← FDA Drug Approvals (Drugs@FDA)
OPVEE
NDA · New Drug Application · Sponsor: INDIVIOR · Approved 2023-05-22
Drug application
- FDA Application #
NDA217470
- Application type
- New Drug Application
- Brand name
- OPVEE
- Generic name
- NALMEFENE HYDROCHLORIDE
- Active ingredients
- NALMEFENE HYDROCHLORIDE
- Dosage form
- SPRAY
- Route
- NASAL
- Marketing status
- Prescription
- Sponsor
- INDIVIOR
- Manufacturer
- Indivior Inc.
- First approval
- 2023-05-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown