Application 202829

Type: ANDA
Sponsor: NOVEL LABS INC

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 Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-080	Amlodipine and Valsartan	Amlodipine and Valsartan	Novel Laboratories, Inc.	ANDA	Current
40032-081	Amlodipine and Valsartan	Amlodipine and Valsartan	Novel Laboratories, Inc.	ANDA	Current
40032-082	Amlodipine and Valsartan	Amlodipine and Valsartan	Novel Laboratories, Inc.	ANDA	Current
40032-083	AMLODIPINE and VALSARTAN	AMLODIPINE and VALSARTAN	Novel Laboratories, Inc.	ANDA	Current
43386-080	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
43386-080	Amlodipine and Valsartan	Amlodipine and Valsartan	Gavis Pharmaceuticals, LLC	ANDA	Current
43386-080	AMLODIPINE AND VALSARTAN	amlodipine and valsartan	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-081	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
43386-081	Amlodipine and Valsartan	Amlodipine and Valsartan	Gavis Pharmaceuticals, LLC	ANDA	Current
43386-081	AMLODIPINE AND VALSARTAN	amlodipine and valsartan	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-082	Amlodipine and Valsartan	Amlodipine and Valsartan	Lupin Pharmaceuticals, Inc.	ANDA	Current
43386-082	Amlodipine and Valsartan	Amlodipine and Valsartan	Gavis Pharmaceuticals, LLC	ANDA	Current
43386-082	AMLODIPINE AND VALSARTAN	amlodipine and valsartan	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-083	AMLODIPINE and VALSARTAN	AMLODIPINE and VALSARTAN	Lupin Pharmaceuticals, Inc.	ANDA	Current
43386-083	AMLODIPINE and VALSARTAN	AMLODIPINE and VALSARTAN	Gavis Pharmaceuticals, LLC	ANDA	Current
43386-083	AMLODIPINE AND VALSARTAN	Amlodipine and Valsartan	Lupin Pharmaceuticals,Inc.	ANDA	Current