glatiramer acetate

FDA Drug Profile — Glatiramer Acetate, GLATIRAMER ACETATE

glatiramer acetate is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including Glatiramer Acetate, GLATIRAMER ACETATE. Available dosage form: injection, solution.

Drug Details

Generic Name
glatiramer acetate
Brand Names
Glatiramer Acetate, GLATIRAMER ACETATE
Application Number
ANDA213382
Sponsor
AJENAT PHARMACEUTICALS LLC
NDC Codes
9
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
GLATIRAMER ACETATE

Indications and Usage

1 INDICATIONS AND USAGE Glatiramer acetate injection is 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. Glatiramer acetate injection is 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 ).