Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211371
Company: SAGE THERAP

• Medication Guide

• REMS

Products on NDA 211371

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZULRESSO	BREXANOLONE	100MG/20ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211371

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
03/19/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – June 17, 2019

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
10/17/2023	SUPPL-10	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.
03/03/2023	SUPPL-8	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.
06/16/2022	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
12/13/2019	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.
09/30/2019	SUPPL-3	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.
09/13/2019	SUPPL-2	Labeling-Medication Guide	Label (PDF) Letter (PDF)
05/17/2019	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.

Labels for NDA 211371

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/16/2022	SUPPL-7	Efficacy-New Patient Population	Label (PDF)
09/13/2019	SUPPL-2	Labeling-Medication Guide	Label (PDF)
03/19/2019	ORIG-1	Approval	Label (PDF)