HETERO LABS LTD V Application 204574

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
31722-821	Tetrabenazine	Tetrabenazine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-822	Tetrabenazine	Tetrabenazine	Camber Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
10358	ORIG	2016-02-05