (RANOLAZINE) RANOLAZINE (NOVAST LABS) APPROVAL= AP YEAR= 2023 , NDA 213085 (pdf 213085.pdf not found) INN (RANOLAZINE) RANOLAZINE (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2023 DISCONTINUED , 914 ; FOSAMPRENAVIR ; 226700-79-4 ; 2003 ; ; ; CLASS ANTIINFECTIVES -- ENZYME INHIBITOR (HIV PROTEASE) -- ANTIVIRAL -- RAPIDLY AND ALMOST COMPLETELY HYDROLYSED TO AMPRENAVIR , ; NDA 021548 (label 21548.pdf) INN (FOSAMPRENAVIR CALCIUM) LEXIVA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 022116 (label 22116.pdf) INN (FOSAMPRENAVIR CALCIUM) LEXIVA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 204060 (label 204060.pdf) INN (FOSAMPRENAVIR CALCIUM) FOSAMPRENAVIR CALCIUM (MYLAN) APPROVAL= AP YEAR= 2016 , NDA 204130 (pdf 204130.pdf not found) INN (FOSAMPRENAVIR CALCIUM) FOSAMPRENAVIR CALCIUM (LUPIN LTD) APPROVAL= TA YEAR= 2016 , NDA 204024 (pdf 204024.pdf not found) INN (FOSAMPRENAVIR CALCIUM) FOSAMPRENAVIR CALCIUM (SUN PHARM) APPROVAL= AP YEAR= 2019 , 915 ; APREPITANT ; 170729-80-3 ; 2003 ; ; ; CLASS METABOLISM -- ANTIEMETICS -- P/NEUROKININ-1 (NK1) RECEPTOR ANTAGONIST -- APREPITANT HAS LITTLE OR NO AFFINITY FOR SEROTONIN (5-HT3), DOPAMINE, AND CORTICOSTEROID RECEPTORS , ; NDA 021549 (label 21549.pdf) INN (APREPITANT) EMEND (MERCK) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 090999 (pdf 90999.pdf not found) INN (APREPITANT) APREPITANT (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 207865 (label 207865.pdf) INN (APREPITANT) EMEND (MSD MERCK CO) APPROVAL= AP YEAR= 2015 , NDA 207777 (pdf 207777.pdf not found) INN (APREPITANT) APREPITANT (GLENMARK SPECLT) APPROVAL= AP YEAR= 2017 , NDA 209296 (label 209296.pdf) INN (APREPITANT) CINVANTI (HERON THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 211835 (pdf 211835.pdf not found) INN (APREPITANT) APREPITANT (TORRENT) APPROVAL= AP YEAR= 2020 , NDA 216457 (label 216457.pdf) INN (APREPITANT) APONVIE (HERON THERAPS INC) APPROVAL= AP YEAR= 2022 NEWAPPLICATION , 916 ; BISACODYL ; 603-50-9 ; 2004 ; ; ; CLASS METABOLISM -- CATHARTIC -- LAXATIVES , ; NDA 021551 (label 21551.pdf) INN (BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE) HALFLYTELY (BRAINTREE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 090197 (pdf 90197.pdf not found) INN (POLYETHYLENE GLYCOL 3350 SODIUM CHLORIDE SODIUM BICARBONATE POTASSIUM CHLORIDE BISACODYL) POLYETHYLENE GLYCOL 3350 SODIUM CHLORIDE SODIUM BICARBONATE POTASSIUM CHLORIDE BISACODYL (NOVEL LABS INC) APPROVAL= TA YEAR= 2010 , NDA 202217 (pdf 202217.pdf not found) INN (BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE) PEG-3350 , SODIUM CHLORIDE , SODIUM BICARBONATE , POTASSIUM CHLORIDE AND BISACODYL (NOVEL LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , 917 ; EPINASTINE ; 80012-43-7 ; 2003 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTIALLERGIC -- HISTAMINE H1 RECEPTOR ANTAGONISTS , ; NDA 021565 (label 21565.pdf) INN (EPINASTINE HYDROCHLORIDE) ELESTAT (ALLERGAN) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 090919 (pdf 90919.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 090951 (pdf 90951.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2011 , NDA 090870 (pdf 90870.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2011 , NDA 090950 (pdf 90950.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2011 , NDA 091626 (pdf 91626.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203384 (pdf 203384.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204055 (pdf 204055.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 918 ; DAPTOMYCIN ; 103060-53-3 ; 2003 ; ; ; CLASS ANTIINFECTIVES -- ANTI-BACTERIAL AGENTS -- GRAM POSITIVE BACTERIA , ; NDA 021572 (label 21572.pdf) INN (DAPTOMYCIN) CUBICIN (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 203797 (pdf 203797.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HOSPIRA INC) APPROVAL= TA YEAR= 2013 , NDA 202857 (pdf 202857.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HOSPIRA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 091039 (pdf 91039.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206005 (pdf 206005.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2016 , NDA 208385 (label 208385.pdf) INN (DAPTOMYCIN) DAPTOMYCIN (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209949 (label 209949.pdf) INN (DAPTOMYCIN) DAPTOMYCIN (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2017 , NDA 206077 (pdf 206077.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 205037 (pdf 205037.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 208375 (pdf 208375.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 207104 (pdf 207104.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211961 (pdf 211961.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 212022 (pdf 212022.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HENGRUI PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212513 (pdf 212513.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (BE PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212667 (pdf 212667.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 211403 (pdf 211403.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213425 (pdf 213425.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (BE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 210282 (label 210282.pdf) INN (DAPTOMYCIN) DAPTOMYCIN (HOSPIRA) APPROVAL= AP YEAR= 2021 , NDA 212250 (pdf 212250.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2021 , NDA 213623 (pdf 213623.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 213786 (pdf 213786.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 213171 (pdf 213171.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215215 (pdf 215215.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HANGZHOU ZHONGMEI) APPROVAL= AP YEAR= 2021 , NDA 215316 (pdf 215316.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2021 , NDA 213645 (label 213645.pdf) INN (DAPTOMYCIN) DAPZURA RT (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , NDA 215890 (pdf 215890.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (HAINAN POLY PHARM) APPROVAL= AP YEAR= 2022 , NDA 216413 (pdf 216413.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 216445 (pdf 216445.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 217415 (label 217415.pdf) INN (DAPTOMYCIN) DAPTOMYCIN (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2023 , NDA 213966 (pdf 213966.pdf not found) INN (DAPTOMYCIN) DAPTOMYCIN (MYLAN) APPROVAL= AP YEAR= 2023 , 919 ; TROSPIUM ; 47608-32-2 ; 2004 ; ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANALGESICS -- PARASYMPATHOLYTICS , ; NDA 021595 (label 21595.pdf) INN (TROSPIUM CHLORIDE) SANCTURA (ALLERGAN) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 022103 (label 22103.pdf) INN (TROSPIUM CHLORIDE) SANCTURA XR (ALLERGAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 091573 (pdf 91573.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2010 , NDA 091575 (pdf 91575.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 091513 (pdf 91513.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 091289 (pdf 91289.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2012 , NDA 201291 (pdf 201291.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2013 , NDA 091635 (pdf 91635.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091688 (pdf 91688.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204945 (pdf 204945.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 213185 (pdf 213185.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 214760 (pdf 214760.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (AMTA) APPROVAL= AP YEAR= 2021 , NDA 215781 (pdf 215781.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (ZAMEER PHARMS) APPROVAL= AP YEAR= 2022 , NDA 206472 (pdf 206472.pdf not found) INN (TROSPIUM CHLORIDE) TROSPIUM CHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , 920 ; BORTEZOMIB ; 179324-69-7 ; 2003 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- PROTEASE INHIBITORS COVALENT BUT REVERSIBLE INHIBITOR , ; NDA 021602 (label 21602.pdf) INN (BORTEZOMIB) VELCADE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 205004 (label 205004.pdf) INN (BORTEZOMIB) BORTEZOMIB (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208645 (pdf 208645.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (ACTAVIS LLC) APPROVAL= TA YEAR= 2016 , NDA 204405 (pdf 204405.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 205533 (pdf 205533.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 208392 (pdf 208392.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (PHARMASCIENCE INC) APPROVAL= AP YEAR= 2022 , NDA 209191 (label 209191.pdf) INN (BORTEZOMIB) BORTEZOMIB (HOSPIRA) APPROVAL= AP YEAR= 2022 , NDA 210824 (pdf 210824.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2022 , NDA 206927 (label 206927.pdf) INN (BORTEZOMIB) BORTEZOMIB (DR REDDYS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 203654 (pdf 203654.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 211898 (pdf 211898.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (RELIANCE LIFE SCI) APPROVAL= AP YEAR= 2022 , NDA 215011 (pdf 215011.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2022 , NDA 205857 (pdf 205857.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 209659 (pdf 209659.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2022 , NDA 210204 (pdf 210204.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 212825 (pdf 212825.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213823 (pdf 213823.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , NDA 202963 (pdf 202963.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 205160 (pdf 205160.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (MYLAN LABS LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 208460 (pdf 208460.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (HOSPIRA) APPROVAL= AP YEAR= 2022 , NDA 209622 (pdf 209622.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (MSN) APPROVAL= AP YEAR= 2022 , NDA 212958 (pdf 212958.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215331 (label 215331.pdf) INN (BORTEZOMIB) BORTEZOMIB (MAIA PHARMS INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215441 (label 215441.pdf) INN (BORTEZOMIB) BORTEZOMIB (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216912 (pdf 216912.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (SCINOPHARM TAIWAN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 212204 (pdf 212204.pdf not found) INN (BORTEZOMIB) BORTEZOMIB (HETERO LABS LTD VI) APPROVAL= AP YEAR= 2024 , 921 ; TINIDAZOLE ; 19387-91-8 ; 2004 ; ; ; CLASS ANTIINFECTIVES -- ANTIPROTOZOAL -- ALKYLATING AGENTS -- ANTITRICHOMONAL AGENTS -- FREE NITRO- RADICAL GENERATED AS A RESULT OF THE REDUCTION MAY BE RESPONSIBLE FOR THE ACTIVITY -- ANTIMALARIALS -- CHEMICALLY REDUCED TINIDAZOLE WAS SHOWN TO RELEASE NITRITES AND CAUSE DAMAGE TO PURIFIED BACTERIAL DNA IN VITRO , ; NDA 021618 (label 21618.pdf) INN (TINIDAZOLE) TINDAMAX (MISSION PHARMA) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 021681 (pdf 21681.pdf not found) INN (TINIDAZOLE) TINDAMAX (MISSION PHARMA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021682 (pdf 21682.pdf not found) INN (TINIDAZOLE) TINDAMAX (MISSION PHARMA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 201172 (pdf 201172.pdf not found) INN (TINIDAZOLE) TINIDAZOLE (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202044 (pdf 202044.pdf not found) INN (TINIDAZOLE) TINIDAZOLE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 202489 (label 202489.pdf) INN (TINIDAZOLE) TINIDAZOLE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2013 , NDA 203808 (pdf 203808.pdf not found) INN (TINIDAZOLE) TINIDAZOLE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2015 , 922 ; ANIDULAFUNGIN ; 166663-25-8 ; 2006 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- ANTIBIOTICS , ; NDA 021632 (label 21632.pdf) INN (ANIDULAFUNGIN) ERAXIS (VICURON HOLDINGS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 021948 (label 21948.pdf) INN (ANIDULAFUNGIN) ERAXIS (PFIZER) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , 923 ; CICLESONIDE ; 126544-47-6 ; 2006 ; ; ; CLASS RESPIRATORY -- ANTIINFLAMMATORY -- ANTI-ALLERGIC AGENTS -- GLUCOCORTICOIDS , ; NDA 021658 (label 21658.pdf) INN (CICLESONIDE) ALVESCO (COVIS) APPROVAL= AP YEAR= 2008 , NDA 022004 (label 22004.pdf) INN (CICLESONIDE) OMNARIS (COVIS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022124 (label 22124.pdf) INN (CICLESONIDE) OMNARIS (NYCOMED US INC) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 202129 (label 202129.pdf) INN (CICLESONIDE) ZETONNA (COVIS) APPROVAL= AP YEAR= 2012 , 924 ; BROMFENAC ; 91714-94-2 ; 2005 ; ; ; CLASS SENSORY -- ANALGESIC -- ANTI-INFLAMMATORY AGENTS NON-STEROIDAL , ; NDA 021664 (label 21664.pdf) INN (BROMFENAC SODIUM) XIBROM (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 201211 (pdf 201211.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (COASTAL PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202030 (pdf 202030.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (AMRING PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203168 (label 203168.pdf) INN (BROMFENAC SODIUM) PROLENSA (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2013 , NDA 202435 (pdf 202435.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202620 (label 202620.pdf) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203395 (pdf 203395.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (SENTISS) APPROVAL= AP YEAR= 2014 , NDA 201941 (pdf 201941.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206911 (label 206911.pdf) INN (BROMFENAC SODIUM) BROMSITE (SUN PHARM) APPROVAL= AP YEAR= 2016 , NDA 203368 (pdf 203368.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210560 (pdf 210560.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 211029 (pdf 211029.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 204813 (pdf 204813.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 202903 (pdf 202903.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 206027 (pdf 206027.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 211239 (pdf 211239.pdf not found) INN (BROMFENAC SODIUM) BROMFENAC SODIUM (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 925 ; CLOFARABINE ; 123318-82-1 ; 2004 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- PURINE ANALOGUES -- INHIBITS DNA SYNTHESIS , ; NDA 021673 (label 21673.pdf) INN (CLOFARABINE) CLOLAR (GENZYME) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 208167 (pdf 208167.pdf not found) INN (CLOFARABINE) CLOFARABINE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2016 , NDA 204029 (label 204029.pdf) INN (CLOFARABINE) CLOFARABINE (ABON PHARMS LLC) APPROVAL= AP YEAR= 2017 , NDA 205375 (pdf 205375.pdf not found) INN (CLOFARABINE) CLOFARABINE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 208857 (pdf 208857.pdf not found) INN (CLOFARABINE) CLOFARABINE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 208860 (pdf 208860.pdf not found) INN (CLOFARABINE) CLOFARABINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 209775 (pdf 209775.pdf not found) INN (CLOFARABINE) CLOFARABINE (MSN) APPROVAL= AP YEAR= 2017 , NDA 207831 (pdf 207831.pdf not found) INN (CLOFARABINE) CLOFARABINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210270 (pdf 210270.pdf not found) INN (CLOFARABINE) CLOFARABINE (NOVAST LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210283 (pdf 210283.pdf not found) INN (CLOFARABINE) CLOFARABINE (HOSPIRA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 212034 (pdf 212034.pdf not found) INN (CLOFARABINE) CLOFARABINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 213461 (pdf 213461.pdf not found) INN (CLOFARABINE) CLOFARABINE (MEITHEAL) APPROVAL= AP YEAR= 2020 , NDA 212457 (pdf 212457.pdf not found) INN (CLOFARABINE) CLOFARABINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , 926 ; CINACALCET ; 226256-56-0 ; 2004 ; ; ; CLASS HORMONES -- CALCIMIMETICS -- TREATMENT OF PARATHYROID CARCINOMA OR PRIMARY HYPERPARATHYROIDISM -- BIAISING ALLOSTERIC MODULATOR (PREFERENTIAL EFFECT ON MEMBRANE RUFFLING VERSUS CALCIUM OR MAPK) , ; NDA 021688 (label 21688.pdf) INN (CINACALCET HYDROCHLORIDE) SENSIPAR (AMGEN) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 090539 (pdf 90539.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (TEVA PHARMS) APPROVAL= TA YEAR= 2017 , NDA 090476 (pdf 90476.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (BARR) APPROVAL= TA YEAR= 2010 , NDA 203422 (pdf 203422.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206125 (pdf 206125.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 208915 (pdf 208915.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 208971 (pdf 208971.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2018 , NDA 209226 (pdf 209226.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210570 (pdf 210570.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 204377 (pdf 204377.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2018 , NDA 207008 (pdf 207008.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 210207 (pdf 210207.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210548 (pdf 210548.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211892 (pdf 211892.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 213325 (pdf 213325.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 208368 (pdf 208368.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 209403 (pdf 209403.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2020 , NDA 204364 (pdf 204364.pdf not found) INN (CINACALCET HYDROCHLORIDE) CINACALCET HYDROCHLORIDE (STEVENS J) APPROVAL= AP YEAR= 2021 DISCONTINUED , 927 ; CONIVAPTAN ; 210101-16-9 ; 2005 ; ; ; CLASS CARDIOVASCULAR -- AQUARESIS PROMOTERS -- DIURETICS -- VASOPRESSIN RECEPTOR ANTAGONIST , ; NDA 021697 (label 21697.pdf) INN (CONIVAPTAN HYDROCHLORIDE) VAPRISOL (CUMBERLAND) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 022016 (label 22016.pdf) INN (CONIVAPTAN HYDROCHLORIDE) VAPRISOL (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , 928 ; LACTIC ACID ; 50-21-5 ; 2006 ; ; NATURAL MOLECULE C00019549 ; CLASS GENITO -- ANTIINFECTIVES -- ANTISEPTICS -- PHARMACOLOGICALLY INACTIVE SOLUTION , ; NDA 021703 (label 21703.pdf) INN (CALCIUM CHLORIDE DEXTROSE LACTIC ACID MAGNESIUM CHLORIDE POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE) PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2006 , NDA 208352 (label 208352.pdf) INN (CITRIC ACID LACTIC ACID POTASSIUM BITARTRATE) PHEXXI (EVOFEM INC) APPROVAL= AP YEAR= 2020 , 929 ; NEBIVOLOL ; 118457-14-0 ; 2007 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC BETA-ANTAGONISTS -- VASODILATOR AGENTS -- BETA BLOCKING AGENTS , ; NDA 021742 (label 21742.pdf) INN (NEBIVOLOL HYDROCHLORIDE) BYSTOLIC (ALLERGAN) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203828 (pdf 203828.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (INDCHEMIE HEALTH) APPROVAL= AP YEAR= 2015 , NDA 203659 (pdf 203659.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203741 (pdf 203741.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203683 (pdf 203683.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206302 (label 206302.pdf) INN (NEBIVOLOL HYDROCHLORIDE VALSARTAN) BYVALSON (ABBVIE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203821 (pdf 203821.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203966 (pdf 203966.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 206729 (pdf 206729.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (MICRO LABS LTD) APPROVAL= TA YEAR= 2020 , NDA 203825 (pdf 203825.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 208717 (pdf 208717.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 211053 (pdf 211053.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 212917 (pdf 212917.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (REYOUNG) APPROVAL= AP YEAR= 2021 , NDA 212682 (pdf 212682.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 213349 (pdf 213349.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213830 (pdf 213830.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210596 (pdf 210596.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE VALSARTAN) VYDUO (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 216172 (pdf 216172.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216568 (pdf 216568.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2023 , NDA 209741 (pdf 209741.pdf not found) INN (NEBIVOLOL HYDROCHLORIDE) NEBIVOLOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , 930 ; ERLOTINIB ; 183321-74-6 ; 2004 ; ; ; CLASS ANTINEOPLASTIC -- SIGNAL TRANSDUCTION INHIBITOR -- GROWTH HORMONE RECEPTOR INHIBITOR -- ANTICANCER -- PROTEIN KINASE INHIBITORS -- TREATMENT OF NON-SMALL CELL LUNG CANCER , ; NDA 021743 (label 21743.pdf) INN (ERLOTINIB HYDROCHLORIDE) TARCEVA (OSI PHARMS) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 091002 (pdf 91002.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 , NDA 091059 (pdf 91059.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2015 , NDA 208488 (pdf 208488.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 208396 (pdf 208396.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 210300 (pdf 210300.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 211960 (pdf 211960.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 211083 (pdf 211083.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213065 (pdf 213065.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214366 (pdf 214366.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2021 , NDA 214719 (pdf 214719.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 216342 (pdf 216342.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 209267 (pdf 209267.pdf not found) INN (ERLOTINIB HYDROCHLORIDE) ERLOTINIB HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 931 ; ALVIMOPAN ; 156053-89-3 ; 2008 ; ; ; CLASS METABOLISM -- MU-TYPE OPIOID ANTAGONIST (KI=0.4 NANOMOLAR) -- GASTROINTESTINAL -- ANTAGONIZES THE PERIPHERAL EFFECTS OF OPIOIDS -- , ; NDA 021775 (label 21775.pdf) INN (ALVIMOPAN) ENTEREG (CUBIST PHARMS) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY DISCONTINUED , NDA 208295 (pdf 208295.pdf not found) INN (ALVIMOPAN) ALVIMOPAN (WATSON LABS TEVA) APPROVAL= AP YEAR= 2019 , NDA 216843 (pdf 216843.pdf not found) INN (ALVIMOPAN) ALVIMOPAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , NDA 217753 (pdf 217753.pdf not found) INN (ALVIMOPAN) ALVIMOPAN (HIKMA) APPROVAL= AP YEAR= 2023 , 932 ; ILOPROST ; 78919-13-8 ; 2004 ; ; ; CLASS BLOOD -- ANTIHYPERTENSIVE -- ANALOG OF PROSTACYLIN INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) , ; NDA 021779 (label 21779.pdf) INN (ILOPROST) VENTAVIS (ACTELION) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 217933 (pdf 217933.pdf not found) INN (ILOPROST) AURLUMYN (EICOS SCI) APPROVAL= AP YEAR= 2024 , 933 ; RAMELTEON ; 196597-26-9 ; 2005 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES -- TREATMENT OF INSOMNIA -- AGONIST , ; NDA 021782 (label 21782.pdf) INN (RAMELTEON) ROZEREM (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 091693 (pdf 91693.pdf not found) INN (RAMELTEON) RAMELTEON (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2013 , NDA 091610 (pdf 91610.pdf not found) INN (RAMELTEON) RAMELTEON (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 , NDA 211567 (pdf 211567.pdf not found) INN (RAMELTEON) RAMELTEON (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212650 (pdf 212650.pdf not found) INN (RAMELTEON) RAMELTEON (I3 PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213186 (pdf 213186.pdf not found) INN (RAMELTEON) RAMELTEON (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 213815 (pdf 213815.pdf not found) INN (RAMELTEON) RAMELTEON (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2020 , NDA 215435 (pdf 215435.pdf not found) INN (RAMELTEON) RAMELTEON (INNOGENIX) APPROVAL= AP YEAR= 2022 , NDA 216209 (pdf 216209.pdf not found) INN (RAMELTEON) RAMELTEON (XIROMED) APPROVAL= AP YEAR= 2022 , NDA 215243 (pdf 215243.pdf not found) INN (RAMELTEON) RAMELTEON (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 215972 (pdf 215972.pdf not found) INN (RAMELTEON) RAMELTEON (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 934 ; DECITABINE ; 2353-33-5 ; 2006 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- TERATOGENS -- TREATMENT OF MYELODYSPLASTIC SYNDROMES (MDS) -- INDUCE HYPOMETHYLATION OF DNA , ; NDA 021790 (label 21790.pdf) INN (DECITABINE) DACOGEN (OTSUKA) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY DISCONTINUED , NDA 203131 (pdf 203131.pdf not found) INN (DECITABINE) DECITABINE (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 202969 (pdf 202969.pdf not found) INN (DECITABINE) DECITABINE (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 205582 (label 205582.pdf) INN (DECITABINE) DECITABINE (SUN PHARM) APPROVAL= AP YEAR= 2014 , NDA 203475 (pdf 203475.pdf not found) INN (DECITABINE) DECITABINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 204607 (pdf 204607.pdf not found) INN (DECITABINE) DECITABINE (PHARMASCIENCE INC) APPROVAL= AP YEAR= 2017 , NDA 206033 (pdf 206033.pdf not found) INN (DECITABINE) DECITABINE (CHEMI SPA) APPROVAL= AP YEAR= 2017 , NDA 208601 (pdf 208601.pdf not found) INN (DECITABINE) DECITABINE (CIPLA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207100 (pdf 207100.pdf not found) INN (DECITABINE) DECITABINE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 210756 (pdf 210756.pdf not found) INN (DECITABINE) DECITABINE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 209056 (pdf 209056.pdf not found) INN (DECITABINE) DECITABINE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2019 , NDA 210984 (pdf 210984.pdf not found) INN (DECITABINE) DECITABINE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 212265 (pdf 212265.pdf not found) INN (DECITABINE) DECITABINE (MSN) APPROVAL= AP YEAR= 2019 , NDA 212576 (label 212576.pdf) INN (CEDAZURIDINE DECITABINE) INQOVI (OTSUKA) APPROVAL= AP YEAR= 2020 , NDA 205539 (pdf 205539.pdf not found) INN (DECITABINE) DECITABINE (GLAND) APPROVAL= AP YEAR= 2020 , NDA 212117 (pdf 212117.pdf not found) INN (DECITABINE) DECITABINE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212826 (pdf 212826.pdf not found) INN (DECITABINE) DECITABINE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2021 , NDA 212959 (pdf 212959.pdf not found) INN (DECITABINE) DECITABINE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 214486 (pdf 214486.pdf not found) INN (DECITABINE) DECITABINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214569 (pdf 214569.pdf not found) INN (DECITABINE) DECITABINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213472 (pdf 213472.pdf not found) INN (DECITABINE) DECITABINE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2022 , NDA 215355 (pdf 215355.pdf not found) INN (DECITABINE) DECITABINE (HETERO LABS LTD VI) APPROVAL= AP YEAR= 2024 , 935 ; DAPSONE ; 80-08-0 ; 1979 ; ; ; CLASS ANTIINFECTIVES -- ANTIMALARIALS -- ANTIMYCOBACTERIALS -- FOLIC ACID ANTAGONISTS -- LEPROSTATIC AGENTS -- ANTI-ACNE -- ANTI-FOLATE , ; NDA 021794 (label 21794.pdf) INN (DAPSONE) ACZONE (ABBVIE) APPROVAL= AP YEAR= 2005 , NDA 086841 (pdf 86841.pdf not found) INN (DAPSONE) DAPSONE (EVEREST LIFE SCI) APPROVAL= AP YEAR= 1979 , NDA 086842 (pdf 86842.pdf not found) INN (DAPSONE) DAPSONE (EVEREST LIFE SCI) APPROVAL= AP YEAR= 1979 , NDA 203887 (pdf 203887.pdf not found) INN (DAPSONE) DAPSONE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 , NDA 204074 (pdf 204074.pdf not found) INN (DAPSONE) DAPSONE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205429 (pdf 205429.pdf not found) INN (DAPSONE) DAPSONE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207154 (label 207154.pdf) INN (DAPSONE) ACZONE (ALMIRALL) APPROVAL= AP YEAR= 2016 , NDA 206505 (pdf 206505.pdf not found) INN (DAPSONE) DAPSONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204380 (pdf 204380.pdf not found) INN (DAPSONE) DAPSONE (ACTAVIS LLC) APPROVAL= AP YEAR= 2017 , NDA 209506 (label 209506.pdf) INN (DAPSONE) DAPSONE (TARO) APPROVAL= AP YEAR= 2017 , NDA 210191 (pdf 210191.pdf not found) INN (DAPSONE) DAPSONE (TARO) APPROVAL= AP YEAR= 2019 , NDA 207165 (pdf 207165.pdf not found) INN (DAPSONE) DAPSONE (RISING) APPROVAL= AP YEAR= 2019 , NDA 209430 (pdf 209430.pdf not found) INN (DAPSONE) DAPSONE (TARO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 214722 (pdf 214722.pdf not found) INN (DAPSONE) DAPSONE (TORRENT) APPROVAL= AP YEAR= 2022 , NDA 210178 (pdf 210178.pdf not found) INN (DAPSONE) DAPSONE (COSETTE) APPROVAL= AP YEAR= 2022 , NDA 213847 (pdf 213847.pdf not found) INN (DAPSONE) DAPSONE (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 212701 (pdf 212701.pdf not found) INN (DAPSONE) DAPSONE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 213907 (pdf 213907.pdf not found) INN (DAPSONE) DAPSONE (BELOTECA) APPROVAL= AP YEAR= 2023 , NDA 209890 (pdf 209890.pdf not found) INN (DAPSONE) DAPSONE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 212383 (pdf 212383.pdf not found) INN (DAPSONE) DAPSONE (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 212657 (pdf 212657.pdf not found) INN (DAPSONE) DAPSONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215087 (pdf 215087.pdf not found) INN (DAPSONE) DAPSONE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215718 (pdf 215718.pdf not found) INN (DAPSONE) DAPSONE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 214019 (pdf 214019.pdf not found) INN (DAPSONE) DAPSONE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 936 ; ENTECAVIR ; 142217-69-4 ; 2005 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI HEPATITIS B -- GUANOSINE NUCLEOSIDE ANALOG , ; NDA 021797 (label 21797.pdf) INN (ENTECAVIR) BARACLUDE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 021798 (label 21798.pdf) INN (ENTECAVIR) BARACLUDE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2005 , NDA 202122 (pdf 202122.pdf not found) INN (ENTECAVIR) ENTECAVIR (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205740 (pdf 205740.pdf not found) INN (ENTECAVIR) ENTECAVIR (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 206217 (pdf 206217.pdf not found) INN (ENTECAVIR) ENTECAVIR (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015 , NDA 206652 (pdf 206652.pdf not found) INN (ENTECAVIR) ENTECAVIR (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206294 (pdf 206294.pdf not found) INN (ENTECAVIR) ENTECAVIR (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206872 (pdf 206872.pdf not found) INN (ENTECAVIR) ENTECAVIR (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 206672 (pdf 206672.pdf not found) INN (ENTECAVIR) ENTECAVIR (CHARTWELL RX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206745 (pdf 206745.pdf not found) INN (ENTECAVIR) ENTECAVIR (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205824 (pdf 205824.pdf not found) INN (ENTECAVIR) ENTECAVIR (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208782 (pdf 208782.pdf not found) INN (ENTECAVIR) ENTECAVIR (PRINSTON INC) APPROVAL= AP YEAR= 2017 , NDA 208721 (pdf 208721.pdf not found) INN (ENTECAVIR) ENTECAVIR (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 , NDA 206226 (pdf 206226.pdf not found) INN (ENTECAVIR) ENTECAVIR (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212126 (pdf 212126.pdf not found) INN (ENTECAVIR) ENTECAVIR (BRIGHTGENE) APPROVAL= AP YEAR= 2019 , NDA 212201 (pdf 212201.pdf not found) INN (ENTECAVIR) ENTECAVIR (YAOPHARMA CO LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211978 (pdf 211978.pdf not found) INN (ENTECAVIR) ENTECAVIR (SUNSHINE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212106 (pdf 212106.pdf not found) INN (ENTECAVIR) ENTECAVIR (VITRUVIAS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208195 (pdf 208195.pdf not found) INN (ENTECAVIR) ENTECAVIR (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2021 , 937 ; QUININE ; 130-95-0 ; 2005 ; ; NATURAL MOLECULE C00002193 ; CLASS ANTIPARASITIC -- ALKALOID -- ANTIMALARIAL , ; NDA 021799 (label 21799.pdf) INN (QUININE SULFATE) QUALAQUIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 , NDA 091661 (pdf 91661.pdf not found) INN (QUININE SULFATE) QUININE SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202581 (pdf 202581.pdf not found) INN (QUININE SULFATE) QUININE SULFATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203112 (pdf 203112.pdf not found) INN (QUININE SULFATE) QUININE SULFATE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 203729 (pdf 203729.pdf not found) INN (QUININE SULFATE) QUININE SULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204372 (pdf 204372.pdf not found) INN (QUININE SULFATE) QUININE SULFATE (NOVAST LABS) APPROVAL= AP YEAR= 2015 , 938 ; TIPRANAVIR ; 174484-41-4 ; 2005 ; ; ; CLASS ANTIINFECTIVES -- HIV PROTEASE INHIBITOR -- ANTIVIRAL , ; NDA 021814 (label 21814.pdf) INN (TIPRANAVIR) APTIVUS (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 021822 (label 21822.pdf) INN (TIPRANAVIR) APTIVUS (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 022292 (label 22292.pdf) INN (TIPRANAVIR) APTIVUS (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2008 DISCONTINUED , 939 ; TIGECYCLINE ; 220620-09-7 ; 2005 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL-- TETRACYCLINE -- , ; NDA 021821 (label 21821.pdf) INN (TIGECYCLINE) TYGACIL (PF PRISM CV) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 091620 (pdf 91620.pdf not found) INN (TIGECYCLINE) TIGECYCLINE (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 205645 (label 205645.pdf) INN (TIGECYCLINE) TIGECYCLINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2016 , NDA 208744 (label 208744.pdf) INN (TIGECYCLINE) TIGECYCLINE (ACCORD HLTHCARE INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 204439 (pdf 204439.pdf not found) INN (TIGECYCLINE) TIGECYCLINE (APOTEX) APPROVAL= AP YEAR= 2018 , NDA 211158 (label 211158.pdf) INN (TIGECYCLINE) TIGECYCLINE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 205722 (pdf 205722.pdf not found) INN (TIGECYCLINE) TIGECYCLINE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206335 (pdf 206335.pdf not found) INN (TIGECYCLINE) TIGECYCLINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 214020 (pdf 214020.pdf not found) INN (TIGECYCLINE) TIGECYCLINE (MEITHEAL) APPROVAL= AP YEAR= 2021 , 940 ; NELARABINE ; 121032-29-9 ; 2005 ; ; ; CLASS ANTINEOPLASTIC -- PRODRUG -- TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL LYMPHOBLASTIC LYMPHOMA , ; NDA 021877 (label 21877.pdf) INN (NELARABINE) ARRANON (SANDOZ) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 215037 (pdf 215037.pdf not found) INN (NELARABINE) NELARABINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 216934 (pdf 216934.pdf not found) INN (NELARABINE) NELARABINE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 214809 (pdf 214809.pdf not found) INN (NELARABINE) NELARABINE (SHORLA) APPROVAL= AP YEAR= 2023 , NDA 215057 (pdf 215057.pdf not found) INN (NELARABINE) NELARABINE (NEXUS) APPROVAL= AP YEAR= 2023 , NDA 216038 (pdf 216038.pdf not found) INN (NELARABINE) NELARABINE (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 216346 (pdf 216346.pdf not found) INN (NELARABINE) NELARABINE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 212605 (pdf 212605.pdf not found) INN (NELARABINE) NELARABINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 941 ; LENALIDOMIDE ; 191732-72-6 ; 2005 ; ; ; CLASS ANTINEOPLASTIC -- THALIDOMIDE ANALOG -- POSSESSES IMMUNOMODULATORY, ANTIANGIOGENIC, AND ANTINEOPLASTIC PROPERTIES -- TARGET NOT KNOWN -- TREATMENT OF MULTIPLE MYELOMA (MM) , ; NDA 021880 (label 21880.pdf) INN (LENALIDOMIDE) REVLIMID (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 210480 (pdf 210480.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2022 , NDA 201452 (pdf 201452.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (ARROW INTL) APPROVAL= AP YEAR= 2021 , NDA 209348 (pdf 209348.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 210154 (pdf 210154.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 213885 (pdf 213885.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 210435 (pdf 210435.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 211022 (pdf 211022.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 213912 (pdf 213912.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 211846 (pdf 211846.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 212414 (pdf 212414.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 213405 (pdf 213405.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214618 (pdf 214618.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (CIPLA) APPROVAL= AP YEAR= 2023 , NDA 217265 (pdf 217265.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (QILU) APPROVAL= AP YEAR= 2024 , 942 ; DEFERASIROX ; 201530-41-8 ; 2005 ; ; ; CLASS IRON CHELATING AGENTS -- BETA THALASSAEMIA (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 021882 (label 21882.pdf) INN (DEFERASIROX) EXJADE (NOVARTIS) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 203560 (label 203560.pdf) INN (DEFERASIROX) DEFERASIROX (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 206910 (label 206910.pdf) INN (DEFERASIROX) JADENU (NOVARTIS PHARMS CORP) APPROVAL= AP YEAR= 2015 , NDA 207968 (label 207968.pdf) INN (DEFERASIROX) JADENU SPRINKLE (NOVARTIS) APPROVAL= AP YEAR= 2017 , NDA 208697 (pdf 208697.pdf not found) INN (DEFERASIROX) DEFERASIROX (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2019 , NDA 209426 (pdf 209426.pdf not found) INN (DEFERASIROX) DEFERASIROX (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2017 , NDA 211383 (pdf 211383.pdf not found) INN (DEFERASIROX) DEFERASIROX (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209223 (pdf 209223.pdf not found) INN (DEFERASIROX) DEFERASIROX (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209782 (pdf 209782.pdf not found) INN (DEFERASIROX) DEFERASIROX (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 209878 (pdf 209878.pdf not found) INN (DEFERASIROX) DEFERASIROX (MSN) APPROVAL= AP YEAR= 2019 , NDA 210060 (pdf 210060.pdf not found) INN (DEFERASIROX) DEFERASIROX (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 210519 (pdf 210519.pdf not found) INN (DEFERASIROX) DEFERASIROX (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210727 (pdf 210727.pdf not found) INN (DEFERASIROX) DEFERASIROX (STEVENS J) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210920 (pdf 210920.pdf not found) INN (DEFERASIROX) DEFERASIROX (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 210945 (pdf 210945.pdf not found) INN (DEFERASIROX) DEFERASIROX (MSN) APPROVAL= AP YEAR= 2019 , NDA 211824 (pdf 211824.pdf not found) INN (DEFERASIROX) DEFERASIROX (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 212995 (pdf 212995.pdf not found) INN (DEFERASIROX) DEFERASIROX (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2019 , NDA 208882 (pdf 208882.pdf not found) INN (DEFERASIROX) DEFERASIROX (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209433 (pdf 209433.pdf not found) INN (DEFERASIROX) DEFERASIROX (GLENMARK SPECLT) APPROVAL= AP YEAR= 2020 , NDA 210555 (pdf 210555.pdf not found) INN (DEFERASIROX) DEFERASIROX (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 211641 (pdf 211641.pdf not found) INN (DEFERASIROX) DEFERASIROX (SUN PHARM) APPROVAL= AP YEAR= 2020 , NDA 211852 (pdf 211852.pdf not found) INN (DEFERASIROX) DEFERASIROX (CIPLA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213374 (pdf 213374.pdf not found) INN (DEFERASIROX) DEFERASIROX (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212669 (pdf 212669.pdf not found) INN (DEFERASIROX) DEFERASIROX (CHARTWELL RX) APPROVAL= AP YEAR= 2021 , NDA 214194 (pdf 214194.pdf not found) INN (DEFERASIROX) DEFERASIROX (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214341 (pdf 214341.pdf not found) INN (DEFERASIROX) DEFERASIROX (ANNORA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214559 (pdf 214559.pdf not found) INN (DEFERASIROX) DEFERASIROX (AUCTA) APPROVAL= AP YEAR= 2021 , NDA 214650 (pdf 214650.pdf not found) INN (DEFERASIROX) DEFERASIROX (MSN) APPROVAL= AP YEAR= 2021 , NDA 214180 (pdf 214180.pdf not found) INN (DEFERASIROX) DEFERASIROX (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215026 (pdf 215026.pdf not found) INN (DEFERASIROX) DEFERASIROX (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 207124 (pdf 207124.pdf not found) INN (DEFERASIROX) DEFERASIROX (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216229 (pdf 216229.pdf not found) INN (DEFERASIROX) DEFERASIROX (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214474 (pdf 214474.pdf not found) INN (DEFERASIROX) DEFERASIROX (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 206585 (pdf 206585.pdf not found) INN (DEFERASIROX) DEFERASIROX (MYLAN) APPROVAL= AP YEAR= 2024 , NDA 211395 (pdf 211395.pdf not found) INN (DEFERASIROX) DEFERASIROX (MYLAN) APPROVAL= AP YEAR= 2024 , NDA 213146 (pdf 213146.pdf not found) INN (DEFERASIROX) DEFERASIROX (MYLAN) APPROVAL= AP YEAR= 2024 , 943 ; TETRABENAZINE ; 58-46-8 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- CNS -- TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON DISEASE -- INHIBITOR -- IS BELIEVED TO BE RELATED TO ITS EFFECT AS A REVERSIBLE DEPLETOR OF MONOAMINES (SUCH AS DOPAMINE, SEROTONIN, NOREPINEPHRINE, AND HISTAMINE) FROM NERVE TERMINALS -- VESICULAR MONOAMINE TRANSPORTER TYPE 2 (VMAT2) (KI=100 NANOMOLAR) , ; NDA 021894 (label 21894.pdf) INN (TETRABENAZINE) XENAZINE (BAUSCH) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 206129 (label 206129.pdf) INN (TETRABENAZINE) TETRABENAZINE (SUN PHARM) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204574 (pdf 204574.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2016 , NDA 206686 (pdf 206686.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 207682 (pdf 207682.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 208826 (pdf 208826.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (BIONPHARMA) APPROVAL= AP YEAR= 2017 , NDA 209284 (pdf 209284.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 210544 (pdf 210544.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 209739 (pdf 209739.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (HIKMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206093 (pdf 206093.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 213316 (pdf 213316.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213621 (pdf 213621.pdf not found) INN (TETRABENAZINE) TETRABENAZINE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , 944 ; LUBIPROSTONE ; 333963-40-9 ; 2006 ; ; ; CLASS METABOLISM -- ANTI-CONSTIPATION AGENTS -- LAXATIVES , ; NDA 021908 (label 21908.pdf) INN (LUBIPROSTONE) AMITIZA (SUCAMPO PHARMA LLC) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 209450 (pdf 209450.pdf not found) INN (LUBIPROSTONE) LUBIPROSTONE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 201442 (pdf 201442.pdf not found) INN (LUBIPROSTONE) LUBIPROSTONE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 206994 (pdf 206994.pdf not found) INN (LUBIPROSTONE) LUBIPROSTONE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 209920 (pdf 209920.pdf not found) INN (LUBIPROSTONE) LUBIPROSTONE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2022 , NDA 214131 (pdf 214131.pdf not found) INN (LUBIPROSTONE) LUBIPROSTONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , 945 ; ARFORMOTEROL ; 67346-49-0 ; 2006 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR AGENTS -- ADRENERGIC BETA AGONIST -- TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) , ; NDA 021912 (label 21912.pdf) INN (ARFORMOTEROL TARTRATE) BROVANA (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 200293 (pdf 200293.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 207306 (pdf 207306.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (CIPLA) APPROVAL= AP YEAR= 2021 , NDA 213132 (pdf 213132.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213762 (pdf 213762.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213068 (pdf 213068.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (LUPIN) APPROVAL= AP YEAR= 2022 , NDA 214736 (pdf 214736.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (RITEDOSE CORP) APPROVAL= AP YEAR= 2022 , NDA 214779 (pdf 214779.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 215385 (pdf 215385.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (SUN PHARM) APPROVAL= AP YEAR= 2022 , NDA 216128 (pdf 216128.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216815 (pdf 216815.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 214901 (pdf 214901.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (PHARMAMAX) APPROVAL= AP YEAR= 2024 , NDA 215032 (pdf 215032.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 216303 (pdf 216303.pdf not found) INN (ARFORMOTEROL TARTRATE) ARFORMOTEROL TARTRATE (CF PHARMTECH) APPROVAL= AP YEAR= 2024 , 946 ; VARENICLINE ; 249296-44-4 ; 2006 ; ; ; CLASS NERVOUS SYSTEM -- NICOTINIC AGONISTS -- USE AS AN AID TO SMOKING CESSATION TREATMENT , ; NDA 021928 (label 21928.pdf) INN (VARENICLINE TARTRATE) CHANTIX (PF PRISM CV) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY DISCONTINUED , NDA 201962 (pdf 201962.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 201920 (pdf 201920.pdf not found) INN (VARENICLINE) VARENICLINE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2013 , NDA 202019 (pdf 202019.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (MYLAN) APPROVAL= AP YEAR= 2024 , NDA 201808 (pdf 201808.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (WATSON LABS INC) APPROVAL= TA YEAR= 2016 , NDA 201785 (pdf 201785.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 213978 (label 213978.pdf) INN (VARENICLINE TARTRATE) TYRVAYA (OYSTER POINT PHARMA) APPROVAL= AP YEAR= 2021 , NDA 216723 (pdf 216723.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (ZYDUS) APPROVAL= AP YEAR= 2023 , NDA 211862 (pdf 211862.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 214255 (pdf 214255.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 214557 (pdf 214557.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 214571 (pdf 214571.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , NDA 217151 (pdf 217151.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (LEADING PHARMA) APPROVAL= AP YEAR= 2023 , NDA 213019 (pdf 213019.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217283 (pdf 217283.pdf not found) INN (VARENICLINE TARTRATE) VARENICLINE TARTRATE (AVALANCHE PHARM) APPROVAL= AP YEAR= 2024 , 947 ; DASATINIB ; 302962-49-8 ; 2006 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE INHIBITORS -- TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE , ; NDA 021986 (label 21986.pdf) INN (DASATINIB) SPRYCEL (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022072 (label 22072.pdf) INN (DASATINIB) SPRYCEL (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 202103 (pdf 202103.pdf not found) INN (DASATINIB) DASATINIB (APOTEX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203180 (pdf 203180.pdf not found) INN (DASATINIB) DASATINIB (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211094 (pdf 211094.pdf not found) INN (DASATINIB) DASATINIB (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2023 , NDA 216261 (pdf 216261.pdf not found) INN (DASATINIB) DASATINIB (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2022 , NDA 214350 (pdf 214350.pdf not found) INN (DASATINIB) DASATINIB (LUPIN) APPROVAL= TA YEAR= 2022 , NDA 216099 (pdf 216099.pdf not found) INN (DASATINIB) PHYRAGO (NANOCOPOEIA) APPROVAL= AP YEAR= 2023 , 948 ; VORINOSTAT ; 149647-78-9 ; 2006 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- HISTONE DEACETYLASES HDAC1, HDAC2 AND HDAC3 (CLASS I) AND HDAC6 (CLASS II) AT NANOMOLAR CONCENTRATIONS (IC50<86 NM) , ; NDA 021991 (label 21991.pdf) INN (VORINOSTAT) ZOLINZA (MSD SUB MERCK) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , 949 ; PALIPERIDONE ; 144598-75-4 ; 2006 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- BENZISOXAZOLE DERIVATIVES -- DOPAMINE D2 RECEPTOR ANTAGONIST -- SEROTONIN TYPE 2 (5HT2A) RECEPTOR ANTAGONIST , ; NDA 021999 (label 21999.pdf) INN (PALIPERIDONE) INVEGA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022043 (label 22043.pdf) INN (PALIPERIDONE) INVEGA (JANSSEN LP) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 202645 (pdf 202645.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 , NDA 203802 (pdf 203802.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (RK PHARMA) APPROVAL= AP YEAR= 2015 , NDA 205618 (pdf 205618.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 204452 (pdf 204452.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (INVENTIA) APPROVAL= AP YEAR= 2019 , NDA 204707 (pdf 204707.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212807 (pdf 212807.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (CSPC OUYI) APPROVAL= AP YEAR= 2020 , NDA 208643 (pdf 208643.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 216174 (pdf 216174.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , 950 ; POSACONAZOLE ; 171228-49-2 ; 2006 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTICS -- TRYPANOCIDAL AGENTS -- TRIAZOLE ANTIFUNGAL AGENT -- BLOCKS THE SYNTHESIS OF ERGOSTEROL , ; NDA 022003 (label 22003.pdf) INN (POSACONAZOLE) NOXAFIL (SCHERING) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022027 (label 22027.pdf) INN (POSACONAZOLE) NOXAFIL (SCHERING) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 205053 (label 205053.pdf) INN (POSACONAZOLE) NOXAFIL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2013 , NDA 205596 (label 205596.pdf) INN (POSACONAZOLE) NOXAFIL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2014 , NDA 211500 (pdf 211500.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 212411 (pdf 212411.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2019 , NDA 208773 (pdf 208773.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213454 (pdf 213454.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (AET PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214770 (label 214770.pdf) INN (POSACONAZOLE) NOXAFIL POWDERMIX KIT (MSD MERCK CO) APPROVAL= AP YEAR= 2021 , NDA 208768 (pdf 208768.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 , NDA 212226 (pdf 212226.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (SPECGX LLC) APPROVAL= AP YEAR= 2022 , NDA 212500 (pdf 212500.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 214476 (pdf 214476.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (BIOCON PHARMA) APPROVAL= AP YEAR= 2022 , NDA 207355 (pdf 207355.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214321 (pdf 214321.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 216626 (pdf 216626.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 214842 (pdf 214842.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216326 (pdf 216326.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (WESTMINSTER PHARMS) APPROVAL= AP YEAR= 2023 , NDA 209983 (pdf 209983.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2023 , NDA 216488 (pdf 216488.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (I 3 PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217553 (pdf 217553.pdf not found) INN (POSACONAZOLE) POSACONAZOLE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 951 ; TELBIVUDINE ; 3424-98-4 ; 2006 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGENTS -- REVERSE TRANSCRIPTASE INHIBITORS -- TREATMENT OF HEPATITIS B -- THYMIDINE NUCLEOSIDE ANALOGUE -- PHOSPHORYLATED BY CELLULAR KINASES TO THE ACTIVE TRIPHOSPHATE FORM , ; NDA 022011 (label 22011.pdf) INN (TELBIVUDINE) TYZEKA (NOVARTIS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY DISCONTINUED , NDA 022154 (label 22154.pdf) INN (TELBIVUDINE) TYZEKA (NOVARTIS) APPROVAL= AP YEAR= 2009 DISCONTINUED , 952 ; MENTHOL ; 89-78-1 ; 2008 ; ; NATURAL MOLECULE C00000810 NPA031239 ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIPRURITIC , ; NDA 022029 (label 22029.pdf) INN (MENTHOL METHYL SALICYLATE) SALONPAS (HISAMITSU PHARM CO) APPROVAL= AP YEAR= 2008 , 953 ; CARBENICILLIN ; 4697-36-3 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CELL WALL SYNTHESIS , ; NDA 050298 (pdf 50298.pdf not found) INN (CARBENICILLIN DISODIUM) PYOPEN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050306 (pdf 50306.pdf not found) INN (CARBENICILLIN DISODIUM) GEOPEN (ROERIG) APPROVAL= - YEAR= 0 DISCONTINUED , 954 ; RETAPAMULIN ; 224452-66-8 ; 2007 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIBACTERIAL -- A SEMISYNTHETIC PLEUROMUTILIN ANTIBIOTIC , ; NDA 022055 (label 22055.pdf) INN (RETAPAMULIN) ALTABAX (ALMIRALL) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY DISCONTINUED , 955 ; IXABEPILONE ; 219989-84-1 ; 2007 ; ; ; CLASS ANTINEOPLASTIC -- CYTOTOXIC ANTIBIOTICS -- MICROTUBULE INHIBITOR , ; NDA 022065 (label 22065.pdf) INN (IXABEPILONE) IXEMPRA KIT (R-PHARM US LLC) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , 956 ; TEMSIROLIMUS ; 162635-04-3 ; 2007 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- TREATMENT OF ADVANCED RENAL CELL CARCINOMA -- PROTEIN-PROTEIN INTERACTION INHIBITOR FKBP12 / MTOR (MAMMALIAN TARGET OF RAPAMYCIN) -- TREATMENT OF MANTLE CELL LYMPHOMA (MCL) (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 022088 (label 22088.pdf) INN (TEMSIROLIMUS) TORISEL (PF PRISM CV) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203153 (pdf 203153.pdf not found) INN (TEMSIROLIMUS) TEMSIROLIMUS (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 207383 (pdf 207383.pdf not found) INN (TEMSIROLIMUS) TEMSIROLIMUS (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , 957 ; DORIPENEM ; 148016-81-3 ; 2007 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIALS -- SYNTHETIC BROAD-SPECTRUM CARBAPENEM ANTIBIOTIC -- INHIBITS BACTERIAL CELL WALL BIOSYNTHESIS , ; NDA 022106 (label 22106.pdf) INN (DORIPENEM) DORIBAX (SHIONOGI INC) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY DISCONTINUED , 958 ; MARAVIROC ; 376348-65-1 ; 2007 ; ; ; CLASS ANTIINFECTIVES -- ANTI-HIV AGENTS -- ANTIVIRAL -- PROTEIN-PROTEIN INTERACTION INHIBITOR -- CCR5 CO-RECEPTOR LIGAND -- HIV-1 GP120 , ; NDA 022128 (label 22128.pdf) INN (MARAVIROC) SELZENTRY (VIIV HLTHCARE) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203347 (pdf 203347.pdf not found) INN (MARAVIROC) MARAVIROC (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 203382 (pdf 203382.pdf not found) INN (MARAVIROC) MARAVIROC (SANDOZ INC) APPROVAL= TA YEAR= 2014 , NDA 208984 (label 208984.pdf) INN (MARAVIROC) SELZENTRY (VIIV HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 217114 (pdf 217114.pdf not found) INN (MARAVIROC) MARAVIROC (I 3 PHARMS) APPROVAL= AP YEAR= 2023 , 959 ; REGADENOSON ; 313348-27-5 ; 2008 ; ; ; CLASS CARDIOVASCULAR -- A2A ADENOSINE RECEPTOR AGONIST (KI = 1.3 MICROMOLAR) -- CORONARY VASODILATOR , ; NDA 022161 (label 22161.pdf) INN (REGADENOSON) LEXISCAN (ASTELLAS) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 207604 (pdf 207604.pdf not found) INN (REGADENOSON) REGADENOSON (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 213210 (pdf 213210.pdf not found) INN (REGADENOSON) REGADENOSON (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 212806 (pdf 212806.pdf not found) INN (REGADENOSON) REGADENOSON (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 213236 (pdf 213236.pdf not found) INN (REGADENOSON) REGADENOSON (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 213856 (pdf 213856.pdf not found) INN (REGADENOSON) REGADENOSON (MYLAN) APPROVAL= AP YEAR= 2023 , NDA 214252 (pdf 214252.pdf not found) INN (REGADENOSON) REGADENOSON (IMS LTD) APPROVAL= AP YEAR= 2022 , NDA 207320 (pdf 207320.pdf not found) INN (REGADENOSON) REGADENOSON (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 214349 (pdf 214349.pdf not found) INN (REGADENOSON) REGADENOSON (HOSPIRA) APPROVAL= AP YEAR= 2022 , NDA 216437 (pdf 216437.pdf not found) INN (REGADENOSON) REGADENOSON (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215827 (pdf 215827.pdf not found) INN (REGADENOSON) REGADENOSON (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 217455 (pdf 217455.pdf not found) INN (REGADENOSON) REGADENOSON (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 , 960 ; CYCLOPENTOLATE ; 204990-62-5 ; 1974 ; ; ; CLASS SENSORY -- MYDRIATIC -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTIMUSCARINIC EYE PREPARATIONS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 040075 (pdf 40075.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040164 (pdf 40164.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AKPENTOLATE (RISING) APPROVAL= AP YEAR= 1997 , NDA 040165 (pdf 40165.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AKPENTOLATE (RISING) APPROVAL= AP YEAR= 1997 , NDA 084108 (pdf 84108.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084109 (pdf 84109.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084110 (pdf 84110.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOGYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 084150 (pdf 84150.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084300 (pdf 84300.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE) CYCLOMYDRIL (ALCON LABS INC) APPROVAL= AP YEAR= 1975 , NDA 084863 (pdf 84863.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085555 (pdf 85555.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) AK-PENTOLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 088150 (pdf 88150.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088643 (pdf 88643.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) PENTOLAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089162 (pdf 89162.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 205937 (pdf 205937.pdf not found) INN (CYCLOPENTOLATE HYDROCHLORIDE) CYCLOPENTOLATE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 961 ; ESTROPIPATE ; 481-97-0 ; 1977 ; ; ; CLASS GENITO -- ESTROGENIC , ; NDA 040135 (pdf 40135.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (BARR) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040296 (pdf 40296.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040359 (pdf 40359.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (MYLAN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 081213 (pdf 81213.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 081214 (pdf 81214.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 081215 (pdf 81215.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 081216 (pdf 81216.pdf not found) INN (ESTROPIPATE) ESTROPIPATE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 083220 (label 83220.pdf) INN (ESTROPIPATE) OGEN .625 (PFIZER) APPROVAL= AP YEAR= 1977 , NDA 084710 (pdf 84710.pdf not found) INN (ESTROPIPATE) OGEN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 089567 (pdf 89567.pdf not found) INN (ESTROPIPATE) ORTHO-EST (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089582 (pdf 89582.pdf not found) INN (ESTROPIPATE) ORTHO-EST (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1991 DISCONTINUED , 962 ; DIMENHYDRINATE ; 85-18-7 ; 1972 ; ; ; CLASS RESPIRATORY -- COMBINATION OF THEOPHYLLINE (ADENOSINE A1 RECEPTOR) ANALOGS WITH CHLORIDE AND DIPHENHYDRAMINE (HISTAMINE H1 RECEPTOR) , ; NDA 040519 (pdf 40519.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 080615 (pdf 80615.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080715 (pdf 80715.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (ALRA) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080841 (pdf 80841.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083531 (pdf 83531.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084316 (pdf 84316.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WYETH AYERST) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084767 (pdf 84767.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085166 (pdf 85166.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085985 (pdf 85985.pdf not found) INN (DIMENHYDRINATE) DIMENHYDRINATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , 963 ; DOXYCYCLINE ; 564-25-0 ; 1967 ; ; NATURAL MOLECULE C00017127 ; CLASS ANTIINFECTIVES -- GUM DISEASE (THERAPEUTIC) -- ANTIMALARIAL -- ANTICOLLAGENASE-- ANTIBIOTIC -- ANTIBACTERIAL -- TETRACYCLINES , ; NDA 050006 (label 50006.pdf) INN (DOXYCYCLINE) VIBRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 050007 (label 50007.pdf) INN (DOXYCYCLINE HYCLATE) VIBRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1967 , NDA 050442 (label 50442.pdf) INN (DOXYCYCLINE HYCLATE) VIBRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 050480 (label 50480.pdf) INN (DOXYCYCLINE CALCIUM) VIBRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1974 , NDA 050533 (label 50533.pdf) INN (DOXYCYCLINE HYCLATE) VIBRA-TABS (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050582 (label 50582.pdf) INN (DOXYCYCLINE HYCLATE) DORYX (MAYNE PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050641 (label 50641.pdf) INN (DOXYCYCLINE) MONODOX (CHARTWELL RX) APPROVAL= AP YEAR= 1989 , NDA 050744 (label 50744.pdf) INN (DOXYCYCLINE HYCLATE) PERIOSTAT (COLLAGENEX) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 050751 (label 50751.pdf) INN (DOXYCYCLINE HYCLATE) ATRIDOX (DEN-MAT) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 050783 (label 50783.pdf) INN (DOXYCYCLINE HYCLATE) PERIOSTAT (GALDERMA LABS LP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 050795 (label 50795.pdf) INN (DOXYCYCLINE HYCLATE) DORYX (MAYNE PHARMA) APPROVAL= AP YEAR= 2005 , NDA 050805 (label 50805.pdf) INN (DOXYCYCLINE) ORACEA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2006 , NDA 061717 (pdf 61717.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061720 (pdf 61720.pdf not found) INN (DOXYCYCLINE) DOXYCHEL (RACHELLE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061953 (pdf 61953.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCHEL HYCLATE (RACHELLE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062031 (pdf 62031.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1982 , NDA 062119 (pdf 62119.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062142 (pdf 62142.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062269 (pdf 62269.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CARIBE HOLDINGS) APPROVAL= AP YEAR= 1982 , NDA 062337 (pdf 62337.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062391 (pdf 62391.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062392 (pdf 62392.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062396 (pdf 62396.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1984 , NDA 062418 (pdf 62418.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062421 (pdf 62421.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1983 , NDA 062432 (pdf 62432.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (MYLAN) APPROVAL= AP YEAR= 1983 , NDA 062434 (pdf 62434.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062442 (pdf 62442.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062450 (pdf 62450.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE (HIKMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062462 (pdf 62462.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062463 (pdf 62463.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062469 (pdf 62469.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062475 (label 62475.pdf) INN (DOXYCYCLINE HYCLATE) DOXY 100 (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 , NDA 062479 (pdf 62479.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (RANBAXY) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062494 (pdf 62494.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062497 (pdf 62497.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXY-LEMMON (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062500 (pdf 62500.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CHARTWELL) APPROVAL= AP YEAR= 1984 , NDA 062505 (pdf 62505.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CHARTWELL) APPROVAL= AP YEAR= 1984 , NDA 062538 (pdf 62538.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062569 (pdf 62569.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062581 (pdf 62581.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXY-LEMMON (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062593 (pdf 62593.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062594 (pdf 62594.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062631 (pdf 62631.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PVT FORM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062643 (pdf 62643.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062653 (pdf 62653.pdf not found) INN (DOXYCYCLINE HYCLATE) DORYX (WARNER CHILCOTT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062675 (pdf 62675.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 062676 (pdf 62676.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 062677 (pdf 62677.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 062763 (pdf 62763.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062764 (pdf 62764.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062992 (pdf 62992.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1989 , NDA 063187 (pdf 63187.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PLIVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 065032 (pdf 65032.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (SANDOZ INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065041 (pdf 65041.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065053 (pdf 65053.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 , NDA 065055 (label 65055.pdf) INN (DOXYCYCLINE) DOXYCYCLINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 , NDA 065070 (pdf 65070.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2000 , NDA 065095 (label 65095.pdf) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2003 , NDA 065103 (pdf 65103.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065134 (pdf 65134.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2005 , NDA 065163 (pdf 65163.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065182 (pdf 65182.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2005 , NDA 065277 (pdf 65277.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2005 , NDA 065281 (pdf 65281.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (BAUSCH) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065285 (pdf 65285.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 065287 (pdf 65287.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (LARKEN LABS) APPROVAL= AP YEAR= 2006 , NDA 065353 (pdf 65353.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (SANDOZ INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065356 (pdf 65356.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 , NDA 065377 (pdf 65377.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (APPCO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065427 (pdf 65427.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (APPCO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065454 (label 65454.pdf) INN (DOXYCYCLINE) DOXYCYCLINE (CHARTWELL) APPROVAL= AP YEAR= 2008 , NDA 065471 (pdf 65471.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090855 (pdf 90855.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (MYLAN) APPROVAL= TA YEAR= 2014 , NDA 090431 (label 90431.pdf) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090505 (pdf 90505.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091052 (pdf 91052.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200065 (pdf 200065.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (IMPAX LABS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090134 (pdf 90134.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2011 , NDA 091605 (pdf 91605.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091406 (pdf 91406.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202778 (pdf 202778.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091277 (pdf 91277.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (LUPIN LTD) APPROVAL= TA YEAR= 2013 , NDA 200856 (pdf 200856.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2013 , NDA 201678 (pdf 201678.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 204234 (pdf 204234.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 205931 (label 205931.pdf) INN (DOXYCYCLINE HYCLATE) ACTICLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2014 , NDA 204446 (pdf 204446.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (COSETTE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203278 (pdf 203278.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (AMNEAL PHARMS) APPROVAL= TA YEAR= 2019 , NDA 205115 (pdf 205115.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207289 (pdf 207289.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 208253 (label 208253.pdf) INN (DOXYCYCLINE HYCLATE) ACTICLATE CAP (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208286 (pdf 208286.pdf not found) INN (DOXYCYCLINE) ZENAVOD (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2016 , NDA 207494 (pdf 207494.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PRINSTON INC) APPROVAL= AP YEAR= 2016 , NDA 208765 (pdf 208765.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 209165 (pdf 209165.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209259 (pdf 209259.pdf not found) INN (DOXYCYCLINE) XYROSA (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2017 , NDA 207558 (pdf 207558.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2017 , NDA 207757 (pdf 207757.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207773 (pdf 207773.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 208818 (pdf 208818.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 209372 (pdf 209372.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209396 (pdf 209396.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2017 , NDA 209582 (pdf 209582.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207774 (pdf 207774.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 206772 (pdf 206772.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209844 (label 209844.pdf) INN (DOXYCYCLINE HYCLATE) LYMEPAK (CHARTWELL PHARMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209969 (pdf 209969.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210527 (pdf 210527.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 211012 (pdf 211012.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209243 (pdf 209243.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 209402 (pdf 209402.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CHANGZHOU PHARM) APPROVAL= AP YEAR= 2019 , NDA 211343 (pdf 211343.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (CHANGZHOU PHARM) APPROVAL= AP YEAR= 2019 , NDA 210536 (pdf 210536.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 210537 (pdf 210537.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 210664 (pdf 210664.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ACELLA) APPROVAL= AP YEAR= 2020 , NDA 211584 (pdf 211584.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211744 (pdf 211744.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 212610 (pdf 212610.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ZHEJIANG YONGTAI) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209393 (pdf 209393.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209987 (pdf 209987.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (RISING) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214207 (pdf 214207.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 208942 (pdf 208942.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (RISING) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213475 (pdf 213475.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PHARMOBEDIENT) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 208263 (pdf 208263.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (NESHER PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212487 (pdf 212487.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (PRAXGEN) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213075 (pdf 213075.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 216599 (pdf 216599.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (AMNEAL) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216631 (pdf 216631.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (LUPIN) APPROVAL= AP YEAR= 2024 , NDA 216690 (pdf 216690.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215583 (pdf 215583.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217674 (pdf 217674.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 208741 (pdf 208741.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (LUPIN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 209560 (pdf 209560.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 214356 (pdf 214356.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 217685 (pdf 217685.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (HAINAN POLY) APPROVAL= AP YEAR= 2024 , NDA 217794 (pdf 217794.pdf not found) INN (DOXYCYCLINE HYCLATE) DOXYCYCLINE HYCLATE (LUPIN LTD) APPROVAL= AP YEAR= 2024 , NDA 218034 (pdf 218034.pdf not found) INN (DOXYCYCLINE) DOXYCYCLINE (DR REDDYS) APPROVAL= AP YEAR= 2024 , 964 ; ERYTHROMYCIN ; 114-07-8 ; 1964 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050182 (pdf 50182.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROCIN (HOSPIRA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050368 (pdf 50368.pdf not found) INN (ERYTHROMYCIN) ILOTYCIN (DISTA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050370 (pdf 50370.pdf not found) INN (ERYTHROMYCIN GLUCEPTATE) ILOTYCIN GLUCEPTATE (DISTA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050526 (label 50526.pdf) INN (ERYTHROMYCIN) STATICIN (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050532 (pdf 50532.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (LILLY) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050536 (label 50536.pdf) INN (ERYTHROMYCIN) ERYC (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1981 , NDA 050557 (label 50557.pdf) INN (BENZOYL PEROXIDE ERYTHROMYCIN) BENZAMYCIN (VALEANT INTL) APPROVAL= AP YEAR= 1984 , NDA 050584 (pdf 50584.pdf not found) INN (ERYTHROMYCIN) AKNE-MYCIN (BAUSCH) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050593 (pdf 50593.pdf not found) INN (ERYTHROMYCIN) ERYC SPRINKLES (HOSPIRA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050594 (pdf 50594.pdf not found) INN (ERYTHROMYCIN) ERYCETTE (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050609 (label 50609.pdf) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROCIN (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 050610 (pdf 50610.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PADDOCK LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050611 (label 50611.pdf) INN (ERYTHROMYCIN) PCE (AZURITY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 050617 (pdf 50617.pdf not found) INN (ERYTHROMYCIN) ERYGEL (MYLAN) APPROVAL= AP YEAR= 1987 , NDA 050769 (label 50769.pdf) INN (BENZOYL PEROXIDE ERYTHROMYCIN) AKTIPAK (BIOFRONTERA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 060272 (pdf 60272.pdf not found) INN (ERYTHROMYCIN) E-MYCIN (ARBOR PHARMS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 060359 (label 60359.pdf) INN (ERYTHROMYCIN STEARATE) ERYTHROCIN STEARATE (AZURITY) APPROVAL= AP YEAR= 1964 , NDA 061304 (pdf 61304.pdf not found) INN (ERYTHROMYCIN STEARATE) BRISTAMYCIN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061461 (pdf 61461.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (ANI PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 061505 (pdf 61505.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (MYLAN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061591 (pdf 61591.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (ANI PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061605 (pdf 61605.pdf not found) INN (ERYTHROMYCIN STEARATE) ETHRIL 250 (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061621 (label 61621.pdf) INN (ERYTHROMYCIN) ERYTHROMYCIN (AZURITY) APPROVAL= AP YEAR= 1972 , NDA 061633 (pdf 61633.pdf not found) INN (ERYTHROMYCIN) ROBIMYCIN (ROBINS AH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061659 (pdf 61659.pdf not found) INN (ERYTHROMYCIN) R-P MYCIN (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061675 (pdf 61675.pdf not found) INN (ERYTHROMYCIN STEARATE) WYAMYCIN S (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061743 (pdf 61743.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061791 (pdf 61791.pdf not found) INN (ERYTHROMYCIN STEARATE) PFIZER-E (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061887 (pdf 61887.pdf not found) INN (ERYTHROMYCIN STEARATE) BRISTAMYCIN (BRISTOL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061910 (pdf 61910.pdf not found) INN (ERYTHROMYCIN) ILOTYCIN (DISTA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 062032 (pdf 62032.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYPAR (PARKE DAVIS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 062089 (pdf 62089.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062121 (pdf 62121.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062290 (pdf 62290.pdf not found) INN (ERYTHROMYCIN) ERYDERM (ARBOR PHARMS INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062298 (label 62298.pdf) INN (ERYTHROMYCIN) ERY-TAB (AZURITY) APPROVAL= AP YEAR= 1982 , NDA 062322 (pdf 62322.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYPAR (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062326 (pdf 62326.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062327 (pdf 62327.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062328 (pdf 62328.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062338 (pdf 62338.pdf not found) INN (ERYTHROMYCIN) ERYC (WARNER CHILCOTT LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062342 (pdf 62342.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062405 (pdf 62405.pdf not found) INN (ERYTHROMYCIN) A/T/S (TARO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062436 (pdf 62436.pdf not found) INN (ERYTHROMYCIN) T-STAT (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062446 (pdf 62446.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062447 (pdf 62447.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PADAGIS US) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062467 (pdf 62467.pdf not found) INN (ERYTHROMYCIN) E-SOLVE 2 (SYOSSET) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062468 (pdf 62468.pdf not found) INN (ERYTHROMYCIN) C-SOLVE-2 (FOUGERA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062481 (pdf 62481.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062485 (pdf 62485.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062508 (pdf 62508.pdf not found) INN (ERYTHROMYCIN) ERYMAX (MERZ PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062522 (pdf 62522.pdf not found) INN (ERYTHROMYCIN) SANSAC (DOW PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062546 (pdf 62546.pdf not found) INN (ERYTHROMYCIN) ERYC (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062563 (pdf 62563.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN (ELKINS SINN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062586 (pdf 62586.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROCIN (ABBOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062604 (pdf 62604.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062616 (pdf 62616.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PHARMAFAIR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062618 (pdf 62618.pdf not found) INN (ERYTHROMYCIN) ERYC (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062638 (label 62638.pdf) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROCIN (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 062648 (pdf 62648.pdf not found) INN (ERYTHROMYCIN) ERYC 125 (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062660 (pdf 62660.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062687 (pdf 62687.pdf not found) INN (ERYTHROMYCIN) ERYTHRA-DERM (MICRO LABS) APPROVAL= AP YEAR= 1988 , NDA 062746 (pdf 62746.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (AZURITY) APPROVAL= AP YEAR= 1986 , NDA 062748 (pdf 62748.pdf not found) INN (ERYTHROMYCIN) T-STAT (WESTWOOD SQUIBB) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062751 (pdf 62751.pdf not found) INN (ERYTHROMYCIN) C-SOLVE-2 (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 062825 (pdf 62825.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062957 (pdf 62957.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062993 (pdf 62993.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062999 (pdf 62999.pdf not found) INN (ERYTHROMYCIN) E-BASE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063028 (pdf 63028.pdf not found) INN (ERYTHROMYCIN) E-BASE (BARR) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063038 (pdf 63038.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PADAGIS US) APPROVAL= AP YEAR= 1991 , NDA 063086 (pdf 63086.pdf not found) INN (ERYTHROMYCIN) E-BASE (BARR) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063098 (pdf 63098.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (BARR) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063107 (pdf 63107.pdf not found) INN (ERYTHROMYCIN) EMGEL (ALTANA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063179 (pdf 63179.pdf not found) INN (ERYTHROMYCIN STEARATE) ERYTHROMYCIN STEARATE (ANI PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063211 (pdf 63211.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PADAGIS US) APPROVAL= AP YEAR= 1993 , NDA 063253 (pdf 63253.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 064030 (pdf 64030.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (SENTISS) APPROVAL= AP YEAR= 1996 , NDA 064039 (pdf 64039.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (BAUSCH) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 064067 (pdf 64067.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 064101 (pdf 64101.pdf not found) INN (ERYTHROMYCIN) ERYTHRO-STATIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064126 (pdf 64126.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PADAGIS US) APPROVAL= AP YEAR= 1996 , NDA 064127 (pdf 64127.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (RENAISSANCE PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064128 (pdf 64128.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (MYLAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064184 (pdf 64184.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 1997 , NDA 064187 (pdf 64187.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 065009 (pdf 65009.pdf not found) INN (ERYTHROMYCIN) E-GLADES (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065112 (pdf 65112.pdf not found) INN (BENZOYL PEROXIDE ERYTHROMYCIN) ERYTHROMYCIN AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065320 (pdf 65320.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 090215 (pdf 90215.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2010 , NDA 065385 (pdf 65385.pdf not found) INN (BENZOYL PEROXIDE ERYTHROMYCIN) ERYTHROMYCIN AND BENZOYL PEROXIDE (LYNE) APPROVAL= AP YEAR= 2015 , NDA 208154 (pdf 208154.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ENCUBE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208100 (pdf 208100.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209720 (pdf 209720.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210954 (pdf 210954.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 212015 (pdf 212015.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (TORRENT) APPROVAL= AP YEAR= 2020 , NDA 211086 (pdf 211086.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (EXELA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213628 (pdf 213628.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214549 (pdf 214549.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 211975 (pdf 211975.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (TORRENT) APPROVAL= AP YEAR= 2021 , NDA 215290 (pdf 215290.pdf not found) INN (ERYTHROMYCIN LACTOBIONATE) ERYTHROMYCIN LACTOBIONATE (NEXUS) APPROVAL= AP YEAR= 2022 , NDA 216066 (pdf 216066.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 212693 (pdf 212693.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 215440 (pdf 215440.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215661 (pdf 215661.pdf not found) INN (ERYTHROMYCIN) ERYTHROMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2023 , 965 ; ERYTHROMYCIN ESTOLATE ; 3521-62-8 ; 1967 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050010 (pdf 50010.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (LILLY) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 050599 (pdf 50599.pdf not found) INN (ERYTHROMYCIN ESTOLATE SULFISOXAZOLE ACETYL) ILOSONE SULFA (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061893 (pdf 61893.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (DISTA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 061894 (pdf 61894.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (LILLY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 061895 (pdf 61895.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (DISTA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 061896 (pdf 61896.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (LILLY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 061897 (pdf 61897.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ILOSONE (LILLY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 062087 (pdf 62087.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062162 (pdf 62162.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (BARR) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062169 (pdf 62169.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (COSETTE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 062237 (pdf 62237.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062353 (pdf 62353.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062362 (pdf 62362.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (LIFE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062409 (pdf 62409.pdf not found) INN (ERYTHROMYCIN ESTOLATE) ERYTHROMYCIN ESTOLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , 966 ; ERYTHROMYCIN ETHYLSUCCINATE ; 8000-15-5 ; 1965 ; ; ; CLASS DERMATOLOGICALS -- ANTIBIOTIC -- ANTIBACTERIAL -- MACROLIDE , ; NDA 050207 (label 50207.pdf) INN (ERYTHROMYCIN ETHYLSUCCINATE) E.E.S. (AZURITY) APPROVAL= AP YEAR= 1965 , NDA 050297 (label 50297.pdf) INN (ERYTHROMYCIN ETHYLSUCCINATE) E.E.S. (AZURITY) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 050529 (pdf 50529.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) PEDIAZOLE (ROSS LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 061639 (label 61639.pdf) INN (ERYTHROMYCIN ETHYLSUCCINATE) E.E.S. 200 (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061905 (label 61905.pdf) INN (ERYTHROMYCIN ETHYLSUCCINATE) E.E.S. 400 (AZURITY) APPROVAL= AP YEAR= 1982 , NDA 062055 (pdf 62055.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (ANI PHARMS) APPROVAL= AP YEAR= 1978 , NDA 062123 (pdf 62123.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) WYAMYCIN E (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062177 (pdf 62177.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (DISTA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062198 (pdf 62198.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) E-MYCIN E (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062200 (pdf 62200.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062231 (pdf 62231.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062256 (pdf 62256.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (BARR) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062304 (pdf 62304.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) PEDIAMYCIN (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062305 (pdf 62305.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) PEDIAMYCIN (ROSS LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062306 (pdf 62306.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) PEDIAMYCIN (ROSS LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062558 (pdf 62558.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062559 (pdf 62559.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062674 (pdf 62674.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062758 (pdf 62758.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) ERYZOLE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062759 (pdf 62759.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE SULFISOXAZOLE ACETYL) ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062847 (pdf 62847.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 061904 (label 61904.pdf) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (AZURITY) APPROVAL= AP YEAR= 1975 , NDA 211204 (pdf 211204.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211991 (pdf 211991.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 216212 (pdf 216212.pdf not found) INN (ERYTHROMYCIN ETHYLSUCCINATE) ERYTHROMYCIN ETHYLSUCCINATE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2022 , 967 ; DICLOXACILLIN ; 3116-76-5 ; 1968 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 050011 (pdf 50011.pdf not found) INN (DICLOXACILLIN SODIUM) PATHOCIL (WYETH AYERST) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 050092 (pdf 50092.pdf not found) INN (DICLOXACILLIN SODIUM) PATHOCIL (WYETH AYERST) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 050337 (pdf 50337.pdf not found) INN (DICLOXACILLIN SODIUM) DYNAPEN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060254 (pdf 60254.pdf not found) INN (DICLOXACILLIN SODIUM) DYCILL (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061454 (pdf 61454.pdf not found) INN (DICLOXACILLIN SODIUM) DICLOXACILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061455 (pdf 61455.pdf not found) INN (DICLOXACILLIN SODIUM) DICLOXACILLIN SODIUM (APOTHECON) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 062238 (pdf 62238.pdf not found) INN (DICLOXACILLIN SODIUM) DYCILL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062286 (pdf 62286.pdf not found) INN (DICLOXACILLIN SODIUM) DICLOXACILLIN SODIUM (TEVA) APPROVAL= AP YEAR= 1982 , NDA 216845 (pdf 216845.pdf not found) INN (DICLOXACILLIN SODIUM) DICLOXACILLIN SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , 968 ; NEOMYCIN ; 1404-04-2 ; 1954 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 050023 (label 50023.pdf) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (HARROW EYE) APPROVAL= AP YEAR= 1963 , NDA 050065 (label 50065.pdf) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (NOVARTIS) APPROVAL= AP YEAR= 1963 , NDA 050081 (pdf 50081.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE PREDNISOLONE ACETATE) POLY-PRED (ALLERGAN) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 050168 (label 50168.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050169 (label 50169.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050176 (pdf 50176.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOSPORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050218 (pdf 50218.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 050237 (pdf 50237.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE) NEO-CORT-DOME (BAYER PHARMS) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050238 (pdf 50238.pdf not found) INN (ACETIC ACID GLACIAL HYDROCORTISONE NEOMYCIN SULFATE) NEO-CORT-DOME (BAYER PHARMS) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 050285 (pdf 50285.pdf not found) INN (NEOMYCIN SULFATE) MYCIFRADIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050322 (pdf 50322.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEODECADRON (MERCK) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 050324 (pdf 50324.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEODECADRON (MERCK) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 050344 (pdf 50344.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) STATROL (ALCON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 050345 (pdf 50345.pdf not found) INN (FLURANDRENOLIDE NEOMYCIN SULFATE) CORDRAN N (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050346 (pdf 50346.pdf not found) INN (FLURANDRENOLIDE NEOMYCIN SULFATE) CORDRAN N (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050356 (label 50356.pdf) INN (COLISTIN SULFATE HYDROCORTISONE ACETATE NEOMYCIN SULFATE THONZONIUM BROMIDE) COLY-MYCIN S (ENDO PHARMS INC) APPROVAL= AP YEAR= 1962 , NDA 050378 (pdf 50378.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE SODIUM PHOSPHATE) NEO-HYDELTRASOL (MERCK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050416 (label 50416.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050417 (label 50417.pdf) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) LUMI-SPORYN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1971 , NDA 050456 (pdf 50456.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) STATROL (ALCON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 050479 (label 50479.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 060188 (pdf 60188.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) COR-OTICIN (AKORN) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 060304 (pdf 60304.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (TEVA) APPROVAL= AP YEAR= 1964 , NDA 060365 (pdf 60365.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060385 (pdf 60385.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060427 (pdf 60427.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEO-POLYCIN (DOW PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060475 (pdf 60475.pdf not found) INN (NEOMYCIN SULFATE) NEOBIOTIC (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060520 (pdf 60520.pdf not found) INN (NEOMYCIN SULFATE) MYCIFRADIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060582 (pdf 60582.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOSPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1968 , NDA 060607 (pdf 60607.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (LANNETT) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 060610 (pdf 60610.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060611 (pdf 60611.pdf not found) INN (METHYLPREDNISOLONE ACETATE NEOMYCIN SULFATE) NEO-MEDROL ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060612 (pdf 60612.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060613 (label 60613.pdf) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CASPORYN HC (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1975 , NDA 060645 (pdf 60645.pdf not found) INN (METHYLPREDNISOLONE NEOMYCIN SULFATE) NEO-MEDROL (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060647 (pdf 60647.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEO-POLYCIN (DOW PHARM) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060700 (pdf 60700.pdf not found) INN (FLUOCINOLONE ACETONIDE NEOMYCIN SULFATE) NEO-SYNALAR (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 1963 , NDA 060707 (pdf 60707.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOSPORIN G.U. IRRIGANT (MONARCH PHARMS) APPROVAL= AP YEAR= 1966 , NDA 060730 (pdf 60730.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOCORT (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060731 (pdf 60731.pdf not found) INN (BACITRACIN HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060751 (pdf 60751.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 060764 (pdf 60764.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 061037 (pdf 61037.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE ACETATE) NEO-DELTA-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061039 (pdf 61039.pdf not found) INN (NEOMYCIN SULFATE PREDNISOLONE ACETATE) NEO-DELTA-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061048 (pdf 61048.pdf not found) INN (BACITRACIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) MYCITRACIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061049 (pdf 61049.pdf not found) INN (HYDROCORTISONE ACETATE NEOMYCIN SULFATE) NEO-CORTEF (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061579 (pdf 61579.pdf not found) INN (NEOMYCIN SULFATE) NEO-RX (X GEN PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061586 (pdf 61586.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061816 (pdf 61816.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOBIONE (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062166 (pdf 62166.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 062167 (pdf 62167.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062173 (pdf 62173.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062339 (pdf 62339.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) STATROL (ALCON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062341 (pdf 62341.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) MAXITROL (SANDOZ) APPROVAL= AP YEAR= 1984 , NDA 062381 (pdf 62381.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062383 (pdf 62383.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062386 (pdf 62386.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062389 (pdf 62389.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) ZINC BACITRACIN , NEOMYCIN SULFATE , POLYMYXIN B SULFATE & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062394 (pdf 62394.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062399 (pdf 62399.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTICAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062411 (pdf 62411.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062423 (pdf 62423.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1983 , NDA 062428 (pdf 62428.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062488 (pdf 62488.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1985 , NDA 062499 (pdf 62499.pdf not found) INN (BACITRACIN ZINC LIDOCAINE NEOMYCIN SULFATE POLYMYXIN B SULFATE) LANABIOTIC (COMBE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062521 (pdf 62521.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTOCORT (ACTAVIS LABS FL INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062539 (pdf 62539.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062544 (pdf 62544.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062566 (pdf 62566.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062595 (pdf 62595.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062598 (pdf 62598.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) MYTREX A (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062600 (pdf 62600.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062607 (pdf 62607.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062608 (pdf 62608.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062609 (pdf 62609.pdf not found) INN (NEOMYCIN SULFATE TRIAMCINOLONE ACETONIDE) MYTREX A (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062617 (pdf 62617.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE , POLYMYXIN B SULFATE & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062623 (pdf 62623.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062664 (pdf 62664.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 062714 (pdf 62714.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062721 (pdf 62721.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062788 (pdf 62788.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062818 (pdf 62818.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (IPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062822 (pdf 62822.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) PEDIOTIC (MONARCH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062833 (pdf 62833.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062874 (pdf 62874.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 062938 (pdf 62938.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (PADAGIS US) APPROVAL= AP YEAR= 1989 , NDA 064047 (pdf 64047.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 , NDA 064053 (pdf 64053.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064055 (pdf 64055.pdf not found) INN (DEXAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE) NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064063 (pdf 64063.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 064064 (pdf 64064.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064065 (pdf 64065.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) OTICAIR (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 , NDA 064068 (pdf 64068.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064135 (pdf 64135.pdf not found) INN (DEXAMETHASONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) DEXASPORIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 065010 (label 65010.pdf) INN (NEOMYCIN SULFATE) NEO-FRADIN (X GEN PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065088 (pdf 65088.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065106 (pdf 65106.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATE (XGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 065108 (pdf 65108.pdf not found) INN (NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATE (XGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 065187 (pdf 65187.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (AMRING PHARMS) APPROVAL= AP YEAR= 2005 , NDA 065216 (pdf 65216.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (AMRING PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065219 (pdf 65219.pdf not found) INN (HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (AMRING PHARMS) APPROVAL= AP YEAR= 2006 , NDA 065220 (pdf 65220.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (XGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 065468 (pdf 65468.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 065213 (pdf 65213.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (AKORN) APPROVAL= AP YEAR= 2012 , NDA 204435 (pdf 204435.pdf not found) INN (NEOMYCIN SULFATE) NEOMYCIN SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2016 DISCONTINUED , 969 ; GENTAMICIN ; 1403-66-3 ; 1966 ; ; ; CLASS ANTIINFECTIVES -- AMINOGLYCOSIDE -- ANTIBIOTIC -- ANTIBACTERIAL -- PROTEIN SYNTHESIS INHIBITORS -- PRODUCED BY MICROMONOSPORA PURPUREA , ; NDA 050039 (pdf 50039.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 050425 (pdf 50425.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 050505 (pdf 50505.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 050586 (label 50586.pdf) INN (GENTAMICIN SULFATE PREDNISOLONE ACETATE) PRED-G (ALLERGAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 050612 (label 50612.pdf) INN (GENTAMICIN SULFATE PREDNISOLONE ACETATE) PRED-G (ALLERGAN) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 060462 (pdf 60462.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 060463 (pdf 60463.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 061716 (pdf 61716.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 061739 (pdf 61739.pdf not found) INN (GENTAMICIN SULFATE) GARAMYCIN (SCHERING) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 062196 (pdf 62196.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (SANDOZ) APPROVAL= AP YEAR= 1980 , NDA 062248 (pdf 62248.pdf not found) INN (GENTAMICIN SULFATE) U-GENCIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062251 (pdf 62251.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1980 , NDA 062264 (pdf 62264.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062288 (pdf 62288.pdf not found) INN (GENTAMICIN SULFATE) BRISTAGEN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062289 (pdf 62289.pdf not found) INN (GENTAMICIN SULFATE) APOGEN (KING PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062307 (pdf 62307.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 062318 (pdf 62318.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062325 (pdf 62325.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062340 (pdf 62340.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PHARM SPEC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062351 (pdf 62351.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PADAGIS US) APPROVAL= AP YEAR= 1982 , NDA 062354 (pdf 62354.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (KALAPHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062356 (pdf 62356.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062366 (label 62366.pdf) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 , NDA 062373 (pdf 62373.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1982 , NDA 062413 (pdf 62413.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (ABBOTT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062414 (pdf 62414.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 062420 (pdf 62420.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 062427 (pdf 62427.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (TARO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062440 (pdf 62440.pdf not found) INN (GENTAMICIN SULFATE) GENTAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062443 (pdf 62443.pdf not found) INN (GENTAMICIN SULFATE) GENTAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062444 (pdf 62444.pdf not found) INN (GENTAMICIN SULFATE) GENTAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062452 (pdf 62452.pdf not found) INN (GENTAMICIN SULFATE) GENOPTIC (ALLERGAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062458 (pdf 62458.pdf not found) INN (GENTAMICIN SULFATE) GENTAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062471 (pdf 62471.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062477 (pdf 62477.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (TARO) APPROVAL= AP YEAR= 1983 , NDA 062480 (pdf 62480.pdf not found) INN (GENTAMICIN SULFATE) GENTACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062493 (pdf 62493.pdf not found) INN (GENTAMICIN SULFATE) GENTAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062496 (pdf 62496.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062501 (pdf 62501.pdf not found) INN (GENTAMICIN SULFATE) GENTACIDIN (NOVARTIS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062507 (pdf 62507.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062523 (pdf 62523.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062530 (pdf 62530.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062531 (pdf 62531.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062533 (pdf 62533.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1984 , NDA 062534 (pdf 62534.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062588 (pdf 62588.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062612 (pdf 62612.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062635 (pdf 62635.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062814 (pdf 62814.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062932 (pdf 62932.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PACO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063106 (pdf 63106.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063149 (pdf 63149.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 064048 (pdf 64048.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 064054 (pdf 64054.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (COSETTE) APPROVAL= AP YEAR= 1994 , NDA 064056 (pdf 64056.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (COSETTE) APPROVAL= AP YEAR= 1994 , NDA 064093 (pdf 64093.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064163 (pdf 64163.pdf not found) INN (GENTAMICIN SULFATE) GENTAK (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065024 (pdf 65024.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (FERA PHARMS LLC) APPROVAL= AP YEAR= 2004 , NDA 065121 (pdf 65121.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 209233 (pdf 209233.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209304 (pdf 209304.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (TELIGENT) APPROVAL= AP YEAR= 2019 OBSOLETE , NDA 215236 (pdf 215236.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2024 , NDA 215237 (pdf 215237.pdf not found) INN (GENTAMICIN SULFATE) GENTAMICIN SULFATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2024 , 970 ; GRISEOFULVIN ; 126-07-8 ; 1962 ; ; NATURAL MOLECULE C00002398 ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- ANTIBACTERIAL -- ANTIBIOTICS -- INDIRECT REMODELLING OF KERATIN INTERMEDIATE FILAMENTS -- TUBULIN BINDING (PUTATIVE TARGET PMID22191585) , ; NDA 050051 (pdf 50051.pdf not found) INN (GRISEOFULVIN MICROCRYSTALLINE) GRISACTIN (WYETH AYERST) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 050448 (pdf 50448.pdf not found) INN (GRISEOFULVIN MICROCRYSTALLINE) GRIFULVIN V (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 050475 (label 50475.pdf) INN (GRISEOFULVIN ULTRAMICROSIZE) GRIS-PEG (BAUSCH) APPROVAL= AP YEAR= 1975 , NDA 060212 (pdf 60212.pdf not found) INN (GRISEOFULVIN MICROCRYSTALLINE) GRISACTIN (WYETH AYERST) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 060569 (pdf 60569.pdf not found) INN (GRISEOFULVIN MICROSIZE) FULVICIN-U/F (CHARTWELL RX) APPROVAL= AP YEAR= 1971 , NDA 060618 (pdf 60618.pdf not found) INN (GRISEOFULVIN MICROCRYSTALLINE) GRIFULVIN V (J AND J) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061996 (pdf 61996.pdf not found) INN (GRISEOFULVIN ULTRAMICROSIZE) FULVICIN P/G (CHARTWELL RX) APPROVAL= AP YEAR= 1982 , NDA 062178 (pdf 62178.pdf not found) INN (GRISEOFULVIN ULTRAMICROCRYSTALLINE) GRISACTIN ULTRA (WYETH AYERST) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062279 (label 62279.pdf) INN (GRISEOFULVIN MICROSIZE) GRIFULVIN V (VALEANT LUXEMBOURG) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062438 (pdf 62438.pdf not found) INN (GRISEOFULVIN ULTRAMICROCRYSTALLINE) GRISACTIN ULTRA (WYETH AYERST) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062483 (pdf 62483.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRIFULVIN V (VALEANT LUXEMBOURG) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062645 (pdf 62645.pdf not found) INN (GRISEOFULVIN ULTRAMICROCRYSTALLINE) ULTRAGRIS-165 (PLIVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 062646 (pdf 62646.pdf not found) INN (GRISEOFULVIN ULTRAMICROCRYSTALLINE) ULTRAGRIS-330 (PLIVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 065200 (pdf 65200.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065354 (pdf 65354.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 065394 (pdf 65394.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2007 , NDA 065438 (pdf 65438.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (COSETTE) APPROVAL= AP YEAR= 2010 , NDA 202482 (pdf 202482.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2012 , NDA 202545 (pdf 202545.pdf not found) INN (GRISEOFULVIN ULTRAMICROSIZE) GRISEOFULVIN , ULTRAMICROSIZE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2012 , NDA 091592 (pdf 91592.pdf not found) INN (GRISEOFULVIN MICROSIZE) GRISEOFULVIN (SANDOZ) APPROVAL= AP YEAR= 2013 , NDA 204371 (pdf 204371.pdf not found) INN (GRISEOFULVIN ULTRAMICROSIZE) GRISEOFULVIN , ULTRAMICROSIZE (MOUNTAIN) APPROVAL= AP YEAR= 2014 , NDA 202805 (pdf 202805.pdf not found) INN (GRISEOFULVIN ULTRAMICROSIZE) GRISEOFULVIN , ULTRAMICROSIZE (SANDOZ) APPROVAL= AP YEAR= 2018 , 971 ; HETACILLIN ; 3511-16-8 ; 1971 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PENICILLINS , ; NDA 050060 (pdf 50060.pdf not found) INN (HETACILLIN) VERSAPEN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061396 (pdf 61396.pdf not found) INN (HETACILLIN POTASSIUM) VERSAPEN-K (BRISTOL) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061398 (pdf 61398.pdf not found) INN (HETACILLIN) VERSAPEN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , 972 ; BACAMPICILLIN ; 50972-17-3 ; 1980 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLIN , ; NDA 050520 (pdf 50520.pdf not found) INN (BACAMPICILLIN HYDROCHLORIDE) SPECTROBID (PFIZER) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 050556 (pdf 50556.pdf not found) INN (BACAMPICILLIN HYDROCHLORIDE) SPECTROBID (PFIZER) APPROVAL= AP YEAR= 1982 DISCONTINUED , 973 ; AMPICILLIN ; 69-53-4 ; 1965 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS -- INHIBITION OF CELL WALL MUCOPEPTIDE BIOSYNTHESIS BUT DEGRADED BY BETA-LACTAMASES , ; NDA 050072 (pdf 50072.pdf not found) INN (AMPICILLIN SODIUM) PENBRITIN-S (WYETH AYERST) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 050309 (pdf 50309.pdf not found) INN (AMPICILLIN SODIUM) POLYCILLIN-N (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050608 (label 50608.pdf) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) UNASYN (PFIZER) APPROVAL= AP YEAR= 1986 , NDA 060626 (pdf 60626.pdf not found) INN (AMPICILLIN SODIUM) OMNIPEN-N (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060677 (pdf 60677.pdf not found) INN (AMPICILLIN SODIUM) TOTACILLIN-N (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061395 (pdf 61395.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1971 , NDA 061936 (pdf 61936.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (CONSOLIDATED PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062565 (pdf 62565.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062634 (pdf 62634.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062692 (pdf 62692.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062718 (pdf 62718.pdf not found) INN (AMPICILLIN SODIUM) OMNIPEN-N (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062719 (pdf 62719.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 1987 , NDA 062727 (pdf 62727.pdf not found) INN (AMPICILLIN SODIUM) TOTACILLIN-N (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062738 (pdf 62738.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 062772 (pdf 62772.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 1993 , NDA 062797 (pdf 62797.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 1993 , NDA 062816 (pdf 62816.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062860 (pdf 62860.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062901 (pdf 62901.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) UNASYN (PFIZER) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062994 (pdf 62994.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063139 (pdf 63139.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 DISCONTINUED OBSOLETE , NDA 063140 (pdf 63140.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 063141 (pdf 63141.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 DISCONTINUED OBSOLETE , NDA 063142 (pdf 63142.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 1993 , NDA 063143 (pdf 63143.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 DISCONTINUED OBSOLETE , NDA 063145 (pdf 63145.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 063146 (pdf 63146.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 063147 (pdf 63147.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HANFORD GC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 065074 (pdf 65074.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 065076 (pdf 65076.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 065176 (pdf 65176.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 2005 , NDA 065188 (pdf 65188.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 2005 , NDA 065222 (pdf 65222.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2005 , NDA 065240 (pdf 65240.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065241 (pdf 65241.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065310 (pdf 65310.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065314 (pdf 65314.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2006 , NDA 065316 (pdf 65316.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (PHARM ASSOC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 050019 (pdf 50019.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PENBRITIN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050056 (pdf 50056.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN '250' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050093 (pdf 50093.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) POLYCILLIN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050308 (pdf 50308.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) POLYCILLIN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050310 (pdf 50310.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) POLYCILLIN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050457 (pdf 50457.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) POLYCILLIN-PRB (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050488 (pdf 50488.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PRINCIPEN W/ PROBENECID (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060060 (pdf 60060.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) TOTACILLIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060127 (pdf 60127.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN '250' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060624 (pdf 60624.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) OMNIPEN AMPICILLIN (WYETH AYERST) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 060625 (pdf 60625.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) OMNIPEN AMPICILLIN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060666 (pdf 60666.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) TOTACILLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 060765 (pdf 60765.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060908 (pdf 60908.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PENBRITIN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061370 (pdf 61370.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (TEVA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061387 (pdf 61387.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061392 (pdf 61392.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061394 (pdf 61394.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN (APOTHECON) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061502 (pdf 61502.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (CHARTWELL RX) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061601 (pdf 61601.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (BELCHER PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061602 (pdf 61602.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (BELCHER PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061741 (pdf 61741.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PROBAMPACIN (COSETTE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061755 (pdf 61755.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061829 (pdf 61829.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061853 (pdf 61853.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061898 (pdf 61898.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) POLYCILLIN-PRB (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061980 (pdf 61980.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (PUREPAC PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 062030 (pdf 62030.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMCILL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062041 (pdf 62041.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMCILL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062049 (pdf 62049.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PFIZERPEN-A (PFIZER) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 062050 (pdf 62050.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PFIZERPEN-A (PFIZER) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 062150 (pdf 62150.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE PROBENECID) PRINCIPEN W/ PROBENECID (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062151 (pdf 62151.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN '125' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062157 (pdf 62157.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN '500' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062208 (pdf 62208.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062212 (pdf 62212.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) TOTACILLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062223 (pdf 62223.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) TOTACILLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062297 (pdf 62297.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) POLYCILLIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062882 (pdf 62882.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062883 (pdf 62883.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062888 (pdf 62888.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) PRINCIPEN (APOTHECON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062982 (pdf 62982.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 064082 (pdf 64082.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 065403 (pdf 65403.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ACS DOBFAR) APPROVAL= AP YEAR= 2009 , NDA 065406 (pdf 65406.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ACS DOBFAR) APPROVAL= AP YEAR= 2009 , NDA 090354 (pdf 90354.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ANTIBIOTICE) APPROVAL= AP YEAR= 2009 , NDA 065493 (pdf 65493.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 065499 (pdf 65499.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 090339 (pdf 90339.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 090340 (pdf 90340.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090349 (pdf 90349.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 090375 (pdf 90375.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090646 (pdf 90646.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090653 (pdf 90653.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090884 (pdf 90884.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090889 (pdf 90889.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2013 , NDA 201404 (pdf 201404.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2013 , NDA 201024 (pdf 201024.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 201025 (pdf 201025.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 202197 (pdf 202197.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 202198 (pdf 202198.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 090581 (pdf 90581.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 090583 (pdf 90583.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 201406 (pdf 201406.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ANTIBIOTICE) APPROVAL= AP YEAR= 2015 , NDA 202864 (pdf 202864.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202865 (pdf 202865.pdf not found) INN (AMPICILLIN SODIUM) AMPICILLIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090578 (pdf 90578.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ASTRAL) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 090579 (pdf 90579.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ASTRAL) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 216554 (pdf 216554.pdf not found) INN (AMPICILLIN/AMPICILLIN TRIHYDRATE) AMPICILLIN TRIHYDRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , 974 ; CHLORAMPHENICOL ; 56-75-7 ; 1950 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIRICKETTSIAL -- ANTIBIOTIC -- ANTIBACTERIAL -- PROTEIN SYNTHESIS INHIBITORS -- PRODUCT BY STREPTOMYCES VENEZUELAE , ; NDA 050091 (label 50091.pdf) INN (CHLORAMPHENICOL) CHLOROPTIC (ALLERGAN) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 050143 (pdf 50143.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKEDALE) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 050153 (pdf 50153.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050155 (label 50155.pdf) INN (CHLORAMPHENICOL SODIUM SUCCINATE) CHLOROMYCETIN (PARKEDALE) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 050156 (pdf 50156.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKEDALE) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 050183 (pdf 50183.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050201 (pdf 50201.pdf not found) INN (CHLORAMPHENICOL HYDROCORTISONE ACETATE POLYMYXIN B SULFATE) OPHTHOCORT (PARKEDALE) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 050202 (pdf 50202.pdf not found) INN (CHLORAMPHENICOL HYDROCORTISONE ACETATE) CHLOROMYCETIN HYDROCORTISONE (PARKEDALE) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 050203 (label 50203.pdf) INN (CHLORAMPHENICOL POLYMYXIN B SULFATE) CHLOROMYXIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050205 (pdf 50205.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKEDALE) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 050294 (pdf 50294.pdf not found) INN (CHLORAMPHENICOL DESOXYRIBONUCLEASE FIBRINOLYSIN) ELASE-CHLOROMYCETIN (PARKE DAVIS) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060058 (pdf 60058.pdf not found) INN (CHLORAMPHENICOL) AMPHICOL (FERRANTE) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 060132 (pdf 60132.pdf not found) INN (CHLORAMPHENICOL SODIUM SUCCINATE) MYCHEL-S (ANGUS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060133 (pdf 60133.pdf not found) INN (CHLORAMPHENICOL) CHLORAMPHENICOL (ALTANA) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 060591 (pdf 60591.pdf not found) INN (CHLORAMPHENICOL) CHLOROMYCETIN (PARKEDALE) APPROVAL= AP YEAR= 1950 DISCONTINUED OBSOLETE , NDA 060851 (pdf 60851.pdf not found) INN (CHLORAMPHENICOL) MYCHEL (ARMENPHARM) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 061187 (pdf 61187.pdf not found) INN (CHLORAMPHENICOL) CHLOROPTIC S.O.P. (ALLERGAN) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 061188 (pdf 61188.pdf not found) INN (CHLORAMPHENICOL PREDNISOLONE) CHLOROPTIC-P S.O.P. (ALLERGAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061220 (pdf 61220.pdf not found) INN (CHLORAMPHENICOL) OPHTHOCHLOR (PARKEDALE) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 061645 (pdf 61645.pdf not found) INN (CHLORAMPHENICOL) ECONOCHLOR (ALCON) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061648 (pdf 61648.pdf not found) INN (CHLORAMPHENICOL) ECONOCHLOR (ALCON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062042 (pdf 62042.pdf not found) INN (CHLORAMPHENICOL) CHLORAMPHENICOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062171 (pdf 62171.pdf not found) INN (CHLORAMPHENICOL) OPTOMYCIN (OPTOPICS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062247 (pdf 62247.pdf not found) INN (CHLORAMPHENICOL) CHLORAMPHENICOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062278 (pdf 62278.pdf not found) INN (CHLORAMPHENICOL SODIUM SUCCINATE) CHLORAMPHENICOL SODIUM SUCCINATE (GRUPPO LEPETIT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062365 (pdf 62365.pdf not found) INN (CHLORAMPHENICOL SODIUM SUCCINATE) CHLORAMPHENICOL SODIUM SUCCINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062406 (pdf 62406.pdf not found) INN (CHLORAMPHENICOL SODIUM SUCCINATE) CHLORAMPHENICOL (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062437 (pdf 62437.pdf not found) INN (CHLORAMPHENICOL) CHLOROFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062439 (pdf 62439.pdf not found) INN (CHLORAMPHENICOL) CHLOROFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062628 (pdf 62628.pdf not found) INN (CHLORAMPHENICOL) CHLORAMPHENICOL (ALCON) APPROVAL= AP YEAR= 1985 DISCONTINUED , 975 ; CHLORAMPHENICOL PALMITATE ; 530-43-8 ; 0 ; DISCONTINUED ; ; CLASS DERMATOLOGICAL -- ANTIBACTERIAL -- ANTIRICKETTSIAL -- ANTIBIOTIC -- PROTEIN SYNTHESIS INHIBITORS , ; NDA 050152 (pdf 50152.pdf not found) INN (CHLORAMPHENICOL PALMITATE) CHLOROMYCETIN PALMITATE (PARKE DAVIS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 062301 (pdf 62301.pdf not found) INN (CHLORAMPHENICOL PALMITATE) CHLOROMYCETIN PALMITATE (PARKE DAVIS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , 976 ; CAPREOMYCIN ; 11003-38-6 ; 1971 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- MACROLIDE -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050095 (label 50095.pdf) INN (CAPREOMYCIN SULFATE) CAPASTAT SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 202634 (pdf 202634.pdf not found) INN (CAPREOMYCIN SULFATE) CAPREOMYCIN SULFATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204796 (pdf 204796.pdf not found) INN (CAPREOMYCIN SULFATE) CAPREOMYCIN SULFATE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2018 DISCONTINUED , 977 ; COLISTIMETHATE ; 8068-28-8 ; 1970 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- GRAM-NEGATIVE BACILLI , ; NDA 050108 (label 50108.pdf) INN (COLISTIMETHATE SODIUM) COLY-MYCIN M (ENDO OPERATIONS) APPROVAL= AP YEAR= 1970 , NDA 064216 (pdf 64216.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (XGEN PHARMS) APPROVAL= AP YEAR= 1999 , NDA 065177 (pdf 65177.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (NEXUS) APPROVAL= AP YEAR= 2004 , NDA 065364 (pdf 65364.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 202359 (pdf 202359.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 201365 (pdf 201365.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 205356 (pdf 205356.pdf not found) INN (COLISTIMETHATE SODIUM) COLISTIMETHATE SODIUM (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2015 , 978 ; NAFCILLIN ; 147-52-4 ; 1965 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS , ; NDA 050111 (pdf 50111.pdf not found) INN (NAFCILLIN SODIUM) UNIPEN (WYETH AYERST) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 050199 (pdf 50199.pdf not found) INN (NAFCILLIN SODIUM) UNIPEN (WYETH AYERST) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 050320 (pdf 50320.pdf not found) INN (NAFCILLIN SODIUM) UNIPEN (WYETH AYERST) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 050462 (pdf 50462.pdf not found) INN (NAFCILLIN SODIUM) UNIPEN (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 050655 (label 50655.pdf) INN (NAFCILLIN SODIUM) NALLPEN IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1989 , NDA 061984 (pdf 61984.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061999 (pdf 61999.pdf not found) INN (NAFCILLIN SODIUM) NALLPEN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062527 (pdf 62527.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062717 (pdf 62717.pdf not found) INN (NAFCILLIN SODIUM) UNIPEN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062732 (pdf 62732.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062755 (pdf 62755.pdf not found) INN (NAFCILLIN SODIUM) NALLPEN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062844 (pdf 62844.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063008 (pdf 63008.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 090005 (pdf 90005.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 090002 (pdf 90002.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 090560 (pdf 90560.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (ANTIBIOTICE) APPROVAL= AP YEAR= 2011 , NDA 090580 (pdf 90580.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 090582 (pdf 90582.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 091613 (pdf 91613.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2012 , NDA 091614 (pdf 91614.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2012 , NDA 200002 (pdf 200002.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 206682 (pdf 206682.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (FRESENIUS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206761 (pdf 206761.pdf not found) INN (NAFCILLIN SODIUM) NAFCILLIN SODIUM (FRESENIUS) APPROVAL= AP YEAR= 2020 , 979 ; METHICILLIN ; 61-32-5 ; 1971 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS , ; NDA 050117 (pdf 50117.pdf not found) INN (METHICILLIN SODIUM) STAPHCILLIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061449 (pdf 61449.pdf not found) INN (METHICILLIN SODIUM) STAPHCILLIN (APOTHECON) APPROVAL= AP YEAR= 1971 DISCONTINUED , 980 ; OXACILLIN ; 66-79-5 ; 1971 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS , ; NDA 050118 (pdf 50118.pdf not found) INN (OXACILLIN SODIUM) PROSTAPHLIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050194 (pdf 50194.pdf not found) INN (OXACILLIN SODIUM) PROSTAPHLIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050195 (pdf 50195.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050640 (label 50640.pdf) INN (OXACILLIN SODIUM) BACTOCILL IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1989 , NDA 061334 (pdf 61334.pdf not found) INN (OXACILLIN SODIUM) BACTOCILL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 061336 (pdf 61336.pdf not found) INN (OXACILLIN SODIUM) BACTOCILL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061450 (pdf 61450.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061457 (pdf 61457.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061490 (pdf 61490.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 062222 (pdf 62222.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (ANI PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062241 (pdf 62241.pdf not found) INN (OXACILLIN SODIUM) BACTOCILL (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062252 (pdf 62252.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (TEVA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062321 (pdf 62321.pdf not found) INN (OXACILLIN SODIUM) BACTOCILL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062711 (pdf 62711.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062736 (pdf 62736.pdf not found) INN (OXACILLIN SODIUM) BACTOCILL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062737 (pdf 62737.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062798 (pdf 62798.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 062856 (pdf 62856.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062984 (pdf 62984.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 091245 (pdf 91245.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 091246 (pdf 91246.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 201538 (pdf 201538.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2013 , NDA 201539 (pdf 201539.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2013 , NDA 091486 (pdf 91486.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 203950 (pdf 203950.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207147 (pdf 207147.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 206681 (pdf 206681.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206760 (pdf 206760.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207148 (pdf 207148.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 206198 (pdf 206198.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 206199 (pdf 206199.pdf not found) INN (OXACILLIN SODIUM) OXACILLIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , 981 ; PENICILLIN G ; 61-33-6 ; 1947 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- PENICILLINS -- ANTIBIOTIC , ; NDA 050126 (pdf 50126.pdf not found) INN (PENICILLIN G BENZATHINE) BICILLIN (WYETH AYERST) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 050128 (pdf 50128.pdf not found) INN (PENICILLIN G BENZATHINE) BICILLIN (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050131 (pdf 50131.pdf not found) INN (PENICILLIN G BENZATHINE) BICILLIN L-A (WYETH AYERST) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 050138 (label 50138.pdf) INN (PENICILLIN G BENZATHINE PENICILLIN G PROCAINE) BICILLIN C-R (KING PHARMS LLC) APPROVAL= AP YEAR= 1953 , NDA 050141 (label 50141.pdf) INN (PENICILLIN G BENZATHINE) BICILLIN L-A (KING PHARMS LLC) APPROVAL= AP YEAR= 1952 , NDA 050638 (label 50638.pdf) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1990 , NDA 060014 (pdf 60014.pdf not found) INN (PENICILLIN G BENZATHINE) PERMAPEN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 060073 (pdf 60073.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060074 (pdf 60074.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (PFIZER) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 060075 (pdf 60075.pdf not found) INN (PENICILLIN G POTASSIUM) PFIZERPEN G (PFIZER) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 060093 (pdf 60093.pdf not found) INN (PENICILLIN G PROCAINE) DURACILLIN A.S. (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060099 (pdf 60099.pdf not found) INN (PENICILLIN G PROCAINE) PENICILLIN G PROCAINE (PFIZER) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 060101 (pdf 60101.pdf not found) INN (PENICILLIN G PROCAINE) PENICILLIN G PROCAINE (KING PHARMS LLC) APPROVAL= AP YEAR= 1948 , NDA 060286 (pdf 60286.pdf not found) INN (PENICILLIN G PROCAINE) PFIZERPEN-AS (PFIZER) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 060306 (pdf 60306.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (TEVA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 060307 (pdf 60307.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN (TEVA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060362 (pdf 60362.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060384 (pdf 60384.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060392 (pdf 60392.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060403 (pdf 60403.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060413 (pdf 60413.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060587 (pdf 60587.pdf not found) INN (PENICILLIN G POTASSIUM) PFIZERPEN G (PFIZER) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 060601 (pdf 60601.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060657 (pdf 60657.pdf not found) INN (PENICILLIN G POTASSIUM) PFIZERPEN (PFIZER) APPROVAL= AP YEAR= 1968 , NDA 060752 (pdf 60752.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060781 (pdf 60781.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (MYLAN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 060800 (pdf 60800.pdf not found) INN (PENICILLIN G PROCAINE) PENICILLIN G PROCAINE (CONSOLIDATED PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060806 (pdf 60806.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (CONSOLIDATED PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061046 (pdf 61046.pdf not found) INN (PENICILLIN G SODIUM) PENICILLIN G SODIUM (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061051 (pdf 61051.pdf not found) INN (PENICILLIN G SODIUM) PENICILLIN G SODIUM (COPANOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061588 (pdf 61588.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061740 (pdf 61740.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061935 (pdf 61935.pdf not found) INN (PENICILLIN G SODIUM) PENICILLIN G SODIUM (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062003 (label 62003.pdf) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062029 (pdf 62029.pdf not found) INN (PENICILLIN G PROCAINE) PENICILLIN G PROCAINE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062149 (pdf 62149.pdf not found) INN (PENICILLIN G POTASSIUM) PENTIDS '200' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062155 (pdf 62155.pdf not found) INN (PENICILLIN G POTASSIUM) PENTIDS '200' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062991 (pdf 62991.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063014 (pdf 63014.pdf not found) INN (PENICILLIN G SODIUM) PENICILLIN G SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 065068 (label 65068.pdf) INN (PENICILLIN G SODIUM) PENICILLIN G SODIUM (SANDOZ) APPROVAL= AP YEAR= 2001 , NDA 065079 (pdf 65079.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 050114 (label 50114.pdf) INN (BENZYLPENICILLOYL POLYLYSINE) PRE-PEN (ALLERQUEST) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY , NDA 065149 (pdf 65149.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 2009 , NDA 065448 (pdf 65448.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2009 , NDA 205043 (pdf 205043.pdf not found) INN (PENICILLIN G POTASSIUM) PENICILLIN G POTASSIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2018 , 982 ; PENICILLIN V ; 87-08-1 ; 1958 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PENICILLINS , ; NDA 060002 (pdf 60002.pdf not found) INN (PENICILLIN V) V-CILLIN (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060003 (pdf 60003.pdf not found) INN (PENICILLIN V POTASSIUM) V-CILLIN K (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060004 (pdf 60004.pdf not found) INN (PENICILLIN V POTASSIUM) V-CILLIN K (LILLY) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 060006 (pdf 60006.pdf not found) INN (PENICILLIN V POTASSIUM) PEN-VEE K (WYETH AYERST) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 060007 (pdf 60007.pdf not found) INN (PENICILLIN V POTASSIUM) PEN-VEE K (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060134 (pdf 60134.pdf not found) INN (PENICILLIN V POTASSIUM) LEDERCILLIN VK (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060136 (pdf 60136.pdf not found) INN (PENICILLIN V POTASSIUM) LEDERCILLIN VK (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060456 (pdf 60456.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN-VK (TEVA) APPROVAL= AP YEAR= 1968 , NDA 060518 (pdf 60518.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060711 (pdf 60711.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN-VK (TEVA) APPROVAL= AP YEAR= 1968 , NDA 061149 (pdf 61149.pdf not found) INN (PENICILLIN V POTASSIUM) BETAPEN-VK (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061150 (pdf 61150.pdf not found) INN (PENICILLIN V POTASSIUM) BETAPEN-VK (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061164 (pdf 61164.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS '250' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061206 (pdf 61206.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS '125' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061410 (pdf 61410.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS (APOTHECON) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061411 (pdf 61411.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS (APOTHECON) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 061528 (pdf 61528.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (BELCHER PHARMS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061529 (pdf 61529.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (BELCHER PHARMS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061530 (pdf 61530.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061571 (pdf 61571.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061624 (pdf 61624.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (MYLAN) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061651 (pdf 61651.pdf not found) INN (PENICILLIN V POTASSIUM) UTICILLIN VK (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061758 (pdf 61758.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (PUREPAC PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 061815 (pdf 61815.pdf not found) INN (PENICILLIN V POTASSIUM) PFIZERPEN VK (PFIZER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061836 (pdf 61836.pdf not found) INN (PENICILLIN V POTASSIUM) PFIZERPEN VK (PFIZER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062001 (pdf 62001.pdf not found) INN (PENICILLIN V POTASSIUM) PENAPAR-VK (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062002 (pdf 62002.pdf not found) INN (PENICILLIN V POTASSIUM) PENAPAR-VK (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062153 (pdf 62153.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS '125' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062156 (pdf 62156.pdf not found) INN (PENICILLIN V POTASSIUM) VEETIDS '500' (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062270 (pdf 62270.pdf not found) INN (PENICILLIN V POTASSIUM) BEEPEN-VK (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062273 (pdf 62273.pdf not found) INN (PENICILLIN V POTASSIUM) BEEPEN-VK (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062935 (pdf 62935.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 062936 (pdf 62936.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 062981 (pdf 62981.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 064071 (label 64071.pdf) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 065435 (pdf 65435.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 090549 (pdf 90549.pdf not found) INN (PENICILLIN V POTASSIUM) PENICILLIN V POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2013 , 983 ; STREPTOZOCIN ; 18883-66-4 ; 1982 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENT OF NITROSOUREA CLASS -- TOXICITY TO BETA CELLS -- PRODUCT OF STREPTOMYCES ACHROMOGENES -- ANTIBIOTIC -- NOT ACTIVE ORALLY , ; NDA 050577 (pdf 50577.pdf not found) INN (STREPTOZOCIN) ZANOSAR (TEVA PHARMS USA) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , 984 ; CLINDAMYCIN ; 18323-44-9 ; 1970 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PROTEIN SYNTHESIS INHIBITORS -- ANTIMALARIALS , ; NDA 050162 (label 50162.pdf) INN (CLINDAMYCIN HYDROCHLORIDE) CLEOCIN HYDROCHLORIDE (PFIZER) APPROVAL= AP YEAR= 1970 , NDA 061809 (pdf 61809.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLEOCIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063027 (pdf 63027.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063029 (pdf 63029.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063082 (pdf 63082.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063083 (pdf 63083.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 065061 (pdf 65061.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2001 , NDA 065194 (pdf 65194.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 , NDA 065217 (pdf 65217.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 065242 (pdf 65242.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (LANNETT) APPROVAL= AP YEAR= 2005 , NDA 065243 (pdf 65243.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2005 , NDA 065442 (pdf 65442.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 091225 (pdf 91225.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 207402 (pdf 207402.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 216957 (pdf 216957.pdf not found) INN (CLINDAMYCIN HYDROCHLORIDE) CLINDAMYCIN HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , 985 ; CEFPODOXIME PROXETIL ; 87239-81-4 ; 1992 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS -- CELL WALL SYNTHESIS , ; NDA 050674 (label 50674.pdf) INN (CEFPODOXIME PROXETIL) VANTIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 050675 (label 50675.pdf) INN (CEFPODOXIME PROXETIL) VANTIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 050687 (label 50687.pdf) INN (CEFPODOXIME PROXETIL) BANAN (SANKYO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 050688 (label 50688.pdf) INN (CEFPODOXIME PROXETIL) BANAN (SANKYO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 065082 (pdf 65082.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065083 (pdf 65083.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065370 (pdf 65370.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065388 (pdf 65388.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 , NDA 065409 (pdf 65409.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2007 , NDA 065462 (label 65462.pdf) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 090031 (label 90031.pdf) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 210568 (pdf 210568.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , 986 ; CLOXACILLIN ; 61-72-3 ; 1971 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLIN , ; NDA 050192 (pdf 50192.pdf not found) INN (CLOXACILLIN SODIUM) TEGOPEN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061452 (pdf 61452.pdf not found) INN (CLOXACILLIN SODIUM) CLOXACILLIN SODIUM (APOTHECON) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 061453 (pdf 61453.pdf not found) INN (CLOXACILLIN SODIUM) TEGOPEN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061806 (pdf 61806.pdf not found) INN (CLOXACILLIN SODIUM) CLOXAPEN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062233 (pdf 62233.pdf not found) INN (CLOXACILLIN SODIUM) CLOXAPEN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062240 (pdf 62240.pdf not found) INN (CLOXACILLIN SODIUM) CLOXACILLIN SODIUM (TEVA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062268 (pdf 62268.pdf not found) INN (CLOXACILLIN SODIUM) CLOXACILLIN SODIUM (TEVA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062978 (pdf 62978.pdf not found) INN (CLOXACILLIN SODIUM) CLOXACILLIN SODIUM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , 987 ; TETRACYCLINE ; 60-54-8 ; 1953 ; ; ; CLASS ANTIINFECTIVES -- ANTI-BACTERIAL AGENTS -- ANTIPROTOZOALS -- PROTEIN SYNTHESIS INHIBITORS -- TETRACYCLINES -- ANTIRICKETTSIAL -- ANTIBIOTIC -- ANTIAMEBIC -- ANTIMALARIALS , ; NDA 050212 (pdf 50212.pdf not found) INN (TETRACYCLINE PHOSPHATE COMPLEX) TETREX (BRISTOL) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050263 (pdf 50263.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN V (LEDERLE) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 050266 (pdf 50266.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (STORZ) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050268 (pdf 50268.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (STORZ) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 050272 (pdf 50272.pdf not found) INN (HYDROCORTISONE TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (LEDERLE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050273 (pdf 50273.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (LEDERLE) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 050276 (pdf 50276.pdf not found) INN (PROCAINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN (LEDERLE) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 050278 (label 50278.pdf) INN (TETRACYCLINE HYDROCHLORIDE) ACHROMYCIN V (AVET) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050493 (pdf 50493.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TOPICYCLINE (SHIRE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 050653 (pdf 50653.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ACTISITE (SCHIFF AND CO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 050719 (label 50719.pdf) INN (BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) HELIDAC (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050786 (label 50786.pdf) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) PYLERA (ALLERGAN) APPROVAL= AP YEAR= 2006 , NDA 060059 (pdf 60059.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060082 (pdf 60082.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYN (PFIPHARMECS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060095 (pdf 60095.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYN (PFIPHARMECS) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 060096 (pdf 60096.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060173 (pdf 60173.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (FERRANTE) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060174 (pdf 60174.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (FERRANTE) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060285 (pdf 60285.pdf not found) INN (PROCAINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE) TETRACYN (PFIZER) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060290 (pdf 60290.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060291 (pdf 60291.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060343 (pdf 60343.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACHEL (ANGUS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060347 (pdf 60347.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) PANMYCIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060400 (pdf 60400.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) SUMYCIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 060429 (pdf 60429.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) SUMYCIN (APOTHECON) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060446 (pdf 60446.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (PROTER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060469 (pdf 60469.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 060471 (pdf 60471.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (VALEANT PHARM INTL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060633 (pdf 60633.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060704 (label 60704.pdf) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 060736 (pdf 60736.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 060768 (pdf 60768.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 060783 (pdf 60783.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 061147 (pdf 61147.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) SUMYCIN (STRIDES PHARMA) APPROVAL= AP YEAR= 1971 , NDA 061148 (pdf 61148.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061214 (pdf 61214.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061443 (pdf 61443.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) RETET (SOLVAY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061468 (pdf 61468.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRAMED (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061471 (pdf 61471.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 061653 (pdf 61653.pdf not found) INN (TETRACYCLINE PHOSPHATE COMPLEX) TETREX (BRISTOL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061658 (pdf 61658.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) BRISTACYCLINE (BRISTOL) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061685 (pdf 61685.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061705 (pdf 61705.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) PANMYCIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061725 (pdf 61725.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) CYCLOPAR (WARNER CHILCOTT) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061734 (pdf 61734.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) ROBITET (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061802 (pdf 61802.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061837 (pdf 61837.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 061888 (pdf 61888.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) BRISTACYCLINE (BRISTOL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061889 (pdf 61889.pdf not found) INN (TETRACYCLINE PHOSPHATE COMPLEX) TETREX (BRISTOL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062085 (pdf 62085.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (MAST MM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 062103 (pdf 62103.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 062175 (pdf 62175.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) CYCLOPAR (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 062300 (pdf 62300.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062332 (pdf 62332.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) CYCLOPAR (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062343 (pdf 62343.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062540 (pdf 62540.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062686 (pdf 62686.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062752 (pdf 62752.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (CHARTWELL TETRA) APPROVAL= AP YEAR= 1988 , NDA 202584 (pdf 202584.pdf not found) INN (BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBSALICYLATE , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (AILEX PHARMS LLC) APPROVAL= AP YEAR= 2018 , NDA 210662 (pdf 210662.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 , NDA 210674 (pdf 210674.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2018 , NDA 212635 (pdf 212635.pdf not found) INN (TETRACYCLINE HYDROCHLORIDE) TETRACYCLINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 205770 (pdf 205770.pdf not found) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBCITRATE POTASSIUM , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 2023 , NDA 217511 (pdf 217511.pdf not found) INN (BISMUTH SUBCITRATE POTASSIUM METRONIDAZOLE TETRACYCLINE HYDROCHLORIDE) BISMUTH SUBCITRATE POTASSIUM , METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2023 , 988 ; PENTOBARBITAL ; 76-74-4 ; 1973 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- BARBITURATES -- GABA MODULATORS -- SEDATIVES -- ANTICONVULSANTS , ; NDA 083239 (pdf 83239.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083244 (pdf 83244.pdf not found) INN (PENTOBARBITAL) NEMBUTAL (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083245 (pdf 83245.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083246 (pdf 83246.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (RISING) APPROVAL= AP YEAR= 1973 , NDA 083247 (pdf 83247.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083259 (pdf 83259.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083261 (pdf 83261.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083264 (pdf 83264.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083270 (pdf 83270.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (ELKINS SINN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083284 (pdf 83284.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (VITARINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083285 (pdf 83285.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083301 (pdf 83301.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083338 (pdf 83338.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083368 (pdf 83368.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083461 (pdf 83461.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084093 (pdf 84093.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084095 (pdf 84095.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084156 (pdf 84156.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PARKE DAVIS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084238 (pdf 84238.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084560 (pdf 84560.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084590 (pdf 84590.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (ANABOLIC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084677 (pdf 84677.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085791 (pdf 85791.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085915 (pdf 85915.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085937 (pdf 85937.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 206404 (pdf 206404.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 203619 (pdf 203619.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (HIKMA) APPROVAL= AP YEAR= 2017 , NDA 206677 (pdf 206677.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (BPI LABS) APPROVAL= AP YEAR= 2017 , 989 ; CEPHALOGLYCIN ; 3577-01-3 ; 1970 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PENICILLIN , ; NDA 050219 (pdf 50219.pdf not found) INN (CEPHALOGLYCIN) KAFOCIN (LILLY) APPROVAL= AP YEAR= 1970 DISCONTINUED , 990 ; NYSTATIN ; 1400-61-9 ; 1964 ; ; ; CLASS DERMATOLOGICALS -- ANTI-BACTERIAL AGENTS -- ANTIFUNGAL AGENTS -- FOR ORAL CAVITY (GASTROINTESTINAL ABSORPTION IS INSIGNIFICANT) , ; NDA 050233 (pdf 50233.pdf not found) INN (NYSTATIN) CANDEX (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050235 (pdf 50235.pdf not found) INN (CLIOQUINOL NYSTATIN) NYSTAFORM (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050299 (pdf 50299.pdf not found) INN (NYSTATIN) NILSTAT (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050478 (pdf 50478.pdf not found) INN (NYSTATIN) NYSERT (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050576 (pdf 50576.pdf not found) INN (NYSTATIN) NILSTAT (STRIDES PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 050619 (pdf 50619.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 060571 (pdf 60571.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060572 (pdf 60572.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 060574 (pdf 60574.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060575 (pdf 60575.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 060576 (pdf 60576.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 060577 (pdf 60577.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060578 (pdf 60578.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 061151 (pdf 61151.pdf not found) INN (NYSTATIN) NILSTAT (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061325 (pdf 61325.pdf not found) INN (NYSTATIN) NILSTAT (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061444 (pdf 61444.pdf not found) INN (NYSTATIN) NILSTAT (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061445 (pdf 61445.pdf not found) INN (NYSTATIN) NILSTAT (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061533 (pdf 61533.pdf not found) INN (NYSTATIN) MYCOSTATIN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061718 (pdf 61718.pdf not found) INN (NYSTATIN) KOROSTATIN (HOLLAND RANTOS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061810 (pdf 61810.pdf not found) INN (NYSTATIN) CANDEX (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061954 (pdf 61954.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCO-TRIACET II (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 061965 (pdf 61965.pdf not found) INN (NYSTATIN) NYSTATIN (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 061966 (pdf 61966.pdf not found) INN (NYSTATIN) NYSTATIN (COSETTE) APPROVAL= AP YEAR= 1976 , NDA 062045 (pdf 62045.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCO-TRIACET II (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062065 (pdf 62065.pdf not found) INN (NYSTATIN) NYSTATIN (SANDOZ) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 062124 (pdf 62124.pdf not found) INN (NYSTATIN) NYSTATIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 1982 , NDA 062129 (pdf 62129.pdf not found) INN (NYSTATIN) NYSTATIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 1979 , NDA 062176 (pdf 62176.pdf not found) INN (NYSTATIN) NYSTATIN (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062186 (pdf 62186.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062225 (pdf 62225.pdf not found) INN (NYSTATIN) NYSTATIN (PADAGIS US) APPROVAL= AP YEAR= 1979 , NDA 062280 (pdf 62280.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062347 (pdf 62347.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062349 (pdf 62349.pdf not found) INN (NYSTATIN) NYSTATIN (G AND W LABS INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062364 (pdf 62364.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1987 , NDA 062367 (pdf 62367.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYKACET (COSETTE) APPROVAL= AP YEAR= 1985 , NDA 062387 (pdf 62387.pdf not found) INN (NYSTATIN) MYKINAC (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062402 (pdf 62402.pdf not found) INN (NYSTATIN) NYSTATIN (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062457 (pdf 62457.pdf not found) INN (NYSTATIN) NYSTATIN (TARO) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 062459 (pdf 62459.pdf not found) INN (NYSTATIN) NYSTATIN (FOUGERA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062460 (pdf 62460.pdf not found) INN (NYSTATIN) NYSTATIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062472 (pdf 62472.pdf not found) INN (NYSTATIN) NYSTATIN (PADAGIS US) APPROVAL= AP YEAR= 1984 , NDA 062474 (pdf 62474.pdf not found) INN (NYSTATIN) NYSTATIN (HERITAGE PHARMS) APPROVAL= AP YEAR= 1983 , NDA 062489 (pdf 62489.pdf not found) INN (NYSTATIN) BARSTATIN 100 (BARLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062502 (pdf 62502.pdf not found) INN (NYSTATIN) NYSTATIN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062506 (pdf 62506.pdf not found) INN (NYSTATIN) NYSTATIN (TEVA) APPROVAL= AP YEAR= 1984 , NDA 062509 (pdf 62509.pdf not found) INN (NYSTATIN) NYSTATIN (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062512 (pdf 62512.pdf not found) INN (NYSTATIN) NYSTATIN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1984 , NDA 062517 (pdf 62517.pdf not found) INN (NYSTATIN) NYSTATIN (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1984 , NDA 062518 (pdf 62518.pdf not found) INN (NYSTATIN) NYSTATIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062519 (pdf 62519.pdf not found) INN (NYSTATIN) NYSTEX (SAVAGE LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062524 (pdf 62524.pdf not found) INN (NYSTATIN) NYSTATIN (CHARTWELL RX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062525 (pdf 62525.pdf not found) INN (NYSTATIN) NYSTATIN (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062541 (pdf 62541.pdf not found) INN (NYSTATIN) NYSTATIN (PHARMAFAIR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062571 (pdf 62571.pdf not found) INN (NYSTATIN) NYSTATIN (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062596 (pdf 62596.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062597 (pdf 62597.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYTREX F (SAVAGE LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062599 (pdf 62599.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1985 , NDA 062601 (pdf 62601.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYTREX F (SAVAGE LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062602 (pdf 62602.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1985 , NDA 062603 (pdf 62603.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN-TRIAMCINOLONE ACETONIDE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062606 (pdf 62606.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYCOLOG-II (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062613 (pdf 62613.pdf not found) INN (NYSTATIN) NYSTATIN (PADDOCK LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062615 (pdf 62615.pdf not found) INN (NYSTATIN) NYSTATIN (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062656 (pdf 62656.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062657 (pdf 62657.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062670 (pdf 62670.pdf not found) INN (NYSTATIN) NYSTATIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062731 (pdf 62731.pdf not found) INN (NYSTATIN) MYKINAC (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062733 (pdf 62733.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) MYKACET (COSETTE) APPROVAL= AP YEAR= 1987 , NDA 062776 (pdf 62776.pdf not found) INN (NYSTATIN) NYSTATIN (COSETTE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062832 (pdf 62832.pdf not found) INN (NYSTATIN) NYSTATIN (MLV) APPROVAL= AP YEAR= 1991 , NDA 062835 (pdf 62835.pdf not found) INN (NYSTATIN) NYSTATIN (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062838 (pdf 62838.pdf not found) INN (NYSTATIN) NYSTATIN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 , NDA 062840 (pdf 62840.pdf not found) INN (NYSTATIN) NYSTATIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1987 , NDA 062876 (pdf 62876.pdf not found) INN (NYSTATIN) NYSTATIN (TARO) APPROVAL= AP YEAR= 1988 , NDA 062949 (pdf 62949.pdf not found) INN (NYSTATIN) NYSTATIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1988 , NDA 063010 (pdf 63010.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063305 (pdf 63305.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TARO) APPROVAL= AP YEAR= 1993 , NDA 064022 (pdf 64022.pdf not found) INN (NYSTATIN) NYSTATIN (TARO) APPROVAL= AP YEAR= 1993 , NDA 064042 (pdf 64042.pdf not found) INN (NYSTATIN) NYSTATIN (AKORN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 064118 (pdf 64118.pdf not found) INN (NYSTATIN) NYSTOP (PADAGIS US) APPROVAL= AP YEAR= 1996 , NDA 064142 (label 64142.pdf) INN (NYSTATIN) NYSTATIN (VISTAPHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065138 (pdf 65138.pdf not found) INN (NYSTATIN) NYSTATIN (LUPIN) APPROVAL= AP YEAR= 2004 , NDA 065148 (pdf 65148.pdf not found) INN (NYSTATIN) NYSTATIN (GENUS) APPROVAL= AP YEAR= 2005 , NDA 065175 (pdf 65175.pdf not found) INN (NYSTATIN) NYSTATIN (ADRASTEA PHARMA) APPROVAL= AP YEAR= 2004 , NDA 065183 (pdf 65183.pdf not found) INN (NYSTATIN) NYSTATIN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 065203 (pdf 65203.pdf not found) INN (NYSTATIN) NYSTATIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2004 , NDA 065315 (pdf 65315.pdf not found) INN (NYSTATIN) NYSTATIN (STRIDES PHARMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065321 (pdf 65321.pdf not found) INN (NYSTATIN) NYSTATIN (NESHER PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065422 (pdf 65422.pdf not found) INN (NYSTATIN) NYSTATIN (VISTAPHARM) APPROVAL= AP YEAR= 2011 OBSOLETE , NDA 203621 (pdf 203621.pdf not found) INN (NYSTATIN) NYSTATIN (PHARM ASSOC) APPROVAL= AP YEAR= 2016 , NDA 208300 (pdf 208300.