ZTALMY
These highlights do not include all the information needed to use ZTALMY safely and effectively. See full prescribing information for ZTALMY. ZTALMY (ganaxolone) oral suspension, CV Initial U.S. Approval: 2022
Approved
Approval ID
d91612c4-b03a-4be4-a1ee-6a13e3b83d4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2023
Manufacturers
FDA
Marinus Pharmaceuticals, Inc.
DUNS: 141007232
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ganaxolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81583-100
Application NumberNDA215904
Product Classification
M
Marketing Category
C73594
G
Generic Name
ganaxolone
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2023
FDA Product Classification
INGREDIENTS (11)
ganaxoloneActive
Quantity: 50 mg in 1 mL
Code: 98WI44OHIQ
Classification: ACTIB
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
polyvinyl alcohol, unspecifiedInactive
Code: 532B59J990
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT