Application 208699

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;10MG	No	No
002	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;20MG	No	No
003	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;40MG	No	No
004	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;80MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-778	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-778	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-778	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-779	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-779	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-779	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-780	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-780	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-780	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-781	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-781	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
16714-781	ezetimibe and simvastatin	ezetimibe and simvastatin	NORTHSTAR RX LLC	ANDA	Current
68462-321	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-321	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-321	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-322	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-322	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-322	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-323	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-323	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-323	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-324	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-324	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-324	ezetimibe and simvastatin	ezetimibe and simvastatin	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Application 208699

Related Records#

Application Products#

NDC Listings For This Application#