FDA
NDA 083176 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) REMSED (BRISTOL MYERS SQUIBB) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083401 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083403 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083532 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 083955 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (EPIC PHARMA LLC) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084027 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084080 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TABLICAPS) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084160 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084166 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084222 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084223 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 084539 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABBOTT) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 086395 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WHITEWORTH TOWN PLSN) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 087518 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 089013 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE (CENCI) APPROVAL= - YEAR= 0 DISCONTINUED
NDA 007935 (label) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (DELCOR ASSET CORP) APPROVAL= AP YEAR= 1951 DISCONTINUED
NDA 008306 (label) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC W/ CODEINE (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED
NDA 008381 (label) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE PLAIN (ANI PHARMS) APPROVAL= AP YEAR= 1952 DISCONTINUED
NDA 008604 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHENERGAN VC (ANI PHARMS) APPROVAL= AP YEAR= 1954 DISCONTINUED
NDA 008857 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (WYETH AYERST) APPROVAL= AP YEAR= 1956 DISCONTINUED
NDA 011265 (label) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (ANI PHARMS) APPROVAL= AP YEAR= 1957
NDA 010926 (label) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (PHARMOBEDIENT) APPROVAL= AP YEAR= 1958 DISCONTINUED
NDA 011689 (label) INN (PROMETHAZINE HYDROCHLORIDE) PHENERGAN (PHARMOBEDIENT) APPROVAL= AP YEAR= 1960 DISCONTINUED
NDA 011730 (label) INN (MEPERIDINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) MEPERGAN (HIKMA) APPROVAL= AP YEAR= 1961 DISCONTINUED
NDA 083204 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED
NDA 083312 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 1973
NDA 083426 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973
NDA 083603 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED
NDA 083604 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED
NDA 083613 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IVAX SUB TEVA PHARMS) APPROVAL= AP YEAR= 1973 DISCONTINUED
NDA 083711 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973
NDA 083712 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1973 DISCONTINUED
NDA 080629 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED
NDA 083838 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1974 DISCONTINUED
NDA 084214 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 1974 DISCONTINUED
NDA 084176 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975
NDA 084234 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 1975 OBSOLETE
NDA 084554 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 084557 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1975 DISCONTINUED
NDA 080949 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 083214 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 083658 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PVT FORM) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 084555 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= AP YEAR= 1976 DISCONTINUED
NDA 085385 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED
NDA 085388 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KV PHARM) APPROVAL= AP YEAR= 1977 DISCONTINUED
NDA 085684 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1977 DISCONTINUED
NDA 083997 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) ZIPAN-25 (ALTANA) APPROVAL= AP YEAR= 1978 DISCONTINUED
NDA 084591 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1978 DISCONTINUED
NDA 084772 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH FORTIS (ALPHARMA US PHARMS) APPROVAL= AP YEAR= 1978 DISCONTINUED
NDA 085953 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETH PLAIN (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1978 DISCONTINUED
NDA 084901 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED
NDA 084902 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHACON (POLYMEDICA) APPROVAL= AP YEAR= 1981 DISCONTINUED
NDA 087953 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE PLAIN (PHARMOBEDIENT) APPROVAL= AP YEAR= 1982
NDA 084233 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 085146 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (RISING) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 087996 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) MYMETHAZINE FORTIS (USL PHARMA) APPROVAL= AP YEAR= 1983 DISCONTINUED
NDA 088761 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETH VC PLAIN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088762 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETH W/ DEXTROMETHORPHAN (G AND W LABS INC) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088763 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (ACTAVIS MID ATLANTIC) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088764 (label) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETH VC W/ CODEINE (CHARTWELL RX) APPROVAL= AP YEAR= 1984 DISCONTINUED
NDA 088875 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (PHARMOBEDIENT) APPROVAL= AP YEAR= 1984
NDA 088814 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088815 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088816 (pdf not found) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (CENCI) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088864 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE W/ DEXTROMETHORPHAN (PHARMOBEDIENT) APPROVAL= AP YEAR= 1985
NDA 088896 (pdf not found) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC W/ CODEINE (WOCKHARDT) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 088897 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE VC PLAIN (XTTRIUM LABS INC) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 089109 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA) APPROVAL= AP YEAR= 1985 DISCONTINUED
