Application 201586

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;40MG	No	No
002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;40MG	No	No
003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;80MG	No	No
004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	TABLET;ORAL	EQ 10MG BASE;80MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-793	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE, Inc.	ANDA	Current
42291-793	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE	ANDA	Current
42291-794	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE, Inc.	ANDA	Current
42291-794	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE	ANDA	Current
42291-795	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE, Inc.	ANDA	Current
42291-795	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE	ANDA	Current
42291-796	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE, Inc.	ANDA	Current
42291-796	Telmisartan and Amlodipine	Telmisartan and Amlodipine	AvKARE	ANDA	Current
68180-196	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-196	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-197	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-197	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-198	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-198	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-199	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-199	Telmisartan and Amlodipine	Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
32119	ORIG	2014-08-29