BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
Summary
FDA approved BELBUCA (BUPRENORPHINE HYDROCHLORIDE) by BDSI. NDA (New Drug) approval (REMS) on 2026-06-18. FILM, BUCCAL.
Details
Source
Drug Approval
External ID
NDA207932-30
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BELBUCA (generic: BUPRENORPHINE HYDROCHLORIDE), FILM, BUCCAL. Application: NDA207932
Company
Context & Analysis
BDSI has 2 FDA actions in our database.
Frequently Asked Questions
How often does BDSI have FDA actions?
BDSI 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 "NDA207932-30" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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