← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WES PHARMA INC · Approved 2020-07-17
Drug application
- FDA Application #
ANDA209069- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Marketing status
- Prescription
- Sponsor
- WES PHARMA INC
- Manufacturer
- Accord Healthcare, Inc
- First approval
- 2020-07-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown