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FDA NDA · NDA211371

ZULRESSO

Sponsor: SAGE THERAP SUPERNUS

APPLICATION
NDA211371
TYPE
NDA
ORIGINAL APPROVAL
2019-03-19
LATEST ACTION
2025-01-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ZULRESSO · ReferenceDiscontinued
BREXANOLONE 100MG/20ML (5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-23REMS · Supplement 11 — Letter ↗AP
2023-10-17REMS · Supplement 10 — Letter ↗AP
2023-03-03REMS · Supplement 8 — Letter ↗AP
2022-06-16Efficacy · Supplement 7 · priority — Letter ↗AP
2019-12-13REMS · Supplement 4 — Letter ↗AP
2019-09-30REMS · Supplement 3 — Letter ↗AP
2019-09-13Labeling · Supplement 2 · standard — Label ↗AP
2019-05-17REMS · Supplement 1 — Letter ↗AP
2019-03-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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