Application 077987

Type: ANDA
Sponsor: GLENMARK GENERICS

Related Records

Company: GLENMARK GENERICS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	10MG	No	No
002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	20MG	No	No
003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	40MG	No	No
004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	80MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8029	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8029	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8029	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8029	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8030	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8030	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8030	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8030	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8158	Pravastatin Sodium	Pravatatin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8158	Pravastatin Sodium	Pravatatin	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8158	Pravastatin Sodium	Pravatatin	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8158	Pravastatin Sodium	Pravatatin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8410	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8410	Pravastatin Sodium	Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
10544-440	Pravastatin Sodium	Pravastatin Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
10544-505	Pravastatin Sodium	Pravastatin Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
10544-507	Pravastatin Sodium	Pravastatin Sodium	Blenheim Pharmacal, Inc.	ANDA	Current
16714-558	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-558	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-559	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-559	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-560	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-560	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-570	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
16714-570	Pravastatin Sodium	Pravastatin Sodium	NorthStar RxLLC	ANDA	Current
42254-131	Pravastatin Sodium	Pravastatin Sodium	Rebel Distributors Corp	ANDA	Current
42254-202	Pravastatin Sodium	Pravastatin Sodium	Rebel Distributors Corp	ANDA	Current
50090-0975	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
50090-1533	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
50090-1533	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
50090-1533	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
50090-1594	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
50090-5809	Pravastatin Sodium	Pravastatin Sodium	A-S Medication Solutions	ANDA	Current
53808-0398	Pravastatin Sodium	Pravastatin Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0764	Pravastatin Sodium	Pravastatin Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
60687-169	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-169	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-169	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-169	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-169	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-178	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-178	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-178	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-178	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-178	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-190	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-190	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-190	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-190	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
60687-190	Pravastatin Sodium	Pravastatin Sodium	American Health Packaging	ANDA	Current
63629-6502	Pravastatin Sodium	Pravastatin Sodium	Bryant Ranch Prepack	ANDA	Current
63629-6502	Pravastatin Sodium	Pravastatin Sodium	Bryant Ranch Prepack	ANDA	Current
68071-2088	Pravastatin Sodium	Pravastatin Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-195	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-196	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-197	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-198	Pravastatin Sodium	Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-0304	Pravastatin Sodium	Pravastatin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0304	Pravastatin Sodium	Pravastatin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0423	Pravastatin Sodium	Pravastatin Sodium	REMEDYREPACK INC.	ANDA	Current