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
5b8fb137-848b-45fd-9107-a6db5a675360
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code69238-1425
Application NumberANDA210155
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (2)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
VIGABATRINActive
Quantity: 500 mg in 1 1
Code: GR120KRT6K
Classification: ACTIB