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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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