← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2016-01-29
Drug application
- FDA Application #
ANDA201760- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- SUN PHARM
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- First approval
- 2016-01-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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