FDA
NDA 012575 (pdf not found) INN (CODEINE PHOSPHATE ; PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) ACTIFED W/ CODEINE (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 017941 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 12 HOUR (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 018935 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CODIMAL-L.A. 12 (SCHWARZ PHARMA) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 018996 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) ACTIFED (GLAXOSMITHKLINE) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 019014 (pdf not found) INN (DIPHENHYDRAMINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BENYLIN (PARKE DAVIS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 071455 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 071798 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 072758 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES (KV PHARM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 088515 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 088578 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUPERPHARM) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 088630 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPHED (TEVA) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 088722 (pdf not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BROMANATE DM (ALPHARMA US PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 089139 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) RESPORAL (PIONEER PHARMS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 013483 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) DRIXORAL (SCHERING PLOUGH) APPROVAL= AP YEAR= 1963 DISCONTINUED
NDA 017603 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) NOVAFED (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 018191 (pdf not found) INN (PSEUDOEPHEDRINE SULFATE) AFRINOL (SCHERING PLOUGH) APPROVAL= AP YEAR= 1980 DISCONTINUED
NDA 018397 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) CHLOR-TRIMETON (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1981 DISCONTINUED
NDA 018506 (pdf not found) INN (AZATADINE MALEATE ; PSEUDOEPHEDRINE SULFATE) TRINALIN (SCHERING) APPROVAL= AP YEAR= 1982 DISCONTINUED
NDA 088116 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) MYFED (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 088117 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WEST WARD) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 088193 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 019279 (pdf not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) DIMETANE-DX (ROBINS AH) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 085273 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088283 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) HISTAFED (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088318 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE (WATSON LABS) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088344 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) ACTAHIST (CENCI) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088833 (pdf not found) INN (CODEINE PHOSPHATE ; PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE (WOCKHARDT) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 018843 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 018844 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (GRAHAM DM) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088474 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRILITRON (NEWTRON PHARMS) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088602 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) CORPHED (FOSUN PHARMA) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088704 (pdf not found) INN (CODEINE PHOSPHATE ; PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIACIN-C (ANIMA) APPROVAL= AP YEAR= 1985
NDA 088811 (pdf not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 1985
NDA 088860 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) ALLERFED (PVT FORM) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 012394 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) DISOPHROL (SCHERING) APPROVAL= AP YEAR= 1986 DISCONTINUED
NDA 018747 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) ISOCLOR (FISONS) APPROVAL= AP YEAR= 1986 DISCONTINUED
NDA 089018 (pdf not found) INN (CODEINE PHOSPHATE ; PSEUDOEPHEDRINE HYDROCHLORIDE ; TRIPROLIDINE HYDROCHLORIDE) TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1986 DISCONTINUED
NDA 019401 (pdf not found) INN (PSEUDOEPHEDRINE POLISTIREX) PSEUDO-12 (UCB INC) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 019453 (pdf not found) INN (ACETAMINOPHEN ; DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) DRIXORAL PLUS (SCHERING PLOUGH) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 089116 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) BROMPHERIL (COPLEY PHARM) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 019428 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (CENT PHARMS) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 089681 (pdf not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BROMFED-DM (WOCKHARDT) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 019771 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 1989
NDA 070770 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) DISOBROM (SANDOZ) APPROVAL= AP YEAR= 1991 DISCONTINUED
NDA 073585 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 12 HOUR (MCNEIL CONS) APPROVAL= AP YEAR= 1991 DISCONTINUED
NDA 019899 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) SINE-AID IB (KENVUE BRANDS) APPROVAL= AP YEAR= 1992
NDA 020021 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) SUDAFED 24 HOUR (KENVUE BRANDS) APPROVAL= AP YEAR= 1992
NDA 019670 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) CLARITIN-D (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1994
NDA 019806 (pdf not found) INN (ACRIVASTINE ; PSEUDOEPHEDRINE HYDROCHLORIDE) SEMPREX-D (ENDO OPERATIONS) APPROVAL= AP YEAR= 1994 DISCONTINUED
NDA 019672 (pdf not found) INN (BROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE (ALZA) APPROVAL= AP YEAR= 1996 DISCONTINUED
NDA 020470 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) CLARITIN-D 24 HOUR (BAYER HEALTHCARE LLC) APPROVAL= AP YEAR= 1996
NDA 020786 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 1997
NDA 021076 (pdf not found) INN (NAPROXEN SODIUM ; PSEUDOEPHEDRINE HYDROCHLORIDE) ALEVE-D SINUS & COLD (BAYER) APPROVAL= AP YEAR= 1999 DISCONTINUED
NDA 075153 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 1999
NDA 021128 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S MOTRIN COLD (KENVUE BRANDS) APPROVAL= AP YEAR= 2000
NDA 021082 (pdf not found) INN (ACETAMINOPHEN ; CLEMASTINE FUMARATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) TAVIST ALLERGY/SINUS/HEADACHE (NOVARTIS) APPROVAL= AP YEAR= 2001 DISCONTINUED
NDA 021150 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) ZYRTEC-D 12 HOUR (KENVUE BRANDS) APPROVAL= AP YEAR= 2001
