dimethyl fumarate

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

Drug Details

Generic Name
dimethyl fumarate
Brand Names
dimethyl fumarate, TECFIDERA, Tecfidera, DIMETHYL FUMARATE
Application Number
ANDA210382
Sponsor
Upsher-Smith Laboratories, LLC
NDC Codes
15
Dosage Forms
CAPSULE, DELAYED RELEASE, CAPSULE, 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 )