SUN PHARM Application 206129

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TETRABENAZINE	TETRABENAZINE	TABLET;ORAL	12.5MG	No	No
002	TETRABENAZINE	TETRABENAZINE	TABLET;ORAL	25MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-179	Tetrabenazine	Tetrabenazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-277	Tetrabenazine	Tetrabenazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
40526	ORIG	2015-08-26
10547	ORIG	2015-08-19