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 206785 (pdf 206785.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 207380 (pdf 207380.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2016 , NDA 208136 (pdf 208136.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 208287 (pdf 208287.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 , NDA 208326 (pdf 208326.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (DR REDDYS) APPROVAL= AP YEAR= 2016 , NDA 207217 (pdf 207217.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (AKORN) APPROVAL= AP YEAR= 2017 , NDA 207741 (pdf 207741.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 208479 (pdf 208479.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2017 , NDA 208581 (pdf 208581.pdf not found) INN (NYSTATIN) NYSTATIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208838 (pdf 208838.pdf not found) INN (NYSTATIN) NYSTATIN (LYNE) APPROVAL= AP YEAR= 2017 , NDA 207730 (pdf 207730.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CROWN LABS INC) APPROVAL= AP YEAR= 2017 , NDA 207731 (pdf 207731.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CROWN LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207733 (pdf 207733.pdf not found) INN (NYSTATIN) NYSTATIN (CROWN LABS INC) APPROVAL= AP YEAR= 2017 , NDA 209114 (pdf 209114.pdf not found) INN (NYSTATIN) NYSTATIN (COSETTE) APPROVAL= AP YEAR= 2017 , NDA 207767 (pdf 207767.pdf not found) INN (NYSTATIN) NYSTATIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 208205 (pdf 208205.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 209082 (pdf 209082.pdf not found) INN (NYSTATIN) NYSTATIN (LYNE) APPROVAL= AP YEAR= 2018 , NDA 209990 (pdf 209990.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210077 (pdf 210077.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210532 (pdf 210532.pdf not found) INN (NYSTATIN) NYSTATIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 207764 (pdf 207764.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CADILA) APPROVAL= AP YEAR= 2018 , NDA 211838 (pdf 211838.pdf not found) INN (NYSTATIN) NYSTATIN (TORRENT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207316 (pdf 207316.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212557 (pdf 212557.pdf not found) INN (NYSTATIN) NYSTATIN (TORRENT) APPROVAL= AP YEAR= 2019 , NDA 213142 (pdf 213142.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (TORRENT) APPROVAL= AP YEAR= 2020 , NDA 213826 (pdf 213826.pdf not found) INN (NYSTATIN) NYSTATIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214090 (pdf 214090.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 213566 (pdf 213566.pdf not found) INN (NYSTATIN) NYSTATIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214751 (pdf 214751.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214186 (pdf 214186.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 214346 (pdf 214346.pdf not found) INN (NYSTATIN) NYSTATIN (LEADING) APPROVAL= AP YEAR= 2022 , NDA 214181 (pdf 214181.pdf not found) INN (NYSTATIN TRIAMCINOLONE ACETONIDE) NYSTATIN AND TRIAMCINOLONE ACETONIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2022 , 991 ; CLIOQUINOL ; 130-26-7 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVE -- ANTIAMEBIC -- ANTIFUNGAL -- METAL CHELATOR , ; NDA 050235 (pdf 50235.pdf not found) INN (CLIOQUINOL NYSTATIN) NYSTAFORM (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 992 ; DEMECLOCYCLINE ; 127-33-3 ; 1960 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- TETRACYCLINES -- PRODUCT BY STREPTOMYCES AUREOFACIENS , ; NDA 050257 (pdf 50257.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DECLOMYCIN (LEDERLE) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 050261 (label 50261.pdf) INN (DEMECLOCYCLINE HYDROCHLORIDE) DECLOMYCIN (COREPHARMA) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050262 (pdf 50262.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DECLOMYCIN (LEDERLE) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 065094 (pdf 65094.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DEMECLOCYCLINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065171 (pdf 65171.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DEMECLOCYCLINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065425 (pdf 65425.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DEMECLOCYCLINE HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 2008 , NDA 065389 (pdf 65389.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DEMECLOCYCLINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 , NDA 065447 (pdf 65447.pdf not found) INN (DEMECLOCYCLINE HYDROCHLORIDE) DEMECLOCYCLINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , 993 ; OXYTETRACYCLINE ; 79-57-2 ; 1964 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- TETRACYCLINES , ; NDA 050286 (pdf 50286.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) TERRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050287 (pdf 50287.pdf not found) INN (OXYTETRACYCLINE) TERRAMYCIN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060179 (pdf 60179.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) OXY-KESSO-TETRA (FERRANTE) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 060567 (pdf 60567.pdf not found) INN (LIDOCAINE HYDROCHLORIDE OXYTETRACYCLINE) TERRAMYCIN (PFIZER) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 060586 (pdf 60586.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) TERRAMYCIN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060595 (pdf 60595.pdf not found) INN (OXYTETRACYCLINE CALCIUM) TERRAMYCIN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060634 (pdf 60634.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) OXYTETRACYCLINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060760 (pdf 60760.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) OXYTETRACYCLINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 060770 (pdf 60770.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) OXYTETRACYCLINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 060869 (pdf 60869.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE) OXYTETRACYCLINE HYDROCHLORIDE (PROTER) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 061009 (pdf 61009.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE POLYMYXIN B SULFATE) TERRAMYCIN-POLYMYXIN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061015 (pdf 61015.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE POLYMYXIN B SULFATE) TERRAMYCIN W/ POLYMYXIN B SULFATE (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 061016 (pdf 61016.pdf not found) INN (HYDROCORTISONE ACETATE OXYTETRACYCLINE HYDROCHLORIDE) TERRA-CORTRIL (PFIZER) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 061841 (pdf 61841.pdf not found) INN (OXYTETRACYCLINE HYDROCHLORIDE POLYMYXIN B SULFATE) TERRAMYCIN W/ POLYMYXIN (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , 994 ; CARBENICILLIN ; 4697-36-3 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CELL WALL SYNTHESIS , ; NDA 050298 (pdf 50298.pdf not found) INN (CARBENICILLIN DISODIUM) PYOPEN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050306 (pdf 50306.pdf not found) INN (CARBENICILLIN DISODIUM) GEOPEN (ROERIG) APPROVAL= - YEAR= 0 DISCONTINUED , 995 ; TETRAHYDROZOLINE ; 84-22-0 ; 1979 ; ; ; CLASS CARDIOVASCULAR -- ADRENERGIC AGONIST -- NASAL DECONGESTANT -- VASOCONSTRICTOR -- IMIDAZOLINE DERIVATIVE , ; NDA 086576 (pdf 86576.pdf not found) INN (TETRAHYDROZOLINE HYDROCHLORIDE) TYZINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1979 , 996 ; AMPHOTERICIN B ; 1397-89-3 ; 1964 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL -- AMEBICIDES -- ANTI-BACTERIAL AGENTS -- ANTIPROTOZOAL AGENTS -- PRODUCED FROM A STRAIN OF STREPTOMYCES NODOSUS -- HIGH AFFINITY FOR THE ERGOSTEROL COMPONENT OF THE FUNGAL CELL MEMBRANE , ; NDA 050313 (pdf 50313.pdf not found) INN (AMPHOTERICIN B) FUNGIZONE (APOTHECON) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 050314 (pdf 50314.pdf not found) INN (AMPHOTERICIN B) FUNGIZONE (APOTHECON) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 050341 (pdf 50341.pdf not found) INN (AMPHOTERICIN B) FUNGIZONE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050724 (pdf 50724.pdf not found) INN (AMPHOTERICIN B) ABELCET (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 1995 , NDA 050729 (pdf 50729.pdf not found) INN (AMPHOTERICIN B) AMPHOTEC (ALKOPHARMA USA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050740 (label 50740.pdf) INN (AMPHOTERICIN B) AMBISOME (ASTELLAS) APPROVAL= AP YEAR= 1997 , NDA 060517 (pdf 60517.pdf not found) INN (AMPHOTERICIN B) FUNGIZONE (APOTHECON) APPROVAL= AP YEAR= 1966 DISCONTINUED , NDA 060570 (pdf 60570.pdf not found) INN (AMPHOTERICIN B) FUNGIZONE (APOTHECON) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 062728 (pdf 62728.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 063206 (pdf 63206.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (XGEN PHARMS) APPROVAL= AP YEAR= 1992 , NDA 064062 (pdf 64062.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (TEVA PARENTERAL) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064141 (pdf 64141.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (ABBOTT) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 212514 (pdf 212514.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (SPIL) APPROVAL= AP YEAR= 2021 , NDA 214010 (pdf 214010.pdf not found) INN (AMPHOTERICIN B) AMPHOTERICIN B (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , 997 ; MINOCYCLINE ; 10118-90-8 ; 1971 ; ; NATURAL MOLECULE C00018686 ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- TETRACYCLINES , ; NDA 050315 (pdf 50315.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCIN (TRIAX PHARMS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050444 (label 50444.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCIN (REMPEX) APPROVAL= AP YEAR= 1972 , NDA 050445 (label 50445.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCIN (BAUSCH) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 050451 (pdf 50451.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (TRIAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 050649 (label 50649.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCIN (BAUSCH) APPROVAL= AP YEAR= 1990 , NDA 050781 (label 50781.pdf) INN (MINOCYCLINE HYDROCHLORIDE) ARESTIN (ORAPHARMA) APPROVAL= AP YEAR= 2001 , NDA 050808 (label 50808.pdf) INN (MINOCYCLINE HYDROCHLORIDE) SOLODYN (BAUSCH) APPROVAL= AP YEAR= 2006 , NDA 062139 (pdf 62139.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCIN (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063009 (label 63009.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (ZYDUS) APPROVAL= AP YEAR= 1992 , NDA 063011 (pdf 63011.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (ZYDUS) APPROVAL= AP YEAR= 1992 , NDA 063065 (label 63065.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 063066 (pdf 63066.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) DYNACIN (CNTY LINE PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 063067 (pdf 63067.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) DYNACIN (ALVOGEN) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063181 (pdf 63181.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 , NDA 065005 (label 65005.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1999 , NDA 065062 (pdf 65062.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2000 , NDA 065131 (label 65131.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 , NDA 065156 (pdf 65156.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2004 , NDA 065436 (pdf 65436.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 065470 (pdf 65470.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 065485 (pdf 65485.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090024 (pdf 90024.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090422 (pdf 90422.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 090911 (label 90911.pdf) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091424 (pdf 91424.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 , NDA 201467 (pdf 201467.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 201922 (label 201922.pdf) INN (MINOCYCLINE HYDROCHLORIDE) XIMINO (JOURNEY) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202261 (pdf 202261.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090867 (pdf 90867.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 , NDA 091118 (pdf 91118.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203443 (pdf 203443.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204394 (pdf 204394.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (SIDMAK LABS INDIA) APPROVAL= AP YEAR= 2015 , NDA 090217 (pdf 90217.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2016 , NDA 204453 (pdf 204453.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 209269 (pdf 209269.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOLIRA (EPI HLTH) APPROVAL= AP YEAR= 2017 , NDA 203553 (pdf 203553.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 212379 (label 212379.pdf) INN (MINOCYCLINE HYDROCHLORIDE) AMZEEQ (JOURNEY) APPROVAL= AP YEAR= 2019 , NDA 213662 (pdf 213662.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213690 (label 213690.pdf) INN (MINOCYCLINE HYDROCHLORIDE) ZILXI (JOURNEY) APPROVAL= AP YEAR= 2020 , NDA 215466 (pdf 215466.pdf not found) INN (MINOCYCLINE HYDROCHLORIDE) MINOCYCLINE HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 214934 (pdf 214934.pdf not found) INN (MINOCYCLINE) MINOCYCLINE (NEXUS PHARMS) APPROVAL= TA YEAR= 2023 , 998 ; LINCOMYCIN ; 154-21-2 ; 1964 ; ; NATURAL MOLECULE NPA024602 ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PROTEIN SYNTHESIS INHIBITORS -- A SUBSTANCE PRODUCED BY LINCOLNENSIS GROUP OF STREPTOMYCES LINCOLNENSIS , ; NDA 050316 (pdf 50316.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOCIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 050317 (label 50317.pdf) INN (LINCOMYCIN HYDROCHLORIDE) LINCOCIN (PFIZER) APPROVAL= AP YEAR= 1964 , NDA 062784 (pdf 62784.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063180 (pdf 63180.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 201746 (pdf 201746.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 212770 (pdf 212770.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (GENEYORK PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215082 (pdf 215082.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2021 , NDA 215657 (pdf 215657.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216662 (pdf 216662.pdf not found) INN (LINCOMYCIN HYDROCHLORIDE) LINCOMYCIN HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , 999 ; TROLEANDOMYCIN ; 2751-09-9 ; 1969 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- MACROLIDES -- DERIVED ACETYLATED ESTER OF OLEANDOMYCIN, AN ANTIBIOTIC ELABORATED BY A SPECIES OF STREPTOMYCES ANTIBIOTICUS , ; NDA 050332 (pdf 50332.pdf not found) INN (TROLEANDOMYCIN) TAO (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050336 (pdf 50336.pdf not found) INN (TROLEANDOMYCIN) TAO (PFIZER) APPROVAL= AP YEAR= 1969 DISCONTINUED , 1000 ; NOVOBIOCIN ; 303-81-1 ; 1964 ; DISCONTINUED ; NATURAL MOLECULE NPA017352 ; CLASS ANTIINFECTIVES -- COUMARIN -- ANTIBIOTIC -- ANTIBACTERIAL -- NUCLEIC ACID SYNTHESIS INHIBITORS , ; NDA 050339 (pdf 50339.pdf not found) INN (NOVOBIOCIN SODIUM) ALBAMYCIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1964 DISCONTINUED , 1001 ; SPECTINOMYCIN ; 1695-77-8 ; 1971 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- AMINOGLYCOSIDE -- ANTIBIOTIC -- ANTIBACTERIAL -- PRODUCED BY A SPECIES OF SOIL MICROORGANISM DESIGNATED AS STREPTOMYCES SPECTABILIS , ; NDA 050347 (label 50347.pdf) INN (SPECTINOMYCIN HYDROCHLORIDE) TROBICIN (PFIZER) APPROVAL= AP YEAR= 1971 DISCONTINUED , 1002 ; CHLORTETRACYCLINE ; 57-62-5 ; 1950 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- QUINONE -- ANTIPROTOZOAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTIAMEBIC , ; NDA 050404 (pdf 50404.pdf not found) INN (CHLORTETRACYCLINE HYDROCHLORIDE) AUREOMYCIN (LEDERLE) APPROVAL= AP YEAR= 1950 DISCONTINUED , 1003 ; CEPHALEXIN ; 15686-71-2 ; 1971 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050405 (label 50405.pdf) INN (CEPHALEXIN) KEFLEX (PRAGMA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050406 (label 50406.pdf) INN (CEPHALEXIN) KEFLEX (PRAGMA) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050440 (pdf 50440.pdf not found) INN (CEPHALEXIN) KEFLET (LILLY) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 050614 (pdf 50614.pdf not found) INN (CEPHALEXIN HYDROCHLORIDE) KEFTAB (LILLY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 061969 (pdf 61969.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 062117 (pdf 62117.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (FACTA FARMA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 062118 (pdf 62118.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (FACTA FARMA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 062702 (pdf 62702.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 , NDA 062703 (label 62703.pdf) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 , NDA 062713 (pdf 62713.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BELCHER PHARMS) APPROVAL= AP YEAR= 1988 , NDA 062745 (pdf 62745.pdf not found) INN (CEPHALEXIN) KEFLET (LILLY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062760 (pdf 62760.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062761 (pdf 62761.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062767 (pdf 62767.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062768 (pdf 62768.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062773 (pdf 62773.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062775 (pdf 62775.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062777 (pdf 62777.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062778 (pdf 62778.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062779 (pdf 62779.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (VITARINE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062781 (pdf 62781.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (VITARINE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062791 (pdf 62791.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062809 (pdf 62809.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062821 (pdf 62821.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062823 (pdf 62823.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062826 (pdf 62826.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062827 (pdf 62827.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062863 (pdf 62863.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062867 (pdf 62867.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062869 (pdf 62869.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (STEVENS J) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062870 (pdf 62870.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (STEVENS J) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062871 (pdf 62871.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (YOSHITOMI) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062872 (pdf 62872.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (YOSHITOMI) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062873 (pdf 62873.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062973 (pdf 62973.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062974 (pdf 62974.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062986 (pdf 62986.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 062987 (pdf 62987.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063023 (pdf 63023.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1989 , NDA 063024 (label 63024.pdf) INN (CEPHALEXIN) CEPHALEXIN (TEVA) APPROVAL= AP YEAR= 1989 , NDA 063063 (pdf 63063.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063186 (pdf 63186.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (APOTHECON) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 065007 (pdf 65007.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 065081 (pdf 65081.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065100 (pdf 65100.pdf not found) INN (CEPHALEXIN) PANIXINE DISPERDOSE (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065152 (pdf 65152.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065215 (pdf 65215.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (HIKMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065229 (pdf 65229.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065234 (pdf 65234.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065248 (pdf 65248.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (ANDA REPOSITORY) APPROVAL= AP YEAR= 2005 , NDA 065253 (pdf 65253.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2005 , NDA 065326 (pdf 65326.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065336 (pdf 65336.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2007 , NDA 065444 (pdf 65444.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (HIKMA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090836 (pdf 90836.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 210221 (pdf 210221.pdf not found) INN (CEPHALEXIN) CEPHALEXIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , 1004 ; RIFAMPIN ; 13292-46-1 ; 1971 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- LEPROSTATIC -- INHIBIOR OF DNA-DEPENDENT RNA POLYMERASE ACTIVITY IN MYCOBACTERIUM TUBERCULOSIS ORGANISMS (DOES NOT INHIBIT THE MAMMALIAN ENZYME) , ; NDA 050420 (label 50420.pdf) INN (RIFAMPIN) RIFADIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050429 (label 50429.pdf) INN (RIFAMPIN) RIMACTANE (OXFORD PHARMS) APPROVAL= AP YEAR= 1971 , NDA 050627 (label 50627.pdf) INN (RIFAMPIN) RIFADIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1989 , NDA 050705 (label 50705.pdf) INN (ISONIAZID PYRAZINAMIDE RIFAMPIN) RIFATER (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 061884 (pdf 61884.pdf not found) INN (ISONIAZID RIFAMPIN) RIFAMATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 062303 (pdf 62303.pdf not found) INN (RIFAMPIN) RIFADIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 064150 (pdf 64150.pdf not found) INN (RIFAMPIN) RIFAMPIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 , NDA 064217 (label 64217.pdf) INN (RIFAMPIN) RIFAMPIN (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 065028 (pdf 65028.pdf not found) INN (RIFAMPIN) RIFAMPIN (HIKMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065221 (pdf 65221.pdf not found) INN (ISONIAZID RIFAMPIN) RIFAMPIN AND ISONIAZID (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065390 (pdf 65390.pdf not found) INN (RIFAMPIN) RIFAMPIN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2008 , NDA 065421 (pdf 65421.pdf not found) INN (RIFAMPIN) RIFAMPIN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 065502 (pdf 65502.pdf not found) INN (RIFAMPIN) RIFAMPIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2010 , NDA 090034 (pdf 90034.pdf not found) INN (RIFAMPIN) RIFAMPIN (LUPIN PHARMS) APPROVAL= AP YEAR= 2013 , NDA 091181 (pdf 91181.pdf not found) INN (RIFAMPIN) RIFAMPIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2014 , NDA 204101 (pdf 204101.pdf not found) INN (RIFAMPIN) RIFAMPIN (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205039 (pdf 205039.pdf not found) INN (RIFAMPIN) RIFAMPIN (HIKMA PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206736 (pdf 206736.pdf not found) INN (RIFAMPIN) RIFAMPIN (WATSON PHARMS TEVA) APPROVAL= AP YEAR= 2016 DISCONTINUED , 1005 ; CEPHAPIRIN ; 21593-23-7 ; 1974 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 050446 (pdf 50446.pdf not found) INN (CEPHAPIRIN SODIUM) CEFADYL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061769 (pdf 61769.pdf not found) INN (CEPHAPIRIN SODIUM) CEFADYL (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062720 (pdf 62720.pdf not found) INN (CEPHAPIRIN SODIUM) CEPHAPIRIN SODIUM (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062723 (pdf 62723.pdf not found) INN (CEPHAPIRIN SODIUM) CEPHAPIRIN SODIUM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062724 (pdf 62724.pdf not found) INN (CEPHAPIRIN SODIUM) CEFADYL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062961 (pdf 62961.pdf not found) INN (CEPHAPIRIN SODIUM) CEFADYL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , 1006 ; MITOMYCIN ; 50-07-7 ; 1981 ; ; NATURAL MOLECULE C00018668 NPA020531 ; CLASS ANTINEOPLASTIC -- CROSS-LINKING REAGENTS -- ALKYLATING AGENTS -- INHIBITS THE SYNTHESIS OF DEOXYRIBONUCLEIC ACID (DNA) -- CYTOTOXIC -- ISOLATED FROM THE BROTH OF STREPTOMYCES VERTICILLUS YINGTANENSIS , ; NDA 050450 (pdf 50450.pdf not found) INN (MITOMYCIN) MUTAMYCIN (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050763 (label 50763.pdf) INN (MITOMYCIN) MITOZYTREX (SUPERGEN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 062336 (pdf 62336.pdf not found) INN (MITOMYCIN) MUTAMYCIN (BRISTOL MYERS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 064106 (pdf 64106.pdf not found) INN (MITOMYCIN) MITOMYCIN (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064117 (pdf 64117.pdf not found) INN (MITOMYCIN) MITOMYCIN (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 064144 (pdf 64144.pdf not found) INN (MITOMYCIN) MITOMYCIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 1998 , NDA 064180 (pdf 64180.pdf not found) INN (MITOMYCIN) MITOMYCIN (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 022572 (label 22572.pdf) INN (MITOMYCIN) MITOSOL (MOBIUS THERAP) APPROVAL= AP YEAR= 2012 , NDA 202670 (pdf 202670.pdf not found) INN (MITOMYCIN) MITOMYCIN (RK PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203386 (pdf 203386.pdf not found) INN (MITOMYCIN) MITOMYCIN (RK PHARMA) APPROVAL= AP YEAR= 2017 , NDA 211728 (label 211728.pdf) INN (MITOMYCIN) JELMYTO (UROGEN PHARMA) APPROVAL= AP YEAR= 2020 , NDA 215687 (pdf 215687.pdf not found) INN (MITOMYCIN) MITOMYCIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214504 (pdf 214504.pdf not found) INN (MITOMYCIN) MITOMYCIN (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 214505 (pdf 214505.pdf not found) INN (MITOMYCIN) MITOMYCIN (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 216648 (pdf 216648.pdf not found) INN (MITOMYCIN) MITOMYCIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216732 (pdf 216732.pdf not found) INN (MITOMYCIN) MITOMYCIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 211269 (pdf 211269.pdf not found) INN (MITOMYCIN) MITOMYCIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2024 , 1007 ; AMOXICILLIN ; 26787-78-0 ; 1974 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- PENICILLINS -- INHIBITION OF CELL WALL BIOSYNTHESIS , ; NDA 050459 (pdf 50459.pdf not found) INN (AMOXICILLIN) AMOXIL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 050460 (pdf 50460.pdf not found) INN (AMOXICILLIN) AMOXIL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 050542 (label 50542.pdf) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050564 (label 50564.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '250' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 050575 (label 50575.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '125' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1984 , NDA 050597 (label 50597.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '125' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050720 (label 50720.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '875' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 , NDA 050725 (label 50725.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '200' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050726 (label 50726.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '200' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050754 (label 50754.pdf) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 050755 (label 50755.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN ES-600 (US ANTIBIOTICS) APPROVAL= AP YEAR= 2001 , NDA 050757 (label 50757.pdf) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) PREVPAC COPACKAGED (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 050760 (label 50760.pdf) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1999 , NDA 050761 (label 50761.pdf) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 050785 (label 50785.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN XR (US ANTIBIOTICS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 050813 (label 50813.pdf) INN (AMOXICILLIN) MOXATAG (PRAGMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 061851 (pdf 61851.pdf not found) INN (AMOXICILLIN) POLYMOX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061885 (pdf 61885.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061886 (pdf 61886.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061926 (pdf 61926.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1976 , NDA 061931 (pdf 61931.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1982 , NDA 062058 (pdf 62058.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (CHARTWELL) APPROVAL= AP YEAR= 1978 , NDA 062059 (pdf 62059.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (CHARTWELL RX) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 062067 (pdf 62067.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062090 (pdf 62090.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062098 (pdf 62098.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062099 (pdf 62099.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062107 (pdf 62107.pdf not found) INN (AMOXICILLIN) UTIMOX (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062120 (pdf 62120.pdf not found) INN (AMOXICILLIN) WYMOX (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062127 (pdf 62127.pdf not found) INN (AMOXICILLIN) UTIMOX (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062131 (pdf 62131.pdf not found) INN (AMOXICILLIN) WYMOX (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062152 (pdf 62152.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062154 (pdf 62154.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062216 (pdf 62216.pdf not found) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1979 , NDA 062226 (pdf 62226.pdf not found) INN (AMOXICILLIN) AMOXIL (US ANTIBIOTICS) APPROVAL= AP YEAR= 1979 , NDA 062323 (pdf 62323.pdf not found) INN (AMOXICILLIN) POLYMOX (APOTHECON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062528 (pdf 62528.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (LABS ATRAL) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062853 (pdf 62853.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062854 (pdf 62854.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062881 (pdf 62881.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062884 (pdf 62884.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062885 (pdf 62885.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062927 (pdf 62927.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062946 (pdf 62946.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063001 (pdf 63001.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063030 (pdf 63030.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063031 (pdf 63031.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063099 (pdf 63099.pdf not found) INN (AMOXICILLIN) TRIMOX (APOTHECON) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 064013 (pdf 64013.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1992 , NDA 064031 (pdf 64031.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064076 (pdf 64076.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SANDOZ) APPROVAL= AP YEAR= 1994 , NDA 064131 (pdf 64131.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064139 (pdf 64139.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 065016 (pdf 65016.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 065021 (pdf 65021.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 065056 (label 65056.pdf) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 2000 , NDA 065059 (label 65059.pdf) INN (AMOXICILLIN) AMOXICILLIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065060 (pdf 65060.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065063 (pdf 65063.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065064 (pdf 65064.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065065 (pdf 65065.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065066 (pdf 65066.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065080 (pdf 65080.pdf not found) INN (AMOXICILLIN) DISPERMOX (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065089 (pdf 65089.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2004 , NDA 065093 (pdf 65093.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065096 (pdf 65096.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 , NDA 065098 (pdf 65098.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065101 (pdf 65101.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2002 , NDA 065102 (pdf 65102.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065109 (pdf 65109.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065113 (pdf 65113.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065117 (pdf 65117.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065119 (label 65119.pdf) INN (AMOXICILLIN) AMOXICILLIN (TEVA) APPROVAL= AP YEAR= 2002 , NDA 065132 (pdf 65132.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065159 (pdf 65159.pdf not found) INN (AMOXICILLIN) DISPERMOX (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065161 (pdf 65161.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065162 (label 65162.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2004 , NDA 065189 (pdf 65189.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065191 (pdf 65191.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 065205 (pdf 65205.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2005 , NDA 065207 (pdf 65207.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065228 (pdf 65228.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065255 (pdf 65255.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 065256 (pdf 65256.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (AUROBINDO) APPROVAL= AP YEAR= 2005 , NDA 065271 (pdf 65271.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (AUROBINDO) APPROVAL= AP YEAR= 2005 , NDA 065291 (pdf 65291.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (HIKMA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065319 (pdf 65319.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 065322 (pdf 65322.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 065324 (pdf 65324.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065325 (pdf 65325.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 065334 (pdf 65334.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (AUROBINDO) APPROVAL= AP YEAR= 2006 , NDA 065358 (pdf 65358.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2007 , NDA 065373 (pdf 65373.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065378 (pdf 65378.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065387 (pdf 65387.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065317 (pdf 65317.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (APOTEX INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065333 (pdf 65333.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (APOTEX INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065344 (pdf 65344.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065431 (pdf 65431.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2008 , NDA 090227 (pdf 90227.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 050824 (label 50824.pdf) INN (AMOXICILLIN CLARITHROMYCIN OMEPRAZOLE) OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201090 (pdf 201090.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 201091 (pdf 201091.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091568 (pdf 91568.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 091569 (pdf 91569.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 065420 (pdf 65420.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2013 , NDA 200218 (pdf 200218.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (ANI PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202588 (pdf 202588.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 204030 (pdf 204030.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 203824 (pdf 203824.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204755 (pdf 204755.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2016 , NDA 205707 (pdf 205707.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2016 , NDA 206006 (pdf 206006.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (RISING) APPROVAL= AP YEAR= 2016 , NDA 209371 (pdf 209371.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 213004 (label 213004.pdf) INN (AMOXICILLIN OMEPRAZOLE MAGNESIUM RIFABUTIN) TALICIA (REDHILL) APPROVAL= AP YEAR= 2019 , NDA 205274 (pdf 205274.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (HIKMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 205187 (pdf 205187.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2021 , NDA 207471 (pdf 207471.pdf not found) INN (AMOXICILLIN) AMOXICILLIN (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 215152 (label 215152.pdf) INN (AMOXICILLIN CLARITHROMYCIN VONOPRAZAN FUMARATE) VOQUEZNA TRIPLE PAK (PHATHOM) APPROVAL= AP YEAR= 2022 , NDA 215153 (label 215153.pdf) INN (AMOXICILLIN VONOPRAZAN FUMARATE) VOQUEZNA DUAL PAK (PHATHOM) APPROVAL= AP YEAR= 2022 , NDA 209351 (pdf 209351.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 209991 (pdf 209991.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 209992 (pdf 209992.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 210374 (pdf 210374.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 210416 (pdf 210416.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 217805 (pdf 217805.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS) APPROVAL= AP YEAR= 2023 , 1008 ; CEFAZOLIN ; 25953-19-9 ; 1973 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050461 (label 50461.pdf) INN (CEFAZOLIN SODIUM) ANCEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 050566 (pdf 50566.pdf not found) INN (CEFAZOLIN SODIUM) ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050779 (label 50779.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN AND DEXTROSE (B BRAUN) APPROVAL= AP YEAR= 2000 , NDA 061773 (pdf 61773.pdf not found) INN (CEFAZOLIN SODIUM) KEFZOL (ACS DOBFAR) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 062557 (pdf 62557.pdf not found) INN (CEFAZOLIN SODIUM) KEFZOL (LILLY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062688 (pdf 62688.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062807 (pdf 62807.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062831 (pdf 62831.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 1988 , NDA 062894 (pdf 62894.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062988 (pdf 62988.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (DR REDDYS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062989 (pdf 62989.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (DR REDDYS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063002 (pdf 63002.pdf not found) INN (CEFAZOLIN SODIUM) ANCEF IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063016 (pdf 63016.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063018 (pdf 63018.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063207 (pdf 63207.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (FACTA FARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063208 (pdf 63208.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (STERI PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063209 (pdf 63209.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (FACTA FARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063214 (pdf 63214.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (FACTA FARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063216 (pdf 63216.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (STERI PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 064033 (pdf 64033.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 064169 (pdf 64169.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 064170 (pdf 64170.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065047 (pdf 65047.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2001 , NDA 065141 (label 65141.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (SAMSON MEDCL) APPROVAL= AP YEAR= 2006 , NDA 065143 (pdf 65143.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2004 , NDA 065226 (pdf 65226.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065244 (pdf 65244.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065247 (label 65247.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065345 (pdf 65345.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065395 (pdf 65395.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065280 (pdf 65280.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (CEPHAZONE PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065295 (pdf 65295.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (CEPHAZONE PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065296 (pdf 65296.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (CEPHAZONE PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065303 (pdf 65303.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (ACS DOBFAR) APPROVAL= AP YEAR= 2008 , NDA 065306 (pdf 65306.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (ACS DOBFAR) APPROVAL= AP YEAR= 2008 , NDA 203661 (pdf 203661.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (QILU) APPROVAL= AP YEAR= 2015 , NDA 207131 (label 207131.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN IN DEXTROSE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2015 , NDA 201654 (pdf 201654.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 209217 (pdf 209217.pdf not found) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (QILU) APPROVAL= AP YEAR= 2018 , NDA 216109 (label 216109.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 211413 (label 211413.pdf) INN (CEFAZOLIN SODIUM) CEFAZOLIN SODIUM (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2023 , 1009 ; DOXORUBICIN ; 23214-92-8 ; 1974 ; ; ; CLASS ANTINEOPLASTIC -- ANTIBIOTICS -- CYTOTOXIC -- ANTHRACYCLINES -- INTERCALANT -- OVARIAN CANCER -- AIDS-RELATED KAPOSI’S SARCOMA -- MULTIPLE MYELOMA -- ANTIMITOTIC -- DOXORUBICINOL THE MAJOR METABOLITE OF DOXORUBICIN WAS DETECTED AT VERY LOW LEVELS , ; NDA 050467 (label 50467.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (PFIZER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 050629 (label 50629.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (PFIZER) APPROVAL= AP YEAR= 1987 , NDA 050718 (label 50718.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXIL LIPOSOMAL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1995 , NDA 062921 (label 62921.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1989 , NDA 062926 (pdf 62926.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) RUBEX (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062975 (label 62975.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1989 , NDA 063097 (pdf 63097.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (PHARMACHEMIE BV) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063165 (pdf 63165.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) ADRIAMYCIN PFS (PFIZER) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063277 (pdf 63277.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1995 , NDA 063336 (pdf 63336.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (PHARMACHEMIE BV) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064097 (label 64097.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 064140 (pdf 64140.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 091418 (pdf 91418.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 , NDA 200901 (pdf 200901.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200170 (pdf 200170.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 065515 (pdf 65515.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (ALMAJECT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200146 (pdf 200146.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (HLTHCARE) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091495 (pdf 91495.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2013 , NDA 203263 (label 203263.pdf) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE LIPOSOMAL (SUN PHARM) APPROVAL= AP YEAR= 2013 , NDA 203622 (pdf 203622.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (ACTAVIS INC) APPROVAL= AP YEAR= 2014 , NDA 208657 (pdf 208657.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE LIPOSOMAL (DR REDDYS) APPROVAL= AP YEAR= 2017 , NDA 208888 (pdf 208888.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 209825 (pdf 209825.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 206062 (pdf 206062.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212299 (pdf 212299.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE LIPOSOMAL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 207228 (pdf 207228.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE LIPOSOMAL (AYANA PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 212219 (pdf 212219.pdf not found) INN (DOXORUBICIN HYDROCHLORIDE) DOXORUBICIN HYDROCHLORIDE LIPOSOMAL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , 1010 ; CEPHALOTHIN ; 153-61-7 ; 1974 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 050482 (pdf 50482.pdf not found) INN (CEPHALOTHIN SODIUM) KEFLIN (LILLY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 062422 (pdf 62422.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 062426 (pdf 62426.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062435 (pdf 62435.pdf not found) INN (CEPHALOTHIN SODIUM) SEFFIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062464 (pdf 62464.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062547 (pdf 62547.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062548 (pdf 62548.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062549 (pdf 62549.pdf not found) INN (CEPHALOTHIN SODIUM) KEFLIN IN PLASTIC CONTAINER (LILLY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062666 (pdf 62666.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062730 (pdf 62730.pdf not found) INN (CEPHALOTHIN SODIUM) CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1987 DISCONTINUED , 1011 ; DAUNORUBICIN ; 20830-81-3 ; 1979 ; ; NATURAL MOLECULE C00043440 ; CLASS ANTINEOPLASTIC -- ANTIBIOTICS -- CYTOTOXIC -- ANTIMITOTIC -- ANTHRACYCLINES -- INDICATED FOR REMISSION INDUCTION IN ACUTE NONLYMPHOCYTIC LEUKEMIA -- INTERCALANT , ; NDA 050484 (pdf 50484.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) CERUBIDINE (WYETH AYERST) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 050704 (pdf 50704.pdf not found) INN (DAUNORUBICIN CITRATE) DAUNOXOME (GALEN (UK)) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050731 (pdf 50731.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 061876 (pdf 61876.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) CERUBIDINE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 064103 (pdf 64103.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) CERUBIDINE (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 064212 (pdf 64212.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065000 (pdf 65000.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 065034 (pdf 65034.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 065035 (pdf 65035.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2000 , NDA 209401 (label 209401.pdf) INN (CYTARABINE DAUNORUBICIN) VYXEOS (CELATOR PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206195 (pdf 206195.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208759 (pdf 208759.pdf not found) INN (DAUNORUBICIN HYDROCHLORIDE) DAUNORUBICIN HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 , 1012 ; VIDARABINE ; 5536-17-4 ; 1976 ; DISCONTINUED ; ; CLASS ANTIVIRAL -- ANTIMETABOLITES -- AN ANTIVIRAL DRUG FOR THE TOPICAL TREATMENT OF EPITHELIAL KERATITIS CAUSED BY HERPES SIMPLEX VIRUS , ; NDA 050486 (pdf 50486.pdf not found) INN (VIDARABINE) VIRA-A (PARKEDALE) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 050523 (pdf 50523.pdf not found) INN (VIDARABINE) VIRA-A (PARKEDALE) APPROVAL= AP YEAR= 1978 DISCONTINUED , 1013 ; AMIKACIN ; 37517-28-5 ; 1981 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- AMINOGLYCOSIDES , ; NDA 050495 (pdf 50495.pdf not found) INN (AMIKACIN SULFATE) AMIKIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050618 (pdf 50618.pdf not found) INN (AMIKACIN SULFATE) AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062311 (pdf 62311.pdf not found) INN (AMIKACIN SULFATE) AMIKIN (APOTHECON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062562 (pdf 62562.pdf not found) INN (AMIKACIN SULFATE) AMIKIN (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063167 (pdf 63167.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063169 (pdf 63169.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063263 (pdf 63263.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063264 (pdf 63264.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063265 (pdf 63265.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (ABBOTT) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063266 (pdf 63266.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (ABBOTT) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063274 (pdf 63274.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063275 (pdf 63275.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063283 (pdf 63283.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063313 (pdf 63313.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 063315 (pdf 63315.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 063350 (pdf 63350.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 064045 (pdf 64045.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (MEITHEAL) APPROVAL= AP YEAR= 1993 , NDA 064098 (pdf 64098.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064099 (pdf 64099.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064146 (pdf 64146.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 204040 (pdf 204040.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 , NDA 205604 (pdf 205604.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 205605 (pdf 205605.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203323 (pdf 203323.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 207356 (label 207356.pdf) INN (AMIKACIN SULFATE) ARIKAYCE KIT (INSMED INC) APPROVAL= AP YEAR= 2018 , NDA 218146 (pdf 218146.pdf not found) INN (AMIKACIN SULFATE) AMIKACIN SULFATE (QILU) APPROVAL= AP YEAR= 2024 , 1014 ; TICARCILLIN ; 34787-01-4 ; 1976 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- PENICILLIN -- ANTIBIOTIC , ; NDA 050497 (pdf 50497.pdf not found) INN (TICARCILLIN DISODIUM) TICAR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 050590 (label 50590.pdf) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050658 (label 50658.pdf) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN IN PLASTIC CONTAINER (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062690 (pdf 62690.pdf not found) INN (TICARCILLIN DISODIUM) TICAR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062691 (pdf 62691.pdf not found) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , 1015 ; CEFAMANDOLE NAFATE ; 42540-40-9 ; 1978 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050504 (pdf 50504.pdf not found) INN (CEFAMANDOLE NAFATE) MANDOL (LILLY) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 062560 (pdf 62560.pdf not found) INN (CEFAMANDOLE NAFATE) MANDOL (LILLY) APPROVAL= AP YEAR= 1985 DISCONTINUED , 1016 ; CYCLACILLIN ; 3485-14-1 ; 1979 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050508 (pdf 50508.pdf not found) INN (CYCLACILLIN) CYCLAPEN-W (WYETH AYERST) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 050509 (pdf 50509.pdf not found) INN (CYCLACILLIN) CYCLAPEN-W (WYETH AYERST) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062895 (pdf 62895.pdf not found) INN (CYCLACILLIN) CYCLACILLIN (TEVA) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1017 ; NATAMYCIN ; 7681-93-8 ; 1978 ; ; ; CLASS ANTIINFECTIVES -- ANTIFUNGAL AGENTS -- ERGOSTEROL-SPECIFIC AND REVERSIBLE INHIBITION OF MEMBRANE TRANSPORT PROTEINS (PMID22733749) , ; NDA 050514 (label 50514.pdf) INN (NATAMYCIN) NATACYN (HARROW EYE) APPROVAL= AP YEAR= 1978 , 1018 ; CEFOXITIN ; 35607-66-0 ; 1978 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS -- INHIBITION OF CELL WALL SYNTHESIS , ; NDA 050517 (label 50517.pdf) INN (CEFOXITIN SODIUM) MEFOXIN (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 050581 (pdf 50581.pdf not found) INN (CEFOXITIN SODIUM) MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (MERCK) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 062757 (pdf 62757.pdf not found) INN (CEFOXITIN SODIUM) MEFOXIN (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 063182 (pdf 63182.pdf not found) INN (CEFOXITIN SODIUM) MEFOXIN IN PLASTIC CONTAINER (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 065011 (pdf 65011.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065012 (pdf 65012.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065050 (pdf 65050.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 065051 (pdf 65051.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 065214 (label 65214.pdf) INN (CEFOXITIN SODIUM) CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2006 , NDA 065312 (pdf 65312.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HOSPIRA INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065313 (pdf 65313.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HOSPIRA INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065238 (pdf 65238.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 065239 (pdf 65239.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 065414 (pdf 65414.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (ACS DOBFAR) APPROVAL= AP YEAR= 2009 , NDA 065415 (pdf 65415.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (ACS DOBFAR) APPROVAL= AP YEAR= 2010 , NDA 065464 (pdf 65464.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 065467 (pdf 65467.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200938 (pdf 200938.pdf not found) INN (CEFOXITIN SODIUM) CEFOXITIN IN PLASTIC CONTAINER (SAMSON MEDCL) APPROVAL= AP YEAR= 2015 , 1019 ; MECLOCYCLINE ; 2013-58-3 ; 0 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIBACTERIAL -- ANTIBIOTIC -- ANTI-ACNE -- ANTI-INFECTIVE -- DERMATOLOGY , ; NDA 050518 (pdf 50518.pdf not found) INN (MECLOCYCLINE SULFOSALICYLATE) MECLAN (JOHNSON AND JOHNSON) APPROVAL= - YEAR= 0 DISCONTINUED , 1020 ; BACAMPICILLIN ; 50972-17-3 ; 1980 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLIN , ; NDA 050520 (pdf 50520.pdf not found) INN (BACAMPICILLIN HYDROCHLORIDE) SPECTROBID (PFIZER) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 050556 (pdf 50556.pdf not found) INN (BACAMPICILLIN HYDROCHLORIDE) SPECTROBID (PFIZER) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1021 ; CEFACLOR ; 53994-73-3 ; 1979 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050521 (label 50521.pdf) INN (CEFACLOR) CECLOR (LILLY) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 050522 (label 50522.pdf) INN (CEFACLOR) CECLOR (LILLY) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 050673 (pdf 50673.pdf not found) INN (CEFACLOR) CECLOR CD (LILLY) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 062205 (pdf 62205.pdf not found) INN (CEFACLOR) CEFACLOR (CEPH INTL) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 062206 (pdf 62206.pdf not found) INN (CEFACLOR) CEFACLOR (FACTA FARMA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 064061 (pdf 64061.pdf not found) INN (CEFACLOR) CEFACLOR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064070 (pdf 64070.pdf not found) INN (CEFACLOR) CEFACLOR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064081 (label 64081.pdf) INN (CEFACLOR) CEFACLOR (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064085 (pdf 64085.pdf not found) INN (CEFACLOR) CEFACLOR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064086 (pdf 64086.pdf not found) INN (CEFACLOR) CEFACLOR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064087 (pdf 64087.pdf not found) INN (CEFACLOR) CEFACLOR (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064107 (pdf 64107.pdf not found) INN (CEFACLOR) CEFACLOR (DAVA PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064110 (pdf 64110.pdf not found) INN (CEFACLOR) CEFACLOR (DAVA PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064114 (pdf 64114.pdf not found) INN (CEFACLOR) CEFACLOR (DAVA PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064115 (pdf 64115.pdf not found) INN (CEFACLOR) CEFACLOR (DAVA PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064116 (pdf 64116.pdf not found) INN (CEFACLOR) CEFACLOR (DAVA PHARMS INC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064145 (pdf 64145.pdf not found) INN (CEFACLOR) CEFACLOR (TEVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064148 (pdf 64148.pdf not found) INN (CEFACLOR) CEFACLOR (CHARTWELL RX) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064155 (pdf 64155.pdf not found) INN (CEFACLOR) CEFACLOR (RANBAXY) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064156 (pdf 64156.pdf not found) INN (CEFACLOR) CEFACLOR (RANBAXY) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064164 (pdf 64164.pdf not found) INN (CEFACLOR) CEFACLOR (RANBAXY) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064165 (pdf 64165.pdf not found) INN (CEFACLOR) CEFACLOR (RANBAXY) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064166 (pdf 64166.pdf not found) INN (CEFACLOR) CEFACLOR (RANBAXY) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064204 (pdf 64204.pdf not found) INN (CEFACLOR) CEFACLOR (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 064205 (pdf 64205.pdf not found) INN (CEFACLOR) CEFACLOR (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 064206 (pdf 64206.pdf not found) INN (CEFACLOR) CEFACLOR (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 064207 (pdf 64207.pdf not found) INN (CEFACLOR) CEFACLOR (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065057 (pdf 65057.pdf not found) INN (CEFACLOR) CEFACLOR (WORLD GEN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065058 (pdf 65058.pdf not found) INN (CEFACLOR) CEFACLOR (TEVA) APPROVAL= AP YEAR= 2002 , NDA 065092 (pdf 65092.pdf not found) INN (CEFACLOR) RANICLOR (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065146 (pdf 65146.pdf not found) INN (CEFACLOR) CEFACLOR (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2004 , NDA 065350 (pdf 65350.pdf not found) INN (CEFACLOR) CEFACLOR (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065412 (pdf 65412.pdf not found) INN (CEFACLOR) CEFACLOR (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2012 , 1022 ; CEPHRADINE ; 38821-53-3 ; 1974 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORIN , ; NDA 050530 (pdf 50530.pdf not found) INN (CEPHRADINE) VELOSEF (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050548 (pdf 50548.pdf not found) INN (CEPHRADINE) VELOSEF '250' (ERSANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061763 (pdf 61763.pdf not found) INN (CEPHRADINE) VELOSEF '125' (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061764 (pdf 61764.pdf not found) INN (CEPHRADINE) VELOSEF (APOTHECON) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061859 (pdf 61859.pdf not found) INN (CEPHRADINE) ANSPOR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061866 (pdf 61866.pdf not found) INN (CEPHRADINE) ANSPOR (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061976 (pdf 61976.pdf not found) INN (CEPHRADINE) VELOSEF (APOTHECON) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 062683 (pdf 62683.pdf not found) INN (CEPHRADINE) CEPHRADINE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062693 (pdf 62693.pdf not found) INN (CEPHRADINE) CEPHRADINE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062762 (pdf 62762.pdf not found) INN (CEPHRADINE) CEPHRADINE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062813 (pdf 62813.pdf not found) INN (CEPHRADINE) CEPHRADINE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062850 (pdf 62850.pdf not found) INN (CEPHRADINE) CEPHRADINE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062851 (pdf 62851.pdf not found) INN (CEPHRADINE) CEPHRADINE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062858 (pdf 62858.pdf not found) INN (CEPHRADINE) CEPHRADINE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062859 (pdf 62859.pdf not found) INN (CEPHRADINE) CEPHRADINE (BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1023 ; NETILMICIN ; 56391-56-1 ; 1983 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- AMINOGLYCOSIDES -- PROTEIN SYNTHESIS INHIBITORS , ; NDA 050544 (pdf 50544.pdf not found) INN (NETILMICIN SULFATE) NETROMYCIN (SCHERING) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , 1024 ; PIPERACILLIN ; 61477-96-1 ; 1981 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS , ; NDA 050545 (label 50545.pdf) INN (PIPERACILLIN SODIUM) PIPRACIL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 050684 (label 50684.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) ZOSYN (WYETH PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 050750 (label 50750.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) ZOSYN IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1998 , NDA 062750 (pdf 62750.pdf not found) INN (PIPERACILLIN SODIUM) PIPRACIL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 065114 (pdf 65114.pdf not found) INN (PIPERACILLIN SODIUM) PIPERACILLIN (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2003 , NDA 065157 (pdf 65157.pdf not found) INN (PIPERACILLIN SODIUM) PIPERACILLIN (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2004 , NDA 065386 (label 65386.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065446 (label 65446.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065362 (pdf 65362.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 065363 (pdf 65363.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 065498 (pdf 65498.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2011 , NDA 065523 (pdf 65523.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 090498 (pdf 90498.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 065458 (pdf 65458.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 203557 (pdf 203557.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 206204 (pdf 206204.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206996 (pdf 206996.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 207146 (pdf 207146.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 207847 (pdf 207847.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (PROVEPHARM SAS) APPROVAL= AP YEAR= 2017 , NDA 207848 (pdf 207848.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (PROVEPHARM SAS) APPROVAL= AP YEAR= 2017 , NDA 203719 (pdf 203719.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI) APPROVAL= AP YEAR= 2018 , NDA 203720 (pdf 203720.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI) APPROVAL= AP YEAR= 2018 , NDA 204959 (pdf 204959.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SHANDONG) APPROVAL= AP YEAR= 2018 , NDA 212287 (pdf 212287.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ASTRAL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208674 (pdf 208674.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 208675 (pdf 208675.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 217243 (pdf 217243.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SHANDONG) APPROVAL= AP YEAR= 2023 , NDA 217409 (pdf 217409.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , 1025 ; CEFOTAXIME ; 63527-52-6 ; 1981 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050547 (label 50547.pdf) INN (CEFOTAXIME SODIUM) CLAFORAN (STERIMAX) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 050596 (label 50596.pdf) INN (CEFOTAXIME SODIUM) CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (STERIMAX) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050792 (label 50792.pdf) INN (CEFOTAXIME SODIUM) CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 062659 (pdf 62659.pdf not found) INN (CEFOTAXIME SODIUM) CLAFORAN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 064200 (pdf 64200.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 064201 (pdf 64201.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065071 (pdf 65071.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065072 (pdf 65072.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065124 (pdf 65124.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (LUPIN) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065197 (pdf 65197.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME (WOCKHARDT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065290 (pdf 65290.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065292 (pdf 65292.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065293 (pdf 65293.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065348 (pdf 65348.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (CEPHAZONE PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 065516 (pdf 65516.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065517 (pdf 65517.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 203132 (pdf 203132.pdf not found) INN (CEFOTAXIME SODIUM) CEFOTAXIME SODIUM (HOSPIRA) APPROVAL= AP YEAR= 2016 DISCONTINUED , 1026 ; MOXALACTAM ; 64952-97-2 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC , ; NDA 050550 (pdf 50550.pdf not found) INN (MOXALACTAM DISODIUM) MOXAM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 1027 ; CEFOPERAZONE ; 62893-19-0 ; 1982 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050551 (label 50551.pdf) INN (CEFOPERAZONE SODIUM) CEFOBID (PFIZER) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 050613 (pdf 50613.pdf not found) INN (CEFOPERAZONE SODIUM) CEFOBID IN PLASTIC CONTAINER (PFIZER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 063333 (pdf 63333.pdf not found) INN (CEFOPERAZONE SODIUM) CEFOBID (PFIZER) APPROVAL= AP YEAR= 1995 DISCONTINUED , 1028 ; CEFORANIDE ; 60925-61-3 ; 1984 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050554 (pdf 50554.pdf not found) INN (CEFORANIDE) PRECEF (BRISTOL) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 062579 (pdf 62579.pdf not found) INN (CEFORANIDE) PRECEF (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , 1029 ; CEFUROXIME ; 55268-75-2 ; 1983 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050558 (label 50558.pdf) INN (CEFUROXIME SODIUM) ZINACEF (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 050643 (label 50643.pdf) INN (CEFUROXIME SODIUM) ZINACEF IN PLASTIC CONTAINER (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050780 (label 50780.pdf) INN (CEFUROXIME SODIUM) CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 062590 (pdf 62590.pdf not found) INN (CEFUROXIME SODIUM) KEFUROX IN PLASTIC CONTAINER (LILLY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062591 (pdf 62591.pdf not found) INN (CEFUROXIME SODIUM) KEFUROX (ACS DOBFAR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062592 (pdf 62592.pdf not found) INN (CEFUROXIME SODIUM) KEFUROX (LILLY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 064035 (pdf 64035.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 064036 (pdf 64036.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (WATSON LABS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 064124 (pdf 64124.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 064125 (pdf 64125.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 1997 , NDA 064191 (pdf 64191.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 064192 (pdf 64192.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (TEVA PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065001 (pdf 65001.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065002 (pdf 65002.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 065046 (pdf 65046.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065048 (pdf 65048.pdf not found) INN (CEFUROXIME) CEFUROXIME (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 065251 (pdf 65251.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM IN PLASTIC CONTAINER (SAMSON MEDCL) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065483 (pdf 65483.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065484 (pdf 65484.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065503 (pdf 65503.pdf not found) INN (CEFUROXIME SODIUM) CEFUROXIME SODIUM (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , 1030 ; CEFUROXIME AXETIL ; 64544-07-6 ; 1987 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050605 (label 50605.pdf) INN (CEFUROXIME AXETIL) CEFTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 050672 (label 50672.pdf) INN (CEFUROXIME AXETIL) CEFTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 065043 (pdf 65043.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065069 (pdf 65069.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 065118 (pdf 65118.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065126 (pdf 65126.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (FOSUN PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065135 (pdf 65135.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (LUPIN) APPROVAL= AP YEAR= 2003 , NDA 065166 (pdf 65166.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065190 (pdf 65190.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065308 (pdf 65308.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 065323 (pdf 65323.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065359 (pdf 65359.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ANDA REPOSITORY) APPROVAL= AP YEAR= 2008 , NDA 065496 (pdf 65496.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2010 , 1031 ; CEFUROXIME AXETIL ; 64544-07-6 ; 1987 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050605 (label 50605.pdf) INN (CEFUROXIME AXETIL) CEFTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 050672 (label 50672.pdf) INN (CEFUROXIME AXETIL) CEFTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 065043 (pdf 65043.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065069 (pdf 65069.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 065118 (pdf 65118.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065126 (pdf 65126.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (FOSUN PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065135 (pdf 65135.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (LUPIN) APPROVAL= AP YEAR= 2003 , NDA 065166 (pdf 65166.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065190 (pdf 65190.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ANI PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065308 (pdf 65308.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 065323 (pdf 65323.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065359 (pdf 65359.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ANDA REPOSITORY) APPROVAL= AP YEAR= 2008 , NDA 065496 (pdf 65496.pdf not found) INN (CEFUROXIME AXETIL) CEFUROXIME AXETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2010 , 1032 ; CEFTIZOXIME ; 68401-81-0 ; 1983 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050560 (pdf 50560.pdf not found) INN (CEFTIZOXIME SODIUM) CEFIZOX (ASTELLAS) APPROVAL= AP YEAR= 1983 NEWMOLECULARENTITY DISCONTINUED , NDA 050589 (pdf 50589.pdf not found) INN (CEFTIZOXIME SODIUM) CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER (ASTELLAS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 063294 (pdf 63294.pdf not found) INN (CEFTIZOXIME SODIUM) CEFIZOX (ASTELLAS) APPROVAL= AP YEAR= 1994 DISCONTINUED , 1033 ; AZLOCILLIN ; 37091-66-0 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- PENICILLINS , ; NDA 050562 (pdf 50562.pdf not found) INN (AZLOCILLIN SODIUM) AZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062388 (pdf 62388.pdf not found) INN (AZLOCILLIN SODIUM) AZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062417 (pdf 62417.pdf not found) INN (AZLOCILLIN SODIUM) AZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 1034 ; CLAVULANATE ; 58001-44-8 ; 1984 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL , ; NDA 050564 (label 50564.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '250' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 050575 (label 50575.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '125' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1984 , NDA 050590 (label 50590.pdf) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050597 (label 50597.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '125' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 050658 (label 50658.pdf) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN IN PLASTIC CONTAINER (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050720 (label 50720.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '875' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 , NDA 050725 (label 50725.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '200' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050726 (label 50726.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN '200' (US ANTIBIOTICS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050755 (label 50755.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN ES-600 (US ANTIBIOTICS) APPROVAL= AP YEAR= 2001 , NDA 050785 (label 50785.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AUGMENTIN XR (US ANTIBIOTICS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 062691 (pdf 62691.pdf not found) INN (CLAVULANATE POTASSIUM TICARCILLIN DISODIUM) TIMENTIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 065063 (pdf 65063.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065064 (pdf 65064.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065065 (pdf 65065.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065066 (pdf 65066.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 065089 (pdf 65089.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2004 , NDA 065093 (pdf 65093.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065096 (pdf 65096.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 , NDA 065098 (pdf 65098.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065101 (pdf 65101.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2002 , NDA 065102 (pdf 65102.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065109 (pdf 65109.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065117 (pdf 65117.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2002 , NDA 065132 (pdf 65132.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065161 (pdf 65161.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065162 (label 65162.pdf) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2004 , NDA 065189 (pdf 65189.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065191 (pdf 65191.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 065205 (pdf 65205.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (TEVA) APPROVAL= AP YEAR= 2005 , NDA 065207 (pdf 65207.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065358 (pdf 65358.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ INC) APPROVAL= AP YEAR= 2007 , NDA 065373 (pdf 65373.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065317 (pdf 65317.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (APOTEX INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065333 (pdf 65333.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (APOTEX INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065431 (pdf 65431.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2008 , NDA 090227 (pdf 90227.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 201090 (pdf 201090.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 201091 (pdf 201091.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091568 (pdf 91568.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 091569 (pdf 91569.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 065420 (pdf 65420.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2013 , NDA 203824 (pdf 203824.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (HIKMA PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204755 (pdf 204755.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2016 , NDA 205707 (pdf 205707.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2016 , NDA 209371 (pdf 209371.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019 , NDA 205187 (pdf 205187.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2021 , NDA 209351 (pdf 209351.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 209991 (pdf 209991.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 209992 (pdf 209992.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 210374 (pdf 210374.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 210416 (pdf 210416.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2023 , NDA 217805 (pdf 217805.pdf not found) INN (AMOXICILLIN CLAVULANATE POTASSIUM) AMOXICILLIN AND CLAVULANATE POTASSIUM (MICRO LABS) APPROVAL= AP YEAR= 2023 , 1035 ; AMDINOCILLIN ; 32887-01-7 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PENICILLINS -- TREATMENT OF URINARY TRACT INFECTIONS , ; NDA 050565 (pdf 50565.pdf not found) INN (AMDINOCILLIN) COACTIN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , 1036 ; CEFMENOXIME ; 65085-01-0 ; 1987 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050571 (pdf 50571.pdf not found) INN (CEFMENOXIME HYDROCHLORIDE) CEFMAX (TAP PHARM) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , 1037 ; STREPTOZOCIN ; 18883-66-4 ; 1982 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING AGENTS -- NITROSOUREAS , ; NDA 050577 (pdf 50577.pdf not found) INN (STREPTOZOCIN) ZANOSAR (TEVA PHARMS USA) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY , 1038 ; CEFTAZIDIME ; 72558-82-8 ; 1985 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050578 (label 50578.pdf) INN (CEFTAZIDIME) FORTAZ (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 050634 (label 50634.pdf) INN (CEFTAZIDIME SODIUM) FORTAZ IN PLASTIC CONTAINER (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050646 (label 50646.pdf) INN (CEFTAZIDIME) CEPTAZ (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 062640 (pdf 62640.pdf not found) INN (CEFTAZIDIME) CEFTAZIDIME (ACS DOBFAR) APPROVAL= AP YEAR= 1985 , NDA 062655 (pdf 62655.pdf not found) INN (CEFTAZIDIME) TAZIDIME (LILLY) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062662 (pdf 62662.pdf not found) INN (CEFTAZIDIME) TAZICEF (HOSPIRA) APPROVAL= AP YEAR= 1986 , NDA 062739 (pdf 62739.pdf not found) INN (CEFTAZIDIME) TAZIDIME IN PLASTIC CONTAINER (LILLY) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 063221 (pdf 63221.pdf not found) INN (CEFTAZIDIME SODIUM) CEFTAZIDIME SODIUM IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 063322 (pdf 63322.pdf not found) INN (CEFTAZIDIME) PENTACEF (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064006 (pdf 64006.pdf not found) INN (CEFTAZIDIME) PENTACEF (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064008 (pdf 64008.pdf not found) INN (CEFTAZIDIME) PENTACEF (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064032 (pdf 64032.pdf not found) INN (CEFTAZIDIME) TAZICEF (HOSPIRA) APPROVAL= AP YEAR= 1993 , NDA 065196 (pdf 65196.pdf not found) INN (CEFTAZIDIME) CEFTAZIDIME (WOCKHARDT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065481 (pdf 65481.pdf not found) INN (CEFTAZIDIME) CEFTAZIDIME (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 065482 (pdf 65482.pdf not found) INN (CEFTAZIDIME) CEFTAZIDIME (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 050823 (label 50823.pdf) INN (CEFTAZIDIME) CEFTAZIDIME IN DEXTROSE CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 206494 (label 206494.pdf) INN (AVIBACTAM SODIUM CEFTAZIDIME) AVYCAZ (ALLERGAN) APPROVAL= AP YEAR= 2015 , 1039 ; CEFONICID ; 61270-58-4 ; 1993 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050579 (pdf 50579.pdf not found) INN (CEFONICID SODIUM) MONOCID (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063295 (pdf 63295.pdf not found) INN (CEFONICID SODIUM) MONOCID (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1993 DISCONTINUED , 1040 ; AZTREONAM ; 78110-38-0 ; 1986 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTI-BACTERIAL -- INHIBITION OF BACTERIAL CELL WALL SYNTHESIS , ; NDA 050580 (label 50580.pdf) INN (AZTREONAM) AZACTAM (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , NDA 050632 (label 50632.pdf) INN (AZTREONAM) AZACTAM IN PLASTIC CONTAINER (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050814 (label 50814.pdf) INN (AZTREONAM) CAYSTON (GILEAD) APPROVAL= AP YEAR= 2010 , NDA 065439 (pdf 65439.pdf not found) INN (AZTREONAM) AZTREONAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 , NDA 065286 (pdf 65286.pdf not found) INN (AZTREONAM) AZTREONAM (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 206517 (pdf 206517.pdf not found) INN (AZTREONAM) AZTREONAM (HOSPIRA) APPROVAL= AP YEAR= 2021 , 1041 ; CEFTRIAXONE ; 73384-59-5 ; 1984 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050585 (label 50585.pdf) INN (CEFTRIAXONE SODIUM LIDOCAINE) ROCEPHIN KIT (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 050624 (label 50624.pdf) INN (CEFTRIAXONE SODIUM) ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 050796 (label 50796.pdf) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2005 , NDA 062510 (pdf 62510.pdf not found) INN (CEFTRIAXONE SODIUM) ROCEPHIN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062654 (pdf 62654.pdf not found) INN (CEFTRIAXONE SODIUM) ROCEPHIN (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 063239 (pdf 63239.pdf not found) INN (CEFTRIAXONE SODIUM) ROCEPHIN (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 065125 (pdf 65125.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (LUPIN) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065168 (label 65168.pdf) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065169 (label 65169.pdf) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065180 (pdf 65180.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (WOCKHARDT) APPROVAL= AP YEAR= 2006 , NDA 065204 (pdf 65204.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (SANDOZ INC) APPROVAL= AP YEAR= 2005 , NDA 065224 (pdf 65224.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2005 , NDA 065227 (pdf 65227.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065230 (pdf 65230.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065231 (pdf 65231.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065232 (pdf 65232.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (HOSPIRA INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065245 (pdf 65245.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065252 (pdf 65252.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065262 (pdf 65262.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065263 (pdf 65263.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (LUPIN) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065268 (pdf 65268.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (FACTA FARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065269 (pdf 65269.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (FACTA FARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065274 (pdf 65274.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065294 (pdf 65294.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (CEPHAZONE PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065305 (pdf 65305.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 , NDA 065328 (pdf 65328.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (ACS DOBFAR) APPROVAL= AP YEAR= 2008 , NDA 065329 (pdf 65329.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (ACS DOBFAR) APPROVAL= AP YEAR= 2008 , NDA 065342 (pdf 65342.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 , NDA 065391 (pdf 65391.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 065465 (pdf 65465.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (BEDFORD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065475 (pdf 65475.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (BEDFORD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065504 (pdf 65504.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065505 (pdf 65505.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090057 (pdf 90057.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (SAMSON MEDCL) APPROVAL= AP YEAR= 2014 , NDA 202563 (pdf 202563.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (HOSPIRA INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091068 (pdf 91068.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (AGILA SPECLTS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203702 (pdf 203702.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (QILU) APPROVAL= AP YEAR= 2016 , NDA 091117 (pdf 91117.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE SODIUM (ANDA REPOSITORY) APPROVAL= AP YEAR= 2017 , NDA 090701 (pdf 90701.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE SODIUM (HIKMA) APPROVAL= AP YEAR= 2017 , NDA 091049 (pdf 91049.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (ASTRAL) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209218 (pdf 209218.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (QILU) APPROVAL= AP YEAR= 2018 , NDA 210197 (pdf 210197.pdf not found) INN (CEFTRIAXONE SODIUM) CEFTRIAXONE (DEVA HOLDING AS) APPROVAL= AP YEAR= 2024 , 1042 ; CILASTATIN ; 82009-34-5 ; 1985 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- DIPEPTIDASE INHIBITOR , ; NDA 050587 (label 50587.pdf) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1985 , NDA 050630 (label 50630.pdf) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 062756 (pdf 62756.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 090825 (pdf 90825.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090577 (pdf 90577.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (ACS DOBFAR) APPROVAL= AP YEAR= 2011 , NDA 091007 (pdf 91007.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 207594 (pdf 207594.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212819 (label 212819.pdf) INN (CILASTATIN SODIUM IMIPENEM RELEBACTAM) RECARBRIO (MSD MERCK CO) APPROVAL= AP YEAR= 2019 , 1043 ; IMIPENEM ; 64221-86-9 ; 1985 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CARBAPENEMS -- INHIBITION OF CELL WALL SYNTHESIS , ; NDA 050587 (label 50587.pdf) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1985 , NDA 050630 (label 50630.pdf) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 062756 (pdf 62756.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) PRIMAXIN (MERCK) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 090825 (pdf 90825.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090577 (pdf 90577.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (ACS DOBFAR) APPROVAL= AP YEAR= 2011 , NDA 091007 (pdf 91007.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 207594 (pdf 207594.pdf not found) INN (CILASTATIN SODIUM IMIPENEM) IMIPENEM AND CILASTATIN (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2019 , NDA 212819 (label 212819.pdf) INN (CILASTATIN SODIUM IMIPENEM RELEBACTAM) RECARBRIO (MSD MERCK CO) APPROVAL= AP YEAR= 2019 , 1044 ; MUPIROCIN ; 12650-69-0 ; 1987 ; ; NATURAL MOLECULE NPA006173 ; CLASS DERMATOLOGICALS -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050591 (label 50591.pdf) INN (MUPIROCIN) BACTROBAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 050703 (label 50703.pdf) INN (MUPIROCIN CALCIUM) BACTROBAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 050746 (label 50746.pdf) INN (MUPIROCIN CALCIUM) BACTROBAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 050788 (label 50788.pdf) INN (MUPIROCIN) CENTANY (PADAGIS US) APPROVAL= AP YEAR= 2002 , NDA 065085 (pdf 65085.pdf not found) INN (MUPIROCIN) MUPIROCIN (TEVA) APPROVAL= AP YEAR= 2003 , NDA 065123 (pdf 65123.pdf not found) INN (MUPIROCIN) MUPIROCIN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003 , NDA 065170 (pdf 65170.pdf not found) INN (MUPIROCIN) MUPIROCIN (TARO) APPROVAL= AP YEAR= 2005 , NDA 065192 (pdf 65192.pdf not found) INN (MUPIROCIN) MUPIROCIN (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 090480 (pdf 90480.pdf not found) INN (MUPIROCIN) MUPIROCIN (GLENMARK PHARMS) APPROVAL= AP YEAR= 2011 , NDA 201587 (pdf 201587.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 207116 (pdf 207116.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (TARO) APPROVAL= AP YEAR= 2020 , NDA 213053 (pdf 213053.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 213076 (pdf 213076.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 212465 (pdf 212465.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214811 (pdf 214811.pdf not found) INN (MUPIROCIN CALCIUM) MUPIROCIN (AMNEAL) APPROVAL= AP YEAR= 2022 , 1045 ; CEFOTIAM ; 61622-34-2 ; 1988 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050601 (pdf 50601.pdf not found) INN (CEFOTIAM HYDROCHLORIDE) CERADON (TAKEDA) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , 1046 ; VANCOMYCIN ; 1404-90-6 ; 1964 ; ; ; CLASS ANTIINFECTIVES -- MACROLIDE -- GLYCOPEPTIDE ANTIBACTERIALS -- ANTIBACTERIAL -- ANTIBIOTIC -- INHIBITION OF CELL-WALL BIOSYNTHESIS , ; NDA 050606 (label 50606.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 , NDA 050671 (label 50671.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1993 , NDA 060180 (label 60180.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 061667 (pdf 61667.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 , NDA 062476 (pdf 62476.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062663 (pdf 62663.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 062682 (pdf 62682.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOLED (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 062716 (pdf 62716.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062812 (pdf 62812.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOCIN HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062845 (pdf 62845.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062879 (pdf 62879.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062911 (label 62911.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 062912 (label 62912.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 062931 (label 62931.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1992 , NDA 062933 (label 62933.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1992 , NDA 062956 (pdf 62956.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOR (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063076 (label 63076.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1990 , NDA 063321 (pdf 63321.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOLED (LEDERLE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 065401 (pdf 65401.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065397 (pdf 65397.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 065432 (pdf 65432.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 065455 (pdf 65455.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2009 , NDA 090250 (pdf 90250.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091469 (pdf 91469.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091554 (pdf 91554.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 065453 (pdf 65453.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 065478 (pdf 65478.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 065490 (pdf 65490.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 , NDA 065510 (pdf 65510.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200837 (pdf 200837.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 201048 (pdf 201048.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (SANDOZ INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202274 (pdf 202274.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202275 (pdf 202275.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202464 (pdf 202464.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090439 (pdf 90439.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 091377 (pdf 91377.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201250 (pdf 201250.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201251 (pdf 201251.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204107 (pdf 204107.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2015 , NDA 204125 (pdf 204125.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2015 , NDA 206243 (pdf 206243.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091532 (pdf 91532.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (SAMSON MEDCL) APPROVAL= AP YEAR= 2016 , NDA 205694 (pdf 205694.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 205779 (pdf 205779.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205780 (pdf 205780.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 208910 (label 208910.pdf) INN (VANCOMYCIN HYDROCHLORIDE) FIRVANQ KIT (AZURITY) APPROVAL= AP YEAR= 2018 , NDA 204360 (pdf 204360.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2018 , NDA 206616 (pdf 206616.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209481 (label 209481.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 210729 (pdf 210729.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (ORIENT PHARMA CO LTD) APPROVAL= AP YEAR= 2019 , NDA 211962 (label 211962.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2019 , NDA 212332 (pdf 212332.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HAINAN POLY PHARM) APPROVAL= AP YEAR= 2019 , NDA 203300 (pdf 203300.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213895 (label 213895.pdf) INN (VANCOMYCIN) VANCOMYCIN (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215821 (pdf 215821.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HAINAN POLY) APPROVAL= AP YEAR= 2021 , NDA 213059 (pdf 213059.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (KNACK) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216591 (pdf 216591.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 214913 (pdf 214913.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 215195 (pdf 215195.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215196 (pdf 215196.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215197 (pdf 215197.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 210274 (label 210274.pdf) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (ZHEJIANG NOVUS PHARM) APPROVAL= AP YEAR= 2023 , NDA 215338 (pdf 215338.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 217401 (pdf 217401.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217489 (pdf 217489.pdf not found) INN (VANCOMYCIN HYDROCHLORIDE) VANCOMYCIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2023 , 1047 ; CEFIXIME ; 79350-37-1 ; 1989 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050621 (label 50621.pdf) INN (CEFIXIME) SUPRAX (LEDERLE) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 050622 (label 50622.pdf) INN (CEFIXIME) SUPRAX (LEDERLE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 065129 (pdf 65129.pdf not found) INN (CEFIXIME) SUPRAX (LUPIN PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065130 (pdf 65130.pdf not found) INN (CEFIXIME) SUPRAX (LUPIN PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065355 (pdf 65355.pdf not found) INN (CEFIXIME) SUPRAX (LUPIN PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065380 (pdf 65380.pdf not found) INN (CEFIXIME) SUPRAX (LUPIN LTD) APPROVAL= AP YEAR= 2010 , NDA 203195 (label 203195.pdf) INN (CEFIXIME) SUPRAX (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 202091 (label 202091.pdf) INN (CEFIXIME) SUPRAX (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 204835 (pdf 204835.pdf not found) INN (CEFIXIME) CEFIXIME (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 206938 (pdf 206938.pdf not found) INN (CEFIXIME) CEFIXIME (BELCHER) APPROVAL= AP YEAR= 2017 , NDA 206939 (label 206939.pdf) INN (CEFIXIME) CEFIXIME (BELCHER) APPROVAL= AP YEAR= 2017 , NDA 206144 (pdf 206144.pdf not found) INN (CEFIXIME) CEFIXIME (SANDOZ) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210574 (pdf 210574.pdf not found) INN (CEFIXIME) CEFIXIME (ALKEM LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 211775 (pdf 211775.pdf not found) INN (CEFIXIME) CEFIXIME (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , 1048 ; CEFPIRAMIDE ; 70797-11-4 ; 1989 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050633 (pdf 50633.pdf not found) INN (CEFPIRAMIDE SODIUM) CEFPIRAMIDE SODIUM (WYETH AYERST) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , 1049 ; CEFMETAZOLE ; 56796-20-4 ; 1989 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; NDA 050637 (pdf 50637.pdf not found) INN (CEFMETAZOLE SODIUM) ZEFAZONE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 050683 (pdf 50683.pdf not found) INN (CEFMETAZOLE SODIUM) ZEFAZONE IN PLASTIC CONTAINER (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1050 ; IDARUBICIN ; 58957-92-9 ; 1990 ; ; ; CLASS ANTINEOPLASTIC -- ANTIBIOTICS -- CYTOTOXIC -- ANTHRACYCLINES -- ANTILEUKEMIC DRUG , ; NDA 050661 (label 50661.pdf) INN (IDARUBICIN HYDROCHLORIDE) IDAMYCIN (PFIZER) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 050734 (label 50734.pdf) INN (IDARUBICIN HYDROCHLORIDE) IDAMYCIN PFS (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 065036 (pdf 65036.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2002 , NDA 065037 (pdf 65037.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065275 (pdf 65275.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 065288 (pdf 65288.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 065440 (pdf 65440.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091293 (pdf 91293.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200144 (pdf 200144.pdf not found) INN (IDARUBICIN HYDROCHLORIDE) IDARUBICIN HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , 1051 ; CLARITHROMYCIN ; 81103-11-9 ; 1991 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- MACROLIDES , ; NDA 050662 (label 50662.pdf) INN (CLARITHROMYCIN) BIAXIN (ABBVIE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 050697 (pdf 50697.pdf not found) INN (CLARITHROMYCIN) BIAXIN XL (ABBVIE INC) APPROVAL= AP YEAR= 1993 NEWAPPLICATION , NDA 050698 (label 50698.pdf) INN (CLARITHROMYCIN) BIAXIN (ABBVIE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 050757 (label 50757.pdf) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) PREVPAC COPACKAGED (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 050775 (label 50775.pdf) INN (CLARITHROMYCIN) BIAXIN XL (ABBVIE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065136 (pdf 65136.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065137 (pdf 65137.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065144 (pdf 65144.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065145 (pdf 65145.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2004 , NDA 065154 (pdf 65154.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2005 , NDA 065155 (pdf 65155.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065174 (pdf 65174.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065178 (pdf 65178.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 065195 (pdf 65195.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065210 (pdf 65210.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (RANBAXY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065250 (pdf 65250.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (ANI PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065266 (pdf 65266.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (WOCKHARDT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065283 (pdf 65283.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065382 (label 65382.pdf) INN (CLARITHROMYCIN) CLARITHROMYCIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065384 (pdf 65384.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (CHARTWELL) APPROVAL= AP YEAR= 2007 , NDA 050824 (label 50824.pdf) INN (AMOXICILLIN CLARITHROMYCIN OMEPRAZOLE) OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 065489 (pdf 65489.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (AUROBINDO) APPROVAL= AP YEAR= 2012 , NDA 200218 (pdf 200218.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (ANI PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202710 (pdf 202710.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (STRIDES PHARMA) APPROVAL= AP YEAR= 2013 , NDA 202588 (pdf 202588.pdf not found) INN (CLARITHROMYCIN) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN (SANDOZ INC) APPROVAL= AP YEAR= 2014 , NDA 203584 (pdf 203584.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (HEC PHARM) APPROVAL= AP YEAR= 2015 , NDA 202532 (pdf 202532.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (LUPIN LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203243 (pdf 203243.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 , NDA 206006 (pdf 206006.pdf not found) INN (AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE) LANSOPRAZOLE , AMOXICILLIN AND CLARITHROMYCIN COPACKAGED (RISING) APPROVAL= AP YEAR= 2016 , NDA 208987 (pdf 208987.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (SUNSHINE) APPROVAL= AP YEAR= 2018 , NDA 206714 (pdf 206714.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210459 (pdf 210459.pdf not found) INN (CLARITHROMYCIN) CLARITHROMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 215152 (label 215152.pdf) INN (AMOXICILLIN CLARITHROMYCIN VONOPRAZAN FUMARATE) VOQUEZNA TRIPLE PAK (PHATHOM) APPROVAL= AP YEAR= 2022 , 1052 ; CEFPROZIL ; 92665-29-7 ; 1991 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050664 (label 50664.pdf) INN (CEFPROZIL) CEFZIL (CORDEN PHARMA) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 050665 (label 50665.pdf) INN (CEFPROZIL) CEFZIL (CORDEN PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 065198 (pdf 65198.pdf not found) INN (CEFPROZIL) CEFPROZIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065202 (pdf 65202.pdf not found) INN (CEFPROZIL) CEFPROZIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065208 (pdf 65208.pdf not found) INN (CEFPROZIL) CEFPROZIL (TEVA) APPROVAL= AP YEAR= 2005 , NDA 065235 (pdf 65235.pdf not found) INN (CEFPROZIL) CEFPROZIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065236 (pdf 65236.pdf not found) INN (CEFPROZIL) CEFPROZIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065257 (pdf 65257.pdf not found) INN (CEFPROZIL) CEFPROZIL (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065261 (pdf 65261.pdf not found) INN (CEFPROZIL) CEFPROZIL (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065267 (pdf 65267.pdf not found) INN (CEFPROZIL) CEFPROZIL (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065276 (pdf 65276.pdf not found) INN (CEFPROZIL) CEFPROZIL (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065284 (pdf 65284.pdf not found) INN (CEFPROZIL) CEFPROZIL (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065327 (pdf 65327.pdf not found) INN (CEFPROZIL) CEFPROZIL (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 065340 (pdf 65340.pdf not found) INN (CEFPROZIL) CEFPROZIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065381 (pdf 65381.pdf not found) INN (CEFPROZIL) CEFPROZIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065428 (pdf 65428.pdf not found) INN (CEFPROZIL) CEFPROZIL (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065351 (pdf 65351.pdf not found) INN (CEFPROZIL) CEFPROZIL (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 090857 (pdf 90857.pdf not found) INN (CEFPROZIL) CEFPROZIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2024 , 1053 ; LORACARBEF ; 76470-66-1 ; 1991 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS -- CARBACEPHEM , ; NDA 050667 (pdf 50667.pdf not found) INN (LORACARBEF) LORABID (KING PHARMS) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 050668 (pdf 50668.pdf not found) INN (LORACARBEF) LORABID (KING PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , 1054 ; AZITHROMYCIN ; 83905-01-5 ; 1991 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- MACROLIDES -- ANTIMALARIALS , ; NDA 050670 (label 50670.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 050693 (label 50693.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1994 , NDA 050710 (label 50710.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1995 , NDA 050711 (label 50711.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1996 , NDA 050730 (label 50730.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 050733 (label 50733.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 050762 (label 50762.pdf) INN (AZITHROMYCIN DIHYDRATE TROVAFLOXACIN MESYLATE) TROVAN/ZITHROMAX COMPLIANCE PAK (PFIZER) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 050784 (label 50784.pdf) INN (AZITHROMYCIN) ZITHROMAX (PFIZER) APPROVAL= AP YEAR= 2002 , NDA 050797 (label 50797.pdf) INN (AZITHROMYCIN) ZMAX (PF PRISM CV) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 050809 (label 50809.pdf) INN (AZITHROMYCIN) AZITHROMYCIN (TEVA PARENTERAL) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 050810 (label 50810.pdf) INN (AZITHROMYCIN) AZASITE (THEA PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065150 (pdf 65150.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065153 (pdf 65153.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065179 (pdf 65179.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 , NDA 065193 (pdf 65193.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (TEVA) APPROVAL= AP YEAR= 2005 , NDA 065209 (pdf 65209.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065211 (pdf 65211.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065212 (pdf 65212.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 065218 (pdf 65218.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (PLIVA) APPROVAL= AP YEAR= 2005 , NDA 065223 (pdf 65223.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (PLIVA) APPROVAL= AP YEAR= 2005 , NDA 065225 (pdf 65225.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (PLIVA) APPROVAL= AP YEAR= 2005 , NDA 065246 (pdf 65246.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (PLIVA) APPROVAL= AP YEAR= 2006 , NDA 065265 (pdf 65265.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065297 (pdf 65297.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065302 (pdf 65302.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 065360 (pdf 65360.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065365 (pdf 65365.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065366 (pdf 65366.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065404 (pdf 65404.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 065405 (pdf 65405.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 065419 (pdf 65419.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065500 (pdf 65500.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (HOSPIRA) APPROVAL= AP YEAR= 2009 , NDA 065501 (pdf 65501.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2009 , NDA 065506 (pdf 65506.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (MYLAN ASI) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065511 (pdf 65511.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (HOSPIRA) APPROVAL= AP YEAR= 2009 , NDA 065507 (pdf 65507.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (APOTEX CORP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 065508 (pdf 65508.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (APOTEX CORP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 065509 (pdf 65509.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (APOTEX CORP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090923 (pdf 90923.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202308 (pdf 202308.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SANDOZ INC) APPROVAL= TA YEAR= 2014 , NDA 065398 (pdf 65398.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 065399 (pdf 65399.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 065400 (pdf 65400.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 065488 (pdf 65488.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203294 (pdf 203294.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 203412 (pdf 203412.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2018 , NDA 202793 (pdf 202793.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (NOVEL LABS INC) APPROVAL= TA YEAR= 2016 , NDA 204732 (pdf 204732.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205666 (pdf 205666.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 207531 (pdf 207531.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2018 , NDA 207370 (pdf 207370.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207398 (pdf 207398.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207566 (pdf 207566.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CSPC OUYI) APPROVAL= AP YEAR= 2018 , NDA 208249 (pdf 208249.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CSPC OUYI) APPROVAL= AP YEAR= 2018 , NDA 209043 (pdf 209043.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SUNSHINE) APPROVAL= AP YEAR= 2018 , NDA 209044 (pdf 209044.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SUNSHINE) APPROVAL= AP YEAR= 2018 , NDA 209045 (pdf 209045.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (SUNSHINE) APPROVAL= AP YEAR= 2018 , NDA 209201 (pdf 209201.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 209999 (pdf 209999.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 211147 (pdf 211147.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 208250 (pdf 208250.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (CSPC OUYI) APPROVAL= AP YEAR= 2019 , NDA 210000 (pdf 210000.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 210001 (pdf 210001.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 211521 (pdf 211521.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (TARO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211068 (pdf 211068.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2020 , NDA 211791 (pdf 211791.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 211792 (pdf 211792.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 211793 (pdf 211793.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 211318 (pdf 211318.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211317 (pdf 211317.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215772 (pdf 215772.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ACI) APPROVAL= AP YEAR= 2022 , NDA 215773 (pdf 215773.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ACI) APPROVAL= AP YEAR= 2022 , NDA 213056 (pdf 213056.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213275 (pdf 213275.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217036 (pdf 217036.pdf not found) INN (AZITHROMYCIN) AZITHROMYCIN (HAINAN POLY) APPROVAL= AP YEAR= 2023 , 1055 ; CEFPODOXIME PROXETIL ; 87239-81-4 ; 1992 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS -- CELL WALL SYNTHESIS , ; NDA 050674 (label 50674.pdf) INN (CEFPODOXIME PROXETIL) VANTIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 050675 (label 50675.pdf) INN (CEFPODOXIME PROXETIL) VANTIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 050687 (label 50687.pdf) INN (CEFPODOXIME PROXETIL) BANAN (SANKYO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 050688 (label 50688.pdf) INN (CEFPODOXIME PROXETIL) BANAN (SANKYO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 065082 (pdf 65082.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065083 (pdf 65083.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065370 (pdf 65370.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065388 (pdf 65388.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 , NDA 065409 (pdf 65409.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2007 , NDA 065462 (label 65462.pdf) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 090031 (label 90031.pdf) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 210568 (pdf 210568.pdf not found) INN (CEFPODOXIME PROXETIL) CEFPODOXIME PROXETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , 1056 ; DIRITHROMYCIN ; 62013-04-1 ; 1995 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- MACROLIDES , ; NDA 050678 (pdf 50678.pdf not found) INN (DIRITHROMYCIN) DYNABAC (LILLY RES LABS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , 1057 ; CEFEPIME ; 88040-23-7 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050679 (label 50679.pdf) INN (CEFEPIME HYDROCHLORIDE) MAXIPIME (HOSPIRA INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 050817 (label 50817.pdf) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 065369 (pdf 65369.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065441 (pdf 65441.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (ACS DOBFAR) APPROVAL= AP YEAR= 2008 , NDA 050821 (label 50821.pdf) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2010 , NDA 090291 (pdf 90291.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202268 (pdf 202268.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 203704 (pdf 203704.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (QILU) APPROVAL= AP YEAR= 2016 , NDA 091048 (pdf 91048.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209408 (pdf 209408.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER (SAMSON MEDCL) APPROVAL= AP YEAR= 2018 , NDA 212721 (pdf 212721.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (ASTRAL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 214402 (pdf 214402.pdf not found) INN (CEFEPIME HYDROCHLORIDE) CEFEPIME HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2024 , NDA 216165 (label 216165.pdf) INN (CEFEPIME HYDROCHLORIDE ENMETAZOBACTAM) EXBLIFEP (ALLECRA THERAPS) APPROVAL= AP YEAR= 2024 DISCONTINUED , 1058 ; DACTINOMYCIN ; 50-76-0 ; 1964 ; ; NATURAL MOLECULE NPA007563 ; CLASS ANTINEOPLASTIC -- CYTOTOXIC -- ACTINOMYCINS -- TREATMENT OF WILMS TUMOR -- CHILDHOOD RHABDOMYOSARCOMA -- EWING SARCOMA -- METASTATIC NONSEMINOMATOUS TESTICULAR CANCER , ; NDA 050682 (label 50682.pdf) INN (DACTINOMYCIN) COSMEGEN (RECORDATI RARE) APPROVAL= AP YEAR= 1964 NEWMOLECULARENTITY DISCONTINUED , NDA 090304 (pdf 90304.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (HIKMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 202562 (pdf 202562.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (AM REGENT) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203385 (pdf 203385.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 203999 (pdf 203999.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (XGEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 207232 (pdf 207232.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 , NDA 213463 (pdf 213463.pdf not found) INN (DACTINOMYCIN) DACTINOMYCIN (MEITHEAL) APPROVAL= AP YEAR= 2020 , 1059 ; TAZOBACTAM ; 89786-04-9 ; 1993 ; ; ; CLASS ANTIINFECTIVES -- BETA-LACTAMASE INHIBITOR , ; NDA 050684 (label 50684.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) ZOSYN (WYETH PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 050750 (label 50750.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) ZOSYN IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1998 , NDA 065386 (label 65386.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065446 (label 65446.pdf) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065362 (pdf 65362.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 065363 (pdf 65363.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 065498 (pdf 65498.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2011 , NDA 065523 (pdf 65523.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 090498 (pdf 90498.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2011 , NDA 065458 (pdf 65458.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 203557 (pdf 203557.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 206829 (label 206829.pdf) INN (CEFTOLOZANE SULFATE TAZOBACTAM SODIUM) ZERBAXA (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2014 , NDA 206204 (pdf 206204.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 206996 (pdf 206996.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 207146 (pdf 207146.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2017 , NDA 207847 (pdf 207847.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (PROVEPHARM SAS) APPROVAL= AP YEAR= 2017 , NDA 207848 (pdf 207848.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (PROVEPHARM SAS) APPROVAL= AP YEAR= 2017 , NDA 203719 (pdf 203719.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI) APPROVAL= AP YEAR= 2018 , NDA 203720 (pdf 203720.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (FRESENIUS KABI) APPROVAL= AP YEAR= 2018 , NDA 204959 (pdf 204959.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SHANDONG) APPROVAL= AP YEAR= 2018 , NDA 212287 (pdf 212287.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (ASTRAL) APPROVAL= AP YEAR= 2019 , NDA 208674 (pdf 208674.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 208675 (pdf 208675.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 217243 (pdf 217243.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (SHANDONG) APPROVAL= AP YEAR= 2023 , NDA 217409 (pdf 217409.pdf not found) INN (PIPERACILLIN SODIUM TAZOBACTAM SODIUM) PIPERACILLIN AND TAZOBACTAM (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , 1060 ; CEFTIBUTEN ; 97519-39-6 ; 1995 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050685 (label 50685.pdf) INN (CEFTIBUTEN DIHYDRATE) CEDAX (SI PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 050686 (label 50686.pdf) INN (CEFTIBUTEN DIHYDRATE) CEDAX (SI PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , 1061 ; RIFABUTIN ; 72559-06-9 ; 1992 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- DNA-DEPENDENT RNA POLYMERASE INHIBITOR , ; NDA 050689 (label 50689.pdf) INN (RIFABUTIN) MYCOBUTIN (PFIZER) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 090033 (pdf 90033.pdf not found) INN (RIFABUTIN) RIFABUTIN (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 213004 (label 213004.pdf) INN (AMOXICILLIN OMEPRAZOLE MAGNESIUM RIFABUTIN) TALICIA (REDHILL) APPROVAL= AP YEAR= 2019 , NDA 215041 (pdf 215041.pdf not found) INN (RIFABUTIN) RIFABUTIN (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , 1062 ; PYRAZINAMIDE ; 98-96-4 ; 1971 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANALOGUE OF NICOTINAMIDE , ; NDA 050705 (label 50705.pdf) INN (ISONIAZID PYRAZINAMIDE RIFAMPIN) RIFATER (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 080157 (pdf 80157.pdf not found) INN (PYRAZINAMIDE) PYRAZINAMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1971 , NDA 081319 (pdf 81319.pdf not found) INN (PYRAZINAMIDE) PYRAZINAMIDE (HIKMA) APPROVAL= AP YEAR= 1992 , NDA 212541 (pdf 212541.pdf not found) INN (PYRAZINAMIDE) PYRAZINAMIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020 , 1063 ; MEROPENEM ; 96036-03-2 ; 1996 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CARBAPENEMS -- PENICILLIN-BINDING PROTEIN INHIBITOR , ; NDA 050706 (label 50706.pdf) INN (MEROPENEM) MERREM (PFIZER) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 090940 (pdf 90940.pdf not found) INN (MEROPENEM) MEROPENEM (HOSPIRA INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091201 (pdf 91201.pdf not found) INN (MEROPENEM) MEROPENEM (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091404 (pdf 91404.pdf not found) INN (MEROPENEM) MEROPENEM (ACS DOBFAR) APPROVAL= AP YEAR= 2011 , NDA 202106 (label 202106.pdf) INN (MEROPENEM) MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2015 , NDA 204854 (pdf 204854.pdf not found) INN (MEROPENEM) MEROPENEM (DAEWOONG PHARM CO) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204139 (pdf 204139.pdf not found) INN (MEROPENEM) MEROPENEM (ACS DOBFAR SPA) APPROVAL= AP YEAR= 2016 , NDA 205883 (label 205883.pdf) INN (MEROPENEM) MEROPENEM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206086 (pdf 206086.pdf not found) INN (MEROPENEM) MEROPENEM (SAVIOR LIFETEC CORP) APPROVAL= AP YEAR= 2016 , NDA 206141 (pdf 206141.pdf not found) INN (MEROPENEM) MEROPENEM (GLAND) APPROVAL= AP YEAR= 2016 , NDA 205835 (pdf 205835.pdf not found) INN (MEROPENEM) MEROPENEM (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209776 (label 209776.pdf) INN (MEROPENEM VABORBACTAM) VABOMERE (REMPEX) APPROVAL= AP YEAR= 2017 , NDA 210773 (pdf 210773.pdf not found) INN (MEROPENEM) MEROPENEM (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2019 , NDA 216154 (pdf 216154.pdf not found) INN (MEROPENEM) MEROPENEM (BROOKS STERISCIENCE) APPROVAL= AP YEAR= 2022 , NDA 215212 (pdf 215212.pdf not found) INN (MEROPENEM) MEROPENEM (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2023 , 1064 ; TACROLIMUS ; 104987-11-3 ; 1994 ; ; ; CLASS IMMUNOMODULATING AGENT -- IMMUNOSUPPRESSIVE -- PHOSPHATASE ACTIVITY OF CALCINEURIN INHIBITED -- PROTEIN-PROTEIN INHIBITOR (PPI) -- PROPHYLAXIS OF ORGAN REJECTION -- MACROLIDE , ; NDA 050708 (label 50708.pdf) INN (TACROLIMUS) PROGRAF (ASTELLAS) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY , NDA 050709 (label 50709.pdf) INN (TACROLIMUS) PROGRAF (ASTELLAS) APPROVAL= AP YEAR= 1994 , NDA 050777 (label 50777.pdf) INN (TACROLIMUS) PROTOPIC (LEO PHARMA AS) APPROVAL= AP YEAR= 2000 , NDA 065461 (label 65461.pdf) INN (TACROLIMUS) TACROLIMUS (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 090402 (pdf 90402.pdf not found) INN (TACROLIMUS) TACROLIMUS (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090509 (pdf 90509.pdf not found) INN (TACROLIMUS) TACROLIMUS (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 090596 (pdf 90596.pdf not found) INN (TACROLIMUS) TACROLIMUS (MYLAN) APPROVAL= AP YEAR= 2010 , NDA 091195 (pdf 91195.pdf not found) INN (TACROLIMUS) TACROLIMUS (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 , NDA 090802 (pdf 90802.pdf not found) INN (TACROLIMUS) TACROLIMUS (PANACEA) APPROVAL= AP YEAR= 2012 , NDA 204096 (label 204096.pdf) INN (TACROLIMUS) ASTAGRAF XL (ASTELLAS) APPROVAL= AP YEAR= 2013 , NDA 090687 (pdf 90687.pdf not found) INN (TACROLIMUS) TACROLIMUS (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 200744 (pdf 200744.pdf not found) INN (TACROLIMUS) TACROLIMUS (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 206406 (label 206406.pdf) INN (TACROLIMUS) ENVARSUS XR (VELOXIS PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 203900 (pdf 203900.pdf not found) INN (TACROLIMUS) TACROLIMUS (HOSPIRA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206651 (pdf 206651.pdf not found) INN (TACROLIMUS) TACROLIMUS (BELCHER) APPROVAL= AP YEAR= 2017 , NDA 210115 (label 210115.pdf) INN (TACROLIMUS) PROGRAF (ASTELLAS) APPROVAL= AP YEAR= 2018 , NDA 210393 (pdf 210393.pdf not found) INN (TACROLIMUS) TACROLIMUS (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 211688 (pdf 211688.pdf not found) INN (TACROLIMUS) TACROLIMUS (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 203740 (pdf 203740.pdf not found) INN (TACROLIMUS) TACROLIMUS (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 206662 (pdf 206662.pdf not found) INN (TACROLIMUS) TACROLIMUS (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 212297 (pdf 212297.pdf not found) INN (TACROLIMUS) TACROLIMUS (BIOCON PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213112 (pdf 213112.pdf not found) INN (TACROLIMUS) TACROLIMUS (CONCORD BIOTECH LTD) APPROVAL= AP YEAR= 2020 , NDA 210929 (pdf 210929.pdf not found) INN (TACROLIMUS) TACROLIMUS (HANGZHOU ZHONGMEI) APPROVAL= AP YEAR= 2023 , NDA 212387 (pdf 212387.pdf not found) INN (TACROLIMUS) TACROLIMUS (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 215012 (pdf 215012.pdf not found) INN (TACROLIMUS) TACROLIMUS (CHENGDU) APPROVAL= AP YEAR= 2024 , 1065 ; FOSFOMYCIN ; 23155-02-4 ; 1996 ; ; NATURAL MOLECULE C00000789 NPA024868 ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- INHIBITOR -- TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS , ; NDA 050717 (label 50717.pdf) INN (FOSFOMYCIN TROMETHAMINE) MONUROL (ZAMBON SPA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 212548 (pdf 212548.pdf not found) INN (FOSFOMYCIN TROMETHAMINE) FOSFOMYCIN TROMETHAMINE (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 214554 (pdf 214554.pdf not found) INN (FOSFOMYCIN TROMETHAMINE) FOSFOMYCIN TROMETHAMINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 211881 (pdf 211881.pdf not found) INN (FOSFOMYCIN TROMETHAMINE) FOSFOMYCIN TROMETHAMINE (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 216600 (pdf 216600.pdf not found) INN (FOSFOMYCIN TROMETHAMINE) FOSFOMYCIN TROMETHAMINE (AMNEAL) APPROVAL= AP YEAR= 2024 , 1066 ; MYCOPHENOLATE MOFETIL ; 128794-94-5 ; 1995 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING AGENT -- IMMUNOSUPPRESSIVE AGENTS -- INHIBITOR OF GUANOSINE NUCLEOTIDE SYNTHESIS -- PREVENTION OF ORGAN REJECTION , ; NDA 050722 (label 50722.pdf) INN (MYCOPHENOLATE MOFETIL) CELLCEPT (ROCHE PALO) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 050723 (label 50723.pdf) INN (MYCOPHENOLATE MOFETIL) CELLCEPT (ROCHE PALO) APPROVAL= AP YEAR= 1997 , NDA 050758 (label 50758.pdf) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) CELLCEPT (ROCHE PALO) APPROVAL= AP YEAR= 1998 , NDA 050759 (label 50759.pdf) INN (MYCOPHENOLATE MOFETIL) CELLCEPT (ROCHE PALO) APPROVAL= AP YEAR= 1998 , NDA 065410 (label 65410.pdf) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 065413 (label 65413.pdf) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 065379 (pdf 65379.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 065416 (pdf 65416.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 065433 (pdf 65433.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065451 (pdf 65451.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 065457 (pdf 65457.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (TEVA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065477 (pdf 65477.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 065491 (pdf 65491.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (TEVA PHARMS) APPROVAL= AP YEAR= 2009 , NDA 065520 (pdf 65520.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 065521 (pdf 65521.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 090111 (pdf 90111.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090253 (pdf 90253.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 090419 (pdf 90419.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (APOTEX CORP) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090499 (pdf 90499.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (APOTEX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090055 (pdf 90055.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090311 (pdf 90311.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2010 , NDA 090456 (pdf 90456.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090464 (pdf 90464.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090606 (pdf 90606.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (AMNEAL) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091249 (pdf 91249.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 091315 (pdf 91315.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200197 (pdf 200197.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 090661 (pdf 90661.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090762 (pdf 90762.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (JUBILANT CADISTA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203005 (pdf 203005.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 203575 (pdf 203575.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 203859 (pdf 203859.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 204043 (pdf 204043.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 , NDA 204076 (pdf 204076.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ZHEJIANG HISUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 204077 (pdf 204077.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (ZHEJIANG HISUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 204473 (pdf 204473.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 210181 (pdf 210181.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (CONCORD BIOTECH LTD) APPROVAL= AP YEAR= 2019 , NDA 210370 (pdf 210370.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (VISTAPHARM) APPROVAL= AP YEAR= 2019 , NDA 212087 (pdf 212087.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (CONCORD BIOTECH LTD) APPROVAL= AP YEAR= 2020 , NDA 211374 (pdf 211374.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212130 (pdf 212130.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 214525 (pdf 214525.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (LANNETT CO INC) APPROVAL= AP YEAR= 2021 , NDA 214871 (pdf 214871.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 211272 (pdf 211272.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 216390 (pdf 216390.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2022 , NDA 214283 (pdf 214283.pdf not found) INN (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) MYCOPHENOLATE MOFETIL HYDROCHLORIDE (BPI LABS) APPROVAL= AP YEAR= 2023 , NDA 212634 (pdf 212634.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 , NDA 213955 (pdf 213955.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 216482 (pdf 216482.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYHIBBIN (AZURITY) APPROVAL= AP YEAR= 2024 , NDA 217828 (pdf 217828.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217937 (pdf 217937.pdf not found) INN (MYCOPHENOLATE MOFETIL) MYCOPHENOLATE MOFETIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , 1067 ; CEFDINIR ; 91832-40-5 ; 1997 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS -- INHIBITION OF CELL WALL SYNTHESIS , ; NDA 050739 (label 50739.pdf) INN (CEFDINIR) OMNICEF (ABBVIE) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 050749 (label 50749.pdf) INN (CEFDINIR) OMNICEF (ABBVIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 065259 (pdf 65259.pdf not found) INN (CEFDINIR) CEFDINIR (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 065264 (pdf 65264.pdf not found) INN (CEFDINIR) CEFDINIR (LUPIN) APPROVAL= AP YEAR= 2006 , NDA 065330 (pdf 65330.pdf not found) INN (CEFDINIR) CEFDINIR (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065332 (pdf 65332.pdf not found) INN (CEFDINIR) CEFDINIR (TEVA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065337 (pdf 65337.pdf not found) INN (CEFDINIR) CEFDINIR (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 065368 (pdf 65368.pdf not found) INN (CEFDINIR) CEFDINIR (TEVA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 065418 (pdf 65418.pdf not found) INN (CEFDINIR) CEFDINIR (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 , NDA 065429 (pdf 65429.pdf not found) INN (CEFDINIR) CEFDINIR (ANDA REPOSITORY) APPROVAL= AP YEAR= 2007 , NDA 065434 (pdf 65434.pdf not found) INN (CEFDINIR) CEFDINIR (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 065473 (pdf 65473.pdf not found) INN (CEFDINIR) CEFDINIR (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 210220 (pdf 210220.pdf not found) INN (CEFDINIR) CEFDINIR (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 210534 (pdf 210534.pdf not found) INN (CEFDINIR) CEFDINIR (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , 1068 ; IVERMECTIN ; 70288-86-7 ; 1996 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTICS -- ANTINEMATODAL AGENTS -- ANTIPROTOZOAL AGENTS -- INCREASE THE PERMEABILITY OF THE CELL MEMBRANE TO CHLORIDE IONS WITH HYPERPOLARIZATION BUT DOES NOT READILY CROSS THE BLOOD-BRAIN BARRIER IN HUMANS -- BINDS GLYCINE RECEPTOR , ; NDA 050742 (label 50742.pdf) INN (IVERMECTIN) STROMECTOL (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 202736 (label 202736.pdf) INN (IVERMECTIN) SKLICE (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2012 , NDA 204154 (label 204154.pdf) INN (IVERMECTIN) IVERMECTIN (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2014 , NDA 206255 (label 206255.pdf) INN (IVERMECTIN) SOOLANTRA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2014 , NDA 210019 (pdf 210019.pdf not found) INN (IVERMECTIN) IVERMECTIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 212485 (pdf 212485.pdf not found) INN (IVERMECTIN) IVERMECTIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210225 (pdf 210225.pdf not found) INN (IVERMECTIN) IVERMECTIN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 , NDA 210720 (pdf 210720.pdf not found) INN (IVERMECTIN) IVERMECTIN (TARO) APPROVAL= AP YEAR= 2020 , NDA 215210 (pdf 215210.pdf not found) INN (IVERMECTIN) IVERMECTIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , 1069 ; QUINUPRISTIN ; 120138-50-3 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- STREPTOGRAMINS -- BACTERIAL RIBOSOME (INHIBITS THE LATE PHASE OF PROTEIN SYNTHESIS) , ; NDA 050747 (label 50747.pdf) INN (QUINUPRISTIN DALFOPRISTIN) SYNERCID (KING PHARMS) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 050748 (label 50748.pdf) INN (DALFOPRISTIN QUINUPRISTIN) SYNERCID (KING PHARMS) APPROVAL= AP YEAR= 1999 , 1070 ; DALFOPRISTIN ; 112362-50-2 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- STREPTOGRAMINS -- BACTERIAL RIBOSOME BLOCKER (EARLY PHASE OF PROTEIN SYNTHESIS) , ; NDA 050747 (label 50747.pdf) INN (QUINUPRISTIN DALFOPRISTIN) SYNERCID (KING PHARMS) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 050748 (label 50748.pdf) INN (DALFOPRISTIN QUINUPRISTIN) SYNERCID (KING PHARMS) APPROVAL= AP YEAR= 1999 , 1071 ; EPIRUBICIN ; 56420-45-2 ; 1999 ; ; ; CLASS ANTINEOPLASTIC -- ANTHRACYCLINES -- BREAST CANCER -- CYTOTOXIC -- DNA HELICASE INHIBITOR -- INTERCALATION TRIGGERS DNA CLEAVAGE BY TOPOISOMERASE II , ; NDA 050778 (label 50778.pdf) INN (EPIRUBICIN HYDROCHLORIDE) ELLENCE (PFIZER INC) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 050807 (label 50807.pdf) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065289 (pdf 65289.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 065331 (pdf 65331.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2007 , NDA 065343 (pdf 65343.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065361 (pdf 65361.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (CIPLA LTD) APPROVAL= AP YEAR= 2007 , NDA 065371 (pdf 65371.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065408 (pdf 65408.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065411 (pdf 65411.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065445 (pdf 65445.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 065339 (pdf 65339.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (EBEWE PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090075 (label 90075.pdf) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2010 , NDA 090163 (pdf 90163.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 , NDA 090266 (pdf 90266.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (ZENNOVA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091599 (pdf 91599.pdf not found) INN (EPIRUBICIN HYDROCHLORIDE) EPIRUBICIN HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , 1072 ; MYCOPHENOLIC ACID ; 24280-93-1 ; 2004 ; ; NATURAL MOLECULE NPA015757 ; CLASS IMMUNOMODULATING AGENT -- IMMUNOSUPPRESSANTS -- INHIBITOR OF GUANOSINE NUCLEOTIDE SYNTHESIS -- PREVENTION OF ORGAN REJECTION , ; NDA 050791 (label 50791.pdf) INN (MYCOPHENOLIC SODIUM) MYFORTIC (NOVARTIS) APPROVAL= AP YEAR= 2004 , NDA 091558 (pdf 91558.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 091248 (pdf 91248.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (RK PHARMA) APPROVAL= AP YEAR= 2014 , NDA 202720 (pdf 202720.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202555 (pdf 202555.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 211173 (pdf 211173.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (CONCORD BIOTECH LTD) APPROVAL= AP YEAR= 2019 , NDA 214376 (pdf 214376.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (AMTA) APPROVAL= AP YEAR= 2021 , NDA 208315 (pdf 208315.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214289 (pdf 214289.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (TWI PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214630 (pdf 214630.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2021 , NDA 217031 (pdf 217031.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (SKG PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216637 (pdf 216637.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (NOVUGEN) APPROVAL= AP YEAR= 2024 , NDA 218603 (pdf 218603.pdf not found) INN (MYCOPHENOLIC SODIUM) MYCOPHENOLIC SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1073 ; AZACITIDINE ; 320-67-2 ; 2004 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- FAB MYELODYSPLASTIC SYNDROME -- CYTOTOXIC -- NUCLEOSIDE ANALOG OF CYTIDINE -- HYPOMETHYLATION OF DNA AND RNA AFTER PHOSPHORYLATION BY KINASE UCK2 , ; NDA 050794 (label 50794.pdf) INN (AZACITIDINE) VIDAZA (BRISTOL-MYERS) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 201537 (pdf 201537.pdf not found) INN (AZACITIDINE) AZACITIDINE (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 204949 (pdf 204949.pdf not found) INN (AZACITIDINE) AZACITIDINE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208216 (label 208216.pdf) INN (AZACITIDINE) AZACITIDINE (ACTAVIS LLC) APPROVAL= AP YEAR= 2016 , NDA 207518 (pdf 207518.pdf not found) INN (AZACITIDINE) AZACITIDINE (SHILPA MEDICARE) APPROVAL= AP YEAR= 2016 , NDA 207234 (pdf 207234.pdf not found) INN (AZACITIDINE) AZACITIDINE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 209540 (pdf 209540.pdf not found) INN (AZACITIDINE) AZACITIDINE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 207475 (pdf 207475.pdf not found) INN (AZACITIDINE) AZACITIDINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 210748 (pdf 210748.pdf not found) INN (AZACITIDINE) AZACITIDINE (LUPIN LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209337 (pdf 209337.pdf not found) INN (AZACITIDINE) AZACITIDINE (EUROHLTH INTL SARL) APPROVAL= AP YEAR= 2020 , NDA 212128 (pdf 212128.pdf not found) INN (AZACITIDINE) AZACITIDINE (MEITHEAL) APPROVAL= AP YEAR= 2020 , NDA 214120 (label 214120.pdf) INN (AZACITIDINE) ONUREG (BRISTOL) APPROVAL= AP YEAR= 2020 , NDA 211549 (pdf 211549.pdf not found) INN (AZACITIDINE) AZACITIDINE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215066 (pdf 215066.pdf not found) INN (AZACITIDINE) AZACITIDINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215905 (pdf 215905.pdf not found) INN (AZACITIDINE) AZACITIDINE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2023 , NDA 212580 (pdf 212580.pdf not found) INN (AZACITIDINE) AZACITIDINE (MSN LABS PVT LTD) APPROVAL= AP YEAR= 2024 , 1074 ; STREPTOMYCIN ; 57-92-1 ; 1946 ; ; ; CLASS METABOLISM -- MACROLIDE -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- AMINOGLYCOSIDES -- PROTEIN SYNTHESIS INHIBITOR , ; NDA 060076 (pdf 60076.pdf not found) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (PFIZER) APPROVAL= AP YEAR= 1946 DISCONTINUED , NDA 060107 (pdf 60107.pdf not found) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060111 (pdf 60111.pdf not found) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (PFIZER) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 060404 (pdf 60404.pdf not found) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060684 (pdf 60684.pdf not found) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (COPANOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064210 (label 64210.pdf) INN (STREPTOMYCIN SULFATE) STREPTOMYCIN SULFATE (XGEN PHARMS) APPROVAL= AP YEAR= 1998 , 1075 ; GRAMICIDIN ; 1405-97-6 ; 1968 ; ; ; CLASS RESPIRATORY -- ANTIBACTERIAL -- ANTIBIOTIC -- FORM ION CONDUCTING CHANNELS IN LIPID BILAYER , ; NDA 060427 (pdf 60427.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEO-POLYCIN (DOW PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060582 (pdf 60582.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOSPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1968 , NDA 062383 (pdf 62383.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062788 (pdf 62788.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062818 (pdf 62818.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (IPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064047 (pdf 64047.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1996 , NDA 065187 (pdf 65187.pdf not found) INN (GRAMICIDIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (AMRING PHARMS) APPROVAL= AP YEAR= 2005 , 1076 ; PAROMOMYCIN ; 7542-37-2 ; 1969 ; ; ; CLASS METABOLISM -- AMINOGLYCOSIDE -- ANTIBACTERIAL -- ANTIAMEBIC -- INTESTINAL ANTIINFECTIVES , ; NDA 060521 (pdf 60521.pdf not found) INN (PAROMOMYCIN SULFATE) HUMATIN (PARKEDALE) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 060522 (pdf 60522.pdf not found) INN (PAROMOMYCIN SULFATE) HUMATIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062310 (pdf 62310.pdf not found) INN (PAROMOMYCIN SULFATE) HUMATIN (KING PFIZER) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 064171 (pdf 64171.pdf not found) INN (PAROMOMYCIN SULFATE) PAROMOMYCIN SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 065173 (pdf 65173.pdf not found) INN (PAROMOMYCIN SULFATE) PAROMOMYCIN SULFATE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2007 , 1077 ; CYCLOSERINE ; 68-41-7 ; 1964 ; ; NATURAL MOLECULE NPA001237 ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANTIMETABOLITES -- PEPTIDOGLYCAN BIOSYNTHESIS INHIBITOR -- NMDA PARTIAL AGONIST , ; NDA 060593 (pdf 60593.pdf not found) INN (CYCLOSERINE) SEROMYCIN (CEROVENE INC) APPROVAL= AP YEAR= 1964 , 1078 ; METHACYCLINE ; 914-00-1 ; 0 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- TETRACYCLINES , ; NDA 060641 (pdf 60641.pdf not found) INN (METHACYCLINE HYDROCHLORIDE) RONDOMYCIN (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , 1079 ; CANDICIDIN ; 1403-17-4 ; 0 ; DISCONTINUED ; ; CLASS GENITO -- ANTIFUNGAL -- ANTIBACTERIAL -- POLYENE ANTIBIOTICS , ; NDA 061596 (pdf 61596.pdf not found) INN (CANDICIDIN) VANOBID (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061613 (pdf 61613.pdf not found) INN (CANDICIDIN) VANOBID (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , 1080 ; PRAMOXINE ; 140-65-8 ; 1973 ; ; ; CLASS DERMATOLOGICALS -- ANESTHETIC , ; NDA 083213 (pdf 83213.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (FERNDALE LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083778 (pdf 83778.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1976 , NDA 085368 (pdf 85368.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1977 , NDA 085979 (pdf 85979.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 085980 (pdf 85980.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PRAMOSONE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1978 , NDA 086195 (pdf 86195.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) PROCTOFOAM HC (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1978 , NDA 086457 (pdf 86457.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) EPIFOAM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1979 , NDA 089440 (pdf 89440.pdf not found) INN (HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE) HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% (GENUS) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1081 ; PENTOBARBITAL ; 76-74-4 ; 1973 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- BARBITURATES -- GABA MODULATORS -- SEDATIVES -- ANTICONVULSANTS , ; NDA 083239 (pdf 83239.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083244 (pdf 83244.pdf not found) INN (PENTOBARBITAL) NEMBUTAL (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083245 (pdf 83245.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083246 (pdf 83246.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (RISING) APPROVAL= AP YEAR= 1973 , NDA 083247 (pdf 83247.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 083259 (pdf 83259.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083261 (pdf 83261.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083264 (pdf 83264.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083270 (pdf 83270.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (ELKINS SINN) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083284 (pdf 83284.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (VITARINE) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083285 (pdf 83285.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083301 (pdf 83301.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083338 (pdf 83338.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083368 (pdf 83368.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083461 (pdf 83461.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084093 (pdf 84093.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084095 (pdf 84095.pdf not found) INN (PENTOBARBITAL SODIUM) NEMBUTAL SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084156 (pdf 84156.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PARKE DAVIS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084238 (pdf 84238.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084560 (pdf 84560.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084590 (pdf 84590.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (ANABOLIC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084677 (pdf 84677.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085791 (pdf 85791.pdf not found) INN (PENTOBARBITAL SODIUM) SODIUM PENTOBARBITAL (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085915 (pdf 85915.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085937 (pdf 85937.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 206404 (pdf 206404.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 203619 (pdf 203619.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (HIKMA) APPROVAL= AP YEAR= 2017 , NDA 206677 (pdf 206677.pdf not found) INN (PENTOBARBITAL SODIUM) PENTOBARBITAL SODIUM (BPI LABS) APPROVAL= AP YEAR= 2017 , 1082 ; GENTIAN VIOLET ; 548-62-9 ; 1977 ; DISCONTINUED ; ; CLASS DERMATOLOGICAL -- ANTIINFECTIVE -- ANTHELMINTIC -- ANTIBACTERIAL -- ANTIFUNGAL -- HEXAMETHYL PARAROSANILINE , ; NDA 083513 (pdf 83513.pdf not found) INN (GENTIAN VIOLET) GVS (SAVAGE LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085017 (pdf 85017.pdf not found) INN (GENTIAN VIOLET) GENAPAX (KEY PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , 1083 ; DIGITOXIN ; 71-63-6 ; 1978 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- ANTIARRHYTHMIC , ; NDA 084100 (pdf 84100.pdf not found) INN (DIGITOXIN) CRYSTODIGIN (LILLY) APPROVAL= AP YEAR= 1978 DISCONTINUED , 1084 ; BENZYL BENZOATE ; 120-51-4 ; 1976 ; DISCONTINUED ; NATURAL MOLECULE C00019221 ; CLASS ANTIPARASITIC -- TOPICAL -- INSECTICIDES , ; NDA 084535 (pdf 84535.pdf not found) INN (BENZYL BENZOATE) BENZYL BENZOATE (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , 1085 ; TETRAHYDROZOLINE ; 84-22-0 ; 1979 ; ; ; CLASS CARDIOVASCULAR -- ADRENERGIC AGONIST -- NASAL DECONGESTANT -- VASOCONSTRICTOR -- IMIDAZOLINE DERIVATIVE , ; NDA 086576 (pdf 86576.pdf not found) INN (TETRAHYDROZOLINE HYDROCHLORIDE) TYZINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1979 , 1086 ; DRONEDARONE ; 141626-36-0 ; 2009 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- MULTI-CHANNEL BLOCKER THAT AFFECTS CALCIUM, POTASSIUM AND SODIUM CHANNELS , ; NDA 022425 (label 22425.pdf) INN (DRONEDARONE HYDROCHLORIDE) MULTAQ (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 205682 (pdf 205682.pdf not found) INN (DRONEDARONE HYDROCHLORIDE) DRONEDARONE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2015 , NDA 205895 (pdf 205895.pdf not found) INN (DRONEDARONE HYDROCHLORIDE) DRONEDARONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2015 , NDA 205903 (pdf 205903.pdf not found) INN (DRONEDARONE HYDROCHLORIDE) DRONEDARONE HYDROCHLORIDE (GLENMARK GENERICS) APPROVAL= TA YEAR= 2015 , NDA 206649 (pdf 206649.pdf not found) INN (DRONEDARONE) DRONEDARONE (AMNEAL PHARMS) APPROVAL= TA YEAR= 2017 , NDA 205744 (pdf 205744.pdf not found) INN (DRONEDARONE HYDROCHLORIDE) DRONEDARONE HYDROCHLORIDE (SANDOZ INC) APPROVAL= TA YEAR= 2021 , NDA 210678 (pdf 210678.pdf not found) INN (DRONEDARONE) DRONEDARONE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2023 , NDA 205904 (pdf 205904.pdf not found) INN (DRONEDARONE HYDROCHLORIDE) DRONEDARONE HYDROCHLORIDE (LUPIN) APPROVAL= AP YEAR= 2024 , 1087 ; ARTEMETHER ; 71963-77-4 ; 2009 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS -- ARTEMISIN DERIVATIVE -- ENDOPEROXIDE GROUP , ; NDA 022268 (label 22268.pdf) INN (ARTEMETHER LUMEFANTRINE) COARTEM (NOVARTIS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , 1088 ; CHLOROQUINE ; 54-05-7 ; 1949 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS , ; NDA 006002 (label 6002.pdf) INN (CHLOROQUINE HYDROCHLORIDE) ARALEN HYDROCHLORIDE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 014860 (pdf 14860.pdf not found) INN (CHLOROQUINE PHOSPHATE PRIMAQUINE PHOSPHATE) ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 040516 (pdf 40516.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IMPAX LABS) APPROVAL= AP YEAR= 2003 , NDA 080880 (pdf 80880.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IMPAX LABS) APPROVAL= AP YEAR= 1974 , NDA 080886 (pdf 80886.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083082 (label 83082.pdf) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (HIKMA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 087228 (pdf 87228.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (MD PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087504 (pdf 87504.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087979 (pdf 87979.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088030 (pdf 88030.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 090249 (pdf 90249.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090610 (label 90610.pdf) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090612 (pdf 90612.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 091621 (pdf 91621.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 214756 (pdf 214756.pdf not found) INN (CHLOROQUINE PHOSPHATE) CHLOROQUINE PHOSPHATE (SUVEN PHARMS) APPROVAL= AP YEAR= 2021 , 1089 ; MEPHENYTOIN ; 50-12-4 ; 1946 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- SODIUM CHANNEL BLOCKER , ; NDA 006008 (pdf 6008.pdf not found) INN (MEPHENYTOIN) MESANTOIN (NOVARTIS) APPROVAL= AP YEAR= 1946 DISCONTINUED , 1090 ; METHADONE ; 76-99-3 ; 1947 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC OPIOID -- ANTITUSSIVE AGENTS -- ANTITUSSIVES NARCOTICS -- OPIOID RECEPTOR AGONISTS -- TREATMENT OF OPIOID ADDICTION -- NMDA ANTAGONIST , ; NDA 006134 (label 6134.pdf) INN (METHADONE HYDROCHLORIDE) DOLOPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006383 (label 6383.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 017058 (label 17058.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973 , NDA 017108 (pdf 17108.pdf not found) INN (METHADONE HYDROCHLORIDE) WESTADONE (SANDOZ) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 017116 (label 17116.pdf) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1973 , NDA 021624 (label 21624.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1947 , NDA 040050 (pdf 40050.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 040088 (pdf 40088.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 1994 , NDA 040180 (pdf 40180.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 040241 (pdf 40241.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 1998 , NDA 040517 (pdf 40517.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2004 , NDA 074081 (pdf 74081.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074184 (pdf 74184.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADOSE (SPECGX LLC) APPROVAL= AP YEAR= 1993 , NDA 075082 (pdf 75082.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM) APPROVAL= AP YEAR= 1998 , NDA 077142 (pdf 77142.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2005 , NDA 087393 (label 87393.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1981 , NDA 087997 (label 87997.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1982 , NDA 088108 (pdf 88108.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 , NDA 088109 (pdf 88109.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 , NDA 089897 (label 89897.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE INTENSOL (HIKMA) APPROVAL= AP YEAR= 1988 , NDA 090635 (pdf 90635.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2009 , NDA 090707 (label 90707.pdf) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090065 (pdf 90065.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , NDA 203502 (pdf 203502.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2015 , NDA 208306 (pdf 208306.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208305 (pdf 208305.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210484 (pdf 210484.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211228 (pdf 211228.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 207368 (pdf 207368.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 207537 (pdf 207537.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 204166 (pdf 204166.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (VISTAPHARM LLC) APPROVAL= AP YEAR= 2020 , NDA 212093 (pdf 212093.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 , NDA 212094 (pdf 212094.pdf not found) INN (METHADONE HYDROCHLORIDE) METHADONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , 1091 ; DOXYLAMINE ; 469-21-6 ; 1948 ; ; ; CLASS RESPIRATORY -- ANTIHISTAMINIC -- HYPNOTIC -- ANTI-ALLERGIC AGENTS -- ANTIEMETICS -- ANTITUSSIVE AGENTS -- HISTAMINE H1 ANTAGONISTS , ; NDA 006412 (pdf 6412.pdf not found) INN (DOXYLAMINE SUCCINATE) DECAPRYN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1948 NEWMOLECULARENTITY DISCONTINUED , NDA 010598 (pdf 10598.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BENDECTIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 018066 (label 18066.pdf) INN (DOXYLAMINE SUCCINATE) UNISOM (CHATTEM) APPROVAL= AP YEAR= 1978 , NDA 019440 (pdf 19440.pdf not found) INN (DOXYLAMINE SUCCINATE) UNISOM (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040167 (pdf 40167.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (PERRIGO) APPROVAL= AP YEAR= 1996 , NDA 040564 (pdf 40564.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (LNK) APPROVAL= AP YEAR= 2004 , NDA 070156 (pdf 70156.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXY-SLEEP-AID (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088603 (pdf 88603.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088900 (pdf 88900.pdf not found) INN (DOXYLAMINE SUCCINATE) DOXYLAMINE SUCCINATE (COPLEY PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 021876 (label 21876.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DICLEGIS (DUCHESNAY) APPROVAL= AP YEAR= 2013 , NDA 205811 (label 205811.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2016 , NDA 209661 (label 209661.pdf) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) BONJESTA (DUCHESNAY) APPROVAL= AP YEAR= 2016 , NDA 208518 (pdf 208518.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (PAR PHARM INC) APPROVAL= AP YEAR= 2017 , NDA 207825 (pdf 207825.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 212472 (pdf 212472.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217000 (pdf 217000.pdf not found) INN (DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDE) DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , 1092 ; DIHYDROARTEMISININ ; 71939-50-9 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS -- ARTEMISIN DERIVATIVE -- ENDOPEROXIDE GROUP , ; 1093 ; BETHANECHOL ; 590-63-6 ; 1948 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINERGIC -- MUSCARINIC AGONISTS -- PARASYMPATHOMIMETICS -- TREATMENT OF URINARY RETENTION , ; NDA 006536 (pdf 6536.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 040483 (pdf 40483.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040485 (pdf 40485.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040492 (pdf 40492.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040509 (pdf 40509.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040518 (pdf 40518.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040532 (pdf 40532.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040533 (pdf 40533.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040534 (pdf 40534.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040551 (pdf 40551.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040552 (pdf 40552.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040553 (pdf 40553.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040554 (pdf 40554.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040633 (pdf 40633.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040634 (pdf 40634.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040635 (pdf 40635.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040636 (pdf 40636.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2005 , NDA 040677 (pdf 40677.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040678 (pdf 40678.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040703 (pdf 40703.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT HOLDINGS INC) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040704 (pdf 40704.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 040721 (pdf 40721.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040725 (pdf 40725.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040726 (pdf 40726.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040727 (pdf 40727.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ECI PHARMS LLC) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040728 (pdf 40728.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 040739 (pdf 40739.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040740 (pdf 40740.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040741 (pdf 40741.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 040855 (pdf 40855.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 2007 , NDA 084074 (pdf 84074.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084188 (pdf 84188.pdf not found) INN (BETHANECHOL CHLORIDE) MYOTONACHOL (GLENWOOD) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084353 (pdf 84353.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084378 (pdf 84378.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084379 (pdf 84379.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084383 (pdf 84383.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084384 (pdf 84384.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084402 (pdf 84402.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084408 (pdf 84408.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084441 (pdf 84441.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084689 (pdf 84689.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084702 (pdf 84702.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084712 (pdf 84712.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (LANNETT) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085228 (pdf 85228.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085229 (pdf 85229.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085230 (pdf 85230.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085839 (pdf 85839.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085841 (pdf 85841.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085842 (pdf 85842.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085882 (pdf 85882.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 086262 (pdf 86262.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 086263 (pdf 86263.pdf not found) INN (BETHANECHOL CHLORIDE) DUVOID (CHARTWELL RX) APPROVAL= AP YEAR= 1978 , NDA 087397 (pdf 87397.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087444 (pdf 87444.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088288 (pdf 88288.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088289 (pdf 88289.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088440 (pdf 88440.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088441 (pdf 88441.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089095 (pdf 89095.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089096 (pdf 89096.pdf not found) INN (BETHANECHOL CHLORIDE) URECHOLINE (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089815 (pdf 89815.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040897 (pdf 40897.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091256 (pdf 91256.pdf not found) INN (BETHANECHOL CHLORIDE) BETHANECHOL CHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , 1094 ; TRIHEXYPHENIDYL ; 144-11-6 ; 1949 ; ; ; CLASS NERVOUS SYSTEM -- ANTICHOLINERGIC -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- MUSCARINIC ANTAGONISTS , ; NDA 006773 (pdf 6773.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) ARTANE (LEDERLE) APPROVAL= AP YEAR= 1949 DISCONTINUED , NDA 012947 (pdf 12947.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) ARTANE (LEDERLE) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 040177 (pdf 40177.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 , NDA 040184 (pdf 40184.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 040251 (label 40251.pdf) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (MIKART) APPROVAL= AP YEAR= 1999 , NDA 040254 (label 40254.pdf) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 1998 , NDA 040337 (pdf 40337.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 080381 (pdf 80381.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TREMIN (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084363 (pdf 84363.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 084364 (pdf 84364.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 , NDA 085105 (pdf 85105.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085117 (pdf 85117.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085622 (pdf 85622.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088035 (pdf 88035.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 089514 (pdf 89514.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (PHARM VENTURES) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 091630 (pdf 91630.pdf not found) INN (TRIHEXYPHENIDYL HYDROCHLORIDE) TRIHEXYPHENIDYL HYDROCHLORIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2010 , 1095 ; PARAMETHADIONE ; 115-67-3 ; 1949 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; NDA 006800 (pdf 6800.pdf not found) INN (PARAMETHADIONE) PARADIONE (ABBVIE) APPROVAL= AP YEAR= 1949 DISCONTINUED , 1096 ; SECOBARBITAL ; 76-73-3 ; 1950 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHESIA -- BARBITURATES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 007392 (pdf 7392.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (LILLY) APPROVAL= AP YEAR= 1950 DISCONTINUED , NDA 083262 (pdf 83262.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WYETH AYERST) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083281 (pdf 83281.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084225 (pdf 84225.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084422 (pdf 84422.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (ANABOLIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084561 (pdf 84561.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PERRIGO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084676 (pdf 84676.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084762 (pdf 84762.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084926 (pdf 84926.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085285 (pdf 85285.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (KV PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085477 (pdf 85477.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085792 (pdf 85792.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085798 (pdf 85798.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085867 (pdf 85867.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085869 (pdf 85869.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (IVAX PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085895 (pdf 85895.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (EVERYLIFE) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085898 (pdf 85898.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085903 (pdf 85903.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085909 (pdf 85909.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086101 (pdf 86101.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086273 (pdf 86273.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086390 (pdf 86390.pdf not found) INN (SECOBARBITAL SODIUM) SECOBARBITAL SODIUM (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086530 (pdf 86530.pdf not found) INN (SECOBARBITAL SODIUM) SECONAL SODIUM (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 1097 ; DYPHYLLINE ; 479-18-5 ; 1951 ; DISCONTINUED ; NATURAL MOLECULE C00030143 ; CLASS RESPIRATORY -- BRONCHODILATOR AGENTS -- PHOSPHODIESTERASE INHIBITORS -- SMOOTH MUSCLE RELAXANTS -- VASODILATOR AGENTS , ; NDA 007794 (pdf 7794.pdf not found) INN (DYPHYLLINE) NEOTHYLLINE (TEVA) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , NDA 009088 (pdf 9088.pdf not found) INN (DYPHYLLINE) NEOTHYLLINE (TEVA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 084514 (pdf 84514.pdf not found) INN (DYPHYLLINE) DILOR (SAVAGE LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084566 (pdf 84566.pdf not found) INN (DYPHYLLINE) LUFYLLIN (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084751 (pdf 84751.pdf not found) INN (DYPHYLLINE) DILOR-400 (SAVAGE LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , 1098 ; PROMETHAZINE ; 60-87-7 ; 1951 ; ; ; CLASS RESPIRATORY -- ANTIHISTAMINIC -- ANTI-ALLERGIC AGENTS -- ANTIPRURITICS -- HISTAMINE H1 ANTAGONISTS -- PHENOTHIAZINE DERIVATIVES -- SEDATIVES -- ANTIEMETIC , ; NDA 007935 (label 7935.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1951 DISCONTINUED , NDA 008306 (label 8306.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC W/ CODEINE (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008381 (label 8381.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE PLAIN (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 008604 (pdf 8604.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC (ANI PHARMS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 008857 (pdf 8857.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (WYETH AYERST) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 010926 (label 10926.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (MYLAN) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011265 (label 11265.pdf) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011689 (label 11689.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (MYLAN) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 011730 (label 11730.pdf) INN (MEPERIDINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) MEPERGAN (HIKMA) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 040026 (pdf 40026.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1998 , NDA 040027 (pdf 40027.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040151 (pdf 40151.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040372 (label 40372.pdf) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 040428 (pdf 40428.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (COSETTE) APPROVAL= AP YEAR= 2002 , NDA 040449 (pdf 40449.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040454 (pdf 40454.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040471 (pdf 40471.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040479 (pdf 40479.