Glatiramer Acetate Injection

FDA Drug Profile — Glatiramer Acetate

Glatiramer Acetate Injection is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Glatiramer Acetate. Available dosage form: injection, solution.

Drug Details

Generic Name
Glatiramer Acetate Injection
Brand Names
Glatiramer Acetate
Application Number
ANDA214741
Sponsor
UPSHER-SMITH LABORATORIES, LLC
NDC Codes
2
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 ).