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 solutionInitial U.S. Approval: 2009
Approved
Approval ID
823cc915-0350-4780-85ed-cd1c338e429d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2022
Manufacturers
FDA
Cipla USA, Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vigabatrin
PRODUCT DETAILS
NDC Product Code69097-964
Application NumberANDA211592
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 5, 2022
Generic Namevigabatrin
INGREDIENTS (2)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
VIGABATRINActive
Quantity: 500 mg in 1 mL
Code: GR120KRT6K
Classification: ACTIB