Application 078021

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
64980-390	Amlodipine Besylate	Amlodipine Besylate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-391	Amlodipine Besylate	Amlodipine Besylate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-392	Amlodipine Besylate	Amlodipine Besylate	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-101	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-101	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-101	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-101	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-101	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-102	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-102	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-102	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-102	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-102	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-103	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-103	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-103	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-103	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current
65862-103	Amlodipine Besylate	Amlodipine Besylate	Aurobindo Pharma Limited	ANDA	Current