← FDA Drug Approvals (Drugs@FDA)
AUVELITY
NDA · New Drug Application · Sponsor: AXSOME · Approved 2022-08-18
Drug application
- FDA Application #
NDA215430- Application type
- New Drug Application
- Brand name
- AUVELITY
- Generic name
- DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE
- Active ingredients
- BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AXSOME
- Manufacturer
- Axsome Therapeutics, Inc.
- First approval
- 2022-08-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown