Vigabatrin
These highlights do not include all the information needed to use VIGABATRIN TABLETS safely and effectively. See full prescribing information for VIGABATRIN TABLETS. VIGABATRIN tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
8dc7bd15-2636-4d58-b651-dd117ca43dbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-3851
Application NumberANDA209822
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (10)
VIGABATRINActive
Quantity: 500 mg in 1 1
Code: GR120KRT6K
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT