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
f6be436e-46c7-e9ab-0fcf-e8d04dc12b72
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2021
Manufacturers
FDA
Dr. Reddys Laboratories Inc.,
DUNS: 802315887
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 Code43598-697
Application NumberANDA211481
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2021
FDA Product Classification
INGREDIENTS (2)
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
VigabatrinActive
Quantity: 50 mg in 1 mL
Code: GR120KRT6K
Classification: ACTIB