NDA 074567 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROHM COLD AND SINUS (OHM LABS) APPROVAL= AP YEAR= 2001
NDA 021373 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL COLD (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002
NDA 021374 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL COLD AND SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002
NDA 021441 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) ADVIL ALLERGY SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2002
NDA 075588 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (CONTRACT PHARMACAL) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 075706 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (P AND L) APPROVAL= AP YEAR= 2003
NDA 076050 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2003
NDA 076478 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 021585 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) MUCINEX D (RB HLTH) APPROVAL= AP YEAR= 2004
NDA 021587 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) CHILDREN'S ADVIL ALLERGY SINUS (HALEON US HOLDINGS) APPROVAL= AP YEAR= 2004
NDA 021704 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION (CHATTEM SANOFI) APPROVAL= AP YEAR= 2004
NDA 075989 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (PERRIGO PHARMA INTL) APPROVAL= AP YEAR= 2004
NDA 076208 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (HERITAGE PHARMA) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 076518 (pdf not found) INN (NAPROXEN SODIUM ; PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (PERRIGO) APPROVAL= AP YEAR= 2004
NDA 076538 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL (MYLAN) APPROVAL= TA YEAR= 2004
NDA 076557 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2004
NDA 021605 (pdf not found) INN (DESLORATADINE ; PSEUDOEPHEDRINE SULFATE) CLARINEX D 24 HOUR (ORGANON) APPROVAL= AP YEAR= 2005 DISCONTINUED
NDA 076236 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2005 DISCONTINUED
NDA 077442 (pdf not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2005
NDA 021313 (pdf not found) INN (DESLORATADINE ; PSEUDOEPHEDRINE SULFATE) CLARINEX-D 12 HOUR (ORGANON LLC) APPROVAL= AP YEAR= 2006
NDA 077381 (pdf not found) INN (NAPROXEN SODIUM ; PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS INC) APPROVAL= AP YEAR= 2006
NDA 077628 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2006
NDA 077170 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 2008
NDA 077991 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS) APPROVAL= AP YEAR= 2008
NDA 076298 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (IMPAX PHARMS) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 077999 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE (PLD ACQUISITIONS LLC) APPROVAL= TA YEAR= 2010
NDA 079043 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2010
NDA 079115 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE (WOCKHARDT) APPROVAL= TA YEAR= 2010
NDA 022439 (pdf not found) INN (CHLORPHENIRAMINE MALEATE ; HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) ZUTRIPRO (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 022442 (pdf not found) INN (HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) REZIRA (PERSION) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 078366 (pdf not found) INN (DESLORATADINE ; PSEUDOEPHEDRINE SULFATE) DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2011
NDA 090922 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS LTD) APPROVAL= AP YEAR= 2012
NDA 078648 (pdf not found) INN (DEXBROMPHENIRAMINE MALEATE ; PSEUDOEPHEDRINE SULFATE) DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (AVANTHI INC) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 076667 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2014
NDA 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 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 not found) INN (HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (TRIS PHARMA INC) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 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 not found) INN (HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PADAGIS US) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 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 (pdf not found) INN (GUAIFENESIN ; HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYCOFENIX (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 090818 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2015
NDA 091071 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015
NDA 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 not found) INN (HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (MAYNE PHARMA INC) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 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 not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017
NDA 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 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 not found) INN (PSEUDOEPHEDRINE HYDROCHLORIDE) PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017
NDA 209116 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017
NDA 209235 (pdf not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017
NDA 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 210719 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (PPI-DAC) APPROVAL= AP YEAR= 2018
NDA 206661 (pdf not found) INN (HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (APOZEAL PHARMS) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 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 not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (EYWA) APPROVAL= AP YEAR= 2020
NDA 212542 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020
NDA 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 not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020
NDA 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 not found) INN (BROMPHENIRAMINE MALEATE ; DEXTROMETHORPHAN HYDROBROMIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (BRECKENRIDGE) APPROVAL= AP YEAR= 2020
NDA 211360 (pdf not found) INN (NAPROXEN SODIUM ; PSEUDOEPHEDRINE HYDROCHLORIDE) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022
NDA 214407 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2022
NDA 215434 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2022
NDA 216082 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED
NDA 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 not found) INN (IBUPROFEN ; PSEUDOEPHEDRINE HYDROCHLORIDE) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED
NDA 218017 (pdf not found) INN (LORATADINE ; PSEUDOEPHEDRINE SULFATE) LORATADINE AND PSEUDOEPHEDRINE SULFATE (BIONPHARMA) APPROVAL= AP YEAR= 2024
NDA 210507 (pdf not found) INN (CETIRIZINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (UNICHEM) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 215232 (pdf not found) INN (FEXOFENADINE HYDROCHLORIDE ; PSEUDOEPHEDRINE HYDROCHLORIDE) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2025