GRANULES PHARMS Application 213469

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIGABATRIN	VIGABATRIN	FOR SOLUTION;ORAL	500MG/PACKET	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0702	Vigabatrin for oral solution USP, 500 mg	Vigabatrin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
70010-083	Vigabatrin for oral solution USP, 500 mg	Vigabatrin	Granules Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
76023	ORIG	2023-11-01