TEMODAR

Merck Sharp & Dohme LLC🇺🇸 United States

FDA Page

Effective Date: Feb 20, 2026
Approval ID: 046a9011-3911-4d3f-a15f-fbb56d5aad56
Products: 7 registered
Version: 37

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) capsules, for oral use TEMODAR (temozolomide) for injection, for intravenous use Initial U.S. Approval: 1999

Quick Stats

Total Products7

Labelers2

Label Sections44

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.