Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215904
Company: MARINUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZTALMY GANAXOLONE 50MG/ML SUSPENSION;ORAL Prescription TBD 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
03/18/2022 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Federal Register Notice (PDF)
Label (PDF)
Letter (PDF)
Review
Date of Approval; FR Notice on DEA Scheduling. Approval Date: June 1, 2022
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
03/18/2022 ORIG-1 Approval Label (PDF)

ZTALMY

There are no Therapeutic Equivalents.

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