dimethyl fumarate

FDA Drug Profile — TECFIDERA, dimethyl fumarate, DIMETHYL FUMARATE, Tecfidera

dimethyl fumarate is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand names including TECFIDERA, dimethyl fumarate, DIMETHYL FUMARATE. Available dosage forms: capsule, capsule, delayed release, kit, capsule, gelatin coated.

Drug Details

Generic Name
dimethyl fumarate
Brand Names
TECFIDERA, dimethyl fumarate, DIMETHYL FUMARATE, Tecfidera
Application Number
NDA204063
Sponsor
Biogen Inc.
NDC Codes
15
Dosage Forms
CAPSULE, CAPSULE, DELAYED RELEASE, KIT, CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients
DIMETHYL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )