← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ETHYPHARM · Approved 2010-09-24
Drug application
- FDA Application #
ANDA090622- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE HYDROCHLORIDE
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- ETHYPHARM
- Manufacturer
- PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- First approval
- 2010-09-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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