SABRIL
These highlights do not include all the information needed to use SABRIL safely and effectively. See full prescribing information for SABRIL . SABRIL ( vigabatrin ) t ablet s , for oral use SABRIL ( vigabatrin ) for o ral s olution Initial U.S. Approval: 2009
Approved
Approval ID
a88ac1b4-e2c9-45c0-b321-4785902172e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2021
Manufacturers
FDA
Lundbeck Pharmaceuticals LLC
DUNS: 009582068
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 Code67386-211
Application NumberNDA022006
Product Classification
M
Marketing Category
C73594
G
Generic Name
vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2021
FDA Product Classification
INGREDIENTS (2)
VIGABATRINActive
Quantity: 50 mg in 1 mL
Code: GR120KRT6K
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT