dimethyl fumarate

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

dimethyl fumarate is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including dimethyl fumarate, TECFIDERA, Tecfidera. Available dosage forms: capsule, delayed release, capsule, capsule, gelatin coated, kit.

Drug Details

Generic Name
dimethyl fumarate
Brand Names
dimethyl fumarate, TECFIDERA, Tecfidera, DIMETHYL FUMARATE
Application Number
ANDA210382
Sponsor
Upsher-Smith Laboratories, LLC
NDC Codes
17
Dosage Forms
CAPSULE, DELAYED RELEASE, CAPSULE, CAPSULE, GELATIN COATED, KIT
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 )