Application 079135

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2MG;180MG	No	No
002	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2MG;240MG	No	No
003	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4MG;240MG	No	No
004	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1MG;240MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-294	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-294	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-295	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-295	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-296	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-296	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-329	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-329	Trandolapril and Verapamil Hydrochloride	Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
9224	ORIG	2010-10-29