Application 078946

Type: ANDA
Sponsor: LUPIN LTD

Related Records

Company: LUPIN LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;320MG	No	No
002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;320MG	No	No
003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;80MG	No	No
004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;160MG	No	No
005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;160MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-976	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50268-790	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	AvPAK	ANDA	Current
50268-791	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	AvPAK	ANDA	Current
50268-792	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	AvPAK	ANDA	Current
50268-793	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	AvPAK	ANDA	Current
50268-794	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	AvPAK	ANDA	Current
53002-1784	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1785	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1787	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1788	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-014	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-023	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57297-101	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-102	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-103	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-104	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
57297-105	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	LUPIN LIMITED	ANDA	Current
68180-101	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-101	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-101	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-102	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-102	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-102	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-103	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-103	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-103	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-104	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-104	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-104	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-105	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-105	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-105	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Lupin Pharmaceuticals, Inc.	ANDA	Current
68258-6969	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Dispensing Solutions, Inc.	ANDA	Current
71205-249	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-249	Valsartan and Hydrochlorothiazide	Valsartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current