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040500 (pdf 40500.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003 , NDA 040504 (pdf 40504.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040515 (pdf 40515.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040524 (pdf 40524.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (BEDFORD LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040558 (pdf 40558.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040593 (pdf 40593.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040596 (pdf 40596.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 040603 (pdf 40603.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2006 , NDA 040622 (pdf 40622.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2006 , NDA 040643 (pdf 40643.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040649 (pdf 40649.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE DM (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2006 , NDA 040650 (pdf 40650.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE WITH CODEINE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 , NDA 040654 (pdf 40654.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (GENUS) APPROVAL= AP YEAR= 2006 , NDA 040660 (pdf 40660.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (GENUS) APPROVAL= AP YEAR= 2006 , NDA 040673 (pdf 40673.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2008 , NDA 040712 (pdf 40712.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006 , NDA 040713 (pdf 40713.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006 , NDA 040718 (pdf 40718.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2007 , NDA 040724 (pdf 40724.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 040737 (pdf 40737.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2008 , NDA 040791 (pdf 40791.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080629 (pdf 80629.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080949 (pdf 80949.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083176 (pdf 83176.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) REMSED (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083204 (pdf 83204.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083214 (pdf 83214.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083312 (pdf 83312.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973 , NDA 083401 (pdf 83401.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083403 (pdf 83403.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083426 (pdf 83426.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 , NDA 083532 (pdf 83532.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083603 (pdf 83603.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083604 (pdf 83604.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083613 (pdf 83613.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083658 (pdf 83658.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083711 (pdf 83711.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 , NDA 083712 (pdf 83712.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083838 (pdf 83838.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083955 (pdf 83955.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083997 (pdf 83997.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) ZIPAN-25 (ALTANA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084027 (pdf 84027.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084080 (pdf 84080.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084160 (pdf 84160.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084166 (pdf 84166.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084176 (pdf 84176.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 , NDA 084214 (pdf 84214.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084222 (pdf 84222.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084223 (pdf 84223.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084233 (pdf 84233.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 084234 (pdf 84234.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 OBSOLETE , NDA 084539 (pdf 84539.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084554 (pdf 84554.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084555 (pdf 84555.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084557 (pdf 84557.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084591 (pdf 84591.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084772 (pdf 84772.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH FORTIS (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 084901 (pdf 84901.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084902 (pdf 84902.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085146 (pdf 85146.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (INVATECH) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085385 (pdf 85385.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085388 (pdf 85388.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085664 (pdf 85664.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085684 (pdf 85684.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085953 (pdf 85953.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH PLAIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085986 (pdf 85986.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 086395 (pdf 86395.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087165 (pdf 87165.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHEGAN (COSETTE) APPROVAL= AP YEAR= 1987 , NDA 087518 (pdf 87518.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087953 (pdf 87953.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE PLAIN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1982 , NDA 087996 (pdf 87996.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) MYMETHAZINE FORTIS (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088739 (pdf 88739.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PHERAZINE W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088761 (pdf 88761.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC PLAIN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088762 (pdf 88762.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETH W/ DEXTROMETHORPHAN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088763 (pdf 88763.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088764 (label 88764.pdf) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETH VC W/ CODEINE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088814 (pdf 88814.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088815 (pdf 88815.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088816 (pdf 88816.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088864 (pdf 88864.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ DEXTROMETHORPHAN (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088868 (pdf 88868.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088870 (pdf 88870.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 088875 (pdf 88875.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1984 , NDA 088896 (pdf 88896.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088897 (pdf 88897.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088913 (pdf 88913.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PHERAZINE DM (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089013 (pdf 89013.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089109 (pdf 89109.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089463 (pdf 89463.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089477 (pdf 89477.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089647 (pdf 89647.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 040785 (pdf 40785.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040863 (pdf 40863.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040882 (pdf 40882.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 040891 (pdf 40891.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2009 , NDA 040902 (pdf 40902.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090180 (pdf 90180.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE CODEINE PHOSPHATE) PROMETHAZINE HYDROCHLORIDE CODEINE PHOSPHATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2010 , NDA 091179 (pdf 91179.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2010 , NDA 090575 (pdf 90575.pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 091054 (pdf 91054.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091675 (pdf 91675.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 091687 (pdf 91687.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE) PROMETHAZINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 200386 (pdf 200386.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 200894 (pdf 200894.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 040674 (pdf 40674.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 040675 (pdf 40675.pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 200963 (pdf 200963.pdf not found) INN (CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 209177 (pdf 209177.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 214238 (pdf 214238.pdf not found) INN (CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 213890 (pdf 213890.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2021 , NDA 216446 (pdf 216446.pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , 1099 ; BROMODIPHENHYDRAMINE ; 1808-12-4 ; 1954 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIHISTAMINES -- HISTAMINE H1 RECEPTOR ANTAGONIST , ; NDA 007984 (pdf 7984.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE) AMBODRYL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 009319 (pdf 9319.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) AMBENYL (FOREST LABS) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 088343 (pdf 88343.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMANYL (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088626 (pdf 88626.pdf not found) INN (BROMODIPHENHYDRAMINE HYDROCHLORIDE CODEINE PHOSPHATE) BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED , 1100 ; CYCRIMINE ; 77-39-4 ; 1953 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIDYSKINETICS -- ANTIPARKINSON -- MUSCARINIC ANTAGONIST , ; NDA 008951 (pdf 8951.pdf not found) INN (CYCRIMINE HYDROCHLORIDE) PAGITANE (LILLY) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , 1101 ; ETHOPROPAZINE ; 522-00-9 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTICHOLINERGIC -- ANTIDYSKINETICS , ; NDA 009078 (pdf 9078.pdf not found) INN (ETHOPROPAZINE HYDROCHLORIDE) PARSIDOL (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1102 ; WARFARIN ; 81-81-2 ; 1954 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- COUMARIN DERIVATIVES , ; NDA 009218 (label 9218.pdf) INN (WARFARIN SODIUM) COUMADIN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 011771 (pdf 11771.pdf not found) INN (WARFARIN SODIUM) ATHROMBIN (PHARM RES ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017020 (pdf 17020.pdf not found) INN (WARFARIN SODIUM) PANWARFIN (ABBOTT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 040145 (pdf 40145.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (BARR) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040196 (pdf 40196.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (CHARTWELL RX) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040301 (label 40301.pdf) INN (WARFARIN SODIUM) WARFARIN SODIUM (TARO) APPROVAL= AP YEAR= 1999 , NDA 040415 (label 40415.pdf) INN (WARFARIN SODIUM) WARFARIN SODIUM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040416 (pdf 40416.pdf not found) INN (WARFARIN SODIUM) JANTOVEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2003 , NDA 040616 (pdf 40616.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (PLIVA) APPROVAL= AP YEAR= 2006 , NDA 040663 (pdf 40663.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2006 , NDA 086118 (pdf 86118.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086119 (pdf 86119.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086120 (pdf 86120.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086122 (pdf 86122.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086123 (pdf 86123.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088719 (pdf 88719.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088720 (pdf 88720.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088721 (pdf 88721.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090935 (pdf 90935.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (INVAGEN PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200104 (pdf 200104.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (IPCA LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202202 (pdf 202202.pdf not found) INN (WARFARIN SODIUM) WARFARIN SODIUM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , 1103 ; GLUTETHIMIDE ; 77-21-4 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES -- ANXIOLYTIC , ; NDA 009519 (pdf 9519.pdf not found) INN (GLUTETHIMIDE) DORIDEN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 083234 (pdf 83234.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083475 (pdf 83475.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084362 (pdf 84362.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085171 (pdf 85171.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085571 (pdf 85571.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085763 (pdf 85763.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 087297 (pdf 87297.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (VITARINE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 089458 (pdf 89458.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089459 (pdf 89459.pdf not found) INN (GLUTETHIMIDE) GLUTETHIMIDE (HALSEY) APPROVAL= AP YEAR= 1986 DISCONTINUED , 1104 ; PROCYCLIDINE ; 77-37-2 ; 1955 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTIDYSKINETICS -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS , ; NDA 009818 (label 9818.pdf) INN (PROCYCLIDINE HYDROCHLORIDE) KEMADRIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , 1105 ; ETHCHLORVYNOL ; 113-18-8 ; 1961 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS -- SEDATIVES -- ANXIOLYTIC , ; NDA 010021 (label 10021.pdf) INN (ETHCHLORVYNOL) PLACIDYL (ABBVIE) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 084463 (pdf 84463.pdf not found) INN (ETHCHLORVYNOL) ETHCHLORVYNOL (BANNER PHARMACAPS) APPROVAL= - YEAR= 0 DISCONTINUED , 1106 ; AMPHETAMINE ; 300-62-9 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- AMPHETAMINES -- SYMPATHOMIMETICS -- BLOCK THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE -- TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) AND NARCOLEPSY -- MONOAMINE TRANSPORTER BLOCKER , ; NDA 010093 (pdf 10093.pdf not found) INN (AMPHETAMINE RESIN COMPLEX DEXTROAMPHETAMINE RESIN COMPLEX) BIPHETAMINE 20 (UCB INC) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 011522 (label 11522.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) ADDERALL 10 (TEVA WOMENS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 021303 (label 21303.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) ADDERALL XR 10 (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2001 , NDA 040422 (label 40422.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (BARR) APPROVAL= AP YEAR= 2002 , NDA 040439 (pdf 40439.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 040440 (pdf 40440.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003 , NDA 040444 (pdf 40444.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 040456 (pdf 40456.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040472 (pdf 40472.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040480 (pdf 40480.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 , NDA 083563 (pdf 83563.pdf not found) INN (AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083564 (pdf 83564.pdf not found) INN (AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083900 (pdf 83900.pdf not found) INN (AMPHETAMINE SULFATE) BENZEDRINE (SMITH KLINE & FRENCH) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083901 (pdf 83901.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 077302 (pdf 77302.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 200166 (pdf 200166.pdf not found) INN (AMPHETAMINE SULFATE) EVEKEO (AZURITY) APPROVAL= AP YEAR= 2012 , NDA 076536 (pdf 76536.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (BARR LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 077488 (pdf 77488.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202424 (pdf 202424.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 206721 (pdf 206721.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208147 (label 208147.pdf) INN (AMPHETAMINE AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE) DYANAVEL XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 076852 (pdf 76852.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 2016 , NDA 204326 (label 204326.pdf) INN (AMPHETAMINE) ADZENYS XR-ODT (NEOS THERAPS) APPROVAL= AP YEAR= 2016 , NDA 206159 (pdf 206159.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206304 (pdf 206304.pdf not found) INN (DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AMPHETAMINE SULFATE) DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AMPHETAMINE SULFATE (COREPHARMA) APPROVAL= TA YEAR= 2016 , NDA 206340 (pdf 206340.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 022063 (label 22063.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) MYDAYIS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 207388 (pdf 207388.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ALVOGEN) APPROVAL= AP YEAR= 2017 , NDA 204325 (label 204325.pdf) INN (AMPHETAMINE) ADZENYS ER (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207340 (pdf 207340.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209799 (pdf 209799.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (NUVO PHARM) APPROVAL= AP YEAR= 2017 , NDA 210080 (pdf 210080.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211139 (pdf 211139.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211352 (pdf 211352.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2018 , NDA 205401 (pdf 205401.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209905 (label 209905.pdf) INN (AMPHETAMINE SULFATE) EVEKEO ODT (AZURITY) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210651 (pdf 210651.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211547 (pdf 211547.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 211639 (pdf 211639.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 211715 (pdf 211715.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2019 , NDA 212037 (pdf 212037.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2019 , NDA 212619 (pdf 212619.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 212919 (pdf 212919.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 210293 (pdf 210293.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (USPHARMA WINDLAS) APPROVAL= AP YEAR= 2020 , NDA 211861 (pdf 211861.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 211876 (pdf 211876.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212582 (pdf 212582.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (CEROVENE INC) APPROVAL= AP YEAR= 2020 , NDA 212901 (pdf 212901.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SENORES PHARMS) APPROVAL= AP YEAR= 2020 , NDA 213898 (pdf 213898.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213720 (pdf 213720.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213763 (pdf 213763.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (NOVAST LABS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213980 (pdf 213980.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212186 (pdf 212186.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213111 (pdf 213111.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213583 (pdf 213583.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2021 , NDA 213709 (pdf 213709.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214574 (pdf 214574.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 210526 (label 210526.pdf) INN (AMPHETAMINE AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE) DYANAVEL XR 5 (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 , NDA 213852 (pdf 213852.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214347 (pdf 214347.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214403 (pdf 214403.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2021 , NDA 214959 (pdf 214959.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215771 (pdf 215771.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 210754 (pdf 210754.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (CEDIPROF INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210876 (pdf 210876.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 215565 (pdf 215565.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2022 , NDA 209253 (pdf 209253.pdf not found) INN (AMPHETAMINE) AMPHETAMINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217027 (pdf 217027.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 211546 (pdf 211546.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2023 , NDA 215997 (pdf 215997.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , NDA 217787 (pdf 217787.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , 1107 ; MECAMYLAMINE ; 60-40-2 ; 1956 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- NICOTINIC ANTAGONISTS -- ANTICHOLINERGIC -- GANGLION BLOCKERS , ; NDA 010251 (pdf 10251.pdf not found) INN (MECAMYLAMINE HYDROCHLORIDE) INVERSINE (TARGACEPT) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 204054 (pdf 204054.pdf not found) INN (MECAMYLAMINE HYDROCHLORIDE) MECAMYLAMINE HYDROCHLORIDE (LGM PHARMA) APPROVAL= AP YEAR= 2013 , 1108 ; CLIDINIUM ; 3485-62-9 ; 1966 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTIARRHYTHMIC AGENTS -- ANTISPASMODICS -- PARASYMPATHOLYTICS -- MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST , ; NDA 010355 (pdf 10355.pdf not found) INN (CLIDINIUM BROMIDE) QUARZAN (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 012750 (label 12750.pdf) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) LIBRAX (BAUSCH) APPROVAL= AP YEAR= 1966 , NDA 211421 (pdf 211421.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 210579 (pdf 210579.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MISEMER) APPROVAL= AP YEAR= 2020 , NDA 213530 (pdf 213530.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 214065 (pdf 214065.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214698 (pdf 214698.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 211476 (pdf 211476.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215555 (pdf 215555.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 215453 (pdf 215453.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (COREPHARMA) APPROVAL= AP YEAR= 2022 , NDA 215835 (pdf 215835.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 216419 (pdf 216419.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216969 (pdf 216969.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 217385 (pdf 217385.pdf not found) INN (CHLORDIAZEPOXIDE HYDROCHLORIDE CLIDINIUM BROMIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1109 ; HYDROXYZINE ; 68-88-2 ; 1956 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTIPRURITICS -- HYPNOTICS -- HISTAMINE H1 ANTAGONISTS , ; NDA 010392 (pdf 10392.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ATARAX (PFIZER) APPROVAL= AP YEAR= 1956 NEWMOLECULARENTITY DISCONTINUED , NDA 010485 (pdf 10485.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ATARAX (ROERIG) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 011111 (pdf 11111.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011459 (label 11459.pdf) INN (HYDROXYZINE PAMOATE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1968 , NDA 011795 (label 11795.pdf) INN (HYDROXYZINE PAMOATE) VISTARIL (PFIZER) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 040010 (label 40010.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 040156 (pdf 40156.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IMPAX LABS INC) APPROVAL= AP YEAR= 1996 , NDA 040391 (label 40391.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040559 (pdf 40559.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040562 (pdf 40562.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040563 (pdf 40563.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040574 (pdf 40574.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 040579 (pdf 40579.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 040580 (pdf 40580.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2005 , NDA 040600 (pdf 40600.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040602 (pdf 40602.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ELITE LABS INC) APPROVAL= AP YEAR= 2004 OBSOLETE , NDA 040604 (pdf 40604.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 , NDA 040786 (pdf 40786.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 , NDA 040787 (pdf 40787.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040788 (pdf 40788.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040804 (pdf 40804.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2008 , NDA 040805 (pdf 40805.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2008 , NDA 040812 (pdf 40812.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040840 (pdf 40840.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040841 (pdf 40841.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040842 (pdf 40842.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 040899 (pdf 40899.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 081054 (pdf 81054.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 081127 (pdf 81127.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081128 (pdf 81128.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081129 (pdf 81129.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 081149 (pdf 81149.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081150 (pdf 81150.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081151 (pdf 81151.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081165 (pdf 81165.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 085247 (pdf 85247.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085551 (pdf 85551.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085778 (pdf 85778.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085779 (pdf 85779.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086183 (pdf 86183.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 086258 (pdf 86258.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086695 (pdf 86695.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086697 (pdf 86697.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086698 (pdf 86698.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086705 (pdf 86705.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086728 (pdf 86728.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086821 (pdf 86821.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086822 (pdf 86822.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086827 (pdf 86827.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086829 (pdf 86829.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086836 (pdf 86836.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086840 (pdf 86840.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086880 (pdf 86880.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ANIMA) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087014 (pdf 87014.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) ORGATRAX (ORGANON USA INC) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087216 (pdf 87216.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087245 (pdf 87245.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087246 (pdf 87246.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087273 (pdf 87273.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087274 (pdf 87274.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087294 (label 87294.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1982 , NDA 087310 (pdf 87310.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087329 (label 87329.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087408 (pdf 87408.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 1981 , NDA 087410 (pdf 87410.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087411 (pdf 87411.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087416 (pdf 87416.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087479 (pdf 87479.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SANDOZ) APPROVAL= AP YEAR= 1981 , NDA 087546 (pdf 87546.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087591 (pdf 87591.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087592 (pdf 87592.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087593 (pdf 87593.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087595 (pdf 87595.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087596 (pdf 87596.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087602 (pdf 87602.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087603 (pdf 87603.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087604 (pdf 87604.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087656 (pdf 87656.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087657 (pdf 87657.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087658 (pdf 87658.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087730 (pdf 87730.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087760 (pdf 87760.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087761 (pdf 87761.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087767 (pdf 87767.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087790 (pdf 87790.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087819 (pdf 87819.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087820 (pdf 87820.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087821 (pdf 87821.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087822 (pdf 87822.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087857 (pdf 87857.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087860 (pdf 87860.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087862 (pdf 87862.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087869 (pdf 87869.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 087870 (pdf 87870.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 087871 (pdf 87871.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 1982 , NDA 088120 (pdf 88120.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088121 (pdf 88121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088122 (pdf 88122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088184 (pdf 88184.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088185 (pdf 88185.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088348 (pdf 88348.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088349 (pdf 88349.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088350 (pdf 88350.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088392 (pdf 88392.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088393 (pdf 88393.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088409 (pdf 88409.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088487 (pdf 88487.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088488 (pdf 88488.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088496 (pdf 88496.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (BARR) APPROVAL= AP YEAR= 1984 , NDA 088529 (pdf 88529.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088540 (pdf 88540.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088551 (pdf 88551.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088593 (pdf 88593.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088594 (pdf 88594.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 088595 (pdf 88595.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088617 (label 88617.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088618 (label 88618.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088619 (label 88619.pdf) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 1986 , NDA 088713 (pdf 88713.pdf not found) INN (HYDROXYZINE PAMOATE) HY-PAM "25" (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088785 (pdf 88785.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088794 (pdf 88794.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088795 (pdf 88795.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088796 (pdf 88796.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088862 (pdf 88862.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088881 (pdf 88881.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089031 (pdf 89031.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089032 (pdf 89032.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089033 (pdf 89033.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (SUPERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089071 (pdf 89071.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089072 (pdf 89072.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089073 (pdf 89073.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089106 (pdf 89106.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089107 (pdf 89107.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089117 (pdf 89117.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089121 (pdf 89121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089122 (pdf 89122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089123 (pdf 89123.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089145 (pdf 89145.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089146 (pdf 89146.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089366 (pdf 89366.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089381 (pdf 89381.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089382 (pdf 89382.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089383 (pdf 89383.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089396 (pdf 89396.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040808 (pdf 40808.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 2008 , NDA 091176 (pdf 91176.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201507 (pdf 201507.pdf not found) INN (HYDROXYZINE PAMOATE) HYDROXYZINE PAMOATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2013 , NDA 201674 (pdf 201674.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 204279 (pdf 204279.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2014 , NDA 207120 (pdf 207120.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2017 OBSOLETE , NDA 207121 (pdf 207121.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207122 (pdf 207122.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (NUVO PHARM) APPROVAL= AP YEAR= 2017 OBSOLETE , NDA 210634 (pdf 210634.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 217652 (pdf 217652.pdf not found) INN (HYDROXYZINE HYDROCHLORIDE) HYDROXYZINE HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2023 , 1110 ; BROMPHENIRAMINE ; 86-22-6 ; 1957 ; ; ; CLASS RESPIRATORY -- H1 ANTIHISTAMINE ANTAGONISTS -- ANTI-ALLERGIC AGENTS -- ANTICHOLINERGIC (DRYING) AND SEDATIVE EFFECTS , ; NDA 010799 (pdf 10799.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE (WYETH CONS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 011418 (pdf 11418.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE-TEN (WYETH AYERST) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 011694 (pdf 11694.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETANE-DC (ROBINS AH) APPROVAL= AP YEAR= 1958 DISCONTINUED OBSOLETE , NDA 012436 (pdf 12436.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1960 DISCONTINUED OBSOLETE , NDA 013087 (pdf 13087.pdf not found) INN (BROMPHENIRAMINE MALEATE) DIMETAPP (WYETH CONS) APPROVAL= AP YEAR= 1962 DISCONTINUED OBSOLETE , NDA 019279 (label 19279.pdf) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) DIMETANE-DX (ROBINS AH) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019672 (pdf 19672.pdf not found) INN (BROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE) EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 071099 (pdf 71099.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMATAPP (COPLEY PHARM) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 083123 (pdf 83123.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083215 (pdf 83215.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083820 (pdf 83820.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083821 (pdf 83821.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084088 (pdf 84088.pdf not found) INN (BROMPHENIRAMINE MALEATE) VELTANE (LANNETT) APPROVAL= AP YEAR= 1974 , NDA 084351 (pdf 84351.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084468 (pdf 84468.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (BARR) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 085466 (pdf 85466.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085521 (pdf 85521.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PHOENIX LABS NY) APPROVAL= - YEAR= 0 , NDA 085592 (pdf 85592.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NYLOS) APPROVAL= - YEAR= 0 , NDA 085769 (pdf 85769.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085850 (pdf 85850.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085888 (pdf 85888.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PVT FORM) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086187 (pdf 86187.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NEXGEN PHARMA INC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086936 (pdf 86936.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086987 (pdf 86987.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (NEWTRON PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087009 (pdf 87009.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087517 (pdf 87517.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087964 (pdf 87964.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088604 (pdf 88604.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMPHENIRAMINE MALEATE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088687 (pdf 88687.pdf not found) INN (BROMPHENIRAMINE MALEATE) BIPHETAP (MORTON GROVE) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088688 (pdf 88688.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMANATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 0 DISCONTINUED OBSOLETE , NDA 088722 (pdf 88722.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMANATE DM (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088723 (pdf 88723.pdf not found) INN (BROMPHENIRAMINE MALEATE) BROMANATE DC (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 088811 (pdf 88811.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985 , NDA 088904 (pdf 88904.pdf not found) INN (BROMPHENIRAMINE MALEATE) MYPHETANE DC (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 089681 (pdf 89681.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 202940 (pdf 202940.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2014 , NDA 205292 (pdf 205292.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 , NDA 203375 (pdf 203375.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ACELLA) APPROVAL= AP YEAR= 2016 , NDA 205112 (pdf 205112.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (TARO) APPROVAL= AP YEAR= 2017 , NDA 207676 (pdf 207676.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 210647 (pdf 210647.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 211170 (pdf 211170.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 213125 (pdf 213125.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 , NDA 202955 (pdf 202955.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 203997 (pdf 203997.pdf not found) INN (BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE , PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , 1111 ; ETHOTOIN ; 86-35-1 ; 1957 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC -- SODIUM CHANNEL BLOCKER , ; NDA 010841 (label 10841.pdf) INN (ETHOTOIN) PEGANONE (RECORDATI RARE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 1112 ; BUCLIZINE ; 82-95-1 ; 1957 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTIEMETIC -- ANTICHOLINERGIC AGENTS -- ANTIHISTAMINES , ; NDA 010911 (pdf 10911.pdf not found) INN (BUCLIZINE HYDROCHLORIDE) BUCLADIN-S (STUART PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , 1113 ; METHOCARBAMOL ; 532-03-6 ; 1957 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- MUSCLE RELAXANT -- SEDATIVE -- CARBAMATE DERIVATIVE OF GUAIFENESIN , ; NDA 011011 (label 11011.pdf) INN (METHOCARBAMOL) ROBAXIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , NDA 011790 (label 11790.pdf) INN (METHOCARBAMOL) ROBAXIN (HIKMA) APPROVAL= AP YEAR= 1959 , NDA 012281 (pdf 12281.pdf not found) INN (ASPIRIN METHOCARBAMOL) ROBAXISAL (ROBINS AH) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 040413 (pdf 40413.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040489 (pdf 40489.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (OXFORD PHARMS) APPROVAL= AP YEAR= 2003 , NDA 081145 (pdf 81145.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (STEVENS J) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 083605 (pdf 83605.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084231 (pdf 84231.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PURACAP PHARM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084259 (pdf 84259.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084276 (pdf 84276.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084277 (pdf 84277.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ANI PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084323 (pdf 84323.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084448 (pdf 84448.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084449 (pdf 84449.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084471 (pdf 84471.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PURACAP PHARM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084486 (pdf 84486.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084488 (pdf 84488.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084615 (pdf 84615.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FOSUN PHARMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084616 (pdf 84616.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FOSUN PHARMA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084648 (pdf 84648.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084649 (pdf 84649.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084675 (pdf 84675.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084756 (pdf 84756.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084846 (pdf 84846.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084924 (pdf 84924.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084927 (pdf 84927.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084928 (pdf 84928.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (IMPAX LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085033 (pdf 85033.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (NYLOS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085123 (pdf 85123.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085136 (pdf 85136.pdf not found) INN (METHOCARBAMOL) FORBAXIN (FOREST LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085137 (pdf 85137.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (INWOOD LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085159 (pdf 85159.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085180 (pdf 85180.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085192 (pdf 85192.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (WATSON LABS) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085454 (pdf 85454.pdf not found) INN (METHOCARBAMOL) DELAXIN (FERNDALE LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085658 (pdf 85658.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (KV PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085660 (pdf 85660.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (KV PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085718 (pdf 85718.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085961 (pdf 85961.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CLONMEL HLTHCARE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085963 (pdf 85963.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (CLONMEL HLTHCARE) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086459 (pdf 86459.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (DR REDDYS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086988 (pdf 86988.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PRINSTON INC) APPROVAL= AP YEAR= 1979 , NDA 086989 (pdf 86989.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PRINSTON INC) APPROVAL= AP YEAR= 1979 OBSOLETE , NDA 087211 (pdf 87211.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087282 (pdf 87282.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087283 (pdf 87283.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087453 (pdf 87453.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087454 (pdf 87454.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (UPSHER SMITH) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087589 (pdf 87589.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087590 (pdf 87590.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087660 (pdf 87660.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ASCOT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087661 (pdf 87661.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ASCOT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088646 (pdf 88646.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088647 (pdf 88647.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088731 (pdf 88731.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089082 (pdf 89082.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089193 (pdf 89193.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089417 (pdf 89417.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089418 (pdf 89418.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089657 (pdf 89657.pdf not found) INN (ASPIRIN METHOCARBAMOL) METHOCARBAMOL AND ASPIRIN (PAR PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089849 (pdf 89849.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 090200 (pdf 90200.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HETERO LABS LTD III) APPROVAL= AP YEAR= 2009 , NDA 200958 (pdf 200958.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (HANGZHOU BINJIANG) APPROVAL= AP YEAR= 2011 , NDA 204404 (pdf 204404.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 206128 (pdf 206128.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 205354 (pdf 205354.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MONTEREY PHARMS LLC) APPROVAL= AP YEAR= 2016 , NDA 203550 (pdf 203550.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (DBL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205404 (pdf 205404.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207496 (pdf 207496.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AM REGENT) APPROVAL= AP YEAR= 2017 , NDA 207522 (pdf 207522.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 208116 (pdf 208116.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208507 (pdf 208507.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 206071 (pdf 206071.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (NAVINTA LLC) APPROVAL= AP YEAR= 2017 , NDA 209312 (pdf 209312.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 209331 (pdf 209331.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 211504 (pdf 211504.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 213967 (pdf 213967.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 212623 (pdf 212623.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MLV) APPROVAL= AP YEAR= 2021 , NDA 215065 (pdf 215065.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212707 (pdf 212707.pdf not found) INN (METHOCARBAMOL) METHOCARBAMOL (MIKART) APPROVAL= AP YEAR= 2023 , 1114 ; PHENPROCOUMON ; 435-97-2 ; 1957 ; DISCONTINUED ; ; CLASS BLOOD -- ANTICOAGULANT -- VITAMIN K ANTAGONIST , ; NDA 011228 (pdf 11228.pdf not found) INN (PHENPROCOUMON) LIQUAMAR (ORGANON USA INC) APPROVAL= AP YEAR= 1957 DISCONTINUED , 1115 ; TRIMEPRAZINE ; 84-96-8 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- PHENOTHIAZINE -- ANTIHISTAMINIC -- NEUROLEPTIC -- SEDATIVE -- ANTIMUSCARINIC -- AMINE BINDING GPCR RECEPTOR ANTAGONIST , ; NDA 011316 (pdf 11316.pdf not found) INN (TRIMEPRAZINE TARTRATE) TEMARIL (ALLERGAN HERBERT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085015 (pdf 85015.pdf not found) INN (TRIMEPRAZINE TARTRATE) TRIMEPRAZINE TARTRATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088285 (pdf 88285.pdf not found) INN (TRIMEPRAZINE TARTRATE) TRIMEPRAZINE TARTRATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , 1116 ; LUMEFANTRINE ; 82186-77-4 ; 2009 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS -- INHIBITS HEMOZOIN FORMATION -- MEMBRANE SCRAMBLING LEADING TO PHOSPHATIDYLSERINE-EXPOSURE AT THE ERYTHROCYTE SURFACE , ; NDA 022268 (label 22268.pdf) INN (ARTEMETHER LUMEFANTRINE) COARTEM (NOVARTIS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , 1117 ; METHOHEXITAL ; 151-83-7 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- ANESTHETIC -- BARBITURATES -- GABA ALLOSTERIC MODULATOR , ; NDA 011559 (label 11559.pdf) INN (METHOHEXITAL SODIUM) BREVITAL SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , 1118 ; OXYPHENCYCLIMINE ; 125-53-1 ; 0 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- ANTISPASMODICS , ; NDA 011612 (pdf 11612.pdf not found) INN (OXYPHENCYCLIMINE HYDROCHLORIDE) DARICON (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , 1119 ; DIETHYLPROPION ; 90-84-6 ; 1959 ; ; ; CLASS METABOLISM -- ANOREXIGENIC AGENTS -- STIMULANTS -- SYMPATHOMIMETIC , ; NDA 011673 (pdf 11673.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TEPANIL (3M) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 011722 (label 11722.pdf) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012546 (label 12546.pdf) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE DOSPAN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 017668 (pdf 17668.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017669 (pdf 17669.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TENUATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017956 (pdf 17956.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) TEPANIL TEN-TAB (3M) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085544 (pdf 85544.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085741 (pdf 85741.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085916 (pdf 85916.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088267 (pdf 88267.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088268 (pdf 88268.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088642 (pdf 88642.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 040828 (pdf 40828.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 201212 (pdf 201212.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (AVANTHI INC) APPROVAL= AP YEAR= 2010 , NDA 091680 (pdf 91680.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , NDA 200177 (pdf 200177.pdf not found) INN (DIETHYLPROPION HYDROCHLORIDE) DIETHYLPROPION HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2011 , 1120 ; THIORIDAZINE ; 50-52-2 ; 1962 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- MANAGEMENT OF SCHIZOPHRENIC PATIENTS -- ANXIOLYTIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 011808 (pdf 11808.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) MELLARIL (NOVARTIS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 017923 (pdf 17923.pdf not found) INN (THIORIDAZINE) MELLARIL-S (NOVARTIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 040125 (pdf 40125.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040126 (pdf 40126.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040187 (pdf 40187.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040213 (pdf 40213.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 087264 (pdf 87264.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087766 (pdf 87766.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088004 (pdf 88004.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1983 , NDA 088131 (pdf 88131.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088132 (pdf 88132.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088133 (pdf 88133.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088134 (pdf 88134.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088135 (pdf 88135.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088136 (pdf 88136.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088137 (pdf 88137.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 088194 (pdf 88194.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088227 (pdf 88227.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088229 (pdf 88229.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088258 (pdf 88258.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088270 (pdf 88270.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088271 (pdf 88271.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088272 (pdf 88272.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088273 (pdf 88273.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088284 (pdf 88284.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088296 (pdf 88296.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088307 (pdf 88307.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088308 (pdf 88308.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088322 (pdf 88322.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088323 (pdf 88323.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088332 (pdf 88332.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088333 (pdf 88333.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088334 (pdf 88334.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088335 (pdf 88335.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088336 (pdf 88336.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088345 (pdf 88345.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088351 (pdf 88351.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088352 (pdf 88352.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088370 (pdf 88370.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088375 (pdf 88375.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088379 (pdf 88379.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088381 (pdf 88381.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088410 (pdf 88410.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088412 (pdf 88412.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088456 (pdf 88456.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088461 (pdf 88461.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088476 (pdf 88476.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088477 (pdf 88477.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088478 (pdf 88478.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088479 (pdf 88479.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088480 (pdf 88480.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088493 (pdf 88493.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088561 (pdf 88561.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088562 (pdf 88562.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088563 (pdf 88563.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088564 (pdf 88564.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088567 (pdf 88567.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088658 (pdf 88658.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088659 (pdf 88659.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088660 (pdf 88660.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088661 (pdf 88661.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088663 (pdf 88663.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088664 (pdf 88664.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088665 (pdf 88665.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088736 (pdf 88736.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088737 (pdf 88737.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088738 (pdf 88738.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088755 (pdf 88755.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088869 (pdf 88869.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088872 (pdf 88872.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088941 (pdf 88941.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088942 (pdf 88942.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089048 (pdf 89048.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089103 (pdf 89103.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089104 (pdf 89104.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089105 (pdf 89105.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089431 (pdf 89431.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089432 (pdf 89432.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089433 (pdf 89433.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 089602 (pdf 89602.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089603 (pdf 89603.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 089764 (pdf 89764.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089765 (pdf 89765.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089953 (pdf 89953.pdf not found) INN (THIORIDAZINE HYDROCHLORIDE) THIORIDAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1121 ; BIPERIDEN ; 514-65-8 ; 1959 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- PERIPHERAL ANTICHOLINERGIC -- ANTISPASMODIC -- ANTIDYSKINETICS -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 012003 (pdf 12003.pdf not found) INN (BIPERIDEN HYDROCHLORIDE) AKINETON (ABBVIE) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 012418 (pdf 12418.pdf not found) INN (BIPERIDEN LACTATE) AKINETON (ABBVIE) APPROVAL= AP YEAR= 1961 DISCONTINUED , 1122 ; TROPICAMIDE ; 1508-75-4 ; 1960 ; ; ; CLASS SENSORY -- ANTISPASMODIC -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- MYDRIATICS , ; NDA 012111 (pdf 12111.pdf not found) INN (TROPICAMIDE) MYDRIACYL (ALCON) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 019261 (label 19261.pdf) INN (HYDROXYAMPHETAMINE HYDROBROMIDE TROPICAMIDE) PAREMYD (AKORN) APPROVAL= AP YEAR= 1992 , NDA 040064 (pdf 40064.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040067 (pdf 40067.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1994 , NDA 040314 (pdf 40314.pdf not found) INN (TROPICAMIDE) TROPICACYL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 040315 (pdf 40315.pdf not found) INN (TROPICAMIDE) TROPICACYL (RISING) APPROVAL= AP YEAR= 2000 , NDA 084305 (pdf 84305.pdf not found) INN (TROPICAMIDE) MYDRIACYL (SANDOZ) APPROVAL= AP YEAR= 1974 , NDA 084306 (pdf 84306.pdf not found) INN (TROPICAMIDE) MYDRIACYL (ALCON LABS INC) APPROVAL= AP YEAR= 1974 , NDA 087636 (pdf 87636.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (MIZA PHARMS USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087637 (pdf 87637.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (MIZA PHARMS USA) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088230 (pdf 88230.pdf not found) INN (TROPICAMIDE) MYDRIAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088274 (pdf 88274.pdf not found) INN (TROPICAMIDE) MYDRIAFAIR (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088447 (pdf 88447.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089171 (pdf 89171.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089172 (pdf 89172.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 207524 (pdf 207524.pdf not found) INN (TROPICAMIDE) TROPICAMIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2019 , NDA 215352 (label 215352.pdf) INN (PHENYLEPHRINE HYDROCHLORIDE TROPICAMIDE) MYDCOMBI (EYENOVIA) APPROVAL= AP YEAR= 2023 , 1123 ; MEPIVACAINE ; 96-88-8 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC LOCAL -- BLOCKER , ; NDA 012125 (pdf 12125.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) CARBOCAINE W/ NEO-COBEFRIN (EASTMAN KODAK) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 012250 (label 12250.pdf) INN (MEPIVACAINE HYDROCHLORIDE) CARBOCAINE (HOSPIRA) APPROVAL= AP YEAR= 1960 , NDA 040806 (pdf 40806.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 080925 (pdf 80925.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) ISOCAINE HYDROCHLORIDE (SEPTODONT) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083559 (pdf 83559.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (BELMORA LLC) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084697 (pdf 84697.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SEPTODONT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084777 (pdf 84777.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) ARESTOCAINE HYDROCHLORIDE (SOLVAY) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084850 (pdf 84850.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN (BELMORA LLC) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 085010 (pdf 85010.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN (SOLVAY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 087509 (pdf 87509.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088387 (pdf 88387.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) SCANDONEST PLAIN (DEPROCO) APPROVAL= AP YEAR= 1984 , NDA 088388 (pdf 88388.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) SCANDONEST L (DEPROCO) APPROVAL= AP YEAR= 1984 , NDA 088653 (pdf 88653.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (DENTSPLY PHARM) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088769 (pdf 88769.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088770 (pdf 88770.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) MEPIVACAINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089406 (pdf 89406.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089407 (pdf 89407.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089408 (pdf 89408.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089409 (pdf 89409.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE-MPF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089410 (pdf 89410.pdf not found) INN (MEPIVACAINE HYDROCHLORIDE) POLOCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 089517 (pdf 89517.pdf not found) INN (LEVONORDEFRIN MEPIVACAINE HYDROCHLORIDE) POLOCAINE W/ LEVONORDEFRIN (DENTSPLY PHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1124 ; CHLOPHEDIANOL ; 791-35-5 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTITUSSIVE , ; NDA 012126 (pdf 12126.pdf not found) INN (CHLOPHEDIANOL HYDROCHLORIDE) ULO (3M) APPROVAL= - YEAR= 0 DISCONTINUED , 1125 ; BENDROFLUMETHIAZIDE ; 73-48-3 ; 1959 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012164 (pdf 12164.pdf not found) INN (BENDROFLUMETHIAZIDE) NATURETIN-2.5 (APOTHECON) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 018647 (label 18647.pdf) INN (BENDROFLUMETHIAZIDE NADOLOL) CORZIDE (KING PHARMS LLC) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 077833 (pdf 77833.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (IMPAX LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078688 (pdf 78688.pdf not found) INN (BENDROFLUMETHIAZIDE NADOLOL) NADOLOL AND BENDROFLUMETHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , 1126 ; TRICHLORMETHIAZIDE ; 133-67-5 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012265 (pdf 12265.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) NAQUIVAL (SCHERING) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012594 (pdf 12594.pdf not found) INN (TRICHLORMETHIAZIDE) METAHYDRIN (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 012972 (pdf 12972.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) METATENSIN #2 (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083436 (pdf 83436.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLOREX (LANNETT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 083462 (pdf 83462.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083847 (pdf 83847.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 083855 (pdf 83855.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 083967 (pdf 83967.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (IMPAX LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085248 (pdf 85248.pdf not found) INN (RESERPINE TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE W/ RESERPINE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 085568 (pdf 85568.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085630 (pdf 85630.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLOREX (LANNETT) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085962 (pdf 85962.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086171 (pdf 86171.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086259 (pdf 86259.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMAS (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086458 (pdf 86458.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 087005 (pdf 87005.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087007 (pdf 87007.pdf not found) INN (TRICHLORMETHIAZIDE) TRICHLORMETHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , 1127 ; CHLORTHALIDONE ; 77-36-1 ; 1960 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012283 (pdf 12283.pdf not found) INN (CHLORTHALIDONE) HYGROTON (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 015103 (pdf 15103.pdf not found) INN (CHLORTHALIDONE RESERPINE) REGROTON (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 017503 (pdf 17503.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) COMBIPRES (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 018760 (label 18760.pdf) INN (ATENOLOL CHLORTHALIDONE) TENORETIC 100 (TWI PHARMS) APPROVAL= AP YEAR= 1984 , NDA 019451 (pdf 19451.pdf not found) INN (CHLORTHALIDONE METOPROLOL TARTRATE) LOPRESSIDONE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019574 (label 19574.pdf) INN (CHLORTHALIDONE) THALITONE (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 019807 (label 19807.pdf) INN (BETAXOLOL HYDROCHLORIDE CHLORTHALIDONE) KERLEDEX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 071142 (pdf 71142.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071178 (pdf 71178.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071179 (pdf 71179.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE (PAR PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071325 (pdf 71325.pdf not found) INN (CHLORTHALIDONE CLONIDINE HYDROCHLORIDE) CLORPRES (MYLAN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072301 (pdf 72301.pdf not found) INN (CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ALVOGEN MALTA) APPROVAL= AP YEAR= 1990 OBSOLETE , NDA 072302 (pdf 72302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (TWI PHARMS) APPROVAL= AP YEAR= 1990 , NDA 073581 (pdf 73581.pdf not found) INN (CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073582 (pdf 73582.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073665 (pdf 73665.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1992 , NDA 074107 (pdf 74107.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074203 (pdf 74203.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074404 (pdf 74404.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOSTRUM LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 086831 (pdf 86831.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MYLAN) APPROVAL= AP YEAR= 1981 , NDA 087029 (pdf 87029.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087050 (pdf 87050.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087082 (pdf 87082.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087100 (pdf 87100.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087118 (pdf 87118.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087176 (pdf 87176.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087247 (pdf 87247.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUPERPHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087292 (pdf 87292.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087293 (pdf 87293.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087296 (pdf 87296.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087311 (pdf 87311.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087312 (pdf 87312.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087364 (pdf 87364.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ABBOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087380 (pdf 87380.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087381 (pdf 87381.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087384 (pdf 87384.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ABBOTT) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087450 (pdf 87450.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087451 (pdf 87451.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087473 (pdf 87473.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087515 (pdf 87515.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087516 (pdf 87516.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087521 (pdf 87521.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087555 (pdf 87555.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087689 (pdf 87689.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087698 (pdf 87698.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087699 (pdf 87699.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ASCOT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087706 (pdf 87706.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087947 (pdf 87947.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (IVAX PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088012 (pdf 88012.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088051 (pdf 88051.pdf not found) INN (CHLORTHALIDONE) THALITONE (MONARCH PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088073 (pdf 88073.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (VANGARD) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088139 (pdf 88139.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088140 (pdf 88140.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088164 (pdf 88164.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ANI PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088651 (pdf 88651.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (COSETTE) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088902 (pdf 88902.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (BARR LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088903 (pdf 88903.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (BARR LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089051 (pdf 89051.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089052 (pdf 89052.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089285 (pdf 89285.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089286 (pdf 89286.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 , NDA 089591 (pdf 89591.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089738 (pdf 89738.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089739 (pdf 89739.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 202331 (label 202331.pdf) INN (AZILSARTAN KAMEDOXOMIL CHLORTHALIDONE) EDARBYCLOR (AZURITY) APPROVAL= AP YEAR= 2011 , NDA 206904 (pdf 206904.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 207222 (pdf 207222.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (UMEDICA) APPROVAL= AP YEAR= 2018 , NDA 210742 (pdf 210742.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207813 (pdf 207813.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210028 (pdf 210028.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211063 (pdf 211063.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 207204 (pdf 207204.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 211627 (pdf 211627.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 213412 (pdf 213412.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213302 (pdf 213302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 214129 (pdf 214129.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 215560 (pdf 215560.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 209068 (pdf 209068.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (SUNNY) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211320 (pdf 211320.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (INVENTIA) APPROVAL= AP YEAR= 2022 , NDA 212875 (pdf 212875.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (TAGI) APPROVAL= AP YEAR= 2022 , NDA 212878 (pdf 212878.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (TAGI) APPROVAL= AP YEAR= 2022 , NDA 215587 (pdf 215587.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216262 (pdf 216262.pdf not found) INN (CHLORTHALIDONE) CHLORTHALIDONE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 1128 ; ETHOSUXIMIDE ; 77-67-8 ; 1960 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- SUCCINIMIDES , ; NDA 012380 (label 12380.pdf) INN (ETHOSUXIMIDE) ZARONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY , NDA 040253 (label 40253.pdf) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2000 , NDA 040430 (pdf 40430.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2002 , NDA 040506 (pdf 40506.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (MIKART) APPROVAL= AP YEAR= 2003 , NDA 040686 (pdf 40686.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 , NDA 080258 (label 80258.pdf) INN (ETHOSUXIMIDE) ZARONTIN (PARKE-DAVIS) APPROVAL= AP YEAR= 1974 , NDA 081306 (pdf 81306.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 200892 (pdf 200892.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 211928 (pdf 211928.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 210654 (pdf 210654.pdf not found) INN (ETHOSUXIMIDE) ETHOSUXIMIDE (PURACAP PHARM LLC) APPROVAL= AP YEAR= 2020 , 1129 ; PROPIOMAZINE ; 362-29-8 ; 1960 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- SEDATIVES -- HYPNOTICS -- PHENOTHIAZINES -- GPCRS AMINE BINDING ANTAGONIST , ; NDA 012382 (pdf 12382.pdf not found) INN (PROPIOMAZINE HYDROCHLORIDE) LARGON (HIKMA) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , 1130 ; ACRISORCIN ; 7527-91-5 ; 0 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- ANTIINFECTIVE , ; NDA 012470 (pdf 12470.pdf not found) INN (ACRISORCIN) AKRINOL (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , 1131 ; METHYCLOTHIAZIDE ; 135-07-9 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC THIAZIDE -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012524 (pdf 12524.pdf not found) INN (METHYCLOTHIAZIDE) ENDURON (ABBVIE) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 012708 (pdf 12708.pdf not found) INN (METHYCLOTHIAZIDE RESERPINE) DIUTENSEN-R (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 012775 (pdf 12775.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) ENDURONYL (ABBOTT) APPROVAL= AP YEAR= 1961 DISCONTINUED , NDA 016047 (pdf 16047.pdf not found) INN (METHYCLOTHIAZIDE PARGYLINE HYDROCHLORIDE) EUTRON (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017364 (pdf 17364.pdf not found) INN (METHYCLOTHIAZIDE) AQUATENSEN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085476 (pdf 85476.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085487 (pdf 85487.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087671 (pdf 87671.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087672 (pdf 87672.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087786 (pdf 87786.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087913 (pdf 87913.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (IVAX PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088452 (pdf 88452.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088486 (pdf 88486.pdf not found) INN (DESERPIDINE METHYCLOTHIAZIDE) METHYCLOTHIAZIDE AND DESERPIDINE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088724 (pdf 88724.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088745 (pdf 88745.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088750 (pdf 88750.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 089135 (pdf 89135.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089136 (pdf 89136.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (PAR PHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089835 (pdf 89835.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 089837 (pdf 89837.pdf not found) INN (METHYCLOTHIAZIDE) METHYCLOTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1132 ; OXYPHENBUTAZONE ; 129-20-4 ; 1960 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- ANTIRHEUMATIC -- ANTIINFLAMMATORY -- NSAID -- INHIBITOR , ; NDA 012542 (pdf 12542.pdf not found) INN (OXYPHENBUTAZONE) TANDEARIL (NOVARTIS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 088399 (pdf 88399.pdf not found) INN (OXYPHENBUTAZONE) OXYPHENBUTAZONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 1133 ; POLYTHIAZIDE ; 346-18-9 ; 1961 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- SODIUM CHLORIDE SYMPORTER INHIBITORS , ; NDA 012845 (pdf 12845.pdf not found) INN (POLYTHIAZIDE) RENESE (PFIZER) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , NDA 013636 (pdf 13636.pdf not found) INN (POLYTHIAZIDE RESERPINE) RENESE-R (PFIZER) APPROVAL= AP YEAR= 1963 DISCONTINUED , NDA 017986 (pdf 17986.pdf not found) INN (POLYTHIAZIDE PRAZOSIN HYDROCHLORIDE) MINIZIDE (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , 1134 ; METAXALONE ; 1665-48-1 ; 1962 ; ; ; CLASS NERVOUS SYSTEM -- MUSCLE RELAXANT -- ANALGESICS -- HYPNOTICS -- SEDATIVES , ; NDA 013217 (label 13217.pdf) INN (METAXALONE) SKELAXIN (KING PHARMS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , NDA 040486 (pdf 40486.pdf not found) INN (METAXALONE) METAXALONE (MOUNTAIN) APPROVAL= AP YEAR= 2015 , NDA 040445 (pdf 40445.pdf not found) INN (METAXALONE) METAXALONE (SANDOZ) APPROVAL= AP YEAR= 2010 , NDA 203399 (pdf 203399.pdf not found) INN (METAXALONE) METAXALONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 022503 (label 22503.pdf) INN (METAXALONE) METAXALONE (PRIMUS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204770 (pdf 204770.pdf not found) INN (METAXALONE) METAXALONE (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 203695 (pdf 203695.pdf not found) INN (METAXALONE) METAXALONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 207466 (pdf 207466.pdf not found) INN (METAXALONE) METAXALONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208774 (pdf 208774.pdf not found) INN (METAXALONE) METAXALONE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 213836 (pdf 213836.pdf not found) INN (METAXALONE) METAXALONE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , 1135 ; QUINETHAZONE ; 73-49-4 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- CARBONIC ANHYDRASE INHIBITOR (PMID23488823) , ; NDA 013264 (pdf 13264.pdf not found) INN (QUINETHAZONE) HYDROMOX (LEDERLE) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 013927 (pdf 13927.pdf not found) INN (QUINETHAZONE RESERPINE) HYDROMOX R (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , 1136 ; PRILOCAINE ; 721-50-6 ; 1965 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC (LOCAL) , ; NDA 014763 (pdf 14763.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE (ASTRAZENECA) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 019941 (label 19941.pdf) INN (LIDOCAINE PRILOCAINE) EMLA (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020962 (pdf 20962.pdf not found) INN (LIDOCAINE PRILOCAINE) EMLA (ASTRAZENECA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 021382 (label 21382.pdf) INN (PRILOCAINE HYDROCHLORIDE) CITANEST PLAIN DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1965 DISCONTINUED , NDA 021383 (label 21383.pdf) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) CITANEST FORTE DENTAL (DENTSPLY PHARM) APPROVAL= AP YEAR= 1965 , NDA 021451 (label 21451.pdf) INN (LIDOCAINE PRILOCAINE) ORAQIX (DENTSPLY PHARM) APPROVAL= AP YEAR= 2003 , NDA 076290 (pdf 76290.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (AKORN) APPROVAL= AP YEAR= 2003 , NDA 076320 (pdf 76320.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ENCUBE) APPROVAL= AP YEAR= 2003 , NDA 076453 (pdf 76453.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 079235 (pdf 79235.pdf not found) INN (PRILOCAINE HYDROCHLORIDE) PRILOCAINE HYDROCHLORIDE (SEPTODONT INC) APPROVAL= AP YEAR= 2010 , NDA 078959 (pdf 78959.pdf not found) INN (EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE) PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (SEPTODONT INC) APPROVAL= AP YEAR= 2011 , NDA 205887 (pdf 205887.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 213253 (pdf 213253.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (RHODES PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212482 (pdf 212482.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (PADAGIS US) APPROVAL= AP YEAR= 2021 , NDA 213923 (pdf 213923.pdf not found) INN (LIDOCAINE PRILOCAINE) LIDOCAINE AND PRILOCAINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , 1137 ; DOXAPRAM ; 309-29-5 ; 1965 ; ; ; CLASS RESPIRATORY SYSTEM -- RESPIRATORY STIMULANT -- CENTRAL NERVOUS SYSTEM STIMULANTS , ; NDA 014879 (label 14879.pdf) INN (DOXAPRAM HYDROCHLORIDE) DOPRAM (HIKMA) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY , NDA 073529 (pdf 73529.pdf not found) INN (DOXAPRAM HYDROCHLORIDE) DOXAPRAM HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 076266 (pdf 76266.pdf not found) INN (DOXAPRAM HYDROCHLORIDE) DOXAPRAM HYDROCHLORIDE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2003 , 1138 ; OXAZEPAM ; 604-75-1 ; 1965 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTI-ANXIETY AGENTS -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 015539 (label 15539.pdf) INN (OXAZEPAM) SERAX (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY DISCONTINUED , NDA 070640 (pdf 70640.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070641 (pdf 70641.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 070650 (pdf 70650.pdf not found) INN (OXAZEPAM) ZAXOPAM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070683 (pdf 70683.pdf not found) INN (OXAZEPAM) OXAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070943 (pdf 70943.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070944 (pdf 70944.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070945 (pdf 70945.pdf not found) INN (OXAZEPAM) OXAZEPAM (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071026 (pdf 71026.pdf not found) INN (OXAZEPAM) OXAZEPAM (UNITED RES LABS) APPROVAL= AP YEAR= 1987 , NDA 071494 (pdf 71494.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071508 (pdf 71508.pdf not found) INN (OXAZEPAM) OXAZEPAM (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071713 (pdf 71713.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071714 (pdf 71714.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071715 (pdf 71715.pdf not found) INN (OXAZEPAM) OXAZEPAM (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071756 (pdf 71756.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071813 (pdf 71813.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071814 (pdf 71814.pdf not found) INN (OXAZEPAM) OXAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1988 , NDA 071955 (pdf 71955.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071956 (pdf 71956.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071957 (pdf 71957.pdf not found) INN (OXAZEPAM) OXAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072251 (pdf 72251.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072252 (pdf 72252.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072253 (pdf 72253.pdf not found) INN (OXAZEPAM) OXAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1988 , NDA 072952 (pdf 72952.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS TEVA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072953 (pdf 72953.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072954 (pdf 72954.pdf not found) INN (OXAZEPAM) OXAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1990 DISCONTINUED , 1139 ; PROPRANOLOL ; 525-66-6 ; 1967 ; ; ; CLASS CARDIOVASCULAR -- NON SELECTIVE BETA ADRENERGIC ANTAGONISTS -- ANTIARRHYTHMIC AGENTS -- ANTIHYPERTENSIVE AGENTS -- VASODILATOR AGENTS , ; NDA 016418 (label 16418.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (WYETH PHARMS) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 016419 (label 16419.pdf) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 018031 (label 18031.pdf) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE-40/25 (WYETH PHARMS INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 018553 (label 18553.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL LA (ANI PHARMS) APPROVAL= AP YEAR= 1983 , NDA 019059 (pdf 19059.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) INDERIDE LA 80/50 (WYETH AYERST) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019536 (pdf 19536.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (WYETH AYERST) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 021438 (label 21438.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INNOPRAN XL (ANI PHARMS) APPROVAL= AP YEAR= 2003 , NDA 070103 (pdf 70103.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070120 (pdf 70120.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070121 (pdf 70121.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070122 (pdf 70122.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070123 (pdf 70123.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070124 (pdf 70124.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SCHERING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070125 (pdf 70125.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070126 (pdf 70126.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070127 (pdf 70127.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070128 (pdf 70128.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070135 (pdf 70135.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070136 (pdf 70136.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070137 (pdf 70137.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070140 (pdf 70140.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070141 (pdf 70141.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070142 (pdf 70142.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070143 (pdf 70143.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070144 (pdf 70144.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070175 (pdf 70175.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070176 (pdf 70176.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070177 (pdf 70177.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070178 (pdf 70178.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 , NDA 070213 (pdf 70213.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1985 , NDA 070217 (pdf 70217.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070218 (pdf 70218.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070219 (pdf 70219.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 , NDA 070220 (pdf 70220.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070221 (pdf 70221.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 , NDA 070232 (pdf 70232.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070233 (pdf 70233.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070234 (pdf 70234.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070301 (pdf 70301.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070305 (pdf 70305.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070306 (pdf 70306.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070307 (pdf 70307.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070308 (pdf 70308.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070309 (pdf 70309.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070310 (pdf 70310.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070319 (pdf 70319.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070320 (pdf 70320.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1985 DISCONTINUED OBSOLETE , NDA 070321 (pdf 70321.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070322 (pdf 70322.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1986 , NDA 070378 (pdf 70378.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070379 (pdf 70379.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070380 (pdf 70380.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070381 (pdf 70381.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070382 (pdf 70382.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070438 (pdf 70438.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070439 (pdf 70439.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070440 (pdf 70440.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070441 (pdf 70441.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070442 (pdf 70442.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070516 (pdf 70516.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070517 (pdf 70517.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070518 (pdf 70518.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070519 (pdf 70519.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070520 (pdf 70520.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070521 (pdf 70521.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070548 (pdf 70548.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070549 (pdf 70549.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070550 (pdf 70550.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070551 (pdf 70551.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070663 (pdf 70663.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070664 (pdf 70664.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070665 (pdf 70665.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070666 (pdf 70666.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070667 (pdf 70667.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070690 (pdf 70690.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 070704 (pdf 70704.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070705 (pdf 70705.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070757 (pdf 70757.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070814 (pdf 70814.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070815 (pdf 70815.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070816 (pdf 70816.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070817 (pdf 70817.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070851 (pdf 70851.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070852 (pdf 70852.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070946 (pdf 70946.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 070947 (pdf 70947.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (RISING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070979 (pdf 70979.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1987 , NDA 071060 (pdf 71060.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071061 (pdf 71061.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071098 (pdf 71098.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071126 (pdf 71126.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071127 (pdf 71127.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071183 (pdf 71183.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071288 (pdf 71288.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071327 (pdf 71327.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071368 (pdf 71368.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071369 (pdf 71369.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071370 (pdf 71370.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071371 (pdf 71371.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INTERPHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071388 (pdf 71388.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE INTENSOL (ROXANE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071495 (pdf 71495.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071496 (pdf 71496.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071498 (pdf 71498.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071501 (pdf 71501.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 071515 (pdf 71515.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071516 (pdf 71516.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071517 (pdf 71517.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071518 (pdf 71518.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071552 (pdf 71552.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071553 (pdf 71553.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071658 (pdf 71658.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071687 (pdf 71687.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071688 (pdf 71688.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071689 (pdf 71689.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071771 (pdf 71771.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071772 (pdf 71772.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071791 (pdf 71791.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071792 (pdf 71792.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071972 (pdf 71972.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 , NDA 071973 (pdf 71973.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071974 (pdf 71974.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071975 (pdf 71975.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 071976 (pdf 71976.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 1988 , NDA 071977 (pdf 71977.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071984 (pdf 71984.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071985 (pdf 71985.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (PAI HOLDINGS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072042 (pdf 72042.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072043 (pdf 72043.pdf not found) INN (HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (ANI PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072063 (pdf 72063.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072066 (pdf 72066.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072067 (pdf 72067.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072068 (pdf 72068.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072069 (pdf 72069.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072117 (pdf 72117.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072118 (pdf 72118.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072119 (pdf 72119.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072120 (pdf 72120.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072197 (pdf 72197.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072198 (pdf 72198.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072275 (pdf 72275.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072499 (pdf 72499.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072500 (pdf 72500.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072501 (pdf 72501.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072502 (pdf 72502.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (INWOOD LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 075792 (pdf 75792.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075826 (pdf 75826.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 076400 (pdf 76400.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077760 (pdf 77760.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 , NDA 078022 (pdf 78022.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078065 (label 78065.pdf) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (NORTEC DEV ASSOC) APPROVAL= AP YEAR= 2007 , NDA 078213 (pdf 78213.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2008 , NDA 078494 (pdf 78494.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2007 , NDA 078955 (pdf 78955.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078311 (pdf 78311.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 016762 (label 16762.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (AKRIMAX PHARMS) APPROVAL= AP YEAR= 1973 OBSOLETE , NDA 017683 (label 17683.pdf) INN (PROPRANOLOL HYDROCHLORIDE) INDERAL (AKRIMAX PHARMS) APPROVAL= AP YEAR= 1976 OBSOLETE , NDA 090321 (pdf 90321.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 078703 (pdf 78703.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (ADARE PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 205410 (label 205410.pdf) INN (PROPRANOLOL HYDROCHLORIDE) HEMANGEOL (PIERRE FABRE) APPROVAL= AP YEAR= 2014 , NDA 212026 (pdf 212026.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (AMTA) APPROVAL= AP YEAR= 2020 , NDA 204349 (pdf 204349.pdf not found) INN (PROPRANOLOL HYDROCHLORIDE) PROPRANOLOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2024 DISCONTINUED , 1140 ; TRIMIPRAMINE ; 739-71-9 ; 1979 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ADRENERGIC UPTAKE INHIBITORS -- NOREPINEPHRINE-REUPTAKE INHIBITORS , ; NDA 016792 (label 16792.pdf) INN (TRIMIPRAMINE MALEATE) SURMONTIL (ODYSSEY PHARMS) APPROVAL= AP YEAR= 1979 NEWMOLECULARENTITY DISCONTINUED , NDA 071283 (pdf 71283.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071284 (pdf 71284.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071285 (pdf 71285.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 077361 (pdf 77361.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (ELITE LABS INC) APPROVAL= AP YEAR= 2006 , NDA 208127 (pdf 208127.pdf not found) INN (TRIMIPRAMINE MALEATE) TRIMIPRAMINE MALEATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2016 , 1141 ; KETAMINE ; 6740-88-1 ; 1970 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- ANALGESICS -- N-METHYL-D-ASPARTATE (NMDA) RECEPTORS ANTAGONIST -- ANTIDEPRESSANT , ; NDA 016812 (label 16812.pdf) INN (KETAMINE HYDROCHLORIDE) KETALAR (ENDO OPERATIONS) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY , NDA 071949 (pdf 71949.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071950 (pdf 71950.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071951 (pdf 71951.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HCL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074524 (pdf 74524.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1996 , NDA 074549 (pdf 74549.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 , NDA 076092 (pdf 76092.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2001 , NDA 215808 (pdf 215808.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216809 (pdf 216809.pdf not found) INN (KETAMINE HYDROCHLORIDE) KETAMINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , 1142 ; BENZQUINAMIDE ; 63-12-7 ; 1974 ; DISCONTINUED ; ; CLASS ANTIEMETIC -- ANTIPSYCHOTICS -- NERVOUS SYSTEM , ; NDA 016818 (pdf 16818.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (ROERIG) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 016820 (pdf 16820.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (PFIZER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , 1143 ; PEMOLINE ; 2152-34-3 ; 1975 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMIMETIC DRUG , ; NDA 016832 (label 16832.pdf) INN (PEMOLINE) CYLERT (ABBOTT) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 017703 (label 17703.pdf) INN (PEMOLINE) CYLERT (ABBOTT) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 075030 (pdf 75030.pdf not found) INN (PEMOLINE) PEMOLINE (TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075286 (pdf 75286.pdf not found) INN (PEMOLINE) PEMOLINE (FOSUN PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075287 (pdf 75287.pdf not found) INN (PEMOLINE) PEMOLINE (WATSON LABS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075328 (pdf 75328.pdf not found) INN (PEMOLINE) PEMOLINE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075555 (pdf 75555.pdf not found) INN (PEMOLINE) PEMOLINE (TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075595 (pdf 75595.pdf not found) INN (PEMOLINE) PEMOLINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075678 (pdf 75678.pdf not found) INN (PEMOLINE) PEMOLINE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075726 (pdf 75726.pdf not found) INN (PEMOLINE) PEMOLINE (MALLINCKRODT) APPROVAL= AP YEAR= 2001 DISCONTINUED , 1144 ; MITOTANE ; 53-19-0 ; 1970 ; ; ; CLASS ANTINEOPLASTIC -- ADRENAL CYTOTOXIC AGENT -- TREATMENT OF INOPERABLE ADRENAL CORTICAL CARCINOMA -- STEROID AND XENOBIOTIC RECEPTOR (SXR) AGONIST (PMID23179081) , ; NDA 016885 (label 16885.pdf) INN (MITOTANE) LYSODREN (HRA PHARMA) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY , 1145 ; BUPIVACAINE ; 2180-92-9 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC (LOCAL) -- ACETYLCHOLINE RECEPTOR ION CHANNEL BLOCKER , ; NDA 016964 (label 16964.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) MARCAINE HYDROCHLORIDE W/ EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 018053 (label 18053.pdf) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018304 (label 18304.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1981 , NDA 018692 (label 18692.pdf) INN (BUPIVACAINE HYDROCHLORIDE) MARCAINE (HOSPIRA) APPROVAL= AP YEAR= 1984 , NDA 019978 (pdf 19978.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE KIT (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 021496 (label 21496.pdf) INN (BUPIVACAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE) DUOCAINE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 022046 (label 22046.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 070552 (pdf 70552.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 070553 (pdf 70553.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 070554 (pdf 70554.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 , NDA 070583 (pdf 70583.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070584 (pdf 70584.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070585 (pdf 70585.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070586 (pdf 70586.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070587 (pdf 70587.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070590 (pdf 70590.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070597 (pdf 70597.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070609 (pdf 70609.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 070966 (pdf 70966.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 070967 (pdf 70967.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 070968 (pdf 70968.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 071165 (label 71165.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071166 (pdf 71166.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071167 (pdf 71167.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071168 (label 71168.pdf) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071169 (pdf 71169.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071170 (pdf 71170.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 , NDA 071171 (pdf 71171.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071202 (label 71202.pdf) INN (BUPIVACAINE HYDROCHLORIDE) SENSORCAINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071810 (pdf 71810.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1987 , NDA 076012 (pdf 76012.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (INTL MEDICATED) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 077250 (pdf 77250.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE (SEPTODONT) APPROVAL= AP YEAR= 2006 , NDA 022496 (label 22496.pdf) INN (BUPIVACAINE) EXPAREL (PACIRA PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 091487 (pdf 91487.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (STERISCIENCE) APPROVAL= AP YEAR= 2011 , NDA 091503 (pdf 91503.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2011 , NDA 203895 (pdf 203895.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 207183 (pdf 207183.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207266 (pdf 207266.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 209087 (pdf 209087.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (B BRAUN MEDICAL INC) APPROVAL= AP YEAR= 2019 , NDA 211096 (pdf 211096.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (CIVICA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212822 (pdf 212822.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HUONS) APPROVAL= AP YEAR= 2019 , NDA 209511 (label 209511.pdf) INN (BUPIVACAINE HYDROCHLORIDE) XARACOLL (INNOCOLL PHARMS) APPROVAL= AP YEAR= 2020 , NDA 204803 (label 204803.pdf) INN (BUPIVACAINE) POSIMIR (INNOCOLL) APPROVAL= AP YEAR= 2021 , NDA 204842 (pdf 204842.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE (HIKMA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 205141 (pdf 205141.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211988 (label 211988.pdf) INN (BUPIVACAINE MELOXICAM) ZYNRELEF KIT (HERON THERAPS INC) APPROVAL= AP YEAR= 2021 , NDA 216039 (pdf 216039.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 216040 (pdf 216040.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 217792 (pdf 217792.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (SOMERSET) APPROVAL= AP YEAR= 2023 , NDA 217821 (pdf 217821.pdf not found) INN (BUPIVACAINE HYDROCHLORIDE) BUPIVACAINE HYDROCHLORIDE (ASPIRO) APPROVAL= AP YEAR= 2024 , 1146 ; ENFLURANE ; 13838-16-9 ; 1972 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA INDUCER (POSITIVE ALLOSTERIC MODULATORS) , ; NDA 017087 (label 17087.pdf) INN (ENFLURANE) ETHRANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY DISCONTINUED , NDA 070803 (pdf 70803.pdf not found) INN (ENFLURANE) ENFLURANE (ABBOTT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 074396 (pdf 74396.pdf not found) INN (ENFLURANE) ENFLURANE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 1994 DISCONTINUED , 1147 ; MOLINDONE ; 7416-34-4 ; 1974 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- MANAGEMENT OF SCHIZOPHRENIA -- DOPAMINE RECEPTOR ANTAGONIST , ; NDA 017111 (label 17111.pdf) INN (MOLINDONE HYDROCHLORIDE) MOBAN (CHARTWELL RX) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 017938 (pdf 17938.pdf not found) INN (MOLINDONE HYDROCHLORIDE) MOBAN (ENDO PHARMS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 090453 (pdf 90453.pdf not found) INN (MOLINDONE HYDROCHLORIDE) MOLINDONE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 , 1148 ; MAZINDOL ; 22232-71-9 ; 1973 ; DISCONTINUED ; ; CLASS METABOLISM -- CNS STIMULANT -- ANTIANOREXIC -- ADRENERGIC UPTAKE INHIBITORS -- DOPAMINE UPTAKE INHIBITORS , ; NDA 017247 (pdf 17247.pdf not found) INN (MAZINDOL) SANOREX (NOVARTIS) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 017980 (pdf 17980.pdf not found) INN (MAZINDOL) MAZANOR (WYETH AYERST) APPROVAL= AP YEAR= 1980 DISCONTINUED , 1149 ; METOLAZONE ; 17560-51-9 ; 1973 ; ; ; CLASS CARDIOVASCULAR -- QUINAZOLINE DIURETIC -- ANTIHYPERTENSIVE -- BLOCKER , ; NDA 017386 (label 17386.pdf) INN (METOLAZONE) ZAROXOLYN (I3 PHARMS) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 018535 (pdf 18535.pdf not found) INN (METOLAZONE) DIULO (GD SEARLE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019532 (label 19532.pdf) INN (METOLAZONE) MYKROX (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 075543 (pdf 75543.pdf not found) INN (METOLAZONE) METOLAZONE (ANI PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076466 (pdf 76466.pdf not found) INN (METOLAZONE) METOLAZONE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076482 (pdf 76482.pdf not found) INN (METOLAZONE) METOLAZONE (ROXANE) APPROVAL= AP YEAR= 2004 , NDA 076600 (pdf 76600.pdf not found) INN (METOLAZONE) METOLAZONE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 076698 (pdf 76698.pdf not found) INN (METOLAZONE) METOLAZONE (MYLAN) APPROVAL= AP YEAR= 2003 , NDA 076732 (pdf 76732.pdf not found) INN (METOLAZONE) METOLAZONE (SANDOZ) APPROVAL= AP YEAR= 2003 , NDA 076833 (pdf 76833.pdf not found) INN (METOLAZONE) METOLAZONE (TEVA) APPROVAL= AP YEAR= 2004 DISCONTINUED OBSOLETE , NDA 076891 (pdf 76891.pdf not found) INN (METOLAZONE) METOLAZONE (WATSON LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 213251 (pdf 213251.pdf not found) INN (METOLAZONE) METOLAZONE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 213827 (pdf 213827.pdf not found) INN (METOLAZONE) METOLAZONE (INNOGENIX) APPROVAL= AP YEAR= 2021 , NDA 214799 (pdf 214799.pdf not found) INN (METOLAZONE) METOLAZONE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2021 , NDA 215184 (pdf 215184.pdf not found) INN (METOLAZONE) METOLAZONE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 215616 (pdf 215616.pdf not found) INN (METOLAZONE) METOLAZONE (RENATA) APPROVAL= AP YEAR= 2022 , NDA 216216 (pdf 216216.pdf not found) INN (METOLAZONE) METOLAZONE (NE RX PHARMA) APPROVAL= AP YEAR= 2022 , NDA 218606 (pdf 218606.pdf not found) INN (METOLAZONE) METOLAZONE (LEADING) APPROVAL= AP YEAR= 2024 , 1150 ; DISOPYRAMIDE ; 3737-09-5 ; 1977 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- SODIUM CHANNEL BLOCKERS -- POTASSIUM CHANNEL BLOCKERS , ; NDA 017447 (pdf 17447.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) NORPACE (PFIZER) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 018655 (pdf 18655.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) NORPACE CR (PFIZER) APPROVAL= AP YEAR= 1982 , NDA 070101 (pdf 70101.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 070102 (pdf 70102.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (TEVA) APPROVAL= AP YEAR= 1985 , NDA 070138 (pdf 70138.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070139 (pdf 70139.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MYLAN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070173 (pdf 70173.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1985 , NDA 070174 (pdf 70174.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (MAYNE PHARMA) APPROVAL= AP YEAR= 1985 OBSOLETE , NDA 070186 (pdf 70186.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070187 (pdf 70187.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070240 (pdf 70240.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070241 (pdf 70241.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070351 (pdf 70351.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070352 (pdf 70352.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070470 (pdf 70470.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070471 (pdf 70471.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (RISING) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070940 (pdf 70940.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070941 (pdf 70941.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071190 (pdf 71190.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071191 (pdf 71191.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (INTERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071200 (pdf 71200.pdf not found) INN (DISOPYRAMIDE PHOSPHATE) DISOPYRAMIDE PHOSPHATE (NESHER PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , 1151 ; MICONAZOLE ; 22916-47-8 ; 1974 ; ; ; CLASS METABOLISM -- ANTIFUNGAL (TOPICAL) -- CYTOCHROME P450 14ALPHA-DEMETHYLASE INHIBITOR -- INHIBITION OF ERGOSTEROL SYNTHESIS (FUNGAL CELL MEMBRANE) , ; NDA 017450 (label 17450.pdf) INN (MICONAZOLE NITRATE) MONISTAT 7 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY , NDA 017494 (pdf 17494.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT-DERM (INSIGHT PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017739 (pdf 17739.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT-DERM (INSIGHT PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018040 (pdf 18040.pdf not found) INN (MICONAZOLE) MONISTAT (JANSSEN PHARMA) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 018520 (pdf 18520.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 7 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1982 , NDA 018592 (pdf 18592.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 5 (PERSONAL PRODS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 018888 (pdf 18888.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 3 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1984 , NDA 020288 (pdf 20288.pdf not found) INN (MICONAZOLE NITRATE) MONISTAT 7 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1993 , NDA 020670 (label 20670.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1996 , NDA 020827 (label 20827.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 1998 , NDA 020968 (label 20968.pdf) INN (MICONAZOLE NITRATE) MONISTAT DUAL- PAK (PERSONAL PRODS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021026 (label 21026.pdf) INN (MICONAZOLE NITRATE WHITE PETROLATUM ZINC OXIDE) VUSION (MYLAN) APPROVAL= AP YEAR= 2006 , NDA 021261 (label 21261.pdf) INN (MICONAZOLE NITRATE) MONISTAT 3 COMBINATION PACK PREFILLED (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 2001 , NDA 021308 (label 21308.pdf) INN (MICONAZOLE NITRATE) MONISTAT 1 COMBINATION PACK (MEDTECH PRODUCTS) APPROVAL= AP YEAR= 2001 , NDA 073507 (pdf 73507.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1993 , NDA 073508 (pdf 73508.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (ACTAVIS PHARMA) APPROVAL= AP YEAR= 1993 , NDA 074030 (pdf 74030.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074136 (pdf 74136.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074164 (pdf 74164.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 7 (P AND L) APPROVAL= AP YEAR= 1996 , NDA 074366 (pdf 74366.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074395 (pdf 74395.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074414 (pdf 74414.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074444 (pdf 74444.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (TARO) APPROVAL= AP YEAR= 1997 , NDA 074586 (pdf 74586.pdf not found) INN (MICONAZOLE NITRATE) M-ZOLE 7 DUAL PACK (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074760 (pdf 74760.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO) APPROVAL= AP YEAR= 1997 , NDA 074926 (label 74926.pdf) INN (MICONAZOLE NITRATE) M-ZOLE 3 COMBINATION PACK (COSETTE) APPROVAL= AP YEAR= 1999 , NDA 075329 (label 75329.pdf) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE COMBINATION PACK (L PERRIGO CO) APPROVAL= AP YEAR= 1999 , NDA 076357 (pdf 76357.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 3 COMBINATION PACK (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076585 (pdf 76585.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 7 COMBINATION PACK (COSETTE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076773 (pdf 76773.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE 3 (TARO) APPROVAL= AP YEAR= 2005 , NDA 022404 (label 22404.pdf) INN (MICONAZOLE) ORAVIG (GALT PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091366 (pdf 91366.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2010 , NDA 079114 (pdf 79114.pdf not found) INN (MICONAZOLE NITRATE) MICONAZOLE NITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2010 , 1152 ; IBUPROFEN ; 15687-27-1 ; 1974 ; ; ; CLASS MUSCULO-SKELETAL -- ANALGESICS -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL (NSAIDS) -- CYCLOOXYGENASE INHIBITORS -- TREATMENT OF A HAEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PRETERM NEWBORN INFANTS (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 017463 (label 17463.pdf) INN (IBUPROFEN) MOTRIN (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 018197 (pdf 18197.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018989 (label 18989.pdf) INN (IBUPROFEN) ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1984 , NDA 019012 (label 19012.pdf) INN (IBUPROFEN) NUPRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1984 , NDA 019771 (label 19771.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1989 , NDA 019784 (pdf 19784.pdf not found) INN (IBUPROFEN) IBU (ABBOTT) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019833 (pdf 19833.pdf not found) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019842 (label 19842.pdf) INN (IBUPROFEN) MOTRIN (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019899 (label 19899.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) SINE-AID IB (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1992 , NDA 020135 (pdf 20135.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL PED) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020267 (label 20267.pdf) INN (IBUPROFEN) JUNIOR STRENGTH ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1996 , NDA 020402 (label 20402.pdf) INN (IBUPROFEN) ADVIL LIQUI-GELS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1995 , NDA 020418 (pdf 20418.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL PED) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 020476 (pdf 20476.pdf not found) INN (IBUPROFEN) MOTRIN (MCNEIL) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020516 (label 20516.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1995 , NDA 020589 (label 20589.pdf) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1996 , NDA 020601 (label 20601.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020602 (label 20602.pdf) INN (IBUPROFEN) JUNIOR STRENGTH MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 , NDA 020603 (label 20603.pdf) INN (IBUPROFEN) CHILDREN'S MOTRIN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1996 , NDA 020716 (label 20716.pdf) INN (HYDROCODONE BITARTRATE IBUPROFEN) VICOPROFEN (ABBVIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020812 (label 20812.pdf) INN (IBUPROFEN) PEDIATRIC ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1998 , NDA 020944 (label 20944.pdf) INN (IBUPROFEN) CHILDREN'S ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1998 , NDA 021128 (label 21128.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S MOTRIN COLD (J AND J CONSUMER INC) APPROVAL= AP YEAR= 2000 , NDA 021373 (label 21373.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL COLD (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021374 (label 21374.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021378 (label 21378.pdf) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) COMBUNOX (FOREST LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021393 (label 21393.pdf) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) ADVIL PM (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2005 , NDA 021394 (label 21394.pdf) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) ADVIL PM (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2005 , NDA 021441 (label 21441.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2002 , NDA 021472 (label 21472.pdf) INN (IBUPROFEN) MIDOL LIQUID GELS (BIONPHARMA) APPROVAL= AP YEAR= 2002 , NDA 021587 (label 21587.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL ALLERGY SINUS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2004 , NDA 021604 (label 21604.pdf) INN (IBUPROFEN) CHILDREN'S ELIXSURE (MOBERG PHARMA NORTH) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021903 (label 21903.pdf) INN (IBUPROFEN LYSINE) NEOPROFEN (RECORDATI RARE) APPROVAL= AP YEAR= 2006 , NDA 070038 (pdf 70038.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070041 (pdf 70041.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070045 (pdf 70045.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070057 (pdf 70057.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070079 (pdf 70079.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070080 (pdf 70080.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070081 (pdf 70081.pdf not found) INN (IBUPROFEN) IBUPROFEN (J AND J CONSUMER INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070083 (pdf 70083.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070088 (pdf 70088.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070099 (pdf 70099.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070328 (pdf 70328.pdf not found) INN (IBUPROFEN) IBUPROFEN (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070329 (pdf 70329.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070330 (pdf 70330.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070435 (pdf 70435.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070436 (pdf 70436.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070437 (pdf 70437.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070469 (pdf 70469.pdf not found) INN (IBUPROFEN) IBUPROHM (OHM LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070475 (pdf 70475.pdf not found) INN (IBUPROFEN) MEDIPREN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070476 (pdf 70476.pdf not found) INN (IBUPROFEN) IBUPROFEN (MCNEIL) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070481 (pdf 70481.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1985 , NDA 070493 (pdf 70493.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070556 (pdf 70556.pdf not found) INN (IBUPROFEN) IBUPROFEN (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070591 (pdf 70591.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070626 (pdf 70626.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070629 (pdf 70629.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEDERLE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070630 (pdf 70630.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEDERLE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070709 (pdf 70709.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUPERPHARM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070733 (pdf 70733.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L DEV LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070734 (pdf 70734.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070735 (pdf 70735.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1986 DISCONTINUED OBSOLETE , NDA 070736 (pdf 70736.pdf not found) INN (IBUPROFEN) IBUPROFEN (RISING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070745 (pdf 70745.pdf not found) INN (IBUPROFEN) IBU (BASF) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070818 (pdf 70818.pdf not found) INN (IBUPROFEN) IBUPROFEN (OHM LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070908 (pdf 70908.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070985 (pdf 70985.pdf not found) INN (IBUPROFEN) IBUPROFEN (MERRO PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070986 (pdf 70986.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071001 (pdf 71001.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071002 (pdf 71002.pdf not found) INN (IBUPROFEN) MIDOL (BAYER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071027 (pdf 71027.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071028 (pdf 71028.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071029 (pdf 71029.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071030 (pdf 71030.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071057 (pdf 71057.pdf not found) INN (IBUPROFEN) IBU-TAB 200 (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071058 (pdf 71058.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071059 (pdf 71059.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071065 (pdf 71065.pdf not found) INN (IBUPROFEN) ACHES-N-PAIN (LEDERLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071122 (pdf 71122.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071123 (pdf 71123.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071124 (pdf 71124.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071125 (pdf 71125.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071144 (pdf 71144.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071145 (pdf 71145.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071146 (pdf 71146.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071154 (pdf 71154.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071163 (pdf 71163.pdf not found) INN (IBUPROFEN) IBUPROFEN (OHM) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071214 (pdf 71214.pdf not found) INN (IBUPROFEN) IBUPROHM (OHM LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071215 (pdf 71215.pdf not found) INN (IBUPROFEN) MEDIPREN (MCNEIL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071229 (pdf 71229.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 , NDA 071230 (pdf 71230.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071231 (pdf 71231.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071232 (pdf 71232.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071264 (pdf 71264.pdf not found) INN (IBUPROFEN) IBUPROFEN (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071265 (pdf 71265.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071266 (pdf 71266.pdf not found) INN (IBUPROFEN) IBUPROFEN (LEINER) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071267 (pdf 71267.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 , NDA 071268 (pdf 71268.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1986 , NDA 071333 (pdf 71333.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1987 , NDA 071334 (pdf 71334.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1986 , NDA 071335 (pdf 71335.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1986 , NDA 071338 (pdf 71338.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071448 (pdf 71448.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071462 (pdf 71462.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071547 (pdf 71547.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071575 (pdf 71575.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071639 (pdf 71639.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071644 (pdf 71644.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071664 (pdf 71664.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071666 (pdf 71666.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071667 (pdf 71667.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071668 (pdf 71668.pdf not found) INN (IBUPROFEN) IBUPROFEN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071732 (pdf 71732.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071735 (pdf 71735.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071765 (pdf 71765.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071769 (pdf 71769.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071773 (pdf 71773.pdf not found) INN (IBUPROFEN) IBUPRIN (PLIVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071807 (pdf 71807.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071870 (pdf 71870.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071905 (pdf 71905.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 071911 (pdf 71911.pdf not found) INN (IBUPROFEN) IBUPROFEN (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071935 (pdf 71935.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1987 , NDA 071938 (pdf 71938.pdf not found) INN (IBUPROFEN) IBUPROFEN (RISING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071964 (pdf 71964.pdf not found) INN (IBUPROFEN) IBUPROFEN (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071965 (pdf 71965.pdf not found) INN (IBUPROFEN) IBU-TAB (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071999 (pdf 71999.pdf not found) INN (IBUPROFEN) IBUPROFEN (MYLAN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072004 (pdf 72004.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072035 (pdf 72035.pdf not found) INN (IBUPROFEN) NUPRIN (BRISTOL MYERS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072036 (pdf 72036.pdf not found) INN (IBUPROFEN) NUPRIN (BRISTOL MYERS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072040 (pdf 72040.pdf not found) INN (IBUPROFEN) IBUPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072064 (pdf 72064.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072065 (pdf 72065.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072095 (pdf 72095.pdf not found) INN (IBUPROFEN) TAB-PROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072096 (pdf 72096.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 , NDA 072097 (pdf 72097.pdf not found) INN (IBUPROFEN) CAP-PROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072098 (pdf 72098.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072137 (pdf 72137.pdf not found) INN (IBUPROFEN) IBUPROFEN (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072169 (pdf 72169.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072199 (pdf 72199.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 1988 , NDA 072249 (pdf 72249.pdf not found) INN (IBUPROFEN) IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072299 (pdf 72299.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1988 , NDA 072300 (pdf 72300.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1988 , NDA 072901 (pdf 72901.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072903 (pdf 72903.pdf not found) INN (IBUPROFEN) IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073019 (pdf 73019.pdf not found) INN (IBUPROFEN) IBUPROFEN (MCNEIL) APPROVAL= AP YEAR= 1994 , NDA 073141 (pdf 73141.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073343 (pdf 73343.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073344 (pdf 73344.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073345 (pdf 73345.pdf not found) INN (IBUPROFEN) IBUPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073691 (pdf 73691.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074525 (pdf 74525.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074533 (pdf 74533.pdf not found) INN (IBUPROFEN) IBUPROFEN (SANDOZ) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074567 (pdf 74567.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROHM COLD AND SINUS (OHM LABS) APPROVAL= AP YEAR= 2001 , NDA 074782 (pdf 74782.pdf not found) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074916 (pdf 74916.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L) APPROVAL= AP YEAR= 1999 , NDA 074931 (label 74931.pdf) INN (IBUPROFEN) IBUPROFEN (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074937 (label 74937.pdf) INN (IBUPROFEN) CHILDREN'S IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 1998 , NDA 074978 (label 74978.pdf) INN (IBUPROFEN) IBUPROFEN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1998 , NDA 075010 (pdf 75010.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 1999 , NDA 075139 (pdf 75139.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 1999 , NDA 075217 (label 75217.pdf) INN (IBUPROFEN) IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 1998 , NDA 075367 (pdf 75367.pdf not found) INN (IBUPROFEN) JUNIOR STRENGTH IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075588 (label 75588.pdf) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075661 (label 75661.pdf) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LA) APPROVAL= AP YEAR= 2001 , NDA 075682 (pdf 75682.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LA) APPROVAL= AP YEAR= 2001 , NDA 075995 (pdf 75995.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076023 (pdf 76023.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (TEVA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076112 (pdf 76112.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2001 , NDA 076117 (pdf 76117.pdf not found) INN (IBUPROFEN) IBUPROFEN (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2001 , NDA 076359 (pdf 76359.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO) APPROVAL= AP YEAR= 2004 , NDA 076460 (pdf 76460.pdf not found) INN (IBUPROFEN) IBUPROFEN (AVEMA PHARMA) APPROVAL= AP YEAR= 2003 , NDA 076478 (pdf 76478.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076604 (pdf 76604.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2003 , NDA 076642 (pdf 76642.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2004 , NDA 076741 (pdf 76741.pdf not found) INN (IBUPROFEN) IBUPROFEN (LNK) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076925 (pdf 76925.pdf not found) INN (IBUPROFEN) IBUPROFEN (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 077114 (pdf 77114.pdf not found) INN (IBUPROFEN) IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077349 (pdf 77349.pdf not found) INN (IBUPROFEN) IBUPROFEN (PERRIGO R AND D) APPROVAL= AP YEAR= 2005 , NDA 077628 (pdf 77628.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 077723 (pdf 77723.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2006 , NDA 077727 (pdf 77727.pdf not found) INN (IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078132 (pdf 78132.pdf not found) INN (IBUPROFEN) IBUPROFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078316 (pdf 78316.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (BARR LABS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078394 (pdf 78394.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078558 (pdf 78558.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2007 , NDA 078769 (pdf 78769.pdf not found) INN (IBUPROFEN OXYCODONE HYDROCHLORIDE) OXYCODONE HYDROCHLORIDE AND IBUPROFEN (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022348 (label 22348.pdf) INN (IBUPROFEN) CALDOLOR (CUMBERLAND PHARMS) APPROVAL= AP YEAR= 2009 , NDA 077338 (pdf 77338.pdf not found) INN (IBUPROFEN) IBUPROFEN (P AND L DEV LLC) APPROVAL= AP YEAR= 2009 , NDA 078329 (pdf 78329.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078682 (pdf 78682.pdf not found) INN (IBUPROFEN) IBUPROFEN (BIONPHARMA) APPROVAL= AP YEAR= 2009 , NDA 079058 (pdf 79058.pdf not found) INN (IBUPROFEN) IBUPROFEN (TRIS PHARMA INC) APPROVAL= AP YEAR= 2009 , NDA 079113 (pdf 79113.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 079205 (pdf 79205.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090619 (pdf 90619.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 022565 (label 22565.pdf) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL CONGESTION RELIEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2010 , NDA 077454 (pdf 77454.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (ANI PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090397 (pdf 90397.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2010 , NDA 079174 (pdf 79174.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES INDIA) APPROVAL= AP YEAR= 2010 , NDA 090796 (pdf 90796.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2010 , NDA 022519 (label 22519.pdf) INN (FAMOTIDINE IBUPROFEN) DUEXIS (HORIZON) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079129 (pdf 79129.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091237 (pdf 91237.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091239 (pdf 91239.pdf not found) INN (IBUPROFEN) IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 091355 (pdf 91355.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 022113 (label 22113.pdf) INN (CHLORPHENIRAMINE MALEATE IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) ADVIL ALLERGY AND CONGESTION RELIEF (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2011 , NDA 200457 (pdf 200457.pdf not found) INN (IBUPROFEN) IBUPROFEN (ARISE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202300 (pdf 202300.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 079233 (pdf 79233.pdf not found) INN (IBUPROFEN) IBUPROFEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 200888 (pdf 200888.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2012 , NDA 201803 (label 201803.pdf) INN (IBUPROFEN SODIUM) ADVIL (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2012 , NDA 091633 (pdf 91633.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203200 (pdf 203200.pdf not found) INN (IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE) IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2014 , NDA 091625 (pdf 91625.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2015 , NDA 206581 (label 206581.pdf) INN (IBUPROFEN SODIUM) IBUPROFEN SODIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202402 (label 202402.pdf) INN (IBUPROFEN LYSINE) IBUPROFEN LYSINE (XGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 204575 (pdf 204575.pdf not found) INN (HYDROCODONE BITARTRATE IBUPROFEN) HYDROCODONE BITARTRATE AND IBUPROFEN (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206568 (pdf 206568.pdf not found) INN (IBUPROFEN) IBUPROFEN (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2016 , NDA 202312 (pdf 202312.pdf not found) INN (IBUPROFEN) IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2016 , NDA 202413 (pdf 202413.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2016 , NDA 203599 (pdf 203599.pdf not found) INN (IBUPROFEN) IBUPROFEN (SOFGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 205647 (pdf 205647.pdf not found) INN (IBUPROFEN) IBUPROFEN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207052 (pdf 207052.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207095 (pdf 207095.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2017 , NDA 209204 (pdf 209204.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2017 , NDA 209207 (pdf 209207.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2017 , NDA 206999 (pdf 206999.pdf not found) INN (IBUPROFEN) IBUPROFEN (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 208865 (pdf 208865.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209235 (pdf 209235.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 204469 (pdf 204469.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209178 (pdf 209178.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 209179 (pdf 209179.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 204062 (pdf 204062.pdf not found) INN (IBUPROFEN) IBUPROFEN (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206989 (pdf 206989.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 206990 (pdf 206990.pdf not found) INN (IBUPROFEN) IBUPROFEN (SHANDONG XINHUA) APPROVAL= AP YEAR= 2018 OBSOLETE , NDA 207753 (pdf 207753.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210149 (pdf 210149.pdf not found) INN (IBUPROFEN) IBUPROFEN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2018 , NDA 210602 (pdf 210602.pdf not found) INN (IBUPROFEN) IBUPROFEN (APTAPHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210755 (pdf 210755.pdf not found) INN (IBUPROFEN) IBUPROFEN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2018 , NDA 210676 (pdf 210676.pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 209076 (pdf 209076.pdf not found) INN (IBUPROFEN) IBUPROFEN (ULTRATAB LABS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211733 (label 211733.pdf) INN (ACETAMINOPHEN IBUPROFEN) ADVIL DUAL ACTION WITH ACETAMINOPHEN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2020 , NDA 213794 (pdf 213794.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211890 (pdf 211890.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214003 (pdf 214003.pdf not found) INN (IBUPROFEN) IBUPROFEN (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211666 (pdf 211666.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211278 (pdf 211278.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 214699 (pdf 214699.pdf not found) INN (IBUPROFEN) IBUPROFEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214071 (pdf 214071.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215311 (pdf 215311.pdf not found) INN (IBUPROFEN) IBUPROFEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215318 (pdf 215318.pdf not found) INN (IBUPROFEN) IBUPROFEN (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2022 , NDA 216204 (pdf 216204.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 209471 (label 209471.pdf) INN (ACETAMINOPHEN IBUPROFEN) COMBOGESIC (AFT PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 213565 (pdf 213565.pdf not found) INN (IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 214836 (pdf 214836.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (L PERRIGO CO) APPROVAL= AP YEAR= 2023 , NDA 216814 (pdf 216814.pdf not found) INN (FAMOTIDINE IBUPROFEN) IBUPROFEN AND FAMOTIDINE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 215320 (pdf 215320.pdf not found) INN (ACETAMINOPHEN IBUPROFEN SODIUM) COMBOGESIC IV (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215777 (pdf 215777.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216592 (pdf 216592.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 216994 (pdf 216994.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216999 (pdf 216999.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 217261 (pdf 217261.pdf not found) INN (IBUPROFEN) IBUPROFEN (TARO) APPROVAL= AP YEAR= 2023 , NDA 203658 (pdf 203658.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE IBUPROFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2024 , NDA 211404 (pdf 211404.pdf not found) INN (DIPHENHYDRAMINE CITRATE IBUPROFEN) IBUPROFEN AND DIPHENHYDRAMINE CITRATE (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 2024 , NDA 213506 (pdf 213506.pdf not found) INN (IBUPROFEN) IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 215925 (pdf 215925.pdf not found) INN (FAMOTIDINE IBUPROFEN) FAMOTIDINE AND IBUPROFEN (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 217236 (pdf 217236.pdf not found) INN (IBUPROFEN) IBUPROFEN (PATHEON SOFTGELS) APPROVAL= AP YEAR= 2024 , NDA 218311 (pdf 218311.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 218359 (pdf 218359.pdf not found) INN (ACETAMINOPHEN IBUPROFEN) ACETAMINOPHEN AND IBUPROFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1153 ; LUMEFANTRINE ; 82186-77-4 ; 2009 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS -- INHIBITS HEMOZOIN FORMATION -- MEMBRANE SCRAMBLING LEADING TO PHOSPHATIDYLSERINE-EXPOSURE AT THE ERYTHROCYTE SURFACE , ; NDA 022268 (label 22268.pdf) INN (ARTEMETHER LUMEFANTRINE) COARTEM (NOVARTIS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , 1154 ; LORAZEPAM ; 846-49-1 ; 1977 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTICONVULSANTS -- ANTIEMETICS -- BENZODIAZEPINES -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 017794 (label 17794.pdf) INN (LORAZEPAM) ATIVAN (BAUSCH) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 018140 (label 18140.pdf) INN (LORAZEPAM) ATIVAN (HIKMA) APPROVAL= AP YEAR= 1980 , NDA 070200 (pdf 70200.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070201 (pdf 70201.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070202 (pdf 70202.pdf not found) INN (LORAZEPAM) LORAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070472 (pdf 70472.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070473 (pdf 70473.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070474 (pdf 70474.pdf not found) INN (LORAZEPAM) LORAZEPAM (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070539 (pdf 70539.pdf not found) INN (LORAZEPAM) LORAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070540 (pdf 70540.pdf not found) INN (LORAZEPAM) LORAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070675 (pdf 70675.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070676 (pdf 70676.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070677 (pdf 70677.pdf not found) INN (LORAZEPAM) LORAZEPAM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070727 (pdf 70727.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070728 (pdf 70728.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070729 (pdf 70729.pdf not found) INN (LORAZEPAM) LORAZEPAM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071038 (pdf 71038.pdf not found) INN (LORAZEPAM) LORAZEPAM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071039 (pdf 71039.pdf not found) INN (LORAZEPAM) LORAZEPAM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071086 (pdf 71086.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071087 (pdf 71087.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071088 (pdf 71088.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071110 (pdf 71110.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071117 (pdf 71117.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071118 (pdf 71118.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071141 (pdf 71141.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 071193 (pdf 71193.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071194 (pdf 71194.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071195 (pdf 71195.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071245 (pdf 71245.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071246 (pdf 71246.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071247 (pdf 71247.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUPERPHARM) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071403 (pdf 71403.pdf not found) INN (LORAZEPAM) LORAZEPAM () APPROVAL= AP YEAR= 1987 , NDA 071404 (pdf 71404.pdf not found) INN (LORAZEPAM) LORAZEPAM (SANDOZ) APPROVAL= AP YEAR= 1987 , NDA 071434 (pdf 71434.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071435 (pdf 71435.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071436 (pdf 71436.pdf not found) INN (LORAZEPAM) LORAZEPAM (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071589 (pdf 71589.pdf not found) INN (LORAZEPAM) LORAZEPAM (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071590 (pdf 71590.pdf not found) INN (LORAZEPAM) LORAZEPAM (MYLAN) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071591 (pdf 71591.pdf not found) INN (LORAZEPAM) LORAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072553 (pdf 72553.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072554 (pdf 72554.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED OBSOLETE , NDA 072555 (pdf 72555.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANDA REPOSITORY) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072755 (pdf 72755.pdf not found) INN (LORAZEPAM) LORAZEPAM INTENSOL (HIKMA) APPROVAL= AP YEAR= 1991 , NDA 072926 (pdf 72926.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 072927 (pdf 72927.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 072928 (pdf 72928.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1991 , NDA 074243 (pdf 74243.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074276 (pdf 74276.pdf not found) INN (LORAZEPAM) LORAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074280 (pdf 74280.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074282 (pdf 74282.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 , NDA 074300 (pdf 74300.pdf not found) INN (LORAZEPAM) LORAZEPAM (HOSPIRA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074496 (label 74496.pdf) INN (LORAZEPAM) LORAZEPAM (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074535 (pdf 74535.pdf not found) INN (LORAZEPAM) LORAZEPAM (DR REDDYS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074551 (pdf 74551.pdf not found) INN (LORAZEPAM) LORAZEPAM (DR REDDYS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074648 (pdf 74648.pdf not found) INN (LORAZEPAM) LORAZEPAM (ROXANE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074793 (label 74793.pdf) INN (LORAZEPAM) LORAZEPAM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074974 (pdf 74974.pdf not found) INN (LORAZEPAM) LORAZEPAM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075025 (pdf 75025.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 1998 , NDA 076045 (pdf 76045.pdf not found) INN (LORAZEPAM) LORAZEPAM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2001 , NDA 076150 (pdf 76150.pdf not found) INN (LORAZEPAM) LORAZEPAM (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2004 , NDA 077074 (pdf 77074.pdf not found) INN (LORAZEPAM) LORAZEPAM PRESERVATIVE FREE (BEDFORD LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077076 (pdf 77076.pdf not found) INN (LORAZEPAM) LORAZEPAM (BEDFORD) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077396 (pdf 77396.pdf not found) INN (LORAZEPAM) LORAZEPAM (ANI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077657 (pdf 77657.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077754 (pdf 77754.pdf not found) INN (LORAZEPAM) LORAZEPAM (OXFORD PHARMS) APPROVAL= AP YEAR= 2006 , NDA 078203 (pdf 78203.pdf not found) INN (LORAZEPAM) LORAZEPAM (LEADING) APPROVAL= AP YEAR= 2007 , NDA 079244 (label 79244.pdf) INN (LORAZEPAM) LORAZEPAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091383 (pdf 91383.pdf not found) INN (LORAZEPAM) LORAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078826 (pdf 78826.pdf not found) INN (LORAZEPAM) LORAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090260 (pdf 90260.pdf not found) INN (LORAZEPAM) LORAZEPAM (PHARM ASSOC) APPROVAL= AP YEAR= 2010 , NDA 200169 (pdf 200169.pdf not found) INN (LORAZEPAM) LORAZEPAM (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091407 (pdf 91407.pdf not found) INN (LORAZEPAM) LORAZEPAM (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 200217 (label 200217.pdf) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 200542 (pdf 200542.pdf not found) INN (LORAZEPAM) LORAZEPAM (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203572 (pdf 203572.pdf not found) INN (LORAZEPAM) LORAZEPAM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2017 , NDA 214826 (label 214826.pdf) INN (LORAZEPAM) LOREEV XR (ALMATICA) APPROVAL= AP YEAR= 2021 , 1155 ; DOBUTAMINE ; 34368-04-2 ; 1978 ; ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETIC -- CATECHOLAMINE , ; NDA 017820 (pdf 17820.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTREX (LILLY) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 020201 (label 20201.pdf) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1993 , NDA 020255 (label 20255.pdf) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1993 , NDA 020269 (pdf 20269.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074086 (pdf 74086.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1993 , NDA 074098 (pdf 74098.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (TELIGENT) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074114 (pdf 74114.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074206 (pdf 74206.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074277 (pdf 74277.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1994 , NDA 074279 (pdf 74279.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074292 (pdf 74292.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074381 (pdf 74381.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074545 (pdf 74545.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074634 (pdf 74634.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074995 (pdf 74995.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 216131 (pdf 216131.pdf not found) INN (DOBUTAMINE HYDROCHLORIDE) DOBUTAMINE HYDROCHLORIDE (HAINAN POLY) APPROVAL= AP YEAR= 2022 , 1156 ; BACLOFEN ; 1134-47-0 ; 1977 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- MUSCLE RELAXANT -- GABA AGONISTS , ; NDA 017851 (pdf 17851.pdf not found) INN (BACLOFEN) LIORESAL (NOVARTIS) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 020075 (label 20075.pdf) INN (BACLOFEN) LIORESAL (AMNEAL) APPROVAL= AP YEAR= 1992 , NDA 021589 (label 21589.pdf) INN (BACLOFEN) KEMSTRO (UCB INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 071260 (pdf 71260.pdf not found) INN (BACLOFEN) BACLOFEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071261 (pdf 71261.pdf not found) INN (BACLOFEN) BACLOFEN (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072234 (pdf 72234.pdf not found) INN (BACLOFEN) BACLOFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072235 (pdf 72235.pdf not found) INN (BACLOFEN) BACLOFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1988 , NDA 072824 (pdf 72824.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072825 (pdf 72825.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073043 (pdf 73043.pdf not found) INN (BACLOFEN) BACLOFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073044 (pdf 73044.pdf not found) INN (BACLOFEN) BACLOFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073092 (pdf 73092.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 073093 (pdf 73093.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074584 (pdf 74584.pdf not found) INN (BACLOFEN) BACLOFEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 1996 , NDA 074698 (pdf 74698.pdf not found) INN (BACLOFEN) BACLOFEN (WATSON LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 077068 (pdf 77068.pdf not found) INN (BACLOFEN) BACLOFEN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2005 , NDA 077088 (pdf 77088.pdf not found) INN (BACLOFEN) BACLOFEN (OXFORD PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077089 (pdf 77089.pdf not found) INN (BACLOFEN) BACLOFEN () APPROVAL= AP YEAR= 2007 , NDA 077121 (pdf 77121.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN) APPROVAL= AP YEAR= 2005 , NDA 077156 (pdf 77156.pdf not found) INN (BACLOFEN) BACLOFEN (VINTAGE PHARMS) APPROVAL= AP YEAR= 2005 OBSOLETE , NDA 077181 (pdf 77181.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077241 (pdf 77241.pdf not found) INN (BACLOFEN) BACLOFEN (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 077862 (pdf 77862.pdf not found) INN (BACLOFEN) BACLOFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077971 (pdf 77971.pdf not found) INN (BACLOFEN) BACLOFEN (IMPAX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077984 (pdf 77984.pdf not found) INN (BACLOFEN) BACLOFEN (CARACO) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 078146 (pdf 78146.pdf not found) INN (BACLOFEN) BACLOFEN (IMPAX LABS) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078220 (pdf 78220.pdf not found) INN (BACLOFEN) BACLOFEN (LANNETT) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 078401 (pdf 78401.pdf not found) INN (BACLOFEN) BACLOFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 078504 (pdf 78504.pdf not found) INN (BACLOFEN) BACLOFEN (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 090334 (pdf 90334.pdf not found) INN (BACLOFEN) BACLOFEN (APPCO) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022462 (label 22462.pdf) INN (BACLOFEN) GABLOFEN (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2010 , NDA 091193 (pdf 91193.pdf not found) INN (BACLOFEN) BACLOFEN (AMNEAL) APPROVAL= AP YEAR= 2016 , NDA 209102 (pdf 209102.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= AP YEAR= 2017 , NDA 209592 (label 209592.pdf) INN (BACLOFEN) BACLOFEN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 209594 (pdf 209594.pdf not found) INN (BACLOFEN) BACLOFEN (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 211659 (pdf 211659.pdf not found) INN (BACLOFEN) BACLOFEN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 211555 (pdf 211555.pdf not found) INN (BACLOFEN) BACLOFEN (EYWA PHARMA) APPROVAL= AP YEAR= 2019 , NDA 208193 (label 208193.pdf) INN (BACLOFEN) OZOBAX (METACEL PHARMS LLC) APPROVAL= AP YEAR= 2019 , NDA 210048 (pdf 210048.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 210315 (pdf 210315.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 212067 (pdf 212067.pdf not found) INN (BACLOFEN) BACLOFEN (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 212378 (pdf 212378.pdf not found) INN (BACLOFEN) BACLOFEN (INNOGENIX) APPROVAL= AP YEAR= 2020 , NDA 210777 (pdf 210777.pdf not found) INN (BACLOFEN) BACLOFEN (MAIA PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214374 (pdf 214374.pdf not found) INN (BACLOFEN) BACLOFEN (RISING) APPROVAL= AP YEAR= 2021 , NDA 214099 (pdf 214099.pdf not found) INN (BACLOFEN) BACLOFEN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214114 (pdf 214114.pdf not found) INN (BACLOFEN) BACLOFEN (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 215422 (label 215422.pdf) INN (BACLOFEN) LYVISPAH (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 215602 (label 215602.pdf) INN (BACLOFEN) FLEQSUVY (AZURITY) APPROVAL= AP YEAR= 2022 , NDA 215885 (pdf 215885.pdf not found) INN (BACLOFEN) BACLOFEN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214445 (pdf 214445.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= TA YEAR= 2023 , NDA 217252 (pdf 217252.pdf not found) INN (BACLOFEN) BACLOFEN (ANI PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217324 (pdf 217324.pdf not found) INN (BACLOFEN) BACLOFEN (RUBICON) APPROVAL= AP YEAR= 2023 , NDA 216309 (pdf 216309.pdf not found) INN (BACLOFEN) BACLOFEN (ACIC PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217687 (pdf 217687.pdf not found) INN (BACLOFEN) BACLOFEN (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 217788 (pdf 217788.pdf not found) INN (BACLOFEN) BACLOFEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2024 , 1157 ; TEMAZEPAM ; 846-50-4 ; 1981 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTICS AND SEDATIVES -- BENZODIAZEPINES -- GABA MODULATORS -- ALLOSTERIC POSITIVE , ; NDA 018163 (label 18163.pdf) INN (TEMAZEPAM) RESTORIL (SPECGX LLC) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 070383 (pdf 70383.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070384 (pdf 70384.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070489 (pdf 70489.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070490 (pdf 70490.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070547 (pdf 70547.pdf not found) INN (TEMAZEPAM) TEMAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070564 (pdf 70564.pdf not found) INN (TEMAZEPAM) TEMAZ (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070920 (pdf 70920.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071174 (pdf 71174.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071175 (pdf 71175.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071427 (pdf 71427.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071428 (pdf 71428.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (CHARTWELL RX) APPROVAL= AP YEAR= 1988 , NDA 071446 (pdf 71446.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071447 (pdf 71447.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (WATSON LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 071456 (pdf 71456.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (NOVEL LABS INC) APPROVAL= AP YEAR= 1987 , NDA 071457 (pdf 71457.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (NOVEL LABS INC) APPROVAL= AP YEAR= 1987 , NDA 071620 (pdf 71620.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 , NDA 071638 (pdf 71638.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071708 (pdf 71708.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071709 (pdf 71709.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (DURAMED PHARMS BARR) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 078581 (pdf 78581.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2009 , NDA 201781 (pdf 201781.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 203482 (pdf 203482.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (AMNEAL PHARMS) APPROVAL= AP YEAR= 2016 , NDA 211542 (pdf 211542.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 217875 (pdf 217875.pdf not found) INN (TEMAZEPAM) TEMAZEPAM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , 1158 ; OXPRENOLOL ; 6452-71-7 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- CORONARY VASODILATOR -- ADRENERGIC BETA ANTAGONISTS -- ANTI-ARRHYTHMIA AGENTS -- ANTI-ANXIETY AGENTS -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS , ; NDA 018166 (pdf 18166.pdf not found) INN (OXPRENOLOL HYDROCHLORIDE) TRASICOR (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1159 ; AMINOGLUTETHIMIDE ; 125-84-8 ; 1980 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- AROMATASE INHIBITORS -- INHIBITOR OF ADRENOCORTICAL STEROID SYNTHESIS -- ANTICONVULSANT (WITHDRAWN) -- SUPPRESSION OF ADRENAL FUNCTION IN SELECTED PATIENTS WITH CUSHING’S SYNDROME , ; NDA 018202 (label 18202.pdf) INN (AMINOGLUTETHIMIDE) CYTADREN (NOVARTIS) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , 1160 ; DIPIVEFRIN ; 52365-63-6 ; 1980 ; DISCONTINUED ; ; CLASS SENSORY -- ADRENERGIC AGONISTS -- SYMPATHOMIMETICS -- CONTROL OF INTRAOCULAR PRESSURE IN CHRONIC OPEN-ANGLE GLAUCOMA , ; NDA 018239 (label 18239.pdf) INN (DIPIVEFRIN HYDROCHLORIDE) PROPINE (ALLERGAN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 073636 (pdf 73636.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) DIPIVEFRIN HYDROCHLORIDE (FALCON PHARMS) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074188 (pdf 74188.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) DIPIVEFRIN HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074382 (pdf 74382.pdf not found) INN (DIPIVEFRIN HYDROCHLORIDE) AKPRO (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1995 DISCONTINUED , 1161 ; ATENOLOL ; 29122-68-7 ; 1981 ; ; ; CLASS CARDIOVASCULAR -- CARDIOTONIC -- ANTIHYPERTENSIVE -- ADRENERGIC (BETA-1) BLOCKER , ; NDA 018240 (label 18240.pdf) INN (ATENOLOL) TENORMIN (TWI PHARMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , NDA 018760 (label 18760.pdf) INN (ATENOLOL CHLORTHALIDONE) TENORETIC 100 (ALMATICA) APPROVAL= AP YEAR= 1984 , NDA 019058 (pdf 19058.pdf not found) INN (ATENOLOL) TENORMIN (ASTRAZENECA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072301 (pdf 72301.pdf not found) INN (ATENOLOL) ATENOLOL AND CHLORTHALIDONE (ALVOGEN MALTA) APPROVAL= AP YEAR= 1990 OBSOLETE , NDA 072302 (pdf 72302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ALVOGEN) APPROVAL= AP YEAR= 1990 , NDA 072303 (pdf 72303.pdf not found) INN (ATENOLOL) ATENOLOL (ALVOGEN MALTA) APPROVAL= AP YEAR= 1988 OBSOLETE , NDA 072304 (pdf 72304.pdf not found) INN (ATENOLOL) ATENOLOL (TWI PHARMS) APPROVAL= AP YEAR= 1988 , NDA 073025 (pdf 73025.pdf not found) INN (ATENOLOL) ATENOLOL (SANDOZ) APPROVAL= AP YEAR= 1991 OBSOLETE , NDA 073026 (pdf 73026.pdf not found) INN (ATENOLOL) ATENOLOL (HLTHCARE) APPROVAL= AP YEAR= 1991 , NDA 073315 (pdf 73315.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073316 (pdf 73316.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073317 (pdf 73317.pdf not found) INN (ATENOLOL) ATENOLOL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073318 (pdf 73318.pdf not found) INN (ATENOLOL) ATENOLOL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073352 (pdf 73352.pdf not found) INN (ATENOLOL) ATENOLOL (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073353 (pdf 73353.pdf not found) INN (ATENOLOL) ATENOLOL (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073456 (pdf 73456.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073457 (pdf 73457.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1992 , NDA 073475 (pdf 73475.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073476 (pdf 73476.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073542 (pdf 73542.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073543 (pdf 73543.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073581 (pdf 73581.pdf not found) INN (ATENOLOL) ATENOLOL AND CHLORTHALIDONE (MUTUAL PHARM) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073582 (pdf 73582.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073646 (pdf 73646.pdf not found) INN (ATENOLOL) ATENOLOL (ALVOGEN MALTA) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 073665 (pdf 73665.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (WATSON LABS) APPROVAL= AP YEAR= 1992 , NDA 073676 (pdf 73676.pdf not found) INN (ATENOLOL) ATENOLOL (SCS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074052 (pdf 74052.pdf not found) INN (ATENOLOL) ATENOLOL (SANDOZ) APPROVAL= AP YEAR= 1992 OBSOLETE , NDA 074056 (pdf 74056.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074099 (pdf 74099.pdf not found) INN (ATENOLOL) ATENOLOL (STRIDES PHARMA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074101 (pdf 74101.pdf not found) INN (ATENOLOL) ATENOLOL (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074107 (pdf 74107.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074120 (pdf 74120.pdf not found) INN (ATENOLOL) ATENOLOL (TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074126 (pdf 74126.pdf not found) INN (ATENOLOL) ATENOLOL (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074127 (pdf 74127.pdf not found) INN (ATENOLOL) ATENOLOL (NOSTRUM LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074203 (pdf 74203.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074265 (pdf 74265.pdf not found) INN (ATENOLOL) ATENOLOL (CHARTWELL RX) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074404 (pdf 74404.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOSTRUM LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074499 (pdf 74499.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 076900 (pdf 76900.pdf not found) INN (ATENOLOL) ATENOLOL (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005 , NDA 076907 (pdf 76907.pdf not found) INN (ATENOLOL) ATENOLOL (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077443 (pdf 77443.pdf not found) INN (ATENOLOL) ATENOLOL (UNIQUE) APPROVAL= AP YEAR= 2006 , NDA 077877 (pdf 77877.pdf not found) INN (ATENOLOL) ATENOLOL (IPCA LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 078210 (pdf 78210.pdf not found) INN (ATENOLOL) ATENOLOL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078512 (pdf 78512.pdf not found) INN (ATENOLOL) ATENOLOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078254 (pdf 78254.pdf not found) INN (ATENOLOL) ATENOLOL (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 210028 (pdf 210028.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 213136 (pdf 213136.pdf not found) INN (ATENOLOL) ATENOLOL (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 213302 (pdf 213302.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (UNICHEM) APPROVAL= AP YEAR= 2020 , NDA 215560 (pdf 215560.pdf not found) INN (ATENOLOL CHLORTHALIDONE) ATENOLOL AND CHLORTHALIDONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , 1162 ; TOCAINIDE ; 41708-72-9 ; 1984 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTI-ARRHYTHMIA AGENTS -- SODIUM CHANNEL BLOCKERS , ; NDA 018257 (pdf 18257.pdf not found) INN (TOCAINIDE HYDROCHLORIDE) TONOCARD (ASTRAZENECA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , 1163 ; PINDOLOL ; 13523-86-9 ; 1982 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE AGENTS -- NON SELECTIVE BETA ADRENERGIC RECEPTOR ANTAGONISTS -- VASODILATOR AGENTS -- SYMPATHOMIMETIC , ; NDA 018285 (label 18285.pdf) INN (PINDOLOL) VISKEN (NOVARTIS) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 018872 (pdf 18872.pdf not found) INN (HYDROCHLOROTHIAZIDE PINDOLOL) VISKAZIDE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073608 (pdf 73608.pdf not found) INN (PINDOLOL) PINDOLOL (IDT AUSTRALIA LTD) APPROVAL= AP YEAR= 1993 OBSOLETE , NDA 073609 (pdf 73609.pdf not found) INN (PINDOLOL) PINDOLOL (ANI PHARMS) APPROVAL= AP YEAR= 1993 , NDA 073661 (pdf 73661.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073687 (pdf 73687.