Application 090682

Type: ANDA
Sponsor: AUROBINDO PHARMA

Related Records

Company: AUROBINDO PHARMA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	No	No
002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 1GM BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6565	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6565	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6565	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6565	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Major Pharmaceuticals	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	NorthStar Rx LLC	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-730	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-883	Valacyclovir	Valacyclovir Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-883	Valacyclovir	Valacyclovir Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1173	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1173	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2223	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2223	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2223	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2224	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2224	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2224	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2224	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3875	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3875	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3880	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3880	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3880	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3880	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5852	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-788	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-788	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-788	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-788	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-789	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-789	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-789	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
50268-789	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	AvPAK	ANDA	Current
52343-051	Valacyclovir	valacyclovir hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
52343-051	Valacyclovir	valacyclovir hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
52343-052	Valacyclovir	valacyclovir hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
52343-052	Valacyclovir	valacyclovir hydrochloride	ACETRIS HEALTH, LLC	ANDA	Current
53002-0061	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0061	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7830	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7830	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-6837	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health	ANDA	Current
55154-6837	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health	ANDA	Current
55154-6837	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health	ANDA	Current
55154-7985	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-7985	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health	ANDA	Current
55154-7985	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Cardinal Health	ANDA	Current
55700-045	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57237-042	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-042	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-042	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-042	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-043	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-043	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-043	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
57237-043	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Rising Health, LLC	ANDA	Current
63187-776	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Proficient Rx LP	ANDA	Current
63187-776	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Proficient Rx LP	ANDA	Current
63187-776	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Proficient Rx LP	ANDA	Current

Documents

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