FDA — authorised 23 October 2015
- Application: NDA207932
- Marketing authorisation holder: BDSI
- Local brand name: BELBUCA
- Indication: FILM — BUCCAL
- Status: approved
🇺🇸 Buprenorphine Buccal Film [Belbuca] in United States
FDA authorised Buprenorphine Buccal Film [Belbuca] on 23 October 2015
Marketing authorisation
Other Pain Management approved in United States
Frequently asked questions
Is Buprenorphine Buccal Film [Belbuca] approved in United States?
Yes. FDA authorised it on 23 October 2015.
Who is the marketing authorisation holder for Buprenorphine Buccal Film [Belbuca] in United States?
BDSI holds the US marketing authorisation.