HETERO LABS LTD V Application 205901

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TELMISARTAN	TELMISARTAN	TABLET;ORAL	20MG	No	No
002	TELMISARTAN	TELMISARTAN	TABLET;ORAL	40MG	No	No
003	TELMISARTAN	TELMISARTAN	TABLET;ORAL	80MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-802	Telmisartan	Telmisartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-803	Telmisartan	Telmisartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-804	Telmisartan	Telmisartan	Camber Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
19698	ORIG	2016-05-03
10527	ORIG	2016-04-26