Application 207821

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, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-759	amlodipine besylate	amlodipine besylate	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-760	amlodipine besylate	amlodipine besylate	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-761	amlodipine besylate	amlodipine besylate	Marlex Pharmaceuticals, Inc.	ANDA	Current
52605-041	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-041	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-041	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-042	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-042	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-042	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-043	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-043	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-043	amlodipine besylate	amlodipine besylate	POLYGEN PHARMACEUTICALS INC.	ANDA	Current