Glatiramer Acetate

UPSHER-SMITH LABORATORIES, LLC🇺🇸 United States

FDA Page

Effective Date: Jan 15, 2026
Approval ID: 707a64ef-964e-44a3-8a0f-fcc2eb5b1af2
Products: 2 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GLATIRAMER ACETATE INJECTION safely and effectively. See full prescribing information for GLATIRAMER ACETATE INJECTION. GLATIRAMER ACETATE injection for subcutaneous use.Initial U.S. Approval: 1996

Quick Stats

Total Products2

Labelers1

Label Sections18

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.