TYRUKO

Sandoz Inc🇺🇸 United States

FDA Page

Effective Date: Oct 31, 2025
Approval ID: ef653c36-dd4b-4e71-9d2d-40b8fea24b67
Products: 1 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TYRUKO safely and effectively. See full prescribing information for . TYRUKO (natalizumab-sztn) injection, for intravenous useInitial U.S. Approval: 2023TYRUKO (natalizumab-sztn) is biosimilar* to TYSABRI (natalizumab).

Quick Stats

Total Products1

Labelers1

Label Sections20

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.