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074013 (pdf 74013.pdf not found) INN (PINDOLOL) PINDOLOL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074018 (pdf 74018.pdf not found) INN (PINDOLOL) PINDOLOL (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074019 (pdf 74019.pdf not found) INN (PINDOLOL) PINDOLOL (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 1992 , NDA 074063 (pdf 74063.pdf not found) INN (PINDOLOL) PINDOLOL (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1994 , NDA 074123 (pdf 74123.pdf not found) INN (PINDOLOL) PINDOLOL (COSETTE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074125 (pdf 74125.pdf not found) INN (PINDOLOL) PINDOLOL (PUREPAC PHARM) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074437 (pdf 74437.pdf not found) INN (PINDOLOL) PINDOLOL (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074474 (pdf 74474.pdf not found) INN (PINDOLOL) PINDOLOL (NOSTRUM LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 205415 (pdf 205415.pdf not found) INN (PINDOLOL) PINDOLOL (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 , NDA 209866 (pdf 209866.pdf not found) INN (PINDOLOL) PINDOLOL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 211712 (pdf 211712.pdf not found) INN (PINDOLOL) PINDOLOL (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2019 , 1164 ; CARPROFEN ; 53716-49-7 ; 1987 ; DISCONTINUED ; ; CLASS ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITOR , ; NDA 018550 (pdf 18550.pdf not found) INN (CARPROFEN) RIMADYL (ROCHE) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , 1165 ; SULCONAZOLE ; 61318-90-9 ; 1985 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- CYTOCHROME P450 INHIBITOR , ; NDA 018737 (label 18737.pdf) INN (SULCONAZOLE NITRATE) EXELDERM (JOURNEY) APPROVAL= AP YEAR= 1989 , NDA 018738 (label 18738.pdf) INN (SULCONAZOLE NITRATE) EXELDERM (JOURNEY) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , 1166 ; ECONAZOLE ; 27220-47-9 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- ANTIFUNGAL -- INHIBITORS , ; NDA 018751 (label 18751.pdf) INN (ECONAZOLE NITRATE) SPECTAZOLE (ALVOGEN) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 076005 (label 76005.pdf) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (TARO) APPROVAL= AP YEAR= 2002 , NDA 076075 (label 76075.pdf) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076479 (pdf 76479.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076574 (pdf 76574.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (ENCUBE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 205175 (label 205175.pdf) INN (ECONAZOLE NITRATE) ECOZA (RESILIA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 210364 (pdf 210364.pdf not found) INN (ECONAZOLE NITRATE) ECONAZOLE NITRATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , 1167 ; KETOPROFEN ; 22071-15-4 ; 1986 ; ; ; CLASS MUSCULO-SKELETEL SYSTEM -- NSAID -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- CYCLOOXYGENASE INHIBITORS -- ANTIRHEUMATIC -- ANTIPYRETIC -- ANALGESIC -- INHIBITORY EFFECTS ON PROSTAGLANDIN AND LEUKOTRIENE SYNTHESIS AND ANTIBRADYKININ ACTIVITY , ; NDA 018754 (label 18754.pdf) INN (KETOPROFEN) ORUDIS (WYETH AYERST) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 019816 (label 19816.pdf) INN (KETOPROFEN) ORUVAIL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020429 (pdf 20429.pdf not found) INN (KETOPROFEN) ORUDIS KT (WYETH CONS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020499 (pdf 20499.pdf not found) INN (KETOPROFEN) ACTRON (BAYER) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073515 (pdf 73515.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073516 (pdf 73516.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073517 (pdf 73517.pdf not found) INN (KETOPROFEN) KETOPROFEN (TEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 074014 (pdf 74014.pdf not found) INN (KETOPROFEN) KETOPROFEN (MISEMER) APPROVAL= AP YEAR= 1993 , NDA 074024 (pdf 74024.pdf not found) INN (KETOPROFEN) KETOPROFEN (RISING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074035 (pdf 74035.pdf not found) INN (KETOPROFEN) KETOPROFEN (RISING) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074879 (pdf 74879.pdf not found) INN (KETOPROFEN) KETOPROFEN (ALKERMES GAINESVILLE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075270 (pdf 75270.pdf not found) INN (KETOPROFEN) KETOPROFEN (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075364 (pdf 75364.pdf not found) INN (KETOPROFEN) KETOPROFEN (PERRIGO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075679 (pdf 75679.pdf not found) INN (KETOPROFEN) KETOPROFEN (MYLAN) APPROVAL= AP YEAR= 2002 , NDA 022470 (pdf 22470.pdf not found) INN (KETOPROFEN) NEXCEDE (NOVARTIS) APPROVAL= AP YEAR= 2009 DISCONTINUED , 1168 ; FLURBIPROFEN ; 5104-49-4 ; 1986 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANALGESICS -- NSAID -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- CYCLOOXYGENASE INHIBITORS , ; NDA 018766 (label 18766.pdf) INN (FLURBIPROFEN) ANSAID (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019404 (label 19404.pdf) INN (FLURBIPROFEN SODIUM) OCUFEN (ALLERGAN) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 074358 (pdf 74358.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (MYLAN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074405 (pdf 74405.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (TEVA) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074411 (pdf 74411.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074431 (pdf 74431.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074447 (pdf 74447.pdf not found) INN (FLURBIPROFEN SODIUM) FLURBIPROFEN SODIUM (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 074448 (pdf 74448.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (RISING) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074560 (pdf 74560.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (THERAGEN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074647 (pdf 74647.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (PLIVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075058 (pdf 75058.pdf not found) INN (FLURBIPROFEN) FLURBIPROFEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , 1169 ; FLECAINIDE ; 54143-55-4 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- CARDIAC DEPRESSANT , ; NDA 018830 (label 18830.pdf) INN (FLECAINIDE ACETATE) TAMBOCOR (ALVOGEN) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 075442 (pdf 75442.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (AMNEAL PHARM) APPROVAL= AP YEAR= 2001 , NDA 075882 (pdf 75882.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076030 (pdf 76030.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076278 (pdf 76278.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076421 (pdf 76421.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 , NDA 079164 (pdf 79164.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (CHARTWELL) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 202821 (pdf 202821.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 210683 (pdf 210683.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 215599 (pdf 215599.pdf not found) INN (FLECAINIDE ACETATE) FLECAINIDE ACETATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2022 , 1170 ; NIMODIPINE ; 66085-59-4 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- CALCIUM CHANNEL ANTAGONIST -- ANTIHYPERTENSIVE AGENTS , ; NDA 018869 (label 18869.pdf) INN (NIMODIPINE) NIMOTOP (BAYER PHARMS) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 076740 (pdf 76740.pdf not found) INN (NIMODIPINE) NIMODIPINE (BIONPHARMA) APPROVAL= AP YEAR= 2008 , NDA 077067 (pdf 77067.pdf not found) INN (NIMODIPINE) NIMODIPINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077811 (pdf 77811.pdf not found) INN (NIMODIPINE) NIMODIPINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2007 , NDA 203340 (label 203340.pdf) INN (NIMODIPINE) NYMALIZE (AZURITY) APPROVAL= AP YEAR= 2013 , NDA 090103 (pdf 90103.pdf not found) INN (NIMODIPINE) NIMODIPINE (THEPHARMANETWORK LLC) APPROVAL= AP YEAR= 2014 , NDA 201832 (pdf 201832.pdf not found) INN (NIMODIPINE) NIMODIPINE (SOFGEN PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 213409 (pdf 213409.pdf not found) INN (NIMODIPINE) NIMODIPINE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2023 , 1171 ; MEXILETINE ; 31828-71-4 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- LOCAL ANESTHETIC -- ANTIARRYTHMIC -- SODIUM CHANNEL BLOCKER , ; NDA 018873 (pdf 18873.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXITIL (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY DISCONTINUED , NDA 074377 (pdf 74377.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074450 (pdf 74450.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1996 , NDA 074711 (pdf 74711.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074865 (label 74865.pdf) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 213500 (pdf 213500.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (CROSSMEDIKA SA) APPROVAL= AP YEAR= 2020 , NDA 214352 (pdf 214352.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2021 , NDA 214089 (pdf 214089.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (SENORES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 215315 (pdf 215315.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ZENARA) APPROVAL= AP YEAR= 2022 , NDA 216463 (pdf 216463.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215876 (pdf 215876.pdf not found) INN (MEXILETINE HYDROCHLORIDE) MEXILETINE HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2023 , 1172 ; ACEBUTOLOL ; 37517-30-9 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ANTIARRHYTHMIC -- ADRENERGIC (BETA) BLOCKER , ; NDA 018917 (label 18917.pdf) INN (ACEBUTOLOL HYDROCHLORIDE) SECTRAL (PROMIUS PHARMA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 074007 (pdf 74007.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 1995 , NDA 074288 (pdf 74288.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075047 (pdf 75047.pdf not found) INN (ACEBUTOLOL HYDROCHLORIDE) ACEBUTOLOL HYDROCHLORIDE (AMNEAL PHARM) APPROVAL= AP YEAR= 1999 , 1173 ; ETODOLAC ; 41340-25-4 ; 1991 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- NSAID -- ANTIINFLAMMATORY -- CYCLOOXYGENASE INHIBITORS , ; NDA 018922 (label 18922.pdf) INN (ETODOLAC) LODINE (WYETH PHARMS INC) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020584 (label 20584.pdf) INN (ETODOLAC) LODINE XL (WYETH PHARMS INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074819 (pdf 74819.pdf not found) INN (ETODOLAC) ETODOLAC (OXFORD PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074839 (pdf 74839.pdf not found) INN (ETODOLAC) ETODOLAC (SHREE HARI INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074840 (pdf 74840.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074841 (pdf 74841.pdf not found) INN (ETODOLAC) ETODOLAC (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074842 (pdf 74842.pdf not found) INN (ETODOLAC) ETODOLAC (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074844 (pdf 74844.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074846 (pdf 74846.pdf not found) INN (ETODOLAC) ETODOLAC (SHREE HARI INTL) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074847 (pdf 74847.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 074883 (pdf 74883.pdf not found) INN (ETODOLAC) ETODOLAC (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074892 (pdf 74892.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074899 (pdf 74899.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074903 (pdf 74903.pdf not found) INN (ETODOLAC) ETODOLAC (SANDOZ) APPROVAL= AP YEAR= 1997 , NDA 074927 (pdf 74927.pdf not found) INN (ETODOLAC) ETODOLAC (BIOPHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074929 (label 74929.pdf) INN (ETODOLAC) ETODOLAC (BIOPHARM) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074932 (pdf 74932.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074942 (pdf 74942.pdf not found) INN (ETODOLAC) ETODOLAC (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075009 (pdf 75009.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075012 (pdf 75012.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075069 (pdf 75069.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075071 (pdf 75071.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075074 (pdf 75074.pdf not found) INN (ETODOLAC) ETODOLAC (TARO PHARM INDS) APPROVAL= AP YEAR= 1998 , NDA 075078 (pdf 75078.pdf not found) INN (ETODOLAC) ETODOLAC (TARO) APPROVAL= AP YEAR= 1998 , NDA 075104 (pdf 75104.pdf not found) INN (ETODOLAC) ETODOLAC (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075126 (pdf 75126.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075226 (pdf 75226.pdf not found) INN (ETODOLAC) ETODOLAC (RANBAXY LABS LTD) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075419 (pdf 75419.pdf not found) INN (ETODOLAC) ETODOLAC (APOTEX) APPROVAL= AP YEAR= 2000 , NDA 075665 (pdf 75665.pdf not found) INN (ETODOLAC) ETODOLAC (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075696 (pdf 75696.pdf not found) INN (ETODOLAC) ETODOLAC (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075829 (pdf 75829.pdf not found) INN (ETODOLAC) ETODOLAC (WATSON LABS FLORIDA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075943 (pdf 75943.pdf not found) INN (ETODOLAC) ETODOLAC (ANI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076004 (pdf 76004.pdf not found) INN (ETODOLAC) ETODOLAC (APOTEX INC) APPROVAL= AP YEAR= 2002 , NDA 076174 (pdf 76174.pdf not found) INN (ETODOLAC) ETODOLAC (TARO) APPROVAL= AP YEAR= 2003 , NDA 091134 (pdf 91134.pdf not found) INN (ETODOLAC) ETODOLAC (ZYDUS PHARMS) APPROVAL= AP YEAR= 2014 , NDA 208834 (pdf 208834.pdf not found) INN (ETODOLAC) ETODOLAC (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209888 (pdf 209888.pdf not found) INN (ETODOLAC) ETODOLAC (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210704 (pdf 210704.pdf not found) INN (ETODOLAC) ETODOLAC (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 212263 (pdf 212263.pdf not found) INN (ETODOLAC) ETODOLAC (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 204729 (pdf 204729.pdf not found) INN (ETODOLAC) ETODOLAC (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 1174 ; FLUOXETINE ; 54910-89-3 ; 1987 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) -- INHIBITION OF CNS NEURONAL UPTAKE OF SEROTONIN , ; NDA 018936 (label 18936.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (ELI LILLY AND CO) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 020101 (label 20101.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (LILLY) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 020974 (label 20974.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC (LILLY) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021235 (label 21235.pdf) INN (FLUOXETINE HYDROCHLORIDE) PROZAC WEEKLY (LILLY) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021520 (label 21520.pdf) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) SYMBYAX (LILLY) APPROVAL= AP YEAR= 2003 , NDA 021860 (label 21860.pdf) INN (FLUOXETINE HYDROCHLORIDE) SARAFEM (APIL) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 074803 (label 74803.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075049 (label 75049.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 2001 , NDA 075207 (pdf 75207.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075245 (pdf 75245.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 , NDA 075292 (pdf 75292.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2002 , NDA 075452 (pdf 75452.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075464 (pdf 75464.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LANDELA PHARM) APPROVAL= AP YEAR= 2002 , NDA 075465 (label 75465.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MARKSANS PHARMA) APPROVAL= AP YEAR= 2002 , NDA 075506 (pdf 75506.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2001 , NDA 075514 (pdf 75514.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075525 (pdf 75525.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075577 (pdf 75577.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075658 (pdf 75658.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075662 (pdf 75662.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075690 (pdf 75690.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075755 (label 75755.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075787 (pdf 75787.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075807 (pdf 75807.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BEXIMCO PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075810 (pdf 75810.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075865 (pdf 75865.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075872 (pdf 75872.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075920 (pdf 75920.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BAJAJ) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076001 (pdf 76001.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 , NDA 076006 (pdf 76006.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2002 , NDA 076015 (pdf 76015.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2002 , NDA 076016 (pdf 76016.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE (ESI LEDERLE) APPROVAL= TA YEAR= 2001 OBSOLETE , NDA 076022 (pdf 76022.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CARLSBAD) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076024 (pdf 76024.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076165 (pdf 76165.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CR DOUBLE CRANE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076251 (pdf 76251.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076287 (pdf 76287.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 076458 (pdf 76458.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076922 (pdf 76922.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076990 (pdf 76990.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077469 (pdf 77469.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077528 (pdf 77528.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 077849 (pdf 77849.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2007 , NDA 078045 (pdf 78045.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078143 (pdf 78143.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078619 (pdf 78619.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2008 , NDA 076237 (pdf 76237.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078572 (pdf 78572.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010 , NDA 079209 (pdf 79209.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090223 (pdf 90223.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 202133 (label 202133.pdf) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2011 , NDA 077742 (pdf 77742.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 078901 (pdf 78901.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2012 , NDA 201336 (pdf 201336.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202074 (pdf 202074.pdf not found) INN (FLUOXETINE HYDROCHLORIDE OLANZAPINE) OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 200151 (pdf 200151.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) SELFEMRA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204597 (pdf 204597.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 203836 (pdf 203836.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 206937 (pdf 206937.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 208698 (pdf 208698.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209419 (pdf 209419.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209695 (pdf 209695.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (INVENTIA HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 211051 (pdf 211051.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211477 (pdf 211477.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 206993 (pdf 206993.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 210935 (pdf 210935.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211282 (pdf 211282.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211632 (pdf 211632.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211653 (pdf 211653.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211696 (pdf 211696.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2019 , NDA 211721 (pdf 211721.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 212191 (pdf 212191.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (G AND W LABS INC) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213265 (pdf 213265.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213286 (pdf 213286.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 202729 (pdf 202729.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 216232 (pdf 216232.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 211444 (pdf 211444.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216448 (pdf 216448.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216953 (pdf 216953.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (APTAPHARMA INC) APPROVAL= AP YEAR= 2022 , NDA 212684 (pdf 212684.pdf not found) INN (FLUOXETINE HYDROCHLORIDE) FLUOXETINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2024 , 1175 ; BEPRIDIL ; 64706-54-3 ; 1990 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- VASODILATOR -- ANTIANGINAL -- CALCIUM CHANNEL BLOCKERS , ; NDA 019001 (pdf 19001.pdf not found) INN (BEPRIDIL HYDROCHLORIDE) BEPADIN (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019002 (pdf 19002.pdf not found) INN (BEPRIDIL HYDROCHLORIDE) VASCOR (JOHNSON AND JOHNSON) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 1176 ; TERAZOSIN ; 63590-64-7 ; 1987 ; ; ; CLASS GENITO -- BENIGN PROSTATIC HYPERPLASIA -- ANTIHYPERTENSIVE -- ALPHA-1-SELECTIVE ADRENOCEPTOR BLOCKING AGENT , ; NDA 019057 (label 19057.pdf) INN (TERAZOSIN HYDROCHLORIDE) HYTRIN (ABBOTT) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 020347 (pdf 20347.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) HYTRIN (ABBOTT) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074315 (label 74315.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074446 (label 74446.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074530 (label 74530.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074651 (pdf 74651.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (LEMMON CO) APPROVAL= TA YEAR= 1997 OBSOLETE , NDA 074657 (label 74657.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074823 (pdf 74823.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (APNAR PHARMA LP) APPROVAL= AP YEAR= 1998 , NDA 075140 (label 75140.pdf) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075317 (pdf 75317.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2004 , NDA 075384 (pdf 75384.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075498 (pdf 75498.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075614 (pdf 75614.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2001 , NDA 075667 (pdf 75667.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2000 , NDA 076021 (pdf 76021.pdf not found) INN (TERAZOSIN HYDROCHLORIDE) TERAZOSIN HYDROCHLORIDE (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2002 DISCONTINUED , 1177 ; IPRATROPIUM ; 60205-81-4 ; 1986 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- ANTICHOLINERGIC (PARASYMPATHOLYTIC) -- CHOLINERGIC ANTAGONISTS , ; NDA 019085 (pdf 19085.pdf not found) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 020228 (pdf 20228.pdf not found) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 020291 (label 20291.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020393 (label 20393.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020394 (label 20394.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020950 (label 20950.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) DUONEB (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021527 (label 21527.pdf) INN (IPRATROPIUM BROMIDE) ATROVENT HFA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2004 , NDA 074755 (label 74755.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075111 (label 75111.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075313 (label 75313.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075441 (pdf 75441.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075507 (pdf 75507.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ZENNOVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075552 (pdf 75552.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075553 (pdf 75553.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075562 (pdf 75562.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (NEPHRON) APPROVAL= AP YEAR= 2001 , NDA 075693 (pdf 75693.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2001 , NDA 075835 (pdf 75835.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075867 (pdf 75867.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (ROXANE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076025 (pdf 76025.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 076103 (label 76103.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (BAUSCH) APPROVAL= AP YEAR= 2003 , NDA 076155 (pdf 76155.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2003 , NDA 076156 (pdf 76156.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2003 , NDA 076291 (pdf 76291.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (WATSON LABS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076598 (pdf 76598.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076664 (pdf 76664.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 076724 (pdf 76724.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076749 (pdf 76749.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (NEPHRON) APPROVAL= AP YEAR= 2007 , NDA 076867 (label 76867.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077063 (pdf 77063.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077072 (pdf 77072.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (LANDELA PHARM) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077117 (pdf 77117.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077559 (pdf 77559.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 021747 (label 21747.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2011 , NDA 202496 (pdf 202496.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2012 , NDA 206543 (pdf 206543.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2016 , NDA 207875 (pdf 207875.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 207903 (pdf 207903.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 206532 (pdf 206532.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 215104 (label 215104.pdf) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215105 (pdf 215105.pdf not found) INN (IPRATROPIUM BROMIDE) IPRATROPIUM BROMIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , 1178 ; PROPAFENONE ; 54063-53-5 ; 1989 ; ; ; CLASS CARDIOVASCULAR -- CLASS 1C ANTIARRHYTHMIC -- CHANNEL BLOCKER , ; NDA 019151 (label 19151.pdf) INN (PROPAFENONE HYDROCHLORIDE) RYTHMOL (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 021416 (label 21416.pdf) INN (PROPAFENONE HYDROCHLORIDE) RYTHMOL SR (GLAXOSMITHKLINE LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075203 (label 75203.pdf) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2000 , NDA 075938 (pdf 75938.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2002 , NDA 075998 (pdf 75998.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2001 , NDA 076193 (pdf 76193.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076550 (pdf 76550.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2004 , NDA 078540 (pdf 78540.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 , NDA 202688 (label 202688.pdf) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2015 , NDA 202445 (pdf 202445.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203803 (pdf 203803.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205268 (pdf 205268.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 205956 (pdf 205956.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 , NDA 210339 (pdf 210339.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2019 , NDA 212744 (pdf 212744.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2020 , NDA 212928 (pdf 212928.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214184 (pdf 214184.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 213096 (pdf 213096.pdf not found) INN (PROPAFENONE HYDROCHLORIDE) PROPAFENONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , 1179 ; METHACHOLINE ; 55-92-5 ; 1986 ; ; ; CLASS BRONCHOCONSTRICTOR AGENT -- RESPIRATORY SYSTEM -- CHOLINERGIC -- INHALATION DIAGNOSTIC CHALLENGE (SUBJECT WITH ASTHM ARE MORE SENSITIVE THAN HEALTHY SUBJECTS) -- MORE SLOWLY HYDROLYZED BY ACETYLCHOLINESTERASES THAN ACETYLCHOLINE -- ACETYLCHOLINE ANALOG THAT INDUCES BRONCHOCONSTRICTION , ; NDA 019193 (label 19193.pdf) INN (METHACHOLINE CHLORIDE) PROVOCHOLINE (METHAPHARM) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , 1180 ; CARTEOLOL ; 51781-06-7 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC (BETA) BLOCKER -- ANTI-ARRHYTHMIA AGENTS -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS -- LOWERING INTRAOCULAR PRESSURE AND MAY BE USED IN PATIENTS WITH CHRONIC OPEN-ANGLE GLAUCOMA AND INTRAOCULAR HYPERTENSION. , ; NDA 019204 (pdf 19204.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTROL (ABBVIE) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY DISCONTINUED , NDA 019972 (pdf 19972.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) OCUPRESS (NOVARTIS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 075476 (pdf 75476.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2000 , NDA 075546 (pdf 75546.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076097 (pdf 76097.pdf not found) INN (CARTEOLOL HYDROCHLORIDE) CARTEOLOL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , 1181 ; BETAXOLOL ; 63659-18-7 ; 1985 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC BETA ANTAGONISTS -- EENT DRUGS -- SYMPATHOLYTICS -- INTRAOCULAR PRESSURE AND IS INDICATED IN THE TREATMENT OF OCULAR HYPERTENSION AND CHRONIC OPEN-ANGLE GLAUCOMA. , ; NDA 019270 (label 19270.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETOPTIC (SANDOZ) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 019507 (label 19507.pdf) INN (BETAXOLOL HYDROCHLORIDE) KERLONE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 019807 (label 19807.pdf) INN (BETAXOLOL HYDROCHLORIDE CHLORTHALIDONE) KERLEDEX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019845 (label 19845.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETOPTIC S (NOVARTIS) APPROVAL= AP YEAR= 1989 , NDA 020619 (pdf 20619.pdf not found) INN (BETAXOLOL HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE) BETOPTIC PILO (ALCON) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075386 (pdf 75386.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (AKORN) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075446 (pdf 75446.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075541 (label 75541.pdf) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (EPIC PHARMA) APPROVAL= AP YEAR= 1999 , NDA 075630 (pdf 75630.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (MEDIMETRIKS PHARMS) APPROVAL= AP YEAR= 2001 , NDA 078962 (pdf 78962.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2008 , NDA 078694 (pdf 78694.pdf not found) INN (BETAXOLOL HYDROCHLORIDE) BETAXOLOL HYDROCHLORIDE (ACELLA) APPROVAL= AP YEAR= 2009 , 1182 ; ESMOLOL ; 81147-92-4 ; 1986 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC (BETA-1) SELECTIVE BLOCKER -- ADRENERGIC BETA-ANTAGONISTS , ; NDA 019386 (label 19386.pdf) INN (ESMOLOL HYDROCHLORIDE) BREVIBLOC (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY , NDA 073323 (pdf 73323.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 073326 (pdf 73326.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076323 (pdf 76323.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 076326 (pdf 76326.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (BEDFORD LABS) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076456 (pdf 76456.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (PHARMAFORCE) APPROVAL= TA YEAR= 2003 OBSOLETE , NDA 076474 (pdf 76474.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2005 , NDA 076573 (pdf 76573.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 205703 (label 205703.pdf) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2016 , NDA 201126 (pdf 201126.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205520 (pdf 205520.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 208538 (pdf 208538.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 206608 (pdf 206608.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 207107 (pdf 207107.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 216244 (pdf 216244.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 214172 (pdf 214172.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (HQ SPCLT PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216603 (pdf 216603.pdf not found) INN (ESMOLOL HYDROCHLORIDE) ESMOLOL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2022 , 1183 ; SUPROFEN ; 40828-46-4 ; 1988 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIINFLAMMATORY -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS , ; NDA 019387 (pdf 19387.pdf not found) INN (SUPROFEN) PROFENAL (ALCON) APPROVAL= AP YEAR= 1988 DISCONTINUED , 1184 ; RIMANTADINE ; 13392-28-4 ; 1993 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI INFLUENZA A -- RESISTANCE OBSERVED -- CHANNEL BLOCKER , ; NDA 019649 (label 19649.pdf) INN (RIMANTADINE HYDROCHLORIDE) FLUMADINE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 019650 (label 19650.pdf) INN (RIMANTADINE HYDROCHLORIDE) FLUMADINE (FOREST LABS) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 075916 (pdf 75916.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076132 (pdf 76132.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2002 , NDA 076375 (pdf 76375.pdf not found) INN (RIMANTADINE HYDROCHLORIDE) RIMANTADINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 DISCONTINUED , 1185 ; EVEROLIMUS ; 159351-69-6 ; 2009 ; ; ; CLASS ANTINEOPLASTIC -- INHIBITOR OF SERINE-THREONINE KINASE MTOR (MAMMALIAN TARGET OF RAPAMYCIN) DOWNSTREAM OF THE PI3K/AKT PATHWAY BY BINDING TO FKBP-12 -- ADVANCED PANCREATIC NEUROENDOCRINE TUMORS -- IMMUNOSUPPRESSANT -- PROPHYLAXIS OF ORGAN REJECTION -- TREATMENT OF RENAL ANGIOMYOLIPOMA ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX AND TREATMENT OF SUBEPENDYMAL GIANT CELL ASTROCYTOMA ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 022334 (label 22334.pdf) INN (EVEROLIMUS) AFINITOR (NOVARTIS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 021560 (label 21560.pdf) INN (EVEROLIMUS) ZORTRESS (NOVARTIS) APPROVAL= AP YEAR= 2010 , NDA 203985 (label 203985.pdf) INN (EVEROLIMUS) AFINITOR DISPERZ (NOVARTIS PHARM) APPROVAL= AP YEAR= 2012 , NDA 207486 (pdf 207486.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 206133 (pdf 206133.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (HIKMA) APPROVAL= AP YEAR= 2018 , NDA 210130 (pdf 210130.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 207934 (pdf 207934.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 210050 (pdf 210050.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 212936 (pdf 212936.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 205426 (pdf 205426.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 , NDA 205432 (pdf 205432.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 , NDA 214182 (pdf 214182.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (BIOCON PHARMA) APPROVAL= AP YEAR= 2021 , NDA 205775 (pdf 205775.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 , NDA 214138 (pdf 214138.pdf not found) INN (EVEROLIMUS) EVEROLIMUS (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , 1186 ; AMLODIPINE ; 88150-42-9 ; 1992 ; ; ; CLASS CARDIVASCULAR -- CALCIUM CHANNEL BLOCKER -- ANTIANGINALS -- ANTIHYPERTENSIVE AGENTS -- VASODILATOR AGENTS -- PYRIDINE CALCIUM ANTAGONIST (CALCIUM ION ANTAGONIST OR SLOW-CHANNEL BLOCKER) , ; NDA 019787 (label 19787.pdf) INN (AMLODIPINE BESYLATE) NORVASC (VIATRIS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020364 (label 20364.pdf) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) LOTREL (SANDOZ) APPROVAL= AP YEAR= 1995 , NDA 021435 (pdf 21435.pdf not found) INN (AMLODIPINE MALEATE) AMVAZ (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021540 (label 21540.pdf) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) CADUET (PHARMACIA) APPROVAL= AP YEAR= 2004 , NDA 021714 (pdf 21714.pdf not found) INN (AMLODIPINE MALEATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE MALEATE BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2006 , NDA 021990 (label 21990.pdf) INN (AMLODIPINE BESYLATE VALSARTAN) EXFORGE (NOVARTIS) APPROVAL= AP YEAR= 2007 , NDA 022026 (label 22026.pdf) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022100 (label 22100.pdf) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AZOR (COSETTE) APPROVAL= AP YEAR= 2007 , NDA 076418 (pdf 76418.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076692 (pdf 76692.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 076719 (pdf 76719.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (COREPHARMA) APPROVAL= AP YEAR= 2007 , NDA 076846 (pdf 76846.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (TEVA) APPROVAL= AP YEAR= 2007 , NDA 076859 (pdf 76859.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077073 (pdf 77073.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 077080 (pdf 77080.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077179 (pdf 77179.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077215 (pdf 77215.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 077262 (pdf 77262.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077333 (pdf 77333.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (GEDEON RICHTER USA) APPROVAL= TA YEAR= 2007 , NDA 077362 (pdf 77362.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (GENPHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077375 (pdf 77375.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077516 (pdf 77516.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2007 , NDA 077671 (pdf 77671.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (WATSON LABS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077759 (pdf 77759.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (AIPING PHARM INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077955 (pdf 77955.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077974 (pdf 77974.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078021 (pdf 78021.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078043 (pdf 78043.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 078081 (pdf 78081.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078131 (pdf 78131.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (PURACAP PHARM) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078224 (pdf 78224.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078226 (pdf 78226.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 078231 (pdf 78231.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078381 (pdf 78381.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078477 (pdf 78477.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078500 (pdf 78500.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078573 (pdf 78573.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (TORRENT PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022314 (label 22314.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) EXFORGE HCT (NOVARTIS) APPROVAL= AP YEAR= 2009 , NDA 022401 (label 22401.pdf) INN (AMLODIPINE BESYLATE TELMISARTAN) TWYNSTA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077183 (pdf 77183.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2010 , NDA 078414 (pdf 78414.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (OXFORD PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078453 (pdf 78453.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ORBION PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078466 (pdf 78466.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (LUPIN PHARMS) APPROVAL= AP YEAR= 2010 , NDA 078552 (pdf 78552.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2009 , NDA 078925 (pdf 78925.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ALKEM) APPROVAL= AP YEAR= 2009 , NDA 079047 (pdf 79047.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090011 (pdf 90011.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (STRIDES PHARMA) APPROVAL= AP YEAR= 2013 , NDA 090144 (pdf 90144.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE AND VALSARTAN (PAR PHARM INC) APPROVAL= AP YEAR= 2010 OBSOLETE , NDA 090364 (pdf 90364.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2011 , NDA 090483 (pdf 90483.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 022545 (label 22545.pdf) INN (ALISKIREN HEMIFUMARATE AMLODIPINE BESYLATE) TEKAMLO (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077890 (pdf 77890.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2010 , NDA 200175 (label 200175.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) TRIBENZOR (COSETTE) APPROVAL= AP YEAR= 2010 , NDA 200045 (label 200045.pdf) INN (ALISKIREN HEMIFUMARATE AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE) AMTURNIDE (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 077771 (pdf 77771.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090149 (pdf 90149.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2011 , NDA 090398 (pdf 90398.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 090752 (pdf 90752.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (CHINA RESOURCES) APPROVAL= AP YEAR= 2011 , NDA 200435 (pdf 200435.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201380 (pdf 201380.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202239 (pdf 202239.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 078652 (pdf 78652.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2013 , NDA 090245 (pdf 90245.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (LUPIN) APPROVAL= AP YEAR= 2015 , NDA 091431 (pdf 91431.pdf not found) INN (AMLODIPINE BESYLATE BENAZEPRIL HYDROCHLORIDE) AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2013 , NDA 200465 (pdf 200465.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (MYLAN) APPROVAL= AP YEAR= 2013 , NDA 200797 (pdf 200797.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 201087 (pdf 201087.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 , NDA 201586 (pdf 201586.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (LUPIN LTD) APPROVAL= AP YEAR= 2014 , NDA 202553 (pdf 202553.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 , NDA 203245 (pdf 203245.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (UNICHEM) APPROVAL= AP YEAR= 2013 , NDA 091235 (pdf 91235.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201593 (pdf 201593.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202377 (pdf 202377.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202516 (pdf 202516.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (MYLAN) APPROVAL= AP YEAR= 2014 , NDA 202517 (pdf 202517.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (TORRENT) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203874 (pdf 203874.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 202713 (pdf 202713.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 202829 (pdf 202829.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 202933 (pdf 202933.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TORRENT) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204900 (pdf 204900.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205003 (label 205003.pdf) INN (AMLODIPINE BESYLATE PERINDOPRIL ARGININE) PRESTALIA (ADHERA) APPROVAL= AP YEAR= 2015 , NDA 091154 (pdf 91154.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206367 (pdf 206367.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206884 (pdf 206884.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 202491 (pdf 202491.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 206512 (pdf 206512.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 203580 (pdf 203580.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 205137 (pdf 205137.pdf not found) INN (AMLODIPINE BESYLATE VALSARTAN) AMLODIPINE BESYLATE AND VALSARTAN (HETERO LABS) APPROVAL= AP YEAR= 2016 , NDA 205234 (pdf 205234.pdf not found) INN (AMLODIPINE BESYLATE TELMISARTAN) TELMISARTAN AND AMLODIPINE (ALEMBIC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206137 (label 206137.pdf) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL) OLMESARTAN MEDOXOMIL , AMLODIPINE AND HYDROCHLOROTHIAZIDE (PAR PHARM INC) APPROVAL= AP YEAR= 2016 , NDA 207216 (pdf 207216.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 207821 (pdf 207821.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (POLYGEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206906 (pdf 206906.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207073 (pdf 207073.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 207450 (pdf 207450.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (JUBILANT GENERICS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207807 (pdf 207807.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 209042 (pdf 209042.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 206180 (pdf 206180.pdf not found) INN (AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE VALSARTAN) AMLODIPINE BESYLATE , VALSARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 207435 (pdf 207435.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (MICRO LABS) APPROVAL= AP YEAR= 2017 , NDA 207771 (pdf 207771.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206524 (pdf 206524.pdf not found) INN (AMLODIPINE BESYLATE) AMLODIPINE BESYLATE (SUNSHINE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210045 (label 210045.pdf) INN (AMLODIPINE BESYLATE CELECOXIB) CONSENSI (PURPLE BIOTECH) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209010 (pdf 209010.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 209600 (pdf 209600.pdf not found) INN (AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL) AMLODIPINE AND OLMESARTAN MEDOXOMIL (ACCORD HLTHCARE INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207762 (pdf 207762.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 205199 (pdf 205199.pdf not found) INN (AMLODIPINE BESYLATE ATORVASTATIN CALCIUM) AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 211340 (label 211340.pdf) INN (AMLODIPINE BENZOATE) KATERZIA (AZURITY) APPROVAL= AP YEAR= 2019 , NDA 214439 (label 214439.pdf) INN (AMLODIPINE BESYLATE) NORLIQVA (CMP DEV LLC) APPROVAL= AP YEAR= 2022 , NDA 215035 (pdf 215035.pdf not found) INN (AMLODIPINE BENZOATE) AMLODIPINE BENZOATE (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1187 ; MIDODRINE ; 42794-76-3 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- VASOCONSTRICTOR -- ADRENERGIC ALPHA-AGONISTS -- SYMPATHOMIMETICS , ; NDA 019815 (label 19815.pdf) INN (MIDODRINE HYDROCHLORIDE) PROAMATINE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , NDA 076449 (pdf 76449.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2004 , NDA 076514 (pdf 76514.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076577 (pdf 76577.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2003 , NDA 076725 (pdf 76725.pdf not found) INN (MIDODRINE HYDROCHLORIDE) ORVATEN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2004 , NDA 077746 (pdf 77746.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2006 , NDA 207169 (pdf 207169.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2018 , NDA 207613 (pdf 207613.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (THINQ PHARM-CRO PVT) APPROVAL= AP YEAR= 2018 , NDA 212543 (pdf 212543.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 207849 (pdf 207849.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (XIROMED) APPROVAL= AP YEAR= 2020 , NDA 212774 (pdf 212774.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 213055 (pdf 213055.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 214734 (pdf 214734.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 211973 (pdf 211973.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (NOVUGEN) APPROVAL= AP YEAR= 2023 , NDA 217271 (pdf 217271.pdf not found) INN (MIDODRINE HYDROCHLORIDE) MIDODRINE HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , 1188 ; FELODIPINE ; 72509-76-3 ; 1991 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ANTIHYPERTENSIVE -- ANTI-ARRHYTHMIA AGENTS -- CALCIUM CHANNEL BLOCKERS -- DIHYDROPYRIDINES -- S ENANTIOMER MORE ACTIVE , ; NDA 019834 (label 19834.pdf) INN (FELODIPINE) PLENDIL (ASTRAZENECA) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020668 (label 20668.pdf) INN (ENALAPRIL MALEATE FELODIPINE) LEXXEL (ASTRAZENECA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 075896 (pdf 75896.pdf not found) INN (FELODIPINE) FELODIPINE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 078855 (pdf 78855.pdf not found) INN (FELODIPINE) FELODIPINE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 090365 (pdf 90365.pdf not found) INN (FELODIPINE) FELODIPINE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 200815 (pdf 200815.pdf not found) INN (FELODIPINE) FELODIPINE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2011 , NDA 202170 (pdf 202170.pdf not found) INN (FELODIPINE) FELODIPINE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 091484 (pdf 91484.pdf not found) INN (FELODIPINE) FELODIPINE (WOCKHARDT) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091200 (pdf 91200.pdf not found) INN (FELODIPINE) FELODIPINE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 201964 (pdf 201964.pdf not found) INN (FELODIPINE) FELODIPINE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2013 , NDA 203417 (pdf 203417.pdf not found) INN (FELODIPINE) FELODIPINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203032 (pdf 203032.pdf not found) INN (FELODIPINE) FELODIPINE (ORBION PHARMS) APPROVAL= AP YEAR= 2015 , NDA 203983 (pdf 203983.pdf not found) INN (FELODIPINE) FELODIPINE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 210847 (pdf 210847.pdf not found) INN (FELODIPINE) FELODIPINE (YILING) APPROVAL= AP YEAR= 2018 , NDA 204800 (pdf 204800.pdf not found) INN (FELODIPINE) FELODIPINE (YUNG SHIN PHARM) APPROVAL= AP YEAR= 2019 , 1189 ; LEVOCETIRIZINE ; 83881-52-1 ; 1995 ; ; ; CLASS RESPIRATORY -- H1 HISTAMINE ANTAGONIST -- ANTIHISTAMINE -- ANTIALLERGIC -- SEASONAL ALLERGIC RHINITIS , ; NDA 019835 (label 19835.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC ALLERGY (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 020346 (label 20346.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC (MCNEIL CONSUMER) APPROVAL= AP YEAR= 1996 , NDA 021150 (label 21150.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC-D 12 HOUR (MCNEIL) APPROVAL= AP YEAR= 2001 , NDA 021621 (label 21621.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S ZYRTEC ALLERGY (PFIZER) APPROVAL= AP YEAR= 2004 , NDA 022155 (label 22155.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S ZYRTEC HIVES RELIEF (MCNEIL CONSUMER) APPROVAL= AP YEAR= 2007 , NDA 076047 (label 76047.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CONTRACT PHARMA) APPROVAL= AP YEAR= 2004 , NDA 076581 (pdf 76581.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TEVA) APPROVAL= TA YEAR= 2004 OBSOLETE , NDA 076601 (pdf 76601.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2006 , NDA 076677 (label 76677.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (MYLAN) APPROVAL= AP YEAR= 2007 , NDA 077170 (label 77170.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077279 (pdf 77279.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077318 (pdf 77318.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (CIPLA LIMITED) APPROVAL= TA YEAR= 2007 , NDA 077472 (pdf 77472.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (RANBAXY) APPROVAL= AP YEAR= 2006 , NDA 077498 (label 77498.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (RANBAXY) APPROVAL= AP YEAR= 2007 , NDA 077499 (label 77499.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CARACO) APPROVAL= AP YEAR= 2007 , NDA 077631 (label 77631.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CARACO) APPROVAL= AP YEAR= 2007 , NDA 077946 (label 77946.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077991 (pdf 77991.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 078317 (label 78317.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 078336 (label 78336.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (PERRIGO R AND D) APPROVAL= AP YEAR= 2007 , NDA 078343 (label 78343.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 078398 (pdf 78398.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (PERRIGO ISRAEL) APPROVAL= AP YEAR= 2008 , NDA 078412 (pdf 78412.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 078427 (label 78427.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (WOCKHARDT) APPROVAL= AP YEAR= 2007 , NDA 078615 (label 78615.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2007 , NDA 078692 (pdf 78692.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 090182 (pdf 90182.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (TARO) APPROVAL= AP YEAR= 2008 , NDA 090183 (pdf 90183.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (RANBAXY) APPROVAL= AP YEAR= 2008 , NDA 090188 (pdf 90188.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (APOTEX) APPROVAL= AP YEAR= 0 , NDA 090254 (pdf 90254.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 , NDA 090378 (pdf 90378.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2008 , NDA 022064 (label 22064.pdf) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) XYZAL (CHATTEM SANOFI) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022157 (label 22157.pdf) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) XYZAL (CHATTEM SANOFI) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022429 (label 22429.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (BANNER PHARMACAPS) APPROVAL= AP YEAR= 2009 , NDA 077829 (pdf 77829.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (UNIQUE PHARM LABS) APPROVAL= AP YEAR= 2009 , NDA 078072 (pdf 78072.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2009 , NDA 078488 (pdf 78488.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (CYPRESS PHARM) APPROVAL= AP YEAR= 2008 , NDA 078496 (pdf 78496.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (VINTAGE) APPROVAL= AP YEAR= 2009 , NDA 078617 (pdf 78617.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2010 , NDA 078680 (pdf 78680.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (UNICHEM) APPROVAL= AP YEAR= 2009 , NDA 078757 (pdf 78757.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2009 , NDA 078780 (pdf 78780.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2010 , NDA 078862 (pdf 78862.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 078870 (pdf 78870.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 079191 (pdf 79191.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (TORRENT PHARMS LLC) APPROVAL= AP YEAR= 2010 , NDA 090191 (pdf 90191.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2009 , NDA 090300 (pdf 90300.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (CYPRESS PHARM) APPROVAL= AP YEAR= 2008 , NDA 090474 (pdf 90474.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 090750 (pdf 90750.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 090751 (pdf 90751.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 090765 (pdf 90765.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090766 (pdf 90766.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 022578 (label 22578.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZYRTEC ALLERGY (MCNEIL CONSUMER) APPROVAL= AP YEAR= 2010 , NDA 078933 (pdf 78933.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CADISTA PHARMS) APPROVAL= AP YEAR= 2010 , NDA 090229 (pdf 90229.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091130 (pdf 91130.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (SILARX) APPROVAL= AP YEAR= 2011 , NDA 201546 (pdf 201546.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (TARO) APPROVAL= AP YEAR= 2011 , NDA 090385 (pdf 90385.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2011 , NDA 090392 (pdf 90392.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 091263 (pdf 91263.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2011 , NDA 090142 (pdf 90142.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2011 , NDA 091327 (pdf 91327.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2011 , NDA 090199 (pdf 90199.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2011 , NDA 078876 (pdf 78876.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (SILARX) APPROVAL= AP YEAR= 2012 , NDA 090572 (pdf 90572.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (TRIS PHARMA INC) APPROVAL= AP YEAR= 2012 , NDA 090922 (pdf 90922.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012 , NDA 204226 (pdf 204226.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (PERRIGO R AND D) APPROVAL= AP YEAR= 2013 , NDA 202277 (pdf 202277.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE HIVES (IPCA LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 091116 (pdf 91116.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 , NDA 091264 (pdf 91264.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2012 , NDA 090362 (pdf 90362.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2013 , NDA 090486 (pdf 90486.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202046 (pdf 202046.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2013 , NDA 202673 (pdf 202673.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2013 , NDA 202915 (pdf 202915.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203646 (pdf 203646.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 201653 (pdf 201653.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203027 (pdf 203027.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090760 (pdf 90760.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 205490 (label 205490.pdf) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (PAR PHARM INC) APPROVAL= AP YEAR= 2015 , NDA 206793 (pdf 206793.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205564 (pdf 205564.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 207235 (pdf 207235.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (APOTEX INC) APPROVAL= AP YEAR= 2016 , NDA 205291 (pdf 205291.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208694 (label 208694.pdf) INN (CETIRIZINE HYDROCHLORIDE) ZERVIATE (NICOX OPHTHALMICS) APPROVAL= AP YEAR= 2017 , NDA 204323 (pdf 204323.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (US ANTIBIOTICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204599 (pdf 204599.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2017 , NDA 209089 (label 209089.pdf) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) XYZAL ALLERGY 24HR (CHATTEM SANOFI) APPROVAL= AP YEAR= 2017 , NDA 209090 (label 209090.pdf) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) XYZAL ALLERGY 24HR (CHATTEM SANOFI) APPROVAL= AP YEAR= 2017 , NDA 209274 (pdf 209274.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY () APPROVAL= AP YEAR= 2017 , NDA 210375 (pdf 210375.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 209107 (pdf 209107.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210719 (pdf 210719.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018 , NDA 210622 (pdf 210622.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 212266 (label 212266.pdf) INN (CETIRIZINE HYDROCHLORIDE) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (QUAGEN) APPROVAL= AP YEAR= 2019 , NDA 211528 (pdf 211528.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (APOTEX INC) APPROVAL= TA YEAR= 2018 , NDA 211551 (pdf 211551.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2018 , NDA 210914 (pdf 210914.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE HYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019 , NDA 211983 (pdf 211983.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2019 , NDA 211415 (label 211415.pdf) INN (CETIRIZINE HYDROCHLORIDE) QUZYTTIR (JDP) APPROVAL= AP YEAR= 2019 , NDA 213513 (pdf 213513.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 213105 (pdf 213105.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE ALLERGY (CATALENT) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213557 (pdf 213557.pdf not found) INN (CETIRIZINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 211443 (pdf 211443.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 212409 (pdf 212409.pdf not found) INN (CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 204626 (pdf 204626.pdf not found) INN (LEVOCETIRIZINE DIHYDROCHLORIDE) LEVOCETIRIZINE DIHYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 1190 ; METIPRANOLOL ; 22664-55-7 ; 1989 ; DISCONTINUED ; ; CLASS SENSORY -- NON-SELECTIVE BETA-ADRENERGIC RECEPTOR ANTAGONIST -- ANTIHYPERTENSIVE AGENTS -- GLAUCOMA , ; NDA 019907 (pdf 19907.pdf not found) INN (METIPRANOLOL HYDROCHLORIDE) OPTIPRANOLOL (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY DISCONTINUED , NDA 075720 (pdf 75720.pdf not found) INN (METIPRANOLOL HYDROCHLORIDE) METIPRANOLOL (SANDOZ) APPROVAL= AP YEAR= 2001 DISCONTINUED , 1191 ; BISOPROLOL ; 66722-44-9 ; 1992 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC BETA-1 ANTAGONIST -- SYMPATHOLYTICS -- ADRENERGIC BETA-2 INVERSE AGONIST , ; NDA 019982 (label 19982.pdf) INN (BISOPROLOL FUMARATE) ZEBETA (TEVA WOMENS) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , NDA 020186 (label 20186.pdf) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) ZIAC (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 1993 , NDA 075469 (pdf 75469.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075474 (pdf 75474.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (UNITED RES LABS) APPROVAL= AP YEAR= 2002 , NDA 075527 (pdf 75527.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075579 (pdf 75579.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2000 , NDA 075632 (pdf 75632.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075642 (pdf 75642.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (APOTHECON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075643 (pdf 75643.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (RUBICON) APPROVAL= AP YEAR= 2000 , NDA 075644 (pdf 75644.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (TEVA PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075672 (pdf 75672.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075686 (pdf 75686.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075768 (pdf 75768.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2000 , NDA 075831 (pdf 75831.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (DASH PHARMS NATCO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077910 (pdf 77910.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078635 (pdf 78635.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (UNICHEM) APPROVAL= AP YEAR= 2009 , NDA 079106 (pdf 79106.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2010 , NDA 204891 (pdf 204891.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 212678 (pdf 212678.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 215562 (pdf 215562.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215563 (pdf 215563.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215995 (pdf 215995.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 215666 (pdf 215666.pdf not found) INN (BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE) BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (CADILA) APPROVAL= AP YEAR= 2022 , NDA 215680 (pdf 215680.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 217368 (pdf 217368.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 217617 (pdf 217617.pdf not found) INN (BISOPROLOL FUMARATE) BISOPROLOL FUMARATE (HARMAN FINOCHEM) APPROVAL= AP YEAR= 2024 , 1192 ; ONDANSETRON ; 99614-02-5 ; 1991 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- 5-HT3 ANTAGONIST , ; NDA 020007 (label 20007.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020103 (label 20103.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020403 (label 20403.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 020605 (label 20605.pdf) INN (ONDANSETRON HYDROCHLORIDE) ZOFRAN (SANDOZ) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020781 (label 20781.pdf) INN (ONDANSETRON) ZOFRAN ODT (SANDOZ) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021915 (label 21915.pdf) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 076183 (pdf 76183.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 , NDA 076252 (pdf 76252.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076506 (pdf 76506.pdf not found) INN (ONDANSETRON) ONDANSETRON (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2006 DISCONTINUED OBSOLETE , NDA 076559 (pdf 76559.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 076693 (pdf 76693.pdf not found) INN (ONDANSETRON) ONDANSETRON (BARR) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076695 (pdf 76695.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= TA YEAR= 2004 , NDA 076696 (pdf 76696.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= TA YEAR= 2004 , NDA 076759 (pdf 76759.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076780 (pdf 76780.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076781 (pdf 76781.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2006 , NDA 076810 (pdf 76810.pdf not found) INN (ONDANSETRON) ONDANSETRON (TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076876 (pdf 76876.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 076930 (pdf 76930.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076960 (pdf 76960.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076967 (pdf 76967.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 076972 (pdf 76972.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 076974 (pdf 76974.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 076978 (pdf 76978.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077009 (pdf 77009.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077011 (pdf 77011.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077050 (pdf 77050.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2007 , NDA 077112 (pdf 77112.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077172 (pdf 77172.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SUN PHARM INDS (IN)) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077173 (pdf 77173.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077303 (pdf 77303.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2007 , NDA 077306 (pdf 77306.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2007 , NDA 077343 (pdf 77343.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077348 (pdf 77348.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 077365 (pdf 77365.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077368 (pdf 77368.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (APOTEX INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077387 (pdf 77387.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (AM REGENT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077406 (pdf 77406.pdf not found) INN (ONDANSETRON) ONDANSETRON (CHARTWELL MOLECULES) APPROVAL= AP YEAR= 2006 , NDA 077430 (pdf 77430.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077473 (pdf 77473.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 077480 (pdf 77480.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (TEVA PHARMS) APPROVAL= AP YEAR= 2006 OBSOLETE , NDA 077517 (pdf 77517.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077535 (pdf 77535.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 077541 (pdf 77541.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HIKMA) APPROVAL= AP YEAR= 2006 , NDA 077544 (pdf 77544.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077545 (pdf 77545.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HIKMA INTL PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077548 (pdf 77548.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 2006 , NDA 077551 (pdf 77551.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 077557 (pdf 77557.pdf not found) INN (ONDANSETRON) ONDANSETRON (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 , NDA 077577 (pdf 77577.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2006 , NDA 077582 (pdf 77582.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077716 (pdf 77716.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (WOCKHARDT) APPROVAL= AP YEAR= 2006 , NDA 077717 (pdf 77717.pdf not found) INN (ONDANSETRON) ONDANSETRON (NESHER PHARMS) APPROVAL= TA YEAR= 2007 , NDA 077729 (pdf 77729.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077840 (pdf 77840.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077851 (pdf 77851.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2007 , NDA 078014 (pdf 78014.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (TARO PHARMS IRELAND) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078050 (pdf 78050.pdf not found) INN (ONDANSETRON) ONDANSETRON (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 078127 (pdf 78127.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078139 (pdf 78139.pdf not found) INN (ONDANSETRON) ONDANSETRON (MYLAN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078152 (pdf 78152.pdf not found) INN (ONDANSETRON) ONDANSETRON (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078180 (pdf 78180.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (SAGENT PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078244 (pdf 78244.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (STERISCIENCE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078257 (pdf 78257.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078308 (pdf 78308.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (CLARIS LIFESCIENCES) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 078539 (pdf 78539.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078776 (pdf 78776.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078291 (pdf 78291.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER (BEDFORD LABS) APPROVAL= AP YEAR= 2009 OBSOLETE , NDA 079032 (pdf 79032.pdf not found) INN (ONDANSETRON) ONDANSETRON (AM REGENT) APPROVAL= AP YEAR= 2008 , NDA 079039 (pdf 79039.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (LUITPOLD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079224 (pdf 79224.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2009 , NDA 090116 (pdf 90116.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090424 (pdf 90424.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090469 (pdf 90469.pdf not found) INN (ONDANSETRON) ONDANSETRON (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2010 , NDA 022524 (label 22524.pdf) INN (ONDANSETRON) ZUPLENZ (AQUESTIVE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090883 (pdf 90883.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078602 (pdf 78602.pdf not found) INN (ONDANSETRON) ONDANSETRON (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091342 (pdf 91342.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 , NDA 091483 (pdf 91483.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011 , NDA 090224 (pdf 90224.pdf not found) INN (ONDANSETRON) ONDANSETRON (ZENOTECH LABS LTD) APPROVAL= AP YEAR= 2011 OBSOLETE , NDA 090648 (pdf 90648.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 202599 (pdf 202599.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202600 (pdf 202600.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (EUGIA PHARMA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078287 (pdf 78287.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 , NDA 078288 (pdf 78288.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078945 (pdf 78945.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202253 (pdf 202253.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 203711 (label 203711.pdf) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2014 , NDA 203761 (pdf 203761.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2014 , NDA 206846 (pdf 206846.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 , NDA 206845 (pdf 206845.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204906 (pdf 204906.pdf not found) INN (ONDANSETRON HYDROCHLORIDE) ONDANSETRON HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209389 (pdf 209389.pdf not found) INN (ONDANSETRON) ONDANSETRON (IPCA LABS LTD) APPROVAL= AP YEAR= 2023 , 1193 ; LOMEFLOXACIN ; 98079-51-7 ; 1992 ; DISCONTINUED ; ; CLASS ANTIBACTERIAL -- ANTIINFECTIVE -- INHIBITOR , ; NDA 020013 (label 20013.pdf) INN (LOMEFLOXACIN HYDROCHLORIDE) MAXAQUIN (PHARMACIA) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 1194 ; DESFLURANE ; 57041-67-5 ; 1992 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 020118 (label 20118.pdf) INN (DESFLURANE) SUPRANE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 208234 (pdf 208234.pdf not found) INN (DESFLURANE) DESFLURANE (SHANGHAI HENGRUI) APPROVAL= AP YEAR= 2018 , 1195 ; HALOFANTRINE ; 69756-53-2 ; 1992 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- SCHIZONTICIDAL ANTIMALARIAL AGENT , ; NDA 020250 (label 20250.pdf) INN (HALOFANTRINE HYDROCHLORIDE) HALFAN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY DISCONTINUED , 1196 ; CARVEDILOL ; 72956-09-3 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- VASODILATOR AGENTS , ; NDA 020297 (label 20297.pdf) INN (CARVEDILOL) COREG (WAYLIS THERAP) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 022012 (label 22012.pdf) INN (CARVEDILOL PHOSPHATE) COREG CR (WAYLIS THERAP) APPROVAL= AP YEAR= 2006 , NDA 076373 (pdf 76373.pdf not found) INN (CARVEDILOL) CARVEDILOL (TEVA) APPROVAL= AP YEAR= 2007 , NDA 076649 (pdf 76649.pdf not found) INN (CARVEDILOL) CARVEDILOL (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007 , NDA 076989 (pdf 76989.pdf not found) INN (CARVEDILOL) CARVEDILOL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077316 (pdf 77316.pdf not found) INN (CARVEDILOL) CARVEDILOL (MYLAN) APPROVAL= AP YEAR= 2007 , NDA 077346 (label 77346.pdf) INN (CARVEDILOL) CARVEDILOL (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077474 (pdf 77474.pdf not found) INN (CARVEDILOL) CARVEDILOL (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2007 , NDA 077614 (pdf 77614.pdf not found) INN (CARVEDILOL) CARVEDILOL (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2007 , NDA 077780 (pdf 77780.pdf not found) INN (CARVEDILOL) CARVEDILOL (TARO) APPROVAL= AP YEAR= 2007 , NDA 077887 (pdf 77887.pdf not found) INN (CARVEDILOL) CARVEDILOL (HIKMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078165 (pdf 78165.pdf not found) INN (CARVEDILOL) CARVEDILOL (RUBICON) APPROVAL= AP YEAR= 2007 , NDA 078217 (pdf 78217.pdf not found) INN (CARVEDILOL) CARVEDILOL (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 078227 (pdf 78227.pdf not found) INN (CARVEDILOL) CARVEDILOL (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 078240 (pdf 78240.pdf not found) INN (CARVEDILOL) CARVEDILOL (PLIVA HRVATSKA DOO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078251 (pdf 78251.pdf not found) INN (CARVEDILOL) CARVEDILOL (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2007 , NDA 078332 (pdf 78332.pdf not found) INN (CARVEDILOL) CARVEDILOL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078384 (pdf 78384.pdf not found) INN (CARVEDILOL) CARVEDILOL (BEXIMCO USA) APPROVAL= AP YEAR= 2007 , NDA 078786 (pdf 78786.pdf not found) INN (CARVEDILOL) CARVEDILOL (ACI) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090132 (pdf 90132.pdf not found) INN (CARVEDILOL PHOSPHATE) CARVEDILOL PHOSPHATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2017 , NDA 204717 (pdf 204717.pdf not found) INN (CARVEDILOL PHOSPHATE) CARVEDILOL PHOSPHATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2018 , 1197 ; BICALUTAMIDE ; 90357-06-5 ; 1995 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR ANTAGONISTS -- R ENANTIOMER IS ACTIVE -- TREATMENT OF METASTATIC CARCINOMA OF THE PROSTATE -- REMOVE SOURCE OF ANDROGENS , ; NDA 020498 (label 20498.pdf) INN (BICALUTAMIDE) CASODEX (ANI PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 078575 (label 78575.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 022310 (label 22310.pdf) INN (BICALUTAMIDE) CASODEX (ASTRAZENECA) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 076932 (label 76932.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (TEVA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077973 (label 77973.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SYNTHON PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077995 (label 77995.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (KUDCO IRELAND) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078634 (pdf 78634.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2009 , NDA 078917 (label 78917.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2009 , NDA 079089 (label 79089.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (ADAPTIS) APPROVAL= AP YEAR= 2009 , NDA 079110 (label 79110.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (SUN PHARM) APPROVAL= AP YEAR= 2009 , NDA 079185 (label 79185.pdf) INN (BICALUTAMIDE) BICALUTAMIDE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079045 (pdf 79045.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078285 (pdf 78285.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (ROXANE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091011 (pdf 91011.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2015 , NDA 200274 (pdf 200274.pdf not found) INN (BICALUTAMIDE) BICALUTAMIDE (APOTEX) APPROVAL= AP YEAR= 2015 , 1198 ; DONEPEZIL ; 120014-06-4 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ACETYLCHOLINESTERASE INHIBITOR (REVERSIBLE) -- COGNITIVE ENHANCER -- ANTI-ALZHEIMER'S DISEASE -- CHOLINESTERASE INHIBITORS -- INCREASES CONCENTRATION OF ACETYLCHOLINE , ; NDA 020690 (label 20690.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 021719 (label 21719.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021720 (label 21720.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT ODT (EISAI INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076786 (pdf 76786.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 076893 (pdf 76893.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (PAR PHARM) APPROVAL= TA YEAR= 2007 , NDA 077344 (pdf 77344.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078662 (pdf 78662.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 077975 (label 77975.pdf) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078388 (pdf 78388.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078841 (pdf 78841.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090056 (pdf 90056.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (AUROBINDO) APPROVAL= AP YEAR= 2011 , NDA 090100 (pdf 90100.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 090686 (pdf 90686.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 022568 (label 22568.pdf) INN (DONEPEZIL HYDROCHLORIDE) ARICEPT (EISAI INC) APPROVAL= AP YEAR= 2010 , NDA 090175 (pdf 90175.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090247 (pdf 90247.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HIKMA PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090290 (pdf 90290.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090425 (pdf 90425.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2011 , NDA 090493 (pdf 90493.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 077518 (pdf 77518.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CIPLA LTD) APPROVAL= AP YEAR= 2011 , NDA 090521 (pdf 90521.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090551 (pdf 90551.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 090768 (pdf 90768.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2011 , NDA 091198 (pdf 91198.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091267 (pdf 91267.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (WOCKHARDT) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200292 (pdf 200292.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2011 , NDA 201001 (pdf 201001.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011 , NDA 201335 (pdf 201335.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201634 (pdf 201634.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (INDICUS PHARMA) APPROVAL= AP YEAR= 2011 , NDA 201146 (pdf 201146.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201787 (pdf 201787.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201724 (pdf 201724.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202114 (pdf 202114.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2013 , NDA 202542 (pdf 202542.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202631 (pdf 202631.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 202723 (label 202723.pdf) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2013 , NDA 203104 (pdf 203104.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (TWI PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203907 (pdf 203907.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 206439 (label 206439.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) NAMZARIC (ABBVIE) APPROVAL= AP YEAR= 2014 , NDA 203034 (pdf 203034.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2015 , NDA 204293 (pdf 204293.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203114 (pdf 203114.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202415 (pdf 202415.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202656 (pdf 202656.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202782 (pdf 202782.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 203419 (pdf 203419.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203656 (pdf 203656.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203713 (pdf 203713.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (DEXCEL) APPROVAL= AP YEAR= 2016 , NDA 204831 (pdf 204831.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 202410 (pdf 202410.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208328 (label 208328.pdf) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203162 (pdf 203162.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204609 (pdf 204609.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 208672 (pdf 208672.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2017 , NDA 205269 (pdf 205269.pdf not found) INN (DONEPEZIL HYDROCHLORIDE) DONEPEZIL HYDROCHLORIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2018 , NDA 212304 (label 212304.pdf) INN (DONEPEZIL HYDROCHLORIDE) ADLARITY (CORIUM) APPROVAL= AP YEAR= 2022 , NDA 216901 (pdf 216901.pdf not found) INN (MEMANTINE DONEPEZIL HYDROCHLORIDES) MEMANTINEDONEPEZIL HYDROCHLORIDES (XIAMEN LP PHARM CO) APPROVAL= TA YEAR= 2024 , NDA 208237 (pdf 208237.pdf not found) INN (DONEPEZIL HYDROCHLORIDE MEMANTINE HYDROCHLORIDE) MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2023 , 1199 ; GREPAFLOXACIN ; 119914-60-2 ; 1997 ; DISCONTINUED ; ; CLASS ANTIBIOTIC -- ANTIBACTERIAL -- ANTIINFECTIVES -- INHIBITOR , ; NDA 020695 (pdf 20695.pdf not found) INN (GREPAFLOXACIN HYDROCHLORIDE) RAXAR (OTSUKA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1200 ; THALIDOMIDE ; 50-35-1 ; 1998 ; ; ; CLASS ANTINEOPLASTIC -- MULTIPLE MYELOMA (MM) -- HYPNOTIC -- ANXIOLYTIC -- ANGIOGENESIS INHIBITORS -- IMMUNOSUPPRESSIVE AGENTS -- LEPROSTATIC AGENTS -- TERATOGENS -- ERYTHEMA NODOSUM LEPROSUM -- POSSESSES IMMUNOMODULATORY, ANTIINFLAMMATORY AND ANTIANGIOGENIC PROPERTIES , ; NDA 020785 (label 20785.pdf) INN (THALIDOMIDE) THALOMID (BRISTOL-MYERS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021430 (label 21430.pdf) INN (THALIDOMIDE) THALOMID (CELGENE) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 213267 (pdf 213267.pdf not found) INN (THALIDOMIDE) THALIDOMIDE (NATCO) APPROVAL= AP YEAR= 2023 , 1201 ; EPINASTINE ; 80012-43-7 ; 2003 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTIHISTAMINE -- ANTIALLERGIC -- HISTAMINE H1 RECEPTOR ANTAGONISTS , ; NDA 021565 (label 21565.pdf) INN (EPINASTINE HYDROCHLORIDE) ELESTAT (ALLERGAN) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY DISCONTINUED , NDA 090919 (pdf 90919.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2011 , NDA 090951 (pdf 90951.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2011 , NDA 090870 (pdf 90870.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2011 , NDA 090950 (pdf 90950.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SANDOZ) APPROVAL= TA YEAR= 2011 , NDA 091626 (pdf 91626.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 203384 (pdf 203384.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204055 (pdf 204055.pdf not found) INN (EPINASTINE HYDROCHLORIDE) EPINASTINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1202 ; LACTIC ACID ; 50-21-5 ; 2006 ; ; NATURAL MOLECULE C00001191 ; CLASS GENITO -- ANTIINFECTIVES -- ANTISEPTICS -- PHARMACOLOGICALLY INACTIVE SOLUTION , ; NDA 021703 (label 21703.pdf) INN (CALCIUM CHLORIDE DEXTROSE LACTIC ACID MAGNESIUM CHLORIDE POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE) PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2006 , NDA 208352 (label 208352.pdf) INN (CITRIC ACID LACTIC ACID POTASSIUM BITARTRATE) PHEXXI (EVOFEM INC) APPROVAL= AP YEAR= 2020 , 1203 ; ILOPROST ; 78919-13-8 ; 2004 ; ; ; CLASS BLOOD -- ANTIHYPERTENSIVE -- ANALOG OF PROSTACYLIN INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) , ; NDA 021779 (label 21779.pdf) INN (ILOPROST) VENTAVIS (ACTELION) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 217933 (pdf 217933.pdf not found) INN (ILOPROST) AURLUMYN (EICOS SCI) APPROVAL= AP YEAR= 2024 , 1204 ; LENALIDOMIDE ; 191732-72-6 ; 2005 ; ; ; CLASS ANTINEOPLASTIC -- THALIDOMIDE ANALOG -- POSSESSES IMMUNOMODULATORY, ANTIANGIOGENIC, AND ANTINEOPLASTIC PROPERTIES -- TARGET NOT KNOWN -- TREATMENT OF MULTIPLE MYELOMA (MM) , ; NDA 021880 (label 21880.pdf) INN (LENALIDOMIDE) REVLIMID (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 210480 (pdf 210480.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (LOTUS PHARM CO LTD) APPROVAL= AP YEAR= 2022 , NDA 201452 (pdf 201452.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (ARROW INTL) APPROVAL= AP YEAR= 2021 , NDA 209348 (pdf 209348.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 210154 (pdf 210154.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 213885 (pdf 213885.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 210435 (pdf 210435.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (CIPLA) APPROVAL= AP YEAR= 2022 , NDA 211022 (pdf 211022.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 213912 (pdf 213912.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (MYLAN) APPROVAL= AP YEAR= 2022 , NDA 211846 (pdf 211846.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 212414 (pdf 212414.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 213405 (pdf 213405.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (TORRENT) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214618 (pdf 214618.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (CIPLA) APPROVAL= AP YEAR= 2023 , NDA 217265 (pdf 217265.pdf not found) INN (LENALIDOMIDE) LENALIDOMIDE (QILU) APPROVAL= AP YEAR= 2024 , 1205 ; PALIPERIDONE ; 144598-75-4 ; 2006 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- BENZISOXAZOLE DERIVATIVES -- DOPAMINE D2 RECEPTOR ANTAGONIST -- SEROTONIN TYPE 2 (5HT2A) RECEPTOR ANTAGONIST , ; NDA 021999 (label 21999.pdf) INN (PALIPERIDONE) INVEGA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022043 (label 22043.pdf) INN (PALIPERIDONE) INVEGA (JANSSEN LP) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 202645 (pdf 202645.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2015 , NDA 203802 (pdf 203802.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (RK PHARMA) APPROVAL= AP YEAR= 2015 , NDA 205618 (pdf 205618.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 204452 (pdf 204452.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (INVENTIA) APPROVAL= AP YEAR= 2019 , NDA 204707 (pdf 204707.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212807 (pdf 212807.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (CSPC OUYI) APPROVAL= AP YEAR= 2020 , NDA 208643 (pdf 208643.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 216174 (pdf 216174.pdf not found) INN (PALIPERIDONE) PALIPERIDONE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , 1206 ; METHANTHELINE ; 5818-17-7 ; 1951 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- CHOLINERGIC RECEPTOR ANTAGONIST -- TREATMENT OF OVERACTIVE BLADDER SYNDROME, HYPERSALIVATION AND HYPERHIDROSIS , ; NDA 007390 (pdf 7390.pdf not found) INN (METHANTHELINE BROMIDE) BANTHINE (SHIRE) APPROVAL= AP YEAR= 1951 NEWMOLECULARENTITY DISCONTINUED , 1207 ; NOREPINEPHRINE ; 51-41-2 ; 1950 ; ; NATURAL MOLECULE C00001424 ; CLASS CARDIOVASCULAR -- ADRENERGIC RECEPTOR AGONIST -- SYMPATHOMIMETICS -- VASOCONSTRICTOR AGENTS -- PERIPHERAL VASOCONSTRICTOR (ALPHA-ADRENERGIC ACTION) AND AS AN INOTROPIC STIMULATOR OF THE HEART AND DILATOR OF CORONARY ARTERIES (BETA-ADRENERGIC ACTION) , ; NDA 007513 (label 7513.pdf) INN (NOREPINEPHRINE BITARTRATE) LEVOPHED (HOSPIRA) APPROVAL= AP YEAR= 1950 NEWMOLECULARENTITY , NDA 008592 (pdf 8592.pdf not found) INN (NOREPINEPHRINE BITARTRATE PROCAINE HYDROCHLORIDE PROPOXYCAINE HYDROCHLORIDE) RAVOCAINE AND NOVOCAIN W/ LEVOPHED (EASTMAN KODAK) APPROVAL= AP YEAR= 1952 DISCONTINUED , NDA 040455 (pdf 40455.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (MEITHEAL) APPROVAL= AP YEAR= 2003 , NDA 040462 (pdf 40462.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (HIKMA) APPROVAL= AP YEAR= 2003 , NDA 040522 (pdf 40522.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (METRICS PHARM) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 040859 (pdf 40859.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2012 , NDA 203662 (pdf 203662.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (HIKMA) APPROVAL= AP YEAR= 2018 , NDA 210839 (pdf 210839.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 211242 (pdf 211242.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 211359 (pdf 211359.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (SANDOZ) APPROVAL= AP YEAR= 2018 , NDA 211382 (pdf 211382.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 211980 (pdf 211980.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 214313 (label 214313.pdf) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2021 , NDA 214323 (pdf 214323.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214455 (pdf 214455.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 , NDA 214628 (pdf 214628.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215700 (label 215700.pdf) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (INFORLIFE) APPROVAL= AP YEAR= 2022 , NDA 216341 (pdf 216341.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217575 (pdf 217575.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (CAPLIN) APPROVAL= AP YEAR= 2023 , NDA 218758 (pdf 218758.pdf not found) INN (NOREPINEPHRINE BITARTRATE) NOREPINEPHRINE BITARTRATE (RISING) APPROVAL= AP YEAR= 2024 , 1208 ; PHENTOLAMINE ; 50-60-2 ; 1952 ; ; ; CLASS CARDIOVASCULAR -- ALPHA ADRENERGIC RECEPTOR ANTAGONIST -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS -- REVERSAL OF SOFT-TISSUE ANESTHESIA , ; NDA 008278 (pdf 8278.pdf not found) INN (PHENTOLAMINE MESYLATE) REGITINE (NOVARTIS) APPROVAL= AP YEAR= 1952 NEWMOLECULARENTITY DISCONTINUED , NDA 022159 (label 22159.pdf) INN (PHENTOLAMINE MESYLATE) ORAVERSE (SEPTODONT HOLDING) APPROVAL= AP YEAR= 2008 , NDA 040235 (pdf 40235.pdf not found) INN (PHENTOLAMINE MESYLATE) PHENTOLAMINE MESYLATE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 207686 (pdf 207686.pdf not found) INN (PHENTOLAMINE MESYLATE) PHENTOLAMINE MESYLATE (PRECISION DOSE INC) APPROVAL= AP YEAR= 2017 , NDA 217064 (pdf 217064.pdf not found) INN (PHENTOLAMINE MESYLATE) RYZUMVI (FAMYGEN LIFE SCI) APPROVAL= AP YEAR= 2023 , 1209 ; PRIMAQUINE ; 90-34-6 ; 1952 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- ANTIPROTOZOAL AGENTS -- CAPABLE OF CLEARING THE INTRA-HEPATIC SCHIZONTS AND HYPNOZOITES OF PLASMODIUM VIVAX -- PRECIPITATE HAEMOLYSIS IN GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENT INDIVIDUALS -- GAMETOCYTOCIDAL AGENT IN FALCIPARUM MALARIA -- INTERFERE WITH THE CELLULAR RESPIRATION OF THE PARASITE BY GENERATING OXYGEN FREE RADICALS AND DEREGULATING THE ELECTRON TRANSPORT , ; NDA 008316 (label 8316.pdf) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1952 , NDA 014860 (pdf 14860.pdf not found) INN (CHLOROQUINE PHOSPHATE PRIMAQUINE PHOSPHATE) ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 203924 (pdf 203924.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (ALVOGEN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204476 (pdf 204476.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2014 , NDA 206043 (pdf 206043.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , 1210 ; PRIMAQUINE ; 90-34-6 ; 1952 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- ANTIPROTOZOAL AGENTS -- CAPABLE OF CLEARING THE INTRA-HEPATIC SCHIZONTS AND HYPNOZOITES OF PLASMODIUM VIVAX -- PRECIPITATE HAEMOLYSIS IN GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENT INDIVIDUALS -- GAMETOCYTOCIDAL AGENT IN FALCIPARUM MALARIA -- INTERFERE WITH THE CELLULAR RESPIRATION OF THE PARASITE BY GENERATING OXYGEN FREE RADICALS AND DEREGULATING THE ELECTRON TRANSPORT , ; NDA 008316 (label 8316.pdf) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1952 , NDA 014860 (pdf 14860.pdf not found) INN (CHLOROQUINE PHOSPHATE PRIMAQUINE PHOSPHATE) ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1968 DISCONTINUED , NDA 203924 (pdf 203924.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (ALVOGEN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204476 (pdf 204476.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (BAYSHORE PHARMS LLC) APPROVAL= AP YEAR= 2014 , NDA 206043 (pdf 206043.pdf not found) INN (PRIMAQUINE PHOSPHATE) PRIMAQUINE PHOSPHATE (NOVAST LABS) APPROVAL= AP YEAR= 2016 , 1211 ; OXYPHENONIUM ; 14214-84-7 ; 0 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 008492 (pdf 8492.pdf not found) INN (OXYPHENONIUM BROMIDE) ANTRENYL (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1212 ; OXYPHENONIUM ; 14214-84-7 ; 0 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS , ; NDA 008492 (pdf 8492.pdf not found) INN (OXYPHENONIUM BROMIDE) ANTRENYL (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1213 ; ERGOLOID ; 8067-24-1 ; 1953 ; ; ; CLASS CARDIOVASCULAR -- COGNITION ENHANCER -- ADRENERGIC ALPHA ANTAGONISTS -- NOOTROPIC AGENTS -- SYMPATHOLYTICS (PMID9787282) , ; NDA 009087 (pdf 9087.pdf not found) INN (ERGOLOID MESYLATES) HYDERGINE (NOVARTIS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , NDA 017993 (pdf 17993.pdf not found) INN (ERGOLOID MESYLATES) HYDERGINE (NOVARTIS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 018418 (pdf 18418.pdf not found) INN (ERGOLOID MESYLATES) HYDERGINE (NOVARTIS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018706 (pdf 18706.pdf not found) INN (ERGOLOID MESYLATES) HYDERGINE LC (NOVARTIS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 081113 (pdf 81113.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1991 , NDA 084868 (pdf 84868.pdf not found) INN (ERGOLOID MESYLATES) CIRCANOL (3M) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084930 (pdf 84930.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085020 (pdf 85020.pdf not found) INN (ERGOLOID MESYLATES) DEAPRIL-ST (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085153 (pdf 85153.pdf not found) INN (ERGOLOID MESYLATES) ALKERGOT (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 085177 (pdf 85177.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085809 (pdf 85809.pdf not found) INN (ERGOLOID MESYLATES) CIRCANOL (3M) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085899 (pdf 85899.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085900 (pdf 85900.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086188 (pdf 86188.pdf not found) INN (ERGOLOID MESYLATES) GERIMAL (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086189 (pdf 86189.pdf not found) INN (ERGOLOID MESYLATES) GERIMAL (WATSON LABS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 086264 (pdf 86264.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086265 (pdf 86265.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (KV PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086433 (pdf 86433.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086984 (pdf 86984.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 086985 (pdf 86985.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (LEDERLE) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087183 (pdf 87183.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087185 (pdf 87185.pdf not found) INN (ERGOLOID MESYLATES) HYDROGENATED ERGOT ALKALOIDS (IVAX PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087186 (pdf 87186.pdf not found) INN (ERGOLOID MESYLATES) HYDROGENATED ERGOT ALKALOIDS (IVAX PHARMS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087233 (pdf 87233.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087244 (pdf 87244.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087407 (pdf 87407.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087417 (pdf 87417.pdf not found) INN (ERGOLOID MESYLATES) ALKERGOT (SANDOZ) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 087552 (pdf 87552.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 088013 (pdf 88013.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088014 (pdf 88014.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (VANGARD) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 088207 (pdf 88207.pdf not found) INN (ERGOLOID MESYLATES) GERIMAL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088891 (pdf 88891.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (MUTUAL PHARM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089233 (pdf 89233.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089234 (pdf 89234.pdf not found) INN (ERGOLOID MESYLATES) ERGOLOID MESYLATES (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED , 1214 ; BENZTROPINE ; 86-13-5 ; 1954 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPARKINSONIAN -- ANTIDYSKINETICS -- MUSCARINIC ANTAGONISTS -- DOPAMINE TRANSPORTER LIGANDS (PMID18786172) , ; NDA 009193 (pdf 9193.pdf not found) INN (BENZTROPINE MESYLATE) COGENTIN (MERCK) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , NDA 012015 (label 12015.pdf) INN (BENZTROPINE MESYLATE) COGENTIN (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1959 DISCONTINUED , NDA 040103 (pdf 40103.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (AIPING PHARM INC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 040699 (pdf 40699.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (PROSAM LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 040705 (pdf 40705.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (PROSAM LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE , NDA 040706 (pdf 40706.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (OXFORD PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 040715 (pdf 40715.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2007 , NDA 040738 (pdf 40738.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (VINTAGE) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 040742 (pdf 40742.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (VINTAGE) APPROVAL= AP YEAR= 2007 OBSOLETE , NDA 072264 (pdf 72264.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1989 , NDA 072265 (pdf 72265.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1989 , NDA 072266 (pdf 72266.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1989 , NDA 081264 (pdf 81264.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 1992 DISCONTINUED OBSOLETE , NDA 081265 (pdf 81265.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 1992 , NDA 088510 (pdf 88510.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088511 (pdf 88511.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088514 (pdf 88514.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088877 (pdf 88877.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (LANNETT CO INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088894 (pdf 88894.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (LANNETT CO INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 088895 (pdf 88895.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (LANNETT CO INC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 089058 (pdf 89058.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (PLIVA) APPROVAL= AP YEAR= 1988 , NDA 089059 (pdf 89059.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (PLIVA) APPROVAL= AP YEAR= 1988 , NDA 089060 (pdf 89060.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (PLIVA) APPROVAL= AP YEAR= 1988 , NDA 089211 (pdf 89211.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089212 (pdf 89212.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089213 (pdf 89213.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090233 (pdf 90233.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 , NDA 090287 (pdf 90287.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 090294 (pdf 90294.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091152 (pdf 91152.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (LUITPOLD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090168 (pdf 90168.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (LEADING) APPROVAL= AP YEAR= 2012 , NDA 091525 (pdf 91525.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (NAVINTA LLC) APPROVAL= AP YEAR= 2013 , NDA 204713 (pdf 204713.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (ASPEN GLOBAL INC) APPROVAL= AP YEAR= 2015 , NDA 209442 (pdf 209442.pdf not found) INN (BENZTROPINE MESYLATE) BENZTROPINE MESYLATE (HIKMA) APPROVAL= AP YEAR= 2021 , 1215 ; CYCLIZINE ; 82-92-8 ; 1954 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTIHISTAMINE -- ANTIEMETIC -- HISTAMINE H1 RECEPTOR ANTAGONIST -- ANTICHOLINERGIC , ; NDA 009495 (pdf 9495.pdf not found) INN (CYCLIZINE LACTATE) MAREZINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1954 DISCONTINUED , 1216 ; DIHYDROCODEINE ; 125-28-0 ; 1958 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- OPIOID RECEPTOR AGONIST , ; NDA 011483 (label 11483.pdf) INN (ASPIRIN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1958 DISCONTINUED , NDA 040109 (pdf 40109.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040316 (pdf 40316.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (MIKART) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040637 (pdf 40637.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WEST-WARD PHARM CORP) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 040688 (pdf 40688.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (WRASER PHARMS LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 040701 (pdf 40701.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE , AND DIHYDROCODEINE BITARTRATE (BOCA PHARMA LLC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 088584 (pdf 88584.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) DHC PLUS (PHARM RES ASSOC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 089166 (pdf 89166.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) SYNALGOS-DC-A (LEITNER PHARMS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 204785 (label 204785.pdf) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) TREZIX (XSPIRE PHARMA) APPROVAL= AP YEAR= 2014 , NDA 204209 (pdf 204209.pdf not found) INN (ACETAMINOPHEN CAFFEINE DIHYDROCODEINE BITARTRATE) ACETAMINOPHEN , CAFFEINE AND DIHYDROCODEINE BITARTRATE (LARKEN LABS INC) APPROVAL= AP YEAR= 2016 , 1217 ; ACETOPHENAZINE ; 2751-68-0 ; 1961 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE RECEPTOR ANTAGONIST , ; NDA 012254 (pdf 12254.pdf not found) INN (ACETOPHENAZINE MALEATE) TINDAL (SCHERING) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , 1218 ; GUANETHIDINE ; 55-65-2 ; 1960 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ADRENERGIC NEURON BLOCKER -- SYMPATHOLYTICS , ; NDA 012329 (pdf 12329.pdf not found) INN (GUANETHIDINE MONOSULFATE) ISMELIN (NOVARTIS) APPROVAL= AP YEAR= 1960 NEWMOLECULARENTITY DISCONTINUED , NDA 013553 (pdf 13553.pdf not found) INN (GUANETHIDINE MONOSULFATE HYDROCHLOROTHIAZIDE) ESIMIL (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086113 (pdf 86113.pdf not found) INN (GUANETHIDINE MONOSULFATE) GUANETHIDINE MONOSULFATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086114 (pdf 86114.pdf not found) INN (GUANETHIDINE MONOSULFATE) GUANETHIDINE MONOSULFATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 1219 ; METHYSERGIDE ; 361-37-5 ; 1962 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- VASOCONSTRICTOR -- ANTIMIGRAINE -- SEROTONIN ANTAGONISTS -- SYMPATHOLYTICS -- 5-HYDROXYTRYPTAMINE RECEPTORS ANATGONISTS -- HALLUCINOGENIC PMID22486742 , ; NDA 012516 (pdf 12516.pdf not found) INN (METHYSERGIDE MALEATE) SANSERT (NOVARTIS) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , 1220 ; CARPHENAZINE ; 2622-30-2 ; 1963 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE RECEPTOR ANTAGONIST , ; NDA 012768 (pdf 12768.pdf not found) INN (CARPHENAZINE MALEATE) PROKETAZINE (WYETH AYERST) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 014173 (pdf 14173.pdf not found) INN (CARPHENAZINE MALEATE) PROKETAZINE (WYETH AYERST) APPROVAL= AP YEAR= 1963 DISCONTINUED , 1221 ; METAPROTERENOL ; 586-06-1 ; 1973 ; ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETICS -- TOCOLYTIC AGENTS , ; NDA 015874 (pdf 15874.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 016402 (pdf 16402.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 017571 (pdf 17571.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017659 (pdf 17659.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018761 (pdf 18761.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 070804 (pdf 70804.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070805 (pdf 70805.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071013 (pdf 71013.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071014 (pdf 71014.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071018 (pdf 71018.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (ASTRAZENECA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071275 (pdf 71275.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (ASTRAZENECA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071656 (pdf 71656.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071726 (pdf 71726.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (NEPHRON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071786 (pdf 71786.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071805 (pdf 71805.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071806 (pdf 71806.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071855 (pdf 71855.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (NEPHRON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072023 (pdf 72023.pdf not found) INN (METAPROTERENOL SULFATE) PROMETA (MURO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072024 (pdf 72024.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072025 (pdf 72025.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072054 (pdf 72054.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072055 (pdf 72055.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072190 (pdf 72190.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072519 (pdf 72519.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072520 (pdf 72520.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072761 (pdf 72761.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (COSETTE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072795 (pdf 72795.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073013 (pdf 73013.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073034 (pdf 73034.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (G AND W LABS INC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073340 (pdf 73340.pdf not found) INN (METAPROTERENOL SULFATE) PROMETA (MURO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073632 (pdf 73632.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (GENUS) APPROVAL= AP YEAR= 1992 , NDA 074702 (pdf 74702.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075235 (pdf 75235.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075402 (pdf 75402.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075403 (pdf 75403.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075586 (pdf 75586.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 2002 DISCONTINUED , 1222 ; METAPROTERENOL ; 586-06-1 ; 1973 ; ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETICS -- TOCOLYTIC AGENTS , ; NDA 015874 (pdf 15874.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 016402 (pdf 16402.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 017571 (pdf 17571.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017659 (pdf 17659.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 018761 (pdf 18761.pdf not found) INN (METAPROTERENOL SULFATE) ALUPENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 070804 (pdf 70804.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 070805 (pdf 70805.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071013 (pdf 71013.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071014 (pdf 71014.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071018 (pdf 71018.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (ASTRAZENECA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071275 (pdf 71275.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (ASTRAZENECA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071656 (pdf 71656.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071726 (pdf 71726.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (NEPHRON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071786 (pdf 71786.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071805 (pdf 71805.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071806 (pdf 71806.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071855 (pdf 71855.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (NEPHRON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072023 (pdf 72023.pdf not found) INN (METAPROTERENOL SULFATE) PROMETA (MURO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072024 (pdf 72024.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072025 (pdf 72025.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072054 (pdf 72054.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072055 (pdf 72055.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072190 (pdf 72190.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072519 (pdf 72519.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072520 (pdf 72520.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072761 (pdf 72761.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (COSETTE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072795 (pdf 72795.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073013 (pdf 73013.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073034 (pdf 73034.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (G AND W LABS INC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073340 (pdf 73340.pdf not found) INN (METAPROTERENOL SULFATE) PROMETA (MURO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073632 (pdf 73632.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (GENUS) APPROVAL= AP YEAR= 1992 , NDA 074702 (pdf 74702.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075235 (pdf 75235.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075402 (pdf 75402.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075403 (pdf 75403.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075586 (pdf 75586.pdf not found) INN (METAPROTERENOL SULFATE) METAPROTERENOL SULFATE (WOCKHARDT) APPROVAL= AP YEAR= 2002 DISCONTINUED , 1223 ; MAFENIDE ; 138-39-6 ; 1969 ; ; ; CLASS DERMATOLOGICALS -- ANTIBACTERIAL -- SULFONAMIDES -- ANTIBIOTIC , ; NDA 016763 (pdf 16763.pdf not found) INN (MAFENIDE ACETATE) SULFAMYLON (RISING) APPROVAL= AP YEAR= 1969 , NDA 019832 (label 19832.pdf) INN (MAFENIDE ACETATE) SULFAMYLON (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 201511 (pdf 201511.pdf not found) INN (MAFENIDE ACETATE) MAFENIDE ACETATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 206716 (pdf 206716.pdf not found) INN (MAFENIDE ACETATE) MAFENIDE ACETATE (NOVAST LABS) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1224 ; MESORIDAZINE ; 5588-33-0 ; 1970 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 016774 (pdf 16774.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 016775 (pdf 16775.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016997 (pdf 16997.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1972 DISCONTINUED , 1225 ; MESORIDAZINE ; 5588-33-0 ; 1970 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE ANTAGONISTS -- PHENOTHIAZINES , ; NDA 016774 (pdf 16774.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , NDA 016775 (pdf 16775.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1970 DISCONTINUED , NDA 016997 (pdf 16997.pdf not found) INN (MESORIDAZINE BESYLATE) SERENTIL (NOVARTIS) APPROVAL= AP YEAR= 1972 DISCONTINUED , 1226 ; CLORAZEPATE ; 23887-31-2 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTICONVULSANTS -- GABA MODULATORS , ; NDA 017105 (label 17105.pdf) INN (CLORAZEPATE DIPOTASSIUM) TRANXENE (AJENAT PHARMS) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 071242 (pdf 71242.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071243 (pdf 71243.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071244 (pdf 71244.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071429 (pdf 71429.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071430 (pdf 71430.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071431 (pdf 71431.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071509 (pdf 71509.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071510 (pdf 71510.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071511 (pdf 71511.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071522 (pdf 71522.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071549 (pdf 71549.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071550 (pdf 71550.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071702 (pdf 71702.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071727 (pdf 71727.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071728 (pdf 71728.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071729 (pdf 71729.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071730 (pdf 71730.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071731 (pdf 71731.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071742 (pdf 71742.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071743 (pdf 71743.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071744 (pdf 71744.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071747 (pdf 71747.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071748 (pdf 71748.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071749 (pdf 71749.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071774 (pdf 71774.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071775 (pdf 71775.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071776 (pdf 71776.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071777 (pdf 71777.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071778 (pdf 71778.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071779 (pdf 71779.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071780 (pdf 71780.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071781 (pdf 71781.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071782 (pdf 71782.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071787 (pdf 71787.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071788 (pdf 71788.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071789 (pdf 71789.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071828 (pdf 71828.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071829 (pdf 71829.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071830 (pdf 71830.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071852 (pdf 71852.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071853 (pdf 71853.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071854 (pdf 71854.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071858 (pdf 71858.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 1987 , NDA 071860 (pdf 71860.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071878 (pdf 71878.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071879 (pdf 71879.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071924 (pdf 71924.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071925 (pdf 71925.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071926 (pdf 71926.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072013 (pdf 72013.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072014 (pdf 72014.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072015 (pdf 72015.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072112 (pdf 72112.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072219 (pdf 72219.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072220 (pdf 72220.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072330 (pdf 72330.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072331 (pdf 72331.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072332 (pdf 72332.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072512 (pdf 72512.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 072513 (pdf 72513.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 072514 (pdf 72514.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 075731 (pdf 75731.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (TARO) APPROVAL= AP YEAR= 2000 , NDA 076911 (pdf 76911.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 213730 (pdf 213730.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215566 (pdf 215566.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (COREPHARMA) APPROVAL= AP YEAR= 2022 , 1227 ; TERBUTALINE ; 23031-25-6 ; 1974 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETIC -- TOCOLYTIC AGENTS , ; NDA 017466 (pdf 17466.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 017618 (pdf 17618.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017849 (pdf 17849.pdf not found) INN (TERBUTALINE SULFATE) BRETHINE (ANI PHARMS) APPROVAL= AP YEAR= 1976 , NDA 018000 (pdf 18000.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018571 (pdf 18571.pdf not found) INN (TERBUTALINE SULFATE) BRETHINE (PHARMACARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018762 (pdf 18762.pdf not found) INN (TERBUTALINE SULFATE) BRETHAIRE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 075877 (pdf 75877.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 2001 , NDA 076770 (pdf 76770.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2004 , NDA 076853 (pdf 76853.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (DR REDDYS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076887 (pdf 76887.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 077152 (pdf 77152.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 078151 (pdf 78151.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078630 (pdf 78630.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 200122 (pdf 200122.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (AREVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 211832 (pdf 211832.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (TWI PHARMS) APPROVAL= AP YEAR= 2020 , 1228 ; CLORAZEPATE ; 23887-31-2 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTICONVULSANTS -- GABA MODULATORS , ; NDA 017105 (label 17105.pdf) INN (CLORAZEPATE DIPOTASSIUM) TRANXENE (AJENAT PHARMS) APPROVAL= AP YEAR= 1972 NEWMOLECULARENTITY , NDA 071242 (pdf 71242.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071243 (pdf 71243.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071244 (pdf 71244.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (USL PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071429 (pdf 71429.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071430 (pdf 71430.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071431 (pdf 71431.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071509 (pdf 71509.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071510 (pdf 71510.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071511 (pdf 71511.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DASH PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071522 (pdf 71522.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071549 (pdf 71549.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071550 (pdf 71550.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071702 (pdf 71702.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071727 (pdf 71727.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071728 (pdf 71728.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071729 (pdf 71729.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (GD SEARLE LLC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071730 (pdf 71730.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071731 (pdf 71731.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071742 (pdf 71742.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071743 (pdf 71743.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071744 (pdf 71744.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (DAVA PHARMS INC) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071747 (pdf 71747.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071748 (pdf 71748.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071749 (pdf 71749.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071774 (pdf 71774.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071775 (pdf 71775.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071776 (pdf 71776.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071777 (pdf 71777.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071778 (pdf 71778.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071779 (pdf 71779.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071780 (pdf 71780.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071781 (pdf 71781.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071782 (pdf 71782.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (ABLE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071787 (pdf 71787.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071788 (pdf 71788.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071789 (pdf 71789.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) GEN-XENE (ALRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071828 (pdf 71828.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071829 (pdf 71829.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071830 (pdf 71830.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WARNER CHILCOTT) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071852 (pdf 71852.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071853 (pdf 71853.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071854 (pdf 71854.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071858 (pdf 71858.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 1987 , NDA 071860 (pdf 71860.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071878 (pdf 71878.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071879 (pdf 71879.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (WATSON LABS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 071924 (pdf 71924.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071925 (pdf 71925.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071926 (pdf 71926.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072013 (pdf 72013.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072014 (pdf 72014.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072015 (pdf 72015.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (LEDERLE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072112 (pdf 72112.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (RISING) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072219 (pdf 72219.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072220 (pdf 72220.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072330 (pdf 72330.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072331 (pdf 72331.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072332 (pdf 72332.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072512 (pdf 72512.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 072513 (pdf 72513.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED OBSOLETE , NDA 072514 (pdf 72514.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 075731 (pdf 75731.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (TARO) APPROVAL= AP YEAR= 2000 , NDA 076911 (pdf 76911.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 213730 (pdf 213730.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215566 (pdf 215566.pdf not found) INN (CLORAZEPATE DIPOTASSIUM) CLORAZEPATE DIPOTASSIUM (COREPHARMA) APPROVAL= AP YEAR= 2022 , 1229 ; TERBUTALINE ; 23031-25-6 ; 1974 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- ADRENERGIC BETA AGONISTS -- SYMPATHOMIMETIC -- TOCOLYTIC AGENTS , ; NDA 017466 (pdf 17466.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , NDA 017618 (pdf 17618.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017849 (pdf 17849.pdf not found) INN (TERBUTALINE SULFATE) BRETHINE (ANI PHARMS) APPROVAL= AP YEAR= 1976 , NDA 018000 (pdf 18000.pdf not found) INN (TERBUTALINE SULFATE) BRICANYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 018571 (pdf 18571.pdf not found) INN (TERBUTALINE SULFATE) BRETHINE (PHARMACARE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018762 (pdf 18762.pdf not found) INN (TERBUTALINE SULFATE) BRETHAIRE (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 075877 (pdf 75877.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 2001 , NDA 076770 (pdf 76770.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2004 , NDA 076853 (pdf 76853.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (DR REDDYS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076887 (pdf 76887.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 077152 (pdf 77152.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2005 , NDA 078151 (pdf 78151.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078630 (pdf 78630.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2009 , NDA 200122 (pdf 200122.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (AREVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 211832 (pdf 211832.pdf not found) INN (TERBUTALINE SULFATE) TERBUTALINE SULFATE (TWI PHARMS) APPROVAL= AP YEAR= 2020 , 1230 ; AZATADINE ; 3964-81-6 ; 1977 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTIHISTAMINE -- HISTAMINE H1 RECEPTOR ANTAGONIST -- ANTICHOLINERGIC -- ANTISEROTONIN -- ANTIANAPHYLACTIC ACTIVITY PMID21737359 , ; NDA 017601 (pdf 17601.pdf not found) INN (AZATADINE MALEATE) OPTIMINE (SCHERING) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 018506 (pdf 18506.pdf not found) INN (AZATADINE MALEATE PSEUDOEPHEDRINE SULFATE) TRINALIN (SCHERING) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1231 ; CLEMASTINE ; 15686-51-8 ; 1977 ; ; ; CLASS DERMATOLOGICALS -- ANTIHISTAMINE -- ANTI-ALLERGIC AGENTS -- ANTIPRURITICS -- HISTAMINE H1 RECEPTOR ANTAGONIST -- ANTICHOLINERGIC , ; NDA 017661 (pdf 17661.pdf not found) INN (CLEMASTINE FUMARATE) TAVIST (NOVARTIS) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 018298 (pdf 18298.pdf not found) INN (CLEMASTINE FUMARATE) TAVIST-D (NOVARTIS) APPROVAL= AP YEAR= 1982 DISCONTINUED OBSOLETE , NDA 018675 (pdf 18675.pdf not found) INN (CLEMASTINE FUMARATE) TAVIST (NOVARTIS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 020640 (pdf 20640.pdf not found) INN (CLEMASTINE FUMARATE) TAVIST-D (NOVARTIS) APPROVAL= AP YEAR= 1996 DISCONTINUED OBSOLETE , NDA 020925 (pdf 20925.pdf not found) INN (CLEMASTINE FUMARATE) TAVIST-1 (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 021082 (label 21082.pdf) INN (ACETAMINOPHEN CLEMASTINE FUMARATE PSEUDOEPHEDRINE HYDROCHLORIDE) TAVIST ALLERGY/SINUS/HEADACHE (NOVARTIS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 073095 (pdf 73095.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (TEVA PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073282 (pdf 73282.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (ANI PHARMS) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073283 (pdf 73283.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073399 (pdf 73399.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (GENUS) APPROVAL= AP YEAR= 1994 , NDA 073458 (pdf 73458.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (PLD ACQUISITIONS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073459 (pdf 73459.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (SANDOZ) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074075 (pdf 74075.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 074512 (pdf 74512.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (L PERRIGO CO) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074863 (pdf 74863.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074884 (pdf 74884.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (NEW HEIGHTS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075703 (pdf 75703.pdf not found) INN (CLEMASTINE FUMARATE) CLEMASTINE FUMARATE (APOTEX INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , 1232 ; BETHANIDINE ; 55-73-2 ; 1981 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ADRENERGIC AGENTS -- ANTIHYPERTENSIVE AGENTS -- SYMPATHOLYTICS , ; NDA 017675 (pdf 17675.pdf not found) INN (BETHANIDINE SULFATE) TENATHAN (ROBINS AH) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , 1233 ; CHLORHEXIDINE ; 55-56-1 ; 1976 ; ; ; CLASS METABOLISM -- ANTIINFECTIVE -- ANTI-BACTERIAL -- DISINFECTANTS -- DESTROYS THE INTEGRITY OF THE CELL MEMBRANE BY INTERACTING WITH THE NEGATIVE CHARGES ASSOCIATED WITH THE CELL WALL AND PLASMA MEMBRANE , ; NDA 017768 (label 17768.pdf) INN (CHLORHEXIDINE GLUCONATE) HIBICLENS (MOLNLYCKE HLTH) APPROVAL= AP YEAR= 1976 , NDA 018300 (label 18300.pdf) INN (CHLORHEXIDINE GLUCONATE) HIBISTAT (MOLNLYCKE HLTH) APPROVAL= AP YEAR= 1980 , NDA 018423 (pdf 18423.pdf not found) INN (CHLORHEXIDINE GLUCONATE) HIBICLENS (MOLNLYCKE HLTH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019028 (label 19028.pdf) INN (CHLORHEXIDINE GLUCONATE) PERIDEX (3M) APPROVAL= AP YEAR= 1986 , NDA 019125 (label 19125.pdf) INN (CHLORHEXIDINE GLUCONATE) EXIDINE (XTTRIUM) APPROVAL= AP YEAR= 1984 , NDA 019127 (label 19127.pdf) INN (CHLORHEXIDINE GLUCONATE) EXIDINE (XTTRIUM) APPROVAL= AP YEAR= 1984 , NDA 019258 (label 19258.pdf) INN (CHLORHEXIDINE GLUCONATE) CIDA-STAT (ECOLAB) APPROVAL= AP YEAR= 1986 , NDA 019421 (pdf 19421.pdf not found) INN (CHLORHEXIDINE GLUCONATE) EXIDINE (XTTRIUM) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019422 (label 19422.pdf) INN (CHLORHEXIDINE GLUCONATE) EXIDINE (XTTRIUM) APPROVAL= AP YEAR= 1985 , NDA 019490 (pdf 19490.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (KENDALL IL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019793 (pdf 19793.pdf not found) INN (CHLORHEXIDINE GLUCONATE) PHARMASEAL SCRUB CARE (CAREFUSION 2200) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019822 (label 19822.pdf) INN (CHLORHEXIDINE GLUCONATE) BIOSCRUB (GRIFFEN) APPROVAL= AP YEAR= 1989 , NDA 020111 (label 20111.pdf) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (BAJAJ) APPROVAL= AP YEAR= 1997 , NDA 020774 (label 20774.pdf) INN (CHLORHEXIDINE GLUCONATE) PERIOCHIP (DEXCEL PHARMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 020832 (label 20832.pdf) INN (CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL) CHLORAPREP ONE-STEP (BECTON DICKINSON CO) APPROVAL= AP YEAR= 2000 , NDA 021074 (label 21074.pdf) INN (ALCOHOL CHLORHEXIDINE GLUCONATE) AVAGARD (3M) APPROVAL= AP YEAR= 2001 , NDA 021524 (label 21524.pdf) INN (CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL) PREVANTICS SWAB (PROF DSPLS) APPROVAL= AP YEAR= 2005 , NDA 021555 (label 21555.pdf) INN (CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL) CHLORAPREP ONE-STEP SEPP (BECTON DICKINSON CO) APPROVAL= AP YEAR= 2002 , NDA 021669 (label 21669.pdf) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (SAGE PRODS) APPROVAL= AP YEAR= 2005 , NDA 070104 (pdf 70104.pdf not found) INN (CHLORHEXIDINE GLUCONATE) STERI-STAT (MATRIX MEDCL) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071419 (pdf 71419.pdf not found) INN (CHLORHEXIDINE GLUCONATE) BRIAN CARE (SOAPCO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072255 (pdf 72255.pdf not found) INN (CHLORHEXIDINE GLUCONATE) MICRODERM (J AND J) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072292 (pdf 72292.pdf not found) INN (CHLORHEXIDINE GLUCONATE) PREVACARE R (J AND J) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072295 (pdf 72295.pdf not found) INN (CHLORHEXIDINE GLUCONATE) MICRODERM (J AND J) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072525 (pdf 72525.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (BECTON DICKINSON) APPROVAL= AP YEAR= 1989 , NDA 073416 (pdf 73416.pdf not found) INN (CHLORHEXIDINE GLUCONATE) E-Z SCRUB (BECTON DICKINSON) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 073695 (pdf 73695.pdf not found) INN (CHLORHEXIDINE GLUCONATE) PERIOGARD (COLGATE PALMOLIVE CO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074291 (pdf 74291.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (LYNE) APPROVAL= AP YEAR= 1995 , NDA 074356 (pdf 74356.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074522 (pdf 74522.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (PHARM ASSOC) APPROVAL= AP YEAR= 1995 , NDA 075006 (pdf 75006.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2004 , NDA 075561 (pdf 75561.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (BAJAJ) APPROVAL= AP YEAR= 2000 , NDA 076434 (pdf 76434.pdf not found) INN (CHLORHEXIDINE GLUCONATE) PAROEX (SUNSTAR AMERICAS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077789 (pdf 77789.pdf not found) INN (CHLORHEXIDINE GLUCONATE) CHLORHEXIDINE GLUCONATE (XTTRIUM) APPROVAL= AP YEAR= 2009 , NDA 203212 (pdf 203212.pdf not found) INN (CHLORHEXIDINE GLUCONATE) PERIOGARD (COLGATE-PALMOLIVE CO) APPROVAL= AP YEAR= 2016 , NDA 207964 (label 207964.pdf) INN (CHLORHEXIDINE GLUCONATE) READYPREP CHG (MEDLINE INDUSTRIES) APPROVAL= AP YEAR= 2018 , NDA 208288 (label 208288.pdf) INN (CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL) SOLUPREP S (3M HEALTH CARE) APPROVAL= AP YEAR= 2018 , 1234 ; DESMOPRESSIN ; 16679-58-6 ; 1978 ; ; ; CLASS HORMONES -- ANTIDIURETIC -- HEMOSTATICS -- RENAL AGENTS -- SYNTHETIC ANALOGUE OF THE NATURAL PITUITARY HORMONE 8-ARGININE VASOPRESSIN (ADH) , ; NDA 017922 (label 17922.pdf) INN (DESMOPRESSIN ACETATE) DDAVP (FERRING PHARMS INC) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 018938 (label 18938.pdf) INN (DESMOPRESSIN ACETATE) DDAVP (FERRING PHARMS INC) APPROVAL= AP YEAR= 1984 , NDA 019776 (pdf 19776.pdf not found) INN (DESMOPRESSIN ACETATE) CONCENTRAID (FERRING) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 019955 (label 19955.pdf) INN (DESMOPRESSIN ACETATE) DDAVP (FERRING PHARMS INC) APPROVAL= AP YEAR= 1995 , NDA 020355 (label 20355.pdf) INN (DESMOPRESSIN ACETATE) STIMATE (FERRING PHARMS INC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 021333 (label 21333.pdf) INN (DESMOPRESSIN ACETATE) MINIRIN (FERRING) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021795 (label 21795.pdf) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (FERRING) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 074574 (pdf 74574.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE PRESERVATIVE FREE (BEDFORD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074575 (pdf 74575.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (BEDFORD) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074830 (pdf 74830.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (BAUSCH) APPROVAL= AP YEAR= 1999 , NDA 074888 (pdf 74888.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (MEITHEAL) APPROVAL= AP YEAR= 1997 , NDA 075220 (pdf 75220.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 076470 (pdf 76470.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076703 (pdf 76703.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE NEEDS NO REFRIGERATION (APOTEX) APPROVAL= AP YEAR= 2005 , NDA 077122 (pdf 77122.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077414 (pdf 77414.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (APOTEX INC) APPROVAL= AP YEAR= 2006 , NDA 077212 (pdf 77212.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078271 (pdf 78271.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE NEEDS NO REFRIGERATION (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091280 (pdf 91280.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 201831 (pdf 201831.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 200653 (pdf 200653.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (NATCO PHARMA USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 201656 (label 201656.pdf) INN (DESMOPRESSIN ACETATE) NOCTIVA (ACERUS PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207880 (pdf 207880.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2017 , NDA 091345 (pdf 91345.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE NEEDS NO REFRIGERATION (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204695 (pdf 204695.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 204751 (pdf 204751.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 022517 (label 22517.pdf) INN (DESMOPRESSIN ACETATE) NOCDURNA (FERRING PHARMS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 091374 (pdf 91374.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (AM REGENT) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208357 (pdf 208357.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (NOVAST LABS) APPROVAL= AP YEAR= 2019 , NDA 210371 (pdf 210371.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (ABHAI LLC) APPROVAL= AP YEAR= 2019 , NDA 210218 (pdf 210218.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (UBI) APPROVAL= AP YEAR= 2020 , NDA 210223 (pdf 210223.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (UBI) APPROVAL= AP YEAR= 2020 , NDA 215961 (pdf 215961.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 216922 (pdf 216922.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216904 (pdf 216904.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (GLAND) APPROVAL= AP YEAR= 2023 , NDA 213095 (pdf 213095.pdf not found) INN (DESMOPRESSIN ACETATE) DESMOPRESSIN ACETATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2024 , 1235 ; CERULETIDE ; 17650-98-5 ; 0 ; DISCONTINUED ; ; CLASS VARIOUS -- SPASMOGENIC EFFECT -- TESTS FOR BILE DUCT PATENCY -- DIAGNOSTIC AGENTS , ; NDA 018296 (pdf 18296.pdf not found) INN (CERULETIDE DIETHYLAMINE) TYMTRAN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , 1236 ; MORPHINE ; 57-27-2 ; 1984 ; ; NATURAL MOLECULE C00001889 ; CLASS NERVOUS SYSTEM -- ANALGESIC -- NARCOTICS -- OPIATE -- OPIOID RECEPTOR AGONISTS , ; NDA 018565 (label 18565.pdf) INN (MORPHINE SULFATE) DURAMORPH PF (HIKMA) APPROVAL= AP YEAR= 1984 , NDA 019516 (label 19516.pdf) INN (MORPHINE SULFATE) MS CONTIN (PURDUE PHARMA LP) APPROVAL= AP YEAR= 1987 , NDA 019916 (label 19916.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (ICU MEDICAL INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019917 (label 19917.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (ICU MEDICAL INC) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019977 (pdf 19977.pdf not found) INN (MORPHINE SULFATE) ORAMORPH SR (XANODYNE PHARMS INC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 019999 (label 19999.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE AUTOINJECTOR (MERIDIAN MEDCL TECHN) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020616 (label 20616.pdf) INN (MORPHINE SULFATE) KADIAN (ALLERGAN) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020631 (label 20631.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 021260 (label 21260.pdf) INN (MORPHINE SULFATE) AVINZA (KING PHARMS LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021671 (label 21671.pdf) INN (MORPHINE SULFATE) DEPODUR (PACIRA PHARMS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022195 (label 22195.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 022207 (label 22207.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2008 , NDA 071050 (pdf 71050.pdf not found) INN (MORPHINE SULFATE) ASTRAMORPH PF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071051 (pdf 71051.pdf not found) INN (MORPHINE SULFATE) ASTRAMORPH PF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071052 (pdf 71052.pdf not found) INN (MORPHINE SULFATE) ASTRAMORPH PF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071053 (pdf 71053.pdf not found) INN (MORPHINE SULFATE) ASTRAMORPH PF (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 071849 (pdf 71849.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071850 (pdf 71850.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 073373 (pdf 73373.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073374 (pdf 73374.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073375 (pdf 73375.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073376 (pdf 73376.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073509 (pdf 73509.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1992 , NDA 073510 (pdf 73510.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1992 , NDA 074769 (label 74769.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 1998 , NDA 074862 (label 74862.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 1998 , NDA 075295 (pdf 75295.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1998 , NDA 075407 (pdf 75407.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (DAVA PHARMS INC) APPROVAL= AP YEAR= 2000 , NDA 075656 (pdf 75656.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076412 (pdf 76412.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003 , NDA 076438 (pdf 76438.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003 , NDA 076720 (pdf 76720.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076733 (pdf 76733.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077855 (pdf 77855.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 022321 (label 22321.pdf) INN (MORPHINE SULFATE NALTREXONE HYDROCHLORIDE) EMBEDA (ALPHARMA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 200812 (pdf 200812.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200824 (pdf 200824.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (RISING) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201517 (label 201517.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202348 (pdf 202348.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2011 , NDA 202515 (label 202515.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (HOSPIRA INC) APPROVAL= AP YEAR= 2011 , NDA 201947 (pdf 201947.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (VISTAPHARM) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078761 (pdf 78761.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012 , NDA 201574 (pdf 201574.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (PADAGIS US) APPROVAL= AP YEAR= 2012 , NDA 079040 (pdf 79040.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 202104 (pdf 202104.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2013 , NDA 204223 (label 204223.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2013 , NDA 201011 (pdf 201011.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202718 (pdf 202718.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203518 (pdf 203518.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 203849 (label 203849.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 , NDA 205758 (pdf 205758.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2015 , NDA 202309 (label 202309.pdf) INN (MORPHINE SULFATE) MORPHINE SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202310 (pdf 202310.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203602 (pdf 203602.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 206544 (label 206544.pdf) INN (MORPHINE SULFATE) MORPHABOND ER (OHEMO LIFE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 091357 (pdf 91357.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 200411 (pdf 200411.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203519 (pdf 203519.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 204053 (pdf 204053.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2016 OBSOLETE , NDA 205386 (pdf 205386.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205634 (pdf 205634.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206420 (pdf 206420.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206573 (pdf 206573.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (PHARM ASSOC) APPROVAL= AP YEAR= 2016 , NDA 206308 (pdf 206308.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208603 (label 208603.pdf) INN (MORPHINE SULFATE) ARYMO ER (ZYLA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208809 (pdf 208809.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205509 (pdf 205509.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 204393 (pdf 204393.pdf not found) INN (MORPHINE SULFATE) MITIGO (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2018 , NDA 210610 (pdf 210610.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2019 , NDA 212451 (pdf 212451.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 202861 (pdf 202861.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (INTL MEDICATION SYS) APPROVAL= AP YEAR= 2021 , NDA 207270 (pdf 207270.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211454 (pdf 211454.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021 , NDA 203158 (pdf 203158.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (NORTEC DEV ASSOC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215584 (pdf 215584.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (INGENUS PHARMS NJ) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211452 (pdf 211452.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 215194 (pdf 215194.pdf not found) INN (MORPHINE SULFATE) MORPHINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2023 , 1237 ; NICOTINE ; 54-11-5 ; 1984 ; ; NATURAL MOLECULE C00002057 ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ANTI-CRAVING AGENTS -- AUTONOMIC DRUGS -- GANGLIONIC STIMULANTS -- NICOTINIC CHOLINERGIC RECEPTOR AGONISTS , ; NDA 018612 (label 18612.pdf) INN (NICOTINE POLACRILEX) NICORETTE (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY , NDA 019983 (label 19983.pdf) INN (NICOTINE) PROSTEP (AVEVA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020066 (label 20066.pdf) INN (NICOTINE POLACRILEX) NICORETTE (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1992 , NDA 020076 (label 20076.pdf) INN (NICOTINE) HABITROL (DR REDDYS LABS SA) APPROVAL= AP YEAR= 1991 , NDA 020165 (label 20165.pdf) INN (NICOTINE) NICODERM CQ (CHATTEM SANOFI) APPROVAL= AP YEAR= 1991 , NDA 020385 (label 20385.pdf) INN (NICOTINE) NICOTROL (PFIZER INC) APPROVAL= AP YEAR= 1996 , NDA 020536 (pdf 20536.pdf not found) INN (NICOTINE) NICOTROL (MCNEIL CONS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020714 (label 20714.pdf) INN (NICOTINE) NICOTROL (PFIZER) APPROVAL= AP YEAR= 1997 , NDA 021330 (label 21330.pdf) INN (NICOTINE POLACRILEX) NICORETTE (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002 , NDA 074507 (label 74507.pdf) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 1999 , NDA 074611 (pdf 74611.pdf not found) INN (NICOTINE) NICOTINE (AVEVA) APPROVAL= AP YEAR= 1997 OBSOLETE , NDA 074612 (pdf 74612.pdf not found) INN (NICOTINE) NICOTINE (AVEVA) APPROVAL= AP YEAR= 1997 , NDA 074645 (pdf 74645.pdf not found) INN (NICOTINE) NICOTINE (AVEVA) APPROVAL= AP YEAR= 1997 OBSOLETE , NDA 074707 (label 74707.pdf) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 1999 , NDA 076568 (pdf 76568.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2004 , NDA 076569 (pdf 76569.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2004 , NDA 076775 (pdf 76775.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 , NDA 076776 (pdf 76776.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076777 (pdf 76777.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 , NDA 076778 (pdf 76778.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076779 (pdf 76779.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 , NDA 076789 (pdf 76789.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (L PERRIGO CO) APPROVAL= AP YEAR= 2004 , NDA 077007 (pdf 77007.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2006 , NDA 077656 (pdf 77656.pdf not found) INN (NICOTINE POLACRILEX) THRIVE (GLAXOSMITHKLINE CONS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077658 (pdf 77658.pdf not found) INN (NICOTINE POLACRILEX) THRIVE (GLAXOSMITHKLINE CONS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078325 (pdf 78325.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2006 , NDA 078326 (pdf 78326.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2006 , NDA 078546 (pdf 78546.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2007 , NDA 078547 (pdf 78547.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2007 , NDA 078967 (pdf 78967.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078968 (pdf 78968.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022360 (label 22360.pdf) INN (NICOTINE POLACRILEX) NICORETTE (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2009 , NDA 076880 (pdf 76880.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077850 (pdf 77850.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078697 (pdf 78697.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2008 , NDA 078699 (pdf 78699.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2008 , NDA 079038 (pdf 79038.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2009 , NDA 079044 (pdf 79044.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2009 , NDA 079216 (pdf 79216.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2009 , NDA 079219 (pdf 79219.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2009 , NDA 090711 (pdf 90711.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2009 , NDA 090821 (pdf 90821.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2009 , NDA 091349 (pdf 91349.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 , NDA 091354 (pdf 91354.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2011 , NDA 203690 (pdf 203690.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2012 , NDA 204794 (pdf 204794.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2016 , NDA 204833 (pdf 204833.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2016 , NDA 206393 (pdf 206393.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2016 , NDA 206394 (pdf 206394.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PERRIGO R AND D) APPROVAL= AP YEAR= 2016 , NDA 208875 (pdf 208875.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2019 , NDA 209206 (pdf 209206.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2018 , NDA 209519 (pdf 209519.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2018 , NDA 207868 (pdf 207868.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (PLD ACQUISITIONS) APPROVAL= AP YEAR= 2019 , NDA 209520 (pdf 209520.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2019 , NDA 210711 (pdf 210711.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2019 , NDA 210712 (pdf 210712.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2019 , NDA 212056 (pdf 212056.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2019 , NDA 212057 (pdf 212057.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (P AND L) APPROVAL= AP YEAR= 2020 , NDA 212796 (pdf 212796.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 , NDA 212983 (pdf 212983.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 , NDA 213233 (pdf 213233.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2020 , NDA 213266 (pdf 213266.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215357 (pdf 215357.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 214354 (pdf 214354.pdf not found) INN (NICOTINE POLACRILEX) NICOTINE POLACRILEX (FERTIN PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1238 ; BITOLTEROL ; 30392-40-6 ; 1984 ; DISCONTINUED ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- SELECTIVE BETA-2-ADRENORECEPTOR AGONISTS , ; NDA 018770 (pdf 18770.pdf not found) INN (BITOLTEROL MESYLATE) TORNALATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 019548 (pdf 19548.pdf not found) INN (BITOLTEROL MESYLATE) TORNALATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1239 ; BITOLTEROL ; 30392-40-6 ; 1984 ; DISCONTINUED ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- SELECTIVE BETA-2-ADRENORECEPTOR AGONISTS , ; NDA 018770 (pdf 18770.pdf not found) INN (BITOLTEROL MESYLATE) TORNALATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 019548 (pdf 19548.pdf not found) INN (BITOLTEROL MESYLATE) TORNALATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1240 ; PENBUTOLOL ; 38363-40-5 ; 1987 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- BETA ADRENERGIC ANTAGONIST , ; NDA 018976 (label 18976.pdf) INN (PENBUTOLOL SULFATE) LEVATOL (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , 1241 ; PIRBUTEROL ; 38677-81-5 ; 1986 ; DISCONTINUED ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- BETA ADRENERGIC AGONISTS -- CARDIOTONIC AGENTS , ; NDA 019009 (label 19009.pdf) INN (PIRBUTEROL ACETATE) MAXAIR (BAUSCH) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 020014 (pdf 20014.pdf not found) INN (PIRBUTEROL ACETATE) MAXAIR (BAUSCH) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1242 ; PIRBUTEROL ; 38677-81-5 ; 1986 ; DISCONTINUED ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- BETA ADRENERGIC AGONISTS -- CARDIOTONIC AGENTS , ; NDA 019009 (label 19009.pdf) INN (PIRBUTEROL ACETATE) MAXAIR (BAUSCH) APPROVAL= AP YEAR= 1986 NEWMOLECULARENTITY DISCONTINUED , NDA 020014 (pdf 20014.pdf not found) INN (PIRBUTEROL ACETATE) MAXAIR (BAUSCH) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1243 ; SUFENTANIL ; 56030-54-7 ; 1984 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- ANESTHETICS -- NARCOTICS -- OPIATE AGONISTS , ; NDA 019050 (label 19050.pdf) INN (SUFENTANIL CITRATE) SUFENTA PRESERVATIVE FREE (RISING) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY , NDA 074406 (pdf 74406.pdf not found) INN (SUFENTANIL CITRATE) SUFENTANIL CITRATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 074413 (pdf 74413.pdf not found) INN (SUFENTANIL CITRATE) SUFENTANIL CITRATE (HIKMA) APPROVAL= AP YEAR= 1995 , NDA 074534 (pdf 74534.pdf not found) INN (SUFENTANIL CITRATE) SUFENTANIL CITRATE (HOSPIRA) APPROVAL= AP YEAR= 1996 , NDA 209128 (label 209128.pdf) INN (SUFENTANIL CITRATE) DSUVIA (VERTICAL PHARMS) APPROVAL= AP YEAR= 2018 , 1244 ; BUTOCONAZOLE ; 64872-76-0 ; 1995 ; ; ; CLASS GENITO -- ANTIFUNGAL -- INHIBITION OF STEROID SYNTHESIS (INHIBITION OF CONVERSION OF LANOSTEROL TO ERGOSTEROL) , ; NDA 019215 (pdf 19215.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT (ROCHE PALO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019359 (pdf 19359.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT (ROCHE PALO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019881 (label 19881.pdf) INN (BUTOCONAZOLE NITRATE) BUTOCONAZOLE NITRATE (PADAGIS US) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020421 (pdf 20421.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT 3 (BAYER) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 200923 (pdf 200923.pdf not found) INN (BUTOCONAZOLE NITRATE) GYNAZOLE-1 (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , 1245 ; BUTOCONAZOLE ; 64872-76-0 ; 1995 ; ; ; CLASS GENITO -- ANTIFUNGAL -- INHIBITION OF STEROID SYNTHESIS (INHIBITION OF CONVERSION OF LANOSTEROL TO ERGOSTEROL) , ; NDA 019215 (pdf 19215.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT (ROCHE PALO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019359 (pdf 19359.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT (ROCHE PALO) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019881 (label 19881.pdf) INN (BUTOCONAZOLE NITRATE) BUTOCONAZOLE NITRATE (PADAGIS US) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020421 (pdf 20421.pdf not found) INN (BUTOCONAZOLE NITRATE) FEMSTAT 3 (BAYER) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 200923 (pdf 200923.pdf not found) INN (BUTOCONAZOLE NITRATE) GYNAZOLE-1 (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , 1246 ; PENTAMIDINE ; 100-33-4 ; 1984 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL AGENTS -- TRYPANOCIDAL AGENTS -- INTERFERES WITH MICROBIAL NUCLEAR 5 METABOLISM BY INHIBITION OF DNA, RNA, PHOSPHOLIPID AND PROTEIN SYNTHESIS -- ACTIVE AGAINST PNEUMOCYSTIS JIROVECI (PJP) -- GROUP I INTRON SPLICE INHIBITOR -- ANTIMALARIALS , ; NDA 019264 (pdf 19264.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY , NDA 019887 (label 19887.pdf) INN (PENTAMIDINE ISETHIONATE) NEBUPENT (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1989 , NDA 073447 (pdf 73447.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTACARINAT (ARMOUR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073479 (pdf 73479.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 073617 (pdf 73617.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074303 (pdf 74303.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (WATSON LABS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 206666 (pdf 206666.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (SETON PHARMS) APPROVAL= AP YEAR= 2017 , NDA 206667 (pdf 206667.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (SETON PHARMS) APPROVAL= AP YEAR= 2019 , NDA 213806 (pdf 213806.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2021 , NDA 206982 (pdf 206982.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (XGEN PHARMS) APPROVAL= AP YEAR= 2022 , NDA 206983 (pdf 206983.pdf not found) INN (PENTAMIDINE ISETHIONATE) PENTAMIDINE ISETHIONATE (X-GEN PHARMS INC) APPROVAL= AP YEAR= 2023 , 1247 ; MILRINONE ; 78415-72-2 ; 1987 ; ; ; CLASS CARDIOVASCULAR -- POSITIVE INOTROPE -- CARDIOTONIC -- PHOSPHODIESTERASE INHIBITORS -- PLATELET AGGREGATION INHIBITORS -- VASODILATOR AGENTS , ; NDA 019436 (label 19436.pdf) INN (MILRINONE LACTATE) PRIMACOR (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY DISCONTINUED , NDA 020343 (pdf 20343.pdf not found) INN (MILRINONE LACTATE) PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 075510 (pdf 75510.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075530 (pdf 75530.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 075660 (label 75660.pdf) INN (MILRINONE LACTATE) MILRINONE LACTATE (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 075830 (label 75830.pdf) INN (MILRINONE LACTATE) MILRINONE LACTATE (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075834 (label 75834.pdf) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2002 , NDA 075852 (label 75852.pdf) INN (MILRINONE LACTATE) MILRINONE LACTATE (HIKMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075884 (pdf 75884.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075885 (pdf 75885.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075936 (pdf 75936.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 076013 (pdf 76013.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (INTL MEDICATED) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076259 (pdf 76259.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076414 (pdf 76414.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076427 (pdf 76427.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2004 , NDA 076428 (pdf 76428.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077151 (pdf 77151.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (WOODWARD) APPROVAL= AP YEAR= 2005 , NDA 077190 (pdf 77190.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 078113 (pdf 78113.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 , NDA 090038 (pdf 90038.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN PLASTIC CONTAINER (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 077966 (pdf 77966.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2010 , NDA 203280 (pdf 203280.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (HOSPIRA) APPROVAL= AP YEAR= 2014 , NDA 211671 (pdf 211671.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (MEITHEAL) APPROVAL= AP YEAR= 2020 , NDA 213585 (pdf 213585.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 209666 (pdf 209666.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE IN DEXTROSE 5% (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 214380 (pdf 214380.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 216373 (pdf 216373.pdf not found) INN (MILRINONE LACTATE) MILRINONE LACTATE (SHANDONG) APPROVAL= AP YEAR= 2023 , 1248 ; PIPECURONIUM ; 68399-58-6 ; 1990 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- MUSCLE RELAXANT -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- CHOLINERGIC RECEPTOR -- NICOTINIC RECEPTOR ANTAGONISTS -- CURARIFORM FAMILY -- ANESTHESIA , ; NDA 019638 (pdf 19638.pdf not found) INN (PIPECURONIUM BROMIDE) ARDUAN (ORGANON USA INC) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , 1249 ; OCTREOTIDE ; 83150-76-9 ; 1988 ; ; ; CLASS HORMONES -- HORMONE REPLACEMENT AGENTS -- SOMATOSTATIN MIMICK -- REDUCE BLOOD LEVELS OF GROWTH HORMONE AND IGF-I (SOMATOMEDIN C) IN ACROMEGALY PATIENTS -- SYMPTOMATIC TREATMENT , ; NDA 019667 (label 19667.pdf) INN (OCTREOTIDE ACETATE) SANDOSTATIN (NOVARTIS) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 021008 (label 21008.pdf) INN (OCTREOTIDE ACETATE) SANDOSTATIN LAR (NOVARTIS) APPROVAL= AP YEAR= 1998 , NDA 075957 (pdf 75957.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (MEITHEAL) APPROVAL= AP YEAR= 2005 , NDA 075959 (pdf 75959.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (MEITHEAL) APPROVAL= AP YEAR= 2005 , NDA 076313 (pdf 76313.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE PRESERVATIVE FREE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2005 , NDA 076330 (pdf 76330.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2005 , NDA 077329 (pdf 77329.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077330 (pdf 77330.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077331 (pdf 77331.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077372 (pdf 77372.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077373 (pdf 77373.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077450 (pdf 77450.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 077457 (pdf 77457.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2006 , NDA 079198 (pdf 79198.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE PRESERVATIVE FREE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2011 , NDA 090985 (pdf 90985.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE PRESERVATIVE FREE (WOCKHARDT USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090986 (pdf 90986.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (WOCKHARDT USA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090834 (pdf 90834.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE PRESERVATIVE FREE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 091041 (pdf 91041.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2013 , NDA 203765 (pdf 203765.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 204669 (pdf 204669.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208232 (label 208232.pdf) INN (OCTREOTIDE ACETATE) MYCAPSSA (CHIESI) APPROVAL= AP YEAR= 2020 , NDA 213224 (label 213224.pdf) INN (OCTREOTIDE ACETATE) BYNFEZIA PEN (SUN PHARM) APPROVAL= AP YEAR= 2020 OBSOLETE , NDA 216807 (pdf 216807.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216839 (pdf 216839.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 210317 (pdf 210317.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2023 , NDA 217860 (pdf 217860.pdf not found) INN (OCTREOTIDE ACETATE) OCTREOTIDE ACETATE (SHUANGCHENG) APPROVAL= AP YEAR= 2024 , 1250 ; DOXAZOSIN ; 74191-85-8 ; 1990 ; ; ; CLASS CARDIOVASCULAR -- ADRENOCEPTOR (ALPHA1) ANTAGONIST -- ANTIHYPERTENSIVE -- VASODILATOR AGENTS -- TREATMENT OF PROSTATIC HYPERPLASIA (BPH) , ; NDA 019668 (label 19668.pdf) INN (DOXAZOSIN MESYLATE) CARDURA (VIATRIS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY , NDA 021269 (label 21269.pdf) INN (DOXAZOSIN MESYLATE) CARDURA XL (VIATRIS) APPROVAL= AP YEAR= 2005 , NDA 075353 (pdf 75353.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075426 (pdf 75426.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (WATSON LABS INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075432 (pdf 75432.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ANI PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075453 (pdf 75453.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075466 (pdf 75466.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (GENPHARM) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075509 (pdf 75509.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2000 , NDA 075536 (pdf 75536.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075574 (pdf 75574.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075580 (pdf 75580.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (APOTEX) APPROVAL= AP YEAR= 2000 , NDA 075609 (label 75609.pdf) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (NESHER PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075646 (pdf 75646.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075750 (pdf 75750.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (PLIVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076161 (pdf 76161.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 202824 (pdf 202824.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 208719 (pdf 208719.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205210 (pdf 205210.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209013 (pdf 209013.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 , NDA 212727 (pdf 212727.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (RISING) APPROVAL= AP YEAR= 2022 , NDA 212329 (pdf 212329.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (UNICHEM) APPROVAL= AP YEAR= 2024 , 1251 ; DOXAZOSIN ; 74191-85-8 ; 1990 ; ; ; CLASS CARDIOVASCULAR -- ADRENOCEPTOR (ALPHA1) ANTAGONIST -- ANTIHYPERTENSIVE -- VASODILATOR AGENTS -- TREATMENT OF PROSTATIC HYPERPLASIA (BPH) , ; NDA 019668 (label 19668.pdf) INN (DOXAZOSIN MESYLATE) CARDURA (VIATRIS) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY , NDA 021269 (label 21269.pdf) INN (DOXAZOSIN MESYLATE) CARDURA XL (VIATRIS) APPROVAL= AP YEAR= 2005 , NDA 075353 (pdf 75353.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (TEVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075426 (pdf 75426.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (WATSON LABS INC) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075432 (pdf 75432.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ANI PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075453 (pdf 75453.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075466 (pdf 75466.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (GENPHARM) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075509 (pdf 75509.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2000 , NDA 075536 (pdf 75536.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (TEVA) APPROVAL= AP YEAR= 2000 , NDA 075574 (pdf 75574.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075580 (pdf 75580.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (APOTEX) APPROVAL= AP YEAR= 2000 , NDA 075609 (label 75609.pdf) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (NESHER PHARMS) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075646 (pdf 75646.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075750 (pdf 75750.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (PLIVA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076161 (pdf 76161.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 202824 (pdf 202824.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 208719 (pdf 208719.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205210 (pdf 205210.