Application 078518

Type: ANDA
Sponsor: MYLAN PHARMS INC

Related Records

Company: MYLAN PHARMS INC

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
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4275	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4276	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-093	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Mylan Institutional Inc.	ANDA	Current
70518-0541	Valacyclovir Hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0541	Valacyclovir Hydrochloride	valacyclovir hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3451	Valacyclovir Hydrochloride	valacyclovir	REMEDYREPACK INC.	ANDA	Current
70518-3451	Valacyclovir Hydrochloride	valacyclovir	REMEDYREPACK INC.	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	valacyclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1341	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1485	Valacyclovir Hydrochloride	valacyclovir	Bryant Ranch Prepack	ANDA	Current
71335-1485	Valacyclovir Hydrochloride	valacyclovir	Bryant Ranch Prepack	ANDA	Current

Documents

No records found.