← FDA DRUG APPROVALS

FDA NDA · NDA217369

ZURZUVAE

zuranolone

Sponsor: BIOGEN

APPLICATION
NDA217369
TYPE
NDA
ORIGINAL APPROVAL
2023-08-04
LATEST ACTION
2026-04-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZURZUVAE · ReferencePrescription
ZURANOLONE 30MG · CAPSULE · ORAL
ZURZUVAE · ReferencePrescription
ZURANOLONE 20MG · CAPSULE · ORAL
ZURZUVAE · ReferencePrescription
ZURANOLONE 25MG · CAPSULE · ORAL

Approval history

2026-04-20Labeling · Supplement 3 · standard — Letter ↗AP
2024-07-31Labeling · Supplement 1 · standard — Letter ↗AP
2023-08-04Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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