KARTHA Application 214663

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPLERENONE	EPLERENONE	TABLET;ORAL	25MG	No	No
002	EPLERENONE	EPLERENONE	TABLET;ORAL	50MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73320-004	Eplerenone	Eplerenone	Kartha Pharmaceuticals, Inc.	ANDA	Current
73320-005	Eplerenone	Eplerenone	Kartha Pharmaceuticals, Inc.	ANDA	Current