Application 077955

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
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 table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-112	Amlodipine Besylate	Amlodipine Besylate	Blenheim Pharmacal, Inc.	ANDA	Current
10544-113	Amlodipine Besylate	Amlodipine Besylate	Blenheim Pharmacal, Inc.	ANDA	Current
12634-600	Amlodipine Besylate	Amlodipine Besylate	Apotheca Inc.	ANDA	Current
31722-237	Amlodipine Besylate	Amlodipine Besylate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-238	Amlodipine Besylate	Amlodipine Besylate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-239	Amlodipine Besylate	Amlodipine Besylate	Camber Pharmaceuticals, Inc.	ANDA	Current
43353-251	Amlodipine besylate	Amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-251	Amlodipine besylate	Amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-989	Amlodipine besylate	Amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-3102	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
51655-053	Amlodipine Besylate	Amolodipine Besylate	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-054	Amlodipine Besylate	Amlodipine Besylate	Northwind Pharmaceuticals, LLC	ANDA	Current
53808-0200	Amlodipine Besylate	amlodipine besylate	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4985	Amlodipine Besylate	Amlodipine Besylate	Cardinal Health	ANDA	Current
60687-263	Amlodipine Besylate	Amlodipine Besylate	American Health Packaging	ANDA	Current
60687-274	Amlodipine Besylate	Amlodipine Besylate	American Health Packaging	ANDA	Current
60687-285	Amlodipine Besylate	Amlodipine Besylate	American Health Packaging	ANDA	Current
60760-239	Amlodipine Besylate	Amlodipine Besylate	St Marys Medical Park Pharmacy	ANDA	Current
61919-295	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Direct Rx	ANDA	Current
61919-295	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Direct Rx	ANDA	Current
63187-197	Amlodipine Besylate	Amlodipine Besylate	Proficient Rx LP	ANDA	Current
63187-197	Amlodipine Besylate	Amlodipine Besylate	Proficient Rx LP	ANDA	Current
63187-198	Amlodipine Besylate	Amlodipine Besylate	Proficient Rx LP	ANDA	Current
63187-198	Amlodipine Besylate	Amlodipine Besylate	Proficient Rx LP	ANDA	Current
63629-1023	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1023	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1023	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1023	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1024	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1024	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1024	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-1025	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-6631	Amlodipine Besylate	Amlodipine Besylate	Bryant Ranch Prepack	ANDA	Current
63629-6631	Amlodipine Besylate	Amlodipine Besylate	Bryant Ranch Prepack	ANDA	Current
63629-7641	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-7641	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-7642	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
63629-7642	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
64725-0238	Amlodipine Besylate	Amlodipine Besylate	TYA Pharmaceuticals	ANDA	Current
67046-004	Amlodipine Besylate	Amlodipine Besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-005	Amlodipine Besylate	Amlodipine Besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-018	Amlodipine Besylate	Amlodipine Besylate	Contract Pharmacy Services-PA	ANDA	Current
67046-019	Amlodipine Besylate	Amlodipine Besylate	Contract Pharmacy Services-PA	ANDA	Current
68151-0995	Amlodipine Besylate	Amlodipine Besylate	Carilion Materials Management	ANDA	Current
68645-515	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-515	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-515	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-515	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-515	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-516	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-516	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-516	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-516	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-516	Amlodipine Besylate	Amlodipine Besylate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-9314	Amlodipine Besylate	Amlodipine Besylate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-836	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
69097-836	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
69097-837	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
69097-837	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
69097-838	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
69097-838	Amlodipine Besylate	Amlodipine Besylate	Cipla USA Inc.	ANDA	Current
71335-0833	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0833	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0833	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0834	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0834	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0843	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0843	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-0843	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-1032	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-1032	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-1032	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71335-1397	Amlodipine besylate	Amlodipine besylate	Bryant Ranch Prepack	ANDA	Current
71610-535	Amlodipine besylate	Amlodipine besylate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-237	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-237	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-238	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-238	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-239	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-239	Amlodipine besylate	Amlodipine besylate	Exelan Pharmaceuticals, Inc.	ANDA	Current

Application 077955

Related Records#

Application Products#

NDC Listings For This Application#