Application 210414

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	120MG	No	No
002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	240MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-024	DIMETHYL FUMARATE	dimethyl fumarate	Solco Healthcare US, LLC	ANDA	Current
43547-025	DIMETHYL FUMARATE	dimethyl fumarate	Solco Healthcare US, LLC	ANDA	Current