Application 090483

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;160MG	No	No
002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;160MG	No	No
003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;320MG	No	No
004	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;320MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1721	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1721	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1721	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1722	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1722	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1722	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1723	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1723	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1723	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1724	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1724	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1724	AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	ANDA	Current