BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
Summary
FDA approved BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE by WES PHARMA INC. ANDA (Generic) approval (Labeling) on 2025-12-22. TABLET, SUBLINGUAL.
Details
Source
Drug Approval
External ID
ANDA209069-16
Action Date
2025-12-22
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE, TABLET, SUBLINGUAL. Application: ANDA209069
Company
Context & Analysis
WES PHARMA INC has 2 FDA actions in our database.
Frequently Asked Questions
How often does WES PHARMA INC have FDA actions?
WES PHARMA INC has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA209069-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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