VIGADRONE
These highlights do not include all the information needed to use VIGA DRONE FOR ORAL SOLUTION safely and effectively. See full prescribing information for VIGADRONE FOR ORAL SOLUTION . VIGADRONE ( vigabatrin ) powder for oral solution Initial U.S. Approval: 2009
Approved
Approval ID
5e5e7554-d0f4-47f7-a434-cc5ca5a9826f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2020
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 079111820
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 Code0245-0556
Application NumberANDA210196
Product Classification
M
Marketing Category
C73584
G
Generic Name
vigabatrin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (1)
VIGABATRINActive
Quantity: 50 mg in 1 mL
Code: GR120KRT6K
Classification: ACTIB