Application 078251

Type: ANDA
Sponsor: GLENMARK GENERICS

Related Records

Company: GLENMARK GENERICS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL	CARVEDILOL	TABLET;ORAL	3.125MG	No	No
002	CARVEDILOL	CARVEDILOL	TABLET;ORAL	6.25MG	No	No
003	CARVEDILOL	CARVEDILOL	TABLET;ORAL	12.5MG	No	No
004	CARVEDILOL	CARVEDILOL	TABLET;ORAL	25MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-537	Carvedilol	Carvedilol	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-848	Carvedilol	Carvedilol	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-512	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-512	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-512	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-512	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-512	Carvedilol	Carvedilol	Lake Erie Medical DBA Qua	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-526	Carvedilol	Carvedilol	Lake Erie Medical DBA Qua	ANDA	Current
35356-908	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-2066	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2066	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2066	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2066	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2119	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2119	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2119	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2119	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2119	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2175	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2175	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2175	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2555	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2555	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2555	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-2555	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-4898	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
51655-033	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
51655-033	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
52959-204	Carvedilol	Carvedilol	H.J. Harkins Company, Inc.	ANDA	Current
53808-0218	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0219	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0221	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0603	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
55700-322	Carvedilol	Carvedilol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0163	Carvedilol	Carvedilol	Clinical Solutions Wholesale	ANDA	Current
58118-0163	Carvedilol	Carvedilol	Clinical Solutions Wholesale	ANDA	Current
58118-0163	Carvedilol	Carvedilol	Clinical Solutions Wholesale	ANDA	Current
60760-532	Carvedilol	Carvedilol	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-532	Carvedilol	Carvedilol	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-131	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63187-131	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63187-131	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
67296-0681	Carvedilol	Carvedilol	RedPharm Drug Inc.	ANDA	Current
68071-2773	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4816	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4980	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4980	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-162	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-162	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-163	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-163	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-164	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-164	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-165	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-165	Carvedilol	Carvedilol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-7458	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7458	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7458	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7458	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7603	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7603	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7603	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7910	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.,	ANDA	Current
68788-8151	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0095	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0095	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0095	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70934-609	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-686	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-707	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-707	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-753	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-753	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-1128	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Date
31350	ORIG	2007-09-07