teriflunomide

FDA Drug Profile — Aubagio, teriflunomide

teriflunomide is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including Aubagio, teriflunomide. Available dosage forms: tablet, film coated, powder.

Drug Details

Generic Name
teriflunomide
Brand Names
Aubagio, teriflunomide
Application Number
NDA202992
Sponsor
OPELLA HEALTHCARE INTERNATIONAL SAS
NDC Codes
9
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
TERIFLUNOMIDE

Indications and Usage

1 INDICATIONS AND USAGE Teriflunomide tablets 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. Teriflunomide tablet is a pyrimidine synthesis inhibitor 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 )