FDA
NDA 018401 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENEX (INDIVIOR) APPROVAL= AP YEAR= 1981 DISCONTINUED
NDA 018410 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENEX (NORWICH-EATON PHARMA) APPROVAL= AP YEAR= 1981 OBSOLETE
NDA 074137 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HOSPIRA) APPROVAL= AP YEAR= 1996
NDA 020732 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) SUBUTEX (INDIVIOR) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 020733 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 076931 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2005
NDA 078331 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (AM REGENT) APPROVAL= AP YEAR= 2007 DISCONTINUED
NDA 078633 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2009
NDA 021306 (pdf not found) INN (BUPRENORPHINE) BUTRANS (PURDUE PHARMA LP) APPROVAL= AP YEAR= 2010
NDA 022410 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) SUBOXONE (INDIVIOR) APPROVAL= AP YEAR= 2010
NDA 090360 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (BARR) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 090622 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ETHYPHARM) APPROVAL= AP YEAR= 2010
NDA 091422 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2013
NDA 203136 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2013
NDA 204242 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) ZUBSOLV (OREXO US INC) APPROVAL= AP YEAR= 2013
NDA 091149 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 203326 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (HIKMA) APPROVAL= AP YEAR= 2014
NDA 205637 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUNAVAIL (BDSI) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 090279 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (RUBICON RESEARCH) APPROVAL= AP YEAR= 2015
NDA 090819 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ACTAVIS ELIZABETH) APPROVAL= AP YEAR= 2015
NDA 201066 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (PHARMOBEDIENT) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 206586 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (PH HEALTH) APPROVAL= AP YEAR= 2015
NDA 204431 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ETHYPHARM USA CORP) APPROVAL= AP YEAR= 2015
NDA 207932 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BELBUCA (BDSI) APPROVAL= AP YEAR= 2015
NDA 201760 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016
NDA 204442 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) PROBUPHINE (REACX PHARMS) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 201633 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2016
NDA 205022 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (LANNETT CO INC) APPROVAL= AP YEAR= 2016
NDA 207276 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2017
NDA 204383 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE (ACTAVIS LABS UT INC) APPROVAL= TA YEAR= 2017
NDA 207000 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SPECGX LLC) APPROVAL= AP YEAR= 2017
NDA 209819 (pdf not found) INN (BUPRENORPHINE) SUBLOCADE (INDIVIOR) APPROVAL= AP YEAR= 2017
NDA 204937 (pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (WATSON LABS TEVA) APPROVAL= AP YEAR= 2018
NDA 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 not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2018
NDA 207607 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2018
NDA 208042 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) CASSIPA (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 205954 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2019
NDA 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 not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (WES PHARMA INC) APPROVAL= AP YEAR= 2020
NDA 205601 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (RHODES PHARMS) APPROVAL= AP YEAR= 2020
NDA 211586 (pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (AMNEAL) APPROVAL= AP YEAR= 2020
NDA 211785 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (MYLAN TECHNOLOGIES) APPROVAL= AP YEAR= 2020
NDA 210162 (pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (MYLAN TECH VIATRIS) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 214930 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021
NDA 210272 (pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (DIFGEN PHARMS) APPROVAL= AP YEAR= 2021
NDA 211594 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (ALVOGEN) APPROVAL= AP YEAR= 2021 DISCONTINUED OBSOLETE
NDA 207490 (pdf not found) INN (BUPRENORPHINE) BUPRENORPHINE (ALVOGEN) APPROVAL= AP YEAR= 2022
NDA 212756 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (AVEVA) APPROVAL= AP YEAR= 2022
NDA 210136 (pdf not found) INN (BUPRENORPHINE) BRIXADI (BRAEBURN) APPROVAL= AP YEAR= 2023
NDA 214737 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE ; NALOXONE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUN PHARM INDUSTRIES) APPROVAL= TA YEAR= 2023
NDA 219302 (pdf not found) INN (BUPRENORPHINE HYDROCHLORIDE) BUPRENORPHINE HYDROCHLORIDE (SOMERSET THERAPS LLC) APPROVAL= AP YEAR= 2025