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Drugs@FDA: FDA-Approved Drugs

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

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)
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