Application 079172

Type: ANDA
Sponsor: GLENMARK PHARMS

Related Records

Company: GLENMARK PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	5MG	No	No
002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	10MG	No	No
003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	20MG	No	No
004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	40MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-988	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-988	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-988	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-988	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-988	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-989	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-989	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-989	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-989	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-989	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-990	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-990	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-990	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-990	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-990	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-991	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-991	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-991	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-991	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
16714-991	Rosuvastatin Calcium	Rosuvastatin Calcium	NorthStar RxLLC	ANDA	Current
50090-3515	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-3515	Rosuvastatin Calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
50090-3515	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-3549	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-3549	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-4738	Rosuvastatin Calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
50090-4738	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-4738	Rosuvastatin Calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
50090-5056	Rosuvastatin calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
50090-5745	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-6302	Rosuvastatin calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
55700-839	Rosuvastatin Calcium	Rosuvastatin Calcium	Quality Care Products, LLC	ANDA	Current
55700-839	Rosuvastatin Calcium	Rosuvastatin Calcium	Quality Care Products, LLC	ANDA	Current
55700-885	Rosuvastatin calcium	Rosuvastatin calcium	Quality Care Products, LLC	ANDA	Current
55700-885	Rosuvastatin calcium	Rosuvastatin calcium	Quality Care Products, LLC	ANDA	Current
55700-885	Rosuvastatin calcium	Rosuvastatin calcium	Quality Care Products, LLC	ANDA	Current
68071-2760	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-261	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-261	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-262	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-263	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin Calcium	Rosuvastatin Calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
68462-264	Rosuvastatin calcium	Rosuvastatin calcium	Glenmark Pharmaceutials Inc., USA	ANDA	Current
71205-279	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71205-279	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71205-279	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71335-1501	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-1501	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-1717	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-1717	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Date
31422	ORIG	2016-07-20