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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2021-06-15
Drug application
- FDA Application #
ANDA214930- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Generic name
- Buprenorphine Hydrochloride
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- First approval
- 2021-06-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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