VIGADRONE by Aucta Pharmaceuticals, Inc.

VIGADRONE by

Drug Labeling and Warnings

VIGADRONE by is a Prescription medication manufactured, distributed, or labeled by Aucta Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

VIGADRONE 
vigabatrin powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73289-0003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIGABATRIN (UNII: GR120KRT6K) (VIGABATRIN - UNII:GR120KRT6K)	VIGABATRIN	50 mg  in 1 mL

Product Characteristics
Color	white (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73289-0003-0	50 in 1 CARTON	06/21/2018
1		10 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210196	06/21/2018	02/15/2023

Labeler - Aucta Pharmaceuticals, Inc. (016894249)

Revised: 2/2023

Document Id: f4c00841-d1a6-069e-e053-2a95a90a2474

34391-3

Set id: dd08986d-d172-e930-e053-2a95a90a1ef9

Version: 4

Effective Time: 20230215