Application 078043

Type: ANDA
Sponsor: LUPIN

Related Records

Company: LUPIN

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
50090-5354	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
50090-5354	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
50090-5354	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
50090-5355	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
50090-5355	Amlodipine Besylate	Amlodipine Besylate	A-S Medication Solutions	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-719	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-720	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-721	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-750	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-751	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-752	Amlodipine Besylate	Amlodipine Besylate	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-1597	Amlodipine Besylate	Amlodipine Besylate	REMEDYREPACK INC.	ANDA	Current
70518-1597	Amlodipine Besylate	Amlodipine Besylate	REMEDYREPACK INC.	ANDA	Current
70518-1914	Amlodipine Besylate	Amlodipine Besylate	REMEDYREPACK INC.	ANDA	Current
70518-1914	Amlodipine Besylate	Amlodipine Besylate	REMEDYREPACK INC.	ANDA	Current
70518-1914	Amlodipine Besylate	Amlodipine Besylate	REMEDYREPACK INC.	ANDA	Current