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ACTIVE SUBSTANCE / INN

BUPRENORPHINE HYDROCHLORIDE

Brand name(s): BELBUCA, BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, SUBUTEX, BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENEX, BUNAVAIL
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA205637
ANDA214737
ACTIVE SUBSTANCE
Buprenorphine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
ACTAVIS LABS UT INC, BDSI, AM REGENT
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BUPRENORPHINE HYDROCHLORIDEANDA078331AM REGENTDiscontinued
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEANDA207000SPECGX LLCPrescription
BUPRENORPHINE HYDROCHLORIDEANDA090279RUBICON RESEARCHPrescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEANDA091149TEVA PHARMS USADiscontinued
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEANDA204383ACTAVIS LABS UT INCNone (Tentative Approval)
BUNAVAILNDA205637BDSIDiscontinued
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEANDA214737SUN PHARM INDUSTRIESNone (Tentative Approval)
SUBUTEXNDA020732INDIVIORDiscontinued
BUPRENEXNDA018401INDIVIORDiscontinued
BELBUCANDA207932BDSIPrescription

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