NDA 085664 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED
NDA 085986 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS) APPROVAL= AP YEAR= 1986 DISCONTINUED
NDA 087165 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHEGAN (COSETTE PHARMS NC) APPROVAL= AP YEAR= 1987
NDA 088868 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 088870 (pdf not found) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHERAZINE VC W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 088913 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PHERAZINE DM (HALSEY) APPROVAL= AP YEAR= 1987 DISCONTINUED
NDA 088739 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PHERAZINE W/ CODEINE (HALSEY) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 089463 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 089477 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MARSAM PHARMS LLC) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 089647 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (PHARM ASSOC) APPROVAL= AP YEAR= 1988 DISCONTINUED
NDA 040027 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (HIKMA) APPROVAL= AP YEAR= 1996 DISCONTINUED
NDA 040151 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (HIKMA) APPROVAL= AP YEAR= 1997 DISCONTINUED
NDA 040026 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (CHARTWELL RX) APPROVAL= AP YEAR= 1998
NDA 040372 (label) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 2000 DISCONTINUED
NDA 040428 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (COSETTE PHARMS NC) APPROVAL= AP YEAR= 2002
NDA 040454 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 040471 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (MYLAN INSTITUTIONAL) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 040449 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040479 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040500 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PADAGIS ISRAEL) APPROVAL= AP YEAR= 2003
NDA 040504 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040515 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 040524 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (BEDFORD LABS) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 040558 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ABLE) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 040596 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ZYDUS PHARMS USA) APPROVAL= AP YEAR= 2005
NDA 040593 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SANDOZ) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 040603 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARMA CANADA) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 040622 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PRINSTON INC) APPROVAL= AP YEAR= 2006
NDA 040643 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (PHARM ASSOC) APPROVAL= AP YEAR= 2006
NDA 040649 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE DM (PAI HOLDINGS) APPROVAL= AP YEAR= 2006
NDA 040650 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE WITH CODEINE (PHARM ASSOC) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 040654 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (PAI HOLDINGS) APPROVAL= AP YEAR= 2006
NDA 040660 (pdf not found) INN (CODEINE PHOSPHATE ; PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (PAI HOLDINGS) APPROVAL= AP YEAR= 2006
NDA 040712 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006
NDA 040713 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (KVK TECH) APPROVAL= AP YEAR= 2006
NDA 040718 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARMA CANADA) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 040673 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2008
NDA 040724 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED OBSOLETE
NDA 040737 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (XGEN PHARMS) APPROVAL= AP YEAR= 2008
NDA 040791 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (IMPAX LABS) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 040785 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (WOCKHARDT BIO AG) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 040863 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2008 DISCONTINUED
NDA 040882 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009 DISCONTINUED
NDA 040891 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2009
NDA 040902 (pdf not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2009
NDA 090180 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE ; CODEINE PHOSPHATE) PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE (CHARTWELL RX) APPROVAL= AP YEAR= 2010
NDA 091179 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2010
NDA 090575 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2011
NDA 091054 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (AUROBINDO PHARMA USA) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 091675 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (COSETTE PHARMS NC) APPROVAL= AP YEAR= 2012
NDA 091687 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (COSETTE PHARMS NC) APPROVAL= AP YEAR= 2012
NDA 200386 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (COSETTE PHARMS NC) APPROVAL= AP YEAR= 2012
NDA 200894 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013
NDA 040674 (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 not found) INN (PHENYLEPHRINE HYDROCHLORIDE ; PROMETHAZINE HYDROCHLORIDE) PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 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 not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (STRIDES PHARMA) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 214238 (pdf not found) INN (CODEINE PHOSPHATE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (QUAGEN) APPROVAL= AP YEAR= 2020
NDA 213890 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (QUAGEN) APPROVAL= AP YEAR= 2021
NDA 216446 (pdf not found) INN (PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE (ANNORA PHARMA) APPROVAL= AP YEAR= 2022
NDA 218264 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2026
NDA 220869 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; PROMETHAZINE HYDROCHLORIDE) PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (RUBICON RESEARCH) APPROVAL= AP YEAR= 2026