Application 078925

Type: ANDA
Sponsor: ALKEM

Related Records

Company: ALKEM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 2.5MG BASE	No	No
002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 5MG BASE	No	No
003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	TABLET;ORAL	EQ 10MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8429	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8430	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8431	Amlodipine Besylate	Amlodipine besylate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
42708-066	Amlodipine Besylate	Amlodipine besylate	QPharma Inc	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-041	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-564	Amlodipine Besylate	Amlodipine besylate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-1627	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2524	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2524	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-2581	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
50090-5059	Amlodipine Besylate	Amlodipine besylate	A-S Medication Solutions	ANDA	Current
53002-2352	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2352	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3351	Amlodipine Besylate	Amlodipine besylate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-541	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-543	Amlodipine Besylate	Amlodipine besylate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-738	Amlodipine Besylate	Amlodipine besylate	Quality Care Products, LLC	ANDA	Current
55700-738	Amlodipine Besylate	Amlodipine besylate	Quality Care Products, LLC	ANDA	Current
60687-477	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-488	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60687-496	Amlodipine Besylate	Amlodipine besylate	American Health Packaging	ANDA	Current
60760-614	Amlodipine Besylate	Amlodipine besylate	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63187-783	Amlodipine Besylate	Amlodipine besylate	Proficient Rx LP	ANDA	Current
63629-7640	Amlodipine Besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-7640	Amlodipine Besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
67046-036	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-036	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-684	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services- PA	ANDA	Current
67046-684	Amlodipine Besylate	Amlodipine besylate	Contract Pharmacy Services- PA	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1530	Amlodipine Besylate	Amlodipine Besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1648	Amlodipine Besylate	Amlodipine besylate	RedPharm Drug, Inc.	ANDA	Current
67296-1648	Amlodipine Besylate	Amlodipine besylate	RedPharm Drug, Inc.	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-197	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-198	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-199	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current
67877-199	Amlodipine Besylate	Amlodipine besylate	Ascend Laboratories, LLC	ANDA	Current