Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215904
Company: MARINUS

• Medication Guide

Products on NDA 215904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZTALMY	GANAXOLONE	50MG/ML	SUSPENSION;ORAL	Prescription	TBD	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215904

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
10/16/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)
08/06/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/16/2025	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)
06/21/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
06/21/2023	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
11/09/2022	SUPPL-2	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)
11/09/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 215904

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
10/16/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)
10/16/2025	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)
08/06/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)
06/21/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)
06/21/2023	SUPPL-4	Labeling-Medication Guide	Label (PDF)
06/21/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)
06/21/2023	SUPPL-3	Labeling-Medication Guide	Label (PDF)
11/09/2022	SUPPL-2	Labeling-Medication Guide	Label (PDF)
11/09/2022	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)
11/09/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)
11/09/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)
03/18/2022	ORIG-1	Approval	Label (PDF)

Therapeutic Equivalents for NDA 215904

ZTALMY

There are no Therapeutic Equivalents.