Application 210309

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
68462-307	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-307	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-307	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-307	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-308	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-308	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-308	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-308	DIMETHYL FUMARATE	dimethyl-fumarate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-570	DIMETHYL FUMARATE	dimethyl fumarate kit	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-570	DIMETHYL FUMARATE	dimethyl fumarate kit	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-570	DIMETHYL FUMARATE	dimethyl fumarate kit	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-570	DIMETHYL FUMARATE	dimethyl fumarate kit	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
61120	ORIG	2019-12-03