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209013 (pdf 209013.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 , NDA 212727 (pdf 212727.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (RISING) APPROVAL= AP YEAR= 2022 , NDA 212329 (pdf 212329.pdf not found) INN (DOXAZOSIN MESYLATE) DOXAZOSIN MESYLATE (UNICHEM) APPROVAL= AP YEAR= 2024 , 1252 ; GOSERELIN ; 65807-02-5 ; 1989 ; ; ; CLASS ANTINEOPLASTIC -- PROSTATE CANCER (THERAPEUTIC) -- GONADOTROPIN RELEASING HORMONE (GNRH) AGONIST -- INHIBITS PITUITARY GONADOTROPIN SECRETION , ; NDA 019726 (label 19726.pdf) INN (GOSERELIN ACETATE) ZOLADEX (TERSERA) APPROVAL= AP YEAR= 1989 NEWMOLECULARENTITY , NDA 020578 (label 20578.pdf) INN (GOSERELIN ACETATE) ZOLADEX (TERSERA) APPROVAL= AP YEAR= 1996 , 1253 ; NAFARELIN ; 76932-56-4 ; 1990 ; ; ; CLASS HORMONES -- TREATMENT OF CENTRAL PRECOCIOUS PUBERTY (CPP) -- GONADOTROPIN-RELEASING HORMONE AGONIST , ; NDA 019886 (label 19886.pdf) INN (NAFARELIN ACETATE) SYNAREL (PFIZER) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY , 1254 ; FENOLDOPAM ; 67227-56-9 ; 1997 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- SHORT-TERM MANAGEMENT OF SEVERE HYPERTENSION -- DOPAMINE AGONISTS -- VASODILATOR AGENTS -- BINDS MODERATLY TO ALPHA-2 ADRENERGIC RECEPTOR -- R-ISOMER HAS 250-FOLD HIGHER AFFINITY THAN S-ISOMER , ; NDA 019922 (label 19922.pdf) INN (FENOLDOPAM MESYLATE) CORLOPAM (HOSPIRA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 076582 (pdf 76582.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076656 (pdf 76656.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (LUITPOLD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077155 (pdf 77155.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077826 (pdf 77826.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2007 DISCONTINUED , 1255 ; FENOLDOPAM ; 67227-56-9 ; 1997 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- SHORT-TERM MANAGEMENT OF SEVERE HYPERTENSION -- DOPAMINE AGONISTS -- VASODILATOR AGENTS -- BINDS MODERATLY TO ALPHA-2 ADRENERGIC RECEPTOR -- R-ISOMER HAS 250-FOLD HIGHER AFFINITY THAN S-ISOMER , ; NDA 019922 (label 19922.pdf) INN (FENOLDOPAM MESYLATE) CORLOPAM (HOSPIRA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 076582 (pdf 76582.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (HIKMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076656 (pdf 76656.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (LUITPOLD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 077155 (pdf 77155.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077826 (pdf 77826.pdf not found) INN (FENOLDOPAM MESYLATE) FENOLDOPAM MESYLATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 2007 DISCONTINUED , 1256 ; PAMIDRONATE ; 57248-88-1 ; 1991 ; ; ; CLASS MUSCOLO-SKELETAL SYSTEM -- ANTI-INFLAMMATORY AGENTS -- ANTINEOPLASTIC AGENTS -- BISPHOSPHONATES -- BONE DENSITY CONSERVATION AGENTS -- INHIBITOR , ; NDA 020036 (label 20036.pdf) INN (PAMIDRONATE DISODIUM) AREDIA (NOVARTIS) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 020927 (label 20927.pdf) INN (PAMIDRONATE DISODIUM) AREDIA (NOVARTIS) APPROVAL= AP YEAR= 1998 NEWAPPLICATION , NDA 021113 (label 21113.pdf) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 075290 (label 75290.pdf) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 075594 (pdf 75594.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (AESGEN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075773 (pdf 75773.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075841 (pdf 75841.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (HOSPIRA) APPROVAL= AP YEAR= 2002 , NDA 076153 (pdf 76153.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076207 (pdf 76207.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 078156 (pdf 78156.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (DR REDDYS) APPROVAL= AP YEAR= 2008 , NDA 078942 (pdf 78942.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (AM REGENT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077433 (pdf 77433.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (AREVA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077703 (pdf 77703.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078300 (pdf 78300.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (MN PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078373 (pdf 78373.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 078520 (pdf 78520.pdf not found) INN (PAMIDRONATE DISODIUM) PAMIDRONATE DISODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , 1257 ; SUMATRIPTAN ; 103628-46-2 ; 1992 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- SELECTIVE SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS -- 5-HYDROXYTRYPTAMINE TYPE 1 RECEPTORS , ; NDA 020080 (label 20080.pdf) INN (SUMATRIPTAN SUCCINATE) IMITREX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1992 NEWMOLECULARENTITY , NDA 020132 (label 20132.pdf) INN (SUMATRIPTAN SUCCINATE) IMITREX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1995 , NDA 020626 (label 20626.pdf) INN (SUMATRIPTAN) IMITREX (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 , NDA 021926 (label 21926.pdf) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) TREXIMET (CURRAX) APPROVAL= AP YEAR= 2008 , NDA 076554 (pdf 76554.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076572 (pdf 76572.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076840 (pdf 76840.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (TEVA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 076847 (pdf 76847.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2009 , NDA 076933 (pdf 76933.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (WATSON LABS) APPROVAL= AP YEAR= 2009 , NDA 076976 (pdf 76976.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (FOSUN PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077163 (pdf 77163.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (MYLAN) APPROVAL= TA YEAR= 2007 , NDA 077332 (pdf 77332.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077696 (pdf 77696.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (CHARTWELL MOLECULAR) APPROVAL= TA YEAR= 2007 , NDA 077744 (pdf 77744.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (MYLAN) APPROVAL= AP YEAR= 2009 , NDA 077907 (label 77907.pdf) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078241 (pdf 78241.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ROXANE) APPROVAL= TA YEAR= 2007 , NDA 078318 (label 78318.pdf) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (TEVA PARENTERAL) APPROVAL= TA YEAR= 2008 , NDA 078327 (pdf 78327.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2009 , NDA 078593 (label 78593.pdf) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (WOCKHARDT) APPROVAL= AP YEAR= 2009 , NDA 022239 (label 22239.pdf) INN (SUMATRIPTAN SUCCINATE) SUMAVEL DOSEPRO (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077871 (pdf 77871.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078067 (label 78067.pdf) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SANDOZ) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078284 (pdf 78284.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ORBION PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078295 (pdf 78295.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SUN PHARM INDS) APPROVAL= AP YEAR= 2009 , NDA 079123 (pdf 79123.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2009 , NDA 079240 (pdf 79240.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079242 (label 79242.pdf) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2009 , NDA 022377 (label 22377.pdf) INN (SUMATRIPTAN SUCCINATE) ALSUMA (MERIDIAN MEDCL) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079122 (pdf 79122.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (WOCKHARDT) APPROVAL= AP YEAR= 2008 OBSOLETE , NDA 090310 (pdf 90310.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ZYDUS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090314 (pdf 90314.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090641 (pdf 90641.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090753 (pdf 90753.pdf not found) INN (SUMATRIPTAN NAPROXEN SODIUM) SUMATRIPTAN NAPROXEN SODIUM (PAR PHARM) APPROVAL= TA YEAR= 2013 , NDA 090930 (pdf 90930.pdf not found) INN (SUMATRIPTAN NAPROXEN SODIUM) SUMATRIPTAN NAPROXEN SODIUM (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 090358 (pdf 90358.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 200183 (pdf 200183.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 200263 (pdf 200263.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (COREPHARMA) APPROVAL= AP YEAR= 2012 , NDA 078298 (pdf 78298.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090872 (pdf 90872.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (RISING) APPROVAL= AP YEAR= 2018 , NDA 202278 (label 202278.pdf) INN (SUMATRIPTAN SUCCINATE) ZECUITY (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202758 (pdf 202758.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 090495 (pdf 90495.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (DR REDDYS) APPROVAL= AP YEAR= 2014 , NDA 203322 (pdf 203322.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 078319 (pdf 78319.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (ANTARES PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204841 (pdf 204841.pdf not found) INN (SUMATRIPTAN) SUMATRIPTAN (LANNETT CO INC) APPROVAL= AP YEAR= 2016 , NDA 206099 (label 206099.pdf) INN (SUMATRIPTAN SUCCINATE) ONZETRA XSAIL (CURRAX) APPROVAL= AP YEAR= 2016 , NDA 208223 (label 208223.pdf) INN (SUMATRIPTAN SUCCINATE) ZEMBRACE SYMTOUCH (TONIX MEDS) APPROVAL= AP YEAR= 2016 , NDA 207457 (pdf 207457.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 202803 (pdf 202803.pdf not found) INN (NAPROXEN SODIUM SUMATRIPTAN SUCCINATE) SUMATRIPTAN AND NAPROXEN SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 210884 (label 210884.pdf) INN (SUMATRIPTAN) TOSYMRA (TONIX MEDS) APPROVAL= AP YEAR= 2019 , NDA 213465 (pdf 213465.pdf not found) INN (SUMATRIPTAN) SUMATRIPTAN (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 , NDA 213650 (pdf 213650.pdf not found) INN (SUMATRIPTAN) SUMATRIPTAN (PERRIGO UK FINCO) APPROVAL= AP YEAR= 2020 , NDA 208967 (pdf 208967.pdf not found) INN (SUMATRIPTAN) SUMATRIPTAN (FLORIDA) APPROVAL= AP YEAR= 2021 , NDA 214209 (pdf 214209.pdf not found) INN (SUMATRIPTAN) SUMATRIPTAN (CIPLA) APPROVAL= AP YEAR= 2021 , NDA 213998 (pdf 213998.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (SOMERSET) APPROVAL= AP YEAR= 2021 , NDA 207101 (pdf 207101.pdf not found) INN (SUMATRIPTAN SUCCINATE) SUMATRIPTAN SUCCINATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1258 ; PENTOSAN POLYSULFATE ; 9014-63-5 ; 1996 ; ; ; CLASS CARDIOVASCULAR -- ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL -- WEAK ANTICOAGULANTS (1/15 THE ACTIVITY OF HEPARIN) -- FIBRINOLYTIC -- HEPARIN-LIKE MACROMOLECULAR CARBOHYDRATE DERIVATIVE -- METABOLIZED BY PARTIAL DESULFATION IN THE LIVER AND SPLEEN , ; NDA 020193 (label 20193.pdf) INN (PENTOSAN POLYSULFATE SODIUM) ELMIRON (JANSSEN PHARMS) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , 1259 ; ROCURONIUM ; 143558-00-3 ; 1994 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- NEUROMUSCULAR NONDEPOLARIZING AGENTS -- BLOCKER -- SKELETAL MUSCLE RELAXANTS -- ANESTHESIA -- CHOLINERGIC RECEPTOR , ; NDA 020214 (label 20214.pdf) INN (ROCURONIUM BROMIDE) ZEMURON (ORGANON USA INC) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 078519 (pdf 78519.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (HOSPIRA) APPROVAL= AP YEAR= 2008 , NDA 078651 (pdf 78651.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 078717 (label 78717.pdf) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079195 (pdf 79195.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (SANDOZ) APPROVAL= AP YEAR= 2008 , NDA 079199 (pdf 79199.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2008 , NDA 091458 (pdf 91458.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 091115 (pdf 91115.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (TAMARANG) APPROVAL= AP YEAR= 2012 , NDA 204679 (pdf 204679.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (WEST WARD PHARM CORP) APPROVAL= AP YEAR= 2017 , NDA 206206 (pdf 206206.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205656 (pdf 205656.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 210437 (pdf 210437.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2019 , NDA 212668 (pdf 212668.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 213453 (pdf 213453.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (MEITHEAL) APPROVAL= AP YEAR= 2023 , NDA 216234 (pdf 216234.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (CAPLIN) APPROVAL= AP YEAR= 2023 , NDA 217034 (pdf 217034.pdf not found) INN (ROCURONIUM BROMIDE) ROCURONIUM BROMIDE (HIKMA) APPROVAL= AP YEAR= 2023 , 1260 ; LEVOMETHADYL ACETATE ; 1477-40-3 ; 1993 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- OPIOID AGONIST -- NARCOTICS -- USAGE IN OPIATE ADDICTION , ; NDA 020315 (pdf 20315.pdf not found) INN (LEVOMETHADYL ACETATE HYDROCHLORIDE) ORLAAM (ROXANE) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , 1261 ; CYSTEAMINE ; 60-23-1 ; 1994 ; ; ; CLASS METABOLISM -- NEPHROPATHIC CYSTINOSIS THERAPY -- REACTANT -- CYSTEAMINE IS AN AMINOTHIOL THAT PARTICIPATES WITHIN LYSOSOMES IN A THIOL-DISULFIDE INTERCHANGE REACTION CONVERTING CYSTINE IN TO CYSTEINE AND CYSTEINE-CYSTEAMINE MIXED DISULFIDE, BOTH OF WHICH CAN EXIT THE LYSOSOME IN PATIENTS WITH CYSTINOSIS , ; NDA 020392 (label 20392.pdf) INN (CYSTEAMINE BITARTRATE) CYSTAGON (MYLAN) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY , NDA 200740 (label 200740.pdf) INN (CYSTEAMINE HYDROCHLORIDE) CYSTARAN (LEADIANT BIOSCI INC) APPROVAL= AP YEAR= 2012 , NDA 203389 (label 203389.pdf) INN (CYSTEAMINE BITARTRATE) PROCYSBI (HORIZON) APPROVAL= AP YEAR= 2013 , NDA 213491 (label 213491.pdf) INN (CYSTEAMINE BITARTRATE) PROCYSBI (HORIZON) APPROVAL= AP YEAR= 2020 , NDA 211302 (label 211302.pdf) INN (CYSTEAMINE HYDROCHLORIDE) CYSTADROPS (RECORDATI RARE) APPROVAL= AP YEAR= 2020 , 1262 ; IBUTILIDE ; 122647-31-8 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- CHANNEL BLOCKER , ; NDA 020491 (label 20491.pdf) INN (IBUTILIDE FUMARATE) CORVERT (PFIZER) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 090240 (pdf 90240.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (LUITPOLD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090643 (pdf 90643.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2010 , NDA 090924 (pdf 90924.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 204146 (pdf 204146.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 1263 ; IBUTILIDE ; 122647-31-8 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- CHANNEL BLOCKER , ; NDA 020491 (label 20491.pdf) INN (IBUTILIDE FUMARATE) CORVERT (PFIZER) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 090240 (pdf 90240.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (LUITPOLD) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090643 (pdf 90643.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2010 , NDA 090924 (pdf 90924.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 204146 (pdf 204146.pdf not found) INN (IBUTILIDE FUMARATE) IBUTILIDE FUMARATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2024 , 1264 ; TOREMIFENE ; 89778-26-7 ; 1997 ; ; ; CLASS ANTINEOPLASTIC -- ANTIESTROGENIC -- METASTATIC BREAST CANCER -- BONE DENSITY CONSERVATION AGENTS -- ESTROGEN RECEPTOR ANTAGONIST OR AGONIST , ; NDA 020497 (label 20497.pdf) INN (TOREMIFENE CITRATE) FARESTON (KYOWA KIRIN) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 208813 (pdf 208813.pdf not found) INN (TOREMIFENE CITRATE) TOREMIFENE CITRATE (RISING) APPROVAL= AP YEAR= 2018 , NDA 212818 (pdf 212818.pdf not found) INN (TOREMIFENE CITRATE) TOREMIFENE CITRATE (MSN) APPROVAL= AP YEAR= 2020 , 1265 ; ROPIVACAINE ; 84057-95-4 ; 1996 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- BLOCKER , ; NDA 020533 (label 20533.pdf) INN (ROPIVACAINE HYDROCHLORIDE) NAROPIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 078601 (pdf 78601.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (NAVINTA LLC) APPROVAL= AP YEAR= 2014 , NDA 090318 (pdf 90318.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 090194 (pdf 90194.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203955 (pdf 203955.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 205612 (label 205612.pdf) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 204636 (pdf 204636.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 , NDA 206166 (pdf 206166.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (INFORLIFE) APPROVAL= AP YEAR= 2018 , NDA 207636 (pdf 207636.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 , NDA 212808 (pdf 212808.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2020 , NDA 214074 (pdf 214074.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 210102 (pdf 210102.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216605 (pdf 216605.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 206091 (pdf 206091.pdf not found) INN (ROPIVACAINE HYDROCHLORIDE) ROPIVACAINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 , 1266 ; BALSALAZIDE ; 80573-04-2 ; 2000 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- ANTI-INFLAMMATORY AGENTS NON-STEROIDAL -- GASTROINTESTINAL AGENTS -- PROSTAGLANDIN G/H SYNTHASE INHIBITOR , ; NDA 020610 (label 20610.pdf) INN (BALSALAZIDE DISODIUM) COLAZAL (VALEANT PHARMS INTL) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY , NDA 077806 (pdf 77806.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (HIKMA) APPROVAL= AP YEAR= 2007 , NDA 077807 (pdf 77807.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (DASH PHARMS NATCO) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077883 (pdf 77883.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (APOTEX INC) APPROVAL= AP YEAR= 2007 , NDA 022205 (label 22205.pdf) INN (BALSALAZIDE DISODIUM) GIAZO (VALEANT PHARMS INTL) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 206336 (pdf 206336.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (STRIDES PHARMA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206909 (pdf 206909.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2015 , NDA 206529 (pdf 206529.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (LUPIN LTD) APPROVAL= TA YEAR= 2016 , NDA 217592 (pdf 217592.pdf not found) INN (BALSALAZIDE DISODIUM) BALSALAZIDE DISODIUM (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , 1267 ; DOLASETRON ; 115956-12-2 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- SEROTONIN 5HT3 ANTAGONIST -- ANTIEMETIC -- , ; NDA 020623 (label 20623.pdf) INN (DOLASETRON MESYLATE) ANZEMET (VALIDUS PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 020624 (label 20624.pdf) INN (DOLASETRON MESYLATE) ANZEMET (VALIDUS PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , 1268 ; SAQUINAVIR ; 127779-20-8 ; 1995 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- HIV PROTEASE INHIBITORS , ; NDA 020628 (label 20628.pdf) INN (SAQUINAVIR MESYLATE) INVIRASE (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 020828 (label 20828.pdf) INN (SAQUINAVIR) FORTOVASE (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021785 (label 21785.pdf) INN (SAQUINAVIR MESYLATE) INVIRASE (HOFFMANN-LA ROCHE) APPROVAL= AP YEAR= 2004 DISCONTINUED , 1269 ; QUETIAPINE ; 111974-69-7 ; 1997 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- DIBENZOTHIAZEPINE FAMILY -- DOPAMINE D2 RECEPTOR ANTAGONIST (IC50=329 NANOMOLAR) -- SEROTONIN (5HT2) ANTAGONIST (IC50=148 NANOMOLAR) -- SEROTONIN 5HT1A ANTAGONIST (IC50=717 NANOMOLAR) -- DOPAMINE D1 ANTAGONIST (IC50=1268 NANOMOLAR) -- HISTAMINE H1 ANTAGONIST (IC50=30 NANOMOLAR) -- ADRENERGIC ALPHA 1 RECEPTOR ANTAGONIST (IC50= 94 NANOMOLAR) -- ADRENARGIC ALPHA 2 RECEPTOR ANTAGONIST (IC50=271 NANOMOLAR) -- NO APPRECIABLE AFFINITY AT CHOLINERGIC MUSCARINIC AND BENZODIAZEPINE RECEPTORS (IC50 SUPERIOR TO 5000 NANOMOLAR) , ; NDA 020639 (label 20639.pdf) INN (QUETIAPINE FUMARATE) SEROQUEL (ASTRAZENECA) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 022047 (label 22047.pdf) INN (QUETIAPINE FUMARATE) SEROQUEL XR (ASTRAZENECA) APPROVAL= AP YEAR= 2007 , NDA 022172 (label 22172.pdf) INN (QUETIAPINE FUMARATE) SEROQUEL XR (ASTRAZENECA) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 077380 (pdf 77380.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 077745 (pdf 77745.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 090482 (label 90482.pdf) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 090681 (label 90681.pdf) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 090120 (pdf 90120.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (HIKMA) APPROVAL= AP YEAR= 2012 , NDA 090749 (pdf 90749.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (HIKMA) APPROVAL= AP YEAR= 2012 , NDA 078679 (pdf 78679.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (SANDOZ) APPROVAL= AP YEAR= 2012 , NDA 090323 (pdf 90323.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090960 (pdf 90960.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ZENNOVA) APPROVAL= AP YEAR= 2012 , NDA 091388 (pdf 91388.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 200363 (pdf 200363.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201109 (pdf 201109.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (LUPIN LTD) APPROVAL= AP YEAR= 2012 , NDA 201190 (pdf 201190.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (SUN PHARM) APPROVAL= AP YEAR= 2012 , NDA 202152 (pdf 202152.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2012 , NDA 201504 (pdf 201504.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 201762 (pdf 201762.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ACTAVIS GRP PTC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203150 (pdf 203150.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202228 (pdf 202228.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (RISING) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 203390 (pdf 203390.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ALEMBIC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202674 (pdf 202674.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (UNICHEM) APPROVAL= AP YEAR= 2016 , NDA 203359 (pdf 203359.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 202939 (label 202939.pdf) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2017 , NDA 204203 (pdf 204203.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 206252 (pdf 206252.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 206260 (label 206260.pdf) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (PHARMADAX INC) APPROVAL= AP YEAR= 2017 , NDA 090757 (pdf 90757.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204253 (pdf 204253.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207655 (pdf 207655.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 208947 (pdf 208947.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (NOVAST LABS) APPROVAL= AP YEAR= 2017 , NDA 209635 (pdf 209635.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209497 (pdf 209497.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (ALIGNSCIENCE PHARMA) APPROVAL= AP YEAR= 2018 , NDA 211405 (pdf 211405.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 204316 (pdf 204316.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 208781 (pdf 208781.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 206954 (pdf 206954.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 215478 (pdf 215478.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (UNICHEM) APPROVAL= AP YEAR= 2022 , NDA 205983 (pdf 205983.pdf not found) INN (QUETIAPINE FUMARATE) QUETIAPINE FUMARATE (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 , 1270 ; PRAMIPEXOLE ; 104632-26-0 ; 1997 ; ; ; CLASS NERVOUS SYSTEM -- NONERGOT DOPAMINE RECEPTOR AGONIST -- RESTLESS LEGS SYNDROME (RLS) -- ANTIPSYCHOTIC -- ANTIPARKINSONIAN -- ANTIGLAUCOMA -- ANTIDYSKINETICS -- DOPAMINE D2 RECEPTOR AGONIST -- DOPAMINE D4 RECEPTOR AGONIST , ; NDA 020667 (label 20667.pdf) INN (PRAMIPEXOLE DIHYDROCHLORIDE) MIRAPEX (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 077724 (pdf 77724.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077854 (pdf 77854.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 022421 (label 22421.pdf) INN (PRAMIPEXOLE DIHYDROCHLORIDE) MIRAPEX ER (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2010 , NDA 022514 (label 22514.pdf) INN (PRAMIPEXOLE DIHYDROCHLORIDE) MIRAPEX ER (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2010 NEWAPPLICATION , NDA 078894 (pdf 78894.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090190 (pdf 90190.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090764 (pdf 90764.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090781 (pdf 90781.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2010 , NDA 078551 (pdf 78551.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 078920 (pdf 78920.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2010 , NDA 090241 (pdf 90241.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090865 (pdf 90865.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2010 , NDA 091254 (pdf 91254.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (HERITAGE PHARMA AVET) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 091450 (pdf 91450.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090151 (pdf 90151.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ZENNOVA) APPROVAL= AP YEAR= 2012 , NDA 202164 (pdf 202164.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202633 (pdf 202633.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 091683 (pdf 91683.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202206 (pdf 202206.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202353 (pdf 202353.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 202702 (pdf 202702.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2014 , NDA 203855 (pdf 203855.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 203354 (pdf 203354.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2015 , NDA 201963 (pdf 201963.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 206156 (pdf 206156.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 203615 (pdf 203615.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 202891 (pdf 202891.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207011 (pdf 207011.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211088 (pdf 211088.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2018 , NDA 204518 (pdf 204518.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 212797 (pdf 212797.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (XIAMEN LP PHARM CO) APPROVAL= AP YEAR= 2021 , NDA 213444 (pdf 213444.pdf not found) INN (PRAMIPEXOLE DIHYDROCHLORIDE) PRAMIPEXOLE DIHYDROCHLORIDE (NOVAST LABS) APPROVAL= AP YEAR= 2022 , 1271 ; INDINAVIR ; 150378-17-9 ; 1996 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- HIV PROTEASE INHIBITOR -- ANTIVIRAL , ; NDA 020685 (label 20685.pdf) INN (INDINAVIR SULFATE) CRIXIVAN (MERCK SHARP DOHME) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY DISCONTINUED , 1272 ; DELAVIRDINE ; 136817-59-9 ; 1997 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) OF HIV-1 -- ANTIVIRAL , ; NDA 020705 (label 20705.pdf) INN (DELAVIRDINE MESYLATE) RESCRIPTOR (VIIV HLTHCARE) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1273 ; EMEDASTINE ; 87233-61-2 ; 1997 ; DISCONTINUED ; ; CLASS ALLERGIC CONJUNCTIVITIS -- SENSORY -- ANTAGONIST -- ANTIHISTAMINE -- ANTIALLERGIC -- H2 (KI=49 NANOMOLAR) -- H3 (KI=12 NANOMOLAR) -- DEVOID OF EFFECTS ON ADRENERGIC, DOPAMINERGIC AND SEROTONIN RECEPTORS , ; NDA 020706 (label 20706.pdf) INN (EMEDASTINE DIFUMARATE) EMADINE (NOVARTIS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1274 ; TILUDRONATE ; 89987-06-4 ; 1997 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL SYSTEM -- BONE DENSITY CONSERVATION AGENTS , ; NDA 020707 (label 20707.pdf) INN (TILUDRONATE DISODIUM) SKELID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1275 ; EPROSARTAN ; 133040-01-4 ; 1997 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II RECEPTOR ANTAGONIST , ; NDA 020738 (label 20738.pdf) INN (EPROSARTAN MESYLATE) TEVETEN (ABBVIE) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 021268 (label 21268.pdf) INN (EPROSARTAN MESYLATE HYDROCHLOROTHIAZIDE) TEVETEN HCT (ABBVIE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 202012 (pdf 202012.pdf not found) INN (EPROSARTAN MESYLATE) EPROSARTAN MESYLATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , 1276 ; TROVAFLOXACIN ; 147059-72-1 ; 1997 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- FLUOROQUINOLONES , ; NDA 020759 (pdf 20759.pdf not found) INN (TROVAFLOXACIN MESYLATE) TROVAN (PFIZER) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , NDA 050762 (label 50762.pdf) INN (AZITHROMYCIN DIHYDRATE TROVAFLOXACIN MESYLATE) TROVAN/ZITHROMAX COMPLIANCE PAK (PFIZER) APPROVAL= AP YEAR= 1998 DISCONTINUED , 1277 ; NELFINAVIR ; 159989-64-7 ; 1997 ; ; ; CLASS ANTIINFECTIVES -- HIV PROTEASE INHIBITOR -- ANTIVIRAL , ; NDA 020778 (label 20778.pdf) INN (NELFINAVIR MESYLATE) VIRACEPT (AGOURON PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020779 (label 20779.pdf) INN (NELFINAVIR MESYLATE) VIRACEPT (AGOURON PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 021503 (label 21503.pdf) INN (NELFINAVIR MESYLATE) VIRACEPT (AGOURON PHARMS) APPROVAL= AP YEAR= 2003 , 1278 ; CITALOPRAM ; 59729-33-8 ; 1998 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) , ; NDA 020822 (label 20822.pdf) INN (CITALOPRAM HYDROBROMIDE) CELEXA (ABBVIE) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021046 (label 21046.pdf) INN (CITALOPRAM HYDROBROMIDE) CELEXA (FOREST LABS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021763 (label 21763.pdf) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (BIOVAIL LABS INTL) APPROVAL= AP YEAR= 2005 , NDA 077031 (pdf 77031.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (AUROBINDO) APPROVAL= AP YEAR= 2004 , NDA 077032 (pdf 77032.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077033 (pdf 77033.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077034 (pdf 77034.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077035 (pdf 77035.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077036 (pdf 77036.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077037 (pdf 77037.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077038 (pdf 77038.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2004 , NDA 077039 (pdf 77039.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077040 (pdf 77040.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077041 (pdf 77041.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (ROXANE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077042 (pdf 77042.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2004 , NDA 077043 (label 77043.pdf) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 077044 (pdf 77044.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2004 , NDA 077045 (pdf 77045.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (EPIC PHARMA) APPROVAL= AP YEAR= 2005 , NDA 077046 (pdf 77046.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (APOTEX) APPROVAL= AP YEAR= 2004 , NDA 077048 (pdf 77048.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (COSETTE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 077052 (pdf 77052.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077141 (pdf 77141.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077213 (pdf 77213.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077232 (pdf 77232.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077278 (pdf 77278.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (TARO) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077289 (pdf 77289.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2006 , NDA 077534 (pdf 77534.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2006 , NDA 077601 (pdf 77601.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077629 (pdf 77629.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2006 , NDA 077668 (label 77668.pdf) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077812 (pdf 77812.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2006 , NDA 078216 (pdf 78216.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (TORRENT PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077654 (pdf 77654.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 201450 (pdf 201450.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2015 , NDA 205407 (pdf 205407.pdf not found) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 215428 (label 215428.pdf) INN (CITALOPRAM HYDROBROMIDE) CITALOPRAM HYDROBROMIDE (ALMATICA) APPROVAL= AP YEAR= 2022 , 1279 ; ESCITALOPRAM ; 128196-01-0 ; 2002 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SEROTONIN REUPTAKE INHIBITOR (SSRI) , ; NDA 021323 (label 21323.pdf) INN (ESCITALOPRAM OXALATE) LEXAPRO (ABBVIE) APPROVAL= AP YEAR= 2002 , NDA 021365 (label 21365.pdf) INN (ESCITALOPRAM OXALATE) LEXAPRO (ABBVIE) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021440 (label 21440.pdf) INN (ESCITALOPRAM OXALATE) LEXAPRO (FOREST LABS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 076765 (pdf 76765.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 076981 (pdf 76981.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM (ALPHAPHARM) APPROVAL= TA YEAR= 2006 , NDA 077412 (pdf 77412.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (TEVA PHARMS) APPROVAL= TA YEAR= 2006 , NDA 077512 (pdf 77512.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (PHARM ASSOC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077550 (pdf 77550.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (DASH PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 077660 (pdf 77660.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077734 (pdf 77734.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2012 , NDA 077798 (pdf 77798.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2007 , NDA 078032 (pdf 78032.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (PRINSTON INC) APPROVAL= AP YEAR= 2015 , NDA 078169 (pdf 78169.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 078219 (pdf 78219.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (CARACO) APPROVAL= TA YEAR= 2007 , NDA 078313 (pdf 78313.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (WATSON LABS) APPROVAL= TA YEAR= 2008 , NDA 078467 (pdf 78467.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (SANDOZ) APPROVAL= TA YEAR= 2007 , NDA 078604 (pdf 78604.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078777 (pdf 78777.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079062 (pdf 79062.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090432 (pdf 90432.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090939 (pdf 90939.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202227 (pdf 202227.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078766 (pdf 78766.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (HIKMA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 079121 (pdf 79121.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (TARO) APPROVAL= AP YEAR= 2012 , NDA 202210 (pdf 202210.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 202221 (pdf 202221.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2012 , NDA 202280 (pdf 202280.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2012 , NDA 202389 (pdf 202389.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2012 , NDA 090477 (pdf 90477.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2013 , NDA 203967 (pdf 203967.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (ANTRIM PHARMS LLC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 202754 (pdf 202754.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 205619 (pdf 205619.pdf not found) INN (ESCITALOPRAM OXALATE) ESCITALOPRAM OXALATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , 1280 ; CLOPIDOGREL ; 113665-84-2 ; 1997 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- ANTIANGINAL -- FIBRINOLYTIC AGENTS -- TREATMENT OF ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, STROKE -- ACTION THROUGH IRREVERSIBLE BINDING OF ITS METABOLITE , ; NDA 020839 (label 20839.pdf) INN (CLOPIDOGREL BISULFATE) PLAVIX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY , NDA 076273 (pdf 76273.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (DR REDDYS) APPROVAL= AP YEAR= 2008 , NDA 076274 (pdf 76274.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 077665 (pdf 77665.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (RISING) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078004 (pdf 78004.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ACME LABS) APPROVAL= AP YEAR= 2012 , NDA 078133 (pdf 78133.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090844 (pdf 90844.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 091023 (pdf 91023.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 090494 (pdf 90494.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (SUN PHARM) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 076999 (pdf 76999.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (TEVA) APPROVAL= AP YEAR= 2012 , NDA 090540 (pdf 90540.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 090625 (pdf 90625.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091216 (pdf 91216.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201686 (pdf 201686.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202266 (pdf 202266.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090307 (pdf 90307.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ACTAVIS TOTOWA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202925 (pdf 202925.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202928 (pdf 202928.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203751 (pdf 203751.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204165 (pdf 204165.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 204359 (pdf 204359.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (RISING) APPROVAL= AP YEAR= 2017 , NDA 206376 (pdf 206376.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 213351 (pdf 213351.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (POLYGEN PHARMS) APPROVAL= AP YEAR= 2020 , NDA 203632 (pdf 203632.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 205345 (pdf 205345.pdf not found) INN (CLOPIDOGREL BISULFATE) CLOPIDOGREL BISULFATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , 1281 ; RIZATRIPTAN ; 144034-80-0 ; 1998 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS , ; NDA 020864 (label 20864.pdf) INN (RIZATRIPTAN BENZOATE) MAXALT (ORGANON LLC) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 020865 (label 20865.pdf) INN (RIZATRIPTAN BENZOATE) MAXALT-MLT (ORGANON) APPROVAL= AP YEAR= 1998 , NDA 077263 (pdf 77263.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078173 (pdf 78173.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 078739 (pdf 78739.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (SANDOZ) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 079230 (pdf 79230.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (SANDOZ) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 077526 (pdf 77526.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 200482 (pdf 200482.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 201967 (pdf 201967.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201993 (pdf 201993.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202047 (pdf 202047.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (CREEKWOOD PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202244 (pdf 202244.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202490 (pdf 202490.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 201914 (pdf 201914.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 202477 (pdf 202477.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203062 (pdf 203062.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203478 (pdf 203478.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 204090 (pdf 204090.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204339 (pdf 204339.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203146 (pdf 203146.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203147 (label 203147.pdf) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2014 , NDA 203252 (pdf 203252.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203334 (pdf 203334.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 203269 (pdf 203269.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2016 , NDA 204722 (pdf 204722.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (PANACEA) APPROVAL= AP YEAR= 2017 , NDA 207835 (pdf 207835.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (UNICHEM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207836 (pdf 207836.pdf not found) INN (RIZATRIPTAN BENZOATE) RIZATRIPTAN BENZOATE (UNICHEM) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205394 (label 205394.pdf) INN (RIZATRIPTAN BENZOATE) RIZAFILM (GENSCO) APPROVAL= AP YEAR= 2023 , 1282 ; SILDENAFIL ; 139755-83-2 ; 1998 ; ; ; CLASS GENITO -- ERECTILE DYSFUNCTION (THERAPEUTIC) -- SPECIFIC PHOSPHODIESTERASE INHIBITORS -- VASODILATOR AGENTS -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (DRUG FOR RARE DISEASE IN EUROPE) , ; NDA 020895 (label 20895.pdf) INN (SILDENAFIL CITRATE) VIAGRA (VIATRIS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021845 (label 21845.pdf) INN (SILDENAFIL CITRATE) REVATIO (VIATRIS) APPROVAL= AP YEAR= 2005 , NDA 077342 (pdf 77342.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TEVA) APPROVAL= AP YEAR= 2016 , NDA 078380 (pdf 78380.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TEVA PHARMS) APPROVAL= AP YEAR= 2013 , NDA 022473 (label 22473.pdf) INN (SILDENAFIL CITRATE) REVATIO (VIATRIS) APPROVAL= AP YEAR= 2009 , NDA 091378 (pdf 91378.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (APOTEX CORP) APPROVAL= TA YEAR= 2011 , NDA 091379 (pdf 91379.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (APOTEX CORP) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 091479 (pdf 91479.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TORRENT PHARMS LTD) APPROVAL= AP YEAR= 2012 , NDA 201150 (pdf 201150.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201171 (pdf 201171.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 202503 (pdf 202503.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (WATSON LABS INC) APPROVAL= AP YEAR= 2012 , NDA 202506 (pdf 202506.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (WATSON LABS INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 202597 (pdf 202597.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2012 , NDA 202598 (pdf 202598.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 , NDA 203109 (label 203109.pdf) INN (SILDENAFIL CITRATE) REVATIO (VIATRIS) APPROVAL= AP YEAR= 2012 , NDA 200149 (pdf 200149.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (ACTAVIS GRP PTC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200165 (pdf 200165.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (ACTAVIS PHARMA) APPROVAL= TA YEAR= 2013 , NDA 202023 (pdf 202023.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2018 , NDA 202025 (pdf 202025.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013 , NDA 202255 (pdf 202255.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 202659 (pdf 202659.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2018 , NDA 203814 (pdf 203814.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 203623 (pdf 203623.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2014 , NDA 203962 (pdf 203962.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 203988 (pdf 203988.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2015 , NDA 203963 (pdf 203963.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 , NDA 204882 (pdf 204882.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (RUBICON) APPROVAL= AP YEAR= 2018 , NDA 204883 (pdf 204883.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (RUBICON) APPROVAL= AP YEAR= 2016 , NDA 206401 (pdf 206401.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 208494 (pdf 208494.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (REYOUNG) APPROVAL= AP YEAR= 2020 , NDA 207178 (pdf 207178.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (APPCO) APPROVAL= AP YEAR= 2020 , NDA 210394 (pdf 210394.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 091448 (pdf 91448.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TORRENT) APPROVAL= AP YEAR= 2018 , NDA 212051 (pdf 212051.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 212260 (pdf 212260.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2019 , NDA 211092 (pdf 211092.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212440 (pdf 212440.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 212883 (pdf 212883.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 205791 (pdf 205791.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211534 (pdf 211534.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 213032 (pdf 213032.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 209302 (pdf 209302.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (UMEDICA) APPROVAL= AP YEAR= 2020 , NDA 213041 (pdf 213041.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (APTAPHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 213014 (pdf 213014.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , NDA 213814 (pdf 213814.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 212312 (pdf 212312.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215522 (pdf 215522.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (TARO) APPROVAL= AP YEAR= 2021 , NDA 211638 (pdf 211638.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 214641 (pdf 214641.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (MSN) APPROVAL= AP YEAR= 2022 , NDA 214773 (pdf 214773.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215708 (pdf 215708.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 214952 (label 214952.pdf) INN (SILDENAFIL CITRATE) LIQREV (CMP DEV LLC) APPROVAL= AP YEAR= 2023 , NDA 214556 (pdf 214556.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 216383 (pdf 216383.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2023 , NDA 218045 (pdf 218045.pdf not found) INN (SILDENAFIL CITRATE) SILDENAFIL CITRATE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2023 , 1283 ; ABACAVIR ; 136470-78-5 ; 1998 ; ; ; CLASS ANTIINFECTIVES -- ANTI-HIV -- ANTIVIRAL -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS , ; NDA 020977 (label 20977.pdf) INN (ABACAVIR SULFATE) ZIAGEN (VIIV HLTHCARE) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY DISCONTINUED , NDA 020978 (label 20978.pdf) INN (ABACAVIR SULFATE) ZIAGEN (VIIV HLTHCARE) APPROVAL= AP YEAR= 1998 , NDA 021205 (label 21205.pdf) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) TRIZIVIR (VIIV HLTHCARE) APPROVAL= AP YEAR= 2000 , NDA 021652 (label 21652.pdf) INN (ABACAVIR SULFATE LAMIVUDINE) EPZICOM (VIIV HLTHCARE) APPROVAL= AP YEAR= 2004 , NDA 021944 (pdf 21944.pdf not found) INN (LAMIVUDINE ZIDOVUDINE ABACAVIR) LAMIVUDINE ZIDOVUDINE ABACAVIR (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2006 , NDA 022293 (pdf 22293.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (AUROBINDO PHARMA) APPROVAL= TA YEAR= 2008 , NDA 077844 (pdf 77844.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 077950 (pdf 77950.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 078119 (pdf 78119.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 078742 (pdf 78742.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (MATRIX LABS) APPROVAL= TA YEAR= 2007 , NDA 090159 (pdf 90159.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 022295 (pdf 22295.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2008 , NDA 079246 (label 79246.pdf) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 090309 (pdf 90309.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (MYLAN PHARMA) APPROVAL= TA YEAR= 2009 , NDA 090519 (pdf 90519.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 091050 (pdf 91050.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 091560 (pdf 91560.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2013 , NDA 200733 (pdf 200733.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2010 , NDA 022547 (pdf 22547.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 078348 (pdf 78348.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 091294 (pdf 91294.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 , NDA 202007 (pdf 202007.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 091144 (pdf 91144.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (CIPLA) APPROVAL= AP YEAR= 2017 , NDA 202381 (pdf 202381.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (MYLAN LABS) APPROVAL= TA YEAR= 2012 , NDA 201107 (label 201107.pdf) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2016 , NDA 201570 (pdf 201570.pdf not found) INN (ABACAVIR SULFATE) ABACAVIR SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202912 (pdf 202912.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE ZIDOVUDINE) ABACAVIR SULFATE , LAMIVUDINE AND ZIDOVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2013 , NDA 204311 (label 204311.pdf) INN (ABACAVIR LAMIVUDINE) ABACAVIR AND LAMIVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 204915 (pdf 204915.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR AND LAMIVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 205412 (pdf 205412.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE LAMIVUDINE (HETERO LABS LTD V) APPROVAL= TA YEAR= 2014 , NDA 205551 (label 205551.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ (VIIV HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 207369 (pdf 207369.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR LAMIVUDINE (HETERO LABS LTD V) APPROVAL= TA YEAR= 2015 , NDA 204004 (pdf 204004.pdf not found) INN (ABACAVIR LAMIVUDINE) EPZICOM (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2016 , NDA 204990 (pdf 204990.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 206151 (pdf 206151.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208775 (pdf 208775.pdf not found) INN (ABACAVIR LAMIVUDINE) ABACAVIR AND LAMIVUDINE (CIPLA LIMITED) APPROVAL= TA YEAR= 2017 , NDA 208990 (pdf 208990.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 215413 (label 215413.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ PD (VIIV HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 216223 (pdf 216223.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 216332 (pdf 216332.pdf not found) INN (ABACAVIR SULFATE LAMIVUDINE) ABACAVIR SULFATE AND LAMIVUDINE (LAURUS) APPROVAL= AP YEAR= 2022 , NDA 217070 (pdf 217070.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , 1284 ; RAPACURONIUM ; 465499-11-0 ; 1999 ; DISCONTINUED ; ; CLASS NEUROMUSCULAR BLOCKER -- MUSCLE RELAXANT -- ANESTHETIC -- NEUROMUSCULAR NONDEPOLARIZING AGENTS , ; NDA 020984 (label 20984.pdf) INN (RAPACURONIUM BROMIDE) RAPLON (ORGANON USA INC) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , 1285 ; ALMOTRIPTAN ; 154323-57-6 ; 2001 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- ANTI-INFLAMMATORY AGENTS -- SELECTIVE SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS , ; NDA 021001 (label 21001.pdf) INN (ALMOTRIPTAN MALATE) AXERT (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 078027 (pdf 78027.pdf not found) INN (ALMOTRIPTAN MALATE) ALMOTRIPTAN MALATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 205171 (pdf 205171.pdf not found) INN (ALMOTRIPTAN MALATE) ALMOTRIPTAN MALATE (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 205523 (pdf 205523.pdf not found) INN (ALMOTRIPTAN MALATE) ALMOTRIPTAN MALATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016 , 1286 ; FROVATRIPTAN ; 158747-02-5 ; 2001 ; ; ; CLASS NERVOUS SYSTEM -- ANTIMIGRAINE -- SEROTONIN AGONISTS -- VASOCONSTRICTOR AGENTS , ; NDA 021006 (label 21006.pdf) INN (FROVATRIPTAN SUCCINATE) FROVA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 202931 (pdf 202931.pdf not found) INN (FROVATRIPTAN SUCCINATE) FROVATRIPTAN SUCCINATE (MYLAN) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204730 (pdf 204730.pdf not found) INN (FROVATRIPTAN SUCCINATE) FROVATRIPTAN SUCCINATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 211292 (pdf 211292.pdf not found) INN (FROVATRIPTAN SUCCINATE) FROVATRIPTAN SUCCINATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 213891 (pdf 213891.pdf not found) INN (FROVATRIPTAN SUCCINATE) FROVATRIPTAN SUCCINATE (RENATA) APPROVAL= AP YEAR= 2022 , 1287 ; ROSIGLITAZONE ; 122320-73-4 ; 1999 ; ; ; CLASS FIBRINOLYTIC AGENTS -- HYPOGLYCEMIC AGENTS -- THAZOLIDINEDIONES -- INSULIN SENSITIZER -- VASODILATOR AGENTS -- ANTIDIABETIC , ; NDA 021071 (label 21071.pdf) INN (ROSIGLITAZONE MALEATE) AVANDIA (WOODWARD) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021410 (label 21410.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) AVANDAMET (SB PHARMCO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021700 (label 21700.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) AVANDARYL (SB PHARMCO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076747 (label 76747.pdf) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 076748 (pdf 76748.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2016 , NDA 077337 (label 77337.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 078023 (pdf 78023.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE (WATSON LABS) APPROVAL= TA YEAR= 2007 , NDA 078695 (pdf 78695.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (ROXANE) APPROVAL= TA YEAR= 2008 , NDA 078658 (pdf 78658.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (HIKMA PHARMS) APPROVAL= TA YEAR= 2009 , NDA 078674 (pdf 78674.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (SANDOZ) APPROVAL= TA YEAR= 2009 , NDA 078709 (label 78709.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 078825 (pdf 78825.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (MYLAN PHARMA) APPROVAL= TA YEAR= 2008 , 1288 ; ROSIGLITAZONE ; 122320-73-4 ; 1999 ; ; ; CLASS METABOLISM -- THIAZOLIDINEDIONE ANTIDIABETIC AGENT -- HYPOGLYCEMIC AGENTS -- ANTAGONIST -- TREATMENT OF TYPE 2 DIABETES , ; NDA 021071 (label 21071.pdf) INN (ROSIGLITAZONE MALEATE) AVANDIA (WOODWARD) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY DISCONTINUED , NDA 021410 (label 21410.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) AVANDAMET (SB PHARMCO) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 021700 (label 21700.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) AVANDARYL (SB PHARMCO) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076747 (label 76747.pdf) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (ANI PHARMS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 076748 (pdf 76748.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2016 , NDA 077337 (label 77337.pdf) INN (METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 078023 (pdf 78023.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE (WATSON LABS) APPROVAL= TA YEAR= 2007 , NDA 078695 (pdf 78695.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (ROXANE) APPROVAL= TA YEAR= 2008 , NDA 078658 (pdf 78658.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (HIKMA PHARMS) APPROVAL= TA YEAR= 2009 , NDA 078674 (pdf 78674.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (SANDOZ) APPROVAL= TA YEAR= 2009 , NDA 078709 (label 78709.pdf) INN (GLIMEPIRIDE ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 078825 (pdf 78825.pdf not found) INN (ROSIGLITAZONE MALEATE) ROSIGLITAZONE MALEATE (MYLAN PHARMA) APPROVAL= TA YEAR= 2008 , 1289 ; OSELTAMIVIR ; 196618-13-0 ; 1999 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- INFLUENZA NEURAMINIDASE INHIBITOR -- CONVERTED BY HEPATIC ESTERASES , ; NDA 021087 (label 21087.pdf) INN (OSELTAMIVIR PHOSPHATE) TAMIFLU (ROCHE) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021246 (label 21246.pdf) INN (OSELTAMIVIR PHOSPHATE) TAMIFLU (ROCHE) APPROVAL= AP YEAR= 2000 , NDA 202595 (label 202595.pdf) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (NATCO) APPROVAL= AP YEAR= 2016 , NDA 208578 (pdf 208578.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209093 (pdf 209093.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2017 , NDA 207211 (pdf 207211.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 208823 (pdf 208823.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (ALVOGEN) APPROVAL= AP YEAR= 2017 , NDA 209113 (label 209113.pdf) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208347 (pdf 208347.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (LUPIN) APPROVAL= AP YEAR= 2018 , NDA 208348 (pdf 208348.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (LUPIN) APPROVAL= AP YEAR= 2018 , NDA 209438 (pdf 209438.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 209421 (pdf 209421.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2018 , NDA 210186 (pdf 210186.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2018 , NDA 211125 (pdf 211125.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 211823 (pdf 211823.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 212544 (pdf 212544.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (MSN) APPROVAL= AP YEAR= 2020 , NDA 212739 (pdf 212739.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (SUNSHINE) APPROVAL= AP YEAR= 2020 , NDA 212784 (pdf 212784.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2020 , NDA 210157 (pdf 210157.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (RISING) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212858 (pdf 212858.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (APTAPHARMA INC) APPROVAL= AP YEAR= 2021 , NDA 215208 (pdf 215208.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2021 , NDA 209590 (pdf 209590.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 211894 (pdf 211894.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213594 (pdf 213594.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (SUNSHINE) APPROVAL= AP YEAR= 2022 , NDA 214949 (pdf 214949.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215313 (pdf 215313.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (MSN) APPROVAL= AP YEAR= 2022 , NDA 214726 (pdf 214726.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215538 (pdf 215538.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 217467 (pdf 217467.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2023 , NDA 218009 (pdf 218009.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (HAINAN POLY) APPROVAL= AP YEAR= 2023 , NDA 218131 (pdf 218131.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 218565 (pdf 218565.pdf not found) INN (OSELTAMIVIR PHOSPHATE) OSELTAMIVIR PHOSPHATE (LAURUS) APPROVAL= AP YEAR= 2024 , 1290 ; GALANTAMINE ; 357-70-0 ; 2001 ; ; NATURAL MOLECULE C00001570 ; CLASS NERVOUS SYSTEM -- ALZHEIMER S DISEASE (AD) -- ALKALOID -- CHOLINESTERASE INHIBITORS , ; NDA 021169 (label 21169.pdf) INN (GALANTAMINE HYDROBROMIDE) RAZADYNE (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 021224 (label 21224.pdf) INN (GALANTAMINE HYDROBROMIDE) RAZADYNE (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021615 (label 21615.pdf) INN (GALANTAMINE HYDROBROMIDE) RAZADYNE ER (JANSSEN PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077585 (pdf 77585.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077587 (pdf 77587.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077588 (pdf 77588.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (RANBAXY) APPROVAL= TA YEAR= 2007 , NDA 077589 (pdf 77589.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 077590 (pdf 77590.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077592 (pdf 77592.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (SUN PHARM INDS) APPROVAL= TA YEAR= 2007 , NDA 077593 (pdf 77593.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 077603 (pdf 77603.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 077604 (pdf 77604.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (YABAO PHARM) APPROVAL= AP YEAR= 2009 , NDA 077605 (label 77605.pdf) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (BARR) APPROVAL= AP YEAR= 2008 , NDA 077608 (pdf 77608.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 077767 (pdf 77767.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (WATSON LABS) APPROVAL= TA YEAR= 2007 , NDA 077781 (pdf 77781.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 078185 (label 78185.pdf) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 2009 , NDA 078189 (pdf 78189.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (BARR) APPROVAL= AP YEAR= 2008 , NDA 078495 (pdf 78495.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (RANBAXY) APPROVAL= TA YEAR= 2007 OBSOLETE , NDA 078484 (pdf 78484.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (IMPAX LABS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 079028 (pdf 79028.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (WATSON LABS) APPROVAL= AP YEAR= 2008 , NDA 078898 (pdf 78898.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 090178 (pdf 90178.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 090900 (pdf 90900.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (MYLAN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090957 (pdf 90957.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2011 , NDA 204895 (pdf 204895.pdf not found) INN (GALANTAMINE HYDROBROMIDE) GALANTAMINE HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , 1291 ; CASPOFUNGIN ; 162808-62-0 ; 2001 ; ; ; CLASS ANTIINFECTIVES -- ECHINOCANDIN ANTIFUNGAL -- INHIBITOR , ; NDA 021227 (label 21227.pdf) INN (CASPOFUNGIN ACETATE) CANCIDAS (MERCK) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 200833 (pdf 200833.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (HENGRUI PHARMA) APPROVAL= AP YEAR= 2018 , NDA 206110 (label 206110.pdf) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2016 , NDA 207092 (pdf 207092.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (GLAND) APPROVAL= AP YEAR= 2017 , NDA 207650 (pdf 207650.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205923 (pdf 205923.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209489 (pdf 209489.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211263 (pdf 211263.pdf not found) INN (CASPOFUNGIN ACETATE) CASPOFUNGIN ACETATE (AREVA PHARMS) APPROVAL= AP YEAR= 2021 , 1292 ; IMATINIB ; 152459-95-5 ; 2001 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- PROTEIN TYROSINE KINASE INHIBITORS -- TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) , ; NDA 021335 (label 21335.pdf) INN (IMATINIB MESYLATE) GLEEVEC (NOVARTIS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 021588 (label 21588.pdf) INN (IMATINIB MESYLATE) GLEEVEC (NOVARTIS) APPROVAL= AP YEAR= 2003 , NDA 078340 (pdf 78340.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (SUN PHARM) APPROVAL= AP YEAR= 2015 , NDA 079179 (pdf 79179.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (APOTEX) APPROVAL= AP YEAR= 2016 , NDA 204285 (pdf 204285.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2016 , NDA 204644 (pdf 204644.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 206547 (pdf 206547.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 207586 (pdf 207586.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 205990 (pdf 205990.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207495 (pdf 207495.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 207818 (pdf 207818.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 208302 (pdf 208302.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (SHILPA) APPROVAL= AP YEAR= 2019 , NDA 208429 (pdf 208429.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 210658 (pdf 210658.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 212773 (pdf 212773.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 212135 (pdf 212135.pdf not found) INN (IMATINIB MESYLATE) IMATINIB MESYLATE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2022 , 1293 ; SERTACONAZOLE ; 99592-32-2 ; 2003 ; ; ; CLASS IMIDAZOLE -- ANTIFUNGAL -- TREATMENT OF INTERDIGITAL TINEA PEDIS -- DERMATOLOGICALS -- BY INHIBITING THE CYTOCHROME P450-DEPENDENT SYNTHESIS OF ERGOSTEROL, KEY COMPONENT OF THE CELL MEMBRANE OF FUNGI , ; NDA 021385 (label 21385.pdf) INN (SERTACONAZOLE NITRATE) ERTACZO (LACER PHARMA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , 1294 ; SERTACONAZOLE ; 99592-32-2 ; 2003 ; ; ; CLASS IMIDAZOLE -- ANTIFUNGAL -- TREATMENT OF INTERDIGITAL TINEA PEDIS -- DERMATOLOGICALS -- BY INHIBITING THE CYTOCHROME P450-DEPENDENT SYNTHESIS OF ERGOSTEROL, KEY COMPONENT OF THE CELL MEMBRANE OF FUNGI , ; NDA 021385 (label 21385.pdf) INN (SERTACONAZOLE NITRATE) ERTACZO (LACER PHARMA) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , 1295 ; TIOTROPIUM ; 186691-13-4 ; 2004 ; ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONISTS -- PARASYMPATHOLYTICS -- COPD , ; NDA 021395 (label 21395.pdf) INN (TIOTROPIUM BROMIDE) SPIRIVA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 021936 (label 21936.pdf) INN (TIOTROPIUM BROMIDE) SPIRIVA RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2014 , NDA 206756 (label 206756.pdf) INN (OLODATEROL HYDROCHLORIDE TIOTROPIUM BROMIDE) STIOLTO RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , NDA 207070 (label 207070.pdf) INN (TIOTROPIUM BROMIDE) SPIRIVA RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 NEWAPPLICATION , NDA 211287 (pdf 211287.pdf not found) INN (TIOTROPIUM BROMIDE) TIOTROPIUM BROMIDE (LUPIN) APPROVAL= AP YEAR= 2023 , 1296 ; METHYL AMINOLEVULINATE ; 33320-16-0 ; 2004 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- PHOTODYNAMIC THERAPY -- TREATMENT OF ACTINIC (SOLAR) KETATOSIS LESIONS -- METABOLIC CONVERSION OF METHYL AMINOLEVULINATE (PRODRUG) TO PHOTOACTIVE PORPHYRINS (PAPS) , ; NDA 021415 (label 21415.pdf) INN (METHYL AMINOLEVULINATE HYDROCHLORIDE) METVIXIA (GALDERMA LABS LP) APPROVAL= AP YEAR= 2004 DISCONTINUED , 1297 ; PEMETREXED ; 137281-23-3 ; 2004 ; ; ; CLASS ANTIMETABOLITES -- ANTINEOPLASTIC -- FOLIC ACID INHIBITORS -- TREATMENT OF NONSQUAMOUS NON-SMALL CELL LUNG CANCER AND MESOTHELIOMA -- PEMETREXED IS CONVERTED TO POLYGLUTAMATE FORMS BY THE ENZYME FOLYLPOLYGLUTAMATE SYNTHETASE. POLYGLUTAMATE ARE INHIBITORS OF TS AND GARFT , ; NDA 021462 (label 21462.pdf) INN (PEMETREXED DISODIUM) ALIMTA (LILLY) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 021677 (label 21677.pdf) INN (PEMETREXED) ALIMTA (LILLY) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 090384 (pdf 90384.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2022 , NDA 202111 (pdf 202111.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (HOSPIRA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 203485 (pdf 203485.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 090352 (pdf 90352.pdf not found) INN (PEMETREXED SODIUM) PEMETREXED (TEVA PHARMS USA) APPROVAL= TA YEAR= 2019 , NDA 204890 (pdf 204890.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2022 , NDA 210661 (pdf 210661.pdf not found) INN (PEMETREXED) PEMETREXED (APOTEX INC) APPROVAL= TA YEAR= 2018 , NDA 208696 (pdf 208696.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2022 , NDA 208927 (pdf 208927.pdf not found) INN (PEMETREXED) PEMETREXED (BIOCON LTD) APPROVAL= TA YEAR= 2018 , NDA 203628 (pdf 203628.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 211090 (pdf 211090.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (BIOCON PHARMA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 208297 (pdf 208297.pdf not found) INN (PEMETREXED) PEMETREXED FOR INJECTION (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2020 , NDA 209472 (label 209472.pdf) INN (PEMETREXED) PEMFEXY (EAGLE PHARMS) APPROVAL= AP YEAR= 2020 , NDA 207352 (pdf 207352.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (NANG KUANG PHARM CO) APPROVAL= AP YEAR= 2022 , NDA 208419 (label 208419.pdf) INN (PEMETREXED) PEMETREXED (ACTAVIS) APPROVAL= AP YEAR= 2020 , NDA 208746 (label 208746.pdf) INN (PEMETREXED DITROMETHAMINE) PEMETREXED DITROMETHAMINE (HOSPIRA) APPROVAL= AP YEAR= 2022 , NDA 214218 (label 214218.pdf) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (HOSPIRA) APPROVAL= AP YEAR= 2022 , NDA 214657 (label 214657.pdf) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 202596 (pdf 202596.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 203774 (pdf 203774.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 209085 (pdf 209085.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 209851 (pdf 209851.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 211899 (pdf 211899.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (RELIANCE LIFE) APPROVAL= AP YEAR= 2022 , NDA 214073 (pdf 214073.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214408 (label 214408.pdf) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 214632 (pdf 214632.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210047 (pdf 210047.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (AMNEAL) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214436 (pdf 214436.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , NDA 215479 (pdf 215479.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215179 (label 215179.pdf) INN (PEMETREXED DISODIUM) PEMETREXED (SHILPA) APPROVAL= AP YEAR= 2023 , NDA 216582 (pdf 216582.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 215460 (pdf 215460.pdf not found) INN (PEMETREXED DISODIUM) PEMETREXED DISODIUM (HETERO LABS LTD VI) APPROVAL= AP YEAR= 2024 , 1298 ; DARIFENACIN ; 133099-04-4 ; 2004 ; ; ; CLASS GENITO -- ANTIINFLAMMATORY -- MUSCARINIC ANTAGONISTS -- URINARY ANTISPASMODICS , ; NDA 021513 (label 21513.pdf) INN (DARIFENACIN HYDROBROMIDE) ENABLEX (ABBVIE) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 091190 (pdf 91190.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205209 (pdf 205209.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (TORRENT) APPROVAL= AP YEAR= 2016 , NDA 205550 (pdf 205550.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (JUBILANT GENERICS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206743 (pdf 206743.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207664 (pdf 207664.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (CIPLA) APPROVAL= AP YEAR= 2016 , NDA 207302 (pdf 207302.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 , NDA 207681 (pdf 207681.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 209571 (pdf 209571.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (XIROMED) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211045 (pdf 211045.pdf not found) INN (DARIFENACIN HYDROBROMIDE) DARIFENACIN HYDROBROMIDE (POLYGEN PHARMS) APPROVAL= AP YEAR= 2020 , 1299 ; SOLIFENACIN ; 242478-37-1 ; 2004 ; ; ; CLASS GENITO -- ANTI-INCONTINENCE AGENTS -- ANTISPASMODICS -- MUSCARINIC ANTAGONISTS , ; NDA 021518 (label 21518.pdf) INN (SOLIFENACIN SUCCINATE) VESICARE (ASTELLAS) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY , NDA 091464 (pdf 91464.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 202551 (pdf 202551.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 207721 (pdf 207721.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210224 (pdf 210224.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 209719 (pdf 209719.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205483 (pdf 205483.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 205575 (pdf 205575.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 209239 (pdf 209239.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 , NDA 209333 (pdf 209333.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (QILU) APPROVAL= AP YEAR= 2019 , NDA 209818 (pdf 209818.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209839 (pdf 209839.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210281 (pdf 210281.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (AUSTARPHARMA) APPROVAL= AP YEAR= 2019 , NDA 210582 (pdf 210582.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (CHARTWELL RX) APPROVAL= AP YEAR= 2019 , NDA 210688 (pdf 210688.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (MSN) APPROVAL= AP YEAR= 2019 , NDA 211657 (pdf 211657.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211423 (pdf 211423.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (RISING) APPROVAL= AP YEAR= 2019 , NDA 211701 (pdf 211701.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 212214 (pdf 212214.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 , NDA 209529 (label 209529.pdf) INN (SOLIFENACIN SUCCINATE) VESICARE LS (ASTELLAS) APPROVAL= AP YEAR= 2020 , NDA 213346 (pdf 213346.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (SUNSHINE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 207477 (pdf 207477.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215761 (pdf 215761.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 206817 (pdf 206817.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 211622 (pdf 211622.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (LANNETT CO INC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204374 (pdf 204374.pdf not found) INN (SOLIFENACIN SUCCINATE) SOLIFENACIN SUCCINATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , 1300 ; ATAZANAVIR ; 198904-31-3 ; 2003 ; ; ; CLASS ANTIINFECTIVES -- HIV PROTEASE INHIBITOR , ; NDA 021567 (label 21567.pdf) INN (ATAZANAVIR SULFATE) REYATAZ (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2003 NEWMOLECULARENTITY , NDA 078785 (pdf 78785.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (EMCURE PHARMA) APPROVAL= TA YEAR= 2008 , NDA 091611 (pdf 91611.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2010 , NDA 200196 (pdf 200196.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (EMCURE PHARMS) APPROVAL= TA YEAR= 2010 , NDA 022282 (pdf 22282.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR) ATAZANAVIR SULFATE AND RITONAVIR (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091673 (pdf 91673.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 , NDA 204806 (pdf 204806.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 205508 (pdf 205508.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR) ATAZANAVIR SULFATE RITONAVIR (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2014 , NDA 206041 (pdf 206041.pdf not found) INN (ATAZANAVIR SULFATE RITONAVIR LAMIVUDINE ZIDOVUDINE) ATAZANAVIR SULFATERITONAVIRLAMIVUDINEZIDOVUDINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 206352 (label 206352.pdf) INN (ATAZANAVIR SULFATE) REYATAZ (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2014 , NDA 206353 (label 206353.pdf) INN (ATAZANAVIR SULFATE COBICISTAT) EVOTAZ (BRISTOL) APPROVAL= AP YEAR= 2015 , NDA 091641 (pdf 91641.pdf not found) INN (ATAZANAVIR) ATAZANAVIR (PHARMACARE LTD) APPROVAL= TA YEAR= 2017 OBSOLETE , NDA 200626 (pdf 200626.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (CIPLA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208177 (pdf 208177.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209717 (pdf 209717.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 210575 (pdf 210575.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212579 (pdf 212579.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (LAURUS) APPROVAL= AP YEAR= 2021 , NDA 212278 (pdf 212278.pdf not found) INN (ATAZANAVIR SULFATE) ATAZANAVIR SULFATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , 1301 ; TETRACAINE ; 94-24-6 ; 2005 ; ; ; CLASS CARDIOVASCULAR -- ANESTHETIC -- BLOCKER OF SODIUM ION CHANNELS , ; NDA 021623 (label 21623.pdf) INN (LIDOCAINE TETRACAINE) SYNERA (GALEN SPECIALTY) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021717 (label 21717.pdf) INN (LIDOCAINE TETRACAINE) PLIAGLIS (TARO PHARMS) APPROVAL= AP YEAR= 2006 , NDA 208135 (label 208135.pdf) INN (TETRACAINE HYDROCHLORIDE) TETRACAINE HYDROCHLORIDE (ALCON LABS) APPROVAL= AP YEAR= 2016 , NDA 208032 (label 208032.pdf) INN (OXYMETAZOLINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE) KOVANAZE (ST RENATUS) APPROVAL= AP YEAR= 2016 , NDA 210821 (label 210821.pdf) INN (TETRACAINE HYDROCHLORIDE) TETRACAINE HYDROCHLORIDE (BAUSCH LOMB IRELAND) APPROVAL= AP YEAR= 2019 , 1302 ; RASAGILINE ; 136236-51-6 ; 2006 ; ; ; CLASS NERVOUS SYSTEM -- COGNITION ENHANCER -- ANTIPARKINSONIAN -- MONOAMINE OXIDASE INHIBITORS -- NEUROPROTECTIVE AGENTS , ; NDA 021641 (label 21641.pdf) INN (RASAGILINE MESYLATE) AZILECT (TEVA) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 201889 (pdf 201889.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 201823 (pdf 201823.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (WATSON LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201950 (pdf 201950.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (APOTEX INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201971 (label 201971.pdf) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2017 , NDA 201899 (pdf 201899.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2015 , NDA 201970 (pdf 201970.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (ORBION PHARMS) APPROVAL= AP YEAR= 2016 , NDA 201892 (pdf 201892.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 207004 (pdf 207004.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 206153 (pdf 206153.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (INDOCO) APPROVAL= AP YEAR= 2019 , NDA 201942 (pdf 201942.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (CARNEGIE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 218163 (pdf 218163.pdf not found) INN (RASAGILINE MESYLATE) RASAGILINE MESYLATE (SKG PHARMA) APPROVAL= AP YEAR= 2024 , 1303 ; SORAFENIB ; 284461-73-0 ; 2005 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE INHIBITOR -- TREATMENT OF HEPATOCELLULAR CARCINOMA AND RENAL CELL CARCINOMA -- MULTIPLE INTRACELLULAR RECEPTOR TYROSINE KINASES -- CELL SURFACE KINASES , ; NDA 021923 (label 21923.pdf) INN (SORAFENIB TOSYLATE) NEXAVAR (BAYER HLTHCARE) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 207012 (pdf 207012.pdf not found) INN (SORAFENIB TOSYLATE) SORAFENIB TOSYLATE (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 209567 (pdf 209567.pdf not found) INN (SORAFENIB TOSYLATE) SORAFENIB TOSYLATE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 , NDA 216073 (pdf 216073.pdf not found) INN (SORAFENIB TOSYLATE) SORAFENIB TOSYLATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 209050 (pdf 209050.pdf not found) INN (SORAFENIB TOSYLATE) SORAFENIB TOSYLATE (YABAO PHARM) APPROVAL= AP YEAR= 2022 , NDA 217095 (pdf 217095.pdf not found) INN (SORAFENIB TOSYLATE) SORAFENIB TOSYLATE (TORRENT) APPROVAL= AP YEAR= 2023 , 1304 ; SUNITINIB ; 557795-19-4 ; 2006 ; ; ; CLASS ANTINEOPLASTIC -- ANGIOGENESIS INHIBITORS -- KINASE INHIBITOR -- TREATMENT OF GASTROINTESTINAL STROMAL TUMOR (GIST), GASTROINTESTINAL STROMAL TUMOR (GIST) AND PANCREATIC NEUROENDOCRINE TUMORS -- INHIBITED THE PHOSPHORYLATION OF MULTIPLE RTKS (MULTIPLE RECEPTOR TYROSINE KINASES) , ; NDA 021938 (label 21938.pdf) INN (SUNITINIB MALATE) SUTENT (CPPI CV) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 021968 (label 21968.pdf) INN (SUNITINIB MALATE) SUTENT (CPPI CV) APPROVAL= AP YEAR= 2006 NEWAPPLICATION , NDA 201275 (label 201275.pdf) INN (SUNITINIB MALATE) SUNITINIB MALATE (MYLAN) APPROVAL= AP YEAR= 2021 , NDA 213803 (pdf 213803.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 213914 (pdf 213914.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 215843 (pdf 215843.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 218012 (pdf 218012.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (NOVUGEN) APPROVAL= AP YEAR= 2023 , NDA 218024 (pdf 218024.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (NATCO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 218615 (pdf 218615.pdf not found) INN (SUNITINIB MALATE) SUNITINIB MALATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2024 , 1305 ; DARUNAVIR ; 206361-99-1 ; 2006 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGENTS -- HIV PROTEASE INHIBITOR , ; NDA 021976 (label 21976.pdf) INN (DARUNAVIR) PREZISTA (JANSSEN PRODS) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 202895 (label 202895.pdf) INN (DARUNAVIR) PREZISTA (JANSSEN PRODS) APPROVAL= AP YEAR= 2011 , NDA 202118 (pdf 202118.pdf not found) INN (DARUNAVIR) DARUNAVIR (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 202136 (pdf 202136.pdf not found) INN (DARUNAVIR) DARUNAVIR (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2024 , NDA 202073 (pdf 202073.pdf not found) INN (DARUNAVIR) DARUNAVIR (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 202083 (pdf 202083.pdf not found) INN (DARUNAVIR) DARUNAVIR (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , NDA 205395 (label 205395.pdf) INN (COBICISTAT DARUNAVIR) PREZCOBIX (JANSSEN PRODS) APPROVAL= AP YEAR= 2015 , NDA 206288 (pdf 206288.pdf not found) INN (DARUNAVIR) DARUNAVIR (CIPLA) APPROVAL= AP YEAR= 2023 , NDA 206555 (pdf 206555.pdf not found) INN (DARUNAVIR) DARUNAVIR (TEVA PHARMS) APPROVAL= TA YEAR= 2017 , NDA 207189 (pdf 207189.pdf not found) INN (DARUNAVIR) DARUNAVIR (CIPLA LTD) APPROVAL= TA YEAR= 2017 , NDA 210455 (label 210455.pdf) INN (COBICISTAT DARUNAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) SYMTUZA (JANSSEN PRODS) APPROVAL= AP YEAR= 2018 , NDA 211578 (pdf 211578.pdf not found) INN (DARUNAVIR) DARUNAVIR (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 215389 (pdf 215389.pdf not found) INN (DARUNAVIR) DARUNAVIR (MSN) APPROVAL= AP YEAR= 2023 , NDA 210187 (pdf 210187.pdf not found) INN (DARUNAVIR ETHANOLATE) DARUNAVIR ETHANOLATE (MICRO LABS USA) APPROVAL= TA YEAR= 2020 , NDA 209847 (pdf 209847.pdf not found) INN (DARUNAVIR RITONAVIR) DARUNAVIR AND RITONAVIR (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2023 , NDA 210677 (pdf 210677.pdf not found) INN (DARUNAVIR) DARUNAVIR (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 212493 (pdf 212493.pdf not found) INN (DARUNAVIR) DARUNAVIR (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 214085 (pdf 214085.pdf not found) INN (DARUNAVIR) DARUNAVIR (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , 1306 ; LISDEXAMFETAMINE ; 608137-32-2 ; 2007 ; ; ; CLASS NERVOUS SYSTEM -- L-LYSINE-D-AMPHETAMINE -- PSYCHOSTIMULANT -- CENTRAL NERVOUS SYSTEM STIMULANT INDICATED FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- A PRODRUG OF DEXTROAMPHETAMINE -- BLOCK THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE INTO THE PRESYNAPTIC NEURON AND INCREASE THE RELEASE OF THESE MONOAMINES INTO THE EXTRANEURONAL SPACE , ; NDA 021977 (label 21977.pdf) INN (LISDEXAMFETAMINE DIMESYLATE) VYVANSE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 202827 (pdf 202827.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 202830 (pdf 202830.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 202835 (pdf 202835.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (MYLAN) APPROVAL= AP YEAR= 2023 , NDA 202802 (pdf 202802.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 202836 (pdf 202836.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SANDOZ INC) APPROVAL= TA YEAR= 2015 , NDA 208510 (label 208510.pdf) INN (LISDEXAMFETAMINE DIMESYLATE) VYVANSE (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 214547 (pdf 214547.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (NORWICH) APPROVAL= AP YEAR= 2023 , NDA 215415 (pdf 215415.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (TEVA PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 216944 (pdf 216944.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 211840 (pdf 211840.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SPECGX LLC) APPROVAL= AP YEAR= 2023 , NDA 214134 (pdf 214134.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , NDA 214484 (pdf 214484.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , NDA 215330 (pdf 215330.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (RHODES PHARMS) APPROVAL= AP YEAR= 2023 , NDA 215802 (pdf 215802.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (LANNETT CO INC) APPROVAL= AP YEAR= 2023 , NDA 216266 (pdf 216266.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 217068 (pdf 217068.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217194 (pdf 217194.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217442 (pdf 217442.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 218306 (pdf 218306.pdf not found) INN (LISDEXAMFETAMINE DIMESYLATE) LISDEXAMFETAMINE DIMESYLATE (MSN) APPROVAL= AP YEAR= 2024 , 1307 ; ALISKIREN ; 173334-57-1 ; 2007 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- LOWER BLOOD PRESSURE -- RENIN INHIBITOR , ; NDA 021985 (label 21985.pdf) INN (ALISKIREN HEMIFUMARATE) TEKTURNA (NODEN PHARMA) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 022107 (label 22107.pdf) INN (ALISKIREN HEMIFUMARATE HYDROCHLOROTHIAZIDE) TEKTURNA HCT (NODEN PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022217 (label 22217.pdf) INN (ALISKIREN HEMIFUMARATE VALSARTAN) VALTURNA (NOVARTIS) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022545 (label 22545.pdf) INN (ALISKIREN HEMIFUMARATE AMLODIPINE BESYLATE) TEKAMLO (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 200045 (label 200045.pdf) INN (ALISKIREN HEMIFUMARATE AMLODIPINE BESYLATE HYDROCHLOROTHIAZIDE) AMTURNIDE (NOVARTIS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 210709 (label 210709.pdf) INN (ALISKIREN HEMIFUMARATE) TEKTURNA (NODEN PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206665 (pdf 206665.pdf not found) INN (ALISKIREN HEMIFUMARATE) ALISKIREN HEMIFUMARATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , 1308 ; SITAGLIPTIN ; 486460-32-6 ; 2006 ; ; ; CLASS METABOLISM -- DPP-4 INHIBITORS -- HYPOGLYCEMIC AGENTS BY SLOWING THE INACTIVATION OF INCRETIN HORMONES -- ANTI-DIABETIC , ; NDA 021995 (label 21995.pdf) INN (SITAGLIPTIN PHOSPHATE) JANUVIA (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2006 NEWMOLECULARENTITY , NDA 022044 (label 22044.pdf) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) JANUMET (MSD SUB MERCK) APPROVAL= AP YEAR= 2007 , NDA 202343 (label 202343.pdf) INN (SIMVASTATIN SITAGLIPTIN PHOSPHATE) JUVISYNC (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202270 (label 202270.pdf) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) JANUMET XR (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2012 , NDA 202473 (pdf 202473.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2012 , NDA 202387 (pdf 202387.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (SANDOZ INC) APPROVAL= TA YEAR= 2021 , NDA 202388 (pdf 202388.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN METFORMIN HYDROCHLORIDE (SANDOZ INC) APPROVAL= TA YEAR= 2013 , NDA 202423 (pdf 202423.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (SUN PHARMA GLOBAL) APPROVAL= TA YEAR= 2013 , NDA 202327 (pdf 202327.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (WATSON LABS INC) APPROVAL= TA YEAR= 2014 , NDA 202425 (pdf 202425.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (APOTEX INC) APPROVAL= TA YEAR= 2014 , NDA 202426 (pdf 202426.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN METFORMIN HYDROCHLORIDE (APOTEX INC) APPROVAL= TA YEAR= 2014 , NDA 202487 (pdf 202487.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2015 , NDA 204144 (pdf 204144.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE (ANCHEN PHARMS) APPROVAL= TA YEAR= 2015 , NDA 202365 (pdf 202365.pdf not found) INN (SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE) SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE (WATSON LABS INC) APPROVAL= TA YEAR= 2015 , NDA 204591 (pdf 204591.pdf not found) INN (SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE) SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2015 , NDA 208535 (pdf 208535.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE) METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2017 , NDA 209805 (label 209805.pdf) INN (ERTUGLIFLOZIN SITAGLIPTIN PHOSPHATE) STEGLUJAN (MSD SUB MERCK) APPROVAL= AP YEAR= 2017 , NDA 208186 (pdf 208186.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2018 , NDA 214784 (pdf 214784.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (AJANTA PHARMA LTD) APPROVAL= TA YEAR= 2021 , NDA 211566 (label 211566.pdf) INN (SITAGLIPTIN) ZITUVIO (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 214693 (pdf 214693.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (UNICHEM LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 215155 (pdf 215155.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN PHOSPHATE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 215220 (pdf 215220.pdf not found) INN (SITAGLIPTIN METFORMIN HYDROCHLORIDE) SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= TA YEAR= 2022 , NDA 216743 (pdf 216743.pdf not found) INN (METFORMIN HYDROCHLORIDE SITAGLIPTIN) ZITUVIMET (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 216919 (pdf 216919.pdf not found) INN (SITAGLIPTIN PHOSPHATE) SITAGLIPTIN (MANKIND PHARMA LTD) APPROVAL= TA YEAR= 2024 , 1309 ; LAPATINIB ; 231277-92-2 ; 2007 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- PROTEIN KINASE INHIBITORS -- METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 , ; NDA 022059 (label 22059.pdf) INN (LAPATINIB DITOSYLATE) TYKERB (NOVARTIS) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203007 (pdf 203007.pdf not found) INN (LAPATINIB DITOSYLATE) LAPATINIB DITOSYLATE (NATCO PHARMA LTD) APPROVAL= AP YEAR= 2020 , 1310 ; NILOTINIB ; 641571-10-0 ; 2007 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE INHIBITORS -- CHRONIC MYELOID LEUKEMIA (CML) -- IC50 VALUES AS INDICATED: BCR-ABL (20-60 NM) PDGFR (69 NM) C-KIT (210 NM) CSF-1R (125-250 NM) AND DDR1 (3.7 NM) , ; NDA 022068 (label 22068.pdf) INN (NILOTINIB HYDROCHLORIDE) TASIGNA (NOVARTIS) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203640 (pdf 203640.pdf not found) INN (NILOTINIB HYDROCHLORIDE) NILOTINIB HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , 1311 ; BACITRACIN ; 1405-87-4 ; 1948 ; ; ; CLASS ANTIINFECTIVES -- ANTI-BACTERIAL -- ANTIBIOTICS -- INTERFERES WITH BACTERIAL CELL WALL SYNTHESIS -- INHIBITION OF DEPHOSPHORYLATION OF THE PEPTIDOGLYCAN CARRIER C55-ISOPRENYL PYROPHOSPHATE (IPP) (UNDECAPRENYL PYROPHOSPHATE C55-PP) , ; NDA 050167 (pdf 50167.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) POLYSPORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050168 (label 50168.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1957 DISCONTINUED , NDA 050416 (label 50416.pdf) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) CORTISPORIN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 050417 (label 50417.pdf) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) LUMI-SPORYN (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1971 , NDA 050598 (pdf 50598.pdf not found) INN (BACITRACIN POLYMYXIN B SULFATE) LANABIOTIC (COMBE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060282 (pdf 60282.pdf not found) INN (BACITRACIN) BACITRACIN (PFIZER) APPROVAL= AP YEAR= 1950 DISCONTINUED OBSOLETE , NDA 060647 (pdf 60647.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEO-POLYCIN (DOW PHARM) APPROVAL= AP YEAR= 1954 DISCONTINUED , NDA 060687 (pdf 60687.pdf not found) INN (BACITRACIN) BACITRACIN (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060731 (pdf 60731.pdf not found) INN (BACITRACIN HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (ALTANA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 060733 (pdf 60733.pdf not found) INN (BACITRACIN) BACITRACIN (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1948 DISCONTINUED OBSOLETE , NDA 060734 (pdf 60734.pdf not found) INN (BACITRACIN) BACIGUENT (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1948 DISCONTINUED , NDA 060764 (pdf 60764.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 061048 (pdf 61048.pdf not found) INN (BACITRACIN NEOMYCIN SULFATE POLYMYXIN B SULFATE) MYCITRACIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061212 (pdf 61212.pdf not found) INN (BACITRACIN) BACITRACIN (PADAGIS US) APPROVAL= AP YEAR= 1971 , NDA 061229 (pdf 61229.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) POLYSPORIN (MONARCH PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 061580 (pdf 61580.pdf not found) INN (BACITRACIN) BACI-RX (X GEN PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061699 (pdf 61699.pdf not found) INN (BACITRACIN) BACITRACIN (APOTHEKERNES) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 061737 (pdf 61737.pdf not found) INN (BACITRACIN ZINC) ZIBA-RX (X GEN PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 062158 (pdf 62158.pdf not found) INN (BACITRACIN) BACITRACIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062166 (pdf 62166.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE ACETATE NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (PADAGIS US) APPROVAL= AP YEAR= 1981 , NDA 062167 (pdf 62167.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN-NEOMYCIN-POLYMYXIN (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062381 (pdf 62381.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062386 (pdf 62386.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062389 (pdf 62389.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) ZINC BACITRACIN , NEOMYCIN SULFATE , POLYMYXIN B SULFATE & HYDROCORTISONE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062430 (pdf 62430.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) OCUMYCIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062453 (pdf 62453.pdf not found) INN (BACITRACIN) BACITRACIN (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062456 (pdf 62456.pdf not found) INN (BACITRACIN) BACITRACIN (PADDOCK LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062499 (pdf 62499.pdf not found) INN (BACITRACIN ZINC LIDOCAINE NEOMYCIN SULFATE POLYMYXIN B SULFATE) LANABIOTIC (COMBE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062696 (pdf 62696.pdf not found) INN (BACITRACIN) BACITRACIN (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062799 (pdf 62799.pdf not found) INN (BACITRACIN) BACITRACIN (COMBE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062833 (pdf 62833.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062849 (pdf 62849.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) BACITRACIN ZINC-POLYMYXIN B SULFATE (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062857 (pdf 62857.pdf not found) INN (BACITRACIN) BACITRACIN (NASKA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064028 (pdf 64028.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) BACITRACIN ZINC AND POLYMYXIN B SULFATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 064046 (pdf 64046.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) BACITRACIN ZINC AND POLYMYXIN B SULFATE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064064 (pdf 64064.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064068 (pdf 64068.pdf not found) INN (BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1995 , NDA 064153 (pdf 64153.pdf not found) INN (BACITRACIN) BACIIM (X GEN PHARMS) APPROVAL= AP YEAR= 1997 DISCONTINUED OBSOLETE , NDA 065022 (pdf 65022.pdf not found) INN (BACITRACIN ZINC POLYMYXIN B SULFATE) BACITRACIN ZINC AND POLYMYXIN B SULFATE (PADAGIS US) APPROVAL= AP YEAR= 2002 , NDA 065088 (pdf 65088.pdf not found) INN (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (AKORN) APPROVAL= AP YEAR= 2004 , NDA 065116 (pdf 65116.pdf not found) INN (BACITRACIN) BACITRACIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED OBSOLETE , NDA 090211 (pdf 90211.pdf not found) INN (BACITRACIN) BACITRACIN (MYLAN ASI) APPROVAL= AP YEAR= 2010 DISCONTINUED OBSOLETE , NDA 065213 (pdf 65213.pdf not found) INN (BACITRACIN ZINC) NEOMYCIN AND POLYMYXIN B SULFATES , BACITRACIN ZINC AND HYDROCORTISONE (AKORN) APPROVAL= AP YEAR= 2012 , NDA 203257 (pdf 203257.pdf not found) INN (BACITRACIN) BACITRACIN (AKORN) APPROVAL= AP YEAR= 2013 OBSOLETE , NDA 203177 (pdf 203177.pdf not found) INN (BACITRACIN) BACITRACIN (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2014 DISCONTINUED OBSOLETE , NDA 206719 (pdf 206719.pdf not found) INN (BACITRACIN) BACITRACIN (AKORN) APPROVAL= AP YEAR= 2017 DISCONTINUED OBSOLETE , 1312 ; COLISTIN ; 1066-17-7 ; 1962 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- POLYMYXIN E -- DISRUPTS THE BACTERIAL CELL MEMBRANE , ; NDA 050355 (pdf 50355.pdf not found) INN (COLISTIN SULFATE) COLY-MYCIN S (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 050356 (label 50356.pdf) INN (COLISTIN SULFATE HYDROCORTISONE ACETATE NEOMYCIN SULFATE THONZONIUM BROMIDE) COLY-MYCIN S (ENDO PHARMS INC) APPROVAL= AP YEAR= 1962 , 1313 ; BLEOMYCIN ; 11056-06-7 ; 1973 ; ; NATURAL MOLECULE NPA020036 ; CLASS ANTINEOPLASTIC -- CYTOTOXIC GLYCOPEPTIDE ANTIBIOTICS ISOLATED FROM A STRAIN OF STREPTOMYCES VERTICILLUS -- SEQUENCE SELECTIVE CLEAVAGE OF DNA (PMID25187079) , ; NDA 050443 (label 50443.pdf) INN (BLEOMYCIN SULFATE) BLENOXANE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1973 NEWMOLECULARENTITY DISCONTINUED , NDA 064084 (pdf 64084.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 065031 (pdf 65031.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 2000 , NDA 065033 (pdf 65033.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065042 (pdf 65042.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 065185 (pdf 65185.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2008 , NDA 065201 (pdf 65201.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (PHARMACHEMIE BV) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 205030 (pdf 205030.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (MEITHEAL) APPROVAL= AP YEAR= 2018 , NDA 209439 (pdf 209439.pdf not found) INN (BLEOMYCIN SULFATE) BLEOMYCIN SULFATE (CIPLA) APPROVAL= AP YEAR= 2019 DISCONTINUED , 1314 ; TOBRAMYCIN ; 32986-56-4 ; 1975 ; ; NATURAL MOLECULE NPA024722 ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- AMINOGLYCOSIDES -- TOPICAL ANTIBIOTIC -- BY INHIBITING PROTEIN SYNTHESIS -- TREATMENT OF CYSTIC FIBROSIS , ; NDA 050477 (pdf 50477.pdf not found) INN (TOBRAMYCIN SULFATE) NEBCIN (LILLY) APPROVAL= AP YEAR= 1975 NEWMOLECULARENTITY DISCONTINUED , NDA 050519 (pdf 50519.pdf not found) INN (TOBRAMYCIN SULFATE) NEBCIN (LILLY) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 050541 (label 50541.pdf) INN (TOBRAMYCIN) TOBREX (NOVARTIS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050555 (label 50555.pdf) INN (TOBRAMYCIN) TOBREX (NOVARTIS) APPROVAL= AP YEAR= 1981 , NDA 050592 (label 50592.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX (NOVARTIS) APPROVAL= AP YEAR= 1988 , NDA 050616 (label 50616.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX (NOVARTIS) APPROVAL= AP YEAR= 1988 , NDA 050628 (label 50628.pdf) INN (FLUOROMETHOLONE ACETATE TOBRAMYCIN) TOBRASONE (EYEVANCE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050753 (label 50753.pdf) INN (TOBRAMYCIN) TOBI (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1997 , NDA 050789 (label 50789.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2004 , NDA 050804 (label 50804.pdf) INN (LOTEPREDNOL ETABONATE TOBRAMYCIN) ZYLET (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2004 , NDA 062008 (pdf 62008.pdf not found) INN (TOBRAMYCIN SULFATE) NEBCIN (LILLY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 062535 (pdf 62535.pdf not found) INN (TOBRAMYCIN) TOBREX (SANDOZ) APPROVAL= AP YEAR= 1984 , NDA 062707 (pdf 62707.pdf not found) INN (TOBRAMYCIN SULFATE) NEBCIN (LILLY) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062945 (pdf 62945.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (WATSON LABS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063080 (pdf 63080.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063081 (label 63081.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HOSPIRA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 063100 (pdf 63100.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063111 (label 63111.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1991 , NDA 063112 (label 63112.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063113 (pdf 63113.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063116 (label 63116.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE PHARMACY BULK (HOSPIRA) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063117 (pdf 63117.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1991 , NDA 063118 (pdf 63118.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063119 (pdf 63119.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (IGI LABS INC) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 063120 (pdf 63120.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063121 (pdf 63121.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063122 (pdf 63122.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063127 (pdf 63127.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063128 (pdf 63128.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HIKMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063161 (pdf 63161.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HOSPIRA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 063176 (pdf 63176.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (ALCON PHARMS LTD) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 064021 (pdf 64021.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (APOTHECON) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 064026 (pdf 64026.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 064052 (pdf 64052.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1993 , NDA 064096 (pdf 64096.pdf not found) INN (TOBRAMYCIN) AKTOB (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064134 (label 64134.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 1999 , NDA 065013 (label 65013.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (XGEN PHARMS) APPROVAL= AP YEAR= 2001 , NDA 065026 (pdf 65026.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (CHARTWELL RX) APPROVAL= AP YEAR= 2001 , NDA 065087 (pdf 65087.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (APOTEX INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 065105 (pdf 65105.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (ROXANE) APPROVAL= TA YEAR= 2002 OBSOLETE , NDA 065120 (pdf 65120.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE PHARMACY BULK (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 065122 (label 65122.pdf) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 , NDA 065407 (pdf 65407.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2008 , NDA 050818 (label 50818.pdf) INN (DEXAMETHASONE TOBRAMYCIN) TOBRADEX ST (EYEVANCE) APPROVAL= AP YEAR= 2009 , NDA 201820 (label 201820.pdf) INN (TOBRAMYCIN) BETHKIS (CHIESI) APPROVAL= AP YEAR= 2012 , NDA 091589 (label 91589.pdf) INN (TOBRAMYCIN) TOBRAMYCIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 201688 (label 201688.pdf) INN (TOBRAMYCIN) TOBI PODHALER (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2013 , NDA 201422 (pdf 201422.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (HIKMA) APPROVAL= AP YEAR= 2014 , NDA 205179 (pdf 205179.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205433 (label 205433.pdf) INN (TOBRAMYCIN) KITABIS PAK (PULMOFLOW INC) APPROVAL= AP YEAR= 2014 , NDA 205685 (pdf 205685.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (XELLIA PHARMS APS) APPROVAL= AP YEAR= 2014 , NDA 205501 (pdf 205501.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2015 , NDA 206965 (pdf 206965.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2016 , NDA 207444 (pdf 207444.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2017 , NDA 208964 (pdf 208964.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (LUPIN) APPROVAL= AP YEAR= 2017 , NDA 209554 (pdf 209554.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (MYLAN) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207080 (pdf 207080.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 211847 (pdf 211847.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 207136 (pdf 207136.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 210915 (pdf 210915.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 209346 (pdf 209346.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE PHARMACY BULK (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 209621 (pdf 209621.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 210871 (pdf 210871.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211189 (pdf 211189.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 212628 (pdf 212628.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 212848 (pdf 212848.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 212991 (pdf 212991.pdf not found) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212715 (pdf 212715.pdf not found) INN (DEXAMETHASONE TOBRAMYCIN) TOBRAMYCIN AND DEXAMETHASONE (PADAGIS US) APPROVAL= AP YEAR= 2022 , NDA 216725 (pdf 216725.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 217029 (pdf 217029.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (HAINAN POLY) APPROVAL= AP YEAR= 2023 , NDA 217519 (pdf 217519.pdf not found) INN (TOBRAMYCIN SULFATE) TOBRAMYCIN SULFATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 214478 (pdf 214478.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217344 (pdf 217344.pdf not found) INN (TOBRAMYCIN) TOBRAMYCIN (MICRO LABS) APPROVAL= AP YEAR= 2023 , 1315 ; MEZLOCILLIN ; 51481-65-3 ; 1981 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PENICILLINS , ; NDA 050549 (pdf 50549.pdf not found) INN (MEZLOCILLIN SODIUM MONOHYDRATE) MEZLIN (BAYER PHARMS) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 062333 (pdf 62333.pdf not found) INN (MEZLOCILLIN SODIUM MONOHYDRATE) MEZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062372 (pdf 62372.pdf not found) INN (MEZLOCILLIN SODIUM MONOHYDRATE) MEZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062697 (pdf 62697.pdf not found) INN (MEZLOCILLIN SODIUM MONOHYDRATE) MEZLIN (BAYER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 1316 ; BENZOYL PEROXIDE ; 94-36-0 ; 1984 ; ; ; CLASS DERMATOLOGICALS -- KERATOLYTIC -- ANTI-ACNE -- OXIDIZING AGENT WITH BACTERIOCIDAL AND KERATOLYTIC EFFECTS -- CONVERTED TO BENZOIC ACID , ; NDA 050557 (label 50557.pdf) INN (BENZOYL PEROXIDE ERYTHROMYCIN) BENZAMYCIN (VALEANT INTL) APPROVAL= AP YEAR= 1984 , NDA 050741 (label 50741.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) DUAC (STIEFEL) APPROVAL= AP YEAR= 2002 , NDA 050756 (label 50756.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZACLIN (BAUSCH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 050769 (label 50769.pdf) INN (BENZOYL PEROXIDE ERYTHROMYCIN) AKTIPAK (BIOFRONTERA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 065112 (pdf 65112.pdf not found) INN (BENZOYL PEROXIDE ERYTHROMYCIN) ERYTHROMYCIN AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022320 (label 22320.pdf) INN (ADAPALENE BENZOYL PEROXIDE) EPIDUO (GALDERMA LABS LP) APPROVAL= AP YEAR= 2008 , NDA 050819 (label 50819.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) ACANYA (BAUSCH) APPROVAL= AP YEAR= 2008 , NDA 065443 (pdf 65443.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2009 , NDA 090979 (pdf 90979.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , NDA 203790 (pdf 203790.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205128 (pdf 205128.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2015 , NDA 207917 (label 207917.pdf) INN (ADAPALENE BENZOYL PEROXIDE) EPIDUO FORTE (GALDERMA LABS) APPROVAL= AP YEAR= 2015 , NDA 065385 (pdf 65385.pdf not found) INN (BENZOYL PEROXIDE ERYTHROMYCIN) ERYTHROMYCIN AND BENZOYL PEROXIDE (LYNE) APPROVAL= AP YEAR= 2015 , NDA 202440 (pdf 202440.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2015 , NDA 208108 (pdf 208108.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 203688 (pdf 203688.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 205033 (pdf 205033.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2018 , NDA 208683 (pdf 208683.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 204087 (pdf 204087.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206959 (pdf 206959.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 206218 (pdf 206218.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2017 , NDA 206164 (pdf 206164.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208776 (pdf 208776.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 207194 (pdf 207194.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209148 (pdf 209148.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 210794 (pdf 210794.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209252 (pdf 209252.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 , NDA 205397 (pdf 205397.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 , NDA 206575 (pdf 206575.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2019 , NDA 212464 (pdf 212464.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2022 , NDA 208757 (pdf 208757.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZOYL PEROXIDE AND CLINDAMYCIN PHOSPHATE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2021 , NDA 212433 (pdf 212433.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 214902 (label 214902.pdf) INN (BENZOYL PEROXIDE TRETINOIN) TWYNEO (GALDERMA LABS LP) APPROVAL= AP YEAR= 2021 , NDA 209641 (pdf 209641.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2022 , NDA 214510 (pdf 214510.pdf not found) INN (BENZOYL PEROXIDE) EPSOLAY (GALDERMA LABS LP) APPROVAL= AP YEAR= 2022 , NDA 214553 (pdf 214553.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214185 (pdf 214185.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE) ADAPALENE AND BENZOYL PEROXIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 209610 (pdf 209610.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE (PERRIGO UK FINCO) APPROVAL= TA YEAR= 2023 , NDA 216632 (pdf 216632.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CABTREO (BAUSCH) APPROVAL= AP YEAR= 2023 , 1317 ; CEFOTETAN ; 69712-56-7 ; 1985 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050588 (label 50588.pdf) INN (CEFOTETAN DISODIUM) CEFOTAN (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 050694 (pdf 50694.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTAN IN PLASTIC CONTAINER (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 063293 (pdf 63293.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTAN (TELIGENT) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 065374 (pdf 65374.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTETAN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 065375 (pdf 65375.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTETAN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065430 (label 65430.pdf) INN (CEFOTETAN DISODIUM) CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER (B BRAUN) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 091030 (pdf 91030.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTETAN (WEST-WARD PHARM CORP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 091031 (pdf 91031.pdf not found) INN (CEFOTETAN DISODIUM) CEFOTETAN (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , 1318 ; KANAMYCIN ; 59-01-8 ; 1973 ; DISCONTINUED ; NATURAL MOLECULE NPA028586 ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- PROTEIN SYNTHESIS INHIBITORS , ; NDA 060516 (pdf 60516.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 061655 (pdf 61655.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 061901 (pdf 61901.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 061911 (pdf 61911.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062170 (pdf 62170.pdf not found) INN (KANAMYCIN SULFATE) KLEBCIL (KING PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062324 (pdf 62324.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN (HIKMA) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 062466 (pdf 62466.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062504 (pdf 62504.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062520 (pdf 62520.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 062564 (pdf 62564.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062605 (pdf 62605.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062642 (pdf 62642.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062668 (pdf 62668.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062669 (pdf 62669.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062672 (pdf 62672.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (PHARMAFAIR) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062726 (pdf 62726.pdf not found) INN (KANAMYCIN SULFATE) KANTREX (APOTHECON) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 063021 (pdf 63021.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (LOCH) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063022 (pdf 63022.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (LOCH) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063025 (pdf 63025.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (LOCH) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063092 (pdf 63092.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 065111 (pdf 65111.pdf not found) INN (KANAMYCIN SULFATE) KANAMYCIN SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2002 DISCONTINUED , 1319 ; HYDROXYAMPHETAMINE ; 103-86-6 ; 1969 ; DISCONTINUED ; NATURAL MOLECULE C00042852 ; CLASS NERVOUS SYSTEM -- ADRENERGIC AGENT -- SYMPATHOMIMETICS -- CAUSES THE RELEASE OF ENDOGENOUS NOREPINEPHRINE -- MYDRIATIC EFFECT -- PROVIDES DIMINISHED PUPIL RESPONSIVENESS TO LIGHT , ; NDA 000004 (pdf 4.pdf not found) INN (HYDROXYAMPHETAMINE HYDROBROMIDE) PAREDRINE (PHARMICS) APPROVAL= AP YEAR= 1969 DISCONTINUED , NDA 019261 (label 19261.pdf) INN (HYDROXYAMPHETAMINE HYDROBROMIDE TROPICAMIDE) PAREMYD (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1320 ; METHYLTESTOSTERONE ; 58-18-4 ; 1971 ; ; ; CLASS GENITO -- HORMONES -- ANDROGENS -- ANTINEOPLASTIC -- ANABOLIC AGENTS , ; NDA 003158 (pdf 3158.pdf not found) INN (METHYLTESTOSTERONE) ORETON METHYL (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 003240 (pdf 3240.pdf not found) INN (METHYLTESTOSTERONE) METANDREN (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080214 (pdf 80214.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080256 (pdf 80256.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (LILLY) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 080271 (pdf 80271.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (USL PHARMA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 080281 (pdf 80281.pdf not found) INN (METHYLTESTOSTERONE) ORETON (SCHERING) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 080308 (pdf 80308.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080309 (pdf 80309.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080310 (pdf 80310.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080313 (pdf 80313.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080475 (pdf 80475.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080767 (pdf 80767.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (IMPAX LABS) APPROVAL= AP YEAR= 1974 , NDA 080839 (pdf 80839.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (INWOOD LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 080931 (pdf 80931.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080933 (pdf 80933.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080973 (pdf 80973.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (INWOOD LABS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083836 (pdf 83836.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PVT FORM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083976 (label 83976.pdf) INN (METHYLTESTOSTERONE) TESTRED (BAUSCH) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 084241 (pdf 84241.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084244 (pdf 84244.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084287 (pdf 84287.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084310 (pdf 84310.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084312 (pdf 84312.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (KV PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084331 (pdf 84331.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084642 (pdf 84642.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (WEST WARD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084967 (pdf 84967.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (HEATHER) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085125 (pdf 85125.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (TABLICAPS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085270 (pdf 85270.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086450 (pdf 86450.pdf not found) INN (METHYLTESTOSTERONE) ANDROID 10 (VALEANT PHARMS NORTH) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087092 (pdf 87092.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (LANNETT) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 087111 (pdf 87111.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (LANNETT) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087147 (pdf 87147.pdf not found) INN (METHYLTESTOSTERONE) ANDROID 25 (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1981 , NDA 087222 (pdf 87222.pdf not found) INN (METHYLTESTOSTERONE) ANDROID 5 (VALEANT PHARM INTL) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087750 (pdf 87750.pdf not found) INN (METHYLTESTOSTERONE) VIRILON (CHARTWELL) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 204851 (pdf 204851.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 , NDA 215270 (pdf 215270.pdf not found) INN (METHYLTESTOSTERONE) METHYLTESTOSTERONE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , 1321 ; MENADIOL ; 481-85-6 ; 1941 ; DISCONTINUED ; ; CLASS VITAMIN K3 , ; NDA 003718 (pdf 3718.pdf not found) INN (MENADIOL SODIUM DIPHOSPHATE) SYNKAYVITE (ROCHE) APPROVAL= AP YEAR= 1941 DISCONTINUED , NDA 005725 (pdf 5725.pdf not found) INN (MENADIOL SODIUM DIPHOSPHATE) KAPPADIONE (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 1322 ; EQUILIN ; 474-86-2 ; 1942 ; ; ; CLASS HORMONES -- ESTROGENIC -- A BLEND OF SYNTHETIC ESTROGENIC SUBSTANCES -- EQUILIN IS ONE EXAMPLE , ; NDA 004782 (label 4782.pdf) INN (ESTROGENS) PREMARIN (WYETH PHARMS) APPROVAL= AP YEAR= 1942 NEWMOLECULARENTITY , NDA 010402 (label 10402.pdf) INN (ESTROGENS) PREMARIN (WYETH PHARMS) APPROVAL= AP YEAR= 1956 , NDA 020216 (label 20216.pdf) INN (ESTROGENS) PREMARIN (WYETH PHARMS) APPROVAL= AP YEAR= 1978 , NDA 020992 (label 20992.pdf) INN (ESTROGENS) CENESTIN (DURAMED) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 021417 (label 21417.pdf) INN (ESTROGENS) PREMARIN (WYETH PHARMS) APPROVAL= AP YEAR= 2003 , NDA 021443 (label 21443.pdf) INN (ESTROGENS) ENJUVIA (DURAMED) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 021609 (label 21609.pdf) INN (ESTROGENS) ENJUVIA (DURAMED) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 083209 (pdf 83209.pdf not found) INN (ESTROGENS) ESTRATAB (SOLVAY) APPROVAL= AP YEAR= 0 , NDA 083266 (pdf 83266.pdf not found) INN (ESTROGENS) AMNESTROGEN (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 0 , NDA 083376 (pdf 83376.pdf not found) INN (ESTROGENS) EVEX (ROCHE PALO) APPROVAL= AP YEAR= 0 , NDA 083414 (pdf 83414.pdf not found) INN (ESTROGENS) ESTERIFIED ESTROGENS (PVT FORM) APPROVAL= AP YEAR= 0 , NDA 083765 (pdf 83765.pdf not found) INN (ESTROGENS) ESTERIFIED ESTROGENS (PVT FORM) APPROVAL= AP YEAR= 0 , NDA 083856 (pdf 83856.pdf not found) INN (ESTROGENS) ESTRATAB (SOLVAY) APPROVAL= AP YEAR= 0 , NDA 083857 (pdf 83857.pdf not found) INN (ESTROGENS) ESTRATAB (SOLVAY) APPROVAL= AP YEAR= 0 , NDA 084215 (pdf 84215.pdf not found) INN (ESTROGENS) EVEX (ROCHE PALO) APPROVAL= AP YEAR= 0 , NDA 084948 (pdf 84948.pdf not found) INN (ESTROGENS) MENEST (MONARCH PHARMS) APPROVAL= AP YEAR= 1977 , NDA 084949 (pdf 84949.pdf not found) INN (ESTROGENS) MENEST (MONARCH PHARMS) APPROVAL= AP YEAR= 1977 , NDA 084950 (pdf 84950.pdf not found) INN (ESTROGENS) MENEST (MONARCH PHARMS) APPROVAL= AP YEAR= 1977 , NDA 084951 (pdf 84951.pdf not found) INN (ESTROGENS) MENEST (MONARCH PHARMS) APPROVAL= AP YEAR= 1977 , NDA 085007 (pdf 85007.pdf not found) INN (ESTROGENS) FEMOGEN (PVT FORM) APPROVAL= AP YEAR= 0 , NDA 085008 (pdf 85008.pdf not found) INN (ESTROGENS) FEMOGEN (PVT FORM) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085076 (pdf 85076.pdf not found) INN (ESTROGENS) FEMOGEN (PVT FORM) APPROVAL= AP YEAR= 0 , NDA 085302 (pdf 85302.pdf not found) INN (ESTROGENS) ESTERIFIED ESTROGENS (SANDOZ) APPROVAL= AP YEAR= 0 , NDA 085907 (pdf 85907.pdf not found) INN (ESTROGENS) ESTERIFIED ESTROGENS (PVT FORM) APPROVAL= AP YEAR= 0 , NDA 086715 (pdf 86715.pdf not found) INN (ESTROGENS) ESTRATAB (SOLVAY) APPROVAL= AP YEAR= 0 , 1323 ; DEXPANTHENOL ; 81-13-0 ; 1947 ; ; ; CLASS METABOLISM -- VITAMIN -- WOUND HEALING , ; NDA 006071 (pdf 6071.pdf not found) INN (DEXPANTHENOL) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (DEXPANTHENOL) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (DEXPANTHENOL) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (DEXPANTHENOL) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (DEXPANTHENOL) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (DEXPANTHENOL) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE HYDROCHLORIDE RIBOFLAVIN 5'-PHOSPHATE SODIUM THIAMINE HYDROCHLORIDE VITAMIN A PALMITATE VITAMIN K) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021265 (label 21265.pdf) INN (ASCORBIC ACID BIOTIN CHOLECALCIFEROL CYANOCOBALAMIN DEXPANTHENOL FOLIC ACID NIACINAMIDE PYRIDOXINE RIBOFLAVIN THIAMINE TOCOPHEROL ACETATE VITAMIN A VITAMIN K) INFUVITE PEDIATRIC (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2001 , NDA 021559 (label 21559.pdf) INN (DEXPANTHENOL) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (DEXPANTHENOL) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (DEXPANTHENOL) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 021646 (label 21646.pdf) INN (DEXPANTHENOL) INFUVITE PEDIATRIC PHARMACY BULK PACKAGE (SANDOZ INC) APPROVAL= AP YEAR= 2004 OBSOLETE , 1324 ; RIBOFLAVIN PHOSPHATE ; 146-17-8 ; 1947 ; ; NATURAL MOLECULE C00019686 ; CLASS VITAMIN B2 -- SUPPLEMENT -- METABOLISM -- PARENTERAL NUTRITION , ; NDA 006071 (pdf 6071.pdf not found) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 008809 (label 8809.pdf) INN (RIBOFLAVIN) M.V.I.-12 ADULT (HOSPIRA) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 018439 (pdf 18439.pdf not found) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) MVC PLUS (WATSON LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018440 (pdf 18440.pdf not found) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) M.V.C. 9+3 (ABRAXIS PHARM) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 018920 (label 18920.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) M.V.I. PEDIATRIC (HOSPIRA) APPROVAL= AP YEAR= 1983 , NDA 018933 (pdf 18933.pdf not found) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) M.V.I.-12 LYOPHILIZED (TELIGENT PHARMA INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 021163 (label 21163.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021559 (label 21559.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021625 (label 21625.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) M.V.I. ADULT (HOSPIRA) APPROVAL= AP YEAR= 2004 , NDA 021643 (label 21643.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE SODIUM) M.V.I. ADULT PHARMACY BULK PACKAGE (HOSPIRA) APPROVAL= AP YEAR= 2004 NEWAPPLICATION , NDA 203324 (label 203324.pdf) INN (RIBOFLAVIN 5'-PHOSPHATE) PHOTREXA (GLAUKOS) APPROVAL= AP YEAR= 2016 , 1325 ; VITAMIN A PALMITATE ; 79-81-2 ; 1947 ; ; ; CLASS VITAMIN -- SUPPLEMENT , ; NDA 006071 (pdf 6071.pdf not found) INN (VITAMIN E) BEROCCA PN (ROCHE) APPROVAL= AP YEAR= 1947 DISCONTINUED , NDA 006823 (pdf 6823.pdf not found) INN (VITAMIN A PALMITATE) AQUASOL A (CASPER PHARMA LLC) APPROVAL= AP YEAR= 1949 , NDA 021163 (label 21163.pdf) INN (VITAMIN K) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021559 (label 21559.pdf) INN (VITAMIN K) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 080702 (pdf 80702.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (BANNER PHARMACAPS) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 080746 (pdf 80746.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (CHASE CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080819 (pdf 80819.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A PALMITATE (BEL MAR) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 080830 (pdf 80830.pdf not found) INN (VITAMIN A PALMITATE) DEL-VI-A (DEL RAY LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080860 (pdf 80860.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080883 (pdf 80883.pdf not found) INN (VITAMIN A PALMITATE) ALPHALIN (LILLY) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080921 (pdf 80921.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A SOLUBILIZED (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080943 (pdf 80943.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 080953 (pdf 80953.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080955 (pdf 80955.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (IMPAX LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080967 (pdf 80967.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (WEST WARD) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 080972 (pdf 80972.pdf not found) INN (VITAMIN A PALMITATE) VI-DOM-A (BAYER PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083035 (pdf 83035.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083114 (pdf 83114.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (EVERYLIFE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083187 (pdf 83187.pdf not found) INN (VITAMIN A PALMITATE) AFAXIN (STERLING WINTHROP) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083190 (pdf 83190.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083207 (pdf 83207.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (CHASE CHEM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083311 (pdf 83311.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A PALMITATE (ARCUM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083321 (pdf 83321.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A PALMITATE (ARCUM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083457 (pdf 83457.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (MK LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083665 (pdf 83665.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (WHARTON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083948 (pdf 83948.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A PALMITATE (BANNER PHARMACAPS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083981 (pdf 83981.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A PALMITATE (BANNER PHARMACAPS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085479 (pdf 85479.pdf not found) INN (VITAMIN A PALMITATE) VITAMIN A (ELKINS SINN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 020176 (pdf 20176.pdf not found) INN (VITAMIN E) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , 1326 ; ABAMETAPIR ; 1762-34-1 ; 2020 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- PEDICULICIDE -- TREATMENT OF HEAD LICE -- METALLOPROTEINASE INHIBITOR , ; NDA 206966 (label 206966.pdf) INN (ABAMETAPIR) XEGLYZE (HATCHTECH) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY DISCONTINUED , 1327 ; HYDROCORTISONE CYPIONATE ; 508-99-6 ; 1955 ; DISCONTINUED ; ; CLASS METABOLISM -- GLUCOCORTICOID -- AGONIST -- ANTI-INFLAMMATORY , ; NDA 009900 (pdf 9900.pdf not found) INN (HYDROCORTISONE CYPIONATE) CORTEF (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1955 DISCONTINUED , 1328 ; HYDROCORTISONE PROBUTATE ; 72590-77-3 ; 1997 ; ; ; CLASS DERMATOLOGICALS -- AGONIST -- GLUCOCORTICOID -- ANTI-INFLAMMATORY , ; NDA 020453 (label 20453.pdf) INN (HYDROCORTISONE PROBUTATE) PANDEL (ANI PHARMS) APPROVAL= AP YEAR= 1997 , 1329 ; TYROSINE ; 60-18-4 ; 0 ; DISCONTINUED ; NATURAL MOLECULE C00001397 ; CLASS NUTRIENT -- SUPPLEMENT -- TREATMENT OF PHENYLKETONURIA (PKU) , ; NDA 008378 (pdf 8378.pdf not found) INN (NIACINAMIDE PYRIDOXINE HYDROCHLORIDE TYROSINE) TPN (INTL MINERALS) APPROVAL= - YEAR= 0 DISCONTINUED , 1330 ; PROPOXYCAINE ; 86-43-1 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 008592 (pdf 8592.pdf not found) INN (PROPOXYCAINE HYDROCHLORIDE) RAVOCAINE AND NOVOCAIN W/ LEVOPHED (EASTMAN KODAK) APPROVAL= - YEAR= 0 DISCONTINUED , 1331 ; PROTOKYLOL ; 912804-63-8 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATATOR -- BETA ADRENERGIC AGONIST , ; NDA 083459 (pdf 83459.pdf not found) INN (PROTOKYLOL HYDROCHLORIDE) VENTAIRE (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , 1332 ; DEXTROAMPHETAMINE ; 51-64-9 ; 1955 ; ; NATURAL MOLECULE C00042226 ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- AMPHETAMINES -- SYMPATHOMIMETICS -- BLOCK THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE -- TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) AND NARCOLEPSY -- MONOAMINE TRANSPORTER BLOCKER , ; NDA 010093 (pdf 10093.pdf not found) INN (AMPHETAMINE RESIN COMPLEX DEXTROAMPHETAMINE RESIN COMPLEX) BIPHETAMINE 20 (UCB INC) APPROVAL= AP YEAR= 1955 DISCONTINUED , NDA 011522 (label 11522.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) ADDERALL 10 (TEVA WOMENS) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 021303 (label 21303.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) ADDERALL XR 10 (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2001 , NDA 040422 (label 40422.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (BARR) APPROVAL= AP YEAR= 2002 , NDA 040439 (pdf 40439.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 040440 (pdf 40440.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003 , NDA 040444 (pdf 40444.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 040456 (pdf 40456.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040472 (pdf 40472.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 040480 (pdf 40480.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2003 , NDA 083563 (pdf 83563.pdf not found) INN (AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083564 (pdf 83564.pdf not found) INN (AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATE) DELCOBESE (TEVA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083900 (pdf 83900.pdf not found) INN (AMPHETAMINE SULFATE) BENZEDRINE (SMITH KLINE & FRENCH) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083901 (pdf 83901.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 017078 (label 17078.pdf) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE (IMPAX LABS INC) APPROVAL= AP YEAR= 1976 , NDA 040299 (pdf 40299.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040361 (label 40361.pdf) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (BARR) APPROVAL= AP YEAR= 2001 , NDA 040365 (pdf 40365.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040367 (pdf 40367.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040436 (pdf 40436.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2002 , NDA 040470 (pdf 40470.pdf not found) INN (DEXTROAMPHETAMINE SACCHARATE) DEXTROAMP SACCHARATE AMP ASPARTATE DEXTROAMP SULFATE AND AMP SULFATE (SANDOZ) APPROVAL= AP YEAR= 2002 OBSOLETE , NDA 040776 (pdf 40776.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (PRASCO) APPROVAL= AP YEAR= 2008 , NDA 076137 (pdf 76137.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076353 (pdf 76353.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2003 , NDA 076814 (pdf 76814.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 083735 (pdf 83735.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXAMPEX (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 083902 (pdf 83902.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 083903 (pdf 83903.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 083930 (pdf 83930.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (HALSEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084001 (pdf 84001.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) FERNDEX (FERNDALE LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 084051 (pdf 84051.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROSTAT (SHIRE) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084125 (pdf 84125.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 084935 (pdf 84935.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXEDRINE (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084986 (pdf 84986.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085355 (pdf 85355.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXAMPEX (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085370 (pdf 85370.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ANI PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085371 (pdf 85371.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (SANDOZ) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085652 (pdf 85652.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (LANNETT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 085892 (pdf 85892.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (VITARINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086521 (pdf 86521.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (MAST MM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090533 (pdf 90533.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AZURITY) APPROVAL= AP YEAR= 2011 , NDA 077302 (pdf 77302.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 200166 (pdf 200166.pdf not found) INN (AMPHETAMINE SULFATE) EVEKEO (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2012 , NDA 076536 (pdf 76536.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (BARR LABS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 077488 (pdf 77488.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202424 (pdf 202424.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 203901 (pdf 203901.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 , NDA 202893 (pdf 202893.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 , NDA 203644 (pdf 203644.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2013 , NDA 090652 (pdf 90652.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 206721 (pdf 206721.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208147 (label 208147.pdf) INN (AMPHETAMINE AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE) DYANAVEL XR (TRIS PHARMA INC) APPROVAL= AP YEAR= 2015 , NDA 076852 (pdf 76852.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (IMPAX LABS) APPROVAL= AP YEAR= 2016 , NDA 204326 (label 204326.pdf) INN (AMPHETAMINE) ADZENYS XR-ODT (NEOS THERAPS) APPROVAL= AP YEAR= 2016 , NDA 206159 (pdf 206159.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (PAR PHARM INC) APPROVAL= AP YEAR= 2019 , NDA 206304 (pdf 206304.pdf not found) INN (DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AMPHETAMINE SULFATE) DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AMPHETAMINE SULFATE (COREPHARMA) APPROVAL= TA YEAR= 2016 , NDA 206340 (pdf 206340.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2016 , NDA 203548 (pdf 203548.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (AVANTHI INC) APPROVAL= AP YEAR= 2015 , NDA 204330 (pdf 204330.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NOVEL LABS INC) APPROVAL= AP YEAR= 2016 , NDA 206588 (pdf 206588.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206735 (pdf 206735.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 022063 (label 22063.pdf) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) MYDAYIS (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 207388 (pdf 207388.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ALVOGEN) APPROVAL= AP YEAR= 2017 , NDA 209111 (pdf 209111.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204325 (label 204325.pdf) INN (AMPHETAMINE) ADZENYS ER (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 207340 (pdf 207340.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209799 (pdf 209799.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (NUVO PHARM) APPROVAL= AP YEAR= 2017 , NDA 205673 (pdf 205673.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 , NDA 210059 (pdf 210059.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (NUVO PHARM) APPROVAL= AP YEAR= 2017 , NDA 210080 (pdf 210080.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (NESHER PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211139 (pdf 211139.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211352 (pdf 211352.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2018 , NDA 205401 (pdf 205401.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ANI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209905 (label 209905.pdf) INN (AMPHETAMINE SULFATE) EVEKEO ODT (ARBOR PHARMS LLC) APPROVAL= AP YEAR= 2019 , NDA 210651 (pdf 210651.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211547 (pdf 211547.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2019 , NDA 211639 (pdf 211639.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2019 , NDA 211715 (pdf 211715.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2019 , NDA 212037 (pdf 212037.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ELITE LABS INC) APPROVAL= AP YEAR= 2019 , NDA 212619 (pdf 212619.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GRANULES PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212919 (pdf 212919.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (BIONPHARMA INC) APPROVAL= AP YEAR= 2019 , NDA 210293 (pdf 210293.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (USPHARMA WINDLAS) APPROVAL= AP YEAR= 2020 , NDA 211861 (pdf 211861.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 211876 (pdf 211876.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212582 (pdf 212582.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (CEROVENE INC) APPROVAL= AP YEAR= 2020 , NDA 212901 (pdf 212901.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (HAVIX) APPROVAL= AP YEAR= 2020 , NDA 213898 (pdf 213898.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (MAYNE PHARMA) APPROVAL= AP YEAR= 2020 , NDA 205077 (pdf 205077.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213720 (pdf 213720.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213763 (pdf 213763.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (NOVAST LABS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213980 (pdf 213980.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212186 (pdf 212186.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213111 (pdf 213111.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 213583 (pdf 213583.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2021 , NDA 213709 (pdf 213709.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214574 (pdf 214574.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2021 , NDA 212160 (pdf 212160.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (WINDER LABS LLC) APPROVAL= AP YEAR= 2021 , NDA 210526 (label 210526.pdf) INN (AMPHETAMINE AMPHETAMINE ASPARTATE DEXTROAMPHETAMINE SULFATE) DYANAVEL XR 5 (TRIS PHARMA INC) APPROVAL= AP YEAR= 2021 , NDA 213852 (pdf 213852.pdf not found) INN (AMPHETAMINE SULFATE) AMPHETAMINE SULFATE (RHODES PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214347 (pdf 214347.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214403 (pdf 214403.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2021 , NDA 214959 (pdf 214959.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 215771 (pdf 215771.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2021 , NDA 210754 (pdf 210754.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (CEDIPROF INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210876 (pdf 210876.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 215565 (pdf 215565.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (LANNETT CO INC) APPROVAL= AP YEAR= 2022 , NDA 215401 (label 215401.pdf) INN (DEXTROAMPHETAMINE) XELSTRYM (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 209253 (pdf 209253.pdf not found) INN (AMPHETAMINE) AMPHETAMINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023 , NDA 217027 (pdf 217027.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (GRANULES) APPROVAL= AP YEAR= 2023 , NDA 206095 (pdf 206095.pdf not found) INN (DEXTROAMPHETAMINE SULFATE) DEXTROAMPHETAMINE SULFATE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211546 (pdf 211546.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SPECGX LLC) APPROVAL= AP YEAR= 2023 , NDA 215997 (pdf 215997.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , NDA 217787 (pdf 217787.pdf not found) INN (AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE) DEXTROAMP SACCHARATE , AMP ASPARTATE , DEXTROAMP SULFATE AND AMP SULFATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , 1333 ; TRIMETHAPHAN ; 7187-66-8 ; 1954 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- GANGLIONIC BLOCKERS -- NICOTINIC ANTAGONISTS -- VASODILATOR AGENTS , ; NDA 008983 (pdf 8983.pdf not found) INN (TRIMETHAPHAN CAMSYLATE) ARFONAD (ROCHE) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , 1334 ; TESTOSTERONE ENANTHATE ; 315-37-7 ; 1953 ; ; ; CLASS HORMONES -- ANDROGENIC -- HYDROLYSED BY ESTERASES , ; NDA 009165 (label 9165.pdf) INN (TESTOSTERONE ENANTHATE) DELATESTRYL (ENDO PHARMS) APPROVAL= AP YEAR= 1953 DISCONTINUED , NDA 040575 (pdf 40575.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (NEXUS) APPROVAL= AP YEAR= 2006 , NDA 083667 (pdf 83667.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085598 (pdf 85598.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (WATSON PHARMS INC) APPROVAL= AP YEAR= 1980 , NDA 085599 (pdf 85599.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085860 (pdf 85860.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085865 (pdf 85865.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE (WATSON LABS) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086423 (pdf 86423.pdf not found) INN (ESTRADIOL VALERATE TESTOSTERONE ENANTHATE) DITATE-DS (SAVAGE LABS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 089324 (pdf 89324.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089325 (pdf 89325.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040647 (pdf 40647.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (RISING) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 091120 (pdf 91120.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2012 , NDA 209863 (label 209863.pdf) INN (TESTOSTERONE ENANTHATE) XYOSTED AUTOINJECTOR (ANTARES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 212659 (pdf 212659.pdf not found) INN (TESTOSTERONE ENANTHATE) TESTOSTERONE ENANTHATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2024 , 1335 ; TESTOSTERONE CYPIONATE ; 58-20-8 ; 1978 ; ; ; CLASS HORMONES -- ANDROGENIC -- HYDROLYSED BY ESTERASES , ; NDA 017968 (pdf 17968.pdf not found) INN (ESTRADIOL CYPIONATE TESTOSTERONE CYPIONATE) DEPO-TESTADIOL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 040530 (pdf 40530.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (PADAGIS US) APPROVAL= AP YEAR= 2005 , NDA 040615 (pdf 40615.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 040652 (pdf 40652.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (RISING) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 084401 (pdf 84401.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085603 (pdf 85603.pdf not found) INN (ESTRADIOL CYPIONATE TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 085635 (label 85635.pdf) INN (TESTOSTERONE CYPIONATE) DEPO-TESTOSTERONE (PFIZER) APPROVAL= AP YEAR= 1979 , NDA 086029 (pdf 86029.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086030 (pdf 86030.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (WATSON PHARMS INC) APPROVAL= AP YEAR= 1981 , NDA 089326 (pdf 89326.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089327 (pdf 89327.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 090387 (pdf 90387.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (HIKMA) APPROVAL= AP YEAR= 2010 , NDA 091244 (pdf 91244.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2012 , NDA 201720 (pdf 201720.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2013 , NDA 207742 (pdf 207742.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (AM REGENT) APPROVAL= AP YEAR= 2017 , NDA 210362 (pdf 210362.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 206368 (pdf 206368.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (WILSHIRE PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 216318 (label 216318.pdf) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215351 (pdf 215351.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (XIROMED) APPROVAL= AP YEAR= 2023 , NDA 211817 (pdf 211817.pdf not found) INN (TESTOSTERONE CYPIONATE) TESTOSTERONE CYPIONATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , 1336 ; HEXAFLUORENIUM ; 4844-10-4 ; 0 ; DISCONTINUED ; ; CLASS MUSCLE RELAXANT , ; NDA 009789 (pdf 9789.pdf not found) INN (HEXAFLUORENIUM BROMIDE) MYLAXEN (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , 1337 ; PREDNISOLONE TEBUTATE ; 7681-14-3 ; 1956 ; DISCONTINUED ; ; CLASS ANTI-INFLAMMATORY -- GLUCOCORTICOID -- ANTINEOPLASTIC -- ADRENERGIC -- CORTICOSTEROIDS , ; NDA 010562 (pdf 10562.pdf not found) INN (PREDNISOLONE TEBUTATE) HYDELTRA-TBA (MERCK) APPROVAL= AP YEAR= 1956 DISCONTINUED , NDA 083362 (pdf 83362.pdf not found) INN (PREDNISOLONE TEBUTATE) PREDNISOLONE TEBUTATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , 1338 ; HEXOCYCLIUM ; 6004-98-4 ; 1957 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTAGONIST , ; NDA 010599 (pdf 10599.pdf not found) INN (HEXOCYCLIUM METHYLSULFATE) TRAL (ABBVIE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 1339 ; HEXOCYCLIUM ; 6004-98-4 ; 1957 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTISPASMODIC -- ANTICHOLINERGIC -- ANTAGONIST , ; NDA 010599 (pdf 10599.pdf not found) INN (HEXOCYCLIUM METHYLSULFATE) TRAL (ABBVIE) APPROVAL= AP YEAR= 1957 NEWMOLECULARENTITY DISCONTINUED , 1340 ; METHYLPREDNISOLONE ACETATE ; 53-36-1 ; 1959 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- CORTICOSTEROIDS -- ANTIEMETICS -- AGONIST -- ANTI-INFLAMMATORY -- IMMUNOSUPPRESSANT -- ANTI-ALLERGIC , ; NDA 011757 (label 11757.pdf) INN (METHYLPREDNISOLONE ACETATE) DEPO-MEDROL (PFIZER) APPROVAL= AP YEAR= 1959 , NDA 012421 (pdf 12421.pdf not found) INN (METHYLPREDNISOLONE ACETATE) MEDROL ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1960 DISCONTINUED , NDA 018102 (pdf 18102.pdf not found) INN (METHYLPREDNISOLONE ACETATE) MEDROL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 040557 (pdf 40557.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (HONG KONG) APPROVAL= AP YEAR= 2005 , NDA 040620 (pdf 40620.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 060611 (pdf 60611.pdf not found) INN (METHYLPREDNISOLONE ACETATE NEOMYCIN SULFATE) NEO-MEDROL ACETATE (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1964 DISCONTINUED , NDA 085374 (pdf 85374.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085595 (pdf 85595.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085597 (pdf 85597.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085600 (pdf 85600.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086507 (pdf 86507.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086666 (pdf 86666.pdf not found) INN (METHYLPREDNISOLONE ACETATE) M-PREDROL (BEL MAR) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086903 (pdf 86903.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087135 (pdf 87135.pdf not found) INN (METHYLPREDNISOLONE ACETATE) M-PREDROL (BEL MAR) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087248 (pdf 87248.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 040719 (pdf 40719.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 040794 (pdf 40794.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (SANDOZ) APPROVAL= AP YEAR= 2009 , NDA 201835 (pdf 201835.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 210043 (pdf 210043.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 214297 (pdf 214297.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 , NDA 211930 (pdf 211930.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 214870 (pdf 214870.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 216502 (pdf 216502.pdf not found) INN (METHYLPREDNISOLONE ACETATE) METHYLPREDNISOLONE ACETATE (AMNEAL) APPROVAL= AP YEAR= 2023 , 1341 ; TRIAMCINOLONE HEXACETONIDE ; 5611-51-8 ; 1969 ; DISCONTINUED ; ; CLASS GLUCOCORTICOID -- AGONIST -- ANTI-INFLAMMATORY AGENTS -- ALOPECIA AREATA -- CYSTIC TUMORS OF AN APONEUROSIS OR TENDON (GANGLIA) -- ECZEMA -- PSORIASIS -- ARTHRITIS -- ALLERGIES -- ULCERATIVE COLITIS -- LUPUS -- SYMPATHETIC OPHTHALMIA -- TEMPORAL ARTERITIS -- UVEITIS -- OCULAR INFLAMMATION -- , ; NDA 016466 (label 16466.pdf) INN (TRIAMCINOLONE HEXACETONIDE) ARISTOSPAN (SANDOZ) APPROVAL= AP YEAR= 1969 DISCONTINUED , 1342 ; TROLAMINE ; 102-71-6 ; 1958 ; DISCONTINUED ; ; CLASS LYSES CERUMEN -- SURFACTANT -- SENSORY , ; NDA 011340 (label 11340.pdf) INN (TROLAMINE POLYPEPTIDE OLEATE CONDENSATE) CERUMENEX (PHARM RES ASSOC) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , 1343 ; FLUPHENAZINE ENANTHATE ; 2746-81-8 ; 1967 ; DISCONTINUED ; ; CLASS ANTIPSYCHOTIC -- NERVOUS SYSTEM -- ANTAGONIST -- HYDROLYSED BY ESTERASES , ; NDA 016110 (pdf 16110.pdf not found) INN (FLUPHENAZINE ENANTHATE) PROLIXIN ENANTHATE (APOTHECON) APPROVAL= AP YEAR= 1967 DISCONTINUED , 1344 ; FLUPHENAZINE DECANOATE ; 5002-47-1 ; 1972 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- PHENOTHIAZINE DERIVATIVE -- ANTAGONIST -- HYDROLYSED BY ESTERASES , ; NDA 016727 (pdf 16727.pdf not found) INN (FLUPHENAZINE DECANOATE) PROLIXIN DECANOATE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 070762 (pdf 70762.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071413 (label 71413.pdf) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1987 , NDA 074531 (pdf 74531.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (HIKMA) APPROVAL= AP YEAR= 1996 , NDA 074795 (pdf 74795.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074966 (pdf 74966.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075918 (pdf 75918.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2001 , NDA 203732 (pdf 203732.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 207739 (pdf 207739.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 , NDA 215509 (pdf 215509.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 215365 (pdf 215365.pdf not found) INN (FLUPHENAZINE DECANOATE) FLUPHENAZINE DECANOATE (MSN) APPROVAL= AP YEAR= 2023 , 1345 ; NANDROLONE PHENPROPIONATE ; 62-90-8 ; 1959 ; DISCONTINUED ; ; CLASS HORMONES -- ANDROGENIC -- AGONIST -- ANABOLIC STEROID , ; NDA 011891 (pdf 11891.pdf not found) INN (NANDROLONE PHENPROPIONATE) DURABOLIN (ORGANON USA INC) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , NDA 086386 (pdf 86386.pdf not found) INN (NANDROLONE PHENPROPIONATE) NANDROLONE PHENPROPIONATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087488 (pdf 87488.pdf not found) INN (NANDROLONE PHENPROPIONATE) NANDROLONE PHENPROPIONATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089297 (pdf 89297.pdf not found) INN (NANDROLONE PHENPROPIONATE) NANDROLONE PHENPROPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089298 (pdf 89298.pdf not found) INN (NANDROLONE PHENPROPIONATE) NANDROLONE PHENPROPIONATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , 1346 ; NANDROLONE DECANOATE ; 360-70-3 ; 1962 ; DISCONTINUED ; ; CLASS HORMONES -- ANDROGENIC -- ANABOLIC -- AGONIST , ; NDA 013132 (pdf 13132.pdf not found) INN (NANDROLONE DECANOATE) DECA-DURABOLIN (WOODWARD SPECL) APPROVAL= AP YEAR= 1962 DISCONTINUED , NDA 086385 (pdf 86385.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 086598 (pdf 86598.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 087519 (pdf 87519.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087598 (pdf 87598.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087599 (pdf 87599.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088128 (pdf 88128.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088290 (pdf 88290.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 088317 (pdf 88317.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (ABRAXIS PHARM) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088554 (pdf 88554.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089248 (pdf 89248.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089249 (pdf 89249.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089250 (pdf 89250.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 091252 (pdf 91252.pdf not found) INN (NANDROLONE DECANOATE) NANDROLONE DECANOATE (AM REGENT) APPROVAL= AP YEAR= 2010 DISCONTINUED , 1347 ; FLUPREDNISOLONE ; 53-34-9 ; 1978 ; DISCONTINUED ; ; CLASS GLUCOCORTICOID -- CORTICOSTEROIDS -- ANTI-INFLAMMATORY , ; NDA 012259 (pdf 12259.pdf not found) INN (FLUPREDNISOLONE) ALPHADROL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1978 DISCONTINUED , 1348 ; BETAMETHASONE BENZOATE ; 22298-29-9 ; 1974 ; DISCONTINUED ; ; CLASS GLUCOCORTICOID -- COTICOSTEROIDS -- AGONIST -- PSORIASIS , ; NDA 016998 (pdf 16998.pdf not found) INN (BETAMETHASONE BENZOATE) UTICORT (PARKE DAVIS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 017244 (pdf 17244.pdf not found) INN (BETAMETHASONE BENZOATE) UTICORT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 017528 (pdf 17528.pdf not found) INN (BETAMETHASONE BENZOATE) UTICORT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018089 (pdf 18089.pdf not found) INN (BETAMETHASONE BENZOATE) UTICORT (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1349 ; BETAMETHASONE DIPROPIONATE ; 5593-20-4 ; 1975 ; ; ; CLASS DERMATOLOGICALS -- GLUCOCORTICOID -- CORTICOSTEROIDS -- AGONIST -- PSORIASIS VULGARIS , ; NDA 017536 (label 17536.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROSONE (SCHERING) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 017691 (label 17691.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROSONE (SCHERING) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 017781 (label 17781.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROSONE (SCHERING) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 017829 (pdf 17829.pdf not found) INN (BETAMETHASONE DIPROPIONATE) DIPROSONE (SCHERING) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018741 (label 18741.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROLENE (ORGANON) APPROVAL= AP YEAR= 1983 , NDA 018827 (label 18827.pdf) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) LOTRISONE (ORGANON) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019136 (pdf 19136.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019137 (pdf 19137.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1984 , NDA 019138 (pdf 19138.pdf not found) INN (BETAMETHASONE DIPROPIONATE) ALPHATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019140 (pdf 19140.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PHARMADERM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019141 (pdf 19141.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1984 , NDA 019143 (pdf 19143.pdf not found) INN (BETAMETHASONE DIPROPIONATE) ALPHATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019408 (pdf 19408.pdf not found) INN (BETAMETHASONE DIPROPIONATE) DIPROLENE (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019555 (label 19555.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROLENE AF (ORGANON) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019716 (label 19716.pdf) INN (BETAMETHASONE DIPROPIONATE) DIPROLENE (ORGANON) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 020010 (label 20010.pdf) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) LOTRISONE (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 021852 (label 21852.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) TACLONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 2006 , NDA 022185 (label 22185.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE HYDRATE) TACLONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 2008 , NDA 070273 (pdf 70273.pdf not found) INN (BETAMETHASONE DIPROPIONATE) ALPHATREX (SAVAGE LABS) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070274 (pdf 70274.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (SHREE HARI INTL) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070275 (pdf 70275.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1985 , NDA 070281 (pdf 70281.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 070885 (pdf 70885.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1987 , NDA 071012 (pdf 71012.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1987 , NDA 071085 (pdf 71085.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071143 (pdf 71143.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071467 (pdf 71467.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (COSETTE) APPROVAL= AP YEAR= 1987 , NDA 071476 (pdf 71476.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071477 (pdf 71477.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071882 (pdf 71882.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (COSETTE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072276 (pdf 72276.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072526 (pdf 72526.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072536 (pdf 72536.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PERRIGO NEW YORK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072538 (pdf 72538.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PADAGIS US) APPROVAL= AP YEAR= 1990 , NDA 073552 (pdf 73552.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 1992 , NDA 074271 (pdf 74271.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 1994 , NDA 074272 (pdf 74272.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074304 (pdf 74304.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1995 , NDA 074579 (pdf 74579.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PERRIGO NEW YORK) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 075276 (label 75276.pdf) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 075373 (pdf 75373.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075502 (pdf 75502.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2001 , NDA 075673 (pdf 75673.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2001 , NDA 076002 (pdf 76002.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2002 , NDA 076215 (pdf 76215.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2003 , NDA 076493 (pdf 76493.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076508 (pdf 76508.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2003 , NDA 076516 (pdf 76516.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076543 (pdf 76543.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2003 , NDA 076592 (pdf 76592.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003 , NDA 076603 (pdf 76603.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076753 (pdf 76753.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 077111 (pdf 77111.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2007 , NDA 077477 (pdf 77477.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2007 , NDA 078930 (pdf 78930.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2008 , NDA 201615 (pdf 201615.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200174 (pdf 200174.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 , NDA 202894 (pdf 202894.pdf not found) INN (BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE) CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2015 , NDA 207589 (label 207589.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) ENSTILAR (LEO PHARMA AS) APPROVAL= AP YEAR= 2015 , NDA 208079 (label 208079.pdf) INN (BETAMETHASONE DIPROPIONATE) SERNIVO (PRIMUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206118 (pdf 206118.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PADAGIS US) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206389 (pdf 206389.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ENCUBE) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209896 (pdf 209896.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210217 (pdf 210217.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (COSETTE) APPROVAL= AP YEAR= 2018 , NDA 208885 (pdf 208885.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 208849 (pdf 208849.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (HIKMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209106 (pdf 209106.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 210765 (pdf 210765.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (COSETTE) APPROVAL= AP YEAR= 2020 , NDA 211722 (pdf 211722.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213422 (label 213422.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) WYNZORA (MC2) APPROVAL= AP YEAR= 2020 , NDA 214048 (pdf 214048.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2020 , NDA 212367 (pdf 212367.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 , NDA 213269 (pdf 213269.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2020 , NDA 215186 (pdf 215186.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (TASMAN PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215847 (pdf 215847.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2022 , NDA 214688 (pdf 214688.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 218289 (pdf 218289.pdf not found) INN (BETAMETHASONE DIPROPIONATE) BETAMETHASONE DIPROPIONATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1350 ; PARAMETHASONE ACETATE ; 1597-82-6 ; 1961 ; DISCONTINUED ; ; CLASS HORMONES -- GLUCOCORTICOID -- ANTI-INFLAMMATORY -- CORTICOSTEROID , ; NDA 012772 (pdf 12772.pdf not found) INN (PARAMETHASONE ACETATE) HALDRONE (LILLY) APPROVAL= AP YEAR= 1961 NEWMOLECULARENTITY DISCONTINUED , 1351 ; STANOZOLOL ; 10418-03-8 ; 1962 ; DISCONTINUED ; ; CLASS METABOLISM -- ANABOLIC STEROID -- ANDROGENIC AGONIST , ; NDA 012885 (pdf 12885.pdf not found) INN (STANOZOLOL) WINSTROL (LUNDBECK INC) APPROVAL= AP YEAR= 1962 NEWMOLECULARENTITY DISCONTINUED , 1352 ; LEVOPROPOXYPHENE ; 2338-37-6 ; 1962 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTITUSSIVE -- OPIOID AGONIST -- ANALGESIC , ; NDA 012928 (pdf 12928.pdf not found) INN (LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS) NOVRAD (LILLY) APPROVAL= AP YEAR= 1962 DISCONTINUED , 1353 ; DROMOSTANOLONE PROPIONATE ; 521-12-0 ; 0 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC (PMID5067664) -- ANABOLIC AGENTS , ; NDA 012936 (pdf 12936.pdf not found) INN (DROMOSTANOLONE PROPIONATE) DROLBAN (LILLY) APPROVAL= - YEAR= 0 DISCONTINUED , 1354 ; SULFAPHENAZOLE ; 526-08-9 ; 1974 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- SULFONAMIDES -- CYTOCHROME P450 INHIBITOR , ; NDA 013092 (pdf 13092.pdf not found) INN (SULFAPHENAZOLE) SULFABID (PURDUE FREDERICK) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 013093 (pdf 13093.pdf not found) INN (SULFAPHENAZOLE) SULFABID (PHARM RES ASSOC) APPROVAL= AP YEAR= 1977 DISCONTINUED , 1355 ; METHIXENE ; 4969-02-2 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- MUSCLE RELAXANT -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS , ; NDA 013420 (pdf 13420.pdf not found) INN (METHIXENE HYDROCHLORIDE) TREST (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1356 ; METHIXENE ; 4969-02-2 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- MUSCLE RELAXANT -- ANTIPARKINSON AGENTS -- MUSCARINIC ANTAGONISTS , ; NDA 013420 (pdf 13420.pdf not found) INN (METHIXENE HYDROCHLORIDE) TREST (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1357 ; PIPERACETAZINE ; 3819-00-9 ; 1969 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA , ; NDA 013615 (pdf 13615.pdf not found) INN (PIPERACETAZINE) QUIDE (DOW PHARM) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , 1358 ; CHLORPHENESIN CARBAMATE ; 886-74-8 ; 1965 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- MUSCLE RELAXANT -- TREATMENT OF PAIN AND DISCOMFORT RELATED TO SKELETAL MUSCLE TRAUMA AND INFLAMMATION , ; NDA 014217 (pdf 14217.pdf not found) INN (CHLORPHENESIN CARBAMATE) MAOLATE (PAMLAB LLC) APPROVAL= AP YEAR= 1965 DISCONTINUED , 1359 ; CHLORPHENESIN CARBAMATE ; 886-74-8 ; 1965 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- MUSCLE RELAXANT -- TREATMENT OF PAIN AND DISCOMFORT RELATED TO SKELETAL MUSCLE TRAUMA AND INFLAMMATION , ; NDA 014217 (pdf 14217.pdf not found) INN (CHLORPHENESIN CARBAMATE) MAOLATE (PAMLAB LLC) APPROVAL= AP YEAR= 1965 DISCONTINUED , 1360 ; LEVOMEPROMAZINE ; 60-99-1 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANALGESICS, NON-NARCOTIC -- ANTIPSYCHOTIC AGENTS -- ANTAGONISTS , ; NDA 015865 (pdf 15865.pdf not found) INN (LEVOMEPROMAZINE) LEVOPROME (IMMUNEX) APPROVAL= - YEAR= 0 DISCONTINUED , 1361 ; HALOPERIDOL LACTATE ; 75478-79-4 ; 1967 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDYSKINETICS -- ANTIEMETICS -- ANTIPSYCHOTIC AGENTS -- BUTYROPHENONES -- DOPAMINE ANTAGONISTS , ; NDA 015922 (pdf 15922.pdf not found) INN (HALOPERIDOL LACTATE) HALDOL (ORTHO MCNEIL) APPROVAL= AP YEAR= 1967 DISCONTINUED , NDA 015923 (label 15923.pdf) INN (HALOPERIDOL LACTATE) HALDOL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1971 DISCONTINUED , NDA 070318 (pdf 70318.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (ALPHARMA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070710 (pdf 70710.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (MORTON GROVE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070713 (pdf 70713.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070714 (pdf 70714.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (WATSON LABS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 070726 (pdf 70726.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SCS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070744 (pdf 70744.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070800 (pdf 70800.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070801 (pdf 70801.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070802 (pdf 70802.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SMITH AND NEPHEW) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070864 (pdf 70864.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071015 (pdf 71015.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (TEVA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071082 (pdf 71082.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071187 (pdf 71187.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (ABRAXIS PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071617 (pdf 71617.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (TEVA PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072045 (pdf 72045.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL INTENSOL (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072516 (pdf 72516.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072517 (pdf 72517.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 073037 (pdf 73037.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (PHARM ASSOC) APPROVAL= AP YEAR= 1993 , NDA 073364 (pdf 73364.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (LANNETT CO INC) APPROVAL= AP YEAR= 1993 , NDA 074536 (pdf 74536.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL LACTATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 075689 (pdf 75689.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2001 , NDA 075858 (pdf 75858.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (HIKMA) APPROVAL= AP YEAR= 2001 , NDA 076035 (pdf 76035.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 076464 (pdf 76464.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (FOSUN PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076774 (pdf 76774.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2004 , NDA 076791 (pdf 76791.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076828 (pdf 76828.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 078347 (pdf 78347.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2009 , NDA 091637 (pdf 91637.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SAGENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 200742 (pdf 200742.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (SAGENT PHARMS) APPROVAL= AP YEAR= 2011 , NDA 204849 (pdf 204849.