← FDA Drug Approvals (Drugs@FDA)
BELBUCA
NDA · New Drug Application · Sponsor: BDSI · Approved 2015-10-23
Drug application
- FDA Application #
NDA207932- Application type
- New Drug Application
- Brand name
- BELBUCA
- Generic name
- BUPRENORPHINE HYDROCHLORIDE
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE
- Dosage form
- FILM
- Route
- BUCCAL
- Marketing status
- Prescription
- Sponsor
- BDSI
- Manufacturer
- BioDelivery Sciences International Inc
- First approval
- 2015-10-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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