Application 078573

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
13668-022	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-022	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-023	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-023	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-024	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-024	Amlodipine besylate	Amlodipine besylate	Torrent Pharmaceuticals Limited	ANDA	Current