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210356 (pdf 210356.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2019 , NDA 218371 (pdf 218371.pdf not found) INN (HALOPERIDOL LACTATE) HALOPERIDOL (RUBICON) APPROVAL= AP YEAR= 2024 , 1362 ; HALOPERIDOL DECANOATE ; 74050-97-8 ; 1986 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- DOPAMINE ANTAGONIST -- DECANOATE ESTER OF THE BUTYROPHENONE -- BLOCKS THE EFFECTS OF DOPAMINE -- THE TREATMENT OF SCHIZOPHRENIC PATIENTS -- BUTYROPHENONE DERIVATIVES , ; NDA 018701 (label 18701.pdf) INN (HALOPERIDOL DECANOATE) HALDOL (JANSSEN PHARMS) APPROVAL= AP YEAR= 1986 , NDA 074811 (pdf 74811.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 074893 (pdf 74893.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1997 , NDA 075176 (label 75176.pdf) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075305 (pdf 75305.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (HIKMA) APPROVAL= AP YEAR= 1998 , NDA 075393 (pdf 75393.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075440 (pdf 75440.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2000 , NDA 076463 (pdf 76463.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 205241 (pdf 205241.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2017 , NDA 209101 (pdf 209101.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2018 , NDA 211180 (pdf 211180.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 214507 (pdf 214507.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 216730 (pdf 216730.pdf not found) INN (HALOPERIDOL DECANOATE) HALOPERIDOL DECANOATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2023 , 1363 ; MEPREDNISONE ; 1247-42-3 ; 1978 ; DISCONTINUED ; ; CLASS HORMONES -- GLUCOCORTICOID -- AGONIST , ; NDA 016053 (pdf 16053.pdf not found) INN (MEPREDNISONE) BETAPAR (SCHERING) APPROVAL= AP YEAR= 1978 DISCONTINUED , 1364 ; ETHACRYNATE ; 6463-21-4 ; 1967 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- KETONE DERIVATIVE OF AN ARYLOXYACETIC ACID -- TREATMENT OF EDEMA , ; NDA 016093 (label 16093.pdf) INN (ETHACRYNATE SODIUM) EDECRIN (BAUSCH) APPROVAL= AP YEAR= 1967 , NDA 016092 (label 16092.pdf) INN (ETHACRYNIC ACID) EDECRIN (BAUSCH) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY , NDA 205473 (pdf 205473.pdf not found) INN (ETHACRYNATE SODIUM) ETHACRYNATE SODIUM (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 , NDA 205609 (label 205609.pdf) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207262 (pdf 207262.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (HIKMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208501 (pdf 208501.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204634 (pdf 204634.pdf not found) INN (ETHACRYNATE SODIUM) ETHACRYNATE SODIUM (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2016 , NDA 208805 (pdf 208805.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 207758 (pdf 207758.pdf not found) INN (ETHACRYNATE SODIUM) ETHACRYNATE SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 205709 (pdf 205709.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211232 (pdf 211232.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211719 (pdf 211719.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211809 (pdf 211809.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (AGNITIO) APPROVAL= AP YEAR= 2019 , NDA 212417 (pdf 212417.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2020 , NDA 208663 (pdf 208663.pdf not found) INN (ETHACRYNATE SODIUM) ETHACRYNATE SODIUM (STERIMAX) APPROVAL= AP YEAR= 2020 , NDA 213240 (pdf 213240.pdf not found) INN (ETHACRYNIC ACID) ETHACRYNIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , 1365 ; METHENAMINE ; 100-97-0 ; 1967 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- METHENAMINE COMPONENT IS HYDROLYZED TO FORMALDEHYDE IN ACID URINE -- MICROORGANISMS DO NOT DEVELOP RESISTANCE TO FORMALDEHYDE , ; NDA 016151 (label 16151.pdf) INN (METHENAMINE HIPPURATE) UREX (ALVOGEN) APPROVAL= AP YEAR= 1967 , NDA 017681 (label 17681.pdf) INN (METHENAMINE HIPPURATE) HIPREX (SS PHARMA) APPROVAL= AP YEAR= 1976 , NDA 076411 (pdf 76411.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (IMPAX LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 205661 (pdf 205661.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 212172 (pdf 212172.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 210068 (pdf 210068.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 217675 (pdf 217675.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2023 , 1366 ; HIPPURATE ; 495-69-2 ; 1967 ; ; NATURAL MOLECULE C00030483 ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- URINARY TRACT ANTISEPTIC DRUG -- HIPPURIC ACID, THE OTHER COMPONENT, ACTS TO KEEP THE URINE ACID , ; NDA 016151 (label 16151.pdf) INN (METHENAMINE HIPPURATE) UREX (CNTY LINE PHARMS) APPROVAL= AP YEAR= 1967 , NDA 017681 (label 17681.pdf) INN (METHENAMINE HIPPURATE) HIPREX (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 076411 (pdf 76411.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (COREPHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 205661 (pdf 205661.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016 , NDA 212172 (pdf 212172.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 210068 (pdf 210068.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (RICONPHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 217675 (pdf 217675.pdf not found) INN (METHENAMINE HIPPURATE) METHENAMINE HIPPURATE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2023 , 1367 ; LYPRESSIN ; 50-57-7 ; 0 ; DISCONTINUED ; ; CLASS HORMONES -- VASOCONSTRICTOR -- ANTIDIURETIC -- VASOPRESSIN ANALOG , ; NDA 016755 (pdf 16755.pdf not found) INN (LYPRESSIN) DIAPID (NOVARTIS) APPROVAL= - YEAR= 0 DISCONTINUED , 1368 ; TRICLOFOS ; 306-52-5 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- SEDATIVE , ; NDA 016809 (pdf 16809.pdf not found) INN (TRICLOFOS SODIUM) TRICLOS (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 016830 (pdf 16830.pdf not found) INN (TRICLOFOS SODIUM) TRICLOS (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , 1369 ; OXYMETHOLONE ; 434-07-1 ; 1972 ; DISCONTINUED ; ; CLASS METABOLISM -- ANDROGENIC -- ANABOLIC -- SYNTHETIC DERIVATIVES OF TESTOSTERONE -- TREATMENT OF ANEMIAS CAUSED BY DEFICIENT RED CELL PRODUCTION -- TREATMENT OF BONE MARROW FAILURE , ; NDA 016848 (label 16848.pdf) INN (OXYMETHOLONE) ANADROL-50 (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1972 DISCONTINUED , 1370 ; THONZONIUM ; 553-08-2 ; 1962 ; ; ; CLASS ANTIINFECTIVES -- SURFACE-ACTIVE AGENT THAT PROMOTES TISSUE CONTACT BY DISPERSION AND PENETRATION OF THE CELLULAR DEBRIS AND EXUDATE -- MONO-CATIONIC DETERGENT , ; NDA 050356 (label 50356.pdf) INN (THONZONIUM BROMIDE) COLY-MYCIN S (ENDO PHARMS INC) APPROVAL= AP YEAR= 1962 , 1371 ; CEFADROXIL ; 50370-12-2 ; 1978 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050512 (label 50512.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) DURICEF (WARNER CHILCOTT) APPROVAL= AP YEAR= 1978 NEWMOLECULARENTITY DISCONTINUED , NDA 050527 (label 50527.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) DURICEF (WARNER CHILCOTT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050528 (label 50528.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) DURICEF (WARNER CHILCOTT) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062291 (pdf 62291.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (SANDOZ) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 062334 (pdf 62334.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062376 (pdf 62376.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) ULTRACEF (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062378 (pdf 62378.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) ULTRACEF (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062390 (pdf 62390.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) ULTRACEF (APOTHECON) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062408 (pdf 62408.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) ULTRACEF (BRISTOL) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062695 (pdf 62695.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062698 (pdf 62698.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (ANI PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062766 (pdf 62766.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062774 (label 62774.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (TEVA PHARMS) APPROVAL= AP YEAR= 1987 , NDA 063017 (pdf 63017.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (PUREPAC PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 065015 (pdf 65015.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 065018 (pdf 65018.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (RANBAXY) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 065115 (label 65115.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 065260 (pdf 65260.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (HIKMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065278 (pdf 65278.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (ANI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065282 (pdf 65282.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (TEVA PHARMS) APPROVAL= AP YEAR= 2006 , NDA 065301 (pdf 65301.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065307 (pdf 65307.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065309 (pdf 65309.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (CHARTWELL RX) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065311 (pdf 65311.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (HIKMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065352 (pdf 65352.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065392 (pdf 65392.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (LUPIN) APPROVAL= AP YEAR= 2007 , NDA 065396 (label 65396.pdf) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (LUPIN) APPROVAL= AP YEAR= 2008 , NDA 091036 (pdf 91036.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (HIKMA PHARMS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 065349 (pdf 65349.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (AUROBINDO) APPROVAL= AP YEAR= 2013 , NDA 205072 (pdf 205072.pdf not found) INN (CEFADROXIL/CEFADROXIL HEMIHYDRATE) CEFADROXIL (CSPC OUYI) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1372 ; SULBACTAM ; 68373-14-8 ; 1986 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- BETA-LACTAMASE INHIBITORS , ; NDA 050608 (label 50608.pdf) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) UNASYN (PFIZER) APPROVAL= AP YEAR= 1986 , NDA 062901 (pdf 62901.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) UNASYN (PFIZER) APPROVAL= AP YEAR= 1988 , NDA 065074 (pdf 65074.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 065076 (pdf 65076.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HIKMA) APPROVAL= AP YEAR= 2002 , NDA 065176 (pdf 65176.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 2005 , NDA 065188 (pdf 65188.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HQ SPECLT PHARMA) APPROVAL= AP YEAR= 2005 , NDA 065222 (pdf 65222.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2005 , NDA 065240 (pdf 65240.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065241 (pdf 65241.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065310 (pdf 65310.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (SANDOZ) APPROVAL= AP YEAR= 2006 , NDA 065314 (pdf 65314.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ISTITUTO BIO ITA SPA) APPROVAL= AP YEAR= 2006 , NDA 065316 (pdf 65316.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (PHARM ASSOC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065403 (pdf 65403.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ACS DOBFAR) APPROVAL= AP YEAR= 2009 , NDA 065406 (pdf 65406.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ACS DOBFAR) APPROVAL= AP YEAR= 2009 , NDA 090339 (pdf 90339.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 090340 (pdf 90340.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090349 (pdf 90349.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (EUGIA PHARMA SPECLTS) APPROVAL= AP YEAR= 2010 , NDA 090375 (pdf 90375.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090646 (pdf 90646.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 090653 (pdf 90653.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (HOSPIRA INC) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 201024 (pdf 201024.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 202197 (pdf 202197.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (STERISCIENCE) APPROVAL= AP YEAR= 2014 , NDA 201406 (pdf 201406.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ANTIBIOTICE) APPROVAL= AP YEAR= 2015 , NDA 090578 (pdf 90578.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ASTRAL) APPROVAL= AP YEAR= 2016 , NDA 090579 (pdf 90579.pdf not found) INN (AMPICILLIN SODIUM SULBACTAM SODIUM) AMPICILLIN AND SULBACTAM (ASTRAL) APPROVAL= AP YEAR= 2016 , NDA 216974 (label 216974.pdf) INN (DURLOBACTAM SODIUM DURLOBACTAM SODIUM SULBACTAM SODIUM) XACDURO COPACKAGED (ENTASIS THERAP) APPROVAL= AP YEAR= 2023 , 1373 ; VIOMYCIN ; 32988-50-4 ; 0 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 061086 (pdf 61086.pdf not found) INN (VIOMYCIN SULFATE) VIOCIN SULFATE (PFIZER) APPROVAL= - YEAR= 0 DISCONTINUED , 1374 ; PROTOKYLOL ; 912804-64-9 ; 0 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATATOR -- BETA ADRENERGIC AGONIST , ; NDA 083459 (pdf 83459.pdf not found) INN (PROTOKYLOL HYDROCHLORIDE) VENTAIRE (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , 1375 ; BENOXINATE ; 99-43-4 ; 1975 ; ; ; CLASS SENSORY -- ANESTHETIC , ; NDA 084149 (pdf 84149.pdf not found) INN (BENOXINATE HYDROCHLORIDE) BENOXINATE HYDROCHLORIDE (SOLA BARNES HIND) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 208582 (label 208582.pdf) INN (BENOXINATE HYDROCHLORIDE FLUORESCEIN SODIUM) ALTAFLUOR BENOX (ALTAIRE PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 211039 (label 211039.pdf) INN (BENOXINATE HYDROCHLORIDE FLUORESCEIN SODIUM) FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE (BAUSCH LOMB IRELAND) APPROVAL= AP YEAR= 2020 , 1376 ; MEBUTAMATE ; 64-55-1 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIHYPERTENSIVE -- ANXIOLYTIC -- SEDATIVE , ; NDA 017374 (pdf 17374.pdf not found) INN (MEBUTAMATE) DORMATE (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , 1377 ; MEBUTAMATE ; 64-55-1 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIHYPERTENSIVE -- ANXIOLYTIC -- SEDATIVE , ; NDA 017374 (pdf 17374.pdf not found) INN (MEBUTAMATE) DORMATE (MEDPOINTE PHARM HLC) APPROVAL= - YEAR= 0 DISCONTINUED , 1378 ; GLYBURIDE ; 10238-21-8 ; 1984 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- BLOOD-GLUCOSE-LOWERING DRUG BY STIMULATING THE RELEASE OF INSULIN FROM THE PANCREAS -- SULFONYLUREA HYPOGLYCEMIC DRUGS , ; NDA 017498 (label 17498.pdf) INN (GLYBURIDE) MICRONASE (PFIZER) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 017532 (label 17532.pdf) INN (GLYBURIDE) DIABETA (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1984 , NDA 020051 (label 20051.pdf) INN (GLYBURIDE) GLYNASE (PFIZER) APPROVAL= AP YEAR= 1992 , NDA 020055 (pdf 20055.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 021178 (label 21178.pdf) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLUCOVANCE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 074388 (pdf 74388.pdf not found) INN (GLYBURIDE) GLYBURIDE (TEVA) APPROVAL= AP YEAR= 1995 , NDA 074591 (pdf 74591.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (STRIDES PHARMA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074686 (pdf 74686.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (TEVA) APPROVAL= AP YEAR= 1999 , NDA 074792 (pdf 74792.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (MYLAN) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075174 (pdf 75174.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (CHARTWELL RX) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075890 (pdf 75890.pdf not found) INN (GLYBURIDE) GLYBURIDE MICRONIZED (HIKMA) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 075947 (pdf 75947.pdf not found) INN (GLYBURIDE) GLYBURIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076257 (pdf 76257.pdf not found) INN (GLYBURIDE) GLYBURIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2002 , NDA 076345 (pdf 76345.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2004 , NDA 076716 (pdf 76716.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2005 , NDA 076731 (pdf 76731.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 076821 (pdf 76821.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 077537 (pdf 77537.pdf not found) INN (GLYBURIDE) GLYBURIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077870 (pdf 77870.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 079009 (pdf 79009.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2009 , NDA 090937 (pdf 90937.pdf not found) INN (GLYBURIDE) GLYBURIDE (HERITAGE PHARMS) APPROVAL= AP YEAR= 2011 , NDA 206079 (pdf 206079.pdf not found) INN (GLYBURIDE) GLYBURIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203581 (pdf 203581.pdf not found) INN (GLYBURIDE) GLYBURIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206748 (pdf 206748.pdf not found) INN (GLYBURIDE METFORMIN HYDROCHLORIDE) GLYBURIDE AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 206749 (pdf 206749.pdf not found) INN (GLYBURIDE) GLYBURIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2016 , NDA 203379 (pdf 203379.pdf not found) INN (GLYBURIDE) GLYBURIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 206483 (pdf 206483.pdf not found) INN (GLYBURIDE) GLYBURIDE (ORIENT PHARMA CO LTD) APPROVAL= AP YEAR= 2019 , 1379 ; ALBUTEROL ; 18559-94-9 ; 1981 ; ; ; CLASS RESPIRATORY SYSTEM -- BETA2-ADRENERGIC BRONCHODILATOR -- AGONIST , ; NDA 017559 (pdf 17559.pdf not found) INN (ALBUTEROL) PROVENTIL (SCHERING) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY DISCONTINUED , NDA 017853 (pdf 17853.pdf not found) INN (ALBUTEROL SULFATE) PROVENTIL (SCHERING) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 018062 (pdf 18062.pdf not found) INN (ALBUTEROL SULFATE) PROVENTIL (SCHERING) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 018473 (pdf 18473.pdf not found) INN (ALBUTEROL) VENTOLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 019112 (pdf 19112.pdf not found) INN (ALBUTEROL SULFATE) VENTOLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019243 (pdf 19243.pdf not found) INN (ALBUTEROL SULFATE) PROVENTIL (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019269 (pdf 19269.pdf not found) INN (ALBUTEROL SULFATE) VENTOLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019383 (pdf 19383.pdf not found) INN (ALBUTEROL SULFATE) PROVENTIL (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019489 (pdf 19489.pdf not found) INN (ALBUTEROL SULFATE) VENTOLIN ROTACAPS (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 019604 (pdf 19604.pdf not found) INN (ALBUTEROL SULFATE) VOLMAX (MURO) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019621 (pdf 19621.pdf not found) INN (ALBUTEROL SULFATE) VENTOLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019773 (pdf 19773.pdf not found) INN (ALBUTEROL SULFATE) VENTOLIN (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 020291 (label 20291.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 020503 (label 20503.pdf) INN (ALBUTEROL SULFATE) PROVENTIL-HFA (KINDEVA) APPROVAL= AP YEAR= 1996 , NDA 020949 (label 20949.pdf) INN (ALBUTEROL SULFATE) ACCUNEB (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 020950 (label 20950.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) DUONEB (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 020983 (label 20983.pdf) INN (ALBUTEROL SULFATE) VENTOLIN HFA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2001 , NDA 021457 (label 21457.pdf) INN (ALBUTEROL SULFATE) PROAIR HFA (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2004 , NDA 072151 (pdf 72151.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072152 (pdf 72152.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072273 (pdf 72273.pdf not found) INN (ALBUTEROL) ALBUTEROL (ARMSTRONG PHARMS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 072316 (pdf 72316.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072317 (pdf 72317.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (PLIVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072449 (pdf 72449.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072450 (pdf 72450.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AM THERAP) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072619 (pdf 72619.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072620 (pdf 72620.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072629 (pdf 72629.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072630 (pdf 72630.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072637 (pdf 72637.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1989 , NDA 072652 (pdf 72652.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (MYLAN SPECLT) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 072764 (pdf 72764.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072765 (pdf 72765.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072779 (pdf 72779.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072780 (pdf 72780.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 072817 (pdf 72817.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072818 (pdf 72818.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WARNER CHILCOTT) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072859 (pdf 72859.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (DAVA PHARMS INC) APPROVAL= AP YEAR= 1989 DISCONTINUED OBSOLETE , NDA 072860 (pdf 72860.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (STRIDES PHARMA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 072893 (pdf 72893.pdf not found) INN (ALBUTEROL) ALBUTEROL SULFATE (MYLAN) APPROVAL= AP YEAR= 1991 OBSOLETE , NDA 072894 (pdf 72894.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (DASH PHARMS NATCO) APPROVAL= AP YEAR= 1991 , NDA 072938 (pdf 72938.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072939 (pdf 72939.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 072966 (pdf 72966.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072967 (pdf 72967.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073045 (pdf 73045.pdf not found) INN (ALBUTEROL) ALBUTEROL (GENPHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 073120 (pdf 73120.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073121 (pdf 73121.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (UCB INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073165 (pdf 73165.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073272 (pdf 73272.pdf not found) INN (ALBUTEROL) ALBUTEROL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 073307 (pdf 73307.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073419 (pdf 73419.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA) APPROVAL= AP YEAR= 1992 , NDA 073495 (pdf 73495.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (COPLEY PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 073533 (pdf 73533.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1995 DISCONTINUED , NDA 074072 (pdf 74072.pdf not found) INN (ALBUTEROL) ALBUTEROL (PLIVA) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 074302 (pdf 74302.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (MOVA) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 074454 (pdf 74454.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (COSETTE) APPROVAL= AP YEAR= 1995 , NDA 074543 (pdf 74543.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (SENTISS) APPROVAL= AP YEAR= 1998 , NDA 074749 (pdf 74749.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (HIKMA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 074880 (pdf 74880.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (NEPHRON) APPROVAL= AP YEAR= 1997 , NDA 075050 (pdf 75050.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (BAUSCH) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075063 (pdf 75063.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075129 (pdf 75129.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (ROXANE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075262 (pdf 75262.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075343 (pdf 75343.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (TEVA PHARMS) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075358 (label 75358.pdf) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (BAUSCH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075394 (pdf 75394.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WOCKHARDT EU OPERATN) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075664 (pdf 75664.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (NEPHRON) APPROVAL= AP YEAR= 2001 , NDA 075717 (pdf 75717.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076130 (pdf 76130.pdf not found) INN (ALBUTEROL SULFATE) VOSPIRE ER (STRIDES PHARMA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076355 (pdf 76355.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (NEPHRON) APPROVAL= AP YEAR= 2004 , NDA 076370 (pdf 76370.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076391 (pdf 76391.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 076724 (pdf 76724.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 076749 (pdf 76749.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (NEPHRON) APPROVAL= AP YEAR= 2007 , NDA 076867 (label 76867.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (FOSUN PHARMA) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077063 (pdf 77063.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077117 (pdf 77117.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (APOTEX INC) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 077559 (pdf 77559.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (CIPLA) APPROVAL= AP YEAR= 2007 , NDA 077569 (pdf 77569.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (LANDELA PHARM) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077772 (pdf 77772.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (WATSON LABS) APPROVAL= AP YEAR= 2007 , NDA 077788 (pdf 77788.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (CHARTWELL RX) APPROVAL= AP YEAR= 2007 , NDA 078092 (pdf 78092.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (RISING) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 078105 (pdf 78105.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2006 , NDA 077839 (pdf 77839.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (RITEDOSE CORP) APPROVAL= AP YEAR= 2008 , NDA 078623 (pdf 78623.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (APOTEX INC) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 079241 (pdf 79241.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2010 , NDA 021747 (label 21747.pdf) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) COMBIVENT RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2011 , NDA 202496 (pdf 202496.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (RITEDOSE CORP) APPROVAL= AP YEAR= 2012 , NDA 205636 (label 205636.pdf) INN (ALBUTEROL SULFATE) PROAIR RESPICLICK (TEVA BRANDED PHARM) APPROVAL= AP YEAR= 2015 , NDA 207857 (pdf 207857.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 207875 (pdf 207875.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2017 , NDA 206224 (pdf 206224.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2017 , NDA 208804 (pdf 208804.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 207046 (pdf 207046.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (RISING) APPROVAL= AP YEAR= 2018 , NDA 211397 (pdf 211397.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (VIRTUS PHARM) APPROVAL= AP YEAR= 2018 , NDA 210948 (pdf 210948.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AIZANT) APPROVAL= AP YEAR= 2019 , NDA 212197 (pdf 212197.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (QUAGEN) APPROVAL= AP YEAR= 2019 , NDA 203760 (pdf 203760.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (PADAGIS US) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206532 (pdf 206532.pdf not found) INN (ALBUTEROL SULFATE IPRATROPIUM BROMIDE) ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209959 (pdf 209959.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 211888 (pdf 211888.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (LUOXIN AUROVITAS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213657 (pdf 213657.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208884 (pdf 208884.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 209954 (pdf 209954.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (LUPIN) APPROVAL= AP YEAR= 2020 , NDA 213524 (pdf 213524.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (EYWA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 207085 (pdf 207085.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (SANDOZ) APPROVAL= AP YEAR= 2021 , NDA 214531 (pdf 214531.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (RITEDOSE CORP) APPROVAL= AP YEAR= 2021 , NDA 214070 (label 214070.pdf) INN (ALBUTEROL SULFATE BUDESONIDE) AIRSUPRA (ASTRAZENECA) APPROVAL= AP YEAR= 2023 , NDA 212447 (pdf 212447.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (ARMSTRONG PHARMS) APPROVAL= AP YEAR= 2024 , NDA 215571 (pdf 215571.pdf not found) INN (ALBUTEROL SULFATE) ALBUTEROL SULFATE (LEXENPHARM) APPROVAL= AP YEAR= 2024 , 1380 ; BETA CAROTENE ; 7235-40-7 ; 0 ; DISCONTINUED ; NATURAL MOLECULE C00000919 ; CLASS METABOLISM -- NUTRIMENT -- SUPPLEMENT -- PRO-VITAMINA , ; NDA 017589 (pdf 17589.pdf not found) INN (BETA CAROTENE) SOLATENE (ROCHE) APPROVAL= - YEAR= 0 DISCONTINUED , 1381 ; PROTIRELIN ; 24305-27-9 ; 1976 ; DISCONTINUED ; ; CLASS ANALOG OF THYROTROPIN-RELEASING HORMONE -- DIAGNOSTIC AGENT -- ASSESSMENT OF THYROID FUNCTION -- TREATMENT OF CNS DISORDERS (PMID16055093) , ; NDA 017638 (pdf 17638.pdf not found) INN (PROTIRELIN) THYPINONE (ABBOTT) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 018087 (pdf 18087.pdf not found) INN (PROTIRELIN) THYREL TRH (FERRING) APPROVAL= AP YEAR= 1978 DISCONTINUED , 1382 ; SINCALIDE ; 25126-32-3 ; 1976 ; ; ; CLASS VARIOUS -- DIAGNOSTIC IMAGING -- CHOLERETIC -- SYNTHETICALLY-PREPARED C-TERMINAL OCTAPEPTIDE OF CHOLECYSTOKININ -- CHOLECYSTOPANCREATIC-GASTROINTESTINAL HORMONE PEPTIDE FOR PARENTERAL ADMINISTRATION , ; NDA 017697 (label 17697.pdf) INN (SINCALIDE) KINEVAC (BRACCO) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY , NDA 210850 (label 210850.pdf) INN (SINCALIDE) SINCALIDE (MAIA PHARMS INC) APPROVAL= AP YEAR= 2022 , 1383 ; DIFLORASONE DIACETATE ; 33564-31-7 ; 1977 ; ; ; CLASS DERMATOLOGICALS -- ANTIINFLAMMATORY -- GLUCOCORTICOIDS -- ANTI-INFLAMMATORY, ANTIPRURITIC AND VASOCONSTRICTIVE ACTIONS , ; NDA 017741 (label 17741.pdf) INN (DIFLORASONE DIACETATE) FLORONE (PFIZER) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY DISCONTINUED , NDA 017994 (label 17994.pdf) INN (DIFLORASONE DIACETATE) PSORCON E (PFIZER) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 019259 (label 19259.pdf) INN (DIFLORASONE DIACETATE) FLORONE E (PFIZER) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 019260 (label 19260.pdf) INN (DIFLORASONE DIACETATE) PSORCON (PFIZER) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 020205 (pdf 20205.pdf not found) INN (DIFLORASONE DIACETATE) PSORCON (TARO PHARMS NORTH) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 075187 (pdf 75187.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (AVONDALE PHARMS) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075331 (pdf 75331.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (TARO) APPROVAL= AP YEAR= 1999 , NDA 075374 (label 75374.pdf) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (AVONDALE PHARMS) APPROVAL= AP YEAR= 1999 , NDA 075508 (pdf 75508.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (TARO) APPROVAL= AP YEAR= 2000 , NDA 076263 (pdf 76263.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (ANI PHARMS) APPROVAL= AP YEAR= 2002 , NDA 206572 (pdf 206572.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (SAPTALIS PHARMS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 207440 (pdf 207440.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (RISING) APPROVAL= AP YEAR= 2017 , NDA 210753 (pdf 210753.pdf not found) INN (DIFLORASONE DIACETATE) DIFLORASONE DIACETATE (THE J MOLNER) APPROVAL= AP YEAR= 2018 , 1384 ; ETIDOCAINE ; 36637-18-0 ; 1976 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 017751 (pdf 17751.pdf not found) INN (ETIDOCAINE HYDROCHLORIDE) DURANEST (ASTRAZENECA) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 021384 (pdf 21384.pdf not found) INN (EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDE) DURANEST (DENTSPLY PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , 1385 ; ETIDOCAINE ; 36637-18-0 ; 1976 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 017751 (pdf 17751.pdf not found) INN (ETIDOCAINE HYDROCHLORIDE) DURANEST (ASTRAZENECA) APPROVAL= AP YEAR= 1976 NEWMOLECULARENTITY DISCONTINUED , NDA 021384 (pdf 21384.pdf not found) INN (EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDE) DURANEST (DENTSPLY PHARM) APPROVAL= AP YEAR= 1976 DISCONTINUED , 1386 ; CLOCORTOLONE PIVALATE ; 34097-16-0 ; 1977 ; ; ; CLASS DERMATOLOGICALS -- CORTICOSTEROID -- ANTIINFLAMMATORY -- ANTI-PRURITIC -- VASOCONTRICTIVE -- GLUCOCORTICOID , ; NDA 017765 (label 17765.pdf) INN (CLOCORTOLONE PIVALATE) CLODERM (LEGACY PHARMA) APPROVAL= AP YEAR= 1977 NEWMOLECULARENTITY , NDA 206370 (pdf 206370.pdf not found) INN (CLOCORTOLONE PIVALATE) CLOCORTOLONE PIVALATE (TARO) APPROVAL= AP YEAR= 2020 , 1387 ; BRETYLIUM ; 59-41-6 ; 1986 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIARRHYTHMIC -- ADRENERGIC ANTAGONISTS -- ANTIHYPERTENSIVE AGENTS -- POTASSIUM CHANNEL BLOCKER AND NA-K-ATPASE INHIBITOR (PMID12763901) , ; NDA 017954 (pdf 17954.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLOL (HOSPIRA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019005 (pdf 19005.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE IN DEXTROSE 5% (ABBOTT) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019008 (pdf 19008.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (HOSPIRA INC) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019030 (pdf 19030.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (HOSPIRA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019033 (pdf 19033.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (HOSPIRA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019121 (pdf 19121.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (B BRAUN) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 019837 (pdf 19837.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070119 (pdf 70119.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (INTL MEDICATION) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070134 (pdf 70134.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070545 (pdf 70545.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070546 (pdf 70546.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (HIKMA) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070891 (pdf 70891.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (LUITPOLD) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071151 (pdf 71151.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071152 (pdf 71152.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071153 (pdf 71153.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071181 (pdf 71181.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071298 (pdf 71298.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 204386 (pdf 204386.pdf not found) INN (BRETYLIUM TOSYLATE) BRETYLIUM TOSYLATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 DISCONTINUED , 1388 ; SARALASIN ; 34273-10-4 ; 0 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II INHIBITOR , ; NDA 018009 (pdf 18009.pdf not found) INN (SARALASIN ACETATE) SARENIN (PROCTER AND GAMBLE) APPROVAL= - YEAR= 0 DISCONTINUED , 1389 ; ESTRAMUSTINE PHOSPHATE ; 4891-15-0 ; 1981 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- TREATMENT OF PATIENTS WITH METASTATIC AND/OR PROGRESSIVE CARCINOMA OF THE PROSTATE , ; NDA 018045 (label 18045.pdf) INN (ESTRAMUSTINE PHOSPHATE SODIUM) EMCYT (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1981 NEWMOLECULARENTITY , 1390 ; CALCIFEDIOL ; 19356-17-3 ; 1980 ; ; NATURAL MOLECULE C00040805 ; CLASS METABOLISM -- CA REGULATOR -- ANTIHYPOCALCEMIC AGENTS , ; NDA 018312 (pdf 18312.pdf not found) INN (CALCIFEDIOL) CALDEROL (ORGANON USA INC) APPROVAL= AP YEAR= 1980 NEWMOLECULARENTITY DISCONTINUED , NDA 208010 (label 208010.pdf) INN (CALCIFEDIOL) RAYALDEE (EIRGEN) APPROVAL= AP YEAR= 2016 , 1391 ; GLUTATHIONE DISULFIDE ; 27025-41-8 ; 1981 ; ; ; CLASS VARIOUS -- ANTIDOTE -- FOR USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING INTRAOCULAR SURGICAL PROCEDURES INVOLVING PERFUSION OF THE EYE , ; NDA 018469 (label 18469.pdf) INN (CALCIUM CHLORIDE DEXTROSE GLUTATHIONE DISULFIDE MAGNESIUM CHLORIDE POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE SODIUM PHOSPHATE) BSS PLUS (ALCON) APPROVAL= AP YEAR= 1981 , NDA 020079 (pdf 20079.pdf not found) INN (CALCIUM CHLORIDE DEXTROSE GLUTATHIONE DISULFIDE MAGNESIUM CHLORIDE POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE SODIUM PHOSPHATE) METHOTREXATE SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 022193 (label 22193.pdf) INN (CALCIUM CHLORIDE DEXTROSE MAGNESIUM CHLORIDE OXIGLUTATIONE POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDE SODIUM PHOSPHATE) NAVSTEL (ALCON PHARMS LTD) APPROVAL= AP YEAR= 2008 DISCONTINUED , 1392 ; DRONABINOL ; 1972-08-3 ; 1985 ; ; ; CLASS METABOLISM -- AGONIST -- CANNABINOID COMPONENT OF CANNABIS SATIVA L. (MARIJUANA) -- ANTIEMETIC -- ANTIANOREXIC -- APPETITE STIMULANT , ; NDA 018651 (label 18651.pdf) INN (DRONABINOL) MARINOL (ALKEM LABS LTD) APPROVAL= AP YEAR= 1985 NEWMOLECULARENTITY , NDA 078292 (pdf 78292.pdf not found) INN (DRONABINOL) DRONABINOL (SVC PHARMA) APPROVAL= AP YEAR= 2008 , NDA 078501 (pdf 78501.pdf not found) INN (DRONABINOL) DRONABINOL (INSYS THERAP) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 079217 (pdf 79217.pdf not found) INN (DRONABINOL) DRONABINOL (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 205525 (label 205525.pdf) INN (DRONABINOL) SYNDROS (BENUVIA OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 201463 (pdf 201463.pdf not found) INN (DRONABINOL) DRONABINOL (LANNETT CO INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207421 (pdf 207421.pdf not found) INN (DRONABINOL) DRONABINOL (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2020 , 1393 ; INAMRINONE ; 60719-84-8 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- PHOSPHODIESTERASE INHIBITORS -- VASODILATOR AGENTS -- CARDIOTONIC , ; NDA 018700 (pdf 18700.pdf not found) INN (INAMRINONE LACTATE) INOCOR (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 074616 (pdf 74616.pdf not found) INN (INAMRINONE LACTATE) AMRINONE LACTATE (HOSPIRA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075513 (pdf 75513.pdf not found) INN (INAMRINONE LACTATE) AMRINONE LACTATE (HIKMA) APPROVAL= AP YEAR= 2000 , NDA 075542 (pdf 75542.pdf not found) INN (INAMRINONE LACTATE) AMRINONE LACTATE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2000 DISCONTINUED , 1394 ; ALCLOMETASONE DIPROPIONATE ; 66734-13-2 ; 1982 ; ; ; CLASS DERMATOLOGICALS -- ANTI-INFLAMMATORY AGENTS -- ANTIPRURITIC AGENTS -- CORTICOSTEROIDS -- GLUCOCORTICOIDS AGONIST , ; NDA 018702 (label 18702.pdf) INN (ALCLOMETASONE DIPROPIONATE) ACLOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1982 NEWMOLECULARENTITY DISCONTINUED , NDA 018707 (label 18707.pdf) INN (ALCLOMETASONE DIPROPIONATE) ACLOVATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 076587 (pdf 76587.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2005 , NDA 076730 (pdf 76730.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (TARO) APPROVAL= AP YEAR= 2004 , NDA 076884 (pdf 76884.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 076973 (pdf 76973.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2005 , NDA 079061 (pdf 79061.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , NDA 079227 (pdf 79227.pdf not found) INN (ALCLOMETASONE DIPROPIONATE) ALCLOMETASONE DIPROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2009 , 1395 ; ETOPOSIDE PHOSPHATE ; 117091-64-2 ; 1996 ; ; ; CLASS ANTINEOPLASTIC -- NUCLEIC ACID SYNTHESIS INHIBITORS -- INDUCTION OF DNA STRAND BREAKS BY AN INTERACTION WITH DNA-TOPOISOMERASE II OR THE FORMATION OF FREE RADICALS , ; NDA 020457 (label 20457.pdf) INN (ETOPOSIDE PHOSPHATE) ETOPOPHOS PRESERVATIVE FREE (CHEPLAPHARM) APPROVAL= AP YEAR= 1996 , NDA 020906 (pdf 20906.pdf not found) INN (ETOPOSIDE PHOSPHATE) ETOPOPHOS PRESERVATIVE FREE (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 1998 DISCONTINUED , 1396 ; ENALAPRILAT ; 76420-72-9 ; 1988 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS , ; NDA 019309 (label 19309.pdf) INN (ENALAPRILAT) VASOTEC (BIOVAIL LABS INTL) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 075456 (pdf 75456.pdf not found) INN (ENALAPRILAT) ENALAPRILAT (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075458 (label 75458.pdf) INN (ENALAPRILAT) ENALAPRILAT (HOSPIRA) APPROVAL= AP YEAR= 2000 , NDA 075571 (pdf 75571.pdf not found) INN (ENALAPRILAT) ENALAPRILAT (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 075578 (pdf 75578.pdf not found) INN (ENALAPRILAT) ENALAPRILAT (DR REDDYS) APPROVAL= AP YEAR= 2000 , NDA 075634 (pdf 75634.pdf not found) INN (ENALAPRILAT) ENALAPRILAT (CHARTWELL INJECTABLE) APPROVAL= AP YEAR= 2000 , NDA 078687 (pdf 78687.pdf not found) INN (ENALAPRILAT) ENALAPRILAT (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2008 , 1397 ; TIOPRONIN ; 1953-02-2 ; 1988 ; ; ; CLASS RESPIRATORY -- MUCOLYTIC -- EXPECTORANT -- USED TO CONTROL THE RATE OF CYSTINE PRECIPITATION AND EXCRETION IN THE DISEASE CYSTINURIA , ; NDA 019569 (label 19569.pdf) INN (TIOPRONIN) THIOLA (MISSION PHARMA) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 211843 (label 211843.pdf) INN (TIOPRONIN) THIOLA EC (MISSION PHARMACAL) APPROVAL= AP YEAR= 2019 , NDA 214326 (pdf 214326.pdf not found) INN (TIOPRONIN) TIOPRONIN (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 216198 (pdf 216198.pdf not found) INN (TIOPRONIN) TIOPRONIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217219 (pdf 217219.pdf not found) INN (TIOPRONIN) TIOPRONIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , NDA 216278 (pdf 216278.pdf not found) INN (TIOPRONIN) TIOPRONIN (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 216990 (pdf 216990.pdf not found) INN (TIOPRONIN) TIOPRONIN (TORRENT) APPROVAL= AP YEAR= 2024 , 1398 ; TIOPRONIN ; 1953-02-2 ; 1988 ; ; ; CLASS RESPIRATORY -- MUCOLYTIC -- EXPECTORANT -- USED TO CONTROL THE RATE OF CYSTINE PRECIPITATION AND EXCRETION IN THE DISEASE CYSTINURIA , ; NDA 019569 (label 19569.pdf) INN (TIOPRONIN) THIOLA (MISSION PHARMA) APPROVAL= AP YEAR= 1988 NEWMOLECULARENTITY , NDA 211843 (label 211843.pdf) INN (TIOPRONIN) THIOLA EC (MISSION PHARMACAL) APPROVAL= AP YEAR= 2019 , NDA 214326 (pdf 214326.pdf not found) INN (TIOPRONIN) TIOPRONIN (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 , NDA 216198 (pdf 216198.pdf not found) INN (TIOPRONIN) TIOPRONIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 217219 (pdf 217219.pdf not found) INN (TIOPRONIN) TIOPRONIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2023 , NDA 216278 (pdf 216278.pdf not found) INN (TIOPRONIN) TIOPRONIN (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 216990 (pdf 216990.pdf not found) INN (TIOPRONIN) TIOPRONIN (TORRENT) APPROVAL= AP YEAR= 2024 , 1399 ; MESALAMINE ; 89-57-6 ; 1987 ; ; ; CLASS METABOLISM -- ANTIINFLAMMATORY -- IT IS POSSIBLE THAT IT DIMINISHES INFLAMMATION BY BLOCKING PRODUCTION OF ARACHIDONIC ACID METABOLITES -- INHIBITOR OF CYCLOOXYGENASE -- MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS , ; NDA 019618 (label 19618.pdf) INN (MESALAMINE) ROWASA (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1987 NEWMOLECULARENTITY , NDA 019651 (label 19651.pdf) INN (MESALAMINE) ASACOL (APIL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 019919 (pdf 19919.pdf not found) INN (MESALAMINE) ROWASA (MEDA PHARMS) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 020049 (label 20049.pdf) INN (MESALAMINE) PENTASA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 1993 , NDA 021252 (label 21252.pdf) INN (MESALAMINE) CANASA (ABBVIE) APPROVAL= AP YEAR= 2001 , NDA 021830 (label 21830.pdf) INN (MESALAMINE) ASACOL HD (ABBVIE) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022000 (label 22000.pdf) INN (MESALAMINE) LIALDA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2007 , NDA 076751 (pdf 76751.pdf not found) INN (MESALAMINE) MESALAMINE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2004 , NDA 076841 (pdf 76841.pdf not found) INN (MESALAMINE) MESALAMINE (G AND W LABS INC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022301 (label 22301.pdf) INN (MESALAMINE) APRISO (SALIX) APPROVAL= AP YEAR= 2008 , NDA 204412 (label 204412.pdf) INN (MESALAMINE) DELZICOL (ABBVIE) APPROVAL= AP YEAR= 2013 , NDA 202065 (pdf 202065.pdf not found) INN (MESALAMINE) MESALAMINE (SANDOZ) APPROVAL= AP YEAR= 2019 , NDA 204354 (label 204354.pdf) INN (MESALAMINE) MESALAMINE (MYLAN) APPROVAL= AP YEAR= 2015 , NDA 091640 (label 91640.pdf) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203286 (pdf 203286.pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 203817 (pdf 203817.pdf not found) INN (MESALAMINE) MESALAMINE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 208362 (pdf 208362.pdf not found) INN (MESALAMINE) MESALAMINE (AMRING PHARMS) APPROVAL= AP YEAR= 2019 , NDA 203574 (pdf 203574.pdf not found) INN (MESALAMINE) MESALAMINE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208953 (pdf 208953.pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 209970 (pdf 209970.pdf not found) INN (MESALAMINE) MESALAMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 207448 (pdf 207448.pdf not found) INN (MESALAMINE) MESALAMINE (PHARM SOURCING) APPROVAL= AP YEAR= 2019 , NDA 207873 (pdf 207873.pdf not found) INN (MESALAMINE) MESALAMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 211858 (pdf 211858.pdf not found) INN (MESALAMINE) MESALAMINE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 207271 (pdf 207271.pdf not found) INN (MESALAMINE) MESALAMINE (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 210509 (pdf 210509.pdf not found) INN (MESALAMINE) MESALAMINE (AMNEAL) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213377 (pdf 213377.pdf not found) INN (MESALAMINE) MESALAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2020 , NDA 205654 (pdf 205654.pdf not found) INN (MESALAMINE) MESALAMINE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2020 , NDA 208954 (pdf 208954.pdf not found) INN (MESALAMINE) MESALAMINE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 214242 (pdf 214242.pdf not found) INN (MESALAMINE) MESALAMINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214585 (pdf 214585.pdf not found) INN (MESALAMINE) MESALAMINE (SUN PHARM) APPROVAL= AP YEAR= 2022 , NDA 216967 (pdf 216967.pdf not found) INN (MESALAMINE) MESALAMINE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 214477 (pdf 214477.pdf not found) INN (MESALAMINE) MESALAMINE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216941 (pdf 216941.pdf not found) INN (MESALAMINE) MESALAMINE (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 217337 (pdf 217337.pdf not found) INN (MESALAMINE) MESALAMINE (SINOTHERAPEUTICS INC) APPROVAL= AP YEAR= 2023 , NDA 217533 (pdf 217533.pdf not found) INN (MESALAMINE) MESALAMINE (AMTA) APPROVAL= AP YEAR= 2023 , NDA 216334 (pdf 216334.pdf not found) INN (MESALAMINE) MESALAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , 1400 ; ACRIVASTINE ; 87848-99-5 ; 1994 ; DISCONTINUED ; ; CLASS RESPIRATORY -- ANTIHISTAMINE -- HISTAMINE H1-RECEPTOR ANTAGONIST -- TREATMENT OF CHRONIC URTICARIA AND ALLERGIC RHINITIS , ; NDA 019806 (label 19806.pdf) INN (ACRIVASTINE PSEUDOEPHEDRINE HYDROCHLORIDE) SEMPREX-D (AUXILIUM PHARMS LLC) APPROVAL= AP YEAR= 1994 DISCONTINUED , 1401 ; HISTRELIN ; 76712-82-8 ; 1991 ; ; ; CLASS GONADOTROPIN RELEASING HORMONE (GNRH) AGONIST -- HORMONES -- TREATMENT OF ADVANCED PROSTATE CANCER INHIBITOR OF GONADOTROPIN SECRETION -- TRANSIENT INCREASE IN CONCENTRATION OF GONADAL STEROIDS (TESTOSTERONE AND DIHYDROTESTOSTERONE IN MALES) -- TREATMENT OF PRECOCIOUS PUBERTY , ; NDA 019836 (pdf 19836.pdf not found) INN (HISTRELIN ACETATE) SUPPRELIN (SHIRE) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 021732 (label 21732.pdf) INN (HISTRELIN ACETATE) VANTAS (ENDO OPERATIONS) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022058 (label 22058.pdf) INN (HISTRELIN ACETATE) SUPPRELIN LA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2007 , 1402 ; EFLORNITHINE ; 70052-12-9 ; 1990 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- INHIBITOR OF ORNITHINE DECARBOXYLASE (ODC) -- REDUCTION OF UNWANTED FACIAL HAIR IN WOMEN -- ANTIPARASITIC , ; NDA 019879 (pdf 19879.pdf not found) INN (EFLORNITHINE HYDROCHLORIDE) ORNIDYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 021145 (label 21145.pdf) INN (EFLORNITHINE HYDROCHLORIDE) VANIQA (SKINMEDICA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 215500 (pdf 215500.pdf not found) INN (EFLORNITHINE HYDROCHLORIDE) IWILFIN (USWM) APPROVAL= AP YEAR= 2023 , 1403 ; FLUTICASONE FUROATE ; 397864-44-7 ; 2007 ; ; ; CLASS RESPIRATORY -- ANTIINFLAMMATORY -- CORTICOSTEROIDS AGONIST -- TREATMENT OF SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS , ; NDA 022051 (label 22051.pdf) INN (FLUTICASONE FUROATE) FLONASE SENSIMIST ALLERGY RELIEF (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2007 , NDA 204275 (label 204275.pdf) INN (FLUTICASONE FUROATE VILANTEROL TRIFENATATE) BREO ELLIPTA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 205625 (label 205625.pdf) INN (FLUTICASONE FUROATE) ARNUITY ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2014 , NDA 209482 (label 209482.pdf) INN (FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE) TRELEGY ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2017 , 1404 ; COLFOSCERIL PALMITATE ; 63-89-8 ; 1990 ; DISCONTINUED ; ; CLASS RESPIRATORY -- LUNG SURFACTANTS , ; NDA 020044 (pdf 20044.pdf not found) INN (CETYL ALCOHOL COLFOSCERIL PALMITATE TYLOXAPOL) EXOSURF NEONATAL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1990 DISCONTINUED , 1405 ; OCTINOXATE ; 5466-77-3 ; 1992 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- PROTECTIVES AGAINST UV-RADIATION -- SUNSCREEN , ; NDA 020045 (pdf 20045.pdf not found) INN (AVOBENZONE OCTINOXATE OXYBENZONE) SHADE UVAGUARD (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1406 ; OCTINOXATE ; 5466-77-3 ; 1992 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- PROTECTIVES AGAINST UV-RADIATION -- SUNSCREEN , ; NDA 020045 (pdf 20045.pdf not found) INN (AVOBENZONE OCTINOXATE OXYBENZONE) SHADE UVAGUARD (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1992 DISCONTINUED , 1407 ; TORSEMIDE ; 56211-40-6 ; 1993 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE AGENTS -- DIURETICS -- ANTIINFLAMMATORY -- INHIBITOR OF THE NA+/K+/2CL- CARRIER SYSTEM IN NEPHRON -- TREATMENT OF EDEMA ASSOCIATED WITH CONGESTIVE HEART FAILURE, RENAL DISEASE, OR HEPATIC DISEASE , ; NDA 020136 (label 20136.pdf) INN (TORSEMIDE) DEMADEX (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , NDA 020137 (pdf 20137.pdf not found) INN (TORSEMIDE) DEMADEX (ROCHE) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 076110 (pdf 76110.pdf not found) INN (TORSEMIDE) TORSEMIDE (TEVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076226 (pdf 76226.pdf not found) INN (TORSEMIDE) TORSEMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 , NDA 076346 (pdf 76346.pdf not found) INN (TORSEMIDE) TORSEMIDE (PLIVA PHARM IND) APPROVAL= AP YEAR= 2003 , NDA 076894 (pdf 76894.pdf not found) INN (TORSEMIDE) TORSEMIDE (COREPHARMA) APPROVAL= AP YEAR= 2005 , NDA 076943 (pdf 76943.pdf not found) INN (TORSEMIDE) TORSEMIDE (HIKMA) APPROVAL= AP YEAR= 2005 , NDA 078007 (pdf 78007.pdf not found) INN (TORSEMIDE) TORSEMIDE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 078249 (pdf 78249.pdf not found) INN (TORSEMIDE) TORSEMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 078478 (pdf 78478.pdf not found) INN (TORSEMIDE) TORSEMIDE (SUN PHARM INDS) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 079234 (pdf 79234.pdf not found) INN (TORSEMIDE) TORSEMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2009 , NDA 090656 (pdf 90656.pdf not found) INN (TORSEMIDE) TORSEMIDE (AM REGENT) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090613 (pdf 90613.pdf not found) INN (TORSEMIDE) TORSEMIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2011 , NDA 213218 (label 213218.pdf) INN (TORSEMIDE) SOAANZ (SARFE PHARMS) APPROVAL= AP YEAR= 2021 , 1408 ; PANTOTHENIC ACID ; 79-83-4 ; 1993 ; DISCONTINUED ; ; CLASS METABOLISM -- VITAMIN B5 -- SUPPLEMENT -- ANIMALS REQUIRE PANTOTHENIC ACID TO SYNTHESIZE COENZYME-A (COA) , ; NDA 020176 (pdf 20176.pdf not found) INN (PANTOTHENIC ACID) VITAPED (HOSPIRA) APPROVAL= AP YEAR= 1993 DISCONTINUED , 1409 ; LODOXAMIDE ; 53882-12-5 ; 1993 ; ; ; CLASS SENSORY -- ANTIASTHMATIC -- ANTIALLERGIC -- MAST CELL STABILIZER -- VERNAL KERATOCONJUNCTIVITIS , ; NDA 020191 (label 20191.pdf) INN (LODOXAMIDE TROMETHAMINE) ALOMIDE (NOVARTIS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , 1410 ; SALMETEROL ; 89365-50-4 ; 1994 ; ; ; CLASS RESPIRATORY -- SYMPATHOMIMETIC -- BETA2-ADRENERGIC BRONCHODILATOR AGONIST , ; NDA 020236 (label 20236.pdf) INN (SALMETEROL XINAFOATE) SEREVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020692 (label 20692.pdf) INN (SALMETEROL XINAFOATE) SEREVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 , NDA 021077 (label 21077.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR DISKUS 100/50 (GLAXO GRP LTD) APPROVAL= AP YEAR= 2000 , NDA 021254 (label 21254.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR HFA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2006 , NDA 208799 (label 208799.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) AIRDUO RESPICLICK (TEVA PHARM) APPROVAL= AP YEAR= 2017 , NDA 208891 (label 208891.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) WIXELA INHUB (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 203433 (pdf 203433.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213948 (pdf 213948.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , 1411 ; SALMETEROL ; 89365-50-4 ; 1994 ; ; ; CLASS RESPIRATORY -- SYMPATHOMIMETIC -- BETA2-ADRENERGIC BRONCHODILATOR AGONIST , ; NDA 020236 (label 20236.pdf) INN (SALMETEROL XINAFOATE) SEREVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1994 NEWMOLECULARENTITY DISCONTINUED , NDA 020692 (label 20692.pdf) INN (SALMETEROL XINAFOATE) SEREVENT (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 1997 , NDA 021077 (label 21077.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR DISKUS 100/50 (GLAXO GRP LTD) APPROVAL= AP YEAR= 2000 , NDA 021254 (label 21254.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) ADVAIR HFA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2006 , NDA 208799 (label 208799.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) AIRDUO RESPICLICK (TEVA PHARM) APPROVAL= AP YEAR= 2017 , NDA 208891 (label 208891.pdf) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) WIXELA INHUB (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 203433 (pdf 203433.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213948 (pdf 213948.pdf not found) INN (FLUTICASONE PROPIONATE SALMETEROL XINAFOATE) FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , 1412 ; CALCIPOTRIENE ; 112965-21-6 ; 1993 ; ; ; CLASS DERMATOLOGICAL -- TOPICAL TREATMENT ANTIPSORIATIC -- SYNTHETIC ANALOG OF VITAMIN D3 -- AGONIST , ; NDA 020273 (label 20273.pdf) INN (CALCIPOTRIENE) DOVONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY , NDA 020554 (label 20554.pdf) INN (CALCIPOTRIENE) DOVONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 1996 , NDA 020611 (label 20611.pdf) INN (CALCIPOTRIENE) DOVONEX (LEO PHARM) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 021852 (label 21852.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) TACLONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 2006 , NDA 022185 (label 22185.pdf) INN (CALCIPOTRIENE HYDRATE) TACLONEX (LEO PHARMA AS) APPROVAL= AP YEAR= 2008 , NDA 077579 (pdf 77579.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (HIKMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 078305 (pdf 78305.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2008 , NDA 077029 (pdf 77029.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (CHARTWELL RX) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090633 (pdf 90633.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (GLENMARK PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 022563 (label 22563.pdf) INN (CALCIPOTRIENE) SORILUX (MAYNE PHARMA) APPROVAL= AP YEAR= 2010 , NDA 078468 (pdf 78468.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (COSETTE) APPROVAL= AP YEAR= 2011 , NDA 200935 (pdf 200935.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (CHARTWELL RX) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201615 (pdf 201615.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (TOLMAR) APPROVAL= AP YEAR= 2013 , NDA 200174 (pdf 200174.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2014 , NDA 205772 (pdf 205772.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2015 , NDA 207589 (label 207589.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) ENSTILAR (LEO PHARMA AS) APPROVAL= AP YEAR= 2015 , NDA 207163 (pdf 207163.pdf not found) INN (CALCIPOTRIENE) CALCIPOTRIENE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 210765 (pdf 210765.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (COSETTE) APPROVAL= AP YEAR= 2020 , NDA 213422 (label 213422.pdf) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) WYNZORA (MC2) APPROVAL= AP YEAR= 2020 , NDA 212367 (pdf 212367.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 , NDA 213269 (pdf 213269.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (TARO PHARMS) APPROVAL= AP YEAR= 2020 , NDA 214688 (pdf 214688.pdf not found) INN (BETAMETHASONE DIPROPIONATE CALCIPOTRIENE) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , 1413 ; TRIMETREXATE ; 52128-35-5 ; 1993 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- ANTINEOPLASTIC -- ANTIPROTOZOALS -- ANTIBIOTICS -- ANTIFUNGAL AGENTS -- FOLIC ACID ANTAGONISTS -- INHIBITOR -- TREATMENT OF MODERATE-TO-SEVERE PNEUMOCYSTIS CARINII PNEUMONIA (PCP) IN IMMUNOCOMPROMISED PATIENTS, INCLUDING PATIENTS WITH THE ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) , ; NDA 020326 (label 20326.pdf) INN (TRIMETREXATE GLUCURONATE) NEUTREXIN (MEDIMMUNE ONCOLOGY) APPROVAL= AP YEAR= 1993 NEWMOLECULARENTITY DISCONTINUED , 1414 ; CANDESARTAN CILEXETIL ; 145040-37-5 ; 1998 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- HYDROLYZED TO CANDESARTAN DURING ABSORPTION FROM THE GASTROINTESTINAL TRACT -- CANDESARTAN IS A SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR ANTAGONIST -- CANDESARTAN BLOCKS THE VASOCONSTRICTOR AND ALDOSTERONE-SECRETING EFFECTS OF ANGIOTENSIN II , ; NDA 020838 (label 20838.pdf) INN (CANDESARTAN CILEXETIL) ATACAND (ANI PHARMS) APPROVAL= AP YEAR= 1998 NEWMOLECULARENTITY , NDA 021093 (label 21093.pdf) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) ATACAND HCT (ANI PHARMS) APPROVAL= AP YEAR= 2000 , NDA 078702 (pdf 78702.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MYLAN) APPROVAL= AP YEAR= 2013 , NDA 090434 (pdf 90434.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 OBSOLETE , NDA 090704 (pdf 90704.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MYLAN) APPROVAL= AP YEAR= 2012 , NDA 200887 (pdf 200887.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2012 , NDA 202884 (pdf 202884.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 202079 (pdf 202079.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (APOTEX) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 202965 (pdf 202965.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 204100 (pdf 204100.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 , NDA 203813 (pdf 203813.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 209119 (pdf 209119.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 091390 (pdf 91390.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 203466 (pdf 203466.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2017 , NDA 207455 (pdf 207455.pdf not found) INN (CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2018 , NDA 210302 (pdf 210302.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (ALEMBIC) APPROVAL= AP YEAR= 2018 , NDA 206233 (pdf 206233.pdf not found) INN (CANDESARTAN CILEXETIL) CANDESARTAN CILEXETIL (PRINSTON INC) APPROVAL= AP YEAR= 2023 , 1415 ; NALMEFENE ; 55096-26-9 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTIC OPIOID ANTAGONIST -- PREVENTS OR REVERSES THE EFFECTS OF OPIOIDS, INCLUDING RESPIRATORY DEPRESSION, SEDATION, AND HYPOTENSION , ; NDA 020459 (label 20459.pdf) INN (NALMEFENE HYDROCHLORIDE) REVEX (HIKMA) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 212955 (pdf 212955.pdf not found) INN (NALMEFENE HYDROCHLORIDE) NALMEFENE HYDROCHLORIDE (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2022 , NDA 217470 (label 217470.pdf) INN (NALMEFENE HYDROCHLORIDE) OPVEE (INDIVIOR) APPROVAL= AP YEAR= 2023 , NDA 216007 (pdf 216007.pdf not found) INN (NALMEFENE HYDROCHLORIDE) NALMEFENE HYDROCHLORIDE (CHENGDU SHUODE) APPROVAL= AP YEAR= 2023 , 1416 ; PHENYLBUTYRATE ; 1716-12-7 ; 1996 ; ; ; CLASS METABOLISM -- SUPPLEMENT -- DECREASED ELEVATED PLASMA AMMONIA GLUTAMINE LEVELS -- ANTIHYPERAMMONEMIC -- UREA CYCLE DISORDERS -- RAPIDLY METABOLIZED TO PHENYLACETATE -- NITROGEN-BINDING AGENT FOR CHRONIC UREAC CYCLE DISORDERS (UCDS) , ; NDA 020572 (label 20572.pdf) INN (SODIUM PHENYLBUTYRATE) BUPHENYL (HORIZON THERAP US) APPROVAL= AP YEAR= 1996 , NDA 020573 (label 20573.pdf) INN (SODIUM PHENYLBUTYRATE) BUPHENYL (HORIZON THERAP US) APPROVAL= AP YEAR= 1996 NEWMOLECULARENTITY , NDA 090910 (pdf 90910.pdf not found) INN (SODIUM PHENYLBUTYRATE) SODIUM PHENYLBUTYRATE (ALVOGEN) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 202819 (pdf 202819.pdf not found) INN (SODIUM PHENYLBUTYRATE) SODIUM PHENYLBUTYRATE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2013 , NDA 203918 (pdf 203918.pdf not found) INN (SODIUM PHENYLBUTYRATE) SODIUM PHENYLBUTYRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 204395 (pdf 204395.pdf not found) INN (SODIUM PHENYLBUTYRATE) SODIUM PHENYLBUTYRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 216513 (label 216513.pdf) INN (SODIUM PHENYLBUTYRATE) PHEBURANE (MEDUNIK) APPROVAL= AP YEAR= 2022 , NDA 214860 (label 214860.pdf) INN (SODIUM PHENYLBUTYRATE) OLPRUVA (ACER) APPROVAL= AP YEAR= 2022 , NDA 216462 (pdf 216462.pdf not found) INN (SODIUM PHENYLBUTYRATE) SODIUM PHENYLBUTYRATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 216660 (label 216660.pdf) INN (SODIUM PHENYLBUTYRATE TAURURSODIOL) RELYVRIO (AMYLYX) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 1417 ; DOXERCALCIFEROL ; 54573-75-0 ; 1999 ; ; ; CLASS HORMONES -- SYNTHETIC VITAMIN D2 ANALOG -- VITAMIN D PROHORMONE -- PARATHYROID HORMONE REGULATOR -- CALCIUM REGULATOR , ; NDA 020862 (label 20862.pdf) INN (DOXERCALCIFEROL) HECTOROL (SANOFI) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 021027 (label 21027.pdf) INN (DOXERCALCIFEROL) HECTOROL (SANOFI) APPROVAL= AP YEAR= 2000 , NDA 090040 (pdf 90040.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (COBREK PHARMA) APPROVAL= TA YEAR= 2011 , NDA 091101 (pdf 91101.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (HIKMA) APPROVAL= AP YEAR= 2013 , NDA 091333 (pdf 91333.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 091433 (pdf 91433.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (HIKMA) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200926 (pdf 200926.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (SANDOZ) APPROVAL= AP YEAR= 2014 , NDA 203929 (pdf 203929.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 201518 (pdf 201518.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (RISING) APPROVAL= AP YEAR= 2016 , NDA 208974 (pdf 208974.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (AMNEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208975 (pdf 208975.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 208614 (label 208614.pdf) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (HOSPIRA) APPROVAL= AP YEAR= 2018 , NDA 210801 (pdf 210801.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 203875 (pdf 203875.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (SUN PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210452 (pdf 210452.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 211670 (pdf 211670.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (MEITHEAL) APPROVAL= AP YEAR= 2020 , NDA 205360 (pdf 205360.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (AVET) APPROVAL= AP YEAR= 2020 , NDA 213717 (pdf 213717.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (EUGIA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215810 (pdf 215810.pdf not found) INN (DOXERCALCIFEROL) DOXERCALCIFEROL (ALEMBIC) APPROVAL= AP YEAR= 2023 , 1418 ; MEQUINOL ; 150-76-5 ; 1999 ; DISCONTINUED ; NATURAL MOLECULE C00035022 ; CLASS DERMATOLOGICAL -- DEPIGMENTANT -- SUBSTRATE FOR THE ENZYME TYROSINASE AND ACTS AS A COMPETITIVE INHIBITOR OF THE FORMATION OF MELANIN PRECURSORS , ; NDA 020922 (label 20922.pdf) INN (MEQUINOL TRETINOIN) SOLAGE (ALMIRALL) APPROVAL= AP YEAR= 1999 DISCONTINUED , 1419 ; ALPHA-TOCOPHEROL ACETATE ; 58-95-7 ; 2000 ; ; ; CLASS METABOLISM -- SUPPLEMENT -- ANTIOXIDANT -- VITAMIN E , ; NDA 021163 (label 21163.pdf) INN (ALPHA-TOCOPHEROL ACETATE) INFUVITE ADULT (SANDOZ CANADA INC) APPROVAL= AP YEAR= 2000 , NDA 021559 (label 21559.pdf) INN (ALPHA-TOCOPHEROL ACETATE) INFUVITE ADULT (SANDOZ INC) APPROVAL= AP YEAR= 2003 OBSOLETE , NDA 021265 (label 21265.pdf) INN (TOCOPHEROL ACETATE) INFUVITE PEDIATRIC (SANDOZ) APPROVAL= AP YEAR= 2001 , NDA 021646 (label 21646.pdf) INN (TOCOPHEROL ACETATE) INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (SANDOZ) APPROVAL= AP YEAR= 2004 OBSOLETE , 1420 ; ARTICAINE ; 23964-58-1 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- LOCAL ANESTHETIC CONTAINING A VASOCONSTRICTOR -- DENTAL PROCEDURE , ; NDA 020971 (label 20971.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2000 , NDA 022010 (pdf 22010.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2006 , NDA 022466 (label 22466.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ORABLOC (PIERREL) APPROVAL= AP YEAR= 2010 , NDA 079138 (pdf 79138.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201750 (pdf 201750.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN FORTE (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 201751 (label 201751.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1421 ; PIPERONYL BUTOXIDE ; 51-03-6 ; 2000 ; DISCONTINUED ; ; CLASS ANTIPARASITIC -- HEAD LICE -- INHIBIT MONO-OXYGENASES AND NONSPECIFIC ESTERASES (PMID17192611) -- PIPERONYL BUTOXIDE ITSELF HAS LIMITED INSECTICIDAL ACTIVITY. ITS SYNERGISTIC INTERACTION WITH PYRETHROIDS TAKES PLACES AT THE MICROSOMAL LEVEL. THE DETAILED MECHANISM HAS NOT BEEN FULLY CLARIFIED. , ; NDA 021043 (label 21043.pdf) INN (PIPERONYL BUTOXIDE PYRETHRINS) RID MOUSSE (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 2000 DISCONTINUED , 1422 ; GANIRELIX ; 124904-93-4 ; 1999 ; ; ; CLASS HORMONES -- GONADOTROPIN-RELEASING HORMONE ANTAGONIST (GNRH ANTAGONIST) -- STIMULATES THE SYNTHESIS AND SECRETION OF LUTEINIZING HORMONE (LH) AND FOLLICLE-STIMULATING HORMONE (FSH) , ; NDA 021057 (label 21057.pdf) INN (GANIRELIX ACETATE) GANIRELIX ACETATE (ORGANON USA ORGANON) APPROVAL= AP YEAR= 1999 NEWMOLECULARENTITY , NDA 204246 (pdf 204246.pdf not found) INN (GANIRELIX ACETATE) FYREMADEL (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 212613 (pdf 212613.pdf not found) INN (GANIRELIX ACETATE) GANIRELIX ACETATE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 214996 (pdf 214996.pdf not found) INN (GANIRELIX ACETATE) GANIRELIX ACETATE (MEITHEAL) APPROVAL= AP YEAR= 2022 , NDA 215658 (pdf 215658.pdf not found) INN (GANIRELIX ACETATE) GANIRELIX ACETATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 216075 (pdf 216075.pdf not found) INN (GANIRELIX ACETATE) GANIRELIX ACETATE (LUPIN LTD) APPROVAL= AP YEAR= 2023 , 1423 ; NORELGESTROMIN ; 53016-31-2 ; 2001 ; ; ; CLASS GENITO -- CONTRACEPTIVE , ; NDA 021180 (label 21180.pdf) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ORTHO EVRA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 200910 (pdf 200910.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) XULANE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2014 , NDA 213950 (pdf 213950.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ETHINYL ESTRADIOL AND NORELGESTROMIN (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 213977 (pdf 213977.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ONSURA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 214594 (pdf 214594.pdf not found) INN (ETHINYL ESTRADIOL NORELGESTROMIN) ETHINYL ESTRADIOL AND NORELGESTROMIN (ZYDUS NOVELTECH INC) APPROVAL= AP YEAR= 2023 , 1424 ; UNOPROSTONE ISOPROPYL ; 120373-24-2 ; 2000 ; DISCONTINUED ; ; CLASS SENSORY -- ANTIHYPERTENSIVE -- ANTIGLAUCOMA -- DOCOSANOID STRUCTURAL ANALOGUE OF AN INACTIVE BIOSYNTHETIC CYCLIC DERIVATIVE OF ARACHIDONIC ACID -- HYDROLYZED BY ESTERASES , ; NDA 021214 (label 21214.pdf) INN (UNOPROSTONE ISOPROPYL) RESCULA (SUCAMPO PHARMA LLC) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED , 1425 ; CEFDITOREN PIVOXIL ; 117467-28-4 ; 2001 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS -- INHIBITOR , ; NDA 021222 (label 21222.pdf) INN (CEFDITOREN PIVOXIL) SPECTRACEF (VANSEN PHARMA) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , 1426 ; ZOLEDRONIC ACID ; 118072-93-8 ; 2001 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- ANTIHYPOCALCEMIC AGENTS -- ANTIRESORPTIVES -- BISPHOSPHONATES -- BONE DENSITY CONSERVATION AGENTS -- INHIBITS OSTEOCLASTIC ACTIVITY AND INDUCES OSTEOCLAST APOPTOSIS , ; NDA 021223 (label 21223.pdf) INN (ZOLEDRONIC ACID) ZOMETA (NOVARTIS) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY DISCONTINUED , NDA 021386 (label 21386.pdf) INN (ZOLEDRONIC ACID) ZOMETA (NOVARTIS) APPROVAL= AP YEAR= 2002 NEWAPPLICATION , NDA 021817 (label 21817.pdf) INN (ZOLEDRONIC ACID) RECLAST (SANDOZ) APPROVAL= AP YEAR= 2007 , NDA 022080 (label 22080.pdf) INN (ZOLEDRONIC ACID) RECLAST (SANDOZ) APPROVAL= AP YEAR= 2007 NEWAPPLICATION , NDA 078533 (pdf 78533.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (APOTEX INC) APPROVAL= TA YEAR= 2009 , NDA 078576 (pdf 78576.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (TEVA PARENTERAL) APPROVAL= TA YEAR= 2009 , NDA 078580 (pdf 78580.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (TEVA PARENTERAL) APPROVAL= TA YEAR= 2009 , NDA 078768 (pdf 78768.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (BEDFORD LABS) APPROVAL= TA YEAR= 2009 OBSOLETE , NDA 090018 (pdf 90018.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 090330 (pdf 90330.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (PHARMAFORCE) APPROVAL= TA YEAR= 2009 , NDA 090621 (pdf 90621.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (HOSPIRA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 090709 (pdf 90709.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (HOSPIRA INC) APPROVAL= TA YEAR= 2010 , NDA 091170 (pdf 91170.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (BRECKENRIDGE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091186 (pdf 91186.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 091187 (pdf 91187.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 091363 (pdf 91363.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 091364 (pdf 91364.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 201783 (pdf 201783.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 , NDA 202828 (pdf 202828.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (INFORLIFE) APPROVAL= AP YEAR= 2013 , NDA 202930 (pdf 202930.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 201801 (pdf 201801.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 203231 (label 203231.pdf) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (INFORLIFE) APPROVAL= AP YEAR= 2013 , NDA 202163 (pdf 202163.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 202182 (pdf 202182.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (HIKMA FARMACEUTICA) APPROVAL= AP YEAR= 2013 , NDA 202472 (pdf 202472.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (ACTAVIS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202571 (pdf 202571.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 202650 (pdf 202650.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (MYLAN LABS LTD) APPROVAL= AP YEAR= 2013 , NDA 202746 (pdf 202746.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SUN PHARMA GLOBAL) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 202837 (pdf 202837.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (HOSPIRA INC) APPROVAL= AP YEAR= 2013 , NDA 204016 (label 204016.pdf) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (HOSPIRA) APPROVAL= AP YEAR= 2015 , NDA 078475 (pdf 78475.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (CIPLA LTD) APPROVAL= TA YEAR= 2014 , NDA 091493 (pdf 91493.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2014 , NDA 200918 (pdf 200918.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 202548 (pdf 202548.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2014 , NDA 202923 (pdf 202923.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (USV) APPROVAL= AP YEAR= 2014 , NDA 204051 (pdf 204051.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SUN PHARMA GLOBAL) APPROVAL= TA YEAR= 2014 , NDA 204138 (pdf 204138.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SUN PHARMA GLOBAL) APPROVAL= TA YEAR= 2014 , NDA 091516 (pdf 91516.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 204367 (pdf 204367.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (APOTEX) APPROVAL= AP YEAR= 2015 , NDA 203344 (pdf 203344.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (PFIZER INC) APPROVAL= TA YEAR= 2016 , NDA 204217 (pdf 204217.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (GLAND) APPROVAL= AP YEAR= 2016 , NDA 205279 (pdf 205279.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2016 , NDA 205749 (pdf 205749.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 207751 (pdf 207751.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 203841 (pdf 203841.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 205254 (pdf 205254.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 207341 (pdf 207341.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (BPI LABS) APPROVAL= AP YEAR= 2017 , NDA 209125 (pdf 209125.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (EUGIA PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 210174 (pdf 210174.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 204344 (pdf 204344.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (DR REDDYS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208513 (pdf 208513.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (SHILPA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209578 (pdf 209578.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 208968 (pdf 208968.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (NOVAST LABS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213371 (pdf 213371.pdf not found) INN (ZOLEDRONIC ACID) ZOLEDRONIC ACID (MEITHEAL) APPROVAL= AP YEAR= 2023 , 1427 ; DEXMETHYLPHENIDATE ; 1072298-18-0 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMINE REUPTAKE INHIBITORS -- NOREPINEPHRINE REUPTAKE INHIBITOR -- NERVOUS SYSTEM , ; NDA 010187 (label 10187.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN (NOVARTIS) APPROVAL= AP YEAR= 1955 , NDA 018029 (label 18029.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN-SR (NOVARTIS) APPROVAL= AP YEAR= 1982 , NDA 021121 (label 21121.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) CONCERTA (ORTHO MCNEIL JANSSEN) APPROVAL= AP YEAR= 2000 , NDA 021259 (label 21259.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE CD (UCB INC) APPROVAL= AP YEAR= 2001 , NDA 021284 (label 21284.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN LA (NOVARTIS) APPROVAL= AP YEAR= 2002 , NDA 021419 (label 21419.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (MALLINCKRODT) APPROVAL= AP YEAR= 2002 , NDA 021475 (label 21475.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (MALLINCKRODT) APPROVAL= AP YEAR= 2003 , NDA 021514 (label 21514.pdf) INN (METHYLPHENIDATE) DAYTRANA (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 040220 (pdf 40220.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 , NDA 040300 (label 40300.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MALLINCKRODT) APPROVAL= AP YEAR= 1998 , NDA 040306 (label 40306.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (UCB INC) APPROVAL= AP YEAR= 1999 , NDA 040321 (pdf 40321.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 , NDA 040404 (pdf 40404.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040410 (pdf 40410.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2001 , NDA 075450 (pdf 75450.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2001 , NDA 075629 (pdf 75629.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN ER (MALLINCKRODT) APPROVAL= AP YEAR= 2000 , NDA 076032 (pdf 76032.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 085799 (pdf 85799.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (UCB INC) APPROVAL= AP YEAR= 1977 , NDA 086428 (pdf 86428.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (UCB INC) APPROVAL= AP YEAR= 1979 , NDA 086429 (pdf 86429.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (UCB INC) APPROVAL= AP YEAR= 1979 , NDA 089601 (pdf 89601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (UCB INC) APPROVAL= AP YEAR= 1988 , NDA 021278 (label 21278.pdf) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) FOCALIN (SANDOZ) APPROVAL= AP YEAR= 2001 , NDA 021802 (label 21802.pdf) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) FOCALIN XR (SANDOZ) APPROVAL= AP YEAR= 2005 , NDA 077107 (pdf 77107.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 091601 (pdf 91601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 078458 (label 78458.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS) APPROVAL= AP YEAR= 2011 , NDA 077707 (pdf 77707.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078873 (pdf 78873.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079031 (pdf 79031.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2012 , NDA 090710 (pdf 90710.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2012 , NDA 200886 (pdf 200886.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS S ATLANTIC) APPROVAL= TA YEAR= 2012 , NDA 202100 (label 202100.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLIVANT XR (NEXTWAVE PHARMS) APPROVAL= AP YEAR= 2012 , NDA 202608 (pdf 202608.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 2012 , NDA 091695 (pdf 91695.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (KUDCO IRELAND) APPROVAL= AP YEAR= 2013 , NDA 201466 (pdf 201466.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2013 , NDA 091159 (pdf 91159.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (COREPHARMA) APPROVAL= AP YEAR= 2014 , NDA 202892 (pdf 202892.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (VINTAGE PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204115 (pdf 204115.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 205831 (label 205831.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) APTENSIO XR (RHODES PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207488 (pdf 207488.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI) APPROVAL= AP YEAR= 2015 , NDA 202580 (pdf 202580.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078908 (pdf 78908.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 078992 (pdf 78992.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2013 , NDA 079108 (pdf 79108.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2013 , NDA 202731 (pdf 202731.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 204534 (pdf 204534.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 203583 (pdf 203583.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MALLINCKRODT INC) APPROVAL= AP YEAR= 2015 , NDA 204602 (pdf 204602.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207416 (pdf 207416.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 207884 (pdf 207884.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207960 (label 207960.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLICHEW ER (PFIZER INC) APPROVAL= AP YEAR= 2015 , NDA 204772 (pdf 204772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEDOR PHARMA INC) APPROVAL= AP YEAR= 2016 , NDA 201231 (pdf 201231.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2015 , NDA 204266 (pdf 204266.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206931 (pdf 206931.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (ABHAI INC) APPROVAL= AP YEAR= 2015 , NDA 076655 (pdf 76655.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS FLORIDA) APPROVAL= TA YEAR= 2016 , NDA 076772 (pdf 76772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2016 , NDA 205105 (pdf 205105.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205756 (pdf 205756.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEDOR PHARMA INC) APPROVAL= AP YEAR= 2016 , NDA 206726 (pdf 206726.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2016 , NDA 206840 (pdf 206840.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CNTY LINE PHARMS) APPROVAL= AP YEAR= 2016 , NDA 207485 (pdf 207485.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2016 , NDA 204954 (pdf 204954.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 205327 (label 205327.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OSMOTICA) APPROVAL= AP YEAR= 2017 , NDA 205489 (label 205489.pdf) INN (METHYLPHENIDATE) COTEMPLA XR-ODT (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 206932 (pdf 206932.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI INC) APPROVAL= AP YEAR= 2017 , NDA 207587 (pdf 207587.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 , NDA 208607 (pdf 208607.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2017 , NDA 208861 (pdf 208861.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= TA YEAR= 2017 , NDA 202842 (pdf 202842.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2016 , NDA 207901 (pdf 207901.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2016 , NDA 203614 (pdf 203614.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2017 , NDA 210354 (pdf 210354.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE () APPROVAL= AP YEAR= 2017 , NDA 206049 (pdf 206049.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE () APPROVAL= AP YEAR= 2018 , NDA 207515 (pdf 207515.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE () APPROVAL= AP YEAR= 2018 , NDA 209753 (pdf 209753.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE () APPROVAL= AP YEAR= 2018 , NDA 208756 (pdf 208756.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209468 (pdf 209468.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209276 (pdf 209276.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209311 (label 209311.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) JORNAY PM (IRONSHORE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210139 (pdf 210139.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210818 (pdf 210818.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN PINE BROOK) APPROVAL= AP YEAR= 2018 , NDA 210924 (pdf 210924.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2018 , NDA 210992 (pdf 210992.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES PHARMS) APPROVAL= AP YEAR= 2018 , NDA 208737 (pdf 208737.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CEDIPROF INC) APPROVAL= AP YEAR= 2019 , NDA 211796 (pdf 211796.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211918 (pdf 211918.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANDOR PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212038 (label 212038.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) ADHANSIA XR (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2019 , NDA 209211 (pdf 209211.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (CEDIPROF INC) APPROVAL= AP YEAR= 2018 , NDA 210279 (pdf 210279.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (ADARE PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 204659 (pdf 204659.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211009 (pdf 211009.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211779 (pdf 211779.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210764 (pdf 210764.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PATRIN PHARMA INC) APPROVAL= AP YEAR= 2020 , NDA 211647 (pdf 211647.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213567 (pdf 213567.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 212631 (pdf 212631.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 209754 (pdf 209754.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 205135 (pdf 205135.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 207414 (pdf 207414.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212288 (pdf 212288.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212697 (pdf 212697.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 213473 (pdf 213473.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213936 (pdf 213936.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 207417 (pdf 207417.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 213813 (pdf 213813.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2020 , NDA 212994 (label 212994.pdf) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE SERDEXMETHYLPHENIDATE CHLORIDE) AZSTARYS (COMMAVE THERAP) APPROVAL= AP YEAR= 2023 , NDA 206497 (pdf 206497.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2022 , NDA 214111 (pdf 214111.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214202 (pdf 214202.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2022 , NDA 216117 (label 216117.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RELEXXII (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2022 , NDA 206734 (pdf 206734.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2021 , NDA 215523 (pdf 215523.pdf not found) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE) DEXMETHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214447 (pdf 214447.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217229 (pdf 217229.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , 1428 ; TENOFOVIR DISOPROXIL ; 201341-05-1 ; 2001 ; ; ; CLASS ANTIINFECTIVE -- ANTIVIRAL -- ANTIRETROVIRAL -- NUCLEOTIDE ANALOG HIV-1 REVERSE TRANSCRIPTASE INHIBITOR AND -- HBV REVERSE TRANSCRIPTASE INHIBITOR -- CHRONIC HEPATITIS B IN ADULTS , ; NDA 021356 (label 21356.pdf) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY , NDA 021752 (label 21752.pdf) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) TRUVADA (GILEAD) APPROVAL= AP YEAR= 2004 , NDA 021937 (label 21937.pdf) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) ATRIPLA (GILEAD SCIENCES) APPROVAL= AP YEAR= 2006 , NDA 022141 (label 22141.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) CIMDUO (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 079071 (pdf 79071.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2024 , NDA 022142 (label 22142.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 078800 (pdf 78800.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2018 , NDA 090049 (pdf 90049.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090437 (pdf 90437.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009 , NDA 090513 (pdf 90513.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 090636 (pdf 90636.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 090647 (pdf 90647.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 022459 (pdf 22459.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009 , NDA 022344 (label 22344.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 090742 (pdf 90742.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 , NDA 200623 (pdf 200623.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011 , NDA 090894 (pdf 90894.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , NDA 091215 (pdf 91215.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 091612 (pdf 91612.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015 , NDA 201806 (pdf 201806.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 202123 (label 202123.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR DISOPROXIL FUMARATE) COMPLERA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2011 , NDA 202171 (pdf 202171.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011 , NDA 022577 (label 22577.pdf) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012 , NDA 091593 (pdf 91593.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012 , NDA 203100 (label 203100.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012 , NDA 203283 (pdf 203283.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012 , NDA 204119 (pdf 204119.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2017 , NDA 022343 (label 22343.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 091055 (pdf 91055.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021 , NDA 202529 (pdf 202529.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2013 , NDA 203041 (pdf 203041.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 203053 (pdf 203053.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 204505 (pdf 204505.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2013 , NDA 204568 (pdf 204568.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= TA YEAR= 2013 , NDA 090958 (pdf 90958.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 203232 (pdf 203232.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018 , NDA 204287 (pdf 204287.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 205355 (pdf 205355.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014 , NDA 205861 (pdf 205861.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2014 , NDA 206042 (pdf 206042.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE NEVIRAPINE) EMTRICITABINETENOFOVIR DISOPROXIL FUMARATENEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014 , NDA 204402 (pdf 204402.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (LUPIN LTD) APPROVAL= TA YEAR= 2015 , NDA 206584 (pdf 206584.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2015 OBSOLETE , NDA 206569 (pdf 206569.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206894 (pdf 206894.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 203470 (pdf 203470.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (PHARMACARE LTD) APPROVAL= TA YEAR= 2016 OBSOLETE , NDA 207315 (pdf 207315.pdf not found) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2017 , NDA 208255 (label 208255.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) SYMFI LO (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 208452 (pdf 208452.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINERILPIVIRINETENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 209670 (pdf 209670.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 206436 (pdf 206436.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 209498 (pdf 209498.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (QILU) APPROVAL= AP YEAR= 2018 , NDA 209550 (label 209550.pdf) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206481 (pdf 206481.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL) APPROVAL= AP YEAR= 2018 , NDA 209721 (pdf 209721.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 210807 (label 210807.pdf) INN (DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DELSTRIGO (MSD MERCK CO) APPROVAL= AP YEAR= 2018 , NDA 211284 (label 211284.pdf) INN (LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) TEMIXYS (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210649 (label 210649.pdf) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210787 (pdf 210787.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 212114 (pdf 212114.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2019 , NDA 203442 (pdf 203442.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 212689 (pdf 212689.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 212786 (pdf 212786.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213038 (pdf 213038.pdf not found) INN (EFAVIRENZ LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020 , NDA 213556 (pdf 213556.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD) APPROVAL= TA YEAR= 2020 , NDA 204131 (pdf 204131.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2021 , NDA 208740 (pdf 208740.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212303 (pdf 212303.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN PHARMS) APPROVAL= TA YEAR= 2021 , NDA 210796 (pdf 210796.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2019 , NDA 213541 (pdf 213541.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ , EMTRICITABINE , AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2021 , NDA 211337 (pdf 211337.pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (REYOUNG) APPROVAL= AP YEAR= 2023 , NDA 211640 (pdf 211640.pdf not found) INN (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 201802 (pdf 201802.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 , NDA 211868 (pdf 211868.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 217016 (pdf 217016.pdf not found) INN (DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE) DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE (STRIDES PHARMA) APPROVAL= TA YEAR= 2023 , 1429 ; ROTIGOTINE ; 99755-59-6 ; 2007 ; ; ; CLASS NERVOUS SYSTEM -- NON-ERGOLINE DOPAMINE AGONISTS -- TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON DISEASE AND RESTLESS LEGS SYNDROME , ; NDA 021829 (label 21829.pdf) INN (ROTIGOTINE) NEUPRO (UCB INC) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , 1430 ; NEPAFENAC ; 78281-72-8 ; 2005 ; ; ; CLASS SENSORY -- ANTIINFLAMMATORY -- NONSTEROIDAL ANTI-INFLAMMATORY (NSAID) PRODRUG -- TREATMENT OF PAIN AND INFLAMMATION ASSOCIATED WITH CATARACT SURGERY -- CONVERTED BY OCULAR TISSUE HYDROLASES TO AMFENAC -- INHIBITOR THE ACTION OF PROSTAGLANDIN H SYNTHASE (CYCLOOXYGENASE) , ; NDA 021862 (label 21862.pdf) INN (NEPAFENAC) NEVANAC (HARROW EYE) APPROVAL= AP YEAR= 2005 NEWMOLECULARENTITY , NDA 203491 (label 203491.pdf) INN (NEPAFENAC) ILEVRO (HARROW EYE) APPROVAL= AP YEAR= 2012 , 1431 ; METHYLNALTREXONE ; 73232-52-7 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTIC ANTAGONISTS -- OPIATE ANTAGONISTS -- TREATMENT OF OPIOID-INDUCED CONSTIPATION -- PERIPHERALLY-ACTING MU-OPIOID RECEPTOR ANTAGONIST -- NOT CROSS BBB (RESTRICTED) , ; NDA 021964 (label 21964.pdf) INN (METHYLNALTREXONE BROMIDE) RELISTOR (SALIX PHARMS) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 208271 (label 208271.pdf) INN (METHYLNALTREXONE BROMIDE) RELISTOR (SALIX) APPROVAL= AP YEAR= 2016 , NDA 208592 (pdf 208592.pdf not found) INN (METHYLNALTREXONE BROMIDE) METHYLNALTREXONE BROMIDE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2017 , NDA 208038 (pdf 208038.pdf not found) INN (METHYLNALTREXONE BROMIDE) METHYLNALTREXONE BROMIDE (US GENERICS , STERILES) APPROVAL= TA YEAR= 2021 , 1432 ; DESVENLAFAXINE ; 93413-62-8 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANTS -- SELECTIVE SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITOR (SNRI) -- TREATMENT OF MAJOR DEPRESSIVE DISORDER [MDD] , ; NDA 021992 (label 21992.pdf) INN (DESVENLAFAXINE SUCCINATE) PRISTIQ (PF PRISM CV) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 204150 (label 204150.pdf) INN (DESVENLAFAXINE) DESVENLAFAXINE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 204683 (label 204683.pdf) INN (DESVENLAFAXINE) KHEDEZLA (OSMOTICA PHARM CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 205208 (label 205208.pdf) INN (DESVENLAFAXINE FUMARATE) DESVENLAFAXINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204082 (pdf 204082.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 204083 (pdf 204083.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 205583 (label 205583.pdf) INN (DESVENLAFAXINE FUMARATE) DESVENLAFAXINE (SUN PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204003 (pdf 204003.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 204028 (pdf 204028.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (RUBICON) APPROVAL= AP YEAR= 2015 , NDA 204095 (pdf 204095.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204172 (pdf 204172.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 204009 (pdf 204009.pdf not found) INN (DESVENLAFAXINE) DESVENLAFAXINE (ANCHEN PHARMS) APPROVAL= TA YEAR= 2016 , NDA 204065 (pdf 204065.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2016 , NDA 204020 (pdf 204020.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 210014 (pdf 210014.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 204805 (pdf 204805.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2019 , 1433 ; DESVENLAFAXINE ; 93413-62-8 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANTS -- SELECTIVE SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITOR (SNRI) -- TREATMENT OF MAJOR DEPRESSIVE DISORDER [MDD] , ; NDA 021992 (label 21992.pdf) INN (DESVENLAFAXINE SUCCINATE) PRISTIQ (PF PRISM CV) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 204150 (label 204150.pdf) INN (DESVENLAFAXINE) DESVENLAFAXINE (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2013 , NDA 204683 (label 204683.pdf) INN (DESVENLAFAXINE) KHEDEZLA (OSMOTICA PHARM CORP) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 205208 (label 205208.pdf) INN (DESVENLAFAXINE FUMARATE) DESVENLAFAXINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 204082 (pdf 204082.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 204083 (pdf 204083.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 205583 (label 205583.pdf) INN (DESVENLAFAXINE FUMARATE) DESVENLAFAXINE (SUN PHARM) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 204003 (pdf 204003.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ALEMBIC) APPROVAL= AP YEAR= 2015 , NDA 204028 (pdf 204028.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (RUBICON) APPROVAL= AP YEAR= 2015 , NDA 204095 (pdf 204095.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204172 (pdf 204172.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (LUPIN LTD) APPROVAL= AP YEAR= 2015 , NDA 204009 (pdf 204009.pdf not found) INN (DESVENLAFAXINE) DESVENLAFAXINE (ANCHEN PHARMS) APPROVAL= TA YEAR= 2016 , NDA 204065 (pdf 204065.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2016 , NDA 204020 (pdf 204020.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 210014 (pdf 210014.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2018 , NDA 204805 (pdf 204805.pdf not found) INN (DESVENLAFAXINE SUCCINATE) DESVENLAFAXINE SUCCINATE (INTELLIPHARMACEUTICS) APPROVAL= AP YEAR= 2019 , 1434 ; FOSAPREPITANT ; 172673-20-0 ; 2008 ; ; ; CLASS METABOLISM -- ANTIEMETIC -- P/NEUROKININ-1 (NK1) RECEPTOR ANTAGONIST , ; NDA 022023 (label 22023.pdf) INN (FOSAPREPITANT DIMEGLUMINE) EMEND (MERCK AND CO INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 203939 (pdf 203939.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (SANDOZ) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206197 (label 206197.pdf) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2016 , NDA 204845 (pdf 204845.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (SAGENT PHARMS) APPROVAL= TA YEAR= 2017 , NDA 210064 (label 210064.pdf) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 209965 (pdf 209965.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (MSN) APPROVAL= AP YEAR= 2019 , NDA 204015 (pdf 204015.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 205020 (pdf 205020.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (APOTEX) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210689 (pdf 210689.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 211624 (pdf 211624.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (ARTHUR GRP) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211860 (pdf 211860.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2019 , NDA 212309 (pdf 212309.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (BE PHARMS) APPROVAL= AP YEAR= 2019 , NDA 204025 (pdf 204025.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211160 (pdf 211160.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 212957 (pdf 212957.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (NAVINTA LLC) APPROVAL= AP YEAR= 2020 , NDA 213106 (pdf 213106.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (QILU PHARM HAINAN) APPROVAL= AP YEAR= 2020 , NDA 210625 (pdf 210625.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 212143 (pdf 212143.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (CHIA TAI TIANQING) APPROVAL= AP YEAR= 2021 , NDA 213199 (pdf 213199.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (ARTHUR GRP) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214616 (pdf 214616.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (ASPIRO) APPROVAL= AP YEAR= 2021 , NDA 214683 (pdf 214683.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOSAPREPITANT DIMEGLUMINE (PIRAMAL CRITICAL) APPROVAL= AP YEAR= 2023 , NDA 216686 (pdf 216686.pdf not found) INN (FOSAPREPITANT DIMEGLUMINE) FOCINVEZ (STERISCIENCE) APPROVAL= AP YEAR= 2023 , 1435 ; METHYL SALICYLATE ; 119-36-8 ; 2008 ; ; NATURAL MOLECULE C00030767 ; CLASS NERVOUS SYSTEM -- ANALGESIC -- CYCLOOXYGENASE INHIBITORS , ; NDA 022029 (label 22029.pdf) INN (MENTHOL METHYL SALICYLATE) SALONPAS (HISAMITSU PHARM CO) APPROVAL= AP YEAR= 2008 , 1436 ; LANREOTIDE ; 108736-35-2 ; 2007 ; ; ; CLASS HORMONES -- SOMATOSTATIN ANALOG -- LONG-TERM TREATMENT OF ACROMEGALIC PATIENTS -- INHIBITOR OF VARIOUS ENDOCRINE, NEUROENDOCRINE, EXOCRINE AND PARACRINE FUNCTIONS -- REDUCTION OF GH AND/OR IGF-1 LEVELS , ; NDA 022074 (label 22074.pdf) INN (LANREOTIDE ACETATE) SOMATULINE DEPOT (IPSEN PHARMA) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 215395 (label 215395.pdf) INN (LANREOTIDE ACETATE) LANREOTIDE ACETATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2021 , NDA 217193 (pdf 217193.pdf not found) INN (LANREOTIDE ACETATE) LANREOTIDE ACETATE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2024 , 1437 ; AMBRISENTAN ; 177036-94-1 ; 2007 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ENDOTHELIN RECEPTOR ANTAGONIST -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) -- AMBRISENTAN IS A SUBSTRATE OF P-GP , ; NDA 022081 (label 22081.pdf) INN (AMBRISENTAN) LETAIRIS (GILEAD) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 208252 (pdf 208252.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (WATSON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 208354 (pdf 208354.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2019 , NDA 208441 (pdf 208441.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 209509 (pdf 209509.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210058 (pdf 210058.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 210715 (pdf 210715.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (CIPLA) APPROVAL= AP YEAR= 2019 , NDA 210784 (pdf 210784.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 210701 (pdf 210701.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 216531 (pdf 216531.pdf not found) INN (AMBRISENTAN) AMBRISENTAN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , 1438 ; RALTEGRAVIR ; 518048-05-0 ; 2007 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRALS -- HUMAN IMMUNODEFICIENCY VIRUS INTEGRASE STRAND TRANSFER INHIBITOR (HIV-1 INSTI) , ; NDA 022145 (label 22145.pdf) INN (RALTEGRAVIR POTASSIUM) ISENTRESS (MSD SUB MERCK) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 203045 (label 203045.pdf) INN (RALTEGRAVIR POTASSIUM) ISENTRESS (MSD SUB MERCK) APPROVAL= AP YEAR= 2011 , NDA 205786 (label 205786.pdf) INN (RALTEGRAVIR POTASSIUM) ISENTRESS (MSD SUB MERCK) APPROVAL= AP YEAR= 2013 , NDA 203540 (pdf 203540.pdf not found) INN (RALTEGRAVIR) RALTEGRAVIR (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014 , NDA 206510 (label 206510.pdf) INN (LAMIVUDINE RALTEGRAVIR POTASSIUM) DUTREBIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2015 DISCONTINUED , 1439 ; CLEVIDIPINE ; 167221-71-8 ; 2008 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ANTIHYPERTENSIVE -- DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER -- REDUCTION OF BLOOD PRESSURE -- THE CARBOXYLIC ACID METABOLITE IS INACTIVE AS AN ANTIHYPERTENSIVE , ; NDA 022156 (label 22156.pdf) INN (CLEVIDIPINE) CLEVIPREX (CHIESI) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , 1440 ; SAPROPTERIN ; 62989-33-7 ; 2007 ; ; NATURAL MOLECULE C00018229 ; CLASS METABOLISM -- AGONIST -- TREATMENT OF HYPERPHENYLALANINAEMIA (HPA) -- REDUCTION OF PHENYLALANINE CONCENTRATION IN PATIENTS WITH PHENYLKETONURIA (PKU) -- COFACTOR FOR THE ENZYME PHENYLALANINE HYDROXYLASE (PAH). TREATMENT WITH BH4 CAN ACTIVATE RESIDUAL PAH AND IMPROVE THE NORMAL OXIDATIVE METABOLISM OF PHE, AND DECREASE PHE LEVELS -- TREATMENT OF TETRAHYDROBIOPTERIN (BH4) DEFICIENCY , ; NDA 022181 (label 22181.pdf) INN (SAPROPTERIN DIHYDROCHLORIDE) KUVAN (BIOMARIN PHARM) APPROVAL= AP YEAR= 2007 NEWMOLECULARENTITY , NDA 205065 (label 205065.pdf) INN (SAPROPTERIN DIHYDROCHLORIDE) KUVAN (BIOMARIN PHARM) APPROVAL= AP YEAR= 2013 , NDA 207200 (pdf 207200.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 209452 (pdf 209452.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 207685 (pdf 207685.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 207207 (pdf 207207.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 210027 (pdf 210027.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2019 , NDA 215798 (pdf 215798.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 215420 (pdf 215420.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 215534 (pdf 215534.pdf not found) INN (SAPROPTERIN DIHYDROCHLORIDE) SAPROPTERIN DIHYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , 1441 ; ETRAVIRINE ; 269055-15-4 ; 2008 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV -- NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS -- IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) , ; NDA 022187 (label 22187.pdf) INN (ETRAVIRINE) INTELENCE (JANSSEN R AND D) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 214196 (pdf 214196.pdf not found) INN (ETRAVIRINE) ETRAVIRINE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 215402 (pdf 215402.pdf not found) INN (ETRAVIRINE) ETRAVIRINE (CARNEGIE) APPROVAL= AP YEAR= 2022 , 1442 ; DIFLUPREDNATE ; 23674-86-4 ; 2008 ; ; ; CLASS DERMATOLOGICALS -- ANTIINFLAMMATORY -- TOPICAL CORTICOSTEROID -- AGONIST , ; NDA 022212 (label 22212.pdf) INN (DIFLUPREDNATE) DUREZOL (SANDOZ) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 211526 (pdf 211526.pdf not found) INN (DIFLUPREDNATE) DIFLUPREDNATE (AMNEAL) APPROVAL= AP YEAR= 2021 , NDA 211776 (pdf 211776.pdf not found) INN (DIFLUPREDNATE) DIFLUPREDNATE (CIPLA) APPROVAL= AP YEAR= 2021 , NDA 214894 (pdf 214894.pdf not found) INN (DIFLUPREDNATE) DIFLUPREDNATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 207284 (pdf 207284.pdf not found) INN (DIFLUPREDNATE) DIFLUPREDNATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2024 , 1443 ; BENDAMUSTINE ; 16506-27-7 ; 2008 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- CHRONIC LYMPHOCYTIC LEUKEMIA -- INDOLENT B-CELL NON-HODGKIN’S LYMPHOMA (NHL) -- FORM COVALENT BONDS WITH ELECTRON-RICH NUCLEOPHILIC MOIETIES RESULTING IN INTERSTRAND DNA CROSSLINKS , ; NDA 022249 (label 22249.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) TREANDA (CEPHALON) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 022303 (label 22303.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) TREANDA (CEPHALON) APPROVAL= AP YEAR= 2008 NEWAPPLICATION , NDA 205580 (label 205580.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BELRAPZO (EAGLE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 205574 (label 205574.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 208194 (label 208194.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDEKA (EAGLE PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204086 (label 204086.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (HOSPIRA INC) APPROVAL= TA YEAR= 2018 , NDA 204771 (label 204771.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2019 , NDA 205476 (label 205476.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (INNOPHARMA LICENSING) APPROVAL= TA YEAR= 2018 , NDA 205447 (pdf 205447.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2023 , NDA 204230 (pdf 204230.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 204104 (pdf 204104.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 210410 (pdf 210410.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (FRESENIUS KABI USA) APPROVAL= TA YEAR= 2018 , NDA 209814 (pdf 209814.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (CELERITY PHARMS) APPROVAL= TA YEAR= 2019 , NDA 211530 (label 211530.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212209 (label 212209.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) VIVIMUSTA (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2022 , NDA 205376 (pdf 205376.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 206554 (pdf 206554.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (NANG KUANG PHARM CO) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215668 (pdf 215668.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 214739 (pdf 214739.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 215033 (label 215033.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 216078 (label 216078.pdf) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2022 , NDA 211001 (pdf 211001.pdf not found) INN (BENDAMUSTINE HYDROCHLORIDE) BENDAMUSTINE HYDROCHLORIDE (KINDOS) APPROVAL= AP YEAR= 2023 , 1444 ; PLICAMYCIN ; 18378-89-7 ; 1970 ; DISCONTINUED ; NATURAL MOLECULE NPA016575 ; CLASS ANTINEOPLASTIC -- CYTOTOXIC ANTIBIOTICS PRODUCED BY STREPTOMYCES ARGILLACEUS , ; NDA 050109 (pdf 50109.pdf not found) INN (PLICAMYCIN) MITHRACIN (PFIZER) APPROVAL= AP YEAR= 1970 NEWMOLECULARENTITY DISCONTINUED , 1445 ; CLINDAMYCIN PHOSPHATE ; 24729-96-2 ; 1972 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 050441 (label 50441.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN PHOSPHATE (PFIZER) APPROVAL= AP YEAR= 1972 , NDA 050537 (label 50537.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN T (PFIZER) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 050600 (label 50600.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN T (PFIZER) APPROVAL= AP YEAR= 1989 , NDA 050615 (label 50615.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN T (PFIZER) APPROVAL= AP YEAR= 1987 , NDA 050635 (pdf 50635.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% (ABRAXIS PHARM) APPROVAL= AP YEAR= 1989 , NDA 050636 (pdf 50636.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% (ABRAXIS PHARM) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050639 (label 50639.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (PFIZER) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050648 (pdf 50648.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 050680 (label 50680.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN (PFIZER) APPROVAL= AP YEAR= 1992 , NDA 050741 (label 50741.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) DUAC (STIEFEL) APPROVAL= AP YEAR= 2002 , NDA 050756 (label 50756.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZACLIN (BAUSCH) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 050767 (label 50767.pdf) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN (PFIZER) APPROVAL= AP YEAR= 1999 , NDA 050782 (label 50782.pdf) INN (CLINDAMYCIN PHOSPHATE) CLINDAGEL (BAUSCH) APPROVAL= AP YEAR= 2000 , NDA 050793 (label 50793.pdf) INN (CLINDAMYCIN PHOSPHATE) CLINDESSE (PADAGIS US) APPROVAL= AP YEAR= 2004 , NDA 050801 (label 50801.pdf) INN (CLINDAMYCIN PHOSPHATE) EVOCLIN (MYLAN) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 050802 (label 50802.pdf) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) ZIANA (BAUSCH) APPROVAL= AP YEAR= 2006 , NDA 061839 (pdf 61839.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN PHOSPHATE (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062363 (pdf 62363.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN T (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 062747 (pdf 62747.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062795 (pdf 62795.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062800 (pdf 62800.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ALMAJECT) APPROVAL= AP YEAR= 1987 , NDA 062801 (pdf 62801.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ALMAJECT) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062803 (pdf 62803.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLEOCIN PHOSPHATE (PFIZER) APPROVAL= AP YEAR= 1987 , NDA 062806 (pdf 62806.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 062811 (pdf 62811.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (G AND W LABS INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062819 (pdf 62819.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062852 (pdf 62852.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SOLOPAK) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062877 (pdf 62877.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062889 (pdf 62889.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1988 , NDA 062900 (pdf 62900.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062905 (pdf 62905.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (LOCH) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062908 (pdf 62908.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062913 (pdf 62913.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 062928 (pdf 62928.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (IGI LABS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062930 (pdf 62930.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (VINTAGE PHARMS) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062943 (pdf 62943.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ALMAJECT) APPROVAL= AP YEAR= 1988 , NDA 062944 (pdf 62944.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (BOCA PHARMA LLC) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 062953 (pdf 62953.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 063041 (pdf 63041.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063068 (pdf 63068.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1989 DISCONTINUED , NDA 063079 (pdf 63079.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063163 (pdf 63163.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (BEDFORD) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 063282 (pdf 63282.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1992 DISCONTINUED , NDA 063304 (pdf 63304.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 063329 (pdf 63329.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDA-DERM (PADAGIS US) APPROVAL= AP YEAR= 1992 , NDA 064050 (pdf 64050.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PADAGIS US) APPROVAL= AP YEAR= 1995 , NDA 064108 (pdf 64108.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (NOVAST LABS) APPROVAL= AP YEAR= 1996 DISCONTINUED , NDA 064136 (pdf 64136.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDETS (PADAGIS US) APPROVAL= AP YEAR= 1996 , NDA 064159 (pdf 64159.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FOUGERA PHARMS INC) APPROVAL= AP YEAR= 1997 , NDA 064160 (pdf 64160.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2000 , NDA 065027 (pdf 65027.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (ABBOTT LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 065049 (pdf 65049.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PADAGIS US) APPROVAL= AP YEAR= 2000 , NDA 065067 (pdf 65067.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2002 , NDA 065139 (pdf 65139.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2004 , NDA 065184 (pdf 65184.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TARO PHARM INDS) APPROVAL= AP YEAR= 2004 , NDA 065206 (pdf 65206.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2004 , NDA 065254 (pdf 65254.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FOUGERA PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065346 (pdf 65346.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 065347 (pdf 65347.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2007 , NDA 050819 (label 50819.pdf) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) ACANYA (BAUSCH) APPROVAL= AP YEAR= 2008 , NDA 065443 (pdf 65443.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2009 , NDA 090785 (pdf 90785.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2010 , NDA 050803 (label 50803.pdf) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) VELTIN (ALMIRALL) APPROVAL= AP YEAR= 2010 , NDA 065513 (pdf 65513.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2010 , NDA 090108 (pdf 90108.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 090109 (pdf 90109.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2011 , NDA 090979 (pdf 90979.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2012 , NDA 201692 (pdf 201692.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER (SANDOZ INC) APPROVAL= AP YEAR= 2012 , NDA 203048 (pdf 203048.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER (RISING) APPROVAL= AP YEAR= 2013 , NDA 202564 (pdf 202564.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 2015 , NDA 203343 (pdf 203343.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205128 (pdf 205128.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ACTAVIS LABS UT INC) APPROVAL= AP YEAR= 2015 , NDA 202440 (pdf 202440.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2015 , NDA 203688 (pdf 203688.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TOLMAR) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206945 (pdf 206945.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PAI HOLDINGS PHARM) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 208683 (pdf 208683.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 204087 (pdf 204087.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208083 (label 208083.pdf) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2017 , NDA 208084 (pdf 208084.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2017 , NDA 204748 (pdf 204748.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 204749 (pdf 204749.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (RISING) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206218 (pdf 206218.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO PHARMS) APPROVAL= AP YEAR= 2017 , NDA 208776 (pdf 208776.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2018 , NDA 209846 (pdf 209846.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 , NDA 207194 (pdf 207194.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208767 (pdf 208767.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2018 , NDA 210794 (pdf 210794.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209252 (pdf 209252.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (GLENMARK PHARMS) APPROVAL= AP YEAR= 2019 , NDA 209914 (pdf 209914.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ENCUBE ETHICALS) APPROVAL= AP YEAR= 2019 , NDA 205397 (pdf 205397.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 , NDA 206575 (pdf 206575.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (TARO) APPROVAL= AP YEAR= 2019 , NDA 210004 (pdf 210004.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TARO) APPROVAL= AP YEAR= 2020 , NDA 211872 (pdf 211872.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2020 , NDA 212104 (pdf 212104.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2020 , NDA 214052 (pdf 214052.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TARO) APPROVAL= AP YEAR= 2020 , NDA 208757 (pdf 208757.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZOYL PEROXIDE AND CLINDAMYCIN PHOSPHATE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2021 , NDA 212433 (pdf 212433.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 212438 (pdf 212438.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ENCUBE) APPROVAL= AP YEAR= 2021 , NDA 214251 (pdf 214251.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 214526 (pdf 214526.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (TARO) APPROVAL= AP YEAR= 2021 , NDA 214604 (pdf 214604.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2021 , NDA 210778 (pdf 210778.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 , NDA 212842 (pdf 212842.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2021 , NDA 215650 (label 215650.pdf) INN (CLINDAMYCIN PHOSPHATE) XACIATO (ORGANON LLC) APPROVAL= AP YEAR= 2021 , NDA 212845 (pdf 212845.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (SOLARIS PHARMA CORP) APPROVAL= AP YEAR= 2022 , NDA 215607 (pdf 215607.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ENCUBE) APPROVAL= AP YEAR= 2022 , NDA 214668 (pdf 214668.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 215219 (pdf 215219.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (AMNEAL) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 209610 (pdf 209610.pdf not found) INN (BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE (PERRIGO UK FINCO) APPROVAL= TA YEAR= 2023 , NDA 214401 (pdf 214401.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 216587 (pdf 216587.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 216632 (pdf 216632.pdf not found) INN (ADAPALENE BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE) CABTREO (BAUSCH) APPROVAL= AP YEAR= 2023 , NDA 216943 (pdf 216943.pdf not found) INN (CLINDAMYCIN PHOSPHATE TRETINOIN) CLINDAMYCIN PHOSPHATE AND TRETINOIN (ENCUBE) APPROVAL= AP YEAR= 2023 , NDA 212466 (pdf 212466.pdf not found) INN (CLINDAMYCIN PHOSPHATE) CLINDAMYCIN PHOSPHATE (ALEMBIC) APPROVAL= AP YEAR= 2024 , 1446 ; CLINDAMYCIN PALMITATE ; 36688-78-5 ; 1986 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL , ; NDA 061827 (pdf 61827.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLEOCIN (PHARMACIA AND UPJOHN) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 062644 (label 62644.pdf) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLEOCIN (PFIZER) APPROVAL= AP YEAR= 1986 , NDA 090902 (pdf 90902.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2010 , NDA 201821 (pdf 201821.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (LYNE) APPROVAL= AP YEAR= 2012 , NDA 202409 (pdf 202409.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013 , NDA 203513 (pdf 203513.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2014 , NDA 203063 (pdf 203063.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206958 (pdf 206958.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2017 , NDA 207047 (pdf 207047.pdf not found) INN (CLINDAMYCIN PALMITATE HYDROCHLORIDE) CLINDAMYCIN PALMITATE HYDROCHLORIDE (HERITAGE PHARMS INC) APPROVAL= AP YEAR= 2018 , 1447 ; CARBENICILLIN INDANYL ; 35531-88-5 ; 1972 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CELL WALL SYNTHESIS , ; NDA 050435 (label 50435.pdf) INN (CARBENICILLIN INDANYL SODIUM) GEOCILLIN (PFIZER) APPROVAL= AP YEAR= 1972 DISCONTINUED , 1448 ; CARBENICILLIN INDANYL ; 35531-88-5 ; 1972 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CELL WALL SYNTHESIS , ; NDA 050435 (label 50435.pdf) INN (CARBENICILLIN INDANYL SODIUM) GEOCILLIN (PFIZER) APPROVAL= AP YEAR= 1972 DISCONTINUED , 1449 ; PLERIXAFOR ; 110078-46-1 ; 2008 ; ; ; CLASS IMMUNOMODULATING -- IMMUNOSTIMULANTS -- HEMATOPOIETIC STEM CEL1 MOBILIZER -- CXCR4 CHEMOKINE RECEPTOR INHIBITOR THAT BLOCKS BINDING OF ITS COGNATE LIGAND: STROMAL CELL-DERIVED FACTOR-LALPHA (SDF-1ALPHA) , ; NDA 022311 (label 22311.pdf) INN (PLERIXAFOR) MOZOBIL (GENZYME) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 205182 (pdf 205182.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 211901 (pdf 211901.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (MSN) APPROVAL= AP YEAR= 2023 , NDA 213672 (pdf 213672.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 215698 (pdf 215698.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 208980 (pdf 208980.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 205197 (pdf 205197.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2023 , NDA 215334 (pdf 215334.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 206644 (pdf 206644.pdf not found) INN (PLERIXAFOR) PLERIXAFOR (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1450 ; ELTROMBOPAG ; 496775-61-2 ; 2008 ; ; ; CLASS BLOOD -- THROMBOPOIETIN RECEPTOR AGONIST (TPO)-- THROMBOCYTOPENIA -- CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP) -- INTERACTS WITH THE TRANSMEMBRANE DOMAIN OF THE HUMAN TPO-RECEPTOR AND INITIATES SIGNALING CASCADES THAT INDUCE PROLIFERATION AND DIFFERENTIATION OF MEGAKARYOCYTES FROM BONE MARROW PROGENITOR CELLS , ; NDA 022291 (label 22291.pdf) INN (ELTROMBOPAG OLAMINE) PROMACTA (NOVARTIS) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 207027 (label 207027.pdf) INN (ELTROMBOPAG OLAMINE) PROMACTA KIT (NOVARTIS) APPROVAL= AP YEAR= 2015 , NDA 206788 (pdf 206788.pdf not found) INN (ELTROMBOPAG) ELTROMBOPAG (HETERO LABS LTD V) APPROVAL= TA YEAR= 2016 , NDA 208815 (pdf 208815.pdf not found) INN (ELTROMBOPAG) ELTROMBOPAG (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2017 , NDA 209938 (pdf 209938.pdf not found) INN (ELTROMBOPAG) ELTROMBOPAG (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2018 , NDA 216774 (label 216774.pdf) INN (ELTROMBOPAG CHOLINE) ALVAIZ (TEVA PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 212884 (pdf 212884.pdf not found) INN (ELTROMBOPAG) ELTROMBOPAG (AMNEAL EU LTD) APPROVAL= TA YEAR= 2024 , NDA 216620 (pdf 216620.pdf not found) INN (ELTROMBOPAG OLAMINE) ELTROMBOPAG OLAMINE (ANNORA PHARMA) APPROVAL= AP YEAR= 2024 , 1451 ; DEGARELIX ; 214766-78-6 ; 2008 ; ; ; CLASS ANTINEOPLASTIC -- PROSTATE CANCER -- GONADOTROPIN-RELEASING HORMONE (GNRH) ANTAGONIST -- IT BINDS REVERSIBLY TO THE PITUITARY GNRH RECEPTORS THEREBY REDUCING THE RELEASE OF GONADOTROPINS AND CONSEQUENTLY TESTOSTERONE , ; NDA 022201 (label 22201.pdf) INN (DEGARELIX ACETATE) FIRMAGON (FERRING) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , 1452 ; FESOTERODINE ; 286930-02-7 ; 2008 ; ; ; CLASS ANTISPASMODICS -- ANTIMUSCARINIC -- MUSCARINIC ANTAGONIST -- OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE -- URINARY ANTISPASMODICS -- GENITO -- HYDROLYSIS BY NONSPECIFIC ESTERASES , ; NDA 022030 (label 22030.pdf) INN (FESOTERODINE FUMARATE) TOVIAZ (PFIZER) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 204504 (pdf 204504.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ANI PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204844 (pdf 204844.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (SANDOZ INC) APPROVAL= TA YEAR= 2015 , NDA 204868 (pdf 204868.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204893 (pdf 204893.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (LUPIN LTD) APPROVAL= TA YEAR= 2015 , NDA 204973 (pdf 204973.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , NDA 204983 (pdf 204983.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 205002 (pdf 205002.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2023 , NDA 205032 (pdf 205032.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (SUN PHARM INDS INC) APPROVAL= TA YEAR= 2015 , NDA 204827 (pdf 204827.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2015 , NDA 204975 (pdf 204975.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 205007 (pdf 205007.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205012 (pdf 205012.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204946 (pdf 204946.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 204792 (pdf 204792.pdf not found) INN (FESOTERODINE FUMARATE) FESOTERODINE FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 1453 ; RUFINAMIDE ; 106308-44-5 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTIC -- PROLONGATION OF THE INACTIVE STATE OF THE CHANNEL -- INHIBITOR , ; NDA 021911 (label 21911.pdf) INN (RUFINAMIDE) BANZEL (EISAI INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 201367 (label 201367.pdf) INN (RUFINAMIDE) BANZEL (EISAI INC) APPROVAL= AP YEAR= 2011 , NDA 204988 (label 204988.pdf) INN (RUFINAMIDE) RUFINAMIDE (HIKMA) APPROVAL= AP YEAR= 2016 , NDA 205075 (label 205075.pdf) INN (RUFINAMIDE) RUFINAMIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016 , NDA 205095 (label 205095.pdf) INN (RUFINAMIDE) RUFINAMIDE (MYLAN) APPROVAL= AP YEAR= 2016 , NDA 207363 (pdf 207363.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HIKMA) APPROVAL= AP YEAR= 2019 , NDA 211388 (pdf 211388.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2019 , NDA 213457 (pdf 213457.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2020 , NDA 214009 (pdf 214009.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2022 , NDA 204993 (pdf 204993.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021 , NDA 213410 (pdf 213410.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 204964 (pdf 204964.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 216549 (pdf 216549.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216688 (pdf 216688.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 217230 (pdf 217230.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 216841 (pdf 216841.pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023 , 1454 ; FOSPROPOFOL ; 258516-89-1 ; 2008 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- SEDATIVE -- HYPNOTIC -- ANESTHESIC -- METABOLIZED BY ALKALINE PHOSPHATASES INTO PROPOFOL , ; NDA 022244 (label 22244.pdf) INN (FOSPROPOFOL DISODIUM) LUSEDRA (EISAI INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY DISCONTINUED , 1455 ; LACOSAMIDE ; 175481-36-4 ; 2008 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTIC -- PARTIAL-ONSET SEIZURES -- FUNCTIONALIZED AMINO ACID -- VOLTAGE GATED SODIUM CHANNELS INHIBITOR , ; NDA 022253 (label 22253.pdf) INN (LACOSAMIDE) VIMPAT (UCB INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , NDA 022254 (label 22254.pdf) INN (LACOSAMIDE) VIMPAT (UCB INC) APPROVAL= AP YEAR= 2008 , NDA 022255 (label 22255.pdf) INN (LACOSAMIDE) VIMPAT (UCB INC) APPROVAL= AP YEAR= 2010 , NDA 204839 (label 204839.pdf) INN (LACOSAMIDE) LACOSAMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 204855 (label 204855.pdf) INN (LACOSAMIDE) LACOSAMIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204857 (label 204857.pdf) INN (LACOSAMIDE) LACOSAMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2022 , NDA 204974 (label 204974.pdf) INN (LACOSAMIDE) LACOSAMIDE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 204994 (label 204994.pdf) INN (LACOSAMIDE) LACOSAMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 205011 (pdf 205011.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 206355 (pdf 206355.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (APOTEX) APPROVAL= AP YEAR= 2022 , NDA 205006 (pdf 205006.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2022 , NDA 205026 (pdf 205026.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2016 OBSOLETE , NDA 204921 (pdf 204921.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MSN LABS PVT LTD) APPROVAL= AP YEAR= 2022 , NDA 204980 (pdf 204980.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2016 , NDA 205031 (pdf 205031.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (SUN PHARM) APPROVAL= AP YEAR= 2022 , NDA 204999 (pdf 204999.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2017 , NDA 214672 (pdf 214672.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 214695 (pdf 214695.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 204947 (pdf 204947.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 204787 (pdf 204787.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 205237 (pdf 205237.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 208308 (pdf 208308.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (INDOCO) APPROVAL= AP YEAR= 2022 , NDA 209301 (pdf 209301.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2022 , NDA 209465 (pdf 209465.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 214301 (pdf 214301.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (INDOCO) APPROVAL= AP YEAR= 2022 , NDA 214677 (pdf 214677.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2022 , NDA 214567 (pdf 214567.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (APOTEX) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215628 (pdf 215628.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216151 (pdf 216151.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216335 (pdf 216335.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (ASPIRO) APPROVAL= AP YEAR= 2022 , NDA 215979 (pdf 215979.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MSN) APPROVAL= AP YEAR= 2023 , NDA 216185 (label 216185.pdf) INN (LACOSAMIDE) MOTPOLY XR (AUCTA) APPROVAL= AP YEAR= 2023 , NDA 216461 (pdf 216461.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (LEADING PHARMA) APPROVAL= AP YEAR= 2023 , NDA 215379 (pdf 215379.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MSN) APPROVAL= AP YEAR= 2023 , NDA 216670 (pdf 216670.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 208466 (pdf 208466.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , NDA 209224 (pdf 209224.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 215154 (pdf 215154.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2024 , NDA 216806 (pdf 216806.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (HIKMA) APPROVAL= AP YEAR= 2024 , NDA 217311 (pdf 217311.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (HAINAN POLY) APPROVAL= AP YEAR= 2024 , NDA 217718 (pdf 217718.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 218014 (pdf 218014.pdf not found) INN (LACOSAMIDE) LACOSAMIDE (MEDLEY PHARMS) APPROVAL= AP YEAR= 2024 , 1456 ; ISOSORBIDE ; 652-67-5 ; 1974 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- VASODILATOR FROM THE RELEASE OF NITRIC OXIDE -- OSMOTIC AGENT TO PROMOTE REDISTRIBUTION OF WATER TOWARD THE CIRCULATION WITH ULTIMATE ELIMINATION IN THE URINE , ; NDA 017063 (pdf 17063.pdf not found) INN (ISOSORBIDE) ISMOTIC (ALCON) APPROVAL= AP YEAR= 1974 DISCONTINUED , 1457 ; BETAMETHASONE PHOSPHATE ; 360-63-4 ; 1965 ; ; ; CLASS HORMONES -- ANTI-INFLAMMATORY -- CORTICOSTEROID -- GLUCOCORTICOID AGONIST , ; NDA 014602 (label 14602.pdf) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) CELESTONE SOLUSPAN (ORGANON) APPROVAL= AP YEAR= 1965 NEWMOLECULARENTITY , NDA 017561 (pdf 17561.pdf not found) INN (BETAMETHASONE SODIUM PHOSPHATE) CELESTONE (SCHERING) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 085738 (pdf 85738.pdf not found) INN (BETAMETHASONE SODIUM PHOSPHATE) BETAMETHASONE SODIUM PHOSPHATE (WATSON LABS) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 090747 (pdf 90747.pdf not found) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (AM REGENT) APPROVAL= AP YEAR= 2009 , NDA 077838 (pdf 77838.pdf not found) INN (BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATE) BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 2023 , 1458 ; BENZYL ALCOHOL ; 100-51-6 ; 2009 ; DISCONTINUED ; NATURAL MOLECULE C00029811 ; CLASS ANTIPARASITIC -- PEDICULOCIDE -- BACTERIOSTATIC PRESERVATIVE -- HEAD LICE , ; NDA 022129 (label 22129.pdf) INN (BENZYL ALCOHOL) ULESFIA (SHIONOGI INC) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY DISCONTINUED , 1459 ; TROGLITAZONE ; 97322-87-7 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- PPAR AGONIST , ; NDA 020719 (label 20719.pdf) INN (TROGLITAZONE) PRELAY (SANKYO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020720 (label 20720.pdf) INN (TROGLITAZONE) REZULIN (PFIZER PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1460 ; BENZQUINAMIDE ; 63-12-7 ; 1974 ; DISCONTINUED ; ; CLASS ANTIEMETIC -- ANTIPSYCHOTICS -- NERVOUS SYSTEM , ; NDA 016818 (pdf 16818.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (ROERIG) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 016820 (pdf 16820.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (PFIZER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , 1461 ; CYCLOTHIAZIDE ; 159405-29-5 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1462 ; CYCLOTHIAZIDE ; 159405-28-4 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1463 ; CYCLOTHIAZIDE ; 134077-75-1 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1464 ; CYCLOTHIAZIDE ; 134077-79-5 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1465 ; CYCLOTHIAZIDE ; 134077-78-4 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1466 ; CYCLOTHIAZIDE ; 134077-81-9 ; 1963 ; DISCONTINUED ; ; CLASS CARDIOVASCULAR -- DIURETIC -- ANTIHYPERTENSIVE -- POSITIVE ALLOSTERIC MODULATORS OF AMPA-TYPE GLUTAMATE RECEPTORS -- POTENTIATOR , ; NDA 013157 (pdf 13157.pdf not found) INN (CYCLOTHIAZIDE) ANHYDRON (LILLY) APPROVAL= AP YEAR= 1963 NEWMOLECULARENTITY DISCONTINUED , NDA 018173 (pdf 18173.pdf not found) INN (CYCLOTHIAZIDE) FLUIDIL (PHARMACIA AND UPJOHN) APPROVAL= AP YEAR= 1982 DISCONTINUED , 1467 ; ISOETHARINE ; 79490-84-9 ; 1978 ; DISCONTINUED ; ; CLASS BRONCHODILATOR -- ADRENERGIC BETA2 AGONISTS (PMID6990745) -- RESPIRATORY SYSTEM , ; NDA 012339 (pdf 12339.pdf not found) INN (ISOETHARINE MESYLATE) BRONKOMETER (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085889 (pdf 85889.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085997 (pdf 85997.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086651 (pdf 86651.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086711 (pdf 86711.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) BETA-2 (NEPHRON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086763 (pdf 86763.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086899 (pdf 86899.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087025 (pdf 87025.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087101 (pdf 87101.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087324 (pdf 87324.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087389 (pdf 87389.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087390 (pdf 87390.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087396 (pdf 87396.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087858 (pdf 87858.pdf not found) INN (ISOETHARINE MESYLATE) ISOETHARINE MESYLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087937 (pdf 87937.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087938 (pdf 87938.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088144 (pdf 88144.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088145 (pdf 88145.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088146 (pdf 88146.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088187 (pdf 88187.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088188 (pdf 88188.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088226 (pdf 88226.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088275 (pdf 88275.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088470 (pdf 88470.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088471 (pdf 88471.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088472 (pdf 88472.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089252 (pdf 89252.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089614 (pdf 89614.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089615 (pdf 89615.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089616 (pdf 89616.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089617 (pdf 89617.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089618 (pdf 89618.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089817 (pdf 89817.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089818 (pdf 89818.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089819 (pdf 89819.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089820 (pdf 89820.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , 1468 ; ISOETHARINE ; 52553-26-1 ; 1978 ; DISCONTINUED ; ; CLASS BRONCHODILATOR -- ADRENERGIC BETA2 AGONISTS (PMID6990745) -- RESPIRATORY SYSTEM , ; NDA 012339 (pdf 12339.pdf not found) INN (ISOETHARINE MESYLATE) BRONKOMETER (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085889 (pdf 85889.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085997 (pdf 85997.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086651 (pdf 86651.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086711 (pdf 86711.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) BETA-2 (NEPHRON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086763 (pdf 86763.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086899 (pdf 86899.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087025 (pdf 87025.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087101 (pdf 87101.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087324 (pdf 87324.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087389 (pdf 87389.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087390 (pdf 87390.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087396 (pdf 87396.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087858 (pdf 87858.pdf not found) INN (ISOETHARINE MESYLATE) ISOETHARINE MESYLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087937 (pdf 87937.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087938 (pdf 87938.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088144 (pdf 88144.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088145 (pdf 88145.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088146 (pdf 88146.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088187 (pdf 88187.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088188 (pdf 88188.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088226 (pdf 88226.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088275 (pdf 88275.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088470 (pdf 88470.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088471 (pdf 88471.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088472 (pdf 88472.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089252 (pdf 89252.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089614 (pdf 89614.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089615 (pdf 89615.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089616 (pdf 89616.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089617 (pdf 89617.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089618 (pdf 89618.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089817 (pdf 89817.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089818 (pdf 89818.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089819 (pdf 89819.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089820 (pdf 89820.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , 1469 ; METHYLPHENIDATE ; 29419-96-3 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMINE REUPTAKE INHIBITORS -- NOREPINEPHRINE REUPTAKE INHIBITOR -- NERVOUS SYSTEM , ; NDA 010187 (label 10187.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN (SANDOZ) APPROVAL= AP YEAR= 1955 , NDA 018029 (label 18029.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN-SR (NOVARTIS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 021121 (label 21121.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) CONCERTA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2000 , NDA 021259 (label 21259.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE CD (AYTU BIOPHARMA) APPROVAL= AP YEAR= 2001 , NDA 021284 (label 21284.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN LA (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 021419 (label 21419.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2002 , NDA 021475 (label 21475.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021514 (label 21514.pdf) INN (METHYLPHENIDATE) DAYTRANA (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 040220 (pdf 40220.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040300 (label 40300.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 1998 , NDA 040306 (label 40306.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040321 (pdf 40321.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040404 (pdf 40404.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040410 (pdf 40410.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075450 (pdf 75450.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075629 (pdf 75629.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN ER (SPECGX LLC) APPROVAL= AP YEAR= 2000 , NDA 076032 (pdf 76032.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 085799 (pdf 85799.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086428 (pdf 86428.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086429 (pdf 86429.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 089601 (pdf 89601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 091601 (pdf 91601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 078458 (label 78458.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 , NDA 077707 (pdf 77707.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078873 (pdf 78873.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079031 (pdf 79031.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090710 (pdf 90710.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2012 , NDA 200886 (pdf 200886.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 202100 (label 202100.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLIVANT XR (NEXTWAVE) APPROVAL= AP YEAR= 2012 , NDA 202608 (pdf 202608.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2012 , NDA 091695 (pdf 91695.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 201466 (pdf 201466.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091159 (pdf 91159.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MOUNTAIN) APPROVAL= AP YEAR= 2014 , NDA 202892 (pdf 202892.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204115 (pdf 204115.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205831 (label 205831.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) APTENSIO XR (RHODES PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207488 (pdf 207488.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2015 , NDA 203583 (pdf 203583.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2015 , NDA 204602 (pdf 204602.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207416 (pdf 207416.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 207884 (pdf 207884.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207960 (label 207960.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLICHEW ER (NEXTWAVE PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204772 (pdf 204772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 076655 (pdf 76655.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 076772 (pdf 76772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 205105 (pdf 205105.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205756 (pdf 205756.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 206726 (pdf 206726.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206840 (pdf 206840.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207485 (pdf 207485.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2016 , NDA 204954 (pdf 204954.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205327 (label 205327.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2017 , NDA 205489 (label 205489.pdf) INN (METHYLPHENIDATE) COTEMPLA XR-ODT (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 206932 (pdf 206932.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI INC) APPROVAL= AP YEAR= 2017 , NDA 207587 (pdf 207587.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208607 (pdf 208607.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208861 (pdf 208861.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2018 , NDA 210354 (pdf 210354.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 206049 (pdf 206049.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2018 , NDA 207515 (pdf 207515.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209753 (pdf 209753.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 209276 (pdf 209276.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209311 (label 209311.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) JORNAY PM (IRONSHORE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210139 (pdf 210139.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210818 (pdf 210818.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210924 (pdf 210924.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210992 (pdf 210992.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 208737 (pdf 208737.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CEDIPROF INC) APPROVAL= AP YEAR= 2019 , NDA 211796 (pdf 211796.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 211918 (pdf 211918.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANDOR PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212038 (label 212038.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) ADHANSIA XR (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 204659 (pdf 204659.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211009 (pdf 211009.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211779 (pdf 211779.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210764 (pdf 210764.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PATRIN) APPROVAL= AP YEAR= 2020 , NDA 211647 (pdf 211647.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213567 (pdf 213567.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 205135 (pdf 205135.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 207414 (pdf 207414.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212288 (pdf 212288.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212697 (pdf 212697.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 213473 (pdf 213473.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213936 (pdf 213936.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 207417 (pdf 207417.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 206497 (pdf 206497.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2022 , NDA 214111 (pdf 214111.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214202 (pdf 214202.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2023 , NDA 216117 (label 216117.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RELEXXII (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2022 , NDA 214447 (pdf 214447.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217229 (pdf 217229.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , 1470 ; METHYLPHENIDATE ; 29419-97-4 ; 1955 ; ; ; CLASS NERVOUS SYSTEM -- CNS STIMULANT -- ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- DOPAMINE REUPTAKE INHIBITORS -- NOREPINEPHRINE REUPTAKE INHIBITOR -- NERVOUS SYSTEM , ; NDA 010187 (label 10187.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN (SANDOZ) APPROVAL= AP YEAR= 1955 , NDA 018029 (label 18029.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN-SR (NOVARTIS) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 021121 (label 21121.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) CONCERTA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2000 , NDA 021259 (label 21259.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE CD (AYTU BIOPHARMA) APPROVAL= AP YEAR= 2001 , NDA 021284 (label 21284.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RITALIN LA (SANDOZ) APPROVAL= AP YEAR= 2002 , NDA 021419 (label 21419.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2002 , NDA 021475 (label 21475.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN (SPECGX LLC) APPROVAL= AP YEAR= 2003 DISCONTINUED , NDA 021514 (label 21514.pdf) INN (METHYLPHENIDATE) DAYTRANA (NOVEN PHARMS INC) APPROVAL= AP YEAR= 2006 , NDA 040220 (pdf 40220.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040300 (label 40300.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 1998 , NDA 040306 (label 40306.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040321 (pdf 40321.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 040404 (pdf 40404.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040410 (pdf 40410.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075450 (pdf 75450.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 075629 (pdf 75629.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLIN ER (SPECGX LLC) APPROVAL= AP YEAR= 2000 , NDA 076032 (pdf 76032.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 085799 (pdf 85799.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 086428 (pdf 86428.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 086429 (pdf 86429.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 089601 (pdf 89601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METADATE ER (LANNETT CO INC) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 091601 (pdf 91601.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2010 , NDA 078458 (label 78458.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2011 , NDA 077707 (pdf 77707.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 078873 (pdf 78873.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2012 , NDA 079031 (pdf 79031.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BARR LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 090710 (pdf 90710.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2012 , NDA 200886 (pdf 200886.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018 , NDA 202100 (label 202100.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLIVANT XR (NEXTWAVE) APPROVAL= AP YEAR= 2012 , NDA 202608 (pdf 202608.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2012 , NDA 091695 (pdf 91695.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2013 , NDA 201466 (pdf 201466.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 091159 (pdf 91159.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (MOUNTAIN) APPROVAL= AP YEAR= 2014 , NDA 202892 (pdf 202892.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OXFORD PHARMS) APPROVAL= AP YEAR= 2014 , NDA 204115 (pdf 204115.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205831 (label 205831.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) APTENSIO XR (RHODES PHARMS) APPROVAL= AP YEAR= 2015 , NDA 207488 (pdf 207488.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2015 , NDA 203583 (pdf 203583.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2015 , NDA 204602 (pdf 204602.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207416 (pdf 207416.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 207884 (pdf 207884.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOVEL LABS INC) APPROVAL= AP YEAR= 2015 , NDA 207960 (label 207960.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) QUILLICHEW ER (NEXTWAVE PHARMS) APPROVAL= AP YEAR= 2015 , NDA 204772 (pdf 204772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 076655 (pdf 76655.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 076772 (pdf 76772.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2018 , NDA 205105 (pdf 205105.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205756 (pdf 205756.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 2016 , NDA 206726 (pdf 206726.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016 , NDA 206840 (pdf 206840.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207485 (pdf 207485.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI LLC) APPROVAL= AP YEAR= 2016 , NDA 204954 (pdf 204954.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205327 (label 205327.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2017 , NDA 205489 (label 205489.pdf) INN (METHYLPHENIDATE) COTEMPLA XR-ODT (NEOS THERAPS INC) APPROVAL= AP YEAR= 2017 , NDA 206932 (pdf 206932.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ABHAI INC) APPROVAL= AP YEAR= 2017 , NDA 207587 (pdf 207587.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208607 (pdf 208607.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANI PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208861 (pdf 208861.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2018 , NDA 210354 (pdf 210354.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 206049 (pdf 206049.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2018 , NDA 207515 (pdf 207515.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209753 (pdf 209753.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 209276 (pdf 209276.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209311 (label 209311.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) JORNAY PM (IRONSHORE PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210139 (pdf 210139.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2018 , NDA 210818 (pdf 210818.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210924 (pdf 210924.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210992 (pdf 210992.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2018 , NDA 208737 (pdf 208737.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CEDIPROF INC) APPROVAL= AP YEAR= 2019 , NDA 211796 (pdf 211796.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2019 , NDA 211918 (pdf 211918.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ANDOR PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212038 (label 212038.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) ADHANSIA XR (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 204659 (pdf 204659.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211009 (pdf 211009.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 211779 (pdf 211779.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 210764 (pdf 210764.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PATRIN) APPROVAL= AP YEAR= 2020 , NDA 211647 (pdf 211647.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 213567 (pdf 213567.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2020 , NDA 205135 (pdf 205135.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020 , NDA 207414 (pdf 207414.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 212288 (pdf 212288.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 212697 (pdf 212697.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2020 , NDA 213473 (pdf 213473.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213936 (pdf 213936.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 207417 (pdf 207417.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 206497 (pdf 206497.pdf not found) INN (METHYLPHENIDATE) METHYLPHENIDATE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2022 , NDA 214111 (pdf 214111.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214202 (pdf 214202.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2023 , NDA 216117 (label 216117.pdf) INN (METHYLPHENIDATE HYDROCHLORIDE) RELEXXII (OSMOTICA PHARM US) APPROVAL= AP YEAR= 2022 , NDA 214447 (pdf 214447.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 217229 (pdf 217229.pdf not found) INN (METHYLPHENIDATE HYDROCHLORIDE) METHYLPHENIDATE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2023 , 1471 ; ILOPERIDONE ; 133454-47-4 ; 2009 ; ; ; CLASS ANTIPSYCHOTIC -- DOPAMINE ANTAGONIST -- SEROTONIN ANTOGONIST -- SCHIZOPHRENIA -- NERVOUS SYSTEM -- SEROTONIN 5-HT2A DOPAMINE D2 AND D3 RECEPTORS (KI VALUES OF 5.6, 6.3, 7.1,NM, RESPECTIVELY). MODERATE AFFINITY FOR DOPAMINE D4, SEROTONIN 5-HT6 AND 5-HT7RECEPTORS AND NOREPINEPHRINE NEAPLHA1 RECEPTORS (KI VALUES OF 25, 43, 22, AND 36 NM RESPECTIVELY), AND LOW AFFINITY FOR THE SEROTONIN 5HT1A, DOPAMINE D1, AND HISTAMINE H1 RECEPTORS (KI VALUES OF 168, 216 AND 473 NM, RESPECTIVELY). NO APPRECIABLE AFFINITY (KI>1000 NM) FOR CHOLINERGIC MUSCARINIC RECEPTORS. , ; NDA 022192 (label 22192.pdf) INN (ILOPERIDONE) FANAPT (VANDA PHARMS INC) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 207231 (pdf 207231.pdf not found) INN (ILOPERIDONE) ILOPERIDONE (INVENTIA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207409 (pdf 207409.pdf not found) INN (ILOPERIDONE) ILOPERIDONE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2018 , NDA 207098 (pdf 207098.pdf not found) INN (ILOPERIDONE) ILOPERIDONE (TARO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 206890 (pdf 206890.pdf not found) INN (ILOPERIDONE) ILOPERIDONE (LUPIN LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1472 ; TOLVAPTAN ; 150683-30-0 ; 2009 ; ; ; CLASS DIURETIC -- VASOPRESSIN ANTAGONISTS , ; NDA 022275 (label 22275.pdf) INN (TOLVAPTAN) SAMSCA (OTSUKA) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 204441 (label 204441.pdf) INN (TOLVAPTAN) JYNARQUE (OTSUKA) APPROVAL= AP YEAR= 2018 NEWAPPLICATION , NDA 207605 (pdf 207605.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 211891 (pdf 211891.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 205646 (pdf 205646.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , NDA 206119 (pdf 206119.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 , NDA 216949 (pdf 216949.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (MSN) APPROVAL= AP YEAR= 2023 , 1473 ; BESIFLOXACIN ; 141388-76-3 ; 2009 ; ; ; CLASS ANTIBIOTIC -- ANTIBACTERIAL -- ANTI-INFECTIVES -- FOURTH-GENERATION FLUOROQUINOLONE ANTIBIOTIC -- ANTIINFECTIVES -- DNA GYRASE INHIBITOR -- TOPOISOMERASE IV INHIBITOR , ; NDA 022308 (label 22308.pdf) INN (BESIFLOXACIN HYDROCHLORIDE) BESIVANCE (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , 1474 ; PRASUGREL ; 150322-43-3 ; 2009 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; NDA 022307 (label 22307.pdf) INN (PRASUGREL HYDROCHLORIDE) EFFIENT (COSETTE) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 205888 (pdf 205888.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205927 (label 205927.pdf) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 205897 (pdf 205897.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (PANACEA) APPROVAL= AP YEAR= 2017 , NDA 205790 (pdf 205790.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (CHARTWELL RX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205987 (pdf 205987.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 205913 (pdf 205913.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 206021 (pdf 206021.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (HEC PHARM) APPROVAL= AP YEAR= 2019 , NDA 205926 (pdf 205926.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (DR REDDYS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 205930 (pdf 205930.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213315 (pdf 213315.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2023 , 1475 ; PITAVASTATIN ; 147511-69-1 ; 2009 ; ; ; CLASS HMG-COA REDUCTASE INHIBITOR -- ANTIHYPERLIPIDEMIC -- CARDIOVASCULAR -- LIPID-LOWERING AGENT , ; NDA 022363 (label 22363.pdf) INN (PITAVASTATIN CALCIUM) LIVALO (KOWA CO) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 206015 (label 206015.pdf) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016 , NDA 206029 (pdf 206029.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 205932 (pdf 205932.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (ORIENT PHARMA CO LTD) APPROVAL= AP YEAR= 2017 , NDA 205955 (pdf 205955.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (SAWAI USA) APPROVAL= AP YEAR= 2017 , NDA 208379 (label 208379.pdf) INN (PITAVASTATIN MAGNESIUM) ZYPITAMAG (MEDICURE) APPROVAL= AP YEAR= 2017 , NDA 209875 (label 209875.pdf) INN (PITAVASTATIN SODIUM) NIKITA (LUPIN LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 206070 (pdf 206070.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 206047 (pdf 206047.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , NDA 205977 (pdf 205977.pdf not found) INN (PITAVASTATIN CALCIUM) PITAVASTATIN CALCIUM (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 1476 ; SAXAGLIPTIN ; 361442-04-8 ; 2009 ; ; ; CLASS ANTIDIABETIC -- DIPEPTIDYL-PEPTIDASE IV INHIBITOR -- HYPOGLYCEMIC AGENTS -- TYPE 2 DIABETES MELLITUS -- METABOLISM -- METABOLITE OF SAXAGLIPTIN IS ONE-HALF AS POTENT AS SAXAGLIPTIN AS DPP4 INHIBITOR , ; NDA 022350 (label 22350.pdf) INN (SAXAGLIPTIN HYDROCHLORIDE) ONGLYZA (ASTRAZENECA AB) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY DISCONTINUED , NDA 200678 (label 200678.pdf) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) KOMBIGLYZE XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2010 , NDA 205941 (pdf 205941.pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 205942 (pdf 205942.pdf not found) INN (SAXAGLIPTIN METFORMIN HYDROCHLORIDE) SAXAGLIPTINMETFORMIN HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= TA YEAR= 2016 , NDA 205972 (pdf 205972.pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 , NDA 205959 (pdf 205959.pdf not found) INN (SAXAGLIPTIN) SAXAGLIPTIN (PAR PHARM) APPROVAL= TA YEAR= 2016 , NDA 209091 (label 209091.pdf) INN (DAPAGLIFLOZIN SAXAGLIPTIN HYDROCHLORIDE) QTERN (ASTRAZENECA AB) APPROVAL= AP YEAR= 2017 , NDA 210874 (label 210874.pdf) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) QTERNMET XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211533 (pdf 211533.pdf not found) INN (DAPAGLIFLOZIN SAXAGLIPTIN) DAPAGLIFLOZIN AND SAXAGLIPTIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 205980 (pdf 205980.pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (MYLAN) APPROVAL= AP YEAR= 2023 , NDA 205994 (pdf 205994.pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 205981 (pdf 205981.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2023 , NDA 206078 (pdf 206078.pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 206081 (pdf 206081.