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BUPRENORPHINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2025-01-30
Drug application
- FDA Application #
ANDA219302- 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
- SOMERSET THERAPS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- First approval
- 2025-01-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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