Application 214992

Type: ANDA
Sponsor: DEXCEL PHARMA

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 Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0470	VIGABATRIN	vigabatrin	Padagis US LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76258	ORIG	2023-11-03