VIGADRONE- vigabatrin powder, for solution 
Aucta Pharmaceuticals, Inc.

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VIGADRONE® for oral solution is available as 500 mg packets containing a white to off-white granular powder. They are supplied in cartons of 50 packets (NDC 73289-0002-1).

The oral syringes are provided separately by the pharmacy.

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VIGADRONE 
vigabatrin powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73289-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VIGABATRIN (UNII: GR120KRT6K) (VIGABATRIN - UNII:GR120KRT6K) VIGABATRIN50 mg  in 1 mL
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73289-0003-050 in 1 CARTON06/21/2018
110 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21019606/21/201802/15/2023
Labeler - Aucta Pharmaceuticals, Inc. (016894249)

Revised: 2/2023
Document Id: f4c00841-d1a6-069e-e053-2a95a90a2474
Set id: dd08986d-d172-e930-e053-2a95a90a1ef9
Version: 4
Effective Time: 20230215
 
Aucta Pharmaceuticals, Inc.