Application 215109

Type: ANDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIGABATRIN	VIGABATRIN	TABLET;ORAL	500MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0201	VIGABATRIN	vigabatrin	Padagis US LLC	ANDA	Current
42799-950	Vigabatrin	Vigabatrin	Edenbridge Pharmaceuticals LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76260	ORIG	2023-11-03