Vigabatrin
These highlights do not include all the information needed to use VIGABATRIN FOR ORAL SOLUTION safely and effectively. See full prescribing information for VIGABATRIN FOR ORAL SOLUTION. VIGABATRIN for oral solution Initial U.S. Approval: 2009
Approved
Approval ID
082d818a-4f4e-4675-98c6-91db0294e63c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vigabatrin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-093
Application NumberANDA215363
Product Classification
M
Marketing Category
C73584
G
Generic Name
vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2020
FDA Product Classification
INGREDIENTS (2)
VIGABATRINActive
Quantity: 50 mg in 1 mL
Code: GR120KRT6K
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT