← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2018-06-14
Drug application
- FDA Application #
ANDA205806- 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
- DR REDDYS LABS SA
- Manufacturer
- Dr.Reddys Laboratories Inc
- First approval
- 2018-06-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown