← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2025-12-10
Drug application
- FDA Application #
ANDA218473- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE HCL
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 2025-12-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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