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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DIFGEN PHARMS · Approved 2022-06-02
Drug application
- FDA Application #
ANDA212756- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE AND NALOXONE
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Dosage form
- FILM
- Route
- BUCCAL, SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- DIFGEN PHARMS
- Manufacturer
- INGENUS PHARMACEUTICALS, LLC
- First approval
- 2022-06-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown