fingolimod

FDA Drug Profile — FINGOLIMOD, fingolimod

fingolimod is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including FINGOLIMOD, fingolimod. Available dosage form: capsule.

Drug Details

Generic Name
fingolimod
Brand Names
FINGOLIMOD, fingolimod
Application Number
ANDA208003
Sponsor
Solco Healthcare US, LLC
NDC Codes
2
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
FINGOLIMOD, FINGOLIMOD HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Fingolimod 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 patients 10 years of age and older. Fingolimod is a sphingosine 1-phosphate receptor modulator 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 patients 10 years of age and older. (1)