← FDA Drug Approvals (Drugs@FDA)
ZULRESSO
NDA · New Drug Application · Sponsor: SAGE THERAP · Approved 2019-03-19
Drug application
- FDA Application #
NDA211371
- Application type
- New Drug Application
- Brand name
- ZULRESSO
- Generic name
- Brexanolone
- Active ingredients
- BREXANOLONE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Discontinued
- Sponsor
- SAGE THERAP
- First approval
- 2019-03-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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