BUPRENORPHINE HYDROCHLORIDE
Summary
FDA approved BUPRENORPHINE HYDROCHLORIDE by AM REGENT. ANDA (Generic) approval (Labeling) on 2025-12-22. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
ANDA078331-10
Action Date
2025-12-22
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
BUPRENORPHINE HYDROCHLORIDE, INJECTABLE, INJECTION. Application: ANDA078331
Company
Context & Analysis
AM REGENT has 14 FDA actions in our database.
Frequently Asked Questions
How often does AM REGENT have FDA actions?
AM REGENT has 14 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 "ANDA078331-10" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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