← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2026-10-15
Drug application
- FDA Application #
ANDA221145- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE
- Generic name
- Buprenorphine Hydrochloride
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- GLAND
- First approval
- 2026-10-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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