Application 215904

Type: NDA
Sponsor: MARINUS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZTALMY	GANAXOLONE	SUSPENSION;ORAL	50MG/ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81583-100	ZTALMY	ganaxolone	Marinus Pharmaceuticals, Inc.	NDA	Current
81583-100	ZTALMY	ganaxolone	Marinus Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83845	SUPPL	2025-10-21
83844	SUPPL	2025-10-21
83843	SUPPL	2025-10-21
83812	SUPPL	2025-10-20
83811	SUPPL	2025-10-20
83126	SUPPL	2025-08-19
83060	SUPPL	2025-08-07
74607	SUPPL	2023-06-22
74605	SUPPL	2023-06-22
74586	SUPPL	2023-06-22
74585	SUPPL	2023-06-22
72598	SUPPL	2022-11-10
72597	SUPPL	2022-11-10
72594	SUPPL	2022-11-10
72593	SUPPL	2022-11-10
72592	SUPPL	2022-11-10
71205	ORIG	2022-06-03
70751	ORIG	2022-04-12
70577	ORIG	2022-03-22
70738	ORIG	2022-03-18
70737	ORIG	2022-03-18
70558	ORIG	2022-03-18