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 207678 (pdf 207678.pdf not found) INN (METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2023 , NDA 211532 (pdf 211532.pdf not found) INN (DAPAGLIFLOZIN SAXAGLIPTIN MONOHYDRATE) DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE (LUPIN LTD) APPROVAL= TA YEAR= 2024 , 1477 ; ASENAPINE ; 65576-45-6 ; 2009 ; ; ; CLASS ANTIPSYCHOTICS -- 5-HT2A RECEPTOR AGONIST -- NERVOUS SYSTEM -- SCHIZOPHRENIA -- BIPOLAR DISORDER -- HIGH AFFINITY FOR SEROTONIN 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6, AND 5-HT7 RECEPTORS (KI VALUES OF 2.5, 4.0, 0.06, 0.16, 0.03, 1.6, 0.25, AND 0.13 NM), DOPAMINE D2, D3, D4, AND D1 RECEPTORS (KI VALUES OF 1.3, 0.42, 1.1, AND 1.4 NM), ALPHA1 AND ALPHA2-ADRENERGIC RECEPTORS (KI VALUES OF 1.2 AND 1.2 NM), AND HISTAMINE H1 RECEPTORS (KI VALUE 1.0 NM), AND MODERATE AFFINITY FOR H2 RECEPTORS (KI VALUE OF 6.2 NM) , ; NDA 022117 (label 22117.pdf) INN (ASENAPINE MALEATE) SAPHRIS (ALLERGAN) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 206098 (pdf 206098.pdf not found) INN (ASENAPINE MALEATE) ASENAPINE MALEATE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 206107 (pdf 206107.pdf not found) INN (ASENAPINE MALEATE) ASENAPINE MALEATE (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2020 , NDA 212268 (label 212268.pdf) INN (ASENAPINE) SECUADO (HISAMITSU) APPROVAL= AP YEAR= 2019 , NDA 205960 (pdf 205960.pdf not found) INN (ASENAPINE MALEATE) ASENAPINE MALEATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 , 1478 ; VIGABATRIN ; 68506-86-5 ; 2009 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTICS -- ANTICONVULSANTS -- REFRACTORY COMPLEX PARTIAL SEIZURES IN ADULTS -- IRREVERSIBLE INHIBITOR OF GAMMA-AMINOBUTYRIC ACID TRANSAMINASE (GABA-T) , ; NDA 020427 (label 20427.pdf) INN (VIGABATRIN) SABRIL (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 022006 (label 22006.pdf) INN (VIGABATRIN) SABRIL (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2009 , NDA 208218 (pdf 208218.pdf not found) INN (VIGABATRIN) VIGABATRIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209824 (pdf 209824.pdf not found) INN (VIGABATRIN) VIGABATRIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 210155 (pdf 210155.pdf not found) INN (VIGABATRIN) VIGABATRIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210196 (pdf 210196.pdf not found) INN (VIGABATRIN) VIGADRONE (AUCTA) APPROVAL= AP YEAR= 2018 , NDA 211481 (pdf 211481.pdf not found) INN (VIGABATRIN) VIGABATRIN (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 209822 (pdf 209822.pdf not found) INN (VIGABATRIN) VIGABATRIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 211592 (pdf 211592.pdf not found) INN (VIGABATRIN) VIGABATRIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 213469 (pdf 213469.pdf not found) INN (VIGABATRIN) VIGABATRIN (GRANULES) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213375 (pdf 213375.pdf not found) INN (VIGABATRIN) VIGABATRIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 214425 (pdf 214425.pdf not found) INN (VIGABATRIN) VIGABATRIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211539 (pdf 211539.pdf not found) INN (VIGABATRIN) VIGABATRIN (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 213519 (pdf 213519.pdf not found) INN (VIGABATRIN) VIGABATRIN (ANNORA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214992 (pdf 214992.pdf not found) INN (VIGABATRIN) VIGABATRIN (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 212626 (pdf 212626.pdf not found) INN (VIGABATRIN) VIGABATRIN (SPECGX LLC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213390 (pdf 213390.pdf not found) INN (VIGABATRIN) VIGABATRIN (PROPEL PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213899 (pdf 213899.pdf not found) INN (VIGABATRIN) VIGABATRIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 215109 (pdf 215109.pdf not found) INN (VIGABATRIN) VIGABATRIN (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 210042 (pdf 210042.pdf not found) INN (VIGABATRIN) VIGABATRIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2022 , NDA 211790 (pdf 211790.pdf not found) INN (VIGABATRIN) VIGABATRIN (CHARTWELL RX) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214961 (pdf 214961.pdf not found) INN (VIGABATRIN) VIGPODER (PYROS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215601 (pdf 215601.pdf not found) INN (VIGABATRIN) VIGABATRIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215707 (pdf 215707.pdf not found) INN (VIGABATRIN) VIGABATRIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 213104 (pdf 213104.pdf not found) INN (VIGABATRIN) VIGABATRIN (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 215363 (pdf 215363.pdf not found) INN (VIGABATRIN) VIGABATRIN (MSN) APPROVAL= AP YEAR= 2022 , NDA 214671 (pdf 214671.pdf not found) INN (VIGABATRIN) VIGABATRIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215519 (pdf 215519.pdf not found) INN (VIGABATRIN) VIGABATRIN (PROPEL PHARMA) APPROVAL= AP YEAR= 2023 , NDA 214749 (pdf 214749.pdf not found) INN (VIGABATRIN) VIGABATRIN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2023 , NDA 217684 (pdf 217684.pdf not found) INN (VIGABATRIN) VIGAFYDE (PYROS PHARMS) APPROVAL= AP YEAR= 2024 , 1479 ; BEPOTASTINE ; 125602-71-3 ; 2009 ; ; ; CLASS ANTI-ALLERGIC -- ANTIHISTAMINES -- HISTAMINE H1 ANTAGONIST -- CONJUNCTIVITIS -- ITCHING -- SENSORY , ; NDA 022288 (label 22288.pdf) INN (BEPOTASTINE BESILATE) BEPREVE (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 206080 (pdf 206080.pdf not found) INN (BEPOTASTINE BESILATE) BEPOTASTINE BESILATE (SANDOZ INC) APPROVAL= TA YEAR= 2017 , NDA 206066 (pdf 206066.pdf not found) INN (BEPOTASTINE BESILATE) BEPOTASTINE BESILATE (APOTEX) APPROVAL= AP YEAR= 2019 , NDA 206220 (pdf 206220.pdf not found) INN (BEPOTASTINE BESILATE) BEPOTASTINE BESILATE (MYLAN) APPROVAL= AP YEAR= 2019 , NDA 214588 (pdf 214588.pdf not found) INN (BEPOTASTINE BESILATE) BEPOTASTINE BESILATE (ALEMBIC) APPROVAL= AP YEAR= 2023 , 1480 ; TELAVANCIN ; 372151-71-8 ; 2009 ; ; ; CLASS ANTIINFECTIVE -- LIPOGLYCOPEPTIDE ANTIBACTERIALS -- SKIN INFECTION -- GRAM-POSITIVE BACTERIA -- SYNTHETIC DERIVATIVE OF VANCOMYCIN -- INHIBITS BACTERIAL CELL WALL SYNTHESIS BY INTERFERING WITH THE POLYMERIZATION AND CROSS-LINKING OF PEPTIDOGLYCAN , ; NDA 022110 (label 22110.pdf) INN (TELAVANCIN HYDROCHLORIDE) VIBATIV (CUMBERLAND) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 022407 (label 22407.pdf) INN (TELAVANCIN) VIBATIV (THERAVANCE INC) APPROVAL= AP YEAR= 2013 NEWAPPLICATION , 1481 ; PRALATREXATE ; 146464-95-1 ; 2009 ; ; ; CLASS ANTINEOPLASTIC -- FOLIC ACID ANALOGUES -- FOLATE ANALOG METABOLIC INHIBITOR -- LYMPHOMA , ; NDA 022468 (label 22468.pdf) INN (PRALATREXATE) FOLOTYN (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 206167 (pdf 206167.pdf not found) INN (PRALATREXATE) PRALATREXATE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2016 , 1482 ; PAZOPANIB ; 444731-52-6 ; 2009 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE INHIBITORS -- RENAL CELL CARCINOMA -- SOFT TISSUE SARCOMA , ; NDA 022465 (label 22465.pdf) INN (PAZOPANIB HYDROCHLORIDE) VOTRIENT (NOVARTIS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 215837 (pdf 215837.pdf not found) INN (PAZOPANIB HYDROCHLORIDE) PAZOPANIB HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 , NDA 217517 (pdf 217517.pdf not found) INN (PAZOPANIB HYDROCHLORIDE) PAZOPANIB HYDROCHLORIDE (TEVA PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217713 (pdf 217713.pdf not found) INN (PAZOPANIB HYDROCHLORIDE) PAZOPANIB HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 218231 (pdf 218231.pdf not found) INN (PAZOPANIB HYDROCHLORIDE) PAZOPANIB HYDROCHLORIDE (NOVUGEN) APPROVAL= AP YEAR= 2024 , 1483 ; ROMIDEPSIN ; 128517-07-7 ; 2009 ; ; ; CLASS ANTINEOPLASTIC -- HISTONE DEACETYLASE (HDAC) INHIBITOR -- CUTANEOUS T-CELL LYMPHOMA (CTCL) , ; NDA 022393 (label 22393.pdf) INN (ROMIDEPSIN) ISTODAX (BRISTOL-MYERS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 208574 (label 208574.pdf) INN (ROMIDEPSIN) ROMIDEPSIN (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206254 (pdf 206254.pdf not found) INN (ROMIDEPSIN) ROMIDEPSIN (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2021 , 1484 ; DALFAMPRIDINE ; 504-24-5 ; 2010 ; ; ; CLASS NERVOUS SYSTEM -- MULTIPLE SCLEROSIS -- BROAD SPECTRUM POTASSIUM ION CHANNELS INHIBITOR (KV) -- INDICATED TO IMPROVE WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS) , ; NDA 022250 (label 22250.pdf) INN (DALFAMPRIDINE) AMPYRA (ACORDA) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 206646 (pdf 206646.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 206765 (pdf 206765.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2018 , NDA 206811 (pdf 206811.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206863 (pdf 206863.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 208292 (pdf 208292.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 206854 (pdf 206854.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2016 , NDA 206858 (pdf 206858.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (RISING) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 206836 (pdf 206836.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2017 , NDA 210158 (pdf 210158.pdf not found) INN (DALFAMPRIDINE) DALFAMPRIDINE (MICRO LABS) APPROVAL= AP YEAR= 2019 , 1485 ; CARGLUMIC ACID ; 1188-38-1 ; 2010 ; ; ; CLASS HYPERAMMONAEMIA -- CARBAMOYL PHOSPHATE SYNTHETASE 1 (CPS 1) AGONIST IN LIVER MITOCHONDRIA -- DEFICIENCY OF THE HEPATIC ENZYME N-ACETYLGLUTAMATE SYNTHASE (NAGS) -- STRUCTURAL ANALOGUE OF N-ACETYLGLUTAMATE (NAG) , ; NDA 022562 (label 22562.pdf) INN (CARGLUMIC ACID) CARBAGLU (RECORDATI RARE) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 213729 (pdf 213729.pdf not found) INN (CARGLUMIC ACID) CARGLUMIC ACID (NOVITIUM PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213395 (pdf 213395.pdf not found) INN (CARGLUMIC ACID) CARGLUMIC ACID (NAVINTA LLC) APPROVAL= AP YEAR= 2022 , 1486 ; FENOFIBRIC ACID ; 42017-89-0 ; 2008 ; ; ; CLASS CARDIOVASCULAR -- HYPOCHOLESTEROLEMIC -- HYPOLIPIDEMIC -- PEROXISOME PROLIFERATOR RECEPTOR ALPHA (PPAR ALPHA) AGONIST , ; NDA 022418 (label 22418.pdf) INN (FENOFIBRIC ACID) FIBRICOR (ATHENA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 022224 (label 22224.pdf) INN (CHOLINE FENOFIBRATE) TRILIPIX (ABBVIE) APPROVAL= AP YEAR= 2008 , NDA 200750 (pdf 200750.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (CHARTWELL RX) APPROVAL= AP YEAR= 2013 , NDA 200913 (pdf 200913.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 201573 (label 201573.pdf) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (ENDO OPERATIONS) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 200920 (pdf 200920.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015 , NDA 200264 (pdf 200264.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (IMPAX LABS INC) APPROVAL= AP YEAR= 2016 , NDA 208705 (pdf 208705.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (ALEMBIC) APPROVAL= AP YEAR= 2017 , NDA 210469 (pdf 210469.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (TWI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 211626 (pdf 211626.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (GRAVITI PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212598 (pdf 212598.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 213450 (pdf 213450.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (MICRO LABS) APPROVAL= AP YEAR= 2020 , NDA 212562 (pdf 212562.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (YICHANG HUMANWELL) APPROVAL= AP YEAR= 2020 , NDA 207796 (pdf 207796.pdf not found) INN (CHOLINE FENOFIBRATE) FENOFIBRIC ACID (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 , 1487 ; PALIPERIDONE PALMITATE ; 199739-10-1 ; 2009 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- BENZISOXAZOLE DERIVATIVES -- DOPAMINE D2 RECEPTOR ANTAGONIST -- SEROTONIN TYPE 2 (5HT2A) RECEPTOR ANTAGONIST , ; NDA 022264 (label 22264.pdf) INN (PALIPERIDONE PALMITATE) INVEGA SUSTENNA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 207946 (label 207946.pdf) INN (PALIPERIDONE PALMITATE) INVEGA TRINZA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 211149 (pdf 211149.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 211995 (pdf 211995.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (TOLMAR) APPROVAL= TA YEAR= 2023 , NDA 210397 (pdf 210397.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (PHARMASCIENCE INC) APPROVAL= TA YEAR= 2024 , NDA 216228 (pdf 216228.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2024 , 1488 ; PALIPERIDONE PALMITATE ; 199739-10-1 ; 2009 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- BENZISOXAZOLE DERIVATIVES -- DOPAMINE D2 RECEPTOR ANTAGONIST -- SEROTONIN TYPE 2 (5HT2A) RECEPTOR ANTAGONIST , ; NDA 022264 (label 22264.pdf) INN (PALIPERIDONE PALMITATE) INVEGA SUSTENNA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2009 , NDA 207946 (label 207946.pdf) INN (PALIPERIDONE PALMITATE) INVEGA TRINZA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2015 , NDA 211149 (pdf 211149.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 , NDA 211995 (pdf 211995.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (TOLMAR) APPROVAL= TA YEAR= 2023 , NDA 210397 (pdf 210397.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (PHARMASCIENCE INC) APPROVAL= TA YEAR= 2024 , NDA 216228 (pdf 216228.pdf not found) INN (PALIPERIDONE PALMITATE) PALIPERIDONE PALMITATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2024 , 1489 ; ABIRATERONE ; 154229-19-3 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- METASTATIC CASTRATION-RESISTANT PROSTATE CANCER -- -- INHIBITOR OF CYP17 , ; 1490 ; CAPSAICIN ; 404-86-4 ; 2009 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- JOINT AND MUSCULAR PAIN -- TRPV1 CHANNEL AGONIST -- NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA (PHN) -- SYNTHETIC EQUIVALENT OF THE NATURALLY OCCURRING COMPOUND FOUND IN CHILI PEPPERS , ; NDA 022395 (label 22395.pdf) INN (CAPSAICIN) QUTENZA (AVERITAS) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , 1491 ; TENOFOVIR ; 147127-20-6 ; 0 ; ; ; CLASS ANTIINFECTIVE -- ANTIVIRAL -- ANTIRETROVIRAL -- NUCLEOTIDE ANALOG HIV-1 REVERSE TRANSCRIPTASE INHIBITOR AND -- HBV REVERSE TRANSCRIPTASE INHIBITOR -- CHRONIC HEPATITIS B IN ADULTS , ; 1492 ; TOLVAPTAN ; 150683-30-0 ; 2009 ; ; ; CLASS CARDIOVASCULAR -- DIURETIC -- VASOPRESSIN V2-RECEPTOR ANTAGONIST -- HYPERVOLEMIC AND EUVOLEMIC HYPONATREMIA , ; NDA 022275 (label 22275.pdf) INN (TOLVAPTAN) SAMSCA (OTSUKA) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 204441 (label 204441.pdf) INN (TOLVAPTAN) JYNARQUE (OTSUKA) APPROVAL= AP YEAR= 2018 NEWAPPLICATION , NDA 207605 (pdf 207605.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 211891 (pdf 211891.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 205646 (pdf 205646.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2021 , NDA 206119 (pdf 206119.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2022 , NDA 216949 (pdf 216949.pdf not found) INN (TOLVAPTAN) TOLVAPTAN (MSN) APPROVAL= AP YEAR= 2023 , 1493 ; PRASUGREL ; 150322-43-3 ; 2009 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; NDA 022307 (label 22307.pdf) INN (PRASUGREL HYDROCHLORIDE) EFFIENT (COSETTE) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 205888 (pdf 205888.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 205927 (label 205927.pdf) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (MYLAN) APPROVAL= AP YEAR= 2017 , NDA 205897 (pdf 205897.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (PANACEA) APPROVAL= AP YEAR= 2017 , NDA 205790 (pdf 205790.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (CHARTWELL RX) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 205987 (pdf 205987.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2018 , NDA 205913 (pdf 205913.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 206021 (pdf 206021.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (HEC PHARM) APPROVAL= AP YEAR= 2019 , NDA 205926 (pdf 205926.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (DR REDDYS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 205930 (pdf 205930.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213315 (pdf 213315.pdf not found) INN (PRASUGREL HYDROCHLORIDE) PRASUGREL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2023 , 1494 ; VIGABATRIN ; 68506-86-5 ; 2009 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTICS -- ANTICONVULSANTS -- REFRACTORY COMPLEX PARTIAL SEIZURES IN ADULTS -- IRREVERSIBLE INHIBITOR OF GAMMA-AMINOBUTYRIC ACID TRANSAMINASE (GABA-T) , ; NDA 020427 (label 20427.pdf) INN (VIGABATRIN) SABRIL (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 022006 (label 22006.pdf) INN (VIGABATRIN) SABRIL (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2009 , NDA 208218 (pdf 208218.pdf not found) INN (VIGABATRIN) VIGABATRIN (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209824 (pdf 209824.pdf not found) INN (VIGABATRIN) VIGABATRIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 210155 (pdf 210155.pdf not found) INN (VIGABATRIN) VIGABATRIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210196 (pdf 210196.pdf not found) INN (VIGABATRIN) VIGADRONE (AUCTA) APPROVAL= AP YEAR= 2018 , NDA 211481 (pdf 211481.pdf not found) INN (VIGABATRIN) VIGABATRIN (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 209822 (pdf 209822.pdf not found) INN (VIGABATRIN) VIGABATRIN (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 211592 (pdf 211592.pdf not found) INN (VIGABATRIN) VIGABATRIN (INVAGEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 213469 (pdf 213469.pdf not found) INN (VIGABATRIN) VIGABATRIN (GRANULES) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213375 (pdf 213375.pdf not found) INN (VIGABATRIN) VIGABATRIN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 214425 (pdf 214425.pdf not found) INN (VIGABATRIN) VIGABATRIN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211539 (pdf 211539.pdf not found) INN (VIGABATRIN) VIGABATRIN (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 213519 (pdf 213519.pdf not found) INN (VIGABATRIN) VIGABATRIN (ANNORA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214992 (pdf 214992.pdf not found) INN (VIGABATRIN) VIGABATRIN (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 212626 (pdf 212626.pdf not found) INN (VIGABATRIN) VIGABATRIN (SPECGX LLC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213390 (pdf 213390.pdf not found) INN (VIGABATRIN) VIGABATRIN (PROPEL PHARMA) APPROVAL= AP YEAR= 2021 , NDA 213899 (pdf 213899.pdf not found) INN (VIGABATRIN) VIGABATRIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 215109 (pdf 215109.pdf not found) INN (VIGABATRIN) VIGABATRIN (DEXCEL) APPROVAL= AP YEAR= 2021 , NDA 210042 (pdf 210042.pdf not found) INN (VIGABATRIN) VIGABATRIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2022 , NDA 211790 (pdf 211790.pdf not found) INN (VIGABATRIN) VIGABATRIN (CHARTWELL RX) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214961 (pdf 214961.pdf not found) INN (VIGABATRIN) VIGPODER (PYROS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215601 (pdf 215601.pdf not found) INN (VIGABATRIN) VIGABATRIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 215707 (pdf 215707.pdf not found) INN (VIGABATRIN) VIGABATRIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 213104 (pdf 213104.pdf not found) INN (VIGABATRIN) VIGABATRIN (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 215363 (pdf 215363.pdf not found) INN (VIGABATRIN) VIGABATRIN (MSN) APPROVAL= AP YEAR= 2022 , NDA 214671 (pdf 214671.pdf not found) INN (VIGABATRIN) VIGABATRIN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215519 (pdf 215519.pdf not found) INN (VIGABATRIN) VIGABATRIN (PROPEL PHARMA) APPROVAL= AP YEAR= 2023 , NDA 214749 (pdf 214749.pdf not found) INN (VIGABATRIN) VIGABATRIN (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2023 , NDA 217684 (pdf 217684.pdf not found) INN (VIGABATRIN) VIGAFYDE (PYROS PHARMS) APPROVAL= AP YEAR= 2024 , 1495 ; PRALATREXATE ; 146464-95-1 ; 2009 ; ; ; CLASS ANTINEOPLASTIC -- FOLIC ACID ANALOGUES -- FOLATE ANALOG METABOLIC INHIBITOR -- LYMPHOMA , ; NDA 022468 (label 22468.pdf) INN (PRALATREXATE) FOLOTYN (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY , NDA 206167 (pdf 206167.pdf not found) INN (PRALATREXATE) PRALATREXATE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2016 , 1496 ; ALCAFTADINE ; 147084-10-4 ; 2010 ; ; ; CLASS RESPIRATORY -- ALLERGIC CONJUNCTIVITIS -- H1 HISTAMINE RECEPTOR ANTAGONIST , ; NDA 022134 (label 22134.pdf) INN (ALCAFTADINE) LASTACAFT (ABBVIE) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 210659 (pdf 210659.pdf not found) INN (ALCAFTADINE) ALCAFTADINE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 209706 (pdf 209706.pdf not found) INN (ALCAFTADINE) ALCAFTADINE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1497 ; DIENOGEST ; 65928-58-7 ; 2010 ; ; ; CLASS GENITO -- CONTRACEPTIVE , ; NDA 022252 (label 22252.pdf) INN (DIENOGEST ESTRADIOL VALERATE) NATAZIA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 202349 (pdf 202349.pdf not found) INN (DIENOGEST ESTRADIOL VALERATE) ESTRADIOL VALERATE AND DIENOGEST (WATSON LABS INC) APPROVAL= TA YEAR= 2017 , NDA 202999 (pdf 202999.pdf not found) INN (ESTRADIOL VALERATE ESTRADIOL VALERATE DIENOGEST) ESTRADIOL VALERATE ESTRADIOL VALERATE DIENOGEST (TEVA PHARMS USA) APPROVAL= TA YEAR= 2016 , 1498 ; ULIPRISTAL ACETATE ; 126784-99-4 ; 2010 ; ; ; CLASS GENITO -- PROGESTERONE PARTIAL AGONIST AND ANTAGONIST EMERGENCY CONTRACEPTIVE , ; NDA 022474 (label 22474.pdf) INN (ULIPRISTAL ACETATE) ELLA (LAB HRA PHARMA) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 207952 (pdf 207952.pdf not found) INN (ULIPRISTAL ACETATE) LOGILIA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017 , 1499 ; DABIGATRAN ETEXILATE ; 211915-06-9 ; 2010 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- THROMBINE INHIBITOR -- TO REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION , ; NDA 022512 (label 22512.pdf) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 207984 (pdf 207984.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2020 , NDA 208057 (pdf 208057.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2017 , NDA 207961 (pdf 207961.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 208040 (pdf 208040.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 208046 (pdf 208046.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2022 , NDA 208048 (pdf 208048.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2020 , NDA 214358 (label 214358.pdf) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2021 , NDA 207922 (pdf 207922.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (BRECKENRIDGE PHARMS) APPROVAL= TA YEAR= 2022 , NDA 208067 (pdf 208067.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2022 , NDA 213879 (pdf 213879.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MSN) APPROVAL= AP YEAR= 2024 , NDA 215233 (pdf 215233.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC) APPROVAL= AP YEAR= 2024 , NDA 208070 (pdf 208070.pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (APOTEX) APPROVAL= AP YEAR= 2023 , 1500 ; FINGOLIMOD ; 162359-55-9 ; 2010 ; ; ; CLASS IMMUNOMODULATING -- IMMUNOSUPPRESSANT -- MULTIPLE SCLEROSIS -- FINGOLIMOD IS METABOLIZED BY SPHINGOSINE KINASE TO THE ACTIVE METABOLITE FINGOLIMOD-PHOSPHATE -- FINGOLIMOD-PHOSPHATE INVOLVES REDUCTION OF LYMPHOCYTE MIGRATION INTO THE CENTRAL NERVOUS SYSTEM -- S1P1 MODULATOR (RECEPTOR DEGRADATION VERSUS RECYCLING TO CELL SURFACE) , ; NDA 022527 (label 22527.pdf) INN (FINGOLIMOD HYDROCHLORIDE) GILENYA (NOVARTIS) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 207983 (pdf 207983.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 208559 (pdf 208559.pdf not found) INN (FINGOLIMOD) FINGOLIMOD (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 207965 (pdf 207965.pdf not found) INN (FINGOLIMOD) FINGOLIMOD (PAR PHARM INC) APPROVAL= TA YEAR= 2017 , NDA 207971 (pdf 207971.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 207979 (pdf 207979.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (BIOCON LTD) APPROVAL= AP YEAR= 2019 , NDA 207985 (pdf 207985.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 207991 (pdf 207991.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 208004 (label 208004.pdf) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 208008 (pdf 208008.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 207939 (pdf 207939.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (HEC PHARM CO LTD) APPROVAL= AP YEAR= 2021 , NDA 208014 (pdf 208014.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 207933 (pdf 207933.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2020 , NDA 207993 (pdf 207993.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2020 , NDA 207994 (pdf 207994.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 , NDA 207940 (pdf 207940.pdf not found) INN (FINGOLIMOD) FINGOLIMOD (STANDARD CHEM AND PHARM CO LTD) APPROVAL= TA YEAR= 2021 , NDA 208000 (pdf 208000.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 208005 (pdf 208005.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2021 , NDA 212152 (pdf 212152.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 214962 (label 214962.pdf) INN (FINGOLIMOD LAURYL SULFATE) TASCENSO ODT (CYCLE) APPROVAL= AP YEAR= 2021 , NDA 208003 (pdf 208003.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 210252 (pdf 210252.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (BIONPHARMA) APPROVAL= AP YEAR= 2023 , NDA 207945 (pdf 207945.pdf not found) INN (FINGOLIMOD HYDROCHLORIDE) FINGOLIMOD HYDROCHLORIDE (EZRA VENTURES) APPROVAL= AP YEAR= 2023 , 1501 ; LEVOMEFOLATE ; 151533-22-1 ; 2010 ; ; ; CLASS GENITO -- PREMENSTRUAL DYSPHORIC DISORDER (PMDD) -- ACNE -- FOLATE SUPPLEMENTATION -- RAISE FOLATE LEVELS FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY -- SUPPLEMENT , ; NDA 022532 (label 22532.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) BEYAZ (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 022574 (label 22574.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) SAFYRAL (BAYER HLTHCARE) APPROVAL= AP YEAR= 2010 , NDA 203593 (label 203593.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 203594 (label 203594.pdf) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (WATSON LABS INC) APPROVAL= AP YEAR= 2016 , NDA 205948 (pdf 205948.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) TYDEMY (LUPIN LTD) APPROVAL= AP YEAR= 2017 , NDA 205947 (pdf 205947.pdf not found) INN (DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM) DROSPIRENONE , ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (LUPIN LTD) APPROVAL= AP YEAR= 2018 , 1502 ; CEFTAROLINE ; 402741-13-3 ; 2010 ; ; ; CLASS ANTIINFECTIVE -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 200327 (label 200327.pdf) INN (CEFTAROLINE FOSAMIL) TEFLARO (ABBVIE) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 208075 (pdf 208075.pdf not found) INN (CEFTAROLINE FOSAMIL) CEFTAROLINE FOSAMIL (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED , 1503 ; LURASIDONE ; 367514-87-2 ; 2010 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- CLASS OF BENZISOTHIAZOL DERIVATIVES -- ANTAGONIST , ; NDA 200603 (label 200603.pdf) INN (LURASIDONE HYDROCHLORIDE) LATUDA (SUNOVION PHARMS INC) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 208002 (pdf 208002.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 , NDA 208031 (pdf 208031.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2019 , NDA 208037 (pdf 208037.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 208058 (pdf 208058.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2019 , NDA 208066 (pdf 208066.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2019 , NDA 208016 (pdf 208016.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 208028 (pdf 208028.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2019 , NDA 208045 (pdf 208045.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 208049 (pdf 208049.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 208055 (pdf 208055.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2019 , NDA 207948 (pdf 207948.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (PAR PHARM INC) APPROVAL= TA YEAR= 2017 , NDA 208052 (pdf 208052.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019 , NDA 208060 (pdf 208060.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212244 (pdf 212244.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2022 , NDA 212091 (pdf 212091.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2020 , NDA 213248 (pdf 213248.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 208047 (pdf 208047.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 212124 (pdf 212124.pdf not found) INN (LURASIDONE HYDROCHLORIDE) LURASIDONE HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2023 , 1504 ; CABAZITAXEL ; 183133-96-2 ; 2010 ; ; ; CLASS ANTINEOPLASTIC -- MICROTUBULE INHIBITOR -- HORMONE-REFRACTORY METASTATIC PROSTATE CANCER -- TAXANE CLASS -- INHIBITION OF MITOTIC AND INTERPHASE CELLULAR FUNCTION , ; NDA 201023 (label 201023.pdf) INN (CABAZITAXEL) JEVTANA KIT (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 207949 (pdf 207949.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 207970 (label 207970.pdf) INN (CABAZITAXEL) CABAZITAXEL (ACTAVIS) APPROVAL= AP YEAR= 2024 , NDA 207693 (pdf 207693.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 207736 (pdf 207736.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 208715 (label 208715.pdf) INN (CABAZITAXEL) CABAZITAXEL (SANDOZ) APPROVAL= TA YEAR= 2023 , NDA 207937 (pdf 207937.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (FRESENIUS KABI USA) APPROVAL= TA YEAR= 2019 , NDA 207619 (pdf 207619.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (BRECKENRIDGE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 207718 (pdf 207718.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (DR REDDYS) APPROVAL= AP YEAR= 2023 , NDA 207735 (pdf 207735.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (BPI LABS LLC) APPROVAL= TA YEAR= 2023 , NDA 207381 (pdf 207381.pdf not found) INN (CABAZITAXEL) CABAZITAXEL (MYLAN LABS LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1505 ; ERIBULIN ; 253128-41-5 ; 2010 ; ; ; CLASS ANTINEOPLASTIC AGENT -- MICROTUBULE INHIBITOR -- ANTICANCER -- MITOTIC INHIBITOR -- METASTATIC BREAST CANCER -- SYNTHETIC ANALOGUE OF HALICHONDRIN B (A PRODUCT ISOLATED FROM THE MARINE SPONGE HALICHONDRIA OKADAI) , ; NDA 201532 (label 201532.pdf) INN (ERIBULIN MESYLATE) HALAVEN (EISAI INC) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , NDA 218047 (pdf 218047.pdf not found) INN (ERIBULIN MESYLATE) ERIBULIN MESYLATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1506 ; EZOGABINE ; 150812-12-7 ; 2011 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- PARTIAL-ONSET SEIZURES -- POTASSIUM CHANNEL OPENER (KCNQ FAMILY OF ION CHANNELS) -- KV7.2 TO 7.5 AGONIST , ; NDA 022345 (label 22345.pdf) INN (EZOGABINE) POTIGA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY DISCONTINUED , 1507 ; GABAPENTIN ENACARBIL ; 478296-72-9 ; 2011 ; ; ; CLASS NERVOUS SYSTEM -- MODERATE-TO-SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS) IN ADULTS -- ANTIEPILEPTIC -- POSTHERPETIC NEURALGIA (PHN) -- GABAB AGONIST , ; NDA 022399 (label 22399.pdf) INN (GABAPENTIN ENACARBIL) HORIZANT (AZURITY) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 213501 (pdf 213501.pdf not found) INN (GABAPENTIN ENACARBIL) GABAPENTIN ENCARBIL (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2020 , 1508 ; GABAPENTIN ENACARBIL ; 478296-72-9 ; 2011 ; ; ; CLASS NERVOUS SYSTEM -- MODERATE-TO-SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS) IN ADULTS -- ANTIEPILEPTIC -- POSTHERPETIC NEURALGIA (PHN) -- GABAB AGONIST , ; NDA 022399 (label 22399.pdf) INN (GABAPENTIN ENACARBIL) HORIZANT (AZURITY) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 213501 (pdf 213501.pdf not found) INN (GABAPENTIN ENACARBIL) GABAPENTIN ENCARBIL (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2020 , 1509 ; VANDETANIB ; 443913-73-3 ; 2011 ; ; ; CLASS ANTINEOPLASTIC -- PROTEIN KINASE INHIBITORS -- TYROSINE KINASE -- MEDULLARY THYROID CANCER , ; NDA 022405 (label 22405.pdf) INN (VANDETANIB) CAPRELSA (GENZYME CORP) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , 1510 ; ROFLUMILAST ; 162401-32-3 ; 2011 ; ; ; CLASS RESPIRATORY -- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) -- PHOSPHODIESTERASE PDE4 INHIBITORS -- ROFLUMILAST IS THREE TIMES MORE POTENT THAN ROFLUMILAST N-OXIDE AT INHIBITION OF THE PDE4 ENZYME IN VITRO THE PLASMA AUC OF ROFLUMILAST N-OXIDE ON AVERAGE IS ABOUT 10-FOLD GREATER THAN THE PLASMA AUC OF ROFLUMILAST , ; NDA 022522 (label 22522.pdf) INN (ROFLUMILAST) DALIRESP (ASTRAZENECA) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 208247 (pdf 208247.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 208257 (pdf 208257.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 208256 (pdf 208256.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (MSN) APPROVAL= AP YEAR= 2022 , NDA 208213 (pdf 208213.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 208236 (pdf 208236.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 , NDA 208272 (pdf 208272.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (TORRENT) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208180 (pdf 208180.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 212490 (pdf 212490.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 208299 (pdf 208299.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (PRINSTON INC) APPROVAL= AP YEAR= 2022 , NDA 208303 (pdf 208303.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215985 (label 215985.pdf) INN (ROFLUMILAST) ZORYVE (ARCUTIS) APPROVAL= AP YEAR= 2022 , NDA 213298 (pdf 213298.pdf not found) INN (ROFLUMILAST) ROFLUMILAST (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 , NDA 217242 (pdf 217242.pdf not found) INN (ROFLUMILAST) ZORYVE (ARCUTIS) APPROVAL= AP YEAR= 2023 , 1511 ; VILAZODONE ; 163521-12-8 ; 2011 ; ; ; CLASS NERVOUS SYSTEM -- MAJOR DEPRESSIVE DISORDER (MDD) -- SEROTONIN REUPTAKE INHIBITOR -- 5-HT1A PARTIAL AGONIST -- AFFINITY FOR SEROTONIN REUPTAKE SITE (KI= 0.1 NM) -- PARTIAL AGONIST OF SEROTONERGIC 5-HT1A RECEPTORS (IC50=2.1 NM) , ; NDA 022567 (label 22567.pdf) INN (VILAZODONE HYDROCHLORIDE) VIIBRYD (ABBVIE) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 208212 (pdf 208212.pdf not found) INN (VILAZODONE HYDROCHLORIDE) VILAZODONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 208202 (pdf 208202.pdf not found) INN (VILAZODONE HYDROCHLORIDE) VILAZODONE HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 208200 (pdf 208200.pdf not found) INN (VILAZODONE HYDROCHLORIDE) VILAZODONE HYDROCHLORIDE (INVAGEN PHARMS) APPROVAL= AP YEAR= 2021 , NDA 208209 (pdf 208209.pdf not found) INN (VILAZODONE HYDROCHLORIDE) VILAZODONE HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 208228 (pdf 208228.pdf not found) INN (VILAZODONE HYDROCHLORIDE) VILAZODONE HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2023 , 1512 ; AZILSARTAN KAMEDOXOMIL ; 863031-21-4 ; 2011 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II RECEPTOR BLOCKER -- SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR ANTAGONIST , ; NDA 200796 (label 200796.pdf) INN (AZILSARTAN KAMEDOXOMIL) EDARBI (AZURITY) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 202331 (label 202331.pdf) INN (AZILSARTAN KAMEDOXOMIL CHLORTHALIDONE) EDARBYCLOR (AZURITY) APPROVAL= AP YEAR= 2011 , NDA 214489 (pdf 214489.pdf not found) INN (AZILSARTAN KAMEDOXOMIL) AZILSARTAN MEDOXOMIL (LUPIN LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1513 ; LINAGLIPTIN ; 668270-12-0 ; 2011 ; ; ; CLASS METABOLISM -- BLOOD GLUCOSE LOWERING -- DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITOR -- TYPE 2 DIABETES MELLITUS , ; NDA 201280 (label 201280.pdf) INN (LINAGLIPTIN) TRADJENTA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 201281 (label 201281.pdf) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) JENTADUETO (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2012 , NDA 206073 (label 206073.pdf) INN (EMPAGLIFLOZIN LINAGLIPTIN) GLYXAMBI (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , NDA 208026 (label 208026.pdf) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) JENTADUETO XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2016 , NDA 208415 (pdf 208415.pdf not found) INN (LINAGLIPTIN) LINAGLIPTIN (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2017 , NDA 208430 (pdf 208430.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN METFORMIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2018 , NDA 208448 (pdf 208448.pdf not found) INN (LINAGLIPTIN) LINAGLIPTIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 208449 (pdf 208449.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2020 , NDA 208454 (pdf 208454.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2020 , NDA 212359 (pdf 212359.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN AND LINAGLIPTIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 212614 (label 212614.pdf) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) TRIJARDY XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2020 , NDA 212354 (pdf 212354.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (KINAPSE LIMITED) APPROVAL= TA YEAR= 2020 , NDA 208427 (pdf 208427.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 208428 (pdf 208428.pdf not found) INN (LINAGLIPTIN) LINAGLIPTIN (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 212364 (pdf 212364.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (ANNORA PHARMA) APPROVAL= TA YEAR= 2021 , NDA 208335 (pdf 208335.pdf not found) INN (LINAGLIPTIN) LINAGLIPTIN (SUNSHINE) APPROVAL= AP YEAR= 2021 , NDA 208336 (pdf 208336.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUNSHINE) APPROVAL= AP YEAR= 2021 , NDA 208473 (pdf 208473.pdf not found) INN (LINAGLIPTIN METFORMIN HYDROCHLORIDE) LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , NDA 212264 (pdf 212264.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN AND LINAGLIPTIN (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , NDA 212366 (pdf 212366.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (ALKEM LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 217049 (pdf 217049.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2024 , 1514 ; FIDAXOMICIN ; 873857-62-6 ; 2011 ; ; ; CLASS ANTIINFECTIVES -- MACROLIDE -- TREATMENT OF CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA -- INHIBITOR RNA SYNTHESIS BY RNA POLYMERASES , ; NDA 201699 (label 201699.pdf) INN (FIDAXOMICIN) DIFICID (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 213138 (label 213138.pdf) INN (FIDAXOMICIN) DIFICID (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2020 , NDA 208443 (pdf 208443.pdf not found) INN (FIDAXOMICIN) FIDAXOMICIN (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2024 , 1515 ; TELAPREVIR ; 402957-28-2 ; 2011 ; DISCONTINUED ; ; CLASS HEPATITIS C VIRUS (HCV) NS3/4A PROTEASE INHIBITOR -- GENOTYPE 1 CHRONIC HEPATITIS C (CHC) , ; NDA 201917 (label 201917.pdf) INN (TELAPREVIR) INCIVEK (VERTEX PHARMS) APPROVAL= AP YEAR= 2011 DISCONTINUED , 1516 ; RILPIVIRINE ; 500287-72-9 ; 2011 ; ; ; CLASS ANTIINFECTIVES -- NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) OF HIV-1 , ; NDA 202022 (label 202022.pdf) INN (RILPIVIRINE HYDROCHLORIDE) EDURANT (JANSSEN PRODS) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 202123 (label 202123.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR DISOPROXIL FUMARATE) COMPLERA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2011 , NDA 205302 (pdf 205302.pdf not found) INN (RILPIVIRINE) RILPIVIRINE (STRIDES ARCOLAB LTD) APPROVAL= TA YEAR= 2015 , NDA 208351 (label 208351.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR ALAFENAMIDE FUMARATE) ODEFSEY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 208452 (pdf 208452.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINERILPIVIRINETENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 210192 (label 210192.pdf) INN (DOLUTEGRAVIR SODIUM RILPIVIRINE HYDROCHLORIDE) JULUCA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 212888 (label 212888.pdf) INN (CABOTEGRAVIR RILPIVIRINE) CABENUVA KIT (VIIV HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 214058 (pdf 214058.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE (CIPLA LIMITED) APPROVAL= TA YEAR= 2022 , NDA 213120 (pdf 213120.pdf not found) INN (DOLUTEGRAVIR RILPIVIRINE) DOLUTEGRAVIR RILPIVIRINE (LUPIN LTD) APPROVAL= TA YEAR= 2023 , NDA 219016 (pdf 219016.pdf not found) INN (RILPIVIRINE HYDROCHLORIDE) EDURANT PED (JANSSEN PRODS) APPROVAL= AP YEAR= 2024 , 1517 ; BOCEPREVIR ; 394730-60-0 ; 2011 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS3/4A PROTEASE INHIBITOR -- COVALENTLY, YET REVERSIBLY, BINDS TO THE NS3 PROTEASE ACTIVE SITE SERINE (S139) , ; NDA 202258 (label 202258.pdf) INN (BOCEPREVIR) VICTRELIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2011 DISCONTINUED , 1518 ; BOCEPREVIR ; 394730-60-0 ; 2011 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS3/4A PROTEASE INHIBITOR -- COVALENTLY, YET REVERSIBLY, BINDS TO THE NS3 PROTEASE ACTIVE SITE SERINE (S139) , ; NDA 202258 (label 202258.pdf) INN (BOCEPREVIR) VICTRELIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2011 DISCONTINUED , 1519 ; ABIRATERONE ACETATE ; 154229-18-2 ; 2011 ; ; ; CLASS ANTINEOPLASTIC -- METASTATIC CASTRATION-RESISTANT PROSTATE CANCER -- -- INHIBITOR OF CYP17 , ; NDA 202379 (label 202379.pdf) INN (ABIRATERONE ACETATE) ZYTIGA (JANSSEN BIOTECH) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 210308 (label 210308.pdf) INN (ABIRATERONE ACETATE) YONSA (SUN PHARM) APPROVAL= AP YEAR= 2018 , NDA 208339 (pdf 208339.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (HIKMA) APPROVAL= AP YEAR= 2018 , NDA 208432 (pdf 208432.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 208446 (pdf 208446.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (MYLAN) APPROVAL= AP YEAR= 2018 , NDA 208453 (pdf 208453.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (APOTEX) APPROVAL= AP YEAR= 2018 , NDA 208327 (pdf 208327.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2019 , NDA 208371 (pdf 208371.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (RISING) APPROVAL= AP YEAR= 2019 , NDA 208380 (pdf 208380.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2019 , NDA 209227 (pdf 209227.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 , NDA 210686 (pdf 210686.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (MSN) APPROVAL= AP YEAR= 2019 , NDA 212462 (pdf 212462.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (QILU) APPROVAL= AP YEAR= 2019 , NDA 208416 (pdf 208416.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 212206 (pdf 212206.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 215947 (pdf 215947.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (NOVUGEN) APPROVAL= AP YEAR= 2022 , NDA 210726 (pdf 210726.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2023 , NDA 215086 (pdf 215086.pdf not found) INN (ABIRATERONE ACETATE) ABIRATERONE ACETATE (FLORIDA) APPROVAL= AP YEAR= 2023 , NDA 216793 (pdf 216793.pdf not found) INN (ABIRATERONE ACETATE NIRAPARIB TOSYLATE) AKEEGA (JANSSEN BIOTECH) APPROVAL= AP YEAR= 2023 , 1520 ; DEFERIPRONE ; 30652-11-0 ; 2011 ; ; ; CLASS VARIOUS -- IRON CHELATOR -- CHELATING AGENT -- THALASSEMIA , ; NDA 021825 (label 21825.pdf) INN (DEFERIPRONE) FERRIPROX (CHIESI) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 208030 (label 208030.pdf) INN (DEFERIPRONE) FERRIPROX (CHIESI) APPROVAL= AP YEAR= 2015 , NDA 208800 (pdf 208800.pdf not found) INN (DEFERIPRONE) DEFERIPRONE (TARO) APPROVAL= AP YEAR= 2019 , NDA 212269 (label 212269.pdf) INN (DEFERIPRONE) FERRIPROX (CHIESI) APPROVAL= AP YEAR= 2020 , NDA 213239 (pdf 213239.pdf not found) INN (DEFERIPRONE) DEFERIPRONE (HIKMA) APPROVAL= AP YEAR= 2021 , 1521 ; ICATIBANT ; 130308-48-4 ; 2011 ; ; ; CLASS BLOOD -- PEPTIDE -- INFLAMMATION -- PAIN -- HEREDITARY ANGIOEDEMA -- BRADYKININ B2 RECEPTOR ANTAGONIST , ; NDA 022150 (label 22150.pdf) INN (ICATIBANT ACETATE) FIRAZYR (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 210118 (pdf 210118.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2019 , NDA 208317 (pdf 208317.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 211021 (pdf 211021.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (JIANGSU HANSOH PHARM) APPROVAL= AP YEAR= 2020 , NDA 212446 (pdf 212446.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 211501 (pdf 211501.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212081 (pdf 212081.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (NANG KUANG PHARM CO) APPROVAL= AP YEAR= 2020 , NDA 213054 (pdf 213054.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (DR REDDYS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213222 (pdf 213222.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213521 (pdf 213521.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , NDA 213773 (pdf 213773.pdf not found) INN (ICATIBANT ACETATE) ICATIBANT ACETATE (ALEMBIC) APPROVAL= AP YEAR= 2024 , 1522 ; INDACATEROL ; 312753-06-3 ; 2011 ; DISCONTINUED ; ; CLASS RESPIRATORY -- BRONCHODILATOR -- SELECTIVE BETA2 ADRENERGIC AGONIST -- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) , ; NDA 022383 (label 22383.pdf) INN (INDACATEROL MALEATE) ARCAPTA NEOHALER (NOVARTIS) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY DISCONTINUED , NDA 207930 (label 207930.pdf) INN (GLYCOPYRROLATE INDACATEROL MALEATE) UTIBRON (NOVARTIS) APPROVAL= AP YEAR= 2015 DISCONTINUED , 1523 ; RIVAROXABAN ; 366789-02-8 ; 2011 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- FACTOR XA INHIBITOR , ; NDA 022406 (label 22406.pdf) INN (RIVAROXABAN) XARELTO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 202439 (label 202439.pdf) INN (RIVAROXABAN) XARELTO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2011 NEWAPPLICATION , NDA 208549 (pdf 208549.pdf not found) INN (RIVAROXABAN) RIVAROXABAN (PRINSTON INC) APPROVAL= TA YEAR= 2019 , NDA 215859 (label 215859.pdf) INN (RIVAROXABAN) XARELTO (JANSSEN PHARMS) APPROVAL= AP YEAR= 2021 , NDA 212220 (pdf 212220.pdf not found) INN (RIVAROXABAN) RIVAROXABAN (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2022 , NDA 208557 (pdf 208557.pdf not found) INN (RIVAROXABAN) RIVAROXABAN (TARO PHARM INDS LTD) APPROVAL= TA YEAR= 2023 , NDA 210301 (pdf 210301.pdf not found) INN (RIVAROXABAN) RIVAROXABAN (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 208555 (pdf 208555.pdf not found) INN (RIVAROXABAN) RIVAROXABAN (LUPIN LTD) APPROVAL= TA YEAR= 2024 , 1524 ; TICAGRELOR ; 274693-27-5 ; 2011 ; ; ; CLASS BLOOD -- P2Y12 PLATELET INHIBITOR -- ANTITHROMBOTIC AGENTS , ; NDA 022433 (label 22433.pdf) INN (TICAGRELOR) BRILINTA (ASTRAZENECA) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 208390 (pdf 208390.pdf not found) INN (TICAGRELOR) TICAGRELOR (WATSON LABS INC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208567 (pdf 208567.pdf not found) INN (TICAGRELOR) TICAGRELOR (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 208599 (pdf 208599.pdf not found) INN (TICAGRELOR) TICAGRELOR (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2023 , NDA 208531 (pdf 208531.pdf not found) INN (TICAGRELOR) TICAGRELOR (AMNEAL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 208575 (pdf 208575.pdf not found) INN (TICAGRELOR) TICAGRELOR (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2019 , NDA 208508 (pdf 208508.pdf not found) INN (TICAGRELOR) TICAGRELOR (SUNSHINE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208596 (pdf 208596.pdf not found) INN (TICAGRELOR) TICAGRELOR (SIGMAPHARM LABS LLC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 208541 (pdf 208541.pdf not found) INN (TICAGRELOR) TICAGRELOR (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2020 , NDA 208597 (pdf 208597.pdf not found) INN (TICAGRELOR) TICAGRELOR (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , 1525 ; CLOBAZAM ; 22316-47-8 ; 2011 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTICS -- ANTIEPILEPTIC -- BENZODIAZEPINE DERIVATIVES -- SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME -- GABAA AGONIST , ; NDA 202067 (label 202067.pdf) INN (CLOBAZAM) ONFI (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 203993 (label 203993.pdf) INN (CLOBAZAM) ONFI (LUNDBECK PHARMS LLC) APPROVAL= AP YEAR= 2012 , NDA 208785 (pdf 208785.pdf not found) INN (CLOBAZAM) CLOBAZAM (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 208819 (pdf 208819.pdf not found) INN (CLOBAZAM) CLOBAZAM (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 208825 (pdf 208825.pdf not found) INN (CLOBAZAM) CLOBAZAM (BIONPHARMA) APPROVAL= AP YEAR= 2018 , NDA 209308 (pdf 209308.pdf not found) INN (CLOBAZAM) CLOBAZAM (BRECKENRIDGE) APPROVAL= AP YEAR= 2018 , NDA 209440 (pdf 209440.pdf not found) INN (CLOBAZAM) CLOBAZAM (TARO) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209687 (pdf 209687.pdf not found) INN (CLOBAZAM) CLOBAZAM (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 , NDA 209715 (pdf 209715.pdf not found) INN (CLOBAZAM) CLOBAZAM (HIKMA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209718 (pdf 209718.pdf not found) INN (CLOBAZAM) CLOBAZAM (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 , NDA 209795 (pdf 209795.pdf not found) INN (CLOBAZAM) CLOBAZAM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018 , NDA 209808 (pdf 209808.pdf not found) INN (CLOBAZAM) CLOBAZAM (PIRAMAL HLTHCARE UK) APPROVAL= AP YEAR= 2018 , NDA 210039 (pdf 210039.pdf not found) INN (CLOBAZAM) CLOBAZAM (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210545 (pdf 210545.pdf not found) INN (CLOBAZAM) CLOBAZAM (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 210546 (pdf 210546.pdf not found) INN (CLOBAZAM) CLOBAZAM (LUPIN LTD) APPROVAL= AP YEAR= 2018 , NDA 210569 (pdf 210569.pdf not found) INN (CLOBAZAM) CLOBAZAM (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210833 (label 210833.pdf) INN (CLOBAZAM) SYMPAZAN (OTTER PHARMS) APPROVAL= AP YEAR= 2018 , NDA 211259 (pdf 211259.pdf not found) INN (CLOBAZAM) CLOBAZAM (MYLAN) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 211449 (pdf 211449.pdf not found) INN (CLOBAZAM) CLOBAZAM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 210978 (pdf 210978.pdf not found) INN (CLOBAZAM) CLOBAZAM (TARO) APPROVAL= AP YEAR= 2019 , NDA 211711 (pdf 211711.pdf not found) INN (CLOBAZAM) CLOBAZAM (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 212398 (pdf 212398.pdf not found) INN (CLOBAZAM) CLOBAZAM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210746 (pdf 210746.pdf not found) INN (CLOBAZAM) CLOBAZAM (VISTAPHARM) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212092 (pdf 212092.pdf not found) INN (CLOBAZAM) CLOBAZAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 212714 (pdf 212714.pdf not found) INN (CLOBAZAM) CLOBAZAM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2019 , NDA 209796 (pdf 209796.pdf not found) INN (CLOBAZAM) CLOBAZAM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 209853 (pdf 209853.pdf not found) INN (CLOBAZAM) CLOBAZAM (APOTEX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211032 (pdf 211032.pdf not found) INN (CLOBAZAM) CLOBAZAM (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213110 (pdf 213110.pdf not found) INN (CLOBAZAM) CLOBAZAM (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2020 , NDA 211959 (pdf 211959.pdf not found) INN (CLOBAZAM) CLOBAZAM (CELLTRION) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213039 (pdf 213039.pdf not found) INN (CLOBAZAM) CLOBAZAM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 213404 (pdf 213404.pdf not found) INN (CLOBAZAM) CLOBAZAM (MSN) APPROVAL= AP YEAR= 2021 , NDA 214404 (pdf 214404.pdf not found) INN (CLOBAZAM) CLOBAZAM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 216008 (pdf 216008.pdf not found) INN (CLOBAZAM) CLOBAZAM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1526 ; RUXOLITINIB ; 941678-49-5 ; 2011 ; ; ; CLASS ANTINEOPLASTIC AGENT -- MYELOFIBROSIS -- PROTEIN KINASE INHIBITOR , ; NDA 202192 (label 202192.pdf) INN (RUXOLITINIB PHOSPHATE) JAKAFI (INCYTE CORP) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 215309 (label 215309.pdf) INN (RUXOLITINIB PHOSPHATE) OPZELURA (INCYTE CORP) APPROVAL= AP YEAR= 2021 NEWAPPLICATION , 1527 ; AXITINIB ; 319460-85-0 ; 2012 ; ; ; CLASS ANTINEOPLASTIC AGENT -- PROTEIN KINASE INHIBITOR -- RENAL CELL CARCINOMA , ; NDA 202324 (label 202324.pdf) INN (AXITINIB) INLYTA (PF PRISM CV) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 210234 (pdf 210234.pdf not found) INN (AXITINIB) AXITINIB (TEVA PHARMS) APPROVAL= TA YEAR= 2018 , NDA 211650 (pdf 211650.pdf not found) INN (AXITINIB) AXITINIB (APOTEX INC) APPROVAL= TA YEAR= 2019 , 1528 ; VEMURAFENIB ; 918504-65-1 ; 2011 ; ; ; CLASS ANTINEOPLASTIC AGENT -- PROTEIN KINASE INHIBITOR -- METASTATIC MELANOMA WITH BRAF-V600E MUTATION , ; NDA 202429 (label 202429.pdf) INN (VEMURAFENIB) ZELBORAF (HOFFMANN LA ROCHE) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , 1529 ; TAFLUPROST ; 209860-87-7 ; 2012 ; ; ; CLASS SENSORY -- OPEN-ANGLE GLAUCOMA -- OCULAR HYPERTENSION -- PROSTAGLANDIN ANALOG -- FP PROSTANOID RECEPTOR AGONIST , ; NDA 202514 (label 202514.pdf) INN (TAFLUPROST) ZIOPTAN (THEA PHARMA) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209040 (pdf 209040.pdf not found) INN (TAFLUPROST) TAFLUPROST (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 209051 (pdf 209051.pdf not found) INN (TAFLUPROST) TAFLUPROST (MICRO LABS) APPROVAL= AP YEAR= 2019 , NDA 218002 (pdf 218002.pdf not found) INN (TAFLUPROST) TAFLUPROST (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2024 DISCONTINUED , 1530 ; CRIZOTINIB ; 877399-52-5 ; 2011 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- TYROSINE KINASE INHIBITOR , ; NDA 202570 (label 202570.pdf) INN (CRIZOTINIB) XALKORI (PF PRISM CV) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 217581 (pdf 217581.pdf not found) INN (CRIZOTINIB) XALKORI (PF PRISM CV) APPROVAL= AP YEAR= 2023 , 1531 ; INGENOL MEBUTATE ; 75567-37-2 ; 2012 ; ; ; CLASS DERMATOLOGICALS -- ACTINIC KERATOSIS -- INDUCES CELL DEATH IS MEDIATED THROUGH THE PKC DELTA/MEK/ERK PATHWAY (PMID26116359) , ; NDA 202833 (label 202833.pdf) INN (INGENOL MEBUTATE) PICATO (LEO LABS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY DISCONTINUED , NDA 209086 (pdf 209086.pdf not found) INN (INGENOL MEBUTATE) INGENOL MEBUTATE (ACTAVIS LABS) APPROVAL= TA YEAR= 2018 , NDA 209018 (pdf 209018.pdf not found) INN (INGENOL MEBUTATE) INGENOL MEBUTATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 209019 (pdf 209019.pdf not found) INN (INGENOL MEBUTATE) INGENOL MEBUTATE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2019 DISCONTINUED , 1532 ; IVACAFTOR ; 873054-44-5 ; 2012 ; ; ; CLASS RESPIRATORY SYSTEM -- CYSTIC FIBROSIS -- POTENTIATOR , ; NDA 203188 (label 203188.pdf) INN (IVACAFTOR) KALYDECO (VERTEX PHARMS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 206038 (label 206038.pdf) INN (IVACAFTOR LUMACAFTOR) ORKAMBI (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 207925 (label 207925.pdf) INN (IVACAFTOR) KALYDECO (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2015 , NDA 210491 (label 210491.pdf) INN (IVACAFTOR TEZACAFTOR) SYMDEKO COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 211358 (label 211358.pdf) INN (IVACAFTOR LUMACAFTOR) ORKAMBI (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 212273 (label 212273.pdf) INN (ELEXACAFTOR IVACAFTOR TEZACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 216074 (pdf 216074.pdf not found) INN (IVACAFTOR) IVACAFTOR (LUPIN LTD) APPROVAL= TA YEAR= 2022 , NDA 217660 (label 217660.pdf) INN (ELEXACAFTOR IVACAFTOR TEZACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2023 , 1533 ; VISMODEGIB ; 879085-55-9 ; 2012 ; ; ; CLASS ANTINEOPLASTIC AGENTS -- HEDGEHOG SIGNALING PATHWAY INHIBITOR , ; NDA 203388 (label 203388.pdf) INN (VISMODEGIB) ERIVEDGE (GENENTECH) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , 1534 ; M TAFLUPROST ; 209860-88-8 ; 0 ; ; ; CLASS OPEN-ANGLE GLAUCOMA -- OCULAR HYPERTENSION -- PROSTAGLANDIN ANALOG -- FP PROSTANOID RECEPTOR AGONIST , ; 1535 ; M FIDAXOMICIN ; 1030825-28-5 ; 0 ; ; ; CLASS ANTIINFECTIVES -- MACROLIDE -- TREATMENT OF CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA -- INHIBITOR RNA SYNTHESIS BY RNA POLYMERASES , ; 1536 ; M AZILSARTAN KAMEDOXOMIL ; 147403-03-0 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN II RECEPTOR BLOCKER -- SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR ANTAGONIST , ; 1537 ; M ROFLUMILAST ; 1026258-58-1 ; 0 ; ; ; CLASS RESPIRATORY -- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) -- PHOSPHODIESTERASE PDE4 INHIBITORS -- ROFLUMILAST IS THREE TIMES MORE POTENT THAN ROFLUMILAST N-OXIDE AT INHIBITION OF THE PDE4 ENZYME IN VITRO THE PLASMA AUC OF ROFLUMILAST N-OXIDE ON AVERAGE IS ABOUT 10-FOLD GREATER THAN THE PLASMA AUC OF ROFLUMILAST , ; 1538 ; M FINGOLIMOD ; 402616-26-6 ; 0 ; ; ; CLASS IMMUNOMODULATING -- IMMUNOSUPPRESSANT -- MULTIPLE SCLEROSIS -- FINGOLIMOD IS METABOLIZED BY SPHINGOSINE KINASE TO THE ACTIVE METABOLITE FINGOLIMOD-PHOSPHATE -- FINGOLIMOD-PHOSPHATE INVOLVES REDUCTION OF LYMPHOCYTE MIGRATION INTO THE CENTRAL NERVOUS SYSTEM -- S1P1 MODULATOR (NOT ANTAGONIST BUT AN AGONIST THAT CAUSES RECEPTOR DEGRADATION VERSUS RECYCLING TO CELL SURFACE) , ; 1539 ; DABIGATRAN ; 211914-51-1 ; 0 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- THROMBINE INHIBITOR -- TO REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION , ; 1540 ; M ULIPRISTAL ACETATE ; 159681-66-0 ; 0 ; ; ; CLASS GENITO -- PROGESTERONE PARTIAL AGONIST AND ANTAGONIST EMERGENCY CONTRACEPTIVE , ; 1541 ; M ALCAFTADINE ; 147083-93-0 ; 0 ; ; ; CLASS RESPIRATORY -- ALLERGIC CONJUNCTIVITIS -- H1 HISTAMINE RECEPTOR ANTAGONIST , ; 1542 ; M PRASUGREL ; 204204-73-9 ; 0 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; 1543 ; M PRASUGREL ; 204204-73-9 ; 0 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; 1544 ; M PRASUGREL ; 204204-73-9 ; 0 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; 1545 ; M PRASUGREL ; 204204-73-9 ; 0 ; ; ; CLASS BLOOD -- ANTITHROMBOTIC AGENTS -- P2Y(12) RECEPTOR ANTAGONIST -- THIENOPYRIDINE CLASS , ; 1546 ; M SAXAGLIPTIN ; 841302-24-7 ; 0 ; ; ; CLASS ANTIDIABETIC -- DIPEPTIDYL-PEPTIDASE IV INHIBITOR -- HYPOGLYCEMIC AGENTS -- TYPE 2 DIABETES MELLITUS -- METABOLISM -- METABOLITE OF SAXAGLIPTIN IS ONE-HALF AS POTENT AS SAXAGLIPTIN AS DPP4 INHIBITOR , ; 1547 ; TROGLITAZONE ; 97322-87-7 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- PPAR AGONIST , ; NDA 020719 (label 20719.pdf) INN (TROGLITAZONE) PRELAY (SANKYO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020720 (label 20720.pdf) INN (TROGLITAZONE) REZULIN (PFIZER PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1548 ; TROGLITAZONE ; 97322-87-7 ; 1997 ; DISCONTINUED ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- PPAR AGONIST , ; NDA 020719 (label 20719.pdf) INN (TROGLITAZONE) PRELAY (SANKYO) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020720 (label 20720.pdf) INN (TROGLITAZONE) REZULIN (PFIZER PHARMS) APPROVAL= AP YEAR= 1997 NEWMOLECULARENTITY DISCONTINUED , 1549 ; M FESOTERODINE ; 207679-81-0 ; 0 ; ; ; CLASS ANTISPASMODICS -- ANTIMUSCARINIC -- MUSCARINIC ANTAGONIST -- OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE -- URINARY ANTISPASMODICS -- GENITO -- HYDROLYSIS BY NONSPECIFIC ESTERASES , ; 1550 ; M DIFLUPREDNATE ; 23640-96-2 ; 0 ; ; ; CLASS DERMATOLOGICALS -- ANTIINFLAMMATORY -- TOPICAL CORTICOSTEROID -- AGONIST , ; 1551 ; CLEVIDIPINE ; 167221-71-8 ; 2008 ; ; ; CLASS CARDIOVASCULAR -- VASODILATOR -- ANTIHYPERTENSIVE -- DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER -- REDUCTION OF BLOOD PRESSURE -- THE CARBOXYLIC ACID METABOLITE IS INACTIVE AS AN ANTIHYPERTENSIVE , ; NDA 022156 (label 22156.pdf) INN (CLEVIDIPINE) CLEVIPREX (CHIESI) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY , 1552 ; AMFENAC ; 51579-82-9 ; 0 ; ; ; CLASS SENSORY -- ANTIINFLAMMATORY -- NONSTEROIDAL ANTI-INFLAMMATORY (NSAID) PRODRUG -- TREATMENT OF PAIN AND INFLAMMATION ASSOCIATED WITH CATARACT SURGERY -- CONVERTED BY OCULAR TISSUE HYDROLASES TO AMFENAC -- INHIBITOR THE ACTION OF PROSTAGLANDIN H SYNTHASE (CYCLOOXYGENASE) , ; 1553 ; CEFDITOREN ; 104145-95-1 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS -- INHIBITORS , ; 1554 ; UNOPROSTONE ; 120373-36-6 ; 0 ; ; ; CLASS SENSORY -- ANTIHYPERTENSIVE -- ANTIGLAUCOMA -- DOCOSANOID STRUCTURAL ANALOGUE OF AN INACTIVE BIOSYNTHETIC CYCLIC DERIVATIVE OF ARACHIDONIC ACID , ; 1555 ; ARTICAINE ; 23964-58-1 ; 2000 ; ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- LOCAL ANESTHETIC CONTAINING A VASOCONSTRICTOR -- DENTAL PROCEDURE , ; NDA 020971 (label 20971.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2000 , NDA 022010 (pdf 22010.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) SEPTOCAINE (DEPROCO) APPROVAL= AP YEAR= 2006 , NDA 022466 (label 22466.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ORABLOC (PIERREL) APPROVAL= AP YEAR= 2010 , NDA 079138 (pdf 79138.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (HOSPIRA) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 201750 (pdf 201750.pdf not found) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN FORTE (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 201751 (label 201751.pdf) INN (ARTICAINE HYDROCHLORIDE EPINEPHRINE BITARTRATE) ULTACAN (HANSAMED INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1556 ; M DOXERCALCIFEROL ; 100496-04-6 ; 0 ; ; ; CLASS HORMONES -- SYNTHETIC VITAMIN D2 ANALOG -- VITAMIN D PROHORMONE -- PARATHYROID HORMONE REGULATOR -- CALCIUM REGULATOR , ; 1557 ; CANDESARTAN ; 139481-59-7 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- CANDESARTAN IS A SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR ANTAGONIST -- CANDESARTAN BLOCKS THE VASOCONSTRICTOR AND ALDOSTERONE-SECRETING EFFECTS OF ANGIOTENSIN II , ; 1558 ; EFLORNITHINE ; 70052-12-9 ; 1990 ; DISCONTINUED ; ; CLASS DERMATOLOGICALS -- INHIBITOR OF ORNITHINE DECARBOXYLASE (ODC) -- REDUCTION OF UNWANTED FACIAL HAIR IN WOMEN -- ANTIPARASITIC , ; NDA 019879 (pdf 19879.pdf not found) INN (EFLORNITHINE HYDROCHLORIDE) ORNIDYL (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1990 NEWMOLECULARENTITY DISCONTINUED , NDA 021145 (label 21145.pdf) INN (EFLORNITHINE HYDROCHLORIDE) VANIQA (SKINMEDICA) APPROVAL= AP YEAR= 2000 DISCONTINUED , NDA 215500 (pdf 215500.pdf not found) INN (EFLORNITHINE HYDROCHLORIDE) IWILFIN (USWM) APPROVAL= AP YEAR= 2023 , 1559 ; ESTRAMUSTINE ; 4891-15-0 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING -- TREATMENT OF PATIENTS WITH METASTATIC AND/OR PROGRESSIVE CARCINOMA OF THE PROSTATE , ; 1560 ; NORPROPOXYPHENE ; 66796-40-5 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANALGESICS -- OPIOID AGONIST -- ANTITUSSIVES -- NARCOTICS , ; 1561 ; M OSELTAMIVIR ; 187227-45-8 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- INFLUENZA NEURAMINIDASE INHIBITOR , ; 1562 ; M RAPACURONIUM ; 736123-17-4 ; 0 ; ; ; CLASS NEUROMUSCULAR BLOCKER -- MUSCLE RELAXANT -- ANESTHETIC -- NEUROMUSCULAR NONDEPOLARIZING AGENTS , ; 1563 ; M SILDENAFIL ; 139755-82-1 ; 0 ; ; ; CLASS GENITO -- ERECTILE DYSFUNCTION (THERAPEUTIC) -- SPECIFIC PHOSPHODIESTERASE INHIBITORS -- VASODILATOR AGENTS -- THE METABOLITE ACCOUNTS FOR ABOUT 20 PERCENT OF SILDENAFIL PHARMACOLOGIC -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (DRUG FOR RARE DISEASE IN EUROPE) , ; 1564 ; M CLOPIDOGREL ; 767612-34-0 ; 0 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- ANTIANGINAL -- FIBRINOLYTIC AGENTS -- TREATMENT OF ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, STROKE -- ACTION THROUGH IRREVERSIBLE BINDING OF ITS METABOLITE , ; 1565 ; M CLOPIDOGREL ; 767612-34-0 ; 0 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- ANTIANGINAL -- FIBRINOLYTIC AGENTS -- TREATMENT OF ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, STROKE -- ACTION THROUGH IRREVERSIBLE BINDING OF ITS METABOLITE , ; 1566 ; M CEFTAROLINE ; 700803-62-9 ; 0 ; ; ; CLASS ANTIINFECTIVE -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; 1567 ; M QUETIAPINE ; 5747-48-8 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- SCHIZOPHRENIA -- DIBENZOTHIAZEPINE FAMILY -- DOPAMINE D2 RECEPTOR ANTAGONIST (IC50=329 NANOMOLAR) -- SEROTONIN (5HT2) ANTAGONIST (IC50=148 NANOMOLAR) -- SEROTONIN 5HT1A ANTAGONIST (IC50=717 NANOMOLAR) -- DOPAMINE D1 ANTAGONIST (IC50=1268 NANOMOLAR) -- HISTAMINE H1 ANTAGONIST (IC50=30 NANOMOLAR) -- ADRENERGIC ALPHA 1 RECEPTOR ANTAGONIST (IC50= 94 NANOMOLAR) -- ADRENARGIC ALPHA 2 RECEPTOR ANTAGONIST (IC50=271 NANOMOLAR) -- NO APPRECIABLE AFFINITY AT CHOLINERGIC MUSCARINIC AND BENZODIAZEPINE RECEPTORS (IC50 SUPERIOR TO 5000 NANOMOLAR) , ; 1568 ; M DOLASETRON ; 127951-99-9 ; 0 ; ; ; CLASS METABOLISM -- SEROTONIN 5HT3 ANTAGONIST -- ANTIEMETIC -- , ; 1569 ; M DOLASETRON ; 127951-99-9 ; 0 ; ; ; CLASS METABOLISM -- SEROTONIN 5HT3 ANTAGONIST -- ANTIEMETIC -- , ; 1570 ; M BECLOMETHASONE DIPROPIONATE ; 5534-18-9 ; 0 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- CORTICOSTEROIDS -- VASOCONSTRICTOR -- BECLOMETHASONE IS A MINOR METABOLITE , ; 1571 ; APIXABAN ; 503612-47-3 ; 2012 ; ; ; CLASS BLOOD -- ANTICOAGULANT -- ACTIVE SITE INHIBITOR OF FXA , ; NDA 202155 (label 202155.pdf) INN (APIXABAN) ELIQUIS (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209845 (pdf 209845.pdf not found) INN (APIXABAN) APIXABAN (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209944 (pdf 209944.pdf not found) INN (APIXABAN) APIXABAN (SUNSHINE LAKE) APPROVAL= TA YEAR= 2019 , NDA 210013 (pdf 210013.pdf not found) INN (APIXABAN) APIXABAN (MICRO LABS) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210156 (pdf 210156.pdf not found) INN (APIXABAN) APIXABAN (TORRENT PHARMS LLC) APPROVAL= TA YEAR= 2019 , NDA 210128 (pdf 210128.pdf not found) INN (APIXABAN) APIXABAN (MYLAN) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210152 (pdf 210152.pdf not found) INN (APIXABAN) APIXABAN (BIONPHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209810 (pdf 209810.pdf not found) INN (APIXABAN) APIXABAN (IMPAX LABS) APPROVAL= TA YEAR= 2020 , NDA 209898 (pdf 209898.pdf not found) INN (APIXABAN) APIXABAN (INDOCO) APPROVAL= AP YEAR= 2020 , NDA 210180 (pdf 210180.pdf not found) INN (APIXABAN) APIXABAN (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 210082 (pdf 210082.pdf not found) INN (APIXABAN) APIXABAN (DR REDDYS LABS INC) APPROVAL= TA YEAR= 2020 , NDA 210142 (pdf 210142.pdf not found) INN (APIXABAN) APIXABAN (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2020 , NDA 210053 (pdf 210053.pdf not found) INN (APIXABAN) APIXABAN (SIGMAPHARM LABS LLC) APPROVAL= TA YEAR= 2022 , NDA 210133 (pdf 210133.pdf not found) INN (APIXABAN) APIXABAN (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , NDA 213903 (pdf 213903.pdf not found) INN (APIXABAN) APIXABAN (ZHEJIANG YONGNING PHARMACEUTICAL CO LTD) APPROVAL= TA YEAR= 2022 , NDA 210171 (pdf 210171.pdf not found) INN (APIXABAN) APIXABAN (SUN PHARM INDUSTRIES) APPROVAL= TA YEAR= 2019 , NDA 210026 (pdf 210026.pdf not found) INN (APIXABAN) APIXABAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 210066 (pdf 210066.pdf not found) INN (APIXABAN) APIXABAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 210185 (pdf 210185.pdf not found) INN (APIXABAN) APIXABAN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 210091 (pdf 210091.pdf not found) INN (APIXABAN) APIXABAN (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , 1572 ; LOMITAPIDE ; 182431-12-5 ; 2012 ; ; ; CLASS CARDIOVASCULAR -- INHIBITOR OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN (MTP) AND REDUCED LEVELS OF PLASMA LDL-C , ; NDA 203858 (label 203858.pdf) INN (LOMITAPIDE MESYLATE) JUXTAPID (CHIESI) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , 1573 ; ICOSAPENT ETHYL ; 86227-47-6 ; 2012 ; ; ; CLASS CARDIOVASCULAR -- ADJUNCT TO DIET TO REDUCE TRIGLYCERIDE (TG) LEVELS IN ADULT PATIENTS WITH SEVERE (>= 500 MG/DL) HYPERTRIGLYCERIDEMIA -- POTENTIAL MECHANISMS OF ACTION INCLUDE INCREASED BETA-OXIDATION -- INHIBITION OF ACYL-COA:1,2-DIACYLGLYCEROL ACYLTRANSFERASE (DGAT) -- DECREASED LIPOGENESIS IN THE LIVER -- AND INCREASED PLASMA LIPOPROTEIN LIPASE ACTIVITY , ; NDA 202057 (label 202057.pdf) INN (ICOSAPENT ETHYL) VASCEPA (AMARIN PHARMS) APPROVAL= AP YEAR= 2012 , NDA 209457 (pdf 209457.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 209499 (pdf 209499.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 209525 (pdf 209525.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 209437 (pdf 209437.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (APOTEX) APPROVAL= AP YEAR= 2021 , NDA 217656 (pdf 217656.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 216811 (pdf 216811.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (ASCENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217844 (pdf 217844.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (STRIDES PHARMA) APPROVAL= AP YEAR= 2023 , NDA 217919 (pdf 217919.pdf not found) INN (ICOSAPENT ETHYL) ICOSAPENT ETHYL (HUMANWELL PURACAP) APPROVAL= AP YEAR= 2023 , 1574 ; ICOSAPENT ; 10417-94-4 ; 0 ; ; NATURAL MOLECULE C00000408 ; CLASS CARDIOVASCULAR -- ADJUNCT TO DIET TO REDUCE TRIGLYCERIDE (TG) LEVELS IN ADULT PATIENTS WITH SEVERE (>= 500 MG/DL) HYPERTRIGLYCERIDEMIA -- POTENTIAL MECHANISMS OF ACTION INCLUDE INCREASED BETA-OXIDATION -- INHIBITION OF ACYL-COA:1,2-DIACYLGLYCEROL ACYLTRANSFERASE (DGAT) -- DECREASED LIPOGENESIS IN THE LIVER -- AND INCREASED PLASMA LIPOPROTEIN LIPASE ACTIVITY , ; 1575 ; LORCASERIN ; 616202-92-7 ; 2012 ; ; ; CLASS METABOLISM -- SEROTONIN 2C RECEPTOR AGONIST 5-HT2C (KD = 13 NANOMOLAR) -- 5-HT2B (KD = 147 NANOMOLAR) -- 5-HT2A (KD = 92 NANOMOLAR) -- WEIGHT MANAGEMENT IN ADULTS -- ANOREXIGENIC , ; NDA 022529 (label 22529.pdf) INN (LORCASERIN HYDROCHLORIDE) BELVIQ (EISAI INC) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , NDA 208524 (label 208524.pdf) INN (LORCASERIN HYDROCHLORIDE) BELVIQ XR (EISAI INC) APPROVAL= AP YEAR= 2016 DISCONTINUED OBSOLETE , NDA 209464 (pdf 209464.pdf not found) INN (LORCASERIN HYDROCHLORIDE) LORCASERIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2019 , 1576 ; CABOZANTINIB ; 849217-68-1 ; 2012 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF PATIENTS WITH PROGRESSIVE METASTATIC MEDULLARY THYROID CANCER -- INHIBITOR OF TYROSINE KINASE , ; NDA 203756 (label 203756.pdf) INN (CABOZANTINIB S-MALATE) COMETRIQ (EXELIXIS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 208692 (label 208692.pdf) INN (CABOZANTINIB S-MALATE) CABOMETYX (EXELIXIS INC) APPROVAL= AP YEAR= 2016 , NDA 215942 (pdf 215942.pdf not found) INN (CABOZANTINIB) CABOZANTINIB (TEVA PHARMS INC) APPROVAL= TA YEAR= 2022 , 1577 ; PASIREOTIDE ; 396091-73-9 ; 2012 ; ; ; CLASS HORMONES -- CUSHING’S DISEASE -- SOMATOSTATIN ANALOGUE -- HUMAN SOMATOSTATIN RECEPTORS (HSST) AGONISTS -- LEADS TO DECREASED CORTISOL SECRETION -- HSST1 (IC50 = 9.3 NANOMOLAR) -- HSST2 (IC50 = 1.0 NANOMOLAR) -- HSST3 (IC50 = 1.5 NANOMOLAR) -- HSST4 (IC50 > 1000 NANOMOLAR) -- HSST5 (IC50 = 0.16 NANOMOLAR) , ; NDA 200677 (label 200677.pdf) INN (PASIREOTIDE DIASPARTATE) SIGNIFOR (RECORDATI RARE) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 203255 (label 203255.pdf) INN (PASIREOTIDE PAMOATE) SIGNIFOR LAR KIT (RECORDATI RARE) APPROVAL= AP YEAR= 2014 , 1578 ; TERIFLUNOMIDE ; 163451-81-8 ; 2012 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATIONG AGENT -- PYRIMIDINE SYNTHESIS INHIBITOR -- TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS -- ANTIINFLAMMATORY , ; NDA 202992 (label 202992.pdf) INN (TERIFLUNOMIDE) AUBAGIO (SANOFI AVENTIS US) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209549 (pdf 209549.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209601 (pdf 209601.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (APOTEX) APPROVAL= AP YEAR= 2018 , NDA 209613 (pdf 209613.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209638 (pdf 209638.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018 , NDA 209663 (pdf 209663.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (GLENMARK SPECLT) APPROVAL= AP YEAR= 2018 , NDA 209668 (pdf 209668.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018 , NDA 209700 (pdf 209700.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 , NDA 209572 (pdf 209572.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (ALEMBIC) APPROVAL= AP YEAR= 2019 , NDA 209623 (pdf 209623.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (MSN) APPROVAL= AP YEAR= 2019 , NDA 209690 (pdf 209690.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 209697 (pdf 209697.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (TORRENT) APPROVAL= AP YEAR= 2024 , NDA 209710 (pdf 209710.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (SANDOZ) APPROVAL= AP YEAR= 2019 , NDA 209677 (pdf 209677.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (SOLA PHARMS) APPROVAL= AP YEAR= 2020 , NDA 209702 (pdf 209702.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (MYLAN) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209583 (pdf 209583.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209555 (pdf 209555.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (NATCO) APPROVAL= AP YEAR= 2023 , NDA 209598 (pdf 209598.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 209639 (pdf 209639.pdf not found) INN (TERIFLUNOMIDE) TERIFLUNOMIDE (BIOCON PHARMA) APPROVAL= AP YEAR= 2023 , 1579 ; PERAMPANEL ; 380917-97-5 ; 2012 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTICS -- NON-COMPETITIVE AMPA GLUTAMATE RECEPTOR ANTAGONIST -- TREATMENT OF PARTIAL-ONSET SEIZURES , ; NDA 202834 (label 202834.pdf) INN (PERAMPANEL) FYCOMPA (CATALYST PHARMS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 208277 (label 208277.pdf) INN (PERAMPANEL) FYCOMPA (CATALYST PHARMS) APPROVAL= AP YEAR= 2016 , NDA 209877 (pdf 209877.pdf not found) INN (PERAMPANEL) PERAMPANEL (ACCORD HLTHCARE) APPROVAL= TA YEAR= 2021 , NDA 209538 (pdf 209538.pdf not found) INN (PERAMPANEL) PERAMPANEL (TARO PHARM INDS LTD) APPROVAL= TA YEAR= 2021 , NDA 209801 (pdf 209801.pdf not found) INN (PERAMPANEL) PERAMPANEL (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2024 , 1580 ; CARFILZOMIB ; 868540-17-4 ; 2012 ; ; ; CLASS ANTINEOPLATIC -- TREATMENT OF MULTIPLE MYELOMA -- PROTEASOME INHIBITOR THAT IRREVERSIBLY (COVALENTLY) BINDS TO THE N-TERMINAL THREONINE-CONTAINING ACTIVE SITES OF THE 20S PROTEASOME , ; NDA 202714 (label 202714.pdf) INN (CARFILZOMIB) KYPROLIS (ONYX PHARMS AMGEN) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209425 (pdf 209425.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (APOTEX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209528 (pdf 209528.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (QILU PHARM CO LTD) APPROVAL= TA YEAR= 2019 , NDA 209422 (pdf 209422.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (DR REDDYS) APPROVAL= AP YEAR= 2019 , NDA 210823 (pdf 210823.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (EUGIA PHARMA) APPROVAL= TA YEAR= 2022 , NDA 211185 (pdf 211185.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (APOTEX) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 209330 (pdf 209330.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (BRECKENRIDGE) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209526 (pdf 209526.pdf not found) INN (CARFILZOMIB) CARFILZOMIB (MSN PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2023 , 1581 ; LINACLOTIDE ; 851199-59-2 ; 2012 ; ; ; CLASS METABOLISM -- GUANYLATE CYCLASE-C AGONIST -- IRRITABLE BOWEL SYNDROME WITH CONSTIPATION -- CHRONIC IDIOPATHIC CONSTIPATION , ; NDA 202811 (label 202811.pdf) INN (LINACLOTIDE) LINZESS (ABBVIE) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209564 (pdf 209564.pdf not found) INN (LINACLOTIDE) LINACLOTIDE (MYLAN) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211255 (pdf 211255.pdf not found) INN (LINACLOTIDE) LINACLOTIDE (ACTAVIS LABS FL INC) APPROVAL= TA YEAR= 2022 , NDA 209611 (pdf 209611.pdf not found) INN (LINACLOTIDE) LINACLOTIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1582 ; M LINACLOTIDE ; 851199-59-2 ; 0 ; ; ; CLASS METABOLISM -- GUANYLATE CYCLASE-C AGONIST -- IRRITABLE BOWEL SYNDROME WITH CONSTIPATION -- CHRONIC IDIOPATHIC CONSTIPATION , ; 1583 ; MIRABEGRON ; 223673-61-8 ; 2012 ; ; ; CLASS GENITO -- TREATMENT OF OVERACTIVE BLADDER (OAB) -- AGONIST OF BETA-3 ADRENERGIC RECEPTOR (AR) , ; NDA 202611 (label 202611.pdf) INN (MIRABEGRON) MYRBETRIQ (APGDI) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209413 (pdf 209413.pdf not found) INN (MIRABEGRON) MIRABEGRON (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2018 , NDA 209446 (pdf 209446.pdf not found) INN (MIRABEGRON) MIRABEGRON (SAWAI USA) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 213801 (label 213801.pdf) INN (MIRABEGRON) MYRBETRIQ GRANULES (APGDI) APPROVAL= AP YEAR= 2021 , NDA 209485 (pdf 209485.pdf not found) INN (MIRABEGRON) MIRABEGRON (LUPIN LTD) APPROVAL= AP YEAR= 2022 , NDA 209488 (pdf 209488.pdf not found) INN (MIRABEGRON) MIRABEGRON (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215948 (pdf 215948.pdf not found) INN (MIRABEGRON) MIRABEGRON (ALKEM LABS LTD) APPROVAL= AP YEAR= 2024 , 1584 ; AVANAFIL ; 330784-47-9 ; 2012 ; ; ; CLASS GENITO -- PHOSPHODIESTERASE 5 (PDE5) INHIBITOR -- TREATMENT OF ERECTILE DYSFUNCTION , ; NDA 202276 (label 202276.pdf) INN (AVANAFIL) STENDRA (METUCHEN PHARMS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 209266 (pdf 209266.pdf not found) INN (AVANAFIL) AVANAFIL (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 1585 ; REGORAFENIB ; 755037-03-7 ; 2012 ; ; ; CLASS ANTINEOPLASTIC -- METASTATIC COLORECTAL CANCER -- KINASES INHIBITOR , ; NDA 203085 (label 203085.pdf) INN (REGORAFENIB) STIVARGA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 204369 (label 204369.pdf) INN (REGORAFENIB) STIVARGA (BAYER HEALTHCARE PHARMS) APPROVAL= AP YEAR= 2013 NEWAPPLICATION , 1586 ; ELVITEGRAVIR ; 697761-98-1 ; 2012 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HIV-1 INFECTION -- INHIBITOR , ; NDA 203100 (label 203100.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012 , NDA 203093 (label 203093.pdf) INN (ELVITEGRAVIR) VITEKTA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 207561 (label 207561.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) GENVOYA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2015 , 1587 ; COBICISTAT ; 1004316-88-4 ; 2012 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HIV-1 INFECTION -- PHARMACOENHANCER -- INHIBITOR OF CYTOCHROME P450 3A -- INHIBIT THE INTESTINAL EFFLUX TRANSPORTERS P-GLYCOPROTEIN AND BREAST CANCER RESISTANCE PROTEIN (PMID22850510) , ; NDA 203100 (label 203100.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012 , NDA 203094 (label 203094.pdf) INN (COBICISTAT) TYBOST (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 , NDA 205395 (label 205395.pdf) INN (COBICISTAT DARUNAVIR) PREZCOBIX (JANSSEN PRODS) APPROVAL= AP YEAR= 2015 , NDA 206353 (label 206353.pdf) INN (ATAZANAVIR SULFATE COBICISTAT) EVOTAZ (BRISTOL) APPROVAL= AP YEAR= 2015 , NDA 207561 (label 207561.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) GENVOYA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2015 , NDA 210455 (label 210455.pdf) INN (COBICISTAT DARUNAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) SYMTUZA (JANSSEN PRODS) APPROVAL= AP YEAR= 2018 , NDA 209986 (pdf 209986.pdf not found) INN (COBICISTAT) COBICISTAT (MYLAN LABS LTD) APPROVAL= AP YEAR= 2024 , 1588 ; ACLIDINIUM ; 727649-81-2 ; 2012 ; ; ; CLASS RESPIRATORY SYSTEM -- ANTICHOLINERGIC -- MUSCARINIC RECEPTOR ANTAGONIST -- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) -- INHIBITION OF M3 RECEPTOR AT THE SMOOTH MUSCLE LEADING TO BRONCHODILATION , ; NDA 202450 (label 202450.pdf) INN (ACLIDINIUM BROMIDE) TUDORZA PRESSAIR (COVIS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 210595 (label 210595.pdf) INN (ACLIDINIUM BROMIDE FORMOTEROL FUMARATE) DUAKLIR PRESSAIR (COVIS) APPROVAL= AP YEAR= 2019 , 1589 ; TOFACITINIB ; 477600-75-2 ; 2012 ; ; ; CLASS IMMUNOMODULATING -- INHIBITOR OF JANUS KINASES (JAKS) -- TREATMENT OF RHEUMATOID ARTHRITIS , ; NDA 203214 (label 203214.pdf) INN (TOFACITINIB CITRATE) XELJANZ (PF PRISM CV) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 208246 (label 208246.pdf) INN (TOFACITINIB CITRATE) XELJANZ XR (PFIZER) APPROVAL= AP YEAR= 2016 , NDA 209738 (pdf 209738.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB CITRATE (MICRO LABS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 209923 (pdf 209923.pdf not found) INN (TOFACITINIB) TOFACITINIB (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2024 , NDA 213082 (label 213082.pdf) INN (TOFACITINIB CITRATE) XELJANZ (PFIZER) APPROVAL= AP YEAR= 2020 , NDA 212943 (pdf 212943.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB CITRATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209633 (pdf 209633.pdf not found) INN (TOFACITINIB) TOFACITINIB (BRECKENRIDGE PHARMS) APPROVAL= TA YEAR= 2021 , NDA 214264 (pdf 214264.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215552 (pdf 215552.pdf not found) INN (TOFACITINIB) TOFACITINIB (YAOPHARMA CO LTD) APPROVAL= TA YEAR= 2022 , NDA 209829 (pdf 209829.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB CITRATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217299 (pdf 217299.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB (MSN PHARMS INC) APPROVAL= TA YEAR= 2023 , NDA 216878 (pdf 216878.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB CITRATE (HIKMA) APPROVAL= AP YEAR= 2023 , NDA 218462 (pdf 218462.pdf not found) INN (TOFACITINIB CITRATE) TOFACITINIB (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , 1590 ; ENZALUTAMIDE ; 915087-33-1 ; 2012 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR -- TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER -- DECREASED PROLIFERATION AND INDUCED CELL DEATH , ; NDA 203415 (label 203415.pdf) INN (ENZALUTAMIDE) XTANDI (ASTELLAS) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 213674 (label 213674.pdf) INN (ENZALUTAMIDE) XTANDI (ASTELLAS) APPROVAL= AP YEAR= 2020 , NDA 209614 (pdf 209614.pdf not found) INN (ENZALUTAMIDE) ENZALUTAMIDE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 209645 (pdf 209645.pdf not found) INN (ENZALUTAMIDE) ENZALUTAMIDE (APOTEX) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 216068 (pdf 216068.pdf not found) INN (ENZALUTAMIDE) ENZALUTAMIDE (SANDOZ INC) APPROVAL= TA YEAR= 2022 , 1591 ; M ENZALUTAMIDE ; 1242137-16-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR -- TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER -- DECREASED PROLIFERATION AND INDUCED CELL DEATH , ; 1592 ; BOSUTINIB ; 380843-75-4 ; 2012 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE INHIBITOR -- TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA (CML) , ; NDA 203341 (label 203341.pdf) INN (BOSUTINIB MONOHYDRATE) BOSULIF (PF PRISM CV) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 217729 (pdf 217729.pdf not found) INN (BOSUTINIB MONOHYDRATE) BOSULIF (PF PRISM CV) APPROVAL= AP YEAR= 2023 , 1593 ; PONATINIB ; 943319-70-8 ; 2012 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE INHIBITOR ABL (IC50 = 0.4 NANOMOLAR) -- TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) -- VEGFR, PDGFR, FGFR, EPH RECEPTORS AND SRC FAMILIES OF KINASES AND KIT, RET, TIE2, AND FLT3 WITH IC50 CONCENTRATIONS BETWEEN 0.1 AND 20 NANOMOLAR , ; NDA 203469 (label 203469.pdf) INN (PONATINIB HYDROCHLORIDE) ICLUSIG (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , NDA 215893 (pdf 215893.pdf not found) INN (PONATINIB HYDROCHLORIDE) PONATINIB HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1594 ; OMACETAXINE MEPESUCCINATE ; 26833-87-4 ; 2012 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) -- PROTEIN SYNTHESIS INHIBITOR -- OMACETAXINE MEPESUCCINATE BINDS TO THE A-SITE CLEFT IN THE PEPTIDYL-TRANSFERASE CENTER OF THE LARGE RIBOSOMAL SUBUNIT FROM A STRAIN OF ARCHAEABACTERIA -- HYDROLYZED TO 4-DMHHT VIA PLASMA ESTERASES , ; NDA 203585 (label 203585.pdf) INN (OMACETAXINE MEPESUCCINATE) SYNRIBO (TEVA PHARMS INTL) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY DISCONTINUED , 1595 ; BEDAQUILINE ; 843663-66-1 ; 2012 ; ; ; CLASS ANTIINFECTIVES -- DIARYLQUINOLINE ANTIMYCOBACTERIAL COMPOUND -- PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB) , ; NDA 204384 (label 204384.pdf) INN (BEDAQUILINE FUMARATE) SIRTURO (JANSSEN THERAP) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , 1596 ; POMALIDOMIDE ; 19171-19-8 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- THALIDOMIDE ANALOG -- TREATMENT OF MULTIPLE MYELOMA -- IMMUNOMODULATORY AGENT , ; NDA 204026 (label 204026.pdf) INN (POMALIDOMIDE) POMALYST (BRISTOL) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 210111 (pdf 210111.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210249 (pdf 210249.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213234 (pdf 213234.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2024 , NDA 209956 (pdf 209956.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210275 (pdf 210275.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (MYLAN) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210164 (pdf 210164.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (APOTEX) APPROVAL= AP YEAR= 2024 , 1597 ; OSPEMIFENE ; 128607-22-7 ; 2013 ; ; ; CLASS DYSPAREUNIA MENOPAUSE -- ESTROGEN AGONIST/ANTAGONIST , ; NDA 203505 (label 203505.pdf) INN (OSPEMIFENE) OSPHENA (DUCHESNAY) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 215574 (pdf 215574.pdf not found) INN (OSPEMIFENE) OSPEMIFENE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2024 , 1598 ; DABRAFENIB ; 1195765-45-7 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- MELANOMA WITH BRAF V600E -- INHIBITOR , ; NDA 202806 (label 202806.pdf) INN (DABRAFENIB MESYLATE) TAFINLAR (NOVARTIS) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 217514 (label 217514.pdf) INN (DABRAFENIB MESYLATE) TAFINLAR (NOVARTIS) APPROVAL= AP YEAR= 2023 , 1599 ; POMALIDOMIDE ; 19171-19-8 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- THALIDOMIDE ANALOG -- TREATMENT OF MULTIPLE MYELOMA -- IMMUNOMODULATORY AGENT , ; NDA 204026 (label 204026.pdf) INN (POMALIDOMIDE) POMALYST (BRISTOL) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 210111 (pdf 210111.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210249 (pdf 210249.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (EUGIA PHARMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213234 (pdf 213234.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2024 , NDA 209956 (pdf 209956.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210275 (pdf 210275.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (MYLAN) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 210164 (pdf 210164.pdf not found) INN (POMALIDOMIDE) POMALIDOMIDE (APOTEX) APPROVAL= AP YEAR= 2024 , 1600 ; TRAMETINIB ; 871700-17-3 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS , ; NDA 204114 (label 204114.pdf) INN (TRAMETINIB DIMETHYL SULFOXIDE) MEKINIST (NOVARTIS) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 217513 (label 217513.pdf) INN (TRAMETINIB) MEKINIST (NOVARTIS) APPROVAL= AP YEAR= 2023 , 1601 ; PICOSULFATE ; 10040-45-6 ; 2012 ; ; ; CLASS METABOLISM -- LAXATIVE -- HYDROLYZED BY COLONIC BACTERIA -- STIMULATE COLONIC PERISTALSIS , ; NDA 202535 (label 202535.pdf) INN (CITRIC ACID MAGNESIUM OXIDE SODIUM PICOSULFATE) PREPOPIK (FERRING PHARMS INC) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY DISCONTINUED , NDA 205743 (pdf 205743.pdf not found) INN (CITRIC ACID MAGNESIUM OXIDE SODIUM PICOSULFATE) CITRIC ACID MAGNESIUM OXIDE SODIUM PICOSULFATE (PAR PHARM INC) APPROVAL= TA YEAR= 2016 , NDA 209589 (label 209589.pdf) INN (CITRIC ACID MAGNESIUM OXIDE SODIUM PICOSULFATE) CLENPIQ (FERRING PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 212789 (pdf 212789.pdf not found) INN (CITRIC ACID MAGNESIUM OXIDE SODIUM PICOSULFATE) SODIUM PICOSULFATE , MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , 1602 ; ALOGLIPTIN ; 850649-61-5 ; 2013 ; ; ; CLASS METABOLISM -- TYPE 2 DIABETES MELLITUS -- INHIBITOR , ; NDA 203414 (label 203414.pdf) INN (ALOGLIPTIN BENZOATE METFORMIN HYDROCHLORIDE) KAZANO (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 022271 (label 22271.pdf) INN (ALOGLIPTIN BENZOATE) NESINA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 022426 (label 22426.pdf) INN (ALOGLIPTIN BENZOATE PIOGLITAZONE HYDROCHLORIDE) OSENI (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 , NDA 210160 (pdf 210160.pdf not found) INN (ALOGLIPTIN METFORMIN HYDROCHLORIDE) ALOGLIPTIN METFORMIN HYDROCHLORIDE (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2018 , NDA 210213 (pdf 210213.pdf not found) INN (ALOGLIPTIN BENZOATE) ALOGLIPTIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2019 , NDA 210002 (pdf 210002.pdf not found) INN (ALOGLIPTIN BENZOATE) ALOGLIPTIN (INDOCO REMEDIES) APPROVAL= TA YEAR= 2019 , NDA 210212 (pdf 210212.pdf not found) INN (ALOGLIPTIN METFORMIN HYDROCHLORIDE) ALOGLIPTIN AND METFORMIN HYDROCHLORIDE (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2019 , 1603 ; CANAGLIFLOZIN ; 842133-18-0 ; 2013 ; ; ; CLASS METABOLISM -- TYPE 2 DIABETES MELLITUS -- SODIUM-GLUCOSE CO-TRANSPORTER 2 INHIBITOR , ; NDA 204042 (label 204042.pdf) INN (CANAGLIFLOZIN) INVOKANA (JANSSEN PHARMS) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 204353 (label 204353.pdf) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) INVOKAMET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2014 , NDA 205879 (label 205879.pdf) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) INVOKAMET XR (JANSSEN PHARMS) APPROVAL= AP YEAR= 2016 , NDA 210297 (pdf 210297.pdf not found) INN (CANAGLIFLOZIN) CANAGLIFLOZIN (SANDOZ INC) APPROVAL= TA YEAR= 2020 , NDA 210451 (pdf 210451.pdf not found) INN (CANAGLIFLOZIN) CANAGLIFLOZIN (TEVA PHARMS USA) APPROVAL= TA YEAR= 2022 , NDA 210503 (pdf 210503.pdf not found) INN (CANAGLIFLOZIN) CANAGLIFLOZIN (LAURUS LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 210541 (pdf 210541.pdf not found) INN (CANAGLIFLOZIN) CANAGLIFLOZIN (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2023 , NDA 210542 (pdf 210542.pdf not found) INN (CANAGLIFLOZIN METFORMIN HYDROCHLORIDE) CANAGLIFLOZIN METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2023 , 1604 ; GLYCEROL PHENYLBUTYRATE ; 611168-24-2 ; 2013 ; ; ; CLASS NITROGEN-BINDING AGENT FOR CHRONIC UREAC CYCLE DISORDERS (UCDS) -- AMMONIA SCAVENGER -- SUBSTRATE METABOLIZED BY LIPASES (PANCREATIC TRIGLYCERIDE LIPASE, CARBOXYL ESTER LIPASE, AND PANCREATIC LIPASE–RELATED PROTEIN 2) AND BY ESTERASES IN HUMAN PLASMA (IN VITRO) , ; NDA 203284 (label 203284.pdf) INN (GLYCEROL PHENYLBUTYRATE) RAVICTI (HORIZON THERAP US) APPROVAL= AP YEAR= 2013 , NDA 205742 (pdf 205742.pdf not found) INN (GLYCEROL PHENYLBUTYRATE) GLYCEROL PHENYLBUTYRATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 215139 (pdf 215139.pdf not found) INN (GLYCEROL PHENYLBUTYRATE) GLYCEROL PHENYLBUTYRATE (ANNORA PHARMA) APPROVAL= TA YEAR= 2022 , 1605 ; VILANTEROL ; 503068-34-6 ; 2013 ; ; ; CLASS RESPIRATORY -- LONG-ACTING BETA2-ADRENERGIC AGONIST (LABA) -- BRONCHIAL SMOOTH MUSCLE -- TREATMENT OF AIRFLOW OBSTRUCTION AND FOR REDUCING EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) , ; NDA 204275 (label 204275.pdf) INN (FLUTICASONE FUROATE VILANTEROL TRIFENATATE) BREO ELLIPTA (GLAXO GRP LTD) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 203975 (label 203975.pdf) INN (UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE) ANORO ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2013 , NDA 209482 (label 209482.pdf) INN (FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE) TRELEGY ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2017 , 1606 ; NEOSTIGMINE ; 59-99-4 ; 2013 ; ; ; CLASS NERVOUS SYSTEM -- CHOLINESTERASE INHIBITOR -- REVERSAL OF THE EFFECTS OF NON-DEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS (NMBAS) AFTER SURGERY , ; NDA 204078 (label 204078.pdf) INN (NEOSTIGMINE METHYLSULFATE) BLOXIVERZ (EXELA PHARMA) APPROVAL= AP YEAR= 2013 , NDA 203629 (label 203629.pdf) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2015 , NDA 207042 (label 207042.pdf) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (HIKMA) APPROVAL= AP YEAR= 2015 , NDA 208405 (pdf 208405.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209933 (pdf 209933.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (AMPHASTAR PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 209182 (pdf 209182.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (AM REGENT) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 209135 (pdf 209135.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (DR REDDYS) APPROVAL= AP YEAR= 2018 , NDA 210051 (pdf 210051.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (AMNEAL) APPROVAL= AP YEAR= 2018 , NDA 210989 (pdf 210989.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (AMRING PHARMS) APPROVAL= AP YEAR= 2018 , NDA 212512 (pdf 212512.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (BE PHARMS) APPROVAL= AP YEAR= 2019 , NDA 212968 (pdf 212968.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212804 (pdf 212804.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (MEITHEAL) APPROVAL= AP YEAR= 2021 , NDA 213074 (pdf 213074.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 210652 (pdf 210652.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (INDOCO) APPROVAL= AP YEAR= 2021 , NDA 216291 (pdf 216291.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (DR REDDYS) APPROVAL= AP YEAR= 2022 , NDA 208230 (pdf 208230.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYSULFATE (AVET LIFESCIENCES) APPROVAL= AP YEAR= 2022 , NDA 212627 (pdf 212627.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 216206 (pdf 216206.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (HIKMA) APPROVAL= AP YEAR= 2022 , NDA 216542 (pdf 216542.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 216903 (label 216903.pdf) INN (GLYCOPYRROLATE NEOSTIGMINE METHYLSULFATE) PREVDUO (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2023 , NDA 213244 (pdf 213244.pdf not found) INN (NEOSTIGMINE METHYLSULFATE) NEOSTIGMINE METHYLSULFATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 , 1607 ; PHENYLACETATE ; 7631-42-7 ; 0 ; ; NATURAL MOLECULE C00000750 ; CLASS NITROGEN-BINDING AGENT FOR CHRONIC UREAC CYCLE DISORDERS (UCDS) -- AMMONIA SCAVENGER -- SUBSTRATE METABOLIZED BY PHENYLACETYL-COA: L-GLUTAMINE-N-ACETYLTRANSFERASE -- COMPOUND THAT CONJUGATES WITH GLUTAMINE VIA ACETYLATION TO FORM PHENYLACETYLGLUTAMINE -- PHENYLACETYLGLUTAMINE THEN IS EXCRETED BY THE KIDNEYS -- ON A MOLAR BASIS, IT IS COMPARABLE TO UREA (EACH CONTAINING TWO MOLES OF NITROGEN) -- THEREFORE, PHENYLACETYLGLUTAMINE PROVIDES AN ALTERNATE VEHICLE FOR WASTE NITROGEN EXCRETION , ; 1608 ; M PICOSULFATE ; 603-41-8 ; 0 ; ; ; CLASS METABOLISM -- LAXATIVE -- STIMULATE COLONIC PERISTALSIS , ; 1609 ; NORFLUOXETINE ; 83891-03-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) -- INHIBITION OF CNS NEURONAL UPTAKE OF SEROTONIN , ; 1610 ; NORFLUOXETINE ; 83891-03-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) -- INHIBITION OF CNS NEURONAL UPTAKE OF SEROTONIN , ; 1611 ; DIACETOLOL ; 22568-64-5 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ANTIARRHYTHMIC -- ADRENERGIC (BETA) BLOCKER , ; 1612 ; DIACETOLOL ; 22568-64-5 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ANTIARRHYTHMIC -- ADRENERGIC (BETA) BLOCKER , ; 1613 ; PYRAZINOIC ACID ; 98-97-5 ; 0 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIFUNGAL -- ANTIBIOTIC -- ANTIBACTERIAL -- ANALOGUE OF NICOTINAMIDE , ; 1614 ; RIOCIGUAT ; 625115-55-1 ; 2013 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH) -- PULMONARY ARTERIAL HYPERTENSION (PAH) -- GUANYLATE CYCLASE (SGC) STIMULATOR (RECEPTOR FOR NITRIC OXIDE (NO)) , ; NDA 204819 (label 204819.pdf) INN (RIOCIGUAT) ADEMPAS (BAYER HLTHCARE) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 211044 (pdf 211044.pdf not found) INN (RIOCIGUAT) RIOCIGUAT (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2022 , NDA 211135 (pdf 211135.pdf not found) INN (RIOCIGUAT) RIOCIGUAT (MSN) APPROVAL= AP YEAR= 2022 , 1615 ; MACITENTAN ; 441798-33-0 ; 2013 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- PULMONARY ARTERIAL HYPERTENSION (PAH) -- ENDOTHELIN RECEPTOR ANTAGONIST ET-1 -- PREVENTS THE BINDING OF ET-1 TO ITS RECEPTORS ETA AND ETB , ; NDA 204410 (label 204410.pdf) INN (MACITENTAN) OPSUMIT (ACTELION) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 211123 (pdf 211123.pdf not found) INN (MACITENTAN) MACITENTAN (SUN PHARM INDS) APPROVAL= TA YEAR= 2021 , NDA 211224 (pdf 211224.pdf not found) INN (MACITENTAN) MACITENTAN (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211195 (pdf 211195.pdf not found) INN (MACITENTAN) MACITENTAN (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 211136 (pdf 211136.pdf not found) INN (MACITENTAN) MACITENTAN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , NDA 211198 (pdf 211198.pdf not found) INN (MACITENTAN) MACITENTAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214112 (pdf 214112.pdf not found) INN (MACITENTAN) MACITENTAN (RHODES PHARMS) APPROVAL= TA YEAR= 2023 , NDA 211107 (pdf 211107.pdf not found) INN (MACITENTAN) MACITENTAN (TORRENT PHARMS LTD) APPROVAL= TA YEAR= 2024 , NDA 218490 (pdf 218490.pdf not found) INN (MACITENTAN TADALAFIL) OPSYNVI (ACTELION) APPROVAL= AP YEAR= 2024 , 1616 ; APROCITENTAN ; 1103522-45-7 ; 2024 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- PULMONARY ARTERIAL HYPERTENSION (PAH) -- ENDOTHELIN RECEPTOR ANTAGONIST ET-1 -- PREVENTS THE BINDING OF ET-1 TO ITS RECEPTORS ETA AND ETB -- METABOLITE 20 PERCENT AS POTENT AS THE PARENT DRUG IN VITRO , ; NDA 217686 (label 217686.pdf) INN (APROCITENTAN) TRYVIO (IDORSIA) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 1617 ; VORTIOXETINE ; 508233-74-7 ; 2013 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER -- ENHANCEMENT OF SEROTONERGIC ACTIVITY -- INHIBITION OF THE REUPTAKE OF SEROTONIN (5-HT) -- SEROTONIN TRANSPORTER INHIBITOR (KI=1.6 NANOMOLAR) -- 5-HT3 RECEPTOR ANTAGONIST (KI=3.7 NANOMOLAR) AND 5-HT1A RECEPTOR AGONIST (KI=15 NANOMOLAR), 5-HT7 (KI=19 NM), 5-HT1D (KI=54 NM), AND 5-HT1B (KI=33 NM), RECEPTORS AND IS A 5-HT3, 5-HT1D, AND 5-HT7 RECEPTOR ANTAGONIST, 5-HT1B RECEPTOR PARTIAL AGONIST, AND 5-HT1A RECEPTOR AGONIST. , ; NDA 204447 (label 204447.pdf) INN (VORTIOXETINE HYDROBROMIDE) TRINTELLIX (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 211085 (pdf 211085.pdf not found) INN (VORTIOXETINE) VORTIOXETINE (CIPLA LTD) APPROVAL= TA YEAR= 2019 , NDA 211089 (pdf 211089.pdf not found) INN (VORTIOXETINE) VORTIOXETINE (ALKEM LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 211101 (pdf 211101.pdf not found) INN (VORTIOXETINE HYDROBROMIDE) VORTIOXETINE HYDROBROMIDE (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2021 , NDA 211146 (pdf 211146.pdf not found) INN (VORTIOXETINE HYDROBROMIDE) VORTIOXETINE HYDROBROMIDE (ZYDUS PHARMS) APPROVAL= TA YEAR= 2024 , NDA 211024 (pdf 211024.pdf not found) INN (VORTIOXETINE) VORTIOXETINE (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , 1618 ; AFATINIB ; 850140-72-6 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER -- TYROSINE KINASE INHIBITOR -- COVALENTLY BINDS TO THE KINASE DOMAINS OF EGFR (ERBB1), HER2 (ERBB2), AND HER4 (ERBB4) AND IRREVERSIBLY INHIBITS TYROSINE KINASE AUTOPHOSPHORYLATION, RESULTING IN DOWNREGULATION OF ERBB SIGNALING , ; NDA 201292 (label 201292.pdf) INN (AFATINIB DIMALEATE) GILOTRIF (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 210804 (pdf 210804.pdf not found) INN (AFATINIB) AFATINIB (MSN PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2023 , 1619 ; LEVOMILNACIPRAN ; 96847-54-0 ; 2013 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER -- SEROTONIN (KI=11 NANOMOLAR) AND NOREPINEPHRINE (KI=91 NANOMOLAR) REUPTAKE INHIBITOR , ; NDA 204168 (label 204168.pdf) INN (LEVOMILNACIPRAN HYDROCHLORIDE) FETZIMA (ABBVIE) APPROVAL= AP YEAR= 2013 , NDA 210790 (pdf 210790.pdf not found) INN (LEVOMILNACIPRAN HYDROCHLORIDE) LEVOMILNACIPRAN HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 210805 (pdf 210805.pdf not found) INN (LEVOMILNACIPRAN) LEVOMILNACIPRAN (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2020 , NDA 210732 (pdf 210732.pdf not found) INN (LEVOMILNACIPRAN HYDROCHLORIDE) LEVOMILNACIPRAN HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210771 (pdf 210771.pdf not found) INN (LEVOMILNACIPRAN HYDROCHLORIDE) LEVOMILNACIPRAN HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2023 , NDA 210826 (pdf 210826.pdf not found) INN (LEVOMILNACIPRAN HYDROCHLORIDE) LEVOMILNACIPRAN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 210857 (pdf 210857.pdf not found) INN (LEVOMILNACIPRAN) LEVOMILNACIPRAN (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2023 , 1620 ; ESLICARBAZEPINE ; 104746-04-5 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTICS -- ANTICONVULSANT , ; 1621 ; ESLICARBAZEPINE ACETATE ; 236395-14-5 ; 2013 ; ; ; CLASS NERVOUS SYSTEM -- ANTIEPILEPTICS , ; NDA 022416 (label 22416.pdf) INN (ESLICARBAZEPINE ACETATE) APTIOM (SUMITOMO PHARMA AM) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 211199 (pdf 211199.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 211238 (pdf 211238.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (DR REDDYS) APPROVAL= AP YEAR= 2021 , NDA 216481 (pdf 216481.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2023 , NDA 211186 (pdf 211186.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 211236 (pdf 211236.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 211227 (pdf 211227.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (TORRENT) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 211246 (pdf 211246.pdf not found) INN (ESLICARBAZEPINE ACETATE) ESLICARBAZEPINE ACETATE (LUPIN LTD) APPROVAL= AP YEAR= 2024 , 1622 ; DOLUTEGRAVIR ; 1051375-16-6 ; 2013 ; ; ; CLASS ANTIINFECTIVES -- HIV-1 ANTIVIRAL AGENT -- HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INTEGRASE STRAND TRANSFER INHIBITOR -- P-GLYCOPROTEIN SUBSTRATE , ; NDA 204790 (label 204790.pdf) INN (DOLUTEGRAVIR SODIUM) TIVICAY (VIIV HLTHCARE) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 205551 (label 205551.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ (VIIV HLTHCARE) APPROVAL= AP YEAR= 2014 , NDA 208355 (pdf 208355.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2016 , NDA 209670 (pdf 209670.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE , AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017 , NDA 210192 (label 210192.pdf) INN (DOLUTEGRAVIR SODIUM RILPIVIRINE HYDROCHLORIDE) JULUCA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2017 , NDA 210787 (pdf 210787.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 211994 (label 211994.pdf) INN (DOLUTEGRAVIR SODIUM LAMIVUDINE) DOVATO (VIIV HLTHCARE) APPROVAL= AP YEAR= 2019 , NDA 209602 (pdf 209602.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (MYLAN LABS LTD) APPROVAL= TA YEAR= 2018 , NDA 209658 (pdf 209658.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (CIPLA LTD) APPROVAL= TA YEAR= 2018 , NDA 210963 (pdf 210963.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 212179 (pdf 212179.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (MICRO LABS LTD) APPROVAL= TA YEAR= 2019 , NDA 213983 (label 213983.pdf) INN (DOLUTEGRAVIR SODIUM) TIVICAY PD (VIIV HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 213556 (pdf 213556.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD) APPROVAL= TA YEAR= 2020 , NDA 210812 (pdf 210812.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (CIPLA LTD) APPROVAL= TA YEAR= 2021 , NDA 212303 (pdf 212303.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR , LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN PHARMS) APPROVAL= TA YEAR= 2021 , NDA 214397 (pdf 214397.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2021 , NDA 214566 (pdf 214566.pdf not found) INN (DOLUTEGRAVIR SODIUM) DOLUTEGRAVIR SODIUM (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2021 , NDA 210796 (pdf 210796.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2019 , NDA 212527 (pdf 212527.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE (CIPLA USA INC.) APPROVAL= TA YEAR= 2022 , NDA 215413 (label 215413.pdf) INN (ABACAVIR SULFATE DOLUTEGRAVIR SODIUM LAMIVUDINE) TRIUMEQ PD (VIIV HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 216223 (pdf 216223.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 213120 (pdf 213120.pdf not found) INN (DOLUTEGRAVIR RILPIVIRINE) DOLUTEGRAVIR RILPIVIRINE (LUPIN LTD) APPROVAL= TA YEAR= 2023 , NDA 214544 (pdf 214544.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE (LUPIN LTD) APPROVAL= TA YEAR= 2023 , NDA 215319 (pdf 215319.pdf not found) INN (DOLUTEGRAVIR) DOLUTEGRAVIR (LAURUS GENERICS INC) APPROVAL= TA YEAR= 2023 , NDA 215448 (pdf 215448.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , NDA 211868 (pdf 211868.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 215187 (pdf 215187.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIRLAMIVUDINETENOFOVIR ALAFENAMIDE (LUPIN PHARMS) APPROVAL= TA YEAR= 2023 , NDA 217016 (pdf 217016.pdf not found) INN (DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE) DOLUTEGRAVIR TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE (STRIDES PHARMA) APPROVAL= TA YEAR= 2023 , NDA 217070 (pdf 217070.pdf not found) INN (ABACAVIR DOLUTEGRAVIR LAMIVUDINE) ABACAVIR DOLUTEGRAVIR LAMIVUDINE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , 1623 ; IBRUTINIB ; 936563-96-1 ; 2013 ; ; ; CLASS ANTINEOPLASTIC -- COVALENT KINASE INHIBITOR -- TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA, CHRONIC LYMPHOCYTIC LEUKEMIA , ; NDA 205552 (label 205552.pdf) INN (IBRUTINIB) IMBRUVICA (PHARMACYCLICS LLC) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 210563 (label 210563.pdf) INN (IBRUTINIB) IMBRUVICA (PHARMACYCLICS LLC) APPROVAL= AP YEAR= 2018 , NDA 211267 (pdf 211267.pdf not found) INN (IBRUTINIB) IBRUTINIB (SANDOZ INC) APPROVAL= TA YEAR= 2022 , NDA 211344 (pdf 211344.pdf not found) INN (IBRUTINIB) IBRUTINIB (ZYDUS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211350 (pdf 211350.pdf not found) INN (IBRUTINIB) IBRUTINIB (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2021 , NDA 212763 (pdf 212763.pdf not found) INN (IBRUTINIB) IBRUTINIB (ALVOGEN PINE BROOK) APPROVAL= TA YEAR= 2021 , NDA 214498 (pdf 214498.pdf not found) INN (IBRUTINIB) IBRUTINIB (ALVOGEN INC) APPROVAL= TA YEAR= 2021 , NDA 214296 (pdf 214296.pdf not found) INN (IBRUTINIB) IBRUTINIB (ZYDUS WORLDWIDE DMCC) APPROVAL= TA YEAR= 2021 , NDA 217003 (label 217003.pdf) INN (IBRUTINIB) IMBRUVICA (PHARMACYCLICS LLC) APPROVAL= AP YEAR= 2022 , NDA 215464 (pdf 215464.pdf not found) INN (IBRUTINIB) IBRUTINIB (SANDOZ INC) APPROVAL= TA YEAR= 2023 , 1624 ; MONOMETHYL FUMARATE ; 2756-87-8 ; 2020 ; ; ; CLASS IMMUNOSUPPRESSANTS -- TREATMENT OF TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS -- ACTIVATES THE NUCLEAR FACTOR (ERYTHROID-DERIVED 2)-LIKE 2 (NRF2) PATHWAY -- NICOTINIC ACID RECEPTOR AGONIST , ; NDA 210296 (label 210296.pdf) INN (MONOMETHYL FUMARATE) BAFIERTAM (BANNER LIFE SCIENCES) APPROVAL= AP YEAR= 2020 , 1625 ; DIMETHYL FUMARATE ; 624-49-7 ; 2013 ; ; ; CLASS IMMUNOSUPPRESSANTS -- TREATMENT OF TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS -- ACTIVATES THE NUCLEAR FACTOR (ERYTHROID-DERIVED 2)-LIKE 2 (NRF2) PATHWAY -- METABOLITE MONOMETHYL FUMARATE IS A NICOTINIC ACID RECEPTOR AGONIST , ; NDA 204063 (label 204063.pdf) INN (DIMETHYL FUMARATE) TECFIDERA (BIOGEN INC) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 210226 (pdf 210226.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (LUPIN) APPROVAL= AP YEAR= 2020 , NDA 210291 (pdf 210291.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (SHILPA MEDICARE LTD) APPROVAL= TA YEAR= 2018 , NDA 210499 (pdf 210499.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2020 , NDA 210538 (pdf 210538.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 210382 (pdf 210382.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (TWI PHARMS) APPROVAL= AP YEAR= 2020 , NDA 210309 (pdf 210309.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2020 , NDA 210305 (pdf 210305.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2020 , NDA 210402 (pdf 210402.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 210440 (pdf 210440.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020 , NDA 210460 (pdf 210460.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (MSN) APPROVAL= AP YEAR= 2020 , NDA 210500 (pdf 210500.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 , NDA 210531 (pdf 210531.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2020 , NDA 210436 (pdf 210436.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (SOLA PHARMS) APPROVAL= AP YEAR= 2021 , NDA 210285 (pdf 210285.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (SAWAI USA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 210385 (pdf 210385.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210414 (pdf 210414.pdf not found) INN (DIMETHYL FUMARATE) DIMETHYL FUMARATE (PRINSTON INC) APPROVAL= AP YEAR= 2022 , 1626 ; SOFOSBUVIR ; 1190307-88-0 ; 2013 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF CHRONIC HEPATITIS C (CHC) INFECTION -- HEPATITIS C VIRUS (HCV) NUCLEOTIDE ANALOG NS5B POLYMERASE INHIBITOR , ; NDA 204671 (label 204671.pdf) INN (SOFOSBUVIR) SOVALDI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , NDA 205834 (label 205834.pdf) INN (LEDIPASVIR SOFOSBUVIR) HARVONI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 , NDA 208341 (label 208341.pdf) INN (SOFOSBUVIR VELPATASVIR) EPCLUSA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 209195 (label 209195.pdf) INN (SOFOSBUVIR VELPATASVIR VOXILAPREVIR) VOSEVI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2017 , NDA 212477 (label 212477.pdf) INN (LEDIPASVIR SOFOSBUVIR) HARVONI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2019 , NDA 212480 (label 212480.pdf) INN (SOFOSBUVIR) SOVALDI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2019 , NDA 214187 (label 214187.pdf) INN (SOFOSBUVIR VELPATASVIR) EPCLUSA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2021 , NDA 211353 (pdf 211353.pdf not found) INN (SOFOSBUVIR) SOFOSBUVIR (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1627 ; M SOFOSBUVIR ; 1015073-42-3 ; 0 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF CHRONIC HEPATITIS C (CHC) INFECTION -- HEPATITIS C VIRUS (HCV) NUCLEOTIDE ANALOG NS5B POLYMERASE INHIBITOR , ; 1628 ; SIMEPREVIR ; 923604-59-5 ; 2013 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS3/4A PROTEASE INHIBITOR -- TREATMENT OF CHRONIC HEPATITIS C (CHC) INFECTION -- A SUBSTRATE OF P-GP , ; NDA 205123 (label 205123.pdf) INN (SIMEPREVIR SODIUM) OLYSIO (JANSSEN PRODS) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY DISCONTINUED , 1629 ; UMECLIDINIUM ; 869113-09-7 ; 2013 ; ; ; CLASS RESPIRATORY -- ANTICHOLINERGIC -- ANTIMUSCARINIC AGENT -- MUSCARINIC RECEPTORS ANTAGONISTS -- INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) , ; NDA 203975 (label 203975.pdf) INN (UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE) ANORO ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2013 , NDA 205382 (label 205382.pdf) INN (UMECLIDINIUM BROMIDE) INCRUSE ELLIPTA (GLAXO GRP ENGLAND) APPROVAL= AP YEAR= 2014 , NDA 209482 (label 209482.pdf) INN (FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE) TRELEGY ELLIPTA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2017 , 1630 ; BAZEDOXIFENE ; 198481-32-2 ; 2013 ; ; ; CLASS GENITO -- TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE -- AGONIST OF ESTROGEN RECEPTORS (ER) ALPHA AND BETA , ; NDA 022247 (label 22247.pdf) INN (BAZEDOXIFENE ACETATE ESTROGENS CONJUGATED) DUAVEE (WYETH PHARMS) APPROVAL= AP YEAR= 2013 , 1631 ; LULICONAZOLE ; 187164-19-8 ; 2013 ; ; ; CLASS ANTIINFECTIVES -- AZOLE ANTIFUNGAL -- TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS, TINEA CRURIS, AND TINEA CORPORIS CAUSED BY THE ORGANISMS TRICHOPHYTON RUBRUM AND EPIDERMOPHYTON FLOCCOSUM -- APPEARS TO INHIBIT ERGOSTEROL SYNTHESIS (CONSTITUENT OF FUNGAL CELL MEMBRANES) BY INHIBITING THE ENZYME LANOSTEROL DEMETHYLASE , ; NDA 204153 (label 204153.pdf) INN (LULICONAZOLE) LUZU (BAUSCH) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , 1632 ; POLIDOCANOL ; 9002-92-0 ; 2010 ; ; ; CLASS CARDIOVASCULAR -- SCLEROSING AGENTS FOR LOCAL INJECTION -- ANTIVARICOSE THERAPY -- DAMAGING EFFECT ON THE ENDOTHELIUM OF BLOOD VESSELS -- ATTACHES TO THE LIPID CELL MEMBRANE OF THE VENOUS ENDOTHELIUM, RESULTING IN DISRUPTION OF THE OSMOTIC BARRIER, DESTRUCTION OF THE VENOUS ENDOTHELIUM, AND VASOSPASM , ; NDA 205098 (label 205098.pdf) INN (POLIDOCANOL) VARITHENA (PROVENSIS) APPROVAL= AP YEAR= 2013 , NDA 021201 (label 21201.pdf) INN (POLIDOCANOL) ASCLERA (CHEMISCH FBRK KRSSLR) APPROVAL= AP YEAR= 2010 NEWMOLECULARENTITY , 1633 ; CEFPODOXIME ; 80210-62-4 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS -- CELL WALL SYNTHESIS , ; 1634 ; CEFPROZIL ; 92665-29-7 ; 1991 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- ANTIBACTERIAL -- CEPHALOSPORINS , ; NDA 050664 (label 50664.pdf) INN (CEFPROZIL) CEFZIL (CORDEN PHARMA) APPROVAL= AP YEAR= 1991 NEWMOLECULARENTITY DISCONTINUED , NDA 050665 (label 50665.pdf) INN (CEFPROZIL) CEFZIL (CORDEN PHARMA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 065198 (pdf 65198.pdf not found) INN (CEFPROZIL) CEFPROZIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065202 (pdf 65202.pdf not found) INN (CEFPROZIL) CEFPROZIL (RANBAXY LABS LTD) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 065208 (pdf 65208.pdf not found) INN (CEFPROZIL) CEFPROZIL (TEVA) APPROVAL= AP YEAR= 2005 , NDA 065235 (pdf 65235.pdf not found) INN (CEFPROZIL) CEFPROZIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 , NDA 065236 (pdf 65236.pdf not found) INN (CEFPROZIL) CEFPROZIL (CHARTWELL RX) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065257 (pdf 65257.pdf not found) INN (CEFPROZIL) CEFPROZIL (SANDOZ) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065261 (pdf 65261.pdf not found) INN (CEFPROZIL) CEFPROZIL (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065267 (pdf 65267.pdf not found) INN (CEFPROZIL) CEFPROZIL (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065276 (pdf 65276.pdf not found) INN (CEFPROZIL) CEFPROZIL (LUPIN) APPROVAL= AP YEAR= 2005 , NDA 065284 (pdf 65284.pdf not found) INN (CEFPROZIL) CEFPROZIL (ORCHID HLTHCARE) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 065327 (pdf 65327.pdf not found) INN (CEFPROZIL) CEFPROZIL (APOTEX INC) APPROVAL= AP YEAR= 2008 , NDA 065340 (pdf 65340.pdf not found) INN (CEFPROZIL) CEFPROZIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065381 (pdf 65381.pdf not found) INN (CEFPROZIL) CEFPROZIL (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2007 , NDA 065428 (pdf 65428.pdf not found) INN (CEFPROZIL) CEFPROZIL (WOCKHARDT) APPROVAL= AP YEAR= 2007 DISCONTINUED , NDA 065351 (pdf 65351.pdf not found) INN (CEFPROZIL) CEFPROZIL (APOTEX INC) APPROVAL= AP YEAR= 2012 , NDA 090857 (pdf 90857.pdf not found) INN (CEFPROZIL) CEFPROZIL (ALKEM LABS LTD) APPROVAL= AP YEAR= 2024 , 1635 ; CEFAMANDOLE ; 34444-01-4 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL -- ANTIBIOTIC -- CEPHALOSPORINS , ; 1636 ; DAUNORUBICINOL ; 28008-55-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIBIOTICS -- CYTOTOXIC -- ANTIMITOTIC -- ANTHRACYCLINES -- INDICATED FOR REMISSION INDUCTION IN ACUTE NONLYMPHOCYTIC LEUKEMIA -- INTERCALANT , ; 1637 ; M TETRABENAZINE ; 85081-18-1 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- CNS -- TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON DISEASE -- INHIBITOR -- IS BELIEVED TO BE RELATED TO ITS EFFECT AS A REVERSIBLE DEPLETOR OF MONOAMINES (SUCH AS DOPAMINE, SEROTONIN, NOREPINEPHRINE, AND HISTAMINE) FROM NERVE TERMINALS -- VESICULAR MONOAMINE TRANSPORTER TYPE 2 (VMAT2) (KI=100 NANOMOLAR) , ; 1638 ; M TETRABENAZINE ; 164104-49-8 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- CNS -- TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON DISEASE -- INHIBITOR -- IS BELIEVED TO BE RELATED TO ITS EFFECT AS A REVERSIBLE DEPLETOR OF MONOAMINES (SUCH AS DOPAMINE, SEROTONIN, NOREPINEPHRINE, AND HISTAMINE) FROM NERVE TERMINALS -- VESICULAR MONOAMINE TRANSPORTER TYPE 2 (VMAT2) (KI=100 NANOMOLAR) , ; 1639 ; M NELARABINE ; 72490-81-4 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL LYMPHOBLASTIC LYMPHOMA -- FOR INCORPORATION INTO DE OXYRIBONUCLEIC ACID (DNA) , ; 1640 ; M ENTECAVIR ; 336608-44-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI HEPATITIS B -- GUANOSINE NUCLEOSIDE ANALOG , ; 1641 ; M CLOFARABINE ; 134646-41-6 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- PURINE ANALOGUES -- INHIBITS DNA SYNTHESIS , ; 1642 ; M CICLESONIDE ; 161115-59-9 ; 0 ; ; ; CLASS RESPIRATORY -- ANTIINFLAMMATORY -- ANTI-ALLERGIC AGENTS -- GLUCOCORTICOIDS , ; 1643 ; TIZOXANIDE ; 173903-47-4 ; 0 ; ; ; CLASS ANTIPARASITIC-- ANTHELMINTIC -- ANTIPROTOZOAL -- INTERFERENCE WITH PYRUVATE:FERREDOXIN OXIDOREDUCTASE (PFOR) ENZYME DEPENDENT ELECTRON TRANSFER REACTION WHICH IS ESSENTIAL TO ANAEROBIC ENERGY METABOLISM , ; 1644 ; ADEFOVIR ; 106941-25-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGENTS -- REVERSE TRANSCRIPTASE INHIBITORS -- TREATMENT OF CHRONIC HEPATITIS B , ; 1645 ; M GANCICLOVIR ; 86761-38-8 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- CYTOMEGALOVIRUS (CMV) -- HERPES SIMPLEX VIRUS (HSV) -- COMPETITIVE INHIBITION OF VIRAL DNA POLYMERASES -- INCORPORATION INTO VIRAL DNA RESULTING IN EVENTUAL TERMINATION OF VIRAL DNA ELONGATION -- NUCLEOSIDE ANALOGUE , ; 1646 ; M GANCICLOVIR ; 86761-38-8 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- CYTOMEGALOVIRUS (CMV) -- HERPES SIMPLEX VIRUS (HSV) -- COMPETITIVE INHIBITION OF VIRAL DNA POLYMERASES -- INCORPORATION INTO VIRAL DNA RESULTING IN EVENTUAL TERMINATION OF VIRAL DNA ELONGATION -- NUCLEOSIDE ANALOGUE , ; 1647 ; OLMESARTAN ; 144689-24-7 ; 0 ; ; ; CLASS CARDIOVASCULAR -- SELECTIVE AT1 SUBTYPE ANGIOTENSIN II RECEPTOR INHIBITOR PRODRUG -- ANTIHYPERTENSIVE -- TREATMENT OF HYPERTENSION , ; 1648 ; M TRAVOPROST ; 54276-17-4 ; 0 ; ; ; CLASS SENSORY --ANTIHYPERTENSIVE -- ANTIGLAUCOMA -- OPHTHALMOLOGICALS -- PROSTAGLANDIN ANALOGUES -- FP PROSTANOID RECEPTOR AGONIST , ; 1649 ; M DESLORATADINE ; 119410-08-1 ; 0 ; ; ; CLASS RESPIRATORY -- HISTAMINE H1 RECEPTOR ANTAGONIST -- ANTIHISTAMINE -- CHOLINERGIC ANTAGONISTS , ; 1650 ; CYCLOGUANIL ; 516-21-2 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- ANTIMETABOLITES -- DIHYDROFOLATE REDUCTASE INHIBITOR , ; 1651 ; M TEMOZOLOMIDE ; 3413-72-7 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ALKYLATING DNA -- ALKYLATION (METHYLATION) OCCURS MAINLY AT THE O6 AND N7 POSITIONS OF GUANINE , ; 1652 ; M RIFAPENTINE ; 79039-56-8 ; 0 ; ; ; CLASS ANTIINFECTIVES -- TUBERCULOSTATIC -- ANTIBIOTIC -- RIFAMYCIN ANTIMYCOBACTERIALS -- INHIBITS DNA-DEPENDENT RNA POLYMERASE , ; 1653 ; M OXCARBAZEPINE ; 104746-03-4 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC , ; 1654 ; M FLUOROURACIL ; 134-46-3 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- BREAST CANCER -- COLORECTAL CANCER -- COLON CANCER -- ANTIMETABOLITES -- NUCLEOSIDE METABOLIC INHIBITOR -- INHIBITS THE FORMATION OF THYMIDYLATE FROM 2’-DEOXYURIDYLATE , ; 1655 ; M FLUOROURACIL ; 2710-64-7 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- BREAST CANCER -- COLORECTAL CANCER -- COLON CANCER -- ANTIMETABOLITES -- NUCLEOSIDE METABOLIC INHIBITOR -- NUCLEAR TRANSCRIPTIONAL ENZYMES CAN MISTAKENLY INCORPORATE FUTP IN PLACE OF URIDINE TRIPHOSPHATE (UTP) DURING THE SYNTHESIS OF RNA , ; 1656 ; M ALBENDAZOLE ; 54029-12-8 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- ANTIPROTOZOAL AGENTS -- TUBULIN MODULATORS -- INHIBITORY EFFECT ON TUBULIN POLYMERIZATION -- ANTIMALARIALS , ; 1657 ; M SIBUTRAMINE ; 168835-59-4 ; 0 ; ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; 1658 ; M SIBUTRAMINE ; 168835-59-4 ; 0 ; ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; 1659 ; M SIBUTRAMINE ; 84467-54-9 ; 0 ; ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; 1660 ; M SIBUTRAMINE ; 84467-54-9 ; 0 ; ; ; CLASS METABOLISM -- ANOREXIC -- ANTIDEPRESSANT -- ANTI-OBESITY -- NOREPINEPHRINE, SEROTONIN AND DOPAMINE REUPTAKE INHIBITOR , ; 1661 ; M PENCICLOVIR ; 145839-78-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- TREATMENT OF HERPES VIRUS HSV-1 AND HSV-2 , ; 1662 ; M PENCICLOVIR ; 145839-78-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- TREATMENT OF HERPES VIRUS HSV-1 AND HSV-2 , ; 1663 ; M CIDOFOVIR ; 142276-30-0 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- SUPPRESS CYTOMEGALOVIRUS (CMV) REPLICATION -- CMV DNA POLYMERASE INHIBITOR , ; 1664 ; M TAZAROTENE ; 118292-41-4 ; 0 ; ; ; CLASS DERMATOLOGIC AGENTS -- KERATOLYTIC AGENTS -- PRODRUGS -- TERATOGENS -- RETINOIDS , ; 1665 ; M LATANOPROST ; 41639-83-2 ; 0 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ANTIHYPERTENSIVE AGENTS -- PROSTANOID , ; 1666 ; M LAMIVUDINE ; 143188-53-8 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV AGENTS -- ANTI-HBV AGENTS -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS) , ; 1667 ; TRANDOLAPRILAT ; 87679-71-8 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS , ; 1668 ; M GEMCITABINE ; 116371-66-5 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES , ; 1669 ; M GEMCITABINE ; 110988-86-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES , ; 1670 ; M ACYCLOVIR ; 66341-18-2 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGAINST HERPES SIMPLEX VIRUS TYPES 1 (HSV-1), TYPES 2 (HSV-2) AND VARICELLA-ZOSTER VIRUS (VZV) , ; 1671 ; M LOSARTAN ; 124750-92-1 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE-- ANGIOTENSIN II RECEPTOR ANTAGONIST -- ANTI-ARRHYTHMIA AGENTS , ; 1672 ; NISOLDIPINE ; 63675-72-9 ; 1995 ; ; ; CLASS CARDIOVASCULAR -- CORONARY VASODILATOR -- ANTIANGINAL -- ANTIHYPERTENSIVE AGENTS -- CALCIUM CHANNEL BLOCKERS , ; NDA 020356 (label 20356.pdf) INN (NISOLDIPINE) SULAR (COVIS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY , NDA 079051 (pdf 79051.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (MYLAN) APPROVAL= AP YEAR= 2008 , NDA 091001 (pdf 91001.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (MYLAN) APPROVAL= AP YEAR= 2011 , NDA 216606 (pdf 216606.pdf not found) INN (NISOLDIPINE) NISOLDIPINE (AMTA) APPROVAL= AP YEAR= 2023 , 1673 ; MOEXIPRILAT ; 103775-14-0 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN CONVERTING ENZYME INHIBITORS , ; 1674 ; M TRAMADOL ; 144830-14-8 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; 1675 ; TRAMADOL ; 152538-36-8 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; NDA 020281 (label 20281.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM (JANSSEN PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 021123 (label 21123.pdf) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) ULTRACET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021692 (label 21692.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM ER (VALEANT PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021693 (label 21693.pdf) INN (TRAMADOL HYDROCHLORIDE) RYBIX ODT (SHIONOGI INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075960 (label 75960.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075962 (label 75962.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075963 (pdf 75963.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075964 (label 75964.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 , NDA 075968 (label 75968.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075974 (label 75974.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ASTA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075977 (label 75977.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075980 (pdf 75980.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075981 (pdf 75981.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075982 (pdf 75982.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075983 (label 75983.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075986 (label 75986.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076003 (label 76003.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076100 (label 76100.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076475 (pdf 76475.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076914 (pdf 76914.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077184 (pdf 77184.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2005 , NDA 077858 (pdf 77858.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2008 , NDA 021745 (label 21745.pdf) INN (TRAMADOL HYDROCHLORIDE) RYZOLT (PURDUE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022370 (label 22370.pdf) INN (TRAMADOL HYDROCHLORIDE) CONZIP (CIPHER PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 078783 (pdf 78783.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090485 (pdf 90485.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078935 (pdf 78935.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090404 (pdf 90404.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 091607 (pdf 91607.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200503 (pdf 200503.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 201384 (pdf 201384.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 202075 (pdf 202075.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 090460 (pdf 90460.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 091609 (pdf 91609.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200491 (pdf 200491.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201952 (pdf 201952.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2012 , NDA 201973 (pdf 201973.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202076 (pdf 202076.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091498 (pdf 91498.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (CSPC OUYI PHARM CO) APPROVAL= AP YEAR= 2013 , NDA 202390 (pdf 202390.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078778 (pdf 78778.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203494 (pdf 203494.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 205702 (pdf 205702.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204421 (label 204421.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205257 (pdf 205257.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206885 (pdf 206885.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207152 (pdf 207152.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206706 (pdf 206706.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MERRO PHARM USA) APPROVAL= AP YEAR= 2019 , NDA 208708 (pdf 208708.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 211825 (pdf 211825.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 214044 (label 214044.pdf) INN (TRAMADOL HYDROCHLORIDE) QDOLO (ATHENA) APPROVAL= AP YEAR= 2020 , NDA 213426 (label 213426.pdf) INN (CELECOXIB TRAMADOL HYDROCHLORIDE) SEGLENTIS (KOWA PHARMS) APPROVAL= AP YEAR= 2021 , 1676 ; M TRAMADOL ; 330999-27-4 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; 1677 ; TRAMADOL ; 123134-25-8 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; NDA 020281 (label 20281.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM (JANSSEN PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 021123 (label 21123.pdf) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) ULTRACET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021692 (label 21692.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM ER (VALEANT PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021693 (label 21693.pdf) INN (TRAMADOL HYDROCHLORIDE) RYBIX ODT (SHIONOGI INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075960 (label 75960.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075962 (label 75962.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075963 (pdf 75963.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075964 (label 75964.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 , NDA 075968 (label 75968.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075974 (label 75974.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ASTA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075977 (label 75977.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075980 (pdf 75980.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075981 (pdf 75981.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075982 (pdf 75982.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075983 (label 75983.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075986 (label 75986.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076003 (label 76003.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076100 (label 76100.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076475 (pdf 76475.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076914 (pdf 76914.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077184 (pdf 77184.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2005 , NDA 077858 (pdf 77858.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2008 , NDA 021745 (label 21745.pdf) INN (TRAMADOL HYDROCHLORIDE) RYZOLT (PURDUE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022370 (label 22370.pdf) INN (TRAMADOL HYDROCHLORIDE) CONZIP (CIPHER PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 078783 (pdf 78783.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090485 (pdf 90485.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078935 (pdf 78935.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090404 (pdf 90404.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 091607 (pdf 91607.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200503 (pdf 200503.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 201384 (pdf 201384.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 202075 (pdf 202075.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 090460 (pdf 90460.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 091609 (pdf 91609.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200491 (pdf 200491.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201952 (pdf 201952.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2012 , NDA 201973 (pdf 201973.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202076 (pdf 202076.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091498 (pdf 91498.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (CSPC OUYI PHARM CO) APPROVAL= AP YEAR= 2013 , NDA 202390 (pdf 202390.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078778 (pdf 78778.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203494 (pdf 203494.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 205702 (pdf 205702.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204421 (label 204421.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205257 (pdf 205257.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206885 (pdf 206885.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207152 (pdf 207152.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206706 (pdf 206706.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MERRO PHARM USA) APPROVAL= AP YEAR= 2019 , NDA 208708 (pdf 208708.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 211825 (pdf 211825.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 214044 (label 214044.pdf) INN (TRAMADOL HYDROCHLORIDE) QDOLO (ATHENA) APPROVAL= AP YEAR= 2020 , NDA 213426 (label 213426.pdf) INN (CELECOXIB TRAMADOL HYDROCHLORIDE) SEGLENTIS (KOWA PHARMS) APPROVAL= AP YEAR= 2021 , 1678 ; M TRAMADOL ; 144830-15-9 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; 1679 ; TRAMADOL ; 27203-92-5 ; 1995 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; NDA 020281 (label 20281.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM (JANSSEN PHARMS) APPROVAL= AP YEAR= 1995 NEWMOLECULARENTITY DISCONTINUED , NDA 021123 (label 21123.pdf) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) ULTRACET (JANSSEN PHARMS) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 021692 (label 21692.pdf) INN (TRAMADOL HYDROCHLORIDE) ULTRAM ER (VALEANT PHARMS) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 021693 (label 21693.pdf) INN (TRAMADOL HYDROCHLORIDE) RYBIX ODT (SHIONOGI INC) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 075960 (label 75960.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075962 (label 75962.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075963 (pdf 75963.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075964 (label 75964.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2002 , NDA 075968 (label 75968.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (GRAVITI PHARMS) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075974 (label 75974.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ASTA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075977 (label 75977.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 2002 , NDA 075980 (pdf 75980.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075981 (pdf 75981.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (APOTEX) APPROVAL= AP YEAR= 2002 , NDA 075982 (pdf 75982.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (PLIVA) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075983 (label 75983.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 075986 (label 75986.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076003 (label 76003.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2002 , NDA 076100 (label 76100.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 2002 DISCONTINUED , NDA 076475 (pdf 76475.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (STRIDES PHARMA) APPROVAL= AP YEAR= 2005 DISCONTINUED , NDA 076914 (pdf 76914.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (GRAVITI PHARMS) APPROVAL= AP YEAR= 2006 DISCONTINUED , NDA 077184 (pdf 77184.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2005 , NDA 077858 (pdf 77858.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (RISING) APPROVAL= AP YEAR= 2008 , NDA 021745 (label 21745.pdf) INN (TRAMADOL HYDROCHLORIDE) RYZOLT (PURDUE PHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 022370 (label 22370.pdf) INN (TRAMADOL HYDROCHLORIDE) CONZIP (CIPHER PHARMS INC) APPROVAL= AP YEAR= 2010 , NDA 078783 (pdf 78783.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009 DISCONTINUED , NDA 090485 (pdf 90485.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 , NDA 078935 (pdf 78935.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (NORTHSTAR HLTHCARE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090404 (pdf 90404.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2011 , NDA 091607 (pdf 91607.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 DISCONTINUED , NDA 200503 (pdf 200503.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (LUPIN LTD) APPROVAL= AP YEAR= 2011 , NDA 201384 (pdf 201384.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2011 , NDA 202075 (pdf 202075.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACI) APPROVAL= AP YEAR= 2011 , NDA 090460 (pdf 90460.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012 , NDA 091609 (pdf 91609.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 200491 (pdf 200491.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 DISCONTINUED , NDA 201952 (pdf 201952.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MICRO LABS LTD INDIA) APPROVAL= AP YEAR= 2012 , NDA 201973 (pdf 201973.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (IPCA LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 202076 (pdf 202076.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ALKEM LABS LTD) APPROVAL= AP YEAR= 2012 , NDA 091498 (pdf 91498.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (CSPC OUYI PHARM CO) APPROVAL= AP YEAR= 2013 , NDA 202390 (pdf 202390.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2013 DISCONTINUED , NDA 078778 (pdf 78778.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (NOSTRUM LABS INC) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 203494 (pdf 203494.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2014 , NDA 205702 (pdf 205702.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 204421 (label 204421.pdf) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 205257 (pdf 205257.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206885 (pdf 206885.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 207152 (pdf 207152.pdf not found) INN (ACETAMINOPHEN TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017 , NDA 206706 (pdf 206706.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (MERRO PHARM USA) APPROVAL= AP YEAR= 2019 , NDA 208708 (pdf 208708.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2019 , NDA 211825 (pdf 211825.pdf not found) INN (TRAMADOL HYDROCHLORIDE) TRAMADOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2019 , NDA 214044 (label 214044.pdf) INN (TRAMADOL HYDROCHLORIDE) QDOLO (ATHENA) APPROVAL= AP YEAR= 2020 , NDA 213426 (label 213426.pdf) INN (CELECOXIB TRAMADOL HYDROCHLORIDE) SEGLENTIS (KOWA PHARMS) APPROVAL= AP YEAR= 2021 , 1680 ; M TRAMADOL ; 144830-14-8 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- NARCOTICS -- CENTRALLY ACTING OPIOID ANALGESIC -- MU OPIOID RECEPTOR AGONIST , ; 1681 ; SPIRAPRILAT ; 83602-05-5 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS , ; 1682 ; M CLADRIBINE ; 106867-30-5 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- IMMUNOSUPPRESSIVE AGENTS -- TREATMENT OF HAIRY CELL LEUKEMIA , ; 1683 ; M AMIFOSTINE ; 31098-42-7 ; 0 ; ; ; CLASS VARIOUS -- RADIATION-PROTECTIVE AGENTS -- REDUCTION OF THE CUMULATIVE RENAL TOXICITY OF CISPLATIN AND FOR THE REDUCTION OF THE TOXIC EFFECTS OF RADIATION ON NORMAL ORAL TISSUES -- SCAVENGE REACTIVE OXYGEN SPECIES , ; 1684 ; M ZALCITABINE ; 66004-77-1 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTI-HIV AGENTS -- ANTIMETABOLITES -- NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS , ; 1685 ; PERINDOPRILAT ; 95153-31-4 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ACE INHIBITOR , ; 1686 ; M DIDANOSINE ; 122406-02-4 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- ANTI-HIV AGENTS -- ANTIMETABOLITES -- REVERSE TRANSCRIPTASE INHIBITORS , ; 1687 ; M FLUDARABINE ; 74832-57-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- IMMUNOSUPPRESSIVE AGENTS -- FLUDARABINE PHOSPHATE IS RAPIDLY DEPHOSPHORYLATED AND THEN PHOSPHORYLATED BY DEOXYCYTIDINE KINASE TO THE ACTIVE TRIPHOSPHATE , ; 1688 ; FLUDARABINE ; 21679-14-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- IMMUNOSUPPRESSIVE AGENTS -- PHOSPHORYLATED BY DEOXYCYTIDINE KINASE TO THE ACTIVE TRIPHOSPHATE , ; 1689 ; M TICLOPIDINE ; 750643-90-4 ; 0 ; ; ; CLASS BLOOD -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- FIBRINOLYTIC AGENTS -- P2Y PURINOCEPTOR 12 ANTAGONIST , ; 1690 ; M TICLOPIDINE ; 750643-90-4 ; 0 ; ; ; CLASS BLOOD -- PLATELET AGGREGATION INHIBITOR -- ANTITHROMBOTIC -- FIBRINOLYTIC AGENTS -- P2Y PURINOCEPTOR 12 ANTAGONIST , ; 1691 ; HALOBETASOL ; 98651-66-2 ; 0 ; ; ; CLASS DERMATOLOGICAL -- ANTI-INFLAMMATORY AGENTS -- VASOCONSTRICTOR AGENTS -- CORTICOSTEROIDS -- ANTIPRURITIC , ; 1692 ; FOSINOPRILAT ; 95399-71-6 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS -- ANTIHYPERTENSIVE AGENTS , ; 1693 ; M CLOMIPRAMINE ; 303-48-0 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTIOBSESSIONAL -- SEROTONIN UPTAKE INHIBITORS , ; 1694 ; RAMIPRILAT ; 87269-97-4 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANGIOTENSIN-CONVERTING ENZYME INHIBITORS -- ANTIHYPERTENSIVE AGENTS , ; 1695 ; QUINAPRILAT ; 82768-85-2 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR , ; 1696 ; BENAZEPRILAT ; 86541-78-8 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS , ; 1697 ; M SIMVASTATIN ; 121009-77-6 ; 0 ; ; ; CLASS CARDIOVASCULAR -- HYPOCHOLESTEROLEMIC -- ANTILIPEMIC AGENTS -- HYDROXYMETHYLGLUTARYL-COA (HMG-COA) REDUCTASE INHIBITORS -- STATIN , ; 1698 ; DIMESNA ; 16208-51-8 ; 0 ; ; ; CLASS VARIOUS -- DETOXIFYING AGENT -- DETOXIFYING AGENT TO INHIBIT THE HEMORRHAGIC CYSTITIS INDUCED BY IFOSFAMIDE -- MESNA REACTS CHEMICALLY WITH THE UROTOXIC IFOSFAMIDE METABOLITES ACROLEIN AND 4-HYDROXY-IFOSFAMIDE , ; 1699 ; M LOVASTATIN ; 75225-51-3 ; 0 ; ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- HYDROXYMETHYLGLUTARYL-COA (HMG-COA) REDUCTASE INHIBITORS , ; 1700 ; M NABUMETONE ; 23981-47-7 ; 0 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- NSAID -- ANALGESIC -- ANTIPYRETIC , ; 1701 ; M MISOPROSTOL ; 259218-79-6 ; 0 ; ; ; CLASS METABOLISM -- ANTIULCERATIVE -- PROSTAGLANDINS -- SYNTHETIC PROSTAGLANDIN E1 ANALOG , ; 1702 ; LABETALOL ; 36894-69-6 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- SYMPATHOLYTICS , ; NDA 018686 (pdf 18686.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 018687 (pdf 18687.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018716 (label 18716.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (ALVOGEN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019046 (pdf 19046.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) NORMOZIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019174 (pdf 19174.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) TRANDATE HCT (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019425 (label 19425.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 074787 (label 74787.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1998 , NDA 074989 (pdf 74989.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075113 (pdf 75113.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075133 (pdf 75133.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 , NDA 075215 (pdf 75215.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1999 , NDA 075223 (pdf 75223.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075239 (label 75239.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075240 (pdf 75240.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075242 (pdf 75242.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075303 (pdf 75303.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 075355 (pdf 75355.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= TA YEAR= 1999 , NDA 075431 (pdf 75431.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 , NDA 075524 (pdf 75524.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076051 (pdf 76051.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2002 , NDA 079134 (pdf 79134.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090699 (pdf 90699.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 200908 (pdf 200908.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 207743 (pdf 207743.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209603 (pdf 209603.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207863 (pdf 207863.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 , NDA 211325 (pdf 211325.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212990 (pdf 212990.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213330 (label 213330.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE IN DEXTROSE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 211953 (pdf 211953.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 214533 (pdf 214533.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 212719 (pdf 212719.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1703 ; LABETALOL ; 36894-69-6 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- SYMPATHOLYTICS , ; NDA 018686 (pdf 18686.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 018687 (pdf 18687.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018716 (label 18716.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (ALVOGEN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019046 (pdf 19046.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) NORMOZIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019174 (pdf 19174.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) TRANDATE HCT (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019425 (label 19425.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 074787 (label 74787.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1998 , NDA 074989 (pdf 74989.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075113 (pdf 75113.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075133 (pdf 75133.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 , NDA 075215 (pdf 75215.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1999 , NDA 075223 (pdf 75223.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075239 (label 75239.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075240 (pdf 75240.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075242 (pdf 75242.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075303 (pdf 75303.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 075355 (pdf 75355.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= TA YEAR= 1999 , NDA 075431 (pdf 75431.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 , NDA 075524 (pdf 75524.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076051 (pdf 76051.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2002 , NDA 079134 (pdf 79134.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090699 (pdf 90699.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 200908 (pdf 200908.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 207743 (pdf 207743.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209603 (pdf 209603.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207863 (pdf 207863.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 , NDA 211325 (pdf 211325.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212990 (pdf 212990.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213330 (label 213330.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE IN DEXTROSE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 211953 (pdf 211953.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 214533 (pdf 214533.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 212719 (pdf 212719.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1704 ; LABETALOL ; 36894-69-6 ; 1984 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIANGINAL -- ADRENERGIC ALPHA ANTAGONISTS -- ADRENERGIC BETA ANTAGONISTS -- SYMPATHOLYTICS , ; NDA 018686 (pdf 18686.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 NEWMOLECULARENTITY DISCONTINUED , NDA 018687 (pdf 18687.pdf not found) INN (LABETALOL HYDROCHLORIDE) NORMODYNE (SCHERING) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 018716 (label 18716.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (ALVOGEN) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 019046 (pdf 19046.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) NORMOZIDE (SCHERING) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 019174 (pdf 19174.pdf not found) INN (HYDROCHLOROTHIAZIDE LABETALOL HYDROCHLORIDE) TRANDATE HCT (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 019425 (label 19425.pdf) INN (LABETALOL HYDROCHLORIDE) TRANDATE (SEBELA IRELAND LTD) APPROVAL= AP YEAR= 1985 DISCONTINUED , NDA 074787 (label 74787.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HERITAGE PHARMA) APPROVAL= AP YEAR= 1998 , NDA 074989 (pdf 74989.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075113 (pdf 75113.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1998 , NDA 075133 (pdf 75133.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1998 , NDA 075215 (pdf 75215.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (INNOGENIX) APPROVAL= AP YEAR= 1999 , NDA 075223 (pdf 75223.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= AP YEAR= 1998 DISCONTINUED , NDA 075239 (label 75239.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075240 (pdf 75240.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 , NDA 075242 (pdf 75242.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 075303 (pdf 75303.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1999 , NDA 075355 (pdf 75355.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APOTHECON) APPROVAL= TA YEAR= 1999 , NDA 075431 (pdf 75431.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 , NDA 075524 (pdf 75524.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 076051 (pdf 76051.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (BAXTER HLTHCARE CORP) APPROVAL= AP YEAR= 2002 , NDA 079134 (pdf 79134.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (STERISCIENCE) APPROVAL= AP YEAR= 2010 DISCONTINUED , NDA 090699 (pdf 90699.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2012 , NDA 200908 (pdf 200908.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2012 , NDA 207743 (pdf 207743.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2017 , NDA 209603 (pdf 209603.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2018 , NDA 207863 (pdf 207863.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EYWA) APPROVAL= AP YEAR= 2019 , NDA 211325 (pdf 211325.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CADILA PHARMS LTD) APPROVAL= AP YEAR= 2019 , NDA 212990 (pdf 212990.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213330 (label 213330.pdf) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE IN DEXTROSE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 211953 (pdf 211953.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (RUBICON) APPROVAL= AP YEAR= 2021 , NDA 214533 (pdf 214533.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (CAPLIN) APPROVAL= AP YEAR= 2021 , NDA 212719 (pdf 212719.pdf not found) INN (LABETALOL HYDROCHLORIDE) LABETALOL HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1705 ; M FLUTAMIDE ; 52806-53-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIANDROGENIC , ; 1706 ; M MINOXIDIL ; 83701-22-8 ; 0 ; ; ; CLASS CARDIOVASCULAR -- ANTIHYPERTENSIVE -- ANTIALOPECIA -- VASODILATOR AGENTS , ; 1707 ; M TAMOXIFEN ; 31750-48-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ESTROGEN ANTAGONIST -- BONE DENSITY CONSERVATION AGENTS -- OMPETES WITH ESTRADIOL FOR ESTROGEN RECEPTOR , ; 1708 ; M SULINDAC ; 49627-27-2 ; 0 ; ; ; CLASS MUSCULO-SKELETAL -- ANTIINFLAMMATORY -- NSAID -- CYCLOOXYGENASE INHIBITORS (EC50 OF 0.02 MICROMOLAR) , ; 1709 ; M DIAZEPAM ; 1088-11-5 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- BENZODIAZEPINES -- MUSCLE RELAXANTS -- SEDATIVE , ; 1710 ; VORAPAXAR ; 618385-01-6 ; 2014 ; DISCONTINUED ; ; CLASS BLOOD -- PROTEASE-ACTIVATED RECEPTOR-1 (PAR-1) ANTAGONIST -- REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS -- INHIBITOR OF PLATELET AGGREGATION -- ITS LONG HALF-LIFE MAKES IT EFFECTIVELY IRREVERSIBLE , ; NDA 204886 (label 204886.pdf) INN (VORAPAXAR SULFATE) ZONTIVITY (KEY THERAP) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY DISCONTINUED , 1711 ; DALBAVANCIN ; 171500-79-1 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF FOR ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS -- LIPOGLYCOPEPTIDE SYNTHESIZED FROM A FERMENTATION PRODUCT OF NONOMURAEA SPECIES -- A MIXTURE OF FIVE CLOSELY RELATED ACTIVE HOMOLOGS (A0, A1, B0, B1 AND B2) -- B0 IS THE MAJOR COMPONENT OF DALBAVANCIN -- INTERFERES WITH CELL WALL SYNTHESIS BY BINDING TO THE D-ALANYL-D-ALANINE TERMINUS OF THE STEM PENTAPEPTIDE IN NASCENT CELL WALL PEPTIDOGLYCAN , ; NDA 021883 (label 21883.pdf) INN (DALBAVANCIN HYDROCHLORIDE) DALVANCE (ABBVIE) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1712 ; EFINACONAZOLE ; 164650-44-6 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- AZOLE ANTIFUNGAL INDICATED FOR THE TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAILS DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES -- INHIBITS FUNGAL LANOSTEROL 14 ALPHA-DEMETHYLASE , ; NDA 203567 (label 203567.pdf) INN (EFINACONAZOLE) JUBLIA (BAUSCH) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 211827 (pdf 211827.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2020 , NDA 211851 (pdf 211851.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (PADAGIS US) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 211969 (pdf 211969.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (NIVAGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 212027 (pdf 212027.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (ALEOR PHARMACEUTICALS LIMITED) APPROVAL= TA YEAR= 2021 , NDA 212066 (pdf 212066.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212169 (pdf 212169.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212178 (pdf 212178.pdf not found) INN (EFINACONAZOLE) EFINACONAZOLE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1713 ; TAVABOROLE ; 174671-46-6 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- OXABOROLE ANTIFUNGAL , ; NDA 204427 (label 204427.pdf) INN (TAVABOROLE) KERYDIN (ANACOR PHARMS INC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY DISCONTINUED , NDA 212215 (pdf 212215.pdf not found) INN (TAVABOROLE) TAVABOROLE (TARO) APPROVAL= AP YEAR= 2021 , NDA 211297 (pdf 211297.pdf not found) INN (TAVABOROLE) TAVABOROLE (ENCUBE) APPROVAL= AP YEAR= 2020 , NDA 211848 (pdf 211848.pdf not found) INN (TAVABOROLE) TAVABOROLE (PADAGIS US) APPROVAL= AP YEAR= 2020 , NDA 212188 (pdf 212188.pdf not found) INN (TAVABOROLE) TAVABOROLE (ALEMBIC) APPROVAL= AP YEAR= 2020 , NDA 212256 (pdf 212256.pdf not found) INN (TAVABOROLE) TAVABOROLE (AMNEAL) APPROVAL= AP YEAR= 2020 , NDA 211963 (pdf 211963.pdf not found) INN (TAVABOROLE) TAVABOROLE (CHARTWELL RX) APPROVAL= AP YEAR= 2021 , NDA 212168 (pdf 212168.pdf not found) INN (TAVABOROLE) TAVABOROLE (LUPIN LTD) APPROVAL= AP YEAR= 2021 , NDA 212224 (pdf 212224.pdf not found) INN (TAVABOROLE) TAVABOROLE (CIPLA) APPROVAL= AP YEAR= 2021 , NDA 212294 (pdf 212294.pdf not found) INN (TAVABOROLE) TAVABOROLE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , 1714 ; ORITAVANCIN ; 171099-57-3 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- LIPOGLYCOPEPTIDE ANTIBACTERIAL -- TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS -- BINDING TO THE STEM PEPTIDE OF PEPTIDOGLYCAN PRECURSORS DURING CELL WALL BIOSYNTHESIS -- DISRUPTION OF BACTERIAL MEMBRANE INTEGRITY , ; NDA 206334 (label 206334.pdf) INN (ORITAVANCIN DIPHOSPHATE) ORBACTIV (MELINTA THERAP) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 214155 (label 214155.pdf) INN (ORITAVANCIN DIPHOSPHATE) KIMYRSA (MELINTA THERAP) APPROVAL= AP YEAR= 2021 , 1715 ; APREMILAST ; 608141-41-9 ; 2014 ; ; ; CLASS IMMUNODULATING AGENT -- INHIBITOR OF PHOSPHODIEASTERASE 4 (PDE4) -- TREATMENT OF PSORIATIC ARTHRITIS , ; NDA 205437 (label 205437.pdf) INN (APREMILAST) OTEZLA (AMGEN INC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 206088 (label 206088.pdf) INN (APREMILAST) OTEZLA (CELGENE CORP) APPROVAL= AP YEAR= 2014 NEWAPPLICATION , NDA 211734 (pdf 211734.pdf not found) INN (APREMILAST) APREMILAST (MANKIND PHARMA) APPROVAL= AP YEAR= 2024 , NDA 211756 (pdf 211756.pdf not found) INN (APREMILAST) APREMILAST (DR REDDYS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 211859 (pdf 211859.pdf not found) INN (APREMILAST) APREMILAST (ZYDUS PHARMS) APPROVAL= TA YEAR= 2022 , NDA 211878 (pdf 211878.pdf not found) INN (APREMILAST) APREMILAST (ANNORA) APPROVAL= AP YEAR= 2023 , NDA 211761 (pdf 211761.pdf not found) INN (APREMILAST) APREMILAST (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 211774 (pdf 211774.pdf not found) INN (APREMILAST) APREMILAST (SHILPA) APPROVAL= AP YEAR= 2023 , NDA 211782 (pdf 211782.pdf not found) INN (APREMILAST) APREMILAST (AMNEAL) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211819 (pdf 211819.pdf not found) INN (APREMILAST) APREMILAST (UNICHEM) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 211897 (pdf 211897.pdf not found) INN (APREMILAST) APREMILAST (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 211674 (pdf 211674.pdf not found) INN (APREMILAST) APREMILAST (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023 , NDA 211716 (pdf 211716.pdf not found) INN (APREMILAST) APREMILAST (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1716 ; TEDIZOLID ; 856866-72-3 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL AGENT OF THE OXAZOLIDINONE CLASS -- BINDING TO THE 50S SUBUNIT OF THE BACTERIAL RIBOSOME , ; 1717 ; TEDIZOLID PHOSPHATE ; 856867-55-5 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- ANTIBACTERIAL AGENT OF THE OXAZOLIDINONE CLASS -- BINDING TO THE 50S SUBUNIT OF THE BACTERIAL RIBOSOME -- PRODRUG OF TEDIZOLID , ; NDA 205435 (label 205435.pdf) INN (TEDIZOLID PHOSPHATE) SIVEXTRO (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 205436 (label 205436.pdf) INN (TEDIZOLID PHOSPHATE) SIVEXTRO (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2014 , 1718 ; TESTOSTERONE UNDECANOATE ; 5949-44-0 ; 2014 ; ; ; CLASS GENITO -- ANDROGEN INDICATED FOR TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES -- CLIVAGE BY TISSUE ESTERASES -- RAPIDLY HYDROLYZED IN TESTOSTERONE , ; NDA 022219 (label 22219.pdf) INN (TESTOSTERONE UNDECANOATE) AVEED (ENDO OPERATIONS) APPROVAL= AP YEAR= 2014 , NDA 207583 (pdf 207583.pdf not found) INN (TESTOSTERONE UNDECANOATE) TESTOSTERONE UNDECANOATE (PADDOCK LABS) APPROVAL= TA YEAR= 2016 , NDA 206089 (label 206089.pdf) INN (TESTOSTERONE UNDECANOATE) JATENZO (TOLMAR) APPROVAL= AP YEAR= 2019 , NDA 208088 (label 208088.pdf) INN (TESTOSTERONE UNDECANOATE) TLANDO (VERITY) APPROVAL= AP YEAR= 2022 , NDA 213953 (label 213953.pdf) INN (TESTOSTERONE UNDECANOATE) KYZATREX (MARIUS PHARMS LLC) APPROVAL= AP YEAR= 2022 , 1719 ; DAPAGLIFLOZIN ; 461432-26-8 ; 2014 ; ; ; CLASS METABOLISM -- A SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITOR -- TREATMENT OF TYPE 2 DIABETES MELLITU -- IMPROVE GLYCEMIC CONTROL , ; NDA 202293 (label 202293.pdf) INN (DAPAGLIFLOZIN) FARXIGA (ASTRAZENECA AB) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 205649 (label 205649.pdf) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE) XIGDUO XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2014 , NDA 209091 (label 209091.pdf) INN (DAPAGLIFLOZIN SAXAGLIPTIN HYDROCHLORIDE) QTERN (ASTRAZENECA AB) APPROVAL= AP YEAR= 2017 , NDA 210874 (label 210874.pdf) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE SAXAGLIPTIN HYDROCHLORIDE) QTERNMET XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211439 (pdf 211439.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (HETERO LABS UNIT III) APPROVAL= TA YEAR= 2019 , NDA 211442 (pdf 211442.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (APOTEX INC) APPROVAL= TA YEAR= 2019 , NDA 211541 (pdf 211541.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2019 , NDA 211533 (pdf 211533.pdf not found) INN (DAPAGLIFLOZIN SAXAGLIPTIN) DAPAGLIFLOZIN AND SAXAGLIPTIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 211564 (pdf 211564.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (GLENMARK GENERICS) APPROVAL= TA YEAR= 2020 , NDA 211478 (pdf 211478.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2021 , NDA 211523 (pdf 211523.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (AIZANT) APPROVAL= TA YEAR= 2023 , NDA 211582 (pdf 211582.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (ZYDUS PHARMS) APPROVAL= TA YEAR= 2024 , NDA 211583 (pdf 211583.pdf not found) INN (DAPAGLIFLOZIN METFORMIN HYDROCHLORIDE) DAPAGLIFLOZINMETFORMIN HYDROCHLORIDE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2022 , NDA 216119 (pdf 216119.pdf not found) INN (DAPAGLIFLOZIN) DAPAGLIFLOZIN (JIANGSU HANSOH PHARM) APPROVAL= TA YEAR= 2022 , NDA 211532 (pdf 211532.pdf not found) INN (DAPAGLIFLOZIN SAXAGLIPTIN MONOHYDRATE) DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE (LUPIN LTD) APPROVAL= TA YEAR= 2024 , 1720 ; EMPAGLIFLOZIN ; 864070-44-0 ; 2014 ; ; ; CLASS METABOLISM -- TREATMENT OF TYPE 2 DIABETES MELLITUS -- SODIUM-GLUCOSE CO-TRANSPORTER2 (SGLT2) INHIBITOR , ; NDA 204629 (label 204629.pdf) INN (EMPAGLIFLOZIN) JARDIANCE (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 206073 (label 206073.pdf) INN (EMPAGLIFLOZIN LINAGLIPTIN) GLYXAMBI (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , NDA 206111 (label 206111.pdf) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) SYNJARDY (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , NDA 208658 (label 208658.pdf) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) SYNJARDY XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2016 , NDA 212359 (pdf 212359.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN AND LINAGLIPTIN (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2020 , NDA 212614 (label 212614.pdf) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) TRIJARDY XR (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2020 , NDA 212198 (pdf 212198.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212354 (pdf 212354.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (KINAPSE LIMITED) APPROVAL= TA YEAR= 2020 , NDA 212364 (pdf 212364.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (ANNORA PHARMA) APPROVAL= TA YEAR= 2021 , NDA 212365 (pdf 212365.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (ANNORA PHARMA) APPROVAL= TA YEAR= 2021 , NDA 213654 (pdf 213654.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZINMETFORMIN HYDROCHLORIDE (LUPIN LTD) APPROVAL= TA YEAR= 2021 , NDA 212322 (pdf 212322.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (AIZANT) APPROVAL= TA YEAR= 2020 , NDA 212264 (pdf 212264.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN AND LINAGLIPTIN (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2022 , NDA 212421 (pdf 212421.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (LAURUS GENERICS INC) APPROVAL= TA YEAR= 2022 , NDA 212138 (pdf 212138.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212366 (pdf 212366.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN) EMPAGLIFLOZIN LINAGLIPTIN (ALKEM LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 212382 (pdf 212382.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (ALKEM LABS LTD) APPROVAL= TA YEAR= 2022 , NDA 212343 (pdf 212343.pdf not found) INN (EMPAGLIFLOZIN) EMPAGLIFLOZIN (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2023 , NDA 212362 (pdf 212362.pdf not found) INN (EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , NDA 217049 (pdf 217049.pdf not found) INN (EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE) EMPAGLIFLOZIN LINAGLIPTIN METFORMIN HYDROCHLORIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2024 , 1721 ; SUVOREXANT ; 1030377-33-3 ; 2014 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF INSOMNIA -- OREXIN RECEPTOR ANTAGONIST , ; NDA 204569 (label 204569.pdf) INN (SUVOREXANT) BELSOMRA (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1722 ; DROXIDOPA ; 23651-95-8 ; 2014 ; ; ; CLASS CARDIOVASCULAR -- TREATMENT OF ORTHOSTATIC DIZZINESS AND LIGHTHEADEDNESS -- SYNTHETIC AMINO ACID PRECURSOR OF NOREPINEPHRINE -- SUBSTRATE OF DOPA-DECARBOXYLASE , ; NDA 203202 (label 203202.pdf) INN (DROXIDOPA) NORTHERA (LUNDBECK NA LTD) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 211818 (pdf 211818.pdf not found) INN (DROXIDOPA) DROXIDOPA (ZYDUS PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211652 (pdf 211652.pdf not found) INN (DROXIDOPA) DROXIDOPA (LUPIN PHARMS) APPROVAL= AP YEAR= 2021 , NDA 211726 (pdf 211726.pdf not found) INN (DROXIDOPA) DROXIDOPA (ANNORA) APPROVAL= AP YEAR= 2021 , NDA 211741 (pdf 211741.pdf not found) INN (DROXIDOPA) DROXIDOPA (MSN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 212835 (pdf 212835.pdf not found) INN (DROXIDOPA) DROXIDOPA (HIKMA) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213033 (pdf 213033.pdf not found) INN (DROXIDOPA) DROXIDOPA (BIONPHARMA) APPROVAL= AP YEAR= 2021 , NDA 213162 (pdf 213162.pdf not found) INN (DROXIDOPA) DROXIDOPA (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213661 (pdf 213661.pdf not found) INN (DROXIDOPA) DROXIDOPA (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 213911 (pdf 213911.pdf not found) INN (DROXIDOPA) DROXIDOPA (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021 , NDA 214017 (pdf 214017.pdf not found) INN (DROXIDOPA) DROXIDOPA (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2021 , NDA 214384 (pdf 214384.pdf not found) INN (DROXIDOPA) DROXIDOPA (SUN PHARM) APPROVAL= AP YEAR= 2021 , NDA 214387 (pdf 214387.pdf not found) INN (DROXIDOPA) DROXIDOPA (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214391 (pdf 214391.pdf not found) INN (DROXIDOPA) DROXIDOPA (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2021 , NDA 214543 (pdf 214543.pdf not found) INN (DROXIDOPA) DROXIDOPA (BLUEPHARMA INDUSTRIA) APPROVAL= AP YEAR= 2021 , NDA 215265 (pdf 215265.pdf not found) INN (DROXIDOPA) DROXIDOPA (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2021 , NDA 214217 (pdf 214217.pdf not found) INN (DROXIDOPA) DROXIDOPA (CHARTWELL RX) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1723 ; PERAMIVIR ; 330600-85-6 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- INFLUENZA VIRUS NEURAMINIDASE INHIBITOR , ; NDA 206426 (label 206426.pdf) INN (PERAMIVIR) RAPIVAB (BIOCRYST) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1724 ; FINAFLOXACIN ; 209342-40-5 ; 2014 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- FLUOROQUINOLONE ANTIMICROBIAL INDICATED FOR THE TREATMENT OF ACUTE OTITIS EXTERNA -- TYPE II TOPOISOMERASE INHIBITOR , ; NDA 206307 (label 206307.pdf) INN (FINAFLOXACIN) XTORO (FONSECA BIOSCIENCES) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY DISCONTINUED , 1725 ; CEFTOLOZANE ; 689293-68-3 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- CEPHALOSPORIN CLASS ANTIBACTERIAL DRUG FOR PARENTERAL ADMINISTRATION -- PENICILLIN-BINDING PROTEINS (PBPS) INHIBITOR , ; NDA 206829 (label 206829.pdf) INN (CEFTOLOZANE SULFATE TAZOBACTAM SODIUM) ZERBAXA (CUBIST PHARMS LLC) APPROVAL= AP YEAR= 2014 , 1726 ; NETUPITANT ; 290297-26-6 ; 2014 ; ; ; CLASS NERVOUS SYSTEM -- A SUBSTANCE P/NEUROKININ 1 (NK1) RECEPTOR ANTAGONIST -- PREVENTION OF ACUTE AND DELAYED NAUSE , ; NDA 205718 (label 205718.pdf) INN (NETUPITANT PALONOSETRON HYDROCHLORIDE) AKYNZEO (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2014 , 1727 ; NALOXEGOL ; 854601-70-0 ; 2014 ; ; ; CLASS METABOLISM -- OPIOID ANTAGONIST -- TREATMENT OF OPIOID-INDUCED CONSTIPATION -- PEGYLATED DERIVATIVE OF NALOXONE -- CNS PENETRATION OF NALOXEGOL IS EXPECTED TO BE NEGLIGIBLE , ; NDA 204760 (label 204760.pdf) INN (NALOXEGOL OXALATE) MOVANTIK (VALINOR) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 212625 (pdf 212625.pdf not found) INN (NALOXEGOL) NALOXEGOL (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2021 , 1728 ; ELIGLUSTAT ; 491833-29-5 ; 2014 ; ; ; CLASS METABOLISM -- A GLUCOSYLCERAMIDE SYNTHASE INHIBITOR -- LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 -- RESEMBLES THE CERAMIDE SUBSTRATE , ; NDA 205494 (label 205494.pdf) INN (ELIGLUSTAT TARTRATE) CERDELGA (GENZYME CORP) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 212463 (pdf 212463.pdf not found) INN (ELIGLUSTAT TARTRATE) ELIGLUSTAT TARTRATE (AIZANT) APPROVAL= AP YEAR= 2021 , NDA 212474 (pdf 212474.pdf not found) INN (ELIGLUSTAT TARTRATE) ELIGLUSTAT TARTRATE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 212449 (pdf 212449.pdf not found) INN (ELIGLUSTAT TARTRATE) ELIGLUSTAT TARTRATE (DR REDDYS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 212420 (pdf 212420.pdf not found) INN (ELIGLUSTAT TARTRATE) ELIGLUSTAT TARTRATE (UPSHER SMITH LABS) APPROVAL= AP YEAR= 2023 , 1729 ; BELINOSTAT ; 414864-00-9 ; 2014 ; ; ; CLASS ANTINEOPLASTIC -- HISTONE DEACETYLASE (HDAC) INHIBITOR -- TREATMENT OF T-CELL LYMPHOMA (PTCL) , ; NDA 206256 (label 206256.pdf) INN (BELINOSTAT) BELEODAQ (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1730 ; IDELALISIB ; 870281-82-6 ; 2014 ; ; ; CLASS ANTINEOPLASTIC -- PHOSPHOINOSITIDE 3-KINASE INHIBITOR -- TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL), RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA AND RELAPSED SMALL LYMPHOCYTIC LYMPHOMA (SLL) -- INDUCE APOPTOSIS , ; NDA 206545 (label 206545.pdf) INN (IDELALISIB) ZYDELIG (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 NEWAPPLICATION , NDA 205858 (label 205858.pdf) INN (IDELALISIB) ZYDELIG (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1731 ; LEDIPASVIR ; 1256388-51-8 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS5A INHIBITOR , ; NDA 205834 (label 205834.pdf) INN (LEDIPASVIR SOFOSBUVIR) HARVONI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2014 , NDA 212477 (label 212477.pdf) INN (LEDIPASVIR SOFOSBUVIR) HARVONI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2019 , 1732 ; MILTEFOSINE ; 58066-85-6 ; 2014 ; ; ; CLASS ANTIPARASITIC -- TREATMENT OF LEISHMANIASIS -- INTERACTION WITH LIPIDS (PHOSPHOLIPIDS AND STEROLS) -- INHIBITION OF CYTOCHROME C OXIDASE -- APOPTOSIS-LIKE CELL DEATH , ; NDA 204684 (label 204684.pdf) INN (MILTEFOSINE) IMPAVIDO (KNIGHT THERAPS) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1733 ; OMBITASVIR ; 1258226-87-7 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF GENOTYPE 1 CHRONIC HEPATITIS C VIRUS (HCV) -- HEPATITIS C VIRUS NS5A INHIBITOR , ; NDA 206619 (label 206619.pdf) INN (OMBITASVIR) VIEKIRA PAK COPACKAGED (ABBVIE INC) APPROVAL= AP YEAR= 2014 , NDA 207931 (label 207931.pdf) INN (OMBITASVIR PARITAPREVIR RITONAVIR) TECHNIVIE (ABBVIE) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208624 (label 208624.pdf) INN (OMBITASVIR) VIEKIRA XR (ABBVIE INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , 1734 ; PARITAPREVIR ; 1216941-48-8 ; 2014 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF GENOTYPE 1 CHRONIC HEPATITIS C VIRUS (HCV) -- HEPATITIS C VIRUS NS3/4A PROTEASE INHIBITOR , ; NDA 206619 (label 206619.pdf) INN (PARITAPREVIR) VIEKIRA PAK COPACKAGED (ABBVIE INC) APPROVAL= AP YEAR= 2014 , NDA 207931 (label 207931.pdf) INN (PARITAPREVIR) TECHNIVIE (ABBVIE INC) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 208624 (label 208624.pdf) INN (PARITAPREVIR) VIEKIRA XR (ABBVIE INC) APPROVAL= AP YEAR= 2016 DISCONTINUED , 1735 ; DASABUVIR ; 1132935-63-7 ; 2014 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- TREATMENT OF GENOTYPE 1 CHRONIC HEPATITIS C VIRUS (HCV) -- HEPATITIS C VIRUS NON-NUCLEOSIDE NS5B PALM POLYMERASE INHIBITOR , ; NDA 206619 (label 206619.pdf) INN (DASABUVIR SODIUM OMBITASVIR PARITAPREVIR RITONAVIR) VIEKIRA PAK COPACKAGED (ABBVIE) APPROVAL= AP YEAR= 2014 DISCONTINUED , NDA 208624 (label 208624.pdf) INN (DASABUVIR SODIUM OMBITASVIR PARITAPREVIR RITONAVIR) VIEKIRA XR (ABBVIE) APPROVAL= AP YEAR= 2016 DISCONTINUED , 1736 ; TASIMELTEON ; 609799-22-6 ; 2014 ; ; ; CLASS NERVOUS SYSTEM -- MELATONIN RECEPTOR AGONIST -- NON-24-HOURSLEEP-WAKE DISORDER (NON-24) -- CONTROL OF CIRCADIAN RHYTHMS , ; NDA 205677 (label 205677.pdf) INN (TASIMELTEON) HETLIOZ (VANDA PHARMS INC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 211654 (pdf 211654.pdf not found) INN (TASIMELTEON) TASIMELTEON (MSN) APPROVAL= AP YEAR= 2023 , NDA 214517 (label 214517.pdf) INN (TASIMELTEON) HETLIOZ LQ (VANDA PHARMS INC) APPROVAL= AP YEAR= 2020 , NDA 211601 (pdf 211601.pdf not found) INN (TASIMELTEON) TASIMELTEON (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2022 , NDA 211607 (pdf 211607.pdf not found) INN (TASIMELTEON) TASIMELTEON (APOTEX) APPROVAL= AP YEAR= 2022 , 1737 ; OLAPARIB ; 763113-22-0 ; 2014 ; ; ; CLASS ANTINEOPLASTIC -- POLY (ADP-RIBOSE) POLYMERASE (PARP) INHIBITOR -- TREATMENT OF OVARIAN CANCER , ; NDA 206162 (label 206162.pdf) INN (OLAPARIB) LYNPARZA (ASTRAZENECA) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY DISCONTINUED , NDA 208558 (label 208558.pdf) INN (OLAPARIB) LYNPARZA (ASTRAZENECA) APPROVAL= AP YEAR= 2017 , 1738 ; CERITINIB ; 1032900-25-6 ; 2014 ; ; ; CLASS ANTINEOPLASTIC -- ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITOR -- TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) , ; NDA 205755 (label 205755.pdf) INN (CERITINIB) ZYKADIA (NOVARTIS) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY DISCONTINUED , NDA 211225 (label 211225.pdf) INN (CERITINIB) ZYKADIA (NOVARTIS) APPROVAL= AP YEAR= 2019 , 1739 ; PIRFENIDONE ; 53179-13-8 ; 2014 ; ; ; CLASS IMMUNOSUPPRESSANTS -- TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) , ; NDA 022535 (label 22535.pdf) INN (PIRFENIDONE) ESBRIET (GENENTECH INC) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 208780 (label 208780.pdf) INN (PIRFENIDONE) ESBRIET (GENENTECH INC) APPROVAL= AP YEAR= 2017 , NDA 212687 (pdf 212687.