CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
Summary
FDA approved CONTRAVE EXTENDED-RELEASE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE) by NALPROPION. NDA (New Drug) approval (Labeling) on 2025-11-05. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA200063-26
Action Date
2025-11-05
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
CONTRAVE EXTENDED-RELEASE (generic: NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE), TABLET, EXTENDED RELEASE, ORAL. Application: NDA200063
Company
Context & Analysis
Frequently Asked Questions
How often does NALPROPION have FDA actions?
This is the only FDA action we have on record for NALPROPION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA200063-26" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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