Application 011366

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DARANIDE	DICHLORPHENAMIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	KEVEYIS	DICHLORPHENAMIDE	TABLET;ORAL	50MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4144	DARANIDE	dichlorphenamide	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current
51672-4177	Keveyis	Dichlorphenamide	Taro Pharmaceuticals U.S.A., inc.	NDA	Current
51672-4177	Keveyis	Dichlorphenamide	Taro Pharmaceuticals U.S.A., inc.	NDA	Current
71090-001	Keveyis	Dichlorphenamide	Strongbridge US Inc.	NDA	Current
71090-001	Keveyis	Dichlorphenamide	Strongbridge US Inc.	NDA	Current
71090-001	Keveyis	Dichlorphenamide	Strongbridge US Inc.	NDA	Current
71090-001	Keveyis	Dichlorphenamide	Strongbridge US Inc.	NDA	Current
72065-001	Keveyis	Dichlorphenamide	Xeris Pharmaceuticals, Inc.	NDA	Current