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 212680 (pdf 212680.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (MICRO LABS) APPROVAL= AP YEAR= 2022 , NDA 212722 (pdf 212722.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (LAURUS) APPROVAL= AP YEAR= 2022 , NDA 212600 (pdf 212600.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 212615 (pdf 212615.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (GRANULES INDIA) APPROVAL= TA YEAR= 2021 , NDA 212560 (pdf 212560.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (SANDOZ) APPROVAL= AP YEAR= 2022 , NDA 212569 (pdf 212569.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 212570 (pdf 212570.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (AMNEAL) APPROVAL= AP YEAR= 2022 , NDA 212708 (pdf 212708.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (ALEMBIC) APPROVAL= AP YEAR= 2022 , NDA 212730 (pdf 212730.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 212731 (pdf 212731.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2022 , NDA 212747 (pdf 212747.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (AIZANT) APPROVAL= AP YEAR= 2022 , NDA 212759 (pdf 212759.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2022 , NDA 212772 (pdf 212772.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (MSN) APPROVAL= AP YEAR= 2022 , NDA 212077 (pdf 212077.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 212078 (pdf 212078.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2022 , NDA 212674 (pdf 212674.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022 , NDA 212724 (pdf 212724.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (LAURUS) APPROVAL= AP YEAR= 2022 , NDA 212709 (pdf 212709.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (APOTEX) APPROVAL= AP YEAR= 2023 , NDA 212403 (pdf 212403.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (CHARTWELL RX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 212404 (pdf 212404.pdf not found) INN (PIRFENIDONE) PIRFENIDONE (CHARTWELL RX) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1740 ; NINTEDANIB ; 656247-17-5 ; 2014 ; ; ; CLASS IMMUNOSUPPRESSANT -- TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF) -- MULTIPLE RECEPTOR TYROSINE KINASES (RTKS) AND NON-RECEPTOR TYROSINE KINASES (NRTKS) INHIBITOR -- PDGFR ALPHA AND BETA -- FGFR 1-3 -- VEGFR 1-3 -- FMS-LIKE TYROSINE KINASE-3 (FLT3) -- LCK -- LYN -- SRC KINASE , ; NDA 205832 (label 205832.pdf) INN (NINTEDANIB ESYLATE) OFEV (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 212732 (pdf 212732.pdf not found) INN (NINTEDANIB) NINTEDANIB (ACCORD HLTHCARE INC) APPROVAL= TA YEAR= 2020 , NDA 212555 (pdf 212555.pdf not found) INN (NINTEDANIB ESYLATE) NINTEDANIB (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2021 , NDA 215123 (pdf 215123.pdf not found) INN (NINTEDANIB) NINTEDANIB (EUGIA PHARMA SPECLTS) APPROVAL= TA YEAR= 2022 , NDA 216915 (pdf 216915.pdf not found) INN (NINTEDANIB) NINTEDANIB (LOTUS PHARM CO LTD) APPROVAL= TA YEAR= 2023 , 1741 ; OLODATEROL ; 868049-49-4 ; 2014 ; ; ; CLASS RESPIRATORY SYSTEM -- SELECTIVE BETA-2 ADRENERGIC AGONISTS -- BRONCHODILATOR TREATMENT (COPD) , ; NDA 203108 (label 203108.pdf) INN (OLODATEROL HYDROCHLORIDE) STRIVERDI RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , NDA 206756 (label 206756.pdf) INN (OLODATEROL HYDROCHLORIDE TIOTROPIUM BROMIDE) STIOLTO RESPIMAT (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2015 , 1742 ; EDOXABAN ; 480449-70-5 ; 2015 ; ; ; CLASS CARDIOVASCULAR -- FACTOR XA INHIBITOR -- TO REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM -- TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM , ; NDA 206316 (label 206316.pdf) INN (EDOXABAN TOSYLATE) SAVAYSA (DAIICHI SANKYO INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 213064 (pdf 213064.pdf not found) INN (EDOXABAN) EDOXABAN (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2022 , 1743 ; AVIBACTAM ; 1192500-31-4 ; 2015 ; ; ; CLASS ANTIINFECTIVES -- CLASS D (OR OXA-TYPE) BETA-LACTAMASES INHIBITOR , ; NDA 206494 (label 206494.pdf) INN (AVIBACTAM SODIUM CEFTAZIDIME) AVYCAZ (ALLERGAN) APPROVAL= AP YEAR= 2015 , 1744 ; PANOBINOSTAT ; 404950-80-7 ; 2015 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- HISTONE DEACETYLASE (HDAC) INHIBITOR -- TREATMENT OF MULTIPLE MYELOMA , ; NDA 205353 (label 205353.pdf) INN (PANOBINOSTAT LACTATE) FARYDAK (SECURA) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY DISCONTINUED , 1745 ; PALBOCICLIB ; 571190-30-2 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF BREAST CANCER -- CYCLIN-DEPENDENT KINASE (CDK) INHIBITORS , ; NDA 207103 (label 207103.pdf) INN (PALBOCICLIB) IBRANCE (PFIZER) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 212436 (label 212436.pdf) INN (PALBOCICLIB) IBRANCE (PFIZER) APPROVAL= AP YEAR= 2019 , NDA 213107 (pdf 213107.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2021 , NDA 213091 (pdf 213091.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2021 , NDA 213086 (pdf 213086.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (EUGIA PHARMA SPECLTS) APPROVAL= TA YEAR= 2022 , NDA 213152 (pdf 213152.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (AIZANT DRUG RESEARCH SOLUTIONS PVT LTD) APPROVAL= TA YEAR= 2022 , NDA 214758 (pdf 214758.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (MSN PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2023 , NDA 215570 (pdf 215570.pdf not found) INN (PALBOCICLIB) PALBOCICLIB (SYNTHON PHARMS INC) APPROVAL= AP YEAR= 2024 , 1746 ; LENVATINIB ; 417716-92-8 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF THYROID CANCER -- RECEPTOR TYROSINE KINASE (RTK) INHIBITOR -- VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) RECEPTORS VEGFR1 (FLT1), VEGFR2 (KDR) AND VEGFR3 (FLT4) INHIBITOR -- FIBROBLAST GROWTH FACTOR (FGF) RECEPTORS FGFR1, 2, 3, AND 4 INHIBITOR -- PDGFRALPHA, KIT AND RET INHIBITOR , ; NDA 206947 (label 206947.pdf) INN (LENVATINIB MESYLATE) LENVIMA (EISAI INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 213092 (pdf 213092.pdf not found) INN (LENVATINIB MESYLATE) LENVATINIB (SUN PHARM INDS INC) APPROVAL= TA YEAR= 2022 , 1747 ; M DOXEPIN ; 67035-76-1 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- TRICYCLIC PSYCHOTHERAPEUTIC AGENT -- ANTI-PRURITIC -- HISTAMINE RECEPTOR ANTAGONIST , ; 1748 ; M DOXEPIN ; 58534-46-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- TRICYCLIC PSYCHOTHERAPEUTIC AGENT -- ANTI-PRURITIC -- HISTAMINE RECEPTOR ANTAGONIST , ; 1749 ; DOXEPIN ; 1668-19-5 ; 1969 ; ; ; CLASS NERVOUS SYSTEM -- ANTIDEPRESSANT -- ANTI-ANXIETY AGENTS -- TRICYCLIC PSYCHOTHERAPEUTIC AGENT -- ANTI-PRURITIC -- HISTAMINE RECEPTOR ANTAGONIST -- TREATMENT OF INSOMNIA , ; NDA 016798 (label 16798.pdf) INN (DOXEPIN HYDROCHLORIDE) SINEQUAN (PFIZER) APPROVAL= AP YEAR= 1969 NEWMOLECULARENTITY DISCONTINUED , NDA 016987 (pdf 16987.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (NEW RIVER) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 017516 (label 17516.pdf) INN (DOXEPIN HYDROCHLORIDE) SINEQUAN (PFIZER) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 020126 (label 20126.pdf) INN (DOXEPIN HYDROCHLORIDE) ZONALON (MYLAN) APPROVAL= AP YEAR= 1994 , NDA 070789 (pdf 70789.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 OBSOLETE , NDA 070790 (pdf 70790.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070791 (label 70791.pdf) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 1986 , NDA 070792 (pdf 70792.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070793 (pdf 70793.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 1986 , NDA 070825 (pdf 70825.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070827 (pdf 70827.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070828 (pdf 70828.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1986 DISCONTINUED , NDA 070931 (pdf 70931.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070932 (pdf 70932.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070952 (pdf 70952.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070953 (pdf 70953.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070954 (pdf 70954.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070955 (pdf 70955.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070972 (pdf 70972.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 070973 (pdf 70973.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071238 (pdf 71238.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071239 (pdf 71239.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071326 (pdf 71326.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071422 (pdf 71422.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ENDO OPERATIONS) APPROVAL= AP YEAR= 1987 , NDA 071437 (pdf 71437.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 , NDA 071485 (pdf 71485.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071486 (pdf 71486.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071487 (pdf 71487.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071502 (pdf 71502.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071521 (pdf 71521.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071562 (pdf 71562.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071595 (pdf 71595.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071608 (pdf 71608.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071609 (label 71609.pdf) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071653 (pdf 71653.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071654 (pdf 71654.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 071669 (pdf 71669.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071673 (pdf 71673.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071674 (pdf 71674.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071675 (pdf 71675.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071676 (pdf 71676.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071685 (pdf 71685.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071686 (pdf 71686.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (DAVA PHARMS INC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071697 (pdf 71697.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PAR PHARM) APPROVAL= AP YEAR= 1987 OBSOLETE , NDA 071763 (pdf 71763.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071764 (pdf 71764.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071918 (pdf 71918.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PHARMOBEDIENT CNSLTG) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 072109 (pdf 72109.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072110 (pdf 72110.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072375 (pdf 72375.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072376 (pdf 72376.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (QUANTUM PHARMICS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072386 (pdf 72386.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072387 (pdf 72387.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 072985 (pdf 72985.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072986 (pdf 72986.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 072987 (pdf 72987.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (WATSON LABS TEVA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 073054 (pdf 73054.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 073055 (pdf 73055.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PUREPAC PHARM) APPROVAL= AP YEAR= 1990 DISCONTINUED , NDA 074721 (pdf 74721.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 1998 , NDA 075924 (pdf 75924.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2004 DISCONTINUED , NDA 022036 (label 22036.pdf) INN (DOXEPIN HYDROCHLORIDE) SILENOR (CURRAX) APPROVAL= AP YEAR= 2010 , NDA 202510 (pdf 202510.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2020 , NDA 201951 (pdf 201951.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013 , NDA 202761 (pdf 202761.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 202337 (pdf 202337.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (RK PHARMA) APPROVAL= AP YEAR= 2016 , NDA 207482 (pdf 207482.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2017 , NDA 211603 (pdf 211603.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 212624 (pdf 212624.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2019 , NDA 213063 (pdf 213063.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TARO) APPROVAL= AP YEAR= 2020 , NDA 210268 (pdf 210268.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2020 , NDA 210675 (pdf 210675.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 212997 (pdf 212997.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2020 DISCONTINUED , NDA 213474 (pdf 213474.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2020 , NDA 211618 (pdf 211618.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (LEADING) APPROVAL= AP YEAR= 2021 , NDA 211619 (pdf 211619.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (CHEMISTRY HLTH) APPROVAL= AP YEAR= 2021 , NDA 214908 (pdf 214908.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (APPCO) APPROVAL= AP YEAR= 2021 , NDA 215076 (pdf 215076.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ALEMBIC) APPROVAL= AP YEAR= 2021 , NDA 213796 (pdf 213796.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (EDENBRIDGE PHARMS) APPROVAL= AP YEAR= 2022 , NDA 215113 (pdf 215113.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2022 , NDA 215483 (pdf 215483.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (JUBILANT CADISTA) APPROVAL= AP YEAR= 2022 , NDA 215710 (pdf 215710.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 210140 (pdf 210140.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 210700 (pdf 210700.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , NDA 212357 (pdf 212357.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (AMNEAL) APPROVAL= AP YEAR= 2023 , NDA 214823 (pdf 214823.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2023 , NDA 215408 (pdf 215408.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (TEVA PHARMS) APPROVAL= AP YEAR= 2023 , NDA 217688 (pdf 217688.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (MICRO LABS) APPROVAL= AP YEAR= 2023 , NDA 217975 (pdf 217975.pdf not found) INN (DOXEPIN HYDROCHLORIDE) DOXEPIN HYDROCHLORIDE (UNIQUE PHARM) APPROVAL= AP YEAR= 2023 , 1750 ; M CYTARABINE ; 13191-15-6 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- -- ANTIMETABOLITES , ; 1751 ; M FLURAZEPAM ; 2886-65-9 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- GABA MODULATORS -- SEDATIVES -- TREATMENT OF INSOMNIA , ; 1752 ; M CARBAMAZEPINE ; 36507-30-9 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANALGESIC -- ANTIMANIC AGENTS -- SPECIFIC ANALGESIC FOR TRIGEMINAL NEURALGIA -- CARBAMAZEPINE INDUCES ITS OWN METABOLISM -- MECHANISM OF ACTION UNKNOWN (NUMEROUS PHARMACOLOGICAL EFFECTS HAVE BEEN DESCRIBED MODULATION OF ION CHANNELS (SODIUM AND CALCIUM), RECEPTOR-MEDIATED NEUROTRANSMISSION (GABAERGIC, GLUTAMATERGIC, AND MONOAMINERGIC), AND INTRACELLULAR SIGNALING PATHWAYS) , ; 1753 ; CLOMIPHENE ; 911-45-5 ; 1967 ; ; ; CLASS GENITO -- INITIATION OF OVULATION -- FERTILITY AGENTS, FEMALE -- ESTROGEN RECEPTOR ANTAGONIST -- ZUCLOMIPHENE (CIS) HAS A LONGER HALF-LIFE THAN ENCLOMIPHENE (TRANS) , ; NDA 016131 (label 16131.pdf) INN (CLOMIPHENE CITRATE) CLOMID (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1967 NEWMOLECULARENTITY DISCONTINUED , NDA 018361 (pdf 18361.pdf not found) INN (CLOMIPHENE CITRATE) SEROPHENE (EMD SERONO) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 072196 (pdf 72196.pdf not found) INN (CLOMIPHENE CITRATE) MILOPHENE (GRANATA BIO) APPROVAL= AP YEAR= 1988 DISCONTINUED , NDA 075528 (pdf 75528.pdf not found) INN (CLOMIPHENE CITRATE) CLOMIPHENE CITRATE (COSETTE) APPROVAL= AP YEAR= 1999 , 1754 ; M CLOFIBRATE ; 882-09-7 ; 0 ; ; ; CLASS CARDIOVASCULAR -- HYPOLIPIDEMIC -- ANTICHOLESTEREMIC AGENTS -- ANTILIPIDEMIC AGENTS -- REDUCE THE VERY LOW-DENSITY LIPOPROTEIN FRACTION , ; 1755 ; M ALLOPURINOL ; 2465-59-0 ; 0 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- TREATMENT OF HYPERURICEMIA (GOUT SUPPRESSANT) -- XANTHINE OXIDASE INHIBITOR -- ANTIMETABOLITES -- ACTS ON PURINE CATABOLISM AND REDUCES THE PRODUCTION OF URIC ACID , ; 1756 ; M NALIDIXIC ACID ; 3759-18-0 ; 0 ; ; ; CLASS ANTIINFECTIVES -- ANTIBIOTIC -- GRAM-NEGATIVE BACTERIA -- QUINOLONE ANTIBACTERIAL AGENT -- NUCLEIC ACID SYNTHESIS INHIBITORS , ; 1757 ; M ACETOHEXAMIDE ; 968-80-9 ; 0 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS , ; 1758 ; M ACETOHEXAMIDE ; 220948-25-4 ; 0 ; ; ; CLASS METABOLISM -- ANTIDIABETIC -- HYPOGLYCEMIC AGENTS -- SULFONYLUREAS , ; 1759 ; M THIOGUANINE ; 15867-02-4 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANTIMETABOLITES -- TREATMENT OF ACUTE NONLYMPHOCYTIC LEUKEMIAS -- THIOGUANINE IS INCORPORATED INTO THE DNA AND THE RNA OF HUMAN BONE MARROW CELLS -- THIOGUANYLIC ACID IS FURTHER CONVERTED TO THE DI- AND TRI-PHOSPHATES , ; 1760 ; THIOPENTAL ; 76-75-5 ; 1959 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC -- GABA MODULATORS -- HYPNOTICS AND SEDATIVES , ; NDA 011679 (pdf 11679.pdf not found) INN (THIOPENTAL SODIUM) PENTOTHAL (ABBOTT) APPROVAL= AP YEAR= 1959 NEWMOLECULARENTITY DISCONTINUED , 1761 ; HALOTHANE ; 151-67-7 ; 1958 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANESTHETIC , ; NDA 011338 (pdf 11338.pdf not found) INN (HALOTHANE) FLUOTHANE (WYETH AYERST) APPROVAL= AP YEAR= 1958 NEWMOLECULARENTITY DISCONTINUED , NDA 080810 (pdf 80810.pdf not found) INN (HALOTHANE) HALOTHANE (HALOCARBON) APPROVAL= AP YEAR= 1972 DISCONTINUED , NDA 083254 (pdf 83254.pdf not found) INN (HALOTHANE) HALOTHANE (HOSPIRA) APPROVAL= AP YEAR= 1975 DISCONTINUED , NDA 084977 (pdf 84977.pdf not found) INN (HALOTHANE) HALOTHANE (BH) APPROVAL= AP YEAR= 1976 DISCONTINUED , 1762 ; M METHSUXIMIDE ; 39122-10-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; 1763 ; M METHSUXIMIDE ; 39122-11-7 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT , ; 1764 ; PHENMETRAZINE ; 134-49-6 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIANOREXIC -- APPETITE DEPRESSANTS -- CNS AGENTS -- SYMPATHOMIMETICS , ; NDA 010460 (pdf 10460.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011752 (pdf 11752.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , 1765 ; PHENMETRAZINE ; 134-49-6 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIANOREXIC -- APPETITE DEPRESSANTS -- CNS AGENTS -- SYMPATHOMIMETICS , ; NDA 010460 (pdf 10460.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011752 (pdf 11752.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , 1766 ; PHENMETRAZINE ; 134-49-6 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTIANOREXIC -- APPETITE DEPRESSANTS -- CNS AGENTS -- SYMPATHOMIMETICS , ; NDA 010460 (pdf 10460.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 011752 (pdf 11752.pdf not found) INN (PHENMETRAZINE HYDROCHLORIDE) PRELUDIN (BOEHRINGER INGELHEIM) APPROVAL= - YEAR= 0 DISCONTINUED , 1767 ; METHYPRYLON ; 125-64-4 ; 1955 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANXIOLYTIC -- SEDATIVES -- HYPNOTICS , ; NDA 009660 (pdf 9660.pdf not found) INN (METHYPRYLON) NOLUDAR (ROCHE) APPROVAL= AP YEAR= 1955 NEWMOLECULARENTITY DISCONTINUED , 1768 ; TALBUTAL ; 115-44-6 ; 1954 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- SEDATIVES , ; NDA 009410 (pdf 9410.pdf not found) INN (TALBUTAL) LOTUSATE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1954 NEWMOLECULARENTITY DISCONTINUED , 1769 ; PHENSUXIMIDE ; 86-34-0 ; 1953 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANT -- ANTIEPILEPTIC , ; NDA 008855 (pdf 8855.pdf not found) INN (PHENSUXIMIDE) MILONTIN (PARKE DAVIS) APPROVAL= AP YEAR= 1953 NEWMOLECULARENTITY DISCONTINUED , 1770 ; M ASPIRIN ; 69-72-7 ; 0 ; ; NATURAL MOLECULE C00000206 ; CLASS NERVOUS SYSTEM -- ANTI-INFLAMMATORY AGENTS -- NSAID -- ANTICOAGULANTS -- CYCLOOXYGENASE INHIBITORS -- FIBRINOLYTIC AGENTS -- PLATELET AGGREGATION INHIBITORS -- SALICYLATES , ; 1771 ; CORTISONE ; 53-06-5 ; 0 ; ; ; CLASS METABOLISM -- GLUCOCORTICOID -- ANTIINFLAMMATORY -- VASOCONSTRICTOR -- REPLACEMENT THERAPY IN ADRENOCORTICAL DEFICIENCY STATES -- PSORIATIC ARTHRITIS RHEUMATOID ARTHRITIS , ; 1772 ; M AMODIAQUINE ; 79352-78-6 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIALS , ; 1773 ; M TRIMETHADIONE ; 695-53-4 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTICONVULSANTS -- CONTROL OF PETIT MAL SEIZURES -- VOLTAGE DEPENDENT T-TYPE CALCIUM CHANNEL INHIBITOR , ; 1774 ; BUTABARBITAL ; 125-40-6 ; 1939 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- HYPNOTIC -- ANXIOLYTIC -- BARBITURATES -- SEDATIVES -- GABA MODULATOR , ; NDA 000793 (label 793.pdf) INN (BUTABARBITAL SODIUM) BUTISOL SODIUM (MYLAN SPECIALITY LP) APPROVAL= AP YEAR= 1939 DISCONTINUED , NDA 083325 (pdf 83325.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083337 (pdf 83337.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WHITEWORTH TOWN PLSN) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083484 (pdf 83484.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED , NDA 083524 (pdf 83524.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (MARSHALL PHARMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083606 (pdf 83606.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083858 (pdf 83858.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (MARSHALL PHARMA) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083896 (pdf 83896.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083897 (pdf 83897.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 083898 (pdf 83898.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SOLVAY) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084040 (pdf 84040.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1974 DISCONTINUED , NDA 084272 (pdf 84272.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 084292 (pdf 84292.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 084719 (pdf 84719.pdf not found) INN (BUTABARBITAL SODIUM) SARISOL NO. 1 (HALSEY) APPROVAL= AP YEAR= 1976 DISCONTINUED , NDA 084723 (pdf 84723.pdf not found) INN (BUTABARBITAL SODIUM) SARISOL (HALSEY) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 085380 (pdf 85380.pdf not found) INN (BUTABARBITAL SODIUM) BUTISOL SODIUM (MEDA PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085381 (pdf 85381.pdf not found) INN (BUTABARBITAL SODIUM) BUTICAPS (MEDPOINTE PHARM HLC) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085383 (pdf 85383.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WOCKHARDT) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 085418 (pdf 85418.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (HIKMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085432 (pdf 85432.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (HIKMA) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085550 (pdf 85550.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL (BUNDY) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085764 (pdf 85764.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085772 (pdf 85772.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED , NDA 085849 (pdf 85849.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085866 (pdf 85866.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085873 (pdf 85873.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARB (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085880 (pdf 85880.pdf not found) INN (BUTABARBITAL SODIUM) BUTALAN (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085881 (pdf 85881.pdf not found) INN (BUTABARBITAL SODIUM) SODIUM BUTABARBITAL (LANNETT) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085934 (pdf 85934.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1982 DISCONTINUED , NDA 085938 (pdf 85938.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088631 (pdf 88631.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088632 (pdf 88632.pdf not found) INN (BUTABARBITAL SODIUM) BUTABARBITAL SODIUM (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED , 1775 ; FLORBETAPIR ; 956103-76-7 ; 2012 ; ; ; CLASS VARIOUS -- DIAGNOSTIC -- IMAGING AGENT -- BINDS TO BETA-AMYLOID PLAQUES (KD = 3.7 NANOMOLAR) , ; NDA 202008 (label 202008.pdf) INN (FLORBETAPIR F-18) AMYVID (AVID RADIOPHARMS INC) APPROVAL= AP YEAR= 2012 NEWMOLECULARENTITY , 1776 ; FLUTEMETAMOL ; 765922-62-1 ; 2013 ; ; ; CLASS VARIOUS -- DIAGNOSTIC -- IMAGING AGENT -- BINDS TO BETA-AMYLOID PLAQUES (KD = 6.7 NANOMOLAR) , ; NDA 203137 (label 203137.pdf) INN (FLUTEMETAMOL F-18) VIZAMYL (GE HEALTHCARE) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , 1777 ; FLORBETABEN ; 902143-01-5 ; 2014 ; ; ; CLASS VARIOUS -- DIAGNOSTIC -- IMAGING AGENT -- BINDS TO BETA-AMYLOID PLAQUES (KD = 16 NANOMOLAR) , ; NDA 204677 (label 204677.pdf) INN (FLORBETABEN F-18) NEURACEQ (LIFE MOLECULAR) APPROVAL= AP YEAR= 2014 NEWMOLECULARENTITY , 1778 ; CANGRELOR ; 163706-06-7 ; 2015 ; ; ; CLASS BLOOD -- P2Y12 PLATELET RECEPTOR INHIBITOR , ; NDA 204958 (label 204958.pdf) INN (CANGRELOR) KENGREAL (CHIESI) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1779 ; SONIDEGIB ; 956697-53-3 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- SMOOTHENED (SMO) ANTAGONIST WHICH INHIBITS THE HEDGEHOG (HH) SIGNALING PATHWAY , ; NDA 205266 (label 205266.pdf) INN (SONIDEGIB PHOSPHATE) ODOMZO (SUN PHARM) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1780 ; BREXPIPRAZOLE ; 913611-97-9 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF MAJOR DEPRESSIVE DISORDER OR SCHIZOPHRENIA -- COMBINATION OF PARTIAL AGONIST ACTIVITY AT SEROTONIN 5-HT1A (KD = 0.12 NANOMOLAR) AND DOPAMINE D2 (KD = 0.30 NANOMOLAR) AND ANTAGONIST ACTIVITY AT SEROTONIN 5-HT2A RECEPTORS (KD= 0.47 NANOMOLAR) , ; NDA 205422 (label 205422.pdf) INN (BREXPIPRAZOLE) REXULTI (OTSUKA) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 213660 (pdf 213660.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213718 (pdf 213718.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213782 (pdf 213782.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2023 , NDA 213788 (pdf 213788.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (ACCORD HLTHCARE INC) APPROVAL= TA YEAR= 2021 , NDA 213477 (pdf 213477.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (ZENARA) APPROVAL= TA YEAR= 2022 , NDA 213570 (pdf 213570.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213692 (pdf 213692.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (TEVA PHARMS USA INC) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213512 (pdf 213512.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213562 (pdf 213562.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213587 (pdf 213587.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (PRINSTON PHARMA INC) APPROVAL= TA YEAR= 2023 , NDA 213683 (pdf 213683.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2023 , NDA 213740 (pdf 213740.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (MSN PHARMS INC) APPROVAL= TA YEAR= 2023 , NDA 213659 (pdf 213659.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213669 (pdf 213669.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2023 , NDA 213758 (pdf 213758.pdf not found) INN (BREXPIPRAZOLE) BREXPIPRAZOLE (OPTIMUS) APPROVAL= AP YEAR= 2023 , 1781 ; CHOLIC ACID ; 81-25-4 ; 2015 ; ; ; CLASS METABOLISM -- TREATMENT OF BILE ACID SYNTHESIS DISORDERS -- ADJUNCTIVE TREATMENT OF PEROXISOMAL DISORDERS (PDS) INCLUDING ZELLWEGER SPECTRUM DISEASE , ; NDA 205750 (label 205750.pdf) INN (CHOLIC ACID) CHOLBAM (MIRUM) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1782 ; LUMACAFTOR ; 936727-05-8 ; 2015 ; ; ; CLASS RESPIRATORY SYSTEM -- CYSTIC FIBROSIS -- POTENTIATOR -- IMPROVES THE CONFORMATIONAL STABILITY OF F508DEL-CFTR RESULTING IN INCREASED PROCESSING AND TRAFFICKING OF MATURE PROTEIN TO THE CELL SURFACE , ; NDA 206038 (label 206038.pdf) INN (IVACAFTOR LUMACAFTOR) ORKAMBI (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 211358 (label 211358.pdf) INN (IVACAFTOR LUMACAFTOR) ORKAMBI (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2018 , 1783 ; IVABRADINE ; 155974-00-8 ; 2015 ; ; ; CLASS CARDIOVASCULAR -- HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNEL BLOCKER , ; NDA 206143 (label 206143.pdf) INN (IVABRADINE HYDROCHLORIDE) CORLANOR (AMGEN INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 209964 (label 209964.pdf) INN (IVABRADINE) CORLANOR (AMGEN INC) APPROVAL= AP YEAR= 2019 , NDA 214051 (pdf 214051.pdf not found) INN (IVABRADINE HYDROCHLORIDE) IVABRADINE HYDROCHLORIDE (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2021 , NDA 215238 (pdf 215238.pdf not found) INN (IVABRADINE HYDROCHLORIDE) IVABRADINE HYDROCHLORIDE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2022 , NDA 213366 (pdf 213366.pdf not found) INN (IVABRADINE HYDROCHLORIDE) IVABRADINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022 , NDA 213442 (pdf 213442.pdf not found) INN (IVABRADINE HYDROCHLORIDE) IVABRADINE HYDROCHLORIDE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 , 1784 ; DEOXYCHOLIC ACID ; 83-44-3 ; 2015 ; ; NATURAL MOLECULE C00030117 ; CLASS DERMATOLOGICAL -- CYTOLYTIC DRUG -- DESTROYS THE CELL MEMBRANE CAUSING LYSIS -- TREATMENT OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT , ; NDA 206333 (label 206333.pdf) INN (DEOXYCHOLIC ACID) KYBELLA (ABBVIE) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 212296 (pdf 212296.pdf not found) INN (DEOXYCHOLIC ACID) DEOXYCHOLIC ACID (SLAYBACK PHARMA LLC) APPROVAL= AP YEAR= 2021 , 1785 ; DACLATASVIR ; 1009119-64-5 ; 2015 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- INHIBITOR OF HCV NONSTRUCTURAL PROTEIN 5A (NS5A) , ; NDA 206843 (label 206843.pdf) INN (DACLATASVIR DIHYDROCHLORIDE) DAKLINZA (BRISTOL-MYERS SQUIBB) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY DISCONTINUED , 1786 ; ELUXADOLINE ; 864821-90-9 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) -- MU-OPIOID RECEPTOR AGONIST (KI = 1.8 NANOMOLAR) -- DELTA-OPIOID RECEPTOR ANTAGONIST (KI = 430 NANOMOLAR) -- KAPPA-OPIOID RECEPTOR AGONIST , ; NDA 206940 (label 206940.pdf) INN (ELUXADOLINE) VIBERZI (ABBVIE) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 213576 (pdf 213576.pdf not found) INN (ELUXADOLINE) ELUXADOLINE (MSN PHARMACEUTICALS INC) APPROVAL= TA YEAR= 2021 , NDA 213613 (pdf 213613.pdf not found) INN (ELUXADOLINE) ELUXADOLINE (ASCEND LABORATORIES , LTD) APPROVAL= TA YEAR= 2021 , 1787 ; ISAVUCONAZONIUM ; 742049-41-8 ; 2015 ; ; ; CLASS ANTIINFECTIVES -- AN AZOLE ANTIFUNGAL -- TREATMENT OF INVASIVE ASPERGILLOSIS AND MUCORMYCOSIS , ; NDA 207500 (label 207500.pdf) INN (ISAVUCONAZONIUM SULFATE) CRESEMBA (ASTELLAS) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 207501 (label 207501.pdf) INN (ISAVUCONAZONIUM SULFATE) CRESEMBA (ASTELLAS) APPROVAL= AP YEAR= 2015 , 1788 ; ISAVUCONAZOLE ; 241479-67-4 ; 0 ; ; ; CLASS ANTIINFECTIVES -- AN AZOLE ANTIFUNGAL -- TREATMENT OF INVASIVE ASPERGILLOSIS AND MUCORMYCOSIS , ; 1789 ; SACUBITRIL ; 149709-62-6 ; 2015 ; ; ; CLASS CARDIOVASCULAR -- NEUTRAL ENDOPEPTIDASE NEPRILYSIN (NEP) INHIBITOR -- TREATMENT OF PATIENTS WITH CHRONIC HEART FAILURE , ; NDA 207620 (label 207620.pdf) INN (SACUBITRIL VALSARTAN) ENTRESTO (NOVARTIS PHARMS CORP) APPROVAL= AP YEAR= 2015 , NDA 213605 (pdf 213605.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (CRYSTAL) APPROVAL= AP YEAR= 2024 , NDA 213676 (pdf 213676.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (LAURUS) APPROVAL= AP YEAR= 2024 , NDA 213682 (pdf 213682.pdf not found) INN (SACUBITRIL VALSARTAN) SACUBITRIL AND VALSARTAN (ALEMBIC) APPROVAL= AP YEAR= 2024 , NDA 218591 (pdf 218591.pdf not found) INN (SACUBITRIL VALSARTAN) ENTRESTO SPRINKLE (NOVARTIS) APPROVAL= AP YEAR= 2024 , 1790 ; M SACUBITRIL ; 149709-44-4 ; 0 ; ; ; CLASS CARDIOVASCULAR -- NEUTRAL ENDOPEPTIDASE NEPRILYSIN (NEP) INHIBITOR -- TREATMENT OF PATIENTS WITH CHRONIC HEART FAILURE , ; 1791 ; DESOXYCORTICOSTERONE ; 64-85-7 ; 0 ; ; ; CLASS HORMONES -- ADRENOCORTICAL STEROID -- PRECURSOR OF ALDOSTERONE -- SUBSTRATE OF ALDOSTERONE SYNTHASE (CYTOCHROME P450 CYP11B2) , ; 1792 ; SUGAMMADEX ; 343306-71-8 ; 2015 ; ; ; CLASS VARIOUS -- CHELATOR -- REVERSAL OF NEUROMUSCULAR BLOCKADE INDUCED BY ROCURONIUM BROMIDE AND VECURONIUM BROMIDE IN ADULTS UNDERGOING SURGERY , ; NDA 022225 (label 22225.pdf) INN (SUGAMMADEX SODIUM) BRIDION (MSD SUB MERCK) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 214311 (pdf 214311.pdf not found) INN (SUGAMMADEX) SUGAMMADEX (SANDOZ INC) APPROVAL= TA YEAR= 2023 , NDA 214319 (pdf 214319.pdf not found) INN (SUGAMMADEX) SUGAMMADEX (SUN PHARM INDS) APPROVAL= TA YEAR= 2022 , NDA 214290 (pdf 214290.pdf not found) INN (SUGAMMADEX SODIUM) SUGAMMADEX SODIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 213915 (pdf 213915.pdf not found) INN (SUGAMMADEX) SUGAMMADEX (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2023 , NDA 214230 (pdf 214230.pdf not found) INN (SUGAMMADEX) SUGAMMADEX (MANKIND PHARMA) APPROVAL= TA YEAR= 2024 , NDA 214337 (pdf 214337.pdf not found) INN (SUGAMMADEX SODIUM) SUGAMMADEX SODIUM (ASPIRO) APPROVAL= AP YEAR= 2023 , NDA 215701 (pdf 215701.pdf not found) INN (SUGAMMADEX SODIUM) SUGAMMADEX SODIUM (SHANDONG) APPROVAL= TA YEAR= 2023 , 1793 ; FLIBANSERIN ; 167933-07-5 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF PREMENOPAUSAL WOMEN WITH ACQUIRED GENERALIZED HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) -- SEROTONIN RECEPTORS -- 5-HT1A AGONIST -- 5-HT2A ANTAGONIST -- DOPAMINE D4, 5-HT2B AND 5-HT2C (ANTAGONIST WITH MODERATE AFFINITY) , ; NDA 022526 (label 22526.pdf) INN (FLIBANSERIN) ADDYI (SPROUT PHARMS) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1794 ; CARIPRAZINE ; 839712-12-8 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- PARTIAL AGONIST DOPAMINE D2 RECEPTOR (KI = 0.49 NANOMOLAR) -- PARTIAL AGONIST SEROTONIN 5-HT1A RECEPTOR (KI = 2.6 NANOMOLAR) -- ANTAGONIST 5-HT2A RECEPTOR (KI = 18.8 NANOMOLAR) -- HISTAMINE H1 RECEPTOR (KI = 23.2 NANOMOLAR) , ; NDA 204370 (label 204370.pdf) INN (CARIPRAZINE HYDROCHLORIDE) VRAYLAR (ABBVIE) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 213932 (pdf 213932.pdf not found) INN (CARIPRAZINE HYDROCHLORIDE) CARIPRAZINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 213984 (pdf 213984.pdf not found) INN (CARIPRAZINE HYDROCHLORIDE) CARIPRAZINE HYDROCHLORIDE (ZYDUS) APPROVAL= AP YEAR= 2022 DISCONTINUED , 1795 ; M CARIPRAZINE ; 839712-15-1 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- PARTIAL AGONIST DOPAMINE D2 RECEPTOR -- PARTIAL AGONIST SEROTONIN 5-HT1A RECEPTOR -- ANTAGONIST 5-HT2A RECEPTOR -- HISTAMINE H1 RECEPTOR , ; 1796 ; M CARIPRAZINE ; 839712-25-3 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF SCHIZOPHRENIA -- PARTIAL AGONIST DOPAMINE D2 RECEPTOR -- PARTIAL AGONIST SEROTONIN 5-HT1A RECEPTOR -- ANTAGONIST 5-HT2A RECEPTOR -- HISTAMINE H1 RECEPTOR , ; 1797 ; METHYLENE BLUE ; 61-73-4 ; 2016 ; ; ; CLASS TREATMENT OF METHEMOGLOBINEMIA -- AN OXIDATION-REDUCTION AGENT -- PROMOTES A NON-ENYZMATIC REDOX CONVERSION OF METHB TO HEMOGLOBIN -- CONVERTED INTO LEUCOMETHYLENE BLUE (LMB) BY NADPH REDUCTASE , ; NDA 204630 (label 204630.pdf) INN (METHYLENE BLUE) PROVAYBLUE (PROVEPHARM SAS) APPROVAL= AP YEAR= 2016 , NDA 215636 (pdf 215636.pdf not found) INN (METHYLENE BLUE) METHYLENE BLUE (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2023 , 1798 ; LEUCOMETHYLENE BLUE ; 613-11-6 ; 0 ; ; ; CLASS TREATMENT OF METHEMOGLOBINEMIA -- AN OXIDATION-REDUCTION AGENT -- PROMOTES A NON-ENYZMATIC REDOX CONVERSION OF METHB TO HEMOGLOBIN -- CONVERTED INTO LEUCOMETHYLENE BLUE (LMB) BY NADPH REDUCTASE , ; 1799 ; BRIVARACETAM ; 357336-20-0 ; 2016 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF PARTIAL-ONSET SEIZURES -- ANTIEPILEPTIC -- HIGH AND SELECTIVE AFFINITY FOR SYNAPTIC VESICLE PROTEIN 2A (SV2A) IN THE BRAIN , ; NDA 205836 (label 205836.pdf) INN (BRIVARACETAM) BRIVIACT (UCB INC) APPROVAL= AP YEAR= 2016 , NDA 205837 (label 205837.pdf) INN (BRIVARACETAM) BRIVIACT (UCB INC) APPROVAL= AP YEAR= 2016 , NDA 205838 (label 205838.pdf) INN (BRIVARACETAM) BRIVIACT (UCB INC) APPROVAL= AP YEAR= 2016 , NDA 214501 (pdf 214501.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214918 (pdf 214918.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (LUPIN LTD) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214748 (pdf 214748.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (SUNSHINE) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214831 (pdf 214831.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (ANNORA PHARMA) APPROVAL= TA YEAR= 2024 , NDA 214848 (pdf 214848.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214921 (pdf 214921.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2023 , NDA 214924 (pdf 214924.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2023 , NDA 214875 (pdf 214875.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (APOTEX INC) APPROVAL= TA YEAR= 2023 , NDA 214922 (pdf 214922.pdf not found) INN (BRIVARACETAM) BRIVARACETAM (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , 1800 ; COBIMETINIB ; 934660-93-2 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION IN COMBINATION WITH VEMURAFENIB -- MAPK KINASE INHIBITOR -- MEK1 AND MEK2 INHIBITOR , ; NDA 206192 (label 206192.pdf) INN (COBIMETINIB FUMARATE) COTELLIC (GENENTECH INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1801 ; ROLAPITANT ; 552292-08-7 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF NAUSEA AND VOMITING INDUCED BY CANCER CHEMOTHERAPY -- SUBSTANCE P/NEUROKININ 1 (NK1) RECEPTOR ANTAGONIST , ; NDA 206500 (label 206500.pdf) INN (ROLAPITANT HYDROCHLORIDE) VARUBI (TERSERA) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 208399 (label 208399.pdf) INN (ROLAPITANT HYDROCHLORIDE) VARUBI (TERSERA) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1802 ; PIMAVANSERIN ; 706779-91-1 ; 2016 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS -- INVERSE AGONIST / ANTAGONIST SEROTONIN 5-HT2A (KI = 0.087 NANOMOLAR) AND 5-HT2C (KI = 0.44 NANOMOLAR) -- SIGMA 1 RECEPTOR (KI = 120 NANOMOLAR) , ; NDA 207318 (label 207318.pdf) INN (PIMAVANSERIN TARTRATE) NUPLAZID (ACADIA PHARMS INC) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , NDA 210793 (label 210793.pdf) INN (PIMAVANSERIN TARTRATE) NUPLAZID (ACADIA PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 214750 (pdf 214750.pdf not found) INN (PIMAVANSERIN) PIMAVANSERIN (TEVA PHARMS USA) APPROVAL= TA YEAR= 2021 , NDA 214502 (pdf 214502.pdf not found) INN (PIMAVANSERIN TARTRATE) PIMAVANSERIN (ZYDUS) APPROVAL= AP YEAR= 2024 , NDA 214782 (pdf 214782.pdf not found) INN (PIMAVANSERIN) PIMAVANSERIN (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2022 , NDA 214925 (pdf 214925.pdf not found) INN (PIMAVANSERIN TARTRATE) PIMAVANSERIN (MSN) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 214493 (pdf 214493.pdf not found) INN (PIMAVANSERIN TARTRATE) PIMAVANSERIN (ZYDUS) APPROVAL= AP YEAR= 2024 , 1803 ; M PIMAVANSERIN ; 639863-77-7 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC -- TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS -- INVERSE AGONIST / ANTAGONIST SEROTONIN 5-HT2A (KI = 0.087 NANOMOLAR) AND 5-HT2C (KI = 0.44 NANOMOLAR) -- SIGMA 1 RECEPTOR (KI = 120 NANOMOLAR) , ; 1804 ; ARIPIPRAZOLE LAUROXIL ; 1259305-29-7 ; 2015 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTICS -- TREATMENT OF BIPOLAR I DISORDER (SCHIZOPHRENIA) -- PRODRUG OF ARIPIPRAZOLE , ; NDA 207533 (label 207533.pdf) INN (ARIPIPRAZOLE LAUROXIL) ARISTADA (ALKERMES INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 209830 (label 209830.pdf) INN (ARIPIPRAZOLE LAUROXIL) ARISTADA INITIO KIT (ALKERMES INC) APPROVAL= AP YEAR= 2018 , 1805 ; TENOFOVIR ALAFENAMIDE ; 379270-37-8 ; 2015 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HIV-1 INFECTION -- CONVERTED IN VIVO TO TENOFOVIR , ; NDA 207561 (label 207561.pdf) INN (COBICISTAT ELVITEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) GENVOYA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2015 , NDA 208215 (label 208215.pdf) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) DESCOVY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 208351 (label 208351.pdf) INN (EMTRICITABINE RILPIVIRINE HYDROCHLORIDE TENOFOVIR ALAFENAMIDE FUMARATE) ODEFSEY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 208464 (label 208464.pdf) INN (TENOFOVIR ALAFENAMIDE FUMARATE) VEMLIDY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 210251 (label 210251.pdf) INN (BICTEGRAVIR SODIUM EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) BIKTARVY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2018 , NDA 210455 (label 210455.pdf) INN (COBICISTAT DARUNAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) SYMTUZA (JANSSEN PRODS) APPROVAL= AP YEAR= 2018 , NDA 213845 (pdf 213845.pdf not found) INN (TENOFOVIR ALAFENAMIDE) TENOFOVIR ALAFENAMIDE (SUNSHINE LAKE) APPROVAL= TA YEAR= 2021 , NDA 212527 (pdf 212527.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE (CIPLA USA INC.) APPROVAL= TA YEAR= 2022 , NDA 214030 (pdf 214030.pdf not found) INN (TENOFOVIR ALAFENAMIDE FUMARATE) TENOFOVIR ALAFENAMIDE FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2023 , NDA 214058 (pdf 214058.pdf not found) INN (EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE (CIPLA LIMITED) APPROVAL= TA YEAR= 2022 , NDA 214072 (pdf 214072.pdf not found) INN (TENOFOVIR ALAFENAMIDE) TENOFOVIR ALAFENAMIDE (SHILPA MEDICARE LTD) APPROVAL= TA YEAR= 2022 , NDA 216875 (pdf 216875.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE TENOFOVIR ALAFENAMIDE (AUROBINDO PHARMA) APPROVAL= TA YEAR= 2022 , NDA 214226 (pdf 214226.pdf not found) INN (TENOFOVIR ALAFENAMIDE FUMARATE) TENOFOVIR ALAFENAMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2023 , NDA 214544 (pdf 214544.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE (LUPIN LTD) APPROVAL= TA YEAR= 2023 , NDA 215448 (pdf 215448.pdf not found) INN (DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIR , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (AUROBINDO PHARMA USA) APPROVAL= TA YEAR= 2023 , NDA 215187 (pdf 215187.pdf not found) INN (DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE) DOLUTEGRAVIRLAMIVUDINETENOFOVIR ALAFENAMIDE (LUPIN PHARMS) APPROVAL= TA YEAR= 2023 , NDA 211148 (pdf 211148.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE) EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2024 , NDA 213509 (pdf 213509.pdf not found) INN (EFAVIRENZ EMTRICITABINE TENOFOVIR ALAFENAMIDE) EFAVIRENZ , EMTRICITABINE AND TENOFOVIR ALAFENAMIDE (MYLAN) APPROVAL= TA YEAR= 2024 , NDA 213867 (pdf 213867.pdf not found) INN (TENOFOVIR ALAFENAMIDE FUMARATE) TENOFOVIR ALAFENAMIDE FUMARATE (APOTEX) APPROVAL= AP YEAR= 2024 DISCONTINUED , NDA 214053 (pdf 214053.pdf not found) INN (EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (APOTEX) APPROVAL= AP YEAR= 2024 , 1806 ; SELEXIPAG ; 475086-01-2 ; 2015 ; ; ; CLASS BLOOD -- SELECTIVE NON-PROSTANOID IP PROSTACYCLIN RECEPTOR AGONIST -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) , ; NDA 207947 (label 207947.pdf) INN (SELEXIPAG) UPTRAVI (ACTELION) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 214367 (pdf 214367.pdf not found) INN (SELEXIPAG) SELEXIPAG (MSN LABORATORIES PRIVATE LTD) APPROVAL= TA YEAR= 2021 , NDA 214275 (label 214275.pdf) INN (SELEXIPAG) UPTRAVI (ACTELION) APPROVAL= AP YEAR= 2021 , NDA 214302 (pdf 214302.pdf not found) INN (SELEXIPAG) SELEXIPAG (ZYDUS LIFESCIENCES) APPROVAL= AP YEAR= 2022 DISCONTINUED , NDA 214055 (pdf 214055.pdf not found) INN (SELEXIPAG) SELEXIPAG (VGYAAN) APPROVAL= TA YEAR= 2023 , NDA 214414 (pdf 214414.pdf not found) INN (SELEXIPAG) SELEXIPAG (ALEMBIC) APPROVAL= AP YEAR= 2023 , 1807 ; M SELEXIPAG ; 475086-28-3 ; 0 ; ; ; CLASS BLOOD -- SELECTIVE NON-PROSTANOID IP PROSTACYCLIN RECEPTOR AGONIST -- TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) , ; 1808 ; TRABECTEDIN ; 114899-77-3 ; 2015 ; ; NATURAL MOLECULE C00044733 ; CLASS ANTINEOPLASTIC -- ALKYLATING DRUG THAT BINDS GUANINE RESIDUES IN THE MINOR GROOVE OF DNA -- TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA , ; NDA 207953 (label 207953.pdf) INN (TRABECTEDIN) YONDELIS (JANSSEN PRODS) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 214837 (pdf 214837.pdf not found) INN (TRABECTEDIN) TRABECTEDIN (NATCO PHARMA LTD) APPROVAL= TA YEAR= 2022 , 1809 ; TIPIRACIL ; 183204-74-2 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- THYMIDINE PHOSPHORYLASE INHIBITOR -- TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER -- TIPIRACIL INCREASES TRIFLURIDINE EXPOSURE BY INHIBITING ITS METABOLISM BY THYMIDINE PHOSPHORYLASE , ; NDA 207981 (label 207981.pdf) INN (TIPIRACIL HYDROCHLORIDE TRIFLURIDINE) LONSURF (TAIHO ONCOLOGY) APPROVAL= AP YEAR= 2015 , NDA 214036 (pdf 214036.pdf not found) INN (TRIFLURIDINE TIPIRACIL) TRIFLURIDINE TIPIRACIL (INTAS PHARMS LTD) APPROVAL= TA YEAR= 2022 , NDA 214008 (pdf 214008.pdf not found) INN (TIPIRACIL HYDROCHLORIDE TRIFLURIDINE) TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (NATCO) APPROVAL= AP YEAR= 2023 , 1810 ; LESINURAD ; 878672-00-5 ; 2015 ; DISCONTINUED ; ; CLASS MUSCULO-SKELETAL -- URAT1 INHIBITOR (KI = 7.3 MICROMOLAR) -- TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT -- REDUCES SERUM URIC ACID LEVELS BY INHIBITING THE FUNCTION OF TRANSPORTER PROTEINS INVOLVED IN URIC ACID REABSORPTION IN THE KIDNEY , ; NDA 207988 (label 207988.pdf) INN (LESINURAD) ZURAMPIC (IRONWOOD PHARMS INC) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY DISCONTINUED , NDA 209203 (label 209203.pdf) INN (ALLOPURINOL LESINURAD) DUZALLO (IRONWOOD PHARMS INC) APPROVAL= AP YEAR= 2017 DISCONTINUED , 1811 ; OBETICHOLIC ACID ; 459789-99-2 ; 2016 ; ; ; CLASS METABOLISM -- FARNESOID X RECEPTOR (FXR) AGONIST -- TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) , ; NDA 207999 (label 207999.pdf) INN (OBETICHOLIC ACID) OCALIVA (INTERCEPT PHARMS INC) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , NDA 215017 (pdf 215017.pdf not found) INN (OBETICHOLIC ACID) OBETICHOLIC ACID (MSN) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214862 (pdf 214862.pdf not found) INN (OBETICHOLIC ACID) OBETICHOLIC ACID (APOTEX) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 214935 (pdf 214935.pdf not found) INN (OBETICHOLIC ACID) OBETICHOLIC ACID (OPTIMUS PHARMA PRIVATE LTD) APPROVAL= TA YEAR= 2023 , NDA 214980 (pdf 214980.pdf not found) INN (OBETICHOLIC ACID) OBETICHOLIC ACID (LUPIN LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1812 ; OSIMERTINIB ; 1421373-65-0 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- COVALENT KINASE INHIBITOR -- TREATMENT OF METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) -- ALSO INHIBITED THE ACTIVITY OF HER2, HER3, HER4, ACK1 AND BLK , ; NDA 208065 (label 208065.pdf) INN (OSIMERTINIB MESYLATE) TAGRISSO (ASTRAZENECA) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , NDA 214263 (pdf 214263.pdf not found) INN (OSIMERTINIB MESYLATE) OSIMERTINIB MESYLATE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2021 , 1813 ; URIDINE TRIACETATE ; 4105-38-8 ; 2015 ; ; ; CLASS VARIOUS -- PYRIMIDINE ANALOG -- ACETYLATED PRO-DRUG OF URIDINE -- EMERGENCY TREATMENT FOLLOWING A FLUOROURACIL OR CAPECITABINE OVERDOSE , ; NDA 208159 (label 208159.pdf) INN (URIDINE TRIACETATE) VISTOGARD (BTG INTL) APPROVAL= AP YEAR= 2015 NEWAPPLICATION , NDA 208169 (label 208169.pdf) INN (URIDINE TRIACETATE) XURIDEN (BTG INTL) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1814 ; URIDINE ; 58-96-8 ; 0 ; ; NATURAL MOLECULE C00019674 ; CLASS VARIOUS -- PYRIMIDINE ANALOG -- ACETYLATED PRO-DRUG OF URIDINE -- EMERGENCY TREATMENT FOLLOWING A FLUOROURACIL OR CAPECITABINE OVERDOSE -- CONVERTED INTO URIDINE TRIPHOSPHATE (UTP) WHICH COMPETES WITH FUTP (5-FLUOROURIDINE TRIPHOSPHATE, METABOLITE OF FLUOROURACIL) FOR INCORPORATION INTO RNA , ; 1815 ; ELBASVIR ; 1370468-36-2 ; 2016 ; ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS5A INHIBITOR , ; NDA 208261 (label 208261.pdf) INN (ELBASVIR GRAZOPREVIR) ZEPATIER (MSD SUB MERCK) APPROVAL= AP YEAR= 2016 , 1816 ; GRAZOPREVIR ; 1350514-68-9 ; 2016 ; ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS3/4A PROTEASE INHIBITOR , ; NDA 208261 (label 208261.pdf) INN (ELBASVIR GRAZOPREVIR) ZEPATIER (MSD SUB MERCK) APPROVAL= AP YEAR= 2016 , 1817 ; EPHEDRINE ; 299-42-3 ; 2016 ; ; NATURAL MOLECULE C00001409 ; CLASS RESPIRATORY -- SYMPATHOMIMETIC -- ALPHA AND BETA ADRENERGIC AGONIST -- NOREPINEPHRINE RELEASING AGENT -- TREATMENT OF CLINICALLY IMPORTANT HYPOTENSION OCCURRING IN THE SETTING OF ANESTHESIA -- METABOLIZED INTO NOREPHEDRINE , ; NDA 208289 (label 208289.pdf) INN (EPHEDRINE SULFATE) AKOVAZ (EXELA PHARMA) APPROVAL= AP YEAR= 2016 , NDA 208609 (label 208609.pdf) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (RENEW PHARMS) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 208943 (label 208943.pdf) INN (EPHEDRINE SULFATE) CORPHEDRA (ENDO OPERATIONS) APPROVAL= AP YEAR= 2017 , NDA 209784 (pdf 209784.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (SANDOZ) APPROVAL= AP YEAR= 2017 , NDA 212932 (pdf 212932.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (AMNEAL) APPROVAL= AP YEAR= 2019 , NDA 213407 (label 213407.pdf) INN (EPHEDRINE SULFATE) EMERPHED (NEXUS) APPROVAL= AP YEAR= 2020 , NDA 209646 (pdf 209646.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2020 , NDA 212649 (pdf 212649.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (DR REDDYS) APPROVAL= AP YEAR= 2020 , NDA 213994 (label 213994.pdf) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (ENDO OPERATIONS) APPROVAL= AP YEAR= 2020 , NDA 214334 (pdf 214334.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (HIKMA) APPROVAL= AP YEAR= 2020 , NDA 213536 (label 213536.pdf) INN (EPHEDRINE HYDROCHLORIDE) REZIPRES (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2021 , NDA 214579 (pdf 214579.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (EUGIA PHARMA) APPROVAL= AP YEAR= 2021 , NDA 215825 (pdf 215825.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (XIROMED) APPROVAL= AP YEAR= 2022 , NDA 216129 (pdf 216129.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (MANKIND PHARMA) APPROVAL= AP YEAR= 2022 , NDA 216146 (pdf 216146.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2022 , NDA 214528 (pdf 214528.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2023 , NDA 217276 (pdf 217276.pdf not found) INN (EPHEDRINE SULFATE) EPHEDRINE SULFATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023 DISCONTINUED , 1818 ; VELPATASVIR ; 1377049-84-7 ; 2016 ; ; ; CLASS ANTIINFECTIVES -- HEPATITIS C VIRUS (HCV) NS5A INHIBITOR , ; NDA 208341 (label 208341.pdf) INN (SOFOSBUVIR VELPATASVIR) EPCLUSA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2016 , NDA 209195 (label 209195.pdf) INN (SOFOSBUVIR VELPATASVIR VOXILAPREVIR) VOSEVI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2017 , NDA 214187 (label 214187.pdf) INN (SOFOSBUVIR VELPATASVIR) EPCLUSA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2021 , 1819 ; ALECTINIB ; 1256580-46-7 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER -- TYROSINE KINASE INHIBITOR (ALK AND RET) , ; NDA 208434 (label 208434.pdf) INN (ALECTINIB HYDROCHLORIDE) ALECENSA (HOFFMANN-LA ROCHE) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1820 ; IXAZOMIB ; 1072833-77-2 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MULTIPLE MYELOMA -- PROTEASOME INHIBITOR -- PRODRUG OF IXAZOMIB -- CHYMOTRYPSIN-LIKE ACTIVITY OF THE BETA 5 SUBUNIT OF THE 20S PROTEASOME , ; 1821 ; IXAZOMIB CITRATE ; 1239908-20-3 ; 2015 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MULTIPLE MYELOMA -- PROTEASOME INHIBITOR -- PRODRUG OF IXAZOMIB -- CHYMOTRYPSIN-LIKE ACTIVITY OF THE BETA 5 SUBUNIT OF THE 20S PROTEASOME , ; NDA 208462 (label 208462.pdf) INN (IXAZOMIB CITRATE) NINLARO (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2015 NEWMOLECULARENTITY , 1822 ; VENETOCLAX ; 1257044-40-8 ; 2016 ; ; ; CLASS ANTINEOPLASTIC -- BCL-2 (B-CELL LYMPHOMA 2) INHIBITOR -- TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION , ; NDA 208573 (label 208573.pdf) INN (VENETOCLAX) VENCLEXTA (ABBVIE) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , 1823 ; CRISABOROLE ; 906673-24-3 ; 2016 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS -- PHOSPHODIESTERASE 4 (PDE-4) INHIBITOR , ; NDA 207695 (label 207695.pdf) INN (CRISABOROLE) EUCRISA (ANACOR PHARMS INC) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , 1824 ; LIFITEGRAST ; 1025967-78-5 ; 2016 ; ; ; CLASS SENSORY -- TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) -- LYMPHOCYTE FUNCTION-ASSOCIATED ANTIGEN-1 (LFA-1) ANTAGONIST -- LFA-1 IS A CELL SURFACE PROTEIN FOUND ON LEUKOCYTES AND BLOCKS THE INTERACTION OF LFA-1 WITH ITS COGNATE LIGAND INTERCELLULAR ADHESION MOLECULE-1 (ICAM-1) , ; NDA 208073 (label 208073.pdf) INN (LIFITEGRAST) XIIDRA (BAUSCH AND LOMB INC) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , NDA 215063 (label 215063.pdf) INN (LIFITEGRAST) LIFITEGRAST (EUGIA PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215081 (pdf 215081.pdf not found) INN (LIFITEGRAST) LIFITEGRAST (MICRO LABS) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215058 (pdf 215058.pdf not found) INN (LIFITEGRAST) LIFITEGRAST (INGENUS PHARMS LLC) APPROVAL= TA YEAR= 2024 , NDA 215126 (pdf 215126.pdf not found) INN (LIFITEGRAST) LIFITEGRAST (SUN PHARM INDS LTD) APPROVAL= TA YEAR= 2023 , 1825 ; PRASTERONE ; 53-43-0 ; 2016 ; ; ; CLASS HORMONES -- TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE -- STEROID -- IS CONVERTED INTO ACTIVE ANDROGENS AND/OR ESTROGENS , ; NDA 208470 (label 208470.pdf) INN (PRASTERONE) INTRAROSA (MILLICENT) APPROVAL= AP YEAR= 2016 , 1826 ; RUCAPARIB ; 283173-50-2 ; 2016 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF OVARIAN CANCER WITH DELETERIOUS BRCA MUTATION -- POLY (ADP-RIBOSE) POLYMERASE (PARP) INHIBITOR , ; NDA 209115 (label 209115.pdf) INN (RUCAPARIB CAMSYLATE) RUBRACA (ZR PHARMA) APPROVAL= AP YEAR= 2016 NEWMOLECULARENTITY , 1827 ; SAFINAMIDE ; 133865-89-1 ; 2017 ; ; ; CLASS NERVOUS SYSTEM -- ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE -- MONOAMINE OXIDASE TYPE B (MAO-B) INHIBITOR -- BLOCKS THE CATABOLISM OF DOPAMINE -- 1000-FOLD SELECTIVITY OVER MAO-A , ; NDA 207145 (label 207145.pdf) INN (SAFINAMIDE MESYLATE) XADAGO (MDD US) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 215902 (pdf 215902.pdf not found) INN (SAFINAMIDE MESYLATE) SAFINAMIDE MESYLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 215945 (pdf 215945.pdf not found) INN (SAFINAMIDE) SAFINAMIDE (RK PHARMA) APPROVAL= TA YEAR= 2023 , NDA 216020 (pdf 216020.pdf not found) INN (SAFINAMIDE) SAFINAMIDE (OPTIMUS PHARMA PRIVATE LTD) APPROVAL= TA YEAR= 2023 , NDA 215739 (pdf 215739.pdf not found) INN (SAFINAMIDE MESYLATE) SAFINAMIDE MESYLATE (PRINSTON INC) APPROVAL= AP YEAR= 2024 , 1828 ; MIDOSTAURIN ; 120685-11-2 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) OR AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) -- MULTIKINASE TYROSINE KINASE INHIBITOR (FLT3, FLT3 MUTANT KINASES (ITD AND TKD), KIT (WILD TYPE AND D816V MUTANT), PDGFR ALPHA/BETA, VEGFR2, AS WELL AS MEMBERS OF THE SERINE/THREONINE KINASE PKC (PROTEIN KINASE C) FAMILY) , ; NDA 207997 (label 207997.pdf) INN (MIDOSTAURIN) RYDAPT (NOVARTIS) APPROVAL= AP YEAR= 2017 , NDA 215834 (pdf 215834.pdf not found) INN (MIDOSTAURIN) MIDOSTAURIN (LOTUS PHARM CO LTD) APPROVAL= TA YEAR= 2022 , NDA 216015 (pdf 216015.pdf not found) INN (MIDOSTAURIN) MIDOSTAURIN (LUPIN) APPROVAL= AP YEAR= 2024 , NDA 216076 (pdf 216076.pdf not found) INN (MIDOSTAURIN) MIDOSTAURIN (TEVA PHARMS) APPROVAL= AP YEAR= 2024 , 1829 ; M MIDOSTAURIN ; 740816-86-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) OR AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) -- MULTIKINASE TYROSINE KINASE INHIBITOR (FLT3, FLT3 MUTANT KINASES (ITD AND TKD), KIT (WILD TYPE AND D816V MUTANT), PDGFR ALPHA/BETA, VEGFR2, AS WELL AS MEMBERS OF THE SERINE/THREONINE KINASE PKC (PROTEIN KINASE C) FAMILY) , ; 1830 ; M MIDOSTAURIN ; 179237-49-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) OR AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) -- MULTIKINASE TYROSINE KINASE INHIBITOR (FLT3, FLT3 MUTANT KINASES (ITD AND TKD), KIT (WILD TYPE AND D816V MUTANT), PDGFR ALPHA/BETA, VEGFR2, AS WELL AS MEMBERS OF THE SERINE/THREONINE KINASE PKC (PROTEIN KINASE C) FAMILY) , ; 1831 ; NERATINIB ; 698387-09-6 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER -- EGFR KINASE INHIBITOR -- HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) AND HER4 INHIBITOR , ; NDA 208051 (label 208051.pdf) INN (NERATINIB MALEATE) NERLYNX (PUMA BIOTECH) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 216236 (pdf 216236.pdf not found) INN (NERATINIB MALEATE) NERATINIB MALEATE (SANDOZ INC) APPROVAL= TA YEAR= 2022 , 1832 ; BETRIXABAN ; 330942-05-7 ; 2017 ; DISCONTINUED ; ; CLASS BLOOD -- PROPHYLAXIS OF VENOUS THROMBOEMBOLISM (VTE) -- FACTOR XA (FXA) INHIBITOR , ; NDA 208383 (label 208383.pdf) INN (BETRIXABAN) BEVYXXA (PORTOLA PHARMS INC) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY DISCONTINUED , 1833 ; ETELCALCETIDE ; 1262780-97-1 ; 2017 ; ; ; CLASS HORMONES -- TREATMENT OF SECONDARY HYPERPARATHYROIDISM (HPT) WITH CHRONIC KIDNEY DISEASE (CKD) ON HEMODIALYSIS -- CALCIUM-SENSING RECEPTOR (CASR) AGONIST , ; NDA 208325 (label 208325.pdf) INN (ETELCALCETIDE) PARSABIV (KAI PHARMS INC) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1834 ; NIRAPARIB ; 1038915-60-4 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER -- POLY(ADP-RIBOSE) POLYMERASE (PARP) INHIBITOR , ; NDA 208447 (label 208447.pdf) INN (NIRAPARIB TOSYLATE) ZEJULA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY DISCONTINUED , NDA 214876 (label 214876.pdf) INN (NIRAPARIB TOSYLATE) ZEJULA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2023 , NDA 216793 (pdf 216793.pdf not found) INN (ABIRATERONE ACETATE NIRAPARIB TOSYLATE) AKEEGA (JANSSEN BIOTECH) APPROVAL= AP YEAR= 2023 , 1835 ; L-GLUTAMINE ; 56-85-9 ; 2004 ; ; NATURAL MOLECULE C00001359 ; CLASS BLOOD -- AMINOACID INDICATED TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE (SCD) -- L-GLUTAMINE MAY IMPROVE THE NAD REDOX POTENTIAL IN SICKLE RBCS THROUGH INCREASING THE AVAILABILITY OF REDUCED GLUTATHIONE , ; NDA 021667 (label 21667.pdf) INN (L-GLUTAMINE) NUTRESTORE (EMMAUS MEDCL) APPROVAL= AP YEAR= 2004 NEWMOLECULARENTITY DISCONTINUED , NDA 208587 (label 208587.pdf) INN (L-GLUTAMINE) ENDARI (EMMAUS MEDCL) APPROVAL= AP YEAR= 2017 , NDA 215647 (pdf 215647.pdf not found) INN (L-GLUTAMINE) L-GLUTAMINE (NOVITIUM PHARMA) APPROVAL= TA YEAR= 2023 , 1836 ; DELAFLOXACIN ; 189279-58-1 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- FLUOROQUINOLONE ANTIBACTERIAL -- TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) , ; NDA 208610 (label 208610.pdf) INN (DELAFLOXACIN MEGLUMINE) BAXDELA (MELINTA) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 208611 (label 208611.pdf) INN (DELAFLOXACIN MEGLUMINE) BAXDELA (MELINTA) APPROVAL= AP YEAR= 2017 , 1837 ; ENASIDENIB ; 1446502-11-9 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION -- ISOCITRATE DEHYDROGENASE-2 (IDH2) INHIBITOR , ; NDA 209606 (label 209606.pdf) INN (ENASIDENIB MESYLATE) IDHIFA (BRISTOL MYERS SQUIBB) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1838 ; DEFLAZACORT ; 14484-47-0 ; 2017 ; ; ; CLASS HORMONES -- CORTICOSTEROID -- TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) -- PRODRUG -- ANTI-INFLAMMATORY -- IMMUNOSUPPRESSIVE , ; NDA 208684 (label 208684.pdf) INN (DEFLAZACORT) EMFLAZA (PTC THERAP) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 208685 (label 208685.pdf) INN (DEFLAZACORT) EMFLAZA (PTC THERAP) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 217123 (pdf 217123.pdf not found) INN (DEFLAZACORT) DEFLAZACORT (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 217813 (pdf 217813.pdf not found) INN (DEFLAZACORT) DEFLAZACORT (TRIS PHARMA INC) APPROVAL= AP YEAR= 2024 , 1839 ; M DEFLAZACORT ; 13649-57-5 ; 0 ; ; ; CLASS HORMONES -- CORTICOSTEROID -- TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) -- PRODRUG -- ANTI-INFLAMMATORY -- IMMUNOSUPPRESSIVE , ; 1840 ; PLECANATIDE ; 467426-54-6 ; 2017 ; ; ; CLASS METABOLISM -- TREATMENT OF CHRONIC IDIOPATHIC CONSTIPATION (CIC) -- GUANYLATE CYCLASE-C AGONIST -- STRUCTURALLY RELATED TO HUMAN UROGUANYLIN , ; NDA 208745 (label 208745.pdf) INN (PLECANATIDE) TRULANCE (SALIX) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1841 ; BRIGATINIB ; 1197953-54-0 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- ALK TYROSINE KINASE INHIBITOR , ; NDA 208772 (label 208772.pdf) INN (BRIGATINIB) ALUNBRIG (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1842 ; TELOTRISTAT ; 1033805-28-5 ; 0 ; ; ; CLASS METABOLISM -- TREATMENT OF CARCINOID SYNDROME DIARRHEA -- TRYPTOPHAN HYDROXYLASE INHIBITOR WHICH MEDIATES THE RATE LIMITING STEP IN SEROTONIN BIOSYNTHESIS , ; 1843 ; TELOTRISTAT ETHYL ; 1033805-22-9 ; 2017 ; ; ; CLASS METABOLISM -- TREATMENT OF CARCINOID SYNDROME DIARRHEA -- TRYPTOPHAN HYDROXYLASE INHIBITOR WHICH MEDIATES THE RATE LIMITING STEP IN SEROTONIN BIOSYNTHESIS , ; NDA 208794 (label 208794.pdf) INN (TELOTRISTAT ETIPRATE) XERMELO (TERSERA) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1844 ; NALDEMEDINE ; 916072-89-4 ; 2017 ; ; ; CLASS METABOLISM -- OPIOID ANTAGONIST INDICATED FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULT PATIENTS WITH CHRONIC NON-CANCER PAIN -- DERIVATIVE OF NALTREXONE , ; NDA 208854 (label 208854.pdf) INN (NALDEMEDINE TOSYLATE) SYMPROIC (BDSI) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1845 ; RIBOCICLIB ; 1211441-98-3 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER -- KINASE INHIBITOR -- INHIBITOR OF CYCLIN-DEPENDENT KINASE (CDK) 4 AND 6 , ; NDA 209092 (label 209092.pdf) INN (RIBOCICLIB SUCCINATE) KISQALI (NOVARTIS) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 209935 (label 209935.pdf) INN (LETROZOLE RIBOCICLIB SUCCINATE) KISQALI FEMARA CO-PACK COPACKAGED (NOVARTIS) APPROVAL= AP YEAR= 2017 , NDA 215975 (pdf 215975.pdf not found) INN (LETROZOLE RIBOCICLIB SUCCINATE) LETROZOLEVRIBOCICLIB SUCCINATE (MSN LABS PVT LTD) APPROVAL= TA YEAR= 2023 , NDA 215677 (pdf 215677.pdf not found) INN (RIBOCICLIB) RIBOCICLIB (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2024 , 1846 ; EDARAVONE ; 89-25-8 ; 2017 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) , ; NDA 209176 (label 209176.pdf) INN (EDARAVONE) RADICAVA (MITSUBISHI TANABE) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 215446 (label 215446.pdf) INN (EDARAVONE) RADICAVA ORS (MITSUBISHI TANABE) APPROVAL= AP YEAR= 2022 , NDA 215508 (pdf 215508.pdf not found) INN (EDARAVONE) EDARAVONE (HIKMA) APPROVAL= AP YEAR= 2024 , NDA 215917 (pdf 215917.pdf not found) INN (EDARAVONE) EDARAVONE (DR REDDYS) APPROVAL= AP YEAR= 2024 , NDA 216199 (pdf 216199.pdf not found) INN (EDARAVONE) EDARAVONE (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2024 , NDA 218349 (pdf 218349.pdf not found) INN (EDARAVONE) EDARAVONE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2024 , NDA 218354 (pdf 218354.pdf not found) INN (EDARAVONE) EDARAVONE (LONG GROVE PHARMS) APPROVAL= AP YEAR= 2024 , 1847 ; VOXILAPREVIR ; 1535212-07-7 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HEPATITIS C VIRUS (HCV) -- NS3/4A PROTEASE INHIBITOR (KI=38-66 PICOMOLAR) , ; NDA 209195 (label 209195.pdf) INN (SOFOSBUVIR VELPATASVIR VOXILAPREVIR) VOSEVI (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2017 , 1848 ; VALBENAZINE ; 1025504-45-3 ; 2017 ; ; ; CLASS NERVOUS SYSTEM -- VESICULAR MONOAMINE TRANSPORTER 2 (VMAT2) INHIBITOR (KI = 150 NANOMOLAR)-- TREATMENT OF ADULTS WITH TARDIVE DYSKINESIA , ; NDA 209241 (label 209241.pdf) INN (VALBENAZINE TOSYLATE) INGREZZA (NEUROCRINE) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 215962 (pdf 215962.pdf not found) INN (VALBENAZINE) VALBENAZINE (SANDOZ INC) APPROVAL= TA YEAR= 2022 , NDA 215984 (pdf 215984.pdf not found) INN (VALBENAZINE TOSYLATE) VALBENAZINE TOSYLATE (TEVA PHARMS INC) APPROVAL= TA YEAR= 2022 , NDA 216137 (pdf 216137.pdf not found) INN (VALBENAZINE TOSYLATE) VALBENAZINE TOSYLATE (ZYDUS WORLDWIDE DMCC) APPROVAL= TA YEAR= 2022 , NDA 216064 (pdf 216064.pdf not found) INN (VALBENAZINE TOSYLATE) VALBENAZINE TOSYLATE (LUPIN LTD) APPROVAL= AP YEAR= 2024 , NDA 218390 (pdf 218390.pdf not found) INN (VALBENAZINE TOSYLATE) INGREZZA SPRINKLE (NEUROCRINE) APPROVAL= AP YEAR= 2024 , 1849 ; M VALBENAZINE ; 3466-75-9 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- VESICULAR MONOAMINE TRANSPORTER 2 (VMAT2) INHIBITOR (KI = 3 NANOMOLAR)-- TREATMENT OF ADULTS WITH TARDIVE DYSKINESIA , ; 1850 ; GLECAPREVIR ; 1365970-03-1 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HEPATITIS C VIRUS (HCV) -- NS3/4A PROTEASE INHIBITOR , ; NDA 209394 (label 209394.pdf) INN (GLECAPREVIR PIBRENTASVIR) MAVYRET (ABBVIE) APPROVAL= AP YEAR= 2017 , NDA 215110 (label 215110.pdf) INN (GLECAPREVIR PIBRENTASVIR) MAVYRET (ABBVIE) APPROVAL= AP YEAR= 2021 , 1851 ; PIBRENTASVIR ; 1353900-92-1 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF HEPATITIS C VIRUS (HCV) -- NS3/4A PROTEASE INHIBITOR , ; NDA 209394 (label 209394.pdf) INN (GLECAPREVIR PIBRENTASVIR) MAVYRET (ABBVIE) APPROVAL= AP YEAR= 2017 , NDA 215110 (label 215110.pdf) INN (GLECAPREVIR PIBRENTASVIR) MAVYRET (ABBVIE) APPROVAL= AP YEAR= 2021 , 1852 ; M MIDOSTAURIN ; 179237-49-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) OR AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) -- MULTIKINASE TYROSINE KINASE INHIBITOR (FLT3, FLT3 MUTANT KINASES (ITD AND TKD), KIT (WILD TYPE AND D816V MUTANT), PDGFR ALPHA/BETA, VEGFR2, AS WELL AS MEMBERS OF THE SERINE/THREONINE KINASE PKC (PROTEIN KINASE C) FAMILY) , ; 1853 ; LEVOLEUCOVORIN ; 68538-85-2 ; 1952 ; ; ; CLASS VARIOUS -- ANTIANEMIC -- ANTIDOTE TO FOLIC ACID ANTAGONISTS -- ANTINEOPLASTIC ADJUNCTS -- RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA -- USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL -- RAPIDLY ABSORBED AND ENTERS THE GENERAL BODY POOL OF REDUCED FOLATES -- CONVERTED TO 5-METHYLTETRAHYDROFOLIC ACID (5-METHYL-THF) , ; NDA 008107 (pdf 8107.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HOSPIRA) APPROVAL= AP YEAR= 1952 NEWMOLECULARENTITY DISCONTINUED , NDA 018342 (pdf 18342.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 018459 (pdf 18459.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 040056 (label 40056.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1995 , NDA 040147 (pdf 40147.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (HOSPIRA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 040174 (pdf 40174.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1997 , NDA 040258 (pdf 40258.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040262 (label 40262.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040286 (pdf 40286.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (FRESENIUS KABI USA) APPROVAL= AP YEAR= 1999 , NDA 040332 (pdf 40332.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (TEVA PARENTERAL) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 040335 (label 40335.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2000 , NDA 040338 (pdf 40338.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (AM REGENT) APPROVAL= AP YEAR= 2001 DISCONTINUED , NDA 040347 (label 40347.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 2000 , NDA 070480 (pdf 70480.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ELKINS SINN) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071104 (pdf 71104.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 071198 (pdf 71198.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (BARR) APPROVAL= AP YEAR= 1987 , NDA 071199 (pdf 71199.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (BARR) APPROVAL= AP YEAR= 1987 , NDA 071598 (pdf 71598.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071600 (pdf 71600.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PAR PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 071962 (pdf 71962.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (XANODYNE PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED , NDA 072733 (pdf 72733.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072734 (pdf 72734.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072735 (pdf 72735.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 072736 (pdf 72736.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 1993 , NDA 073099 (pdf 73099.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 073101 (pdf 73101.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 074544 (pdf 74544.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 1997 , NDA 075327 (pdf 75327.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ANI PHARMS INC) APPROVAL= AP YEAR= 1999 DISCONTINUED , NDA 081224 (pdf 81224.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ELKINS SINN) APPROVAL= AP YEAR= 1994 DISCONTINUED , NDA 081277 (pdf 81277.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PHARMS USA) APPROVAL= AP YEAR= 1993 , NDA 081278 (pdf 81278.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (TEVA PARENTERAL) APPROVAL= AP YEAR= 1993 DISCONTINUED , NDA 087439 (pdf 87439.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088939 (pdf 88939.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABRAXIS PHARM) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089352 (pdf 89352.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089353 (pdf 89353.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (ABIC) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089384 (label 89384.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1987 , NDA 089465 (pdf 89465.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089496 (pdf 89496.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089503 (pdf 89503.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089504 (pdf 89504.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089628 (pdf 89628.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 089636 (pdf 89636.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (QUAD PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089717 (label 89717.pdf) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (WEST-WARD PHARMS INT) APPROVAL= AP YEAR= 1988 , NDA 089833 (pdf 89833.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089834 (pdf 89834.pdf not found) INN (LEUCOVORIN CALCIUM) WELLCOVORIN (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089915 (pdf 89915.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (PHARMACHEMIE USA) APPROVAL= AP YEAR= 1997 DISCONTINUED , NDA 020140 (label 20140.pdf) INN (LEVOLEUCOVORIN CALCIUM) FUSILEV (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2008 DISCONTINUED , NDA 200753 (pdf 200753.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 200855 (pdf 200855.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS) APPROVAL= AP YEAR= 2012 , NDA 203563 (label 203563.pdf) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (SANDOZ) APPROVAL= AP YEAR= 2015 , NDA 203576 (pdf 203576.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (MYLAN TEORANTA) APPROVAL= AP YEAR= 2015 DISCONTINUED , NDA 206263 (label 206263.pdf) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (HIKMA) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 207547 (pdf 207547.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (AMNEAL) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 203800 (pdf 203800.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (MYLAN LABS LTD) APPROVAL= AP YEAR= 2017 , NDA 208723 (label 208723.pdf) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (ACTAVIS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED , NDA 206516 (pdf 206516.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (ACTAVIS LLC) APPROVAL= AP YEAR= 2017 DISCONTINUED , NDA 209110 (pdf 209110.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM PRESERVATIVE FREE (SAGENT PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 207241 (pdf 207241.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 207548 (pdf 207548.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (AMNEAL) APPROVAL= AP YEAR= 2017 , NDA 210623 (pdf 210623.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (NOVAST LABS) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 207226 (pdf 207226.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (FRESENIUS KABI USA) APPROVAL= AP YEAR= 2018 , NDA 210917 (pdf 210917.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (INGENUS PHARMS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED , NDA 210892 (pdf 210892.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (GLAND PHARMA LTD) APPROVAL= AP YEAR= 2018 , NDA 211226 (label 211226.pdf) INN (LEVOLEUCOVORIN) KHAPZORY (ACROTECH BIOPHARMA) APPROVAL= AP YEAR= 2018 , NDA 211002 (pdf 211002.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (MEITHEAL) APPROVAL= AP YEAR= 2019 , NDA 211003 (pdf 211003.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (MEITHEAL) APPROVAL= AP YEAR= 2019 DISCONTINUED , NDA 211132 (pdf 211132.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (NOVAST LABS) APPROVAL= AP YEAR= 2020 , NDA 213929 (pdf 213929.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (LEADING PHARMA LLC) APPROVAL= AP YEAR= 2020 , NDA 213797 (pdf 213797.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (AILEX PHARMS LLC) APPROVAL= AP YEAR= 2021 DISCONTINUED , NDA 217314 (pdf 217314.pdf not found) INN (LEVOLEUCOVORIN CALCIUM) LEVOLEUCOVORIN CALCIUM (HAINAN POLY PHARM) APPROVAL= AP YEAR= 2023 , NDA 216590 (pdf 216590.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (KINDOS) APPROVAL= AP YEAR= 2023 , NDA 217021 (pdf 217021.pdf not found) INN (LEUCOVORIN CALCIUM) LEUCOVORIN CALCIUM (HAINAN POLY) APPROVAL= AP YEAR= 2023 , 1854 ; CALICHEAMICIN ; 108212-76-6 ; 2000 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) -- CD33- OR CD22-DIRECTED ANTIBODY-DRUG CONJUGATE (ADC) -- RELEASE OF N-ACETYL-GAMMA-CALICHEAMICIN THAT CAUSES DOUBLE-STRANDED DNA BREAKS , ; NDA 761040 (label 761040.pdf) INN (INOTUZUMAB OZOGAMICIN) BESPONSA (WYETH PHARMS INC) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 761060 (label 761060.pdf) INN (GEMTUZUMAB OZOGAMICIN) MYLOTARG (WYETH PHARMS INC) APPROVAL= AP YEAR= 2017 , NDA 021174 (label 21174.pdf) INN (GEMTUZUMAB OZOGAMICIN) MYLOTARG (WYETH PHARMS INC) APPROVAL= AP YEAR= 2000 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , 1855 ; MAYTANSINE ; 139504-50-0 ; 2013 ; ; NATURAL MOLECULE C00002351 ; CLASS ANTINEOPLASTIC -- TREATMENT OF PATIENTS WITH HER2-POSITIVE, METASTATIC BREAST CANCER WHO PREVIOUSLY RECEIVED TRASTUZUMAB AND A TAXANE, SEPARATELY OR IN COMBINATION -- HER2-TARGETED ANTIBODY-DRUG CONJUGATE (ADC) -- EMTANSINE REFERS TO THE MCC-DM1 -- DM1 IS A MAYTANSINE DERIVATIVE AND MCC IS STABLE THIOETHER LINKER (4-[N-MALEIMIDOMETHYL] CYCLOHEXANE-1-CARBOXYLATE)-- LEAD TO THE RELEASE OF DM1 A MICROTUBULE INHIBITOR , ; NDA 125427 (label 125427.pdf) INN (ADO-TRASTUZUMAB EMTANSINE) KADCYLA (GENENTECH) APPROVAL= AP YEAR= 2013 NEWMOLECULARENTITY , 1856 ; MMAE ; 474645-27-7 ; 2011 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF PATIENTS WITH HODGKIN LYMPHOMA, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (SALCL), PRIMARY CUTANEOUS ANAPLASTIC LARGE CELL LYMPHOMA (PCALCL) OR CD30EXPRESSING MYCOSIS FUNGOIDES (MF) -- CD30-DIRECTED ANTIBODY-DRUG CONJUGATE (ADC) -- LEAD TO THE RELEASE OF THE MICROTUBULE DISRUPTING AGENT MMAE , ; NDA 125388 (label 125388.pdf) INN (BRENTUXIMAB VEDOTIN) ADCETRIS (SEATTLE GENETICS) APPROVAL= AP YEAR= 2011 NEWMOLECULARENTITY , NDA 125399 (label 125399.pdf) INN (BRENTUXIMAB VEDOTIN) ADCETRIS (SEATTLE GENETICS) APPROVAL= AP YEAR= 2011 , NDA 761121 (label 761121.pdf) INN (POLATUZUMAB VEDOTIN-PIIQ) POLIVY (GENENTECH) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 761137 (label 761137.pdf) INN (ENFORTUMAB VEDOTIN-EJFV) PADCEV (ASTELLAS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 761208 (label 761208.pdf) INN (TISOTUMAB VEDOTIN-TFTV) TIVDAK (SEAGEN) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 1857 ; MACIMORELIN ; 381231-18-1 ; 2017 ; DISCONTINUED ; ; CLASS VARIOUS -- TESTS FOR PITUITARY FUNCTION -- GROWTH HORMONE (GH) SECRETAGOGUE RECEPTOR AGONIST INDICATED FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY , ; NDA 205598 (label 205598.pdf) INN (MACIMORELIN ACETATE) MACRILEN (NOVO) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY DISCONTINUED , 1858 ; LATANOPROSTENE BUNOD ; 860005-21-6 ; 2017 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- ANTIHYPERTENSIVE AGENTS -- PROSTAGLANDIN ANALOG -- LOWER INTRAOCULAR PRESSURE BY INCREASING OUTFLOW OF AQUEOUS HUMOR , ; NDA 207795 (label 207795.pdf) INN (LATANOPROSTENE BUNOD) VYZULTA (BAUSCH AND LOMB) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1859 ; BARICITINIB ; 1187594-09-7 ; 2018 ; ; ; CLASS IMMUNOMODULATING -- JANUS KINASES (JAKS) INHIBITOR -- TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS , ; NDA 207924 (label 207924.pdf) INN (BARICITINIB) OLUMIANT (ELI LILLY AND CO) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1860 ; NETARSUDIL ; 1254032-66-0 ; 2017 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- RHO KINASE INHIBITOR -- REDUCE IOP BY INCREASING THE OUTFLOW OF AQUEOUS HUMOR -- ANTIHYPERTENSIVE , ; NDA 208254 (label 208254.pdf) INN (NETARSUDIL MESYLATE) RHOPRESSA (ALCON LABS INC) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 208259 (label 208259.pdf) INN (LATANOPROST NETARSUDIL DIMESYLATE) ROCKLATAN (ALCON LABS INC) APPROVAL= AP YEAR= 2019 , NDA 216855 (pdf 216855.pdf not found) INN (NETARSUDIL) NETARSUDIL MESYLATE (GLAND PHARMA LTD) APPROVAL= TA YEAR= 2024 , 1861 ; M NETARSUDIL ; 1254032-16-0 ; 0 ; ; ; CLASS SENSORY -- ANTIGLAUCOMA -- RHO KINASE INHIBITOR -- REDUCE IOP BY INCREASING THE OUTFLOW OF AQUEOUS HUMOR -- ANTIHYPERTENSIVE , ; 1862 ; BENZHYDROCODONE ; 1259440-61-3 ; 2018 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- ANALGESIC -- NARCOTICS -- PRODRUG OF HYDROCODONE AND HYDROMORPHONE -- CONVERTED TO ACTIVE HYDROCODONE BY ENZYMES IN THE INTESTINAL TRACT , ; NDA 208653 (label 208653.pdf) INN (ACETAMINOPHEN BENZHYDROCODONE HYDROCHLORIDE) APADAZ (ZEVRA THERAP) APPROVAL= AP YEAR= 2018 DISCONTINUED , 1863 ; ABEMACICLIB ; 1231929-97-7 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ADVANCED OR METASTATIC BREAST CANCER -- INHIBITOR OF CYCLIN-DEPENDENT KINASES 4 AND 6 (CDK4 AND CDK6) , ; NDA 208716 (label 208716.pdf) INN (ABEMACICLIB) VERZENIO (ELI LILLY AND CO) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 208855 (label 208855.pdf) INN (ABEMACICLIB) VERZENIO (ELI LILLY AND CO) APPROVAL= AP YEAR= 2018 NEWAPPLICATION , 1864 ; OZENOXACIN ; 245765-41-7 ; 2017 ; ; ; CLASS DERMATOLOGICALS -- ANTIBIOTICS -- QUINOLONE -- TOPICAL TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES , ; NDA 208945 (label 208945.pdf) INN (OZENOXACIN) XEPI (FERRER INTERNACIONAL) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1865 ; LOFEXIDINE ; 31036-80-3 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- CENTRAL ALPHA-2 ADRENERGIC AGONIST -- INDICATED FOR MITIGATION OF OPIOID WITHDRAWAL SYMPTOMS TO FACILITATE ABRUPT OPIOID DISCONTINUATION IN ADULTS , ; NDA 209229 (label 209229.pdf) INN (LOFEXIDINE HYDROCHLORIDE) LUCEMYRA (USWM) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1866 ; LOFEXIDINE ; 31036-80-3 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- CENTRAL ALPHA-2 ADRENERGIC AGONIST -- INDICATED FOR MITIGATION OF OPIOID WITHDRAWAL SYMPTOMS TO FACILITATE ABRUPT OPIOID DISCONTINUATION IN ADULTS , ; NDA 209229 (label 209229.pdf) INN (LOFEXIDINE HYDROCHLORIDE) LUCEMYRA (USWM) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1867 ; FOSTAMATINIB ; 901119-35-5 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE SYK INHIBITOR -- INDICATED FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA -- METABOLIZED IN THE GUT BY ALKALINE PHOSPHATASE , ; NDA 209299 (label 209299.pdf) INN (FOSTAMATINIB DISODIUM) TAVALISSE (RIGEL PHARMS INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1868 ; M FOSTAMATINIB ; 841290-80-0 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE SYK INHIBITOR -- INDICATED FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA -- METABOLIZED IN THE GUT BY ALKALINE PHOSPHATASE , ; 1869 ; ANGIOTENSIN II ; 4474-91-3 ; 2017 ; ; ; CLASS CARDIOVASCULAR -- A VASOCONSTRICTOR TO INCREASE BLOOD PRESSURE IN ADULTS WITH SEPTIC OR OTHER DISTRIBUTIVE SHOCK , ; NDA 209360 (label 209360.pdf) INN (ANGIOTENSIN II ACETATE) GIAPREZA (LA JOLLA PHARMA) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1870 ; SECNIDAZOLE ; 3366-95-8 ; 2017 ; ; ; CLASS ANTIPARASITIC -- A NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN -- 5-NITROIMIDAZOLES ENTER THE BACTERIAL CELL AS AN INACTIVE PRODRUG WHERE THE NITRO GROUP IS REDUCED BY BACTERIAL ENZYMES TO RADICAL ANIONS. IT IS BELIEVED THAT THESE RADICAL ANIONS INTERFERE WITH BACTERIAL DNA SYNTHESIS OF SUSCEPTIBLE ISOLATES , ; NDA 209363 (label 209363.pdf) INN (SECNIDAZOLE) SOLOSEC (LUPIN) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1871 ; SECNIDAZOLE ; 3366-95-8 ; 2017 ; ; ; CLASS ANTIPARASITIC -- A NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN -- 5-NITROIMIDAZOLES ENTER THE BACTERIAL CELL AS AN INACTIVE PRODRUG WHERE THE NITRO GROUP IS REDUCED BY BACTERIAL ENZYMES TO RADICAL ANIONS. IT IS BELIEVED THAT THESE RADICAL ANIONS INTERFERE WITH BACTERIAL DNA SYNTHESIS OF SUSCEPTIBLE ISOLATES , ; NDA 209363 (label 209363.pdf) INN (SECNIDAZOLE) SOLOSEC (LUPIN) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1872 ; BENZNIDAZOLE ; 22994-85-0 ; 2017 ; ; ; CLASS ANTIPARASITIC -- A NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF CHAGAS DISEASE CAUSED BY TRYPANOSOMA CRUZI -- BENZNIDAZOLE INHIBITS THE SYNTHESIS OF DNA, RNA, AND PROTEINS WITHIN THE T. CRUZI PARASITE , ; NDA 209570 (label 209570.pdf) INN (BENZNIDAZOLE) BENZNIDAZOLE (CHEMO RESEARCH SL) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , 1873 ; VABORBACTAM ; 1360457-46-0 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- A BETA-LACTAMASE INHIBITOR -- TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS , ; NDA 209776 (label 209776.pdf) INN (MEROPENEM VABORBACTAM) VABOMERE (REMPEX) APPROVAL= AP YEAR= 2017 , 1874 ; ERTUGLIFLOZIN ; 1210344-57-2 ; 2017 ; ; ; CLASS METABOLISM -- TYPE 2 DIABETES MELLITUS -- SODIUM-GLUCOSE CO-TRANSPORTER 2 (SGLT2) INHIBITOR , ; NDA 209803 (label 209803.pdf) INN (ERTUGLIFLOZIN) STEGLATRO (MSD SUB MERCK) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 209805 (label 209805.pdf) INN (ERTUGLIFLOZIN SITAGLIPTIN PHOSPHATE) STEGLUJAN (MSD SUB MERCK) APPROVAL= AP YEAR= 2017 , NDA 209806 (label 209806.pdf) INN (ERTUGLIFLOZIN METFORMIN HYDROCHLORIDE) SEGLUROMET (MSD SUB MERCK) APPROVAL= AP YEAR= 2017 , NDA 216842 (pdf 216842.pdf not found) INN (ERTUGLIFLOZIN) ERTUGLIFLOZIN (ZENARA) APPROVAL= TA YEAR= 2023 , NDA 216947 (pdf 216947.pdf not found) INN (ERTUGLIFLOZIN) ERTUGLIFLOZIN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED , NDA 217071 (pdf 217071.pdf not found) INN (ERTUGLIFLOZIN) ERTUGLIFLOZIN (HETERO LABS) APPROVAL= TA YEAR= 2024 , 1875 ; COPANLISIB ; 1032568-63-0 ; 2017 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- PHOSPHATIDYLINOSITOL-3-KINASE (PI3K) INHIBITOR WITH INHIBITORY ACTIVITY PREDOMINANTLY AGAINST PI3K-ALPHA AND PI3K-DELTA ISOFORMS EXPRESSED IN MALIGNANT B CELLS -- TREATMENT OF FOLLICULAR LYMPHOMA , ; NDA 209936 (label 209936.pdf) INN (COPANLISIB DIHYDROCHLORIDE) ALIQOPA (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY DISCONTINUED , 1876 ; LETERMOVIR ; 917389-32-3 ; 2017 ; ; ; CLASS ANTIINFECTIVES -- DNA TERMINASE COMPLEX (PUL51, PUL56, AND PUL89) INHIBITOR -- PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION , ; NDA 209939 (label 209939.pdf) INN (LETERMOVIR) PREVYMIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 209940 (label 209940.pdf) INN (LETERMOVIR) PREVYMIS (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2017 , NDA 216799 (pdf 216799.pdf not found) INN (LETERMOVIR) LETERMOVIR (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2024 , 1877 ; COCAINE ; 50-36-2 ; 2017 ; ; NATURAL MOLECULE C00002285 ; CLASS NERVOUS SYSTEM -- ESTER LOCAL ANESTHETIC -- LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES OF THE NASAL CAVITIES -- REVERSIBLY BLOCKING SODIUM CHANNELS , ; NDA 209963 (label 209963.pdf) INN (COCAINE HYDROCHLORIDE) GOPRELTO (NODEN PHARMA) APPROVAL= AP YEAR= 2017 , NDA 209575 (label 209575.pdf) INN (COCAINE HYDROCHLORIDE) NUMBRINO (OMNIVIUM PHARMS) APPROVAL= AP YEAR= 2020 , 1878 ; AVATROMBOPAG ; 570406-98-3 ; 2018 ; ; ; CLASS BLOOD -- THROMBOPOIETIN RECEPTOR AGONIST (TPO) -- TREATMENT OF THROMBOCYTOPENIA -- INCREASED PRODUCTION OF PLATELETS , ; NDA 210238 (label 210238.pdf) INN (AVATROMBOPAG MALEATE) DOPTELET (AKARX INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1879 ; BICTEGRAVIR ; 1611493-60-7 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) -- TREATMENT OF HIV-1 INFECTION , ; NDA 210251 (label 210251.pdf) INN (BICTEGRAVIR SODIUM EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE) BIKTARVY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2018 , 1880 ; ACALABRUTINIB ; 1420477-60-6 ; 2017 ; ; ; CLASS ANTINEOPLASTIC -- BRUTON TYROSINE KINASE (BTK) INHIBITOR -- TREATMENT OF MANTLE CELL LYMPHOMA (MCL) -- FORM A COVALENT BOND WITH A CYSTEINE RESIDUE IN THE BTK ACTIVE SITE -- ACP-5862 IS THE MAJOR ACTIVE METABOLITE BUT ACTIVITY IS 50 PERCENT LESS POTENT , ; NDA 210259 (label 210259.pdf) INN (ACALABRUTINIB) CALQUENCE (ASTRAZENECA) APPROVAL= AP YEAR= 2017 NEWMOLECULARENTITY , NDA 216387 (label 216387.pdf) INN (ACALABRUTINIB MALEATE) CALQUENCE (ASTRAZENECA) APPROVAL= AP YEAR= 2022 , NDA 216775 (pdf 216775.pdf not found) INN (ACALABRUTINIB) ACALABRUTINIB (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2023 , 1881 ; TEZACAFTOR ; 1152311-62-0 ; 2018 ; ; ; CLASS RESPIRATORY SYSTEM -- CYSTIC FIBROSIS WITH F508DEL MUTATION-- POTENTIATOR -- METABOLITE M1 HAS SIMILAR POTENCY TO THAT OF TEZACAFTOR , ; NDA 210491 (label 210491.pdf) INN (IVACAFTOR TEZACAFTOR) SYMDEKO COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2018 , NDA 212273 (label 212273.pdf) INN (ELEXACAFTOR IVACAFTOR TEZACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2019 , NDA 217660 (label 217660.pdf) INN (ELEXACAFTOR IVACAFTOR TEZACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2023 , 1882 ; FOSNETUPITANT ; 1703748-89-3 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- PRODRUG OF NETUPITANT -- A SUBSTANCE P/NEUROKININ 1 (NK1) RECEPTOR ANTAGONIST --PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH CANCER CHEMOTHERAPY , ; NDA 210493 (label 210493.pdf) INN (FOSNETUPITANT CHLORIDE HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE) AKYNZEO (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2018 , 1883 ; APALUTAMIDE ; 956104-40-8 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR INDICATED FOR THE TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER , ; NDA 210951 (label 210951.pdf) INN (APALUTAMIDE) ERLEADA (JANSSEN BIOTECH) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1884 ; M APALUTAMIDE ; 1332391-11-3 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR INDICATED FOR THE TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER -- N-DESMETHYL APALUTAMIDE, IS A LESS POTENT INHIBITOR OF AR, AND EXHIBITED ONE-THIRD THE ACTIVITY , ; 1885 ; STIRIPENTOL ; 137767-55-6 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM -- THE MECHANISM OF ACTION IS UNKNOWN , ; NDA 206709 (label 206709.pdf) INN (STIRIPENTOL) DIACOMIT (BIOCODEX SA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 207223 (label 207223.pdf) INN (STIRIPENTOL) DIACOMIT (BIOCODEX SA) APPROVAL= AP YEAR= 2018 , 1886 ; STIRIPENTOL ; 137767-55-6 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM -- THE MECHANISM OF ACTION IS UNKNOWN , ; NDA 206709 (label 206709.pdf) INN (STIRIPENTOL) DIACOMIT (BIOCODEX SA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 207223 (label 207223.pdf) INN (STIRIPENTOL) DIACOMIT (BIOCODEX SA) APPROVAL= AP YEAR= 2018 , 1887 ; AMIFAMPRIDINE ; 54-96-6 ; 2018 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) -- BROAD SPECTRUM VOLTAGE-GATED POTASSIUM CHANNEL BLOCKER -- THE MECHANISM OF ACTION HAS NOT BEEN FULLY ELUCIDATED , ; NDA 208078 (label 208078.pdf) INN (AMIFAMPRIDINE PHOSPHATE) FIRDAPSE (CATALYST PHARMS) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 209321 (label 209321.pdf) INN (AMIFAMPRIDINE) RUZURGI (JACOBUS PHARM CO INC) APPROVAL= TA YEAR= 2019 , 1888 ; MIGALASTAT ; 108147-54-2 ; 2018 ; ; ; CLASS METABOLISM -- AN ALPHA-GALACTOSIDASE A (ALPHA-GAL A) PHARMACOLOGICAL CHAPERONE -- TREATMENT OF FABRY DISEASE -- ANALOGUE OF THE TERMINAL GALACTOSE OF GLOBOTRIAOSYLCERAMIDE (GL-3) , ; NDA 208623 (label 208623.pdf) INN (MIGALASTAT HYDROCHLORIDE) GALAFOLD (AMICUS THERAP US) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1889 ; TECOVIRIMAT ; 869572-92-9 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL AGAINST VARIOLA -- TREATMENT OF HUMAN SMALLPOX DISEASE -- INHIBITOR OF THE ORTHOPOXVIRUS VP37 ENVELOPE -- BLOCKS ITS INTERACTION WITH CELLULAR RAB9 GTPASE AND TIP47 , ; NDA 208627 (label 208627.pdf) INN (TECOVIRIMAT) TPOXX (SIGA TECHNOLOGIES) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 214518 (label 214518.pdf) INN (TECOVIRIMAT) TPOXX (SIGA TECHNOLOGIES) APPROVAL= AP YEAR= 2022 , 1890 ; TRICLABENDAZOLE ; 68786-66-3 ; 2019 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF FASCIOLIASIS -- TRICLABENDAZOLE AND ITS METABOLITES ARE ACTIVE AGAINST THE IMMATURE AND MATURE WORMS , ; NDA 208711 (label 208711.pdf) INN (TRICLABENDAZOLE) EGATEN (NOVARTIS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1891 ; M TRICLABENDAZOLE ; 100648-13-3 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF FASCIOLIASIS -- TRICLABENDAZOLE AND ITS METABOLITES ARE ACTIVE AGAINST THE IMMATURE AND MATURE WORMS , ; 1892 ; M TRICLABENDAZOLE ; 106791-37-1 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF FASCIOLIASIS -- TRICLABENDAZOLE AND ITS METABOLITES ARE ACTIVE AGAINST THE IMMATURE AND MATURE WORMS , ; 1893 ; SARECYCLINE ; 1035654-66-0 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- TETRACYCLINE-CLASS DRUG -- TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS , ; NDA 209521 (label 209521.pdf) INN (SARECYCLINE HYDROCHLORIDE) SEYSARA (ALMIRALL) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1894 ; SEGESTERONE ACETATE ; 7759-35-5 ; 2018 ; ; ; CLASS GENITO -- PROGESTIN CHC TO PREVENT PREGNANCY , ; NDA 209627 (label 209627.pdf) INN (ETHINYL ESTRADIOL SEGESTERONE ACETATE) ANNOVERA (MAYNE PHARMA) APPROVAL= AP YEAR= 2018 , 1895 ; OMADACYCLINE ; 389139-89-3 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- TETRACYCLINE CLASS OF ANTIBACTERIAL DRUGS , ; NDA 209816 (label 209816.pdf) INN (OMADACYCLINE TOSYLATE) NUZYRA (PARATEK PHARMS INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 209817 (label 209817.pdf) INN (OMADACYCLINE TOSYLATE) NUZYRA (PARATEK PHARMS INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1896 ; SIPONIMOD ; 1230487-00-9 ; 2019 ; ; ; CLASS IMMUNOSUPPRESSANTS -- A SPHINGOSINE 1-PHOSPHATE RECEPTOR MODULATOR (SIP RECEPTORS 1 AND 5) -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) -- -- REDUCES THE NUMBER OF LYMPHOCYTES IN PERIPHERAL BLOOD , ; NDA 209884 (label 209884.pdf) INN (SIPONIMOD) MAYZENT (NOVARTIS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1897 ; PRUCALOPRIDE ; 179474-81-8 ; 2018 ; ; ; CLASS METABOLISM -- SEROTONIN-4 (5-HT4) RECEPTOR AGONIST -- TREATMENT OF CHRONIC IDIOPATHIC CONSTIPATION (CIC) , ; NDA 210166 (label 210166.pdf) INN (PRUCALOPRIDE SUCCINATE) MOTEGRITY (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1898 ; PLAZOMICIN ; 1154757-24-0 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- AMINOGLYCOSIDE ANTIBACTERIAL DERIVED FROM SISOMICIN -- TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS , ; NDA 210303 (label 210303.pdf) INN (PLAZOMICIN SULFATE) ZEMDRI (CIPLA USA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1899 ; GLYCOPYRRONIUM ; 596-51-0 ; 2018 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- COMPETITIVE INHIBITOR OF ACETYLCHOLINE RECEPTORS -- TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS , ; NDA 210361 (label 210361.pdf) INN (GLYCOPYRRONIUM TOSYLATE) QBREXZA (JOURNEY) APPROVAL= AP YEAR= 2018 , 1900 ; GLYCOPYRRONIUM ; 596-51-0 ; 2018 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- COMPETITIVE INHIBITOR OF ACETYLCHOLINE RECEPTORS -- TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS , ; NDA 210361 (label 210361.pdf) INN (GLYCOPYRRONIUM TOSYLATE) QBREXZA (JOURNEY) APPROVAL= AP YEAR= 2018 , 1901 ; GLYCOPYRRONIUM ; 596-51-0 ; 2018 ; ; ; CLASS METABOLISM -- ANTICHOLINERGIC -- COMPETITIVE INHIBITOR OF ACETYLCHOLINE RECEPTORS -- TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS , ; NDA 210361 (label 210361.pdf) INN (GLYCOPYRRONIUM TOSYLATE) QBREXZA (JOURNEY) APPROVAL= AP YEAR= 2018 , 1902 ; CANNABIDIOL ; 13956-29-1 ; 2018 ; ; NATURAL MOLECULE C00002641 ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME OR DRAVET SYNDROME -- ANTICONVULSANT -- AGONIST OF CANNABINOID (CB) RECEPTORS , ; NDA 210365 (label 210365.pdf) INN (CANNABIDIOL) EPIDIOLEX (JAZZ PHARMS RES) APPROVAL= AP YEAR= 2018 , 1903 ; M CANNABIDIOL ; 50725-17-2 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME OR DRAVET SYNDROME -- ANTICONVULSANT -- AGONIST OF CANNABINOID (CB) RECEPTORS , ; 1904 ; ELAGOLIX ; 834153-87-6 ; 2018 ; ; ; CLASS HORMONES -- GONADOTROPIN-RELEASING HORMONE (GNRH) RECEPTOR ANTAGONIST -- TREATMENT OF PAIN ASSOCIATED WITH ENDOMETRIOSIS , ; NDA 210450 (label 210450.pdf) INN (ELAGOLIX SODIUM) ORILISSA (ABBVIE) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 213388 (label 213388.pdf) INN (ELAGOLIX SODIUM) ORIAHNN COPACKAGED (ABBVIE INC) APPROVAL= AP YEAR= 2020 , 1905 ; ENCORAFENIB ; 1269440-17-6 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- BRAF V600E KINASE INHIBITOR (KD=0.35 NANOMOLAR) -- TREATMENT OF MELANOMA WITH A BRAF V600E OR V600K MUTATION -- ALSO BINDS JNK1, JNK2, JNK3, LIMK1, LIMK2, MEK4, AND STK36 KINASES , ; NDA 210496 (label 210496.pdf) INN (ENCORAFENIB) BRAFTOVI (ARRAY BIOPHARMA INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1906 ; BINIMETINIB ; 606143-89-9 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- MEK1 AND MEK2 KINASE INHIBITOR -- TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION , ; NDA 210498 (label 210498.pdf) INN (BINIMETINIB) MEKTOVI (ARRAY BIOPHARMA INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 217678 (pdf 217678.pdf not found) INN (BINIMETINIB) BINIMETINIB (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2024 , 1907 ; TAFENOQUINE ; 106635-80-7 ; 2018 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- 8-AMINOQUINOLINE -- ACTIVE AGAINST ALL THE STAGES OF PLASMODIUM SPECIES -- INHIBITS HEMATIN POLYMERIZATION AND INDUCES APOPTOTIC LIKE DEATH OF THE PARASITE , ; NDA 210795 (label 210795.pdf) INN (TAFENOQUINE SUCCINATE) KRINTAFEL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 210607 (label 210607.pdf) INN (TAFENOQUINE SUCCINATE) ARAKODA (60 DEGREES PHARMS) APPROVAL= AP YEAR= 2018 , 1908 ; TAFENOQUINE ; 106635-80-7 ; 2018 ; ; ; CLASS ANTIPARASITIC -- ANTIMALARIAL -- 8-AMINOQUINOLINE -- ACTIVE AGAINST ALL THE STAGES OF PLASMODIUM SPECIES -- INHIBITS HEMATIN POLYMERIZATION AND INDUCES APOPTOTIC LIKE DEATH OF THE PARASITE , ; NDA 210795 (label 210795.pdf) INN (TAFENOQUINE SUCCINATE) KRINTAFEL (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 210607 (label 210607.pdf) INN (TAFENOQUINE SUCCINATE) ARAKODA (60 DEGREES PHARMS) APPROVAL= AP YEAR= 2018 , 1909 ; REVEFENACIN ; 864750-70-9 ; 2018 ; ; ; CLASS RESPIRATORY -- TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONIST LEADING TO BRONCHODILATION , ; NDA 210598 (label 210598.pdf) INN (REVEFENACIN) YUPELRI (MYLAN IRELAND LTD) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1910 ; M REVEFENACIN ; 909800-36-8 ; 0 ; ; ; CLASS RESPIRATORY -- TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) -- ANTICHOLINERGIC -- MUSCARINIC ANTAGONIST LEADING TO BRONCHODILATION , ; 1911 ; GLASDEGIB ; 1095173-27-5 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- INHIBITOR OF THE HEDGEHOG PATHWAY -- INHIBITS SMOOTHENED TRANSMEMBRANE PROTEIN (SMO) -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) , ; NDA 210656 (label 210656.pdf) INN (GLASDEGIB MALEATE) DAURISMO (PFIZER) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1912 ; DORAVIRINE ; 1338225-97-0 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- ANTIRETROVIRAL DRUG -- A PYRIDINONE NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) -- TREATMENT OF HIV-1 INFECTION , ; NDA 210806 (label 210806.pdf) INN (DORAVIRINE) PIFELTRO (MSD MERCK CO) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 210807 (label 210807.pdf) INN (DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE) DELSTRIGO (MSD MERCK CO) APPROVAL= AP YEAR= 2018 , 1913 ; BALOXAVIR MARBOXIL ; 1985606-14-1 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- PRODRUG -- POLYMERASE ACIDIC (PA) ENDONUCLEASE INHIBITOR -- TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA , ; NDA 210854 (label 210854.pdf) INN (BALOXAVIR MARBOXIL) XOFLUZA (GENENTECH INC) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 214410 (label 214410.pdf) INN (BALOXAVIR MARBOXIL) XOFLUZA (GENENTECH INC) APPROVAL= AP YEAR= 2020 , 1914 ; BALOXAVIR ; 1985605-59-1 ; 0 ; ; ; CLASS ANTIINFECTIVES -- PRODRUG -- POLYMERASE ACIDIC (PA) ENDONUCLEASE INHIBITOR -- TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA , ; 1915 ; LAROTRECTINIB ; 1223403-58-4 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF SOLID TUMOR -- INHIBITOR OF THE TROPOMYOSIN RECEPTOR KINASES (TRK), TRKA, TRKB, AND TRKC , ; NDA 210861 (label 210861.pdf) INN (LAROTRECTINIB SULFATE) VITRAKVI (BAYER HLTHCARE) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 211710 (label 211710.pdf) INN (LAROTRECTINIB SULFATE) VITRAKVI (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2018 , 1916 ; MOXIDECTIN ; 113507-06-5 ; 2018 ; ; ; CLASS ANTIPARASITIC -- ANTHELMINTIC -- TREATMENT OF ONCHOCERCIASIS -- MACROCYCLIC LACTONE -- MILBEMYCIN , ; NDA 210867 (label 210867.pdf) INN (MOXIDECTIN) MOXIDECTIN (MDGH) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1917 ; LORLATINIB ; 1454846-35-5 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- ACTIVITY AGAINST ALK AND ROS1 AS WELL AS TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, AND ACK , ; NDA 210868 (label 210868.pdf) INN (LORLATINIB) LORBRENA (PFIZER) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1918 ; RIFAMYCIN ; 6998-60-3 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF TRAVELERS DIARRHEA CAUSED BY NONINVASIVE STRAINS OF ESCHERICHIA COLI -- ANSAMYCIN CLASS OF ANTIBACTERIAL DRUGS , ; NDA 210910 (label 210910.pdf) INN (RIFAMYCIN SODIUM) AEMCOLO (REDHILL) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1919 ; LUSUTROMBOPAG ; 1110766-97-6 ; 2018 ; ; ; CLASS BLOOD -- THROMBOPOIETIN RECEPTOR (TPO) AGONIST -- TREATMENT OF THROMBOCYTOPENIA , ; NDA 210923 (label 210923.pdf) INN (LUSUTROMBOPAG) MULPLETA (VANCOCIN ITALIA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1920 ; ERAVACYCLINE ; 1207283-85-9 ; 2018 ; ; ; CLASS ANTIINFECTIVES -- TETRACYCLINE CLASS ANTIBACTERIAL -- TREATMENT OF INTRA-ABDOMINAL INFECTIONS , ; NDA 211109 (label 211109.pdf) INN (ERAVACYCLINE DIHYDROCHLORIDE) XERAVA (TETRAPHASE PHARMS) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1921 ; DUVELISIB ; 1201438-56-3 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- PI3K DELTA AND PI3K GAMMA KINASE INHIBITOR -- TREATMENT OF REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) , ; NDA 211155 (label 211155.pdf) INN (DUVELISIB) COPIKTRA (SECURA) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1922 ; IVOSIDENIB ; 1448347-49-6 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- TARGETS MUTANT ISOCITRATE DEHYDROGENASE-1 (IDH1) IDH1 R132 -- INHIBITOR -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) , ; NDA 211192 (label 211192.pdf) INN (IVOSIDENIB) TIBSOVO (SERVIER) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1923 ; SOLRIAMFETOL ; 178429-62-4 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- A DOPAMINE AND NOREPINEPHRINE REUPTAKE INHIBITOR (DNRI) -- TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) , ; NDA 211230 (label 211230.pdf) INN (SOLRIAMFETOL HYDROCHLORIDE) SUNOSI (AXSOME MALTA) APPROVAL= AP YEAR= 2019 , 1924 ; DACOMITINIB ; 1110813-31-4 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- IRREVERSIBLE KINASE INHIBITOR OF EGFR FAMILY (EGFR/HER1, HER2 AND HER4) -- COMPLEX PDB 4I23 -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- ALSO INHIBITED THE ACTIVITY OF DDR1, EPHA6, LCK, DDR2, AND MNK1 AT CLINICALLY RELEVANT CONCENTRATIONS , ; NDA 211288 (label 211288.pdf) INN (DACOMITINIB) VIZIMPRO (PFIZER) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1925 ; GILTERITINIB ; 1254053-43-4 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH A FLT3 MUTATION -- TYROSINE KINASES INHIBITOR -- INHIBITOR OF FMS-LIKE TYROSINE KINASE 3 (FLT3) INCLUDING FLT3-D835Y AND FLT3-ITD-D835Y MUTATIONS , ; NDA 211349 (label 211349.pdf) INN (GILTERITINIB FUMARATE) XOSPATA (ASTELLAS) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , 1926 ; BREXANOLONE ; 516-54-1 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- A NEUROACTIVE STEROID GAMMA-AMINOBUTYRIC ACID (GABA) A RECEPTOR POSITIVE MODULATOR -- TREATMENT OF POSTPARTUM DEPRESSION (PPD) , ; NDA 211371 (label 211371.pdf) INN (BREXANOLONE) ZULRESSO (SAGE THERAP) APPROVAL= AP YEAR= 2019 , 1927 ; TALAZOPARIB ; 1207456-01-6 ; 2018 ; ; ; CLASS ANTINEOPLASTIC -- INHIBITOR OF POLYADENOSINE 5’-DIPHOSPHORIBOSE POLYMERASE (PARP) PARP1 AND PARP2 -- , ; NDA 211651 (label 211651.pdf) INN (TALAZOPARIB TOSYLATE) TALZENNA (PFIZER) APPROVAL= AP YEAR= 2018 NEWMOLECULARENTITY , NDA 217439 (pdf 217439.pdf not found) INN (TALAZOPARIB TOSYLATE) TALZENNA (PFIZER) APPROVAL= AP YEAR= 2024 , 1928 ; TAFAMIDIS ; 594839-88-0 ; 2019 ; ; ; CLASS CARDIOVASCULAR -- TRANSTHYRETIN STABILIZERS -- TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS -- TAFAMIDIS BINDS TO TTR AT THE THYROXINE BINDING SITES , ; NDA 211996 (label 211996.pdf) INN (TAFAMIDIS MEGLUMINE) VYNDAQEL (FOLDRX PHARMS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 212161 (label 212161.pdf) INN (TAFAMIDIS) VYNDAMAX (FOLDRX PHARMS) APPROVAL= AP YEAR= 2019 , 1929 ; ERDAFITINIB ; 1346242-81-6 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- FGFR1, FGFR2, FGFR3 AND FGFR4 KINASE INHIBITOR -- TREATMENT OF ADVANCED OR METASTATIC UROTHELIAL CARCINOMA -- ALSO BINDS TO RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT AND VEGFR2 , ; NDA 212018 (label 212018.pdf) INN (ERDAFITINIB) BALVERSA (JANSSEN BIOTECH) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1930 ; ALPELISIB ; 1217486-61-7 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF BREAST CANCER -- INHIBITOR OF PHOSPHATIDYLINOSITOL-3-KINASE (PI3K) , ; NDA 212526 (label 212526.pdf) INN (ALPELISIB) PIQRAY (NOVARTIS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 215039 (label 215039.pdf) INN (ALPELISIB) VIJOICE (NOVARTIS) APPROVAL= AP YEAR= 2022 NEWAPPLICATION , NDA 218466 (pdf 218466.pdf not found) INN (ALPELISIB) VIJOICE (NOVARTIS) APPROVAL= AP YEAR= 2024 , 1931 ; ISTRADEFYLLINE ; 155270-99-8 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- ADENOSINE RECEPTOR ANTAGONIST INDICATED AS ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN ADULT PATIENTS WITH PARKINSON’S DISEASE (PD) EXPERIENCING OFF EPISODES , ; NDA 022075 (label 22075.pdf) INN (ISTRADEFYLLINE) NOURIANZ (KYOWA KIRIN) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1932 ; CEFIDEROCOL ; 1225208-94-5 ; 2019 ; ; ; CLASS ANTIINFECTIVES -- CEPHALOSPORIN ANTIBACTERIAL -- TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) -- BINDS TO EXTRACELLULAR FREE FERRIC IRON FOR A PASSIVE DIFFUSION VIA PORIN CHANNEL , ; NDA 209445 (label 209445.pdf) INN (CEFIDEROCOL SULFATE TOSYLATE) FETROJA (SHIONOGI INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1933 ; LUMATEPERONE ; 313368-91-1 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- ANTIPSYCHOTIC INDICATED FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS -- ACTIVITY COULD BE ANTAGONISTIC ACTIVITY AT CENTRAL SEROTONIN 5-HT2A RECEPTORS (KI = 0.54 NM) AND DOPAMINE D2 RECEPTORS (KI = 32 NM) , ; NDA 209500 (label 209500.pdf) INN (LUMATEPERONE TOSYLATE) CAPLYTA (INTRA-CELLULAR) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1934 ; AMISULPRIDE ; 71675-85-9 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- DOPAMINE-2 (D2) ANTAGONIST FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING (PONV) , ; NDA 209510 (label 209510.pdf) INN (AMISULPRIDE) BARHEMSYS (ACACIA) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1935 ; AMISULPRIDE ; 71675-85-9 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- DOPAMINE-2 (D2) ANTAGONIST FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING (PONV) , ; NDA 209510 (label 209510.pdf) INN (AMISULPRIDE) BARHEMSYS (ACACIA) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1936 ; OZANIMOD ; 1306760-87-1 ; 2020 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING -- SPHINGOSINE 1- PHOSPHATE RECEPTOR (SIP) MODULATOR -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) , ; NDA 209899 (label 209899.pdf) INN (OZANIMOD HYDROCHLORIDE) ZEPOSIA (BRISTOL) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1937 ; M OZANIMOD ; 2251699-84-8 ; 0 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING -- SPHINGOSINE 1- PHOSPHATE RECEPTOR (SIP) MODULATOR -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) , ; 1938 ; M OZANIMOD ; 1306760-61-1 ; 0 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING -- SPHINGOSINE 1- PHOSPHATE RECEPTOR (SIP) MODULATOR -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) , ; 1939 ; M OZANIMOD ; 1306760-60-0 ; 0 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING -- SPHINGOSINE 1- PHOSPHATE RECEPTOR (SIP) MODULATOR -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) , ; 1940 ; BREMELANOTIDE ; 189691-06-3 ; 2019 ; ; ; CLASS MELANOCORTIN RECEPTOR (MCR) AGONIST -- TREATMENT OF PREMENOPAUSAL WOMEN WITH ACQUIRED, GENERALIZED HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) , ; NDA 210557 (label 210557.pdf) INN (BREMELANOTIDE ACETATE) VYLEESI AUTOINJECTOR (COSETTE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1941 ; AFAMELANOTIDE ; 75921-69-6 ; 2019 ; ; ; CLASS DERMATOLOGICALS -- MELANOCORTIN 1 RECEPTOR (MC1-R) AGONIST -- TREATMENT OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) -- A STRUCTURAL ANALOG OF ALPHA-MELANOCYTE STIMULATING HORMONE (ALPHA-MSH) , ; NDA 210797 (label 210797.pdf) INN (AFAMELANOTIDE) SCENESSE (CLIVUNEL INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1942 ; PITOLISANT ; 362665-56-3 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- HISTAMINE-3 (H3) RECEPTOR ANTAGONIST/INVERSE AGONIST (KI = 1NM) -- TREATMENT OF NARCOLEPSY , ; NDA 211150 (label 211150.pdf) INN (PITOLISANT HYDROCHLORIDE) WAKIX (HARMONY) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1943 ; LASMIDITAN ; 439239-90-4 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- SEROTONIN (5-HT) 1F RECEPTOR AGONIST -- TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS , ; NDA 211280 (label 211280.pdf) INN (LASMIDITAN SUCCINATE) REYVOW (ELI LILLY AND CO) APPROVAL= AP YEAR= 2020 , 1944 ; TRIFAROTENE ; 895542-09-3 ; 2019 ; ; ; CLASS DERMATOLOGICALS -- RETINOID -- TREATMENT OF ACNE VULGARIS -- RETINOIC ACID RECEPTORS (RAR) AGONIST WITH PARTICULAR ACTIVITY AT THE GAMMA SUBTYPE OF RAR , ; NDA 211527 (label 211527.pdf) INN (TRIFAROTENE) AKLIEF (GALDERMA LABS LP) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1945 ; BEMPEDOIC ACID ; 738606-46-7 ; 2020 ; ; ; CLASS CARDIOVASCULAR -- ADENOSINE TRIPHOSPHATE-CITRATE LYASE (ACL) INHIBITOR -- TREATMENT OF OF ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE -- IT LOWERS LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) , ; NDA 211616 (label 211616.pdf) INN (BEMPEDOIC ACID) NEXLETOL (ESPERION THERAPS INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , NDA 211617 (label 211617.pdf) INN (BEMPEDOIC ACID EZETIMIBE) NEXLIZET (ESPERION THERAPS INC) APPROVAL= AP YEAR= 2020 , 1946 ; LEFAMULIN ; 1061337-51-6 ; 2019 ; ; ; CLASS ANTIINFECTIVES -- PLEUROMUTILIN ANTIBACTERIAL -- TREATMENT OF BACTERIAL PNEUMONIA (CABP) -- INTERACTS WITH A- AND P-SITES OF THE PEPTIDYL TRANSFERASE CENTER (PTC) IN DOMAIN V OF THE 23S RRNA OF THE 50S SUBUNIT , ; NDA 211672 (label 211672.pdf) INN (LEFAMULIN ACETATE) XENLETA (NABRIVA) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 211673 (label 211673.pdf) INN (LEFAMULIN ACETATE) XENLETA (NABRIVA) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1947 ; UPADACITINIB ; 1310726-60-3 ; 2019 ; ; ; CLASS IMMUNOMODULATING -- A JANUS KINASE (JAK) INHIBITOR -- TREATMENT OF RHEUMATOID ARTHRITIS , ; NDA 211675 (label 211675.pdf) INN (UPADACITINIB) RINVOQ (ABBVIE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 218347 (pdf 218347.pdf not found) INN (UPADACITINIB) RINVOQ LQ (ABBVIE) APPROVAL= AP YEAR= 2024 , 1948 ; TAZEMETOSTAT ; 1403254-99-8 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- METHYLTRANSFERASE INHIBITOR -- TREATMENT OF METASTATIC OR LOCAL ADVANCED EPITHELIOID SARCOMA NOT ELIGIBLE FOR COMPLETE RESECTION , ; NDA 211723 (label 211723.pdf) INN (TAZEMETOSTAT HYDROBROMIDE) TAZVERIK (EPIZYME INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , NDA 213400 (label 213400.pdf) INN (TAZEMETOSTAT HYDROBROMIDE) TAZVERIK (EPIZYME INC) APPROVAL= AP YEAR= 2020 NEWAPPLICATION , 1949 ; UBROGEPANT ; 1374248-77-7 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- CALCITONIN GENE-RELATED PEPTIDE RECEPTOR ANTAGONIST -- TREATMENT OF MIGRAINE , ; NDA 211765 (label 211765.pdf) INN (UBROGEPANT) UBRELVY (ABBVIE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1950 ; TENAPANOR ; 1234423-95-0 ; 2019 ; ; ; CLASS NERVOUS SYSTEM -- SODIUM/HYDROGEN EXCHANGER 3 (NHE3) INHIBITOR -- TREATMENT OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C) , ; NDA 211801 (label 211801.pdf) INN (TENAPANOR HYDROCHLORIDE) IBSRELA (ARDELYX INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 213931 (pdf 213931.pdf not found) INN (TENAPANOR HYDROCHLORIDE) XPHOZAH (ARDELYX INC) APPROVAL= AP YEAR= 2023 NEWAPPLICATION , 1951 ; PEXIDARTINIB ; 1029044-16-3 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE INHIBITOR COLONY STIMULATING ACTOR 1 RECEPTOR (CSF1R), KIT PROTO-ONCOGENE RECEPTOR TYROSINE KINASE (KIT), AND FMS-LIKE TYROSINE KINASE 3 (FLT3) -- TREATMENT OF SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) , ; NDA 211810 (label 211810.pdf) INN (PEXIDARTINIB HYDROCHLORIDE) TURALIO (DAIICHI SANKYO INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1952 ; DIROXIMEL ; 1577222-14-0 ; 2019 ; ; ; CLASS IMMUNOSUPPRESSANTS -- TREATMENT OF MULTIPLE SCLEROSIS (MS) -- ACTIVE METABOLITE MONOMETHYL FUMARATE (MMF) ACTIVATES NUCLEAR FACTOR (ERYTHROID-DERIVED 2)-LIKE 2 (NRF2) PATHWAY , ; NDA 211855 (label 211855.pdf) INN (DIROXIMEL FUMARATE) VUMERITY (BIOGEN INC) APPROVAL= AP YEAR= 2019 , 1953 ; LEMBOREXANT ; 1369764-02-2 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- OREXIN RECEPTOR ANTAGONIST -- TREATMENT OF INSOMNIA , ; NDA 212028 (label 212028.pdf) INN (LEMBOREXANT) DAYVIGO (EISAI INC) APPROVAL= AP YEAR= 2020 , 1954 ; DAROLUTAMIDE ; 1297538-32-9 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR -- TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER , ; NDA 212099 (label 212099.pdf) INN (DAROLUTAMIDE) NUBEQA (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1955 ; DAROLUTAMIDE ; 1297538-32-9 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR -- TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER , ; NDA 212099 (label 212099.pdf) INN (DAROLUTAMIDE) NUBEQA (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1956 ; M DAROLUTAMIDE ; 1297537-33-7 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- ANDROGEN RECEPTOR INHIBITOR -- TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER , ; 1957 ; FENFLURAMINE ; 458-24-2 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME -- INCREASE EXTRACELLULAR LEVELS OF SEROTONIN THROUGH INTERACTION WITH SEROTONIN TRANSPORTER PROTEINS -- EXHIBIT AGONIST ACTIVITY AT SEROTONIN 5HT-2 RECEPTORS , ; NDA 212102 (label 212102.pdf) INN (FENFLURAMINE HYDROCHLORIDE) FINTEPLA (UCB INC) APPROVAL= AP YEAR= 2020 , 1958 ; FENFLURAMINE ; 458-24-2 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME -- INCREASE EXTRACELLULAR LEVELS OF SEROTONIN THROUGH INTERACTION WITH SEROTONIN TRANSPORTER PROTEINS -- EXHIBIT AGONIST ACTIVITY AT SEROTONIN 5HT-2 RECEPTORS , ; NDA 212102 (label 212102.pdf) INN (FENFLURAMINE HYDROCHLORIDE) FINTEPLA (UCB INC) APPROVAL= AP YEAR= 2020 , 1959 ; M FENFLURAMINE ; 1886-26-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME -- INCREASE EXTRACELLULAR LEVELS OF SEROTONIN THROUGH INTERACTION WITH SEROTONIN TRANSPORTER PROTEINS -- EXHIBIT AGONIST ACTIVITY AT SEROTONIN 5HT-2 RECEPTORS , ; 1960 ; M FENFLURAMINE ; 1886-26-6 ; 0 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME -- INCREASE EXTRACELLULAR LEVELS OF SEROTONIN THROUGH INTERACTION WITH SEROTONIN TRANSPORTER PROTEINS -- EXHIBIT AGONIST ACTIVITY AT SEROTONIN 5HT-2 RECEPTORS , ; 1961 ; FLORTAUCIPIR ; 1522051-90-6 ; 2020 ; ; ; CLASS VARIOUS -- RADIOACTIVE DIAGNOSTIC AGENT -- PET IMAGING OF THE BRAIN -- ESTIMATES THE DENSITY AND DISTRIBUTION OF AGGREGATED TAU NEUROFIBRILLARY TANGLES (NFTS) (KD = 0.57 NM) -- BIND WITH LOW NANOMOLAR AFFINITY TO MONOAMINE OXIDASE-A AND MONOAMINE OXIDASE-B , ; NDA 212123 (label 212123.pdf) INN (FLORTAUCIPIR F-18) TAUVID (AVID RADIOPHARMS INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1962 ; ELEXACAFTOR ; 2216712-66-0 ; 2019 ; ; ; CLASS RESPIRATORY SYSTEM -- TREATMENT OF CYSTIC FIBROSIS (CF) -- THE COMBINED EFFECT OF ELEXACAFTOR, TEZACAFTOR AND IVACAFTOR IS INCREASED QUANTITY AND FUNCTION OF F508DEL-CFTR AT THE CELL SURFACE -- ELEXACAFTOR AND TEZACAFTOR BIND TO DIFFERENT SITES ON THE CFTR PROTEIN , ; NDA 212273 (label 212273.pdf) INN (ELEXACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 217660 (label 217660.pdf) INN (ELEXACAFTOR IVACAFTOR TEZACAFTOR) TRIKAFTA COPACKAGED (VERTEX PHARMS INC) APPROVAL= AP YEAR= 2023 , 1963 ; REMIMAZOLAM ; 308242-62-8 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- BENZODIAZEPINE -- INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION -- DID NOT SHOW CLEAR SELECTIVITY BETWEEN SUBTYPES OF THE GABAA RECEPTOR , ; NDA 212295 (label 212295.pdf) INN (REMIMAZOLAM BESYLATE) BYFAVO (ACACIA) APPROVAL= AP YEAR= 2020 , 1964 ; SELINEXOR ; 1393477-72-9 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- NUCLEAR EXPORT EXPORTIN 1 (XPO1) INHIBITOR -- IN COMBINATION WITH DEXAMETHASONE -- TREATMENT OF REFRACTORY MULTIPLE MYELOMA (RRMM) , ; NDA 212306 (label 212306.pdf) INN (SELINEXOR) XPOVIO (KARYOPHARM THERAPS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1965 ; FEDRATINIB ; 936091-26-8 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- JANUS ASSOCIATED KINASE 2 INHIBITOR (JAK2) -- FMS-LIKE TYROSINE KINASE 3 (FLT3) INHIBITOR -- TREATMENT OF INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS (MF) , ; NDA 212327 (label 212327.pdf) INN (FEDRATINIB HYDROCHLORIDE) INREBIC (BRISTOL-MYERS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1966 ; OPICAPONE ; 923287-50-7 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- A CATECHOL-O-METHYLTRANSFERASE (COMT) INHIBITOR -- TREATMENT OF PARKINSON’S DISEASE (PD) , ; NDA 212489 (label 212489.pdf) INN (OPICAPONE) ONGENTYS (AMNEAL) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1967 ; CEDAZURIDINE ; 1141397-80-9 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- A CYTIDINE DEAMINASE (CDA) INHIBITOR -- TREATMENT OF MYELODYSPLASTIC SYNDROMES (MDS) , ; NDA 212576 (label 212576.pdf) INN (CEDAZURIDINE DECITABINE) INQOVI (OTSUKA) APPROVAL= AP YEAR= 2020 , 1968 ; AVAPRITINIB ; 1703793-34-3 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- A TYROSINE KINASE INHIBITOR PDGFRA AND PDGFRA D842 MUTANTS AND KIT -- TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) , ; NDA 212608 (label 212608.pdf) INN (AVAPRITINIB) AYVAKIT (BLUEPRINT MEDICINES) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1969 ; ENTRECTINIB ; 1108743-60-7 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- A TROPOMYOSIN RECEPTOR TYROSINE KINASES INHIBITOR (TRK) TRKA, TRKB, AND TRKC -- PROTO-ONCOGENE TYROSINE-PROTEIN KINASE ROS1 INHIBITOR -- ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITOR -- ALSO INHIBITS JAK2 AND TNK2 -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) , ; NDA 212725 (label 212725.pdf) INN (ENTRECTINIB) ROZLYTREK (GENENTECH INC) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 212726 (label 212726.pdf) INN (ENTRECTINIB) ROZLYTREK (GENENTECH INC) APPROVAL= AP YEAR= 2019 NEWAPPLICATION , NDA 218550 (pdf 218550.pdf not found) INN (ENTRECTINIB) ROZLYTREK (GENENTECH INC) APPROVAL= AP YEAR= 2023 , 1970 ; M ENTRECTINIB ; 1108743-80-1 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- A TROPOMYOSIN RECEPTOR TYROSINE KINASES INHIBITOR (TRK) TRKA, TRKB, AND TRKC -- PROTO-ONCOGENE TYROSINE-PROTEIN KINASE ROS1 INHIBITOR -- ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITOR -- ALSO INHIBITS JAK2 AND TNK2 -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) , ; 1971 ; RIMEGEPANT ; 1289023-67-1 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MIGRAINE WITH OR WITHOUT AURA --A CALCITONIN GENE-RELATED PEPTIDE RECEPTOR ANTAGONIST , ; NDA 212728 (label 212728.pdf) INN (RIMEGEPANT SULFATE) NURTEC ODT (PFIZER) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1972 ; OSILODROSTAT ; 928134-65-0 ; 2020 ; ; ; CLASS HORMONES -- CORTISOL SYNTHESIS INHIBITOR -- TREATMENT OF CUSHING’S DISEASE -- INHIBITOR OF 11 BETA-HYDROXYLASE (CYP11B1) (IC50 = 2.5 NM) , ; NDA 212801 (label 212801.pdf) INN (OSILODROSTAT PHOSPHATE) ISTURISA (RECORDATI RARE) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1973 ; RELEBACTAM ; 1174018-99-5 ; 2019 ; ; ; CLASS ANTIINFECTIVES -- A BETA-LACTAMASE INHIBITOR -- ANTIBACTERIAL , ; NDA 212819 (label 212819.pdf) INN (CILASTATIN SODIUM IMIPENEM RELEBACTAM) RECARBRIO (MSD MERCK CO) APPROVAL= AP YEAR= 2019 , 1974 ; CENOBAMATE ; 913088-80-9 ; 2020 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF PARTIAL-ONSET SEIZURES -- INHIBITS VOLTAGE-GATED SODIUM CURRENTS -- POSITIVE ALLOSTERIC MODULATOR OF THE GAMMA-AMINOBUTYRIC ACID (GABAA) ION CHANNEL , ; NDA 212839 (label 212839.pdf) INN (CENOBAMATE) XCOPRI (SK LIFE) APPROVAL= AP YEAR= 2020 , 1975 ; PRETOMANID ; 187235-37-6 ; 2019 ; ; ; CLASS ANTIINFECTIVES -- NITROIMIDAZOOXAZINE ANTIMYCOBACTERIAL DRUG -- TREATMENT OF ADULTS WITH PULMONARY EXTENSIVELY DRUG RESISTANT (XDR) TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB) -- INHIBITING MYCOLIC ACID BIOSYNTHESIS , ; NDA 212862 (label 212862.pdf) INN (PRETOMANID) PRETOMANID (MYLAN IRELAND LTD) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1976 ; FOSTEMSAVIR ; 864953-29-7 ; 2020 ; ; ; CLASS ANTIINFECTIVES -- A HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GP120-DIRECTED ATTACHMENT INHIBITOR -- A PRODRUG OF TEMSAVIR -- ANTIRETROVIRAL , ; NDA 212950 (label 212950.pdf) INN (FOSTEMSAVIR TROMETHAMINE) RUKOBIA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1977 ; TEMSAVIR ; 701213-36-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- A HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GP120-DIRECTED ATTACHMENT INHIBITOR -- ANTIRETROVIRAL , ; 1978 ; ARTESUNATE ; 88495-63-0 ; 2020 ; ; ; CLASS ANTIINFECTIVES -- ANTIMALARIAL -- TREATMENT OF SEVERE MALARIA -- SEMI-SYNTHETIC ARTEMISININ DERIVATIVE -- RAPIDLY CONVERTED TO DHA BY BLOOD ESTERASES -- ANTIPARASITIC , ; NDA 213036 (label 213036.pdf) INN (ARTESUNATE) ARTESUNATE (AMIVAS) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1979 ; VOXELOTOR ; 1446321-46-5 ; 2019 ; ; ; CLASS BLOOD -- A HEMOGLOBIN S POLYMERIZATION INHIBITOR -- TREATMENT OF SICKLE CELL DISEASE , ; NDA 213137 (label 213137.pdf) INN (VOXELOTOR) OXBRYTA (GLOBAL BLOOD THERAPS) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , NDA 216157 (label 216157.pdf) INN (VOXELOTOR) OXBRYTA (GLOBAL BLOOD THERAPS) APPROVAL= AP YEAR= 2021 , 1980 ; ZANUBRUTINIB ; 1691249-45-2 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- BRUTON TYROSINE KINASE (BTK) COVALENT INHIBITOR -- TREATMENT OF MANTLE CELL LYMPHOMA (MCL) , ; NDA 213217 (label 213217.pdf) INN (ZANUBRUTINIB) BRUKINSA (BEIGENE) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1981 ; SELPERCATINIB ; 2152628-33-4 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- RET KINASE INHIBITOR -- TREATMENT OF METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) -- INHIBITOR OF VEGFR1 AND VEGFR3 AND FGFR 1, 2, AND 3 , ; NDA 213246 (label 213246.pdf) INN (SELPERCATINIB) RETEVMO (LOXO ONCOL ELI LILLY) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , NDA 218160 (pdf 218160.pdf not found) INN (SELPERCATINIB) RETEVMO (LOXO ONCOL ELI LILLY) APPROVAL= AP YEAR= 2024 , 1982 ; TUCATINIB ; 937263-43-9 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- A TYROSINE KINASE INHIBITOR OF HER2 -- TREATMENT OF BREAST CANCER , ; NDA 213411 (label 213411.pdf) INN (TUCATINIB) TUKYSA (SEAGEN) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1983 ; CAPMATINIB ; 1029712-80-8 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- MET KINASE INHIBITOR , ; NDA 213591 (label 213591.pdf) INN (CAPMATINIB HYDROCHLORIDE) TABRECTA (NOVARTIS PHARM) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1984 ; TRIHEPTANOIN ; 620-67-7 ; 2020 ; ; ; CLASS METABOLISM -- MEDIUM-CHAIN TRIGLYCERIDE -- TREATMENT OF LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) -- LONG-CHAIN FAOD ENZYME DEFICIENCIES -- EXTENSIVELY HYDROLYZED TO HEPTANOATE AND GLYCEROL BY PANCREATIC LIPASES , ; NDA 213687 (label 213687.pdf) INN (TRIHEPTANOIN) DOJOLVI (ULTRAGENYX PHARM INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1985 ; M TRIHEPTANOIN ; 7563-37-3 ; 0 ; ; ; CLASS METABOLISM -- MEDIUM-CHAIN TRIGLYCERIDE -- TREATMENT OF LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) , ; 1986 ; LURBINECTEDIN ; 497871-47-3 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF METASTATIC SMALL CELL LUNG CANCER (SCLC) -- COVALENT ALKYLATING DRUG -- BINDS GUANINE RESIDUES IN THE MINOR GROOVE OF DNA FORMING ADDUCTS , ; NDA 213702 (label 213702.pdf) INN (LURBINECTEDIN) ZEPZELCA (JAZZ) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1987 ; PEMIGATINIB ; 1513857-77-6 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- FGFR1, 2 AND 3 KINASE INHIBITOR -- TREATMENT OF METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) , ; NDA 213736 (label 213736.pdf) INN (PEMIGATINIB) PEMAZYRE (INCYTE CORP) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1988 ; SELUMETINIB ; 606143-52-6 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF PEDIATRIC NEUROFIBROMAS (PN) -- MITOGEN-ACTIVATED PROTEIN KINASE KINASES 1 AND 2 INHIBITOR , ; NDA 213756 (label 213756.pdf) INN (SELUMETINIB SULFATE) KOSELUGO (ASTRAZENECA) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1989 ; M SELUMETINIB ; 606143-88-8 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF PEDIATRIC NEUROFIBROMAS (PN) -- MITOGEN-ACTIVATED PROTEIN KINASE KINASES 1 AND 2 INHIBITOR -- N-DESMETHYL SELUMETINIB REPRESENTS LESS THAN 10% OF SELUMETINIB LEVELS IN HUMAN PLASMA BUT IS APPROXIMATELY 3 TO 5 TIMES MORE POTENT CONTRIBUTING TO ABOUT 21% TO 35% OF THE OVERALL PHARMACOLOGIC ACTIVITY , ; 1990 ; RIPRETINIB ; 1442472-39-0 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- KIT PROTO-ONCOGENE RECEPTOR TYROSINE KINASE INHIBITOR -- PLATELET DERIVED GROWTH FACTOR RECEPTOR A (PDGFRA) INHIBITOR -- TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST) -- INHIBITS PDGFRB, TIE2, VEGFR2, AND BRAF , ; NDA 213973 (label 213973.pdf) INN (RIPRETINIB) QINLOCK (DECIPHERA PHARMS) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1991 ; M RIPRETINIB ; 1442473-09-7 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- KIT PROTO-ONCOGENE RECEPTOR TYROSINE KINASE INHIBITOR -- PLATELET DERIVED GROWTH FACTOR RECEPTOR A (PDGFRA) INHIBITOR -- TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST) -- INHIBITS PDGFRB, TIE2, VEGFR2, AND BRAF , ; 1992 ; SN38 ; 86639-52-3 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- ANTIBODY-DRUG CONJUGATE (ADC) -- A TOPOISOMERASE INHIBITOR -- TREATMENT OF METASTATIC TRIPLE-NEGATIVE BREAST CANCER (MTNBC) , ; NDA 761115 (label 761115.pdf) INN (SACITUZUMAB GOVITECAN-HZIY) TRODELVY (IMMUNOMEDICS INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 1993 ; EXATECAN ; 171335-80-1 ; 2019 ; ; ; CLASS ANTINEOPLASTIC -- ANTIBODY-DRUG CONJUGATE (ADC) -- A TOPOISOMERASE INHIBITOR -- TREATMENT OF UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER -- INTRACELLULAR LINKER LEAVAGE BY LYSOSOMAL ENZYMES -- THE MEMBRANE-PERMEABLE DXD CAUSES DNA DAMAGE , ; NDA 761139 (label 761139.pdf) INN (FAM-TRASTUZUMAB DERUXTECAN-NXKI) ENHERTU (DAIICHI SANKYO) APPROVAL= AP YEAR= 2019 NEWMOLECULARENTITY , 1994 ; OLICERIDINE ; 1401028-24-7 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- OPIOID AGONIST -- TREATMENT OF ACUTE PAIN -- ANALGESIC , ; NDA 210730 (label 210730.pdf) INN (OLICERIDINE) OLINVYK (TREVENA) APPROVAL= AP YEAR= 2021 , 1995 ; VILOXAZINE ; 46817-91-8 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR -- TREATMENT OF ADHD , ; NDA 211964 (label 211964.pdf) INN (VILOXAZINE HYDROCHLORIDE) QELBREE (SUPERNUS PHARMS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 1996 ; VILOXAZINE ; 46817-91-8 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR -- TREATMENT OF ADHD , ; NDA 211964 (label 211964.pdf) INN (VILOXAZINE HYDROCHLORIDE) QELBREE (SUPERNUS PHARMS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 1997 ; CABOTEGRAVIR ; 1051375-10-0 ; 2021 ; ; ; CLASS ANTIINFECTIVES -- (HIV-1) INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) -- ANTIRETROVIRAL DRUG , ; NDA 212887 (label 212887.pdf) INN (CABOTEGRAVIR SODIUM) VOCABRIA (VIIV HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 212888 (label 212888.pdf) INN (CABOTEGRAVIR RILPIVIRINE) CABENUVA KIT (VIIV HLTHCARE) APPROVAL= AP YEAR= 2021 , NDA 215499 (label 215499.pdf) INN (CABOTEGRAVIR) APRETUDE (VIIV HLTHCARE) APPROVAL= AP YEAR= 2021 , 1998 ; TIVOZANIB ; 475108-18-0 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- TYROSINE KINASE INHIBITOR (VEGFR-1 VEGFR-2 VEGFR-3 AND PDGFR-BETA) , ; NDA 212904 (label 212904.pdf) INN (TIVOZANIB HYDROCHLORIDE) FOTIVDA (AVEO PHARMS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 1999 ; SERDEXMETHYLPHENIDATE ; 1996626-29-9 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- PRODRUG OF DEXMETHYLPHENIDATE -- CENTRAL NERVOUS SYSTEM STIMULANT -- TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) -- BLOCKS THE REUPTAKE OF NOREPINEPHRINE AND DOPAMINE , ; NDA 212994 (label 212994.pdf) INN (DEXMETHYLPHENIDATE HYDROCHLORIDE SERDEXMETHYLPHENIDATE CHLORIDE) AZSTARYS (COMMAVE THERAP) APPROVAL= AP YEAR= 2021 , 2000 ; VIBEGRON ; 1190389-15-1 ; 2020 ; ; ; CLASS MUSCULO-SKELETAL -- TREATMENT OF OVERACTIVE BLADDER (OAB) -- INCREASES BLADDER CAPACITY BY RELAXING THE DETRUSOR SMOOTH MUSCLE DURING BLADDER FILLING , ; NDA 213006 (label 213006.pdf) INN (VIBEGRON) GEMTESA (UROVANT) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2001 ; UMBRALISIB ; 1532533-67-7 ; 2021 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF LYMPHOMA -- KINASE INHIBITOR (PI3K-DELTA, CASEIN KINASE CK1-EPSILON) , ; NDA 213176 (label 213176.pdf) INN (UMBRALISIB TOSYLATE) UKONIQ (TG THERAPS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY DISCONTINUED , 2002 ; TIRBANIBULIN ; 897016-82-9 ; 2020 ; ; ; CLASS DERMATOLOGICALS -- MICROTUBULE INHIBITOR -- TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP , ; NDA 213189 (label 213189.pdf) INN (TIRBANIBULIN) KLISYRI (ALMIRALL) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2003 ; SAMIDORPHAN ; 852626-89-2 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF SCHIZOPHRENIA OR BIPOLAR I DISORDER -- OPIOID RECEPTOR ANTAGONIST OR PARTIAL AGONIST -- N-DEALKYLATED AND N-OXIDE ARE ACTIVE METABOLITES BUT THEY DO NOT HAVE CAS NUMBER THUS NOT YET INCLUDED HERE , ; NDA 213378 (label 213378.pdf) INN (OLANZAPINE SAMIDORPHAN L-MALATE) LYBALVI (ALKERMES INC) APPROVAL= AP YEAR= 2021 , 2004 ; CLASCOTERONE ; 19608-29-8 ; 2020 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF ACNE VULGARIS -- ANDROGEN RECEPTOR ANTAGONIST -- CORTEXOLONE-17 ALPHA PROPIONATE , ; NDA 213433 (label 213433.pdf) INN (CLASCOTERONE) WINLEVI (SUN PHARM) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2005 ; NIFURTIMOX ; 23256-30-6 ; 2020 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL -- TREATMENT OF CHAGAS DISEASE CAUSED BY TRYPANOSOMA CRUZI -- PRODUCTION OF TOXIC INTERMEDIATE METABOLITES AND/OR REACTIVE OXYGEN SPECIES THAT INDUCE DNA DAMAGE AND CELL DEATH , ; NDA 213464 (label 213464.pdf) INN (NIFURTIMOX) LAMPIT (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2006 ; NIFURTIMOX ; 23256-30-6 ; 2020 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL -- TREATMENT OF CHAGAS DISEASE CAUSED BY TRYPANOSOMA CRUZI -- PRODUCTION OF TOXIC INTERMEDIATE METABOLITES AND/OR REACTIVE OXYGEN SPECIES THAT INDUCE DNA DAMAGE AND CELL DEATH , ; NDA 213464 (label 213464.pdf) INN (NIFURTIMOX) LAMPIT (BAYER HEALTHCARE) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2007 ; PONESIMOD ; 854107-55-4 ; 2021 ; ; ; CLASS IMMUNOMODULATING -- IMMUNOSUPPRESSANT -- SPHINGOSINE1-PHOSPHATE (S1P) RECEPTOR 1 MODULATOR -- TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS) , ; NDA 213498 (label 213498.pdf) INN (PONESIMOD) PONVORY (VANDA PHARMS INC) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2008 ; RISDIPLAM ; 1825352-65-5 ; 2020 ; ; ; CLASS MUSCULO-SKELETAL -- TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) -- A SURVIVAL OF MOTOR NEURON 2 (SMN2)-DIRECTED RNA SPLICING MODIFIER , ; NDA 213535 (label 213535.pdf) INN (RISDIPLAM) EVRYSDI (GENENTECH INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2009 ; VOCLOSPORIN ; 515814-01-4 ; 2021 ; ; ; CLASS IMMUNOMODULATING -- CYCLOPHILIN LIGAND -- A CALCINEURIN-INHIBITOR IMMUNOSUPPRESSANT , ; NDA 213716 (label 213716.pdf) INN (VOCLOSPORIN) LUPKYNIS (AURINIA) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2010 ; PRALSETINIB ; 2097132-94-8 ; 2020 ; ; ; CLASS ANTINEOPLASTIC -- RET PROTEIN TYROSINE KINASE INHIBITOR -- TREATMENT OF NON-SMALL CELL LUNG CANCER (NSCLC) -- INHIBITS DDR1 -- RKC -- FLT3 -- JAK1-2 -- TRKA -- VEGFR2 -- PDGFRB -- FGFR1 , ; NDA 213721 (label 213721.pdf) INN (PRALSETINIB) GAVRETO (BLUEPRINT MEDICINES) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , NDA 214701 (label 214701.pdf) INN (PRALSETINIB) GAVRETO (BLUEPRINT MEDICINES) APPROVAL= AP YEAR= 2020 NEWAPPLICATION , 2011 ; SETMELANOTIDE ; 920014-72-8 ; 2020 ; ; ; CLASS METABOLISM -- MELANOCORTIN 4 (MC4) RECEPTOR AGONIST -- CHRONIC WEIGHT MANAGEMENT -- 8 AMINO ACID CYCLIC PEPTIDE ANALOG OF ENDOGEN OUS MELANOCORTIN PEPTIDE ALPHA-MSH (ALPHA-MELANOCYTE STIMULATING HORMONE) , ; NDA 213793 (label 213793.pdf) INN (SETMELANOTIDE ACETATE) IMCIVREE (RHYTHM) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2012 ; LONAFARNIB ; 193275-84-2 ; 2020 ; ; ; CLASS VARIOUS -- FARNESYL PROTEIN TRANSFERASE INHIBITOR -- TREATMENT OF PROCESSING-DEFICIENT PROGEROID LAMINOPATHIES -- TO REDUCE THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) , ; NDA 213969 (label 213969.pdf) INN (LONAFARNIB) ZOKINVY (SENTYNL THERAPS INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2013 ; FOSDENOPTERIN ; 150829-29-1 ; 2021 ; ; NATURAL MOLECULE C00019569 ; CLASS METABOLISM -- CYCLIC PYRANOPTERIN MONOPHOSPHATE (CPMP) -- TREATMENT OF MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A -- PROVIDES AN EXOGENOUS SOURCE OF CPMP -- IS CONVERTED INTO MOLYBDOPTERIN , ; NDA 214018 (label 214018.pdf) INN (FOSDENOPTERIN HYDROBROMIDE) NULIBRY (SENTYNL THERAPS INC) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2014 ; BEROTRALSTAT ; 1809010-50-1 ; 2020 ; ; ; CLASS CARDIOVASCULAR -- INDICATED FOR PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) -- PLASMA KALLIKREIN PROTEASE INHIBITOR , ; NDA 214094 (label 214094.pdf) INN (BEROTRALSTAT HYDROCHLORIDE) ORLADEYO (BIOCRYST) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2015 ; TEPOTINIB ; 1100598-32-0 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- MET INHIBITOR -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- INHIBITS MELATONIN 2 RECEPTOR AND IMIDAZOLINE 1 RECEPTOR , ; NDA 214096 (label 214096.pdf) INN (TEPOTINIB HYDROCHLORIDE) TEPMETKO (EMD SERONO INC) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2016 ; ESTETROL ; 15183-37-6 ; 2021 ; ; ; CLASS GENITO -- ORAL CONTRACEPTIVE -- SYNTHETIC ESTROGEN , ; NDA 214154 (label 214154.pdf) INN (DROSPIRENONE ESTETROL) NEXTSTELLIS (MAYNE PHARMA) APPROVAL= AP YEAR= 2021 , 2017 ; TRILACICLIB ; 1374743-00-6 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- CDK4 AND CDK6 KINASE INHIBITOR -- TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION , ; NDA 214200 (label 214200.pdf) INN (TRILACICLIB DIHYDROCHLORIDE) COSELA (G1 THERAP) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2018 ; VERICIGUAT ; 1350653-20-1 ; 2021 ; ; ; CLASS CARDIOVASCULAR -- GUANYLATE CYCLASE (SGC) STIMULATOR -- REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) , ; NDA 214377 (label 214377.pdf) INN (VERICIGUAT) VERQUVO (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2019 ; MELPHALAN FLUFENAMIDE ; 380449-51-4 ; 2021 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- A PEPTIDE CONJUGATED ALKYLATING DRUG -- TREATMENT OF REFRACTORY MULTIPLE MYELOMA -- NITROGEN MUSTARD DRUG -- PRODRUG , ; NDA 214383 (label 214383.pdf) INN (MELPHALAN FLUFENAMIDE HYDROCHLORIDE) PEPAXTO (ONCOPEPTIDES AB) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY DISCONTINUED OBSOLETE , 2020 ; BRINCIDOFOVIR ; 444805-28-1 ; 2021 ; ; ; CLASS ANTIINFECTIVES -- ORTHOPOXVIRUS NUCLEOTIDE ANALOG DNA POLYMERASE INHIBITOR -- TREATMENT OF HUMAN SMALLPOX DISEASE -- ANTIVARIOLA -- METABOLIZED BY SPHINGOMYELINASE , ; NDA 214460 (label 214460.pdf) INN (BRINCIDOFOVIR) TEMBEXA (EMERGENT BIODEFENSE) APPROVAL= AP YEAR= 2021 , NDA 214461 (label 214461.pdf) INN (BRINCIDOFOVIR) TEMBEXA (EMERGENT BIODEFENSE) APPROVAL= AP YEAR= 2021 , 2021 ; RELUGOLIX ; 737789-87-6 ; 2020 ; ; ; CLASS HORMONES -- TREATMENT OF PROSTATE CANCER -- A GONADOTROPIN-RELEASING HORMONE (GNRH) RECEPTOR ANTAGONIST , ; NDA 214621 (label 214621.pdf) INN (RELUGOLIX) ORGOVYX (SUMITOMO PHARMA) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , NDA 214846 (label 214846.pdf) INN (ESTRADIOL NORETHINDRONE ACETATE RELUGOLIX) MYFEMBREE (MYOVANT SCIENCES) APPROVAL= AP YEAR= 2021 , 2022 ; INFIGRATINIB ; 872511-34-7 ; 2021 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF METASTATIC CHOLANGIOCARCINOMA , ; NDA 214622 (label 214622.pdf) INN (INFIGRATINIB PHOSPHATE) TRUSELTIQ (HELSINN HLTHCARE) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY DISCONTINUED , 2023 ; SOTORASIB ; 2296729-00-3 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) -- INHIBITOR OF THE RAS GTPASE FAMILY -- COVALENT DRUG , ; NDA 214665 (label 214665.pdf) INN (SOTORASIB) LUMAKRAS (AMGEN INC) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2024 ; REMDESIVIR ; 1809249-37-3 ; 2020 ; ; ; CLASS ANTIINFECTIVES -- SARS-COV-2 NUCLEOTIDE ANALOG RNA POLYMERASE INHIBITOR -- ANTIVIRAL , ; NDA 214787 (label 214787.pdf) INN (REMDESIVIR) VEKLURY (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY , 2025 ; M REMDESIVIR ; 1191237-69-0 ; 0 ; ; ; CLASS ANTIINFECTIVES -- SARS-COV-2 NUCLEOTIDE ANALOG RNA POLYMERASE INHIBITOR -- ANTIVIRAL , ; 2026 ; IBREXAFUNGERP ; 1207753-03-4 ; 2021 ; ; ; CLASS ANTIINFECTIVES -- A TRITERPENOID ANTIFUNGAL -- TREATMENT OF VULVOVAGINAL CANDIDIASIS (VVC) -- INHIBITS GLUCAN SYNTHASE , ; NDA 214900 (label 214900.pdf) INN (IBREXAFUNGERP CITRATE) BREXAFEMME (SCYNEXIS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2027 ; MAFODOTIN ; 863971-19-1 ; 2020 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MULTIPLE MYELOMA -- ANTIBODY-DRUG CONJUGATE (ADC) -- MICROTUBULE INHIBITOR , ; NDA 761158 (label 761158.pdf) INN (BELANTAMAB MAFODOTIN-BLMF) BLENREP (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2020 NEWMOLECULARENTITY OBSOLETE , 2028 ; SG3199 ; 1595275-71-0 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF B-CELL LYMPHOMA -- ANTIBODY-DRUG CONJUGATE (ADC) TARGETING CD19 -- PYRROLOBENZODIAZEPINE (PBD) DIMER CYTOTOXIC ALKYLAT ING AGENT , ; NDA 761196 (label 761196.pdf) INN (LONCASTUXIMAB TESIRINE-LPYL) ZYNLONTA (ADC THERAPEUTICS SA) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2029 ; PACRITINIB ; 937272-79-2 ; 2022 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MYELOFIBROSIS -- JANUS ASSOCIATED KINASE 2 (JAK2) INHIBITOR -- FMS-LIKE TYROSINE KINASE 3 (FLT3) INHIBITOR , ; NDA 208712 (label 208712.pdf) INN (PACRITINIB CITRATE) VONJO (CTI BIOPHARMA CORP) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2030 ; ABROCITINIB ; 1622902-68-4 ; 2022 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF ATOPIC DERMATITIS -- JANUS KINASE 1 (JAK1) INHIBITOR , ; NDA 213871 (label 213871.pdf) INN (ABROCITINIB) CIBINQO (PFIZER) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2031 ; M ABROCITINIB ; 2744171-53-5 ; 0 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF ATOPIC DERMATITIS -- JANUS KINASE 1 (JAK1) INHIBITOR , ; 2032 ; M ABROCITINIB ; 2744171-52-4 ; 0 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF ATOPIC DERMATITIS -- JANUS KINASE 1 (JAK1) INHIBITOR , ; 2033 ; LEVOKETOCONAZOLE ; 142128-57-2 ; 2021 ; ; ; CLASS GENITO -- CORTISOL SYNTHESIS INHIBITOR INDICATED FOR THE TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA -- CYTOCHROME CYP11B1 (11 BETA HYDROLASE), CYP11A1 (CHOLESTEROL SIDE-CHAIN CLEAVAGE) AND CYP17A1 (17 ALPHA HYDROLASE) INHIBITOR -- SUBSTRATE OF INTESTINAL AND LIVER P-GPP , ; NDA 214133 (label 214133.pdf) INN (LEVOKETOCONAZOLE) RECORLEV (STRONGBRIDGE) APPROVAL= AP YEAR= 2021 , 2034 ; FEXINIDAZOLE ; 59729-37-2 ; 2021 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL -- NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE , ; NDA 214429 (label 214429.pdf) INN (FEXINIDAZOLE) FEXINIDAZOLE (SANOFI) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2035 ; M FEXINIDAZOLE ; 62351-99-9 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL -- NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE , ; 2036 ; M FEXINIDAZOLE ; 64570-18-9 ; 0 ; ; ; CLASS ANTIPARASITIC -- ANTIPROTOZOAL -- NITROIMIDAZOLE ANTIMICROBIAL -- TREATMENT OF HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE , ; 2037 ; AVACOPAN ; 1346623-17-3 ; 2021 ; ; ; CLASS IMMUNOSUPPRESSANTS -- COMPLEMENT 5A RECEPTOR (C5AR) ANTAGONIST -- TREATMENT OF PATIENTS WITH ANCA-ASSOCIATED VASCULITIS -- BLOCKS C5A-INDUCED UPREGULATION OF CD11B ON NEUTROPHILS , ; NDA 214487 (label 214487.pdf) INN (AVACOPAN) TAVNEOS (CHEMOCENTRYX) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2038 ; MARALIXIBAT ; 716313-53-0 ; 2021 ; ; ; CLASS METABOLISM -- TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) -- ILEAL BILE ACID TRANSPORTER (IBAT) INHIBITOR , ; NDA 214662 (label 214662.pdf) INN (MARALIXIBAT CHLORIDE) LIVMARLI (MIRUM) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2039 ; BELUMOSUDIL ; 911417-87-3 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (GVHD) -- RHO-ASSOCIATED COILED-COIL ROCK KINASE INHIBITOR (ROCK2 IC50= 100 NANOMOLAR -- ROCK1 IC50=3 MICROMOLAR) , ; NDA 214783 (label 214783.pdf) INN (BELUMOSUDIL MESYLATE) REZUROCK (KADMON PHARMS LLC) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2040 ; DIFELIKEFALIN ; 1024828-77-0 ; 2021 ; ; ; CLASS VARIOUS -- TREATMENT OF PRURITUS ASSOCIATED WITH KIDNEY DISEASE (CKD-AP) -- KAPPA OPIOID RECEPTOR AGONIST -- SYNTHETIC PEPTIDE , ; NDA 214916 (label 214916.pdf) INN (DIFELIKEFALIN ACETATE) KORSUVA (CARA THERAP) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2041 ; DARIDOREXANT ; 1505484-82-1 ; 2022 ; ; ; CLASS NERVOUS SYSTEM -- OREXIN RECEPTOR ANTAGONIST -- TREATMENT OF INSOMNIA -- OREXIN-1 RECEPTOR (KI=0.47 NANOMOLAR) OREXIN-2 RECEPTOR (KI=0.93 NANOMOLAR) , ; NDA 214985 (label 214985.pdf) INN (DARIDOREXANT HYDROCHLORIDE) QUVIVIQ (IDORSIA) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2042 ; MAVACAMTEN ; 1642288-47-8 ; 2022 ; ; ; CLASS CARDIOVASCULAR -- CARDIAC MYOSIN INHIBITOR -- TREATMENT OF NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) , ; NDA 214998 (label 214998.pdf) INN (MAVACAMTEN) CAMZYOS (BRISTOL) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2043 ; VONOPRAZAN ; 881681-00-1 ; 2022 ; ; ; CLASS METABOLISM -- POTASSIUM-COMPETITIVE ACID BLOCKER (PCAB) -- SUPPRESSES BASAL AND STIMULATED GASTRIC ACID SECRETION -- ACID (PROTON) PUMP , ; NDA 215152 (label 215152.pdf) INN (AMOXICILLIN CLARITHROMYCIN VONOPRAZAN FUMARATE) VOQUEZNA TRIPLE PAK (PHATHOM) APPROVAL= AP YEAR= 2022 , NDA 215153 (label 215153.pdf) INN (AMOXICILLIN VONOPRAZAN FUMARATE) VOQUEZNA DUAL PAK (PHATHOM) APPROVAL= AP YEAR= 2022 , NDA 215151 (pdf 215151.pdf not found) INN (VONOPRAZAN FUMARATE) VOQUEZNA (PHATHOM) APPROVAL= AP YEAR= 2023 NEWAPPLICATION , 2044 ; ATOGEPANT ; 1374248-81-3 ; 2021 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF EPISODIC MIGRAINE -- CALCITONIN GENE-RELATED PEPTIDE RECEPTOR ANTAGONIST (CGRP) , ; NDA 215206 (label 215206.pdf) INN (ATOGEPANT) QULIPTA (ABBVIE) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2045 ; TAPINAROF ; 79338-84-4 ; 2022 ; ; ; CLASS DERMATOLOGICALS -- TREATMENT OF PLAQUE PSORIASIS -- ARYL HYDROCARBON RECEPTOR AGONIST (AHR) , ; NDA 215272 (label 215272.pdf) INN (TAPINAROF) VTAMA (DERMAVANT SCI) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2046 ; MOBOCERTINIB ; 1847461-43-1 ; 2021 ; DISCONTINUED ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF NSCLC WITH EGFR EXON 20 INSERTION MUTATIONS -- INHIBITS KINASES HER2, HER4 AND BLK WITH IC50 BELOW 2 NANOMOLAR , ; NDA 215310 (label 215310.pdf) INN (MOBOCERTINIB SUCCINATE) EXKIVITY (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY DISCONTINUED , 2047 ; M MOBOCERTINIB ; 1847462-25-2 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF NSCLC WITH EGFR EXON 20 INSERTION MUTATIONS , ; 2048 ; M MOBOCERTINIB ; 1847461-70-4 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF NSCLC WITH EGFR EXON 20 INSERTION MUTATIONS , ; 2049 ; FINERENONE ; 1050477-31-0 ; 2021 ; ; ; CLASS CARDIOVASCULAR -- NON STEROIDAL MINERALOCORTICOID RECEPTOR ANTAGONIST (MRA) -- TREATMENT OF PATIENTS WITH CHRONIC KIDNEY DISEASE ASSOCIATED WITH TYPE 2 DIABETES , ; NDA 215341 (label 215341.pdf) INN (FINERENONE) KERENDIA (BAYER HLTHCARE) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2050 ; ASCIMINIB ; 1492952-76-7 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- ABL1 KINASE INHIBITOR -- TREATMENT OF CHRONIC MYELOID LEUKEMIA (CML) -- INHIBITS THE ABL1 KINASE ACTIVITY OF THE BCR-ABL1 FUSION PROTEIN , ; NDA 215358 (label 215358.pdf) INN (ASCIMINIB HYDROCHLORIDE) SCEMBLIX (NOVARTIS) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2051 ; BELZUTIFAN ; 1672668-24-4 ; 2021 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF HIPPEL-LINDAU (VHL) DISEASE -- INHIBITOR OF HYPOXIA-INDUCIBLE FACTOR-2 ALPHA (HIF-2A) TRANSCRIPTION FACTOR , ; NDA 215383 (label 215383.pdf) INN (BELZUTIFAN) WELIREG (MERCK SHARP DOHME) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2052 ; ODEVIXIBAT ; 501692-44-0 ; 2021 ; ; ; CLASS METABOLISM -- ILEAL BILE ACID TRANSPORTER INHIBITOR (IBAT) -- TREATMENT OF PRURITUS IN PATIENTS WITH PFIC , ; NDA 215498 (label 215498.pdf) INN (ODEVIXIBAT) BYLVAY (IPSEN) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2053 ; MARIBAVIR ; 176161-24-3 ; 2021 ; ; ; CLASS ANTIINFECTIVES -- TREATMENT OF CYTOMEGALOVIRUS (CMV) PUL97 KINASE INHIBITOR , ; NDA 215596 (label 215596.pdf) INN (MARIBAVIR) LIVTENCITY (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2021 NEWMOLECULARENTITY , 2054 ; OTESECONAZOLE ; 1340593-59-0 ; 2022 ; ; ; CLASS ANTIINFECTIVES -- AZOLE ANTIFUNGAL -- TREATMENT OF VULVOVAGINAL CANDIDIASIS -- INHIBITS FUNGAL STEROL 14-ALPHA DEMETHYLASE (CYP51) , ; NDA 215888 (label 215888.pdf) INN (OTESECONAZOLE) VIVJOA (MYCOVIA PHARMS) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2055 ; GANAXOLONE ; 38398-32-2 ; 2022 ; ; ; CLASS NERVOUS SYSTEM -- NEUROACTIVE STEROID GAMMA-AMINOBUTYRIC ACID (GABA) A RECEPTOR POSITIVE MODULATOR -- TREATMENT OF SEIZURES ASSOCIATED WITH CDKL5 DEFICIENCY DISORDER -- ANALOG OF ENDOGENOUS NEUROSTEROID ALLOPREGNANOLONE , ; NDA 215904 (label 215904.pdf) INN (GANAXOLONE) ZTALMY (MARINUS) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2056 ; MITAPIVAT ; 1260075-17-9 ; 2022 ; ; ; CLASS METABOLISM -- TREATMENT OF HEMOLYTIC ANEMIA WITH PYRUVATE KINASE (PK) DEFICIENCY -- PYRUVATE KINASE ACTIVATOR -- BINDS THE PROTEIN TETRAMER , ; NDA 216196 (label 216196.pdf) INN (MITAPIVAT SULFATE) PYRUKYND (AGIOS PHARMS INC) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2057 ; TERLIPRESSIN ; 14636-12-5 ; 2022 ; ; ; CLASS HORMONE -- VASOPRESSIN RECEPTOR AGONIST WITH TWICE THE SELECTIVITY FOR VASOPRESSIN V1 RECEPTORS VERSUS V2 RECEPTORS -- INDICATED TO IMPROVE KIDNEY FUNCTION IN ADULTS -- THE MAJOR ACTIVE METABOLITE IS LYSINE- VASOPRESSIN , ; NDA 022231 (label 22231.pdf) INN (TERLIPRESSIN ACETATE) TERLIVAZ (MALLINCKRODT IRELAND) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2058 ; BEXAGLIFLOZIN ; 1118567-05-7 ; 2023 ; ; ; CLASS METABOLISM -- SODIUM-GLUCOSE CO-TRANSPORTER 2 (SGLT2) INHIBITOR -- ANTIDIABETIC -- REDUCES RENAL REABSORPTION OF FILTERED GLUCOSE -- TREATMENT OF TYPE 2 DIABETES MELLITUS , ; NDA 214373 (label 214373.pdf) INN (BEXAGLIFLOZIN) BRENZAVVY (THERACOSBIO) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2059 ; FUTIBATINIB ; 1448169-71-8 ; 2022 ; ; ; CLASS ANTINEOPLASTIC -- FGFR2 1, 2 AND 3 KINASE COVALENT INHIBITOR (IC50 VALUES OF LESS THAN 4 NANOMOLAR) -- TREATMENT OF INTRAHEPATIC CHOLANGIOCARCINOMA -- , ; NDA 214801 (label 214801.pdf) INN (FUTIBATINIB) LYTGOBI (TAIHO ONCOLOGY) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2060 ; DEUCRAVACITINIB ; 1609392-27-9 ; 2022 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING AGENTS -- TYROSINE KINASE 2 (TYK2) ALLOSTERIC INHIBITOR -- TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS , ; NDA 214958 (label 214958.pdf) INN (DEUCRAVACITINIB) SOTYKTU (BRISTOL) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2061 ; M DEUCRAVACITINIB ; 1609393-48-7 ; 0 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING AGENTS -- TYROSINE KINASE 2 (TYK2) ALLOSTERIC INHIBITOR -- TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS -- BMT-153261 ACCOUNTS FOR APPROXIMATELY 20 PERCENT OF THE SYSTEMIC EXPOSURE , ; 2062 ; OMIDENEPAG ISOPROPYL ; 1187451-19-9 ; 2022 ; DISCONTINUED ; ; CLASS SENSORY -- SELECTIVE PROSTAGLANDIN E2 (EP2) RECEPTOR AGONIST -- REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION , ; NDA 215092 (label 215092.pdf) INN (OMIDENEPAG ISOPROPYL) OMLONTI (VISIOX PHARMA) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY DISCONTINUED , 2063 ; OMIDENEPAG ; 1187451-41-7 ; 0 ; ; ; CLASS SENSORY -- SELECTIVE PROSTAGLANDIN E2 (EP2) RECEPTOR AGONIST -- REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION , ; 2064 ; OLUTASIDENIB ; 1887014-12-1 ; 2022 ; ; ; CLASS ANTINEOPLASTIC -- ISOCITRATE DEHYDROGENASE-1 (IDH1) INHIBITOR -- TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE IDH1 MUTATION , ; NDA 215814 (label 215814.pdf) INN (OLUTASIDENIB) REZLIDHIA (RIGEL PHARMS INC) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2065 ; RITLECITINIB ; 1792180-81-4 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- JANUS KINASE 3 (JAK3) KINASE INHIBITOR -- TREATMENT OF SEVERE ALOPECIA AREATA IN ADULTS AND ADOLESCENTS 12 YEARS AND OLDER , ; NDA 215830 (label 215830.pdf) INN (RITLECITINIB TOSYLATE) LITFULO (PFIZER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2066 ; PHENOBARBITAL ; 50-06-6 ; 2022 ; ; ; CLASS NERVOUS SYSTEM -- BARBITURATE INDICATED FOR THE TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS -- GABA MODULATOR , ; NDA 215910 (label 215910.pdf) INN (PHENOBARBITAL SODIUM) SEZABY (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2022 , 2067 ; LENACAPAVIR ; 2189684-44-2 ; 2022 ; ; ; CLASS ANTIINFECTIVES -- HIV-1 ANTIRETROVIRAL AGENT -- HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) CAPSID INHIBITOR , ; NDA 215973 (label 215973.pdf) INN (LENACAPAVIR SODIUM) SUNLENCA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , NDA 215974 (label 215974.pdf) INN (LENACAPAVIR SODIUM) SUNLENCA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2068 ; PIRTOBRUTINIB ; 2101700-15-4 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- BTK KINASE INHIBITOR -- TREATMENT OF MANTLE CELL LYMPHOMA (MCL) , ; NDA 216059 (label 216059.pdf) INN (PIRTOBRUTINIB) JAYPIRCA (LOXO ONCOL) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2069 ; SOTAGLIFLOZIN ; 1018899-04-1 ; 2023 ; ; ; CLASS METABOLISM -- SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITOR -- SODIUM-GLUCOSE COTRANSPORTER 1 (SGLT1) INHIBITOR , ; NDA 216203 (label 216203.pdf) INN (SOTAGLIFLOZIN) INPEFA (LEXICON PHARMS INC) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2070 ; ADAGRASIB ; 2326521-71-3 ; 2022 ; ; ; CLASS ANTINEOPLASTIC -- COVALENT INHIBITOR OF THE RAS GTPASE FAMILY KRAS G12C MUTANT -- TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) , ; NDA 216340 (label 216340.pdf) INN (ADAGRASIB) KRAZATI (MIRATI THERAPS) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2071 ; ZAVEGEPANT ; 1337918-83-8 ; 2023 ; ; ; CLASS NERVOUS SYSTEM -- CALCITONIN GENE-RELATED PEPTIDE RECEPTOR ANTAGONIST -- TREATMENT OF MIGRAINE , ; NDA 216386 (label 216386.pdf) INN (ZAVEGEPANT HYDROCHLORIDE) ZAVZPRET (PFIZER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2072 ; SPARSENTAN ; 254740-64-2 ; 2023 ; ; ; CLASS CARDIOVASCULAR -- ENDOTHELIN TYPE A RECEPTOR (ETAR) (KI = 12.8 NANOMOLAR) AND ANGIOTENSIN II TYPE 1 RECEPTOR ANTAGONIST (KI = 0.36 NANOMOLAR) -- REDUCE PROTEINURIA , ; NDA 216403 (label 216403.pdf) INN (SPARSENTAN) FILSPARI (TRAVERE) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2073 ; FEZOLINETANT ; 1629229-37-3 ; 2023 ; ; ; CLASS GENITO -- NEUROKININ 3 (NK3) RECEPTOR ANTAGONIST -- TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE , ; NDA 216578 (label 216578.pdf) INN (FEZOLINETANT) VEOZAH (ASTELLAS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2074 ; TAURURSODIOL ; 14605-22-2 ; 2022 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) -- AMBIPHILIC BILE ACID -- TAURINE CONJUGATE OF URSODIOL , ; NDA 216660 (label 216660.pdf) INN (SODIUM PHENYLBUTYRATE TAURURSODIOL) RELYVRIO (AMYLYX) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2075 ; OMAVELOXOLONE ; 1474034-05-3 ; 2023 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF FRIEDREICH’S ATAXIA -- ACTIVATE THE NUCLEAR FACTOR (ERYTHROID-DERIVED 2)-LIKE 2 (NRF2) PATHWAY , ; NDA 216718 (label 216718.pdf) INN (OMAVELOXOLONE) SKYCLARYS (REATA PHARMS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2076 ; DAPRODUSTAT ; 960539-70-2 ; 2023 ; DISCONTINUED ; ; CLASS BLOOD -- HYPOXIA-INDUCIBLE FACTOR PROLYL HYDROXYLASE (HIF PH) INHIBITOR -- PROLYL 4- HYDROXYLASES (PH)1, PH2 AND PH3 INHIBITOR -- TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE , ; NDA 216951 (label 216951.pdf) INN (DAPRODUSTAT) JESDUVROQ (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY DISCONTINUED , 2077 ; DURLOBACTAM ; 1467829-71-5 ; 2023 ; ; ; CLASS ANTIINFECTIVES -- A DIAZABICYCLOOCTANE BETA LACTAMASE INHIBITOR -- TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) CAUSED BY SUSCEPTIBLE ISOLATES OF ACINETOBACTER BAUMANNII-CALCOACETICUS COMPLEX , ; NDA 216974 (label 216974.pdf) INN (DURLOBACTAM SODIUM DURLOBACTAM SODIUM SULBACTAM SODIUM) XACDURO COPACKAGED (ENTASIS THERAP) APPROVAL= AP YEAR= 2023 , 2078 ; TROFINETIDE ; 853400-76-7 ; 2023 ; ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF RETT SYNDROME , ; NDA 217026 (label 217026.pdf) INN (TROFINETIDE) DAYBUE (ACADIA PHARMS INC) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2079 ; NIRMATRELVIR ; 2628280-40-8 ; 2023 ; ; ; CLASS ANTIINFECTIVES -- ANTIVIRAL -- SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) MAIN PROTEASE (MPRO: ALSO REFERRED TO AS 3CLPRO OR NSP5 PROTEASE) INHIBITOR , ; NDA 217188 (label 217188.pdf) INN (NIRMATRELVIR RITONAVIR) PAXLOVID COPACKAGED (PFIZER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2080 ; REZAFUNGIN ; 1396640-59-7 ; 2023 ; ; ; CLASS ANTIINFECTIVES -- ECHINOCANDIN ANTIFUNGAL -- TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS -- SEMISYNTHETIC LIPOPEPTIDE -- INHIBITS THE SYNTHESIS OF 1,3-BETA-D-GLUCAN , ; NDA 217417 (label 217417.pdf) INN (REZAFUNGIN ACETATE) REZZAYO (MUNDIPHARMA) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2081 ; ELACESTRANT ; 722533-56-4 ; 2023 ; ; ; CLASS GENITO -- ESTROGEN RECEPTOR ANTAGONIST -- TREATMENT OF POSTMENOPAUSAL WOMEN OR ADULT MEN WITH ERPOSITIVE HER2-NEGATIVE ESR1-MUTATED ADVANCED OR METASTATIC BREAST CANCER , ; NDA 217639 (label 217639.pdf) INN (ELACESTRANT DIHYDROCHLORIDE) ORSERDU (STEMLINE THERAP) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2082 ; LENIOLISIB ; 1354690-24-6 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR INDICATED FOR THE TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) , ; NDA 217759 (label 217759.pdf) INN (LENIOLISIB PHOSPHATE) JOENJA (PHARMING) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2083 ; SORAVTANSINE ; 796073-69-3 ; 2022 ; ; NATURAL MOLECULE C00002351 ; CLASS ANTINEOPLASTIC -- FOLATE RECEPTOR ALPHA (FRALPHA)-DIRECTED ANTIBODY -- MICROTUBULE INHIBITOR CONJUGATE -- ANTIBODY-DRUG CONJUGATE (ADC) -- DM4 IS A MAYTANSINE DERIVATIVE -- DM4 DISRUPTS THE MICROTUBULE NETWORK WITHIN THE CELL, RESULTING IN CELL CYCLE ARREST AND APOPTOTIC CELL DEATH -- TREATMENT OF ADULT PATIENTS WITH FR ALPHA POSITIVE, PLATINUM-RESISTANT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER , ; NDA 761310 (label 761310.pdf) INN (MIRVETUXIMAB SORAVTANSINE-GYNX) ELAHERE (IMMUNOGEN INC) APPROVAL= AP YEAR= 2022 NEWMOLECULARENTITY , 2084 ; GEPIRONE ; 83928-76-1 ; 2023 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS -- 5HT1A RECEPTOR AGONIST , ; NDA 021164 (label 21164.pdf) INN (GEPIRONE HYDROCHLORIDE) EXXUA (FABRE KRAMER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY DISCONTINUED , 2085 ; M GEPIRONE ; 477930-33-9 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS -- 5HT1A RECEPTOR AGONIST , ; 2086 ; M GEPIRONE ; 20980-22-7 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS -- ALPHA2 ADRENERGIC RECEPTOR ANTAGONIST , ; 2087 ; CANTHARIDIN ; 56-25-7 ; 2023 ; ; NATURAL MOLECULE C00010979 ; CLASS DERMATOLOGICALS -- TREATMENT OF MOLLUSCUM CONTAGIOSUM , ; NDA 212905 (label 212905.pdf) INN (CANTHARIDIN) YCANTH (VERRICA PHARMS) APPROVAL= AP YEAR= 2023 , 2088 ; TAUROLIDINE ; 19388-87-5 ; 2023 ; ; ; CLASS BLOOD -- ANTIMICROBIAL AGENT DERIVED FROM THE NATURALLY OCCURRING AMINO ACID TAURINE , ; NDA 214520 (label 214520.pdf) INN (HEPARIN SODIUM TAUROLIDINE) DEFENCATH (CORMEDIX) APPROVAL= AP YEAR= 2023 , 2089 ; M GEPIRONE ; 477930-32-8 ; 0 ; DISCONTINUED ; ; CLASS NERVOUS SYSTEM -- TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS -- 5HT1A RECEPTOR AGONIST , ; 2090 ; VADADUSTAT ; 1000025-07-9 ; 2024 ; ; ; CLASS BLOOD -- TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE (CKD) -- HYPOXIA-INDUCIBLE FACTOR PROLYL HYDROXYLASE (HIF PH) INHIBITOR , ; NDA 215192 (label 215192.pdf) INN (VADADUSTAT) VAFSEO (AKEBIA) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2091 ; VAMOROLONE ; 13209-41-1 ; 2023 ; ; ; CLASS HORMONES -- TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) -- CORTICOSTEROID , ; NDA 215239 (label 215239.pdf) INN (VAMOROLONE) AGAMREE (CATALYST PHARMS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2092 ; PALOVAROTENE ; 410528-02-8 ; 2023 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- RETINOID -- REDUCTION IN THE VOLUME OF NEW HETEROTOPIC OSSIFICATION -- TREATMENT OF FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) -- RAR AGONIST , ; NDA 215559 (label 215559.pdf) INN (PALOVAROTENE) SOHONOS (IPSEN) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2093 ; ENMETAZOBACTAM ; 1001404-83-6 ; 2024 ; DISCONTINUED ; ; CLASS ANTIINFECTIVES -- BETA-LACTAMASE INHIBITOR -- TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS , ; NDA 216165 (label 216165.pdf) INN (CEFEPIME HYDROCHLORIDE ENMETAZOBACTAM) EXBLIFEP (ALLECRA THERAPS) APPROVAL= AP YEAR= 2024 DISCONTINUED , 2094 ; PIVMECILLINAM ; 32886-97-8 ; 2024 ; ; ; CLASS ANTIINFECTIVES -- PENICILLIN -- ANTIBACTERIAL -- TREATMENT OF URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI , PROTEUS MIRABILIS AND STAPHYLOCOCCUS SAPROPHYTICUS -- RAPIDLY HYDROLYZED TO MECILLINAM BY NON-SPECIFIC ESTERASES , ; NDA 216483 (label 216483.pdf) INN (PIVMECILLINAM HYDROCHLORIDE) PIVYA (UTILITY THERAP) APPROVAL= AP YEAR= 2024 , 2095 ; MOMELOTINIB ; 1056634-68-4 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MYELOFIBROSIS -- JANUS KINASE 1 AND 2 (JAK1/JAK2) INHIBITOR AND AND MUTANT JAK2V617F , ; NDA 216873 (label 216873.pdf) INN (MOMELOTINIB DIHYDROCHLORIDE) OJJAARA (GLAXOSMITHKLINE) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2096 ; M MOMELOTINIB ; 1841094-23-2 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF MYELOFIBROSIS -- JANUS KINASE 1 AND 2 (JAK1/JAK2) INHIBITOR AND AND MUTANT JAK2V617F , ; 2097 ; ETRASIMOD ; 1206123-37-6 ; 2023 ; ; ; CLASS IMMUNOSUPPRESSANTS -- IMMUNOMODULATING AGENTS -- SPHINGOSINE 1-PHOSPHATE (S1P) RECEPTOR MODULATOR -- TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS , ; NDA 216956 (label 216956.pdf) INN (ETRASIMOD ARGININE) VELSIPITY (PFIZER) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2098 ; QUIZARTINIB ; 950769-58-1 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) -- TYROSINE KINASE FLT3 INHIBITOR -- BIND TO THE ADENOSINE TRIPHOSPHATE (ATP) BINDING DOMAIN , ; NDA 216993 (label 216993.pdf) INN (QUIZARTINIB DIHYDROCHLORIDE) VANFLYTA (DAIICHI SANKYO INC) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2099 ; M QUIZARTINIB ; 1225542-12-0 ; 0 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) -- TYROSINE KINASE FLT3 INHIBITOR -- BIND TO THE ADENOSINE TRIPHOSPHATE (ATP) BINDING DOMAIN , ; 2100 ; SOFPIRONIUM ; 1628251-49-9 ; 2024 ; ; ; CLASS DERMATOLOGICALS -- ANTICHOLINERGIC DRUG -- COMPETITIVE INHIBITOR OF ACETYLCHOLINE RECEPTOR , ; NDA 217347 (label 217347.pdf) INN (SOFPIRONIUM) SOFDRA (BOTANIX SB INC.) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2101 ; ZURANOLONE ; 1632051-40-1 ; 2023 ; ; ; CLASS NERVOUS SYSTEM -- NEUROACTIVE STEROID GAMMA-AMINOBUTYRIC ACID (GABA) A RECEPTOR POSITIVE MODULATOR INDICATED FOR THE TREATMENT OF POSTPARTUM DEPRESSION (PPD) , ; NDA 217369 (label 217369.pdf) INN (ZURANOLONE) ZURZUVAE (BIOGEN INC) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2102 ; FRUQUINTINIB ; 1194506-26-7 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF METASTATIC COLORECTAL CANCER (MCRC) -- INHIBITOR OF VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTORS (VEGFR)-1, -2, AND -3 , ; NDA 217564 (label 217564.pdf) INN (FRUQUINTINIB) FRUZAQLA (TAKEDA PHARMS USA) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2103 ; LOTILANER ; 1369852-71-0 ; 2023 ; ; ; CLASS ANTIPARASITIC -- TREATMENT OF DEMODEX BLEPHARITIS -- GAMMA-AMINOBUTYRIC ACID (GABA)-GATED CHLORIDE CHANNEL INHIBITOR SELECTIVE FOR MITES (NOT AN INHIBITOR OF MAMMALIAN GABA) , ; NDA 217603 (label 217603.pdf) INN (LOTILANER) XDEMVY (TARSUS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2104 ; NIROGACESTAT ; 1290543-63-3 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- GAMMA SECRETASE INHIBITOR -- TREATMENT OF PROGRESSING DESMOID TUMORS -- BLOCKS PROTEOLYTIC ACTIVATION OF THE NOTCH RECEPTOR , ; NDA 217677 (label 217677.pdf) INN (NIROGACESTAT HYDROBROMIDE) OGSIVEO (SPRINGWORKS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2105 ; TOVORAFENIB ; 1096708-71-2 ; 2024 ; ; ; CLASS ANTINEOPLASTIC -- KINASE INHIBITOR -- TREATMENT OF LOW- GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT OR BRAF V600 MUTATION , ; NDA 217700 (label 217700.pdf) INN (TOVORAFENIB) OJEMDA (DAY ONE BIOPHARMS) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , NDA 218033 (label 218033.pdf) INN (TOVORAFENIB) OJEMDA (DAY ONE BIOPHARMS) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2106 ; RESMETIROM ; 920509-32-6 ; 2024 ; ; ; CLASS HORMONES -- THYROID HORMONE RECEPTOR-BETA (THR-BETA) AGONIST -- TREATMENT OF NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) , ; NDA 217785 (label 217785.pdf) INN (RESMETIROM) REZDIFFRA (MADRIGAL) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2107 ; GIVINOSTAT ; 497833-27-9 ; 2024 ; ; ; CLASS MUSCULO-SKELETAL SYSTEM -- HISTONE DEACETYLASE INHIBITOR -- TREATMENT OF OF DUCHENNE MUSCULAR DYSTROPHY (DMD) , ; NDA 217865 (label 217865.pdf) INN (GIVINOSTAT HYDROCHLORIDE) DUVYZAT (ITALFARMACO SPA) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2108 ; DANICOPAN ; 1903768-17-1 ; 2024 ; ; ; CLASS IMMUNOSUPPRESSANTS -- COMPLEMENT FACTOR D INHIBITOR -- TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) -- PREVENTS THE CLEAVAGE OF COMPLEMENT FACTOR B INTO THE BA AND BB FRAGMENTS , ; NDA 218037 (label 218037.pdf) INN (DANICOPAN) VOYDEYA (ALEXION PHARMS INC) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2109 ; CAPIVASERTIB ; 1143532-39-1 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF BREAST CANCER -- INHIBITOR OF SERINE/THREONINE KINASE AKT (AKT1, AKT2 AND AKT3) , ; NDA 218197 (label 218197.pdf) INN (CAPIVASERTIB) TRUQAP (ASTRAZENECA) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2110 ; REPOTRECTINIB ; 1802220-02-5 ; 2023 ; ; ; CLASS ANTINEOPLASTIC -- TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER -- INHIBITOR OF PROTO-ONCOGENE TYROSINE-PROTEIN KINASE ROS1 (ROS1) AND OF THE TROPOMYOSIN RECEPTOR TYROSINE KINASES (TRKS) TRKA, TRKB, AND TRKC , ; NDA 218213 (label 218213.pdf) INN (REPOTRECTINIB) AUGTYRO (BRISTOL) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2111 ; CEFTOBIPROLE MEDOCARIL ; 376653-43-9 ; 2024 ; ; ; CLASS ANTIINFECTIVES -- CEPHALOSPORIN ANTIBACTERIAL -- TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS -- INHIBITION OF BACTERIAL CELL WALL SYNTHESIS -- INHIBITION OF TRANSPEPTIDASE ACTIVITY , ; NDA 218275 (label 218275.pdf) INN (CEFTOBIPROLE MEDOCARIL SODIUM) ZEVTERA (BASILEA PHARM ALLSCH) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2112 ; CEFTOBIPROLE ; 209467-52-7 ; 0 ; ; ; CLASS ANTIINFECTIVES -- CEPHALOSPORIN ANTIBACTERIAL -- TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS -- INHIBITION OF BACTERIAL CELL WALL SYNTHESIS -- INHIBITION OF TRANSPEPTIDASE ACTIVITY , ; 2113 ; IPTACOPAN ; 1644670-37-0 ; 2023 ; ; ; CLASS IMMUNOSUPPRESSANTS -- A COMPLEMENT FACTOR B INHIBITOR -- TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) , ; NDA 218276 (label 218276.pdf) INN (IPTACOPAN HYDROCHLORIDE) FABHALTA (NOVARTIS) APPROVAL= AP YEAR= 2023 NEWMOLECULARENTITY , 2114 ; MAVORIXAFOR ; 558447-26-0 ; 2024 ; ; ; CLASS BLOOD -- CXC CHEMOKINE RECEPTOR 4 (CXCR4) ANTAGONIST -- TREATMENT OF WHIM SYNDROME (WARTS, HYPOGAMMAGLOBULINEMIA, INFECTIONS AND MYELOKATHEXIS) , ; NDA 218709 (label 218709.pdf) INN (MAVORIXAFOR) XOLREMDI (X4 PHARMS) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2115 ; ELAFIBRANOR ; 923978-27-2 ; 2024 ; ; ; CLASS METABOLISM -- PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) PPAR-ALPHA, PPAR-GAMMA, AND PPAR-DELTA AGONIST -- TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) , ; NDA 218860 (label 218860.pdf) INN (ELAFIBRANOR) IQIRVO (IPSEN BIOPHARM LTD) APPROVAL= AP YEAR= 2024 NEWMOLECULARENTITY , 2116 ; BENZQUINAMIDE ; 63-12-7 ; 1974 ; DISCONTINUED ; ; CLASS ANTIEMETIC -- ANTIPSYCHOTICS -- NERVOUS SYSTEM , ; NDA 016818 (pdf 16818.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (ROERIG) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 016820 (pdf 16820.pdf not found) INN (BENZQUINAMIDE HYDROCHLORIDE) EMETE-CON (PFIZER) APPROVAL= AP YEAR= 1974 NEWMOLECULARENTITY DISCONTINUED , 2117 ; ISOETHARINE ; 530-08-5 ; 1978 ; DISCONTINUED ; ; CLASS RESPIRATORY SYSTEM -- BRONCHODILATOR -- ADRENERGIC BETA2 AGONISTS (PMID6990745) , ; NDA 012339 (pdf 12339.pdf not found) INN (ISOETHARINE MESYLATE) BRONKOMETER (SANOFI AVENTIS US) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 085889 (pdf 85889.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 085997 (pdf 85997.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (PARKE DAVIS) APPROVAL= AP YEAR= 1978 DISCONTINUED , NDA 086651 (pdf 86651.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (INTL MEDICATION) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086711 (pdf 86711.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) BETA-2 (NEPHRON) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 086763 (pdf 86763.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 086899 (pdf 86899.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1979 DISCONTINUED , NDA 087025 (pdf 87025.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1980 DISCONTINUED , NDA 087101 (pdf 87101.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087324 (pdf 87324.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087389 (pdf 87389.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087390 (pdf 87390.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087396 (pdf 87396.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1981 DISCONTINUED , NDA 087858 (pdf 87858.pdf not found) INN (ISOETHARINE MESYLATE) ISOETHARINE MESYLATE (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 087937 (pdf 87937.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 087938 (pdf 87938.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088144 (pdf 88144.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088145 (pdf 88145.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1984 DISCONTINUED , NDA 088146 (pdf 88146.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (BAXTER HLTHCARE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088187 (pdf 88187.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088188 (pdf 88188.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088226 (pdf 88226.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088275 (pdf 88275.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ROXANE) APPROVAL= AP YEAR= 1983 DISCONTINUED , NDA 088470 (pdf 88470.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088471 (pdf 88471.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 088472 (pdf 88472.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089252 (pdf 89252.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089614 (pdf 89614.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089615 (pdf 89615.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089616 (pdf 89616.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089617 (pdf 89617.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089618 (pdf 89618.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE (ASTRAZENECA) APPROVAL= AP YEAR= 1991 DISCONTINUED , NDA 089817 (pdf 89817.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089818 (pdf 89818.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089819 (pdf 89819.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , NDA 089820 (pdf 89820.pdf not found) INN (ISOETHARINE HYDROCHLORIDE) ISOETHARINE HYDROCHLORIDE S/F (DEY) APPROVAL= - YEAR= 0 DISCONTINUED , 2118 ; M ELAFIBRANOR ; 1000334-85-9 ; 0 ; ; ; CLASS METABOLISM -- PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) PPAR-ALPHA, PPAR-GAMMA, AND PPAR-DELTA AGONIST -- TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) , ;