Drug Index

CONTRAVE

Generic: BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Review priority: 901 REQUIRED Marketing status: Prescription

Route: ORAL
Class: General Medications
Safety profile: routine
Latest regulatory update: 05 Nov 2025, 12:00 am (UTC)

Structured Monograph

Approval overview CONTRAVE is listed in Drugs@FDA under application 200063 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG Sponsor NALPROPION Submission history Latest submission status date: 2025-11-05 00:00:00. Submission type: SUPPL.