← FDA Drug Approvals (Drugs@FDA)
ZURZUVAE
NDA · New Drug Application · Sponsor: BIOGEN INC · Approved 2023-08-04
Drug application
- FDA Application #
NDA217369
- Application type
- New Drug Application
- Brand name
- ZURZUVAE
- Generic name
- ZURANOLONE
- Active ingredients
- ZURANOLONE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BIOGEN INC
- Manufacturer
- Biogen MA Inc.
- First approval
- 2023-08-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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