Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 200063

CONTRAVE (BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE)
90MG;8MG Marketing Status: Prescription

Active Ingredient: BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Proprietary Name: CONTRAVE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 90MG;8MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200063
Product Number: 001
Approval Date: Sep 10, 2014
Applicant Holder Full Name: NALPROPION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English