Tafinlar

Novartis Pharmaceuticals Corporation🇺🇸 United States

FDA Page

Effective Date: May 20, 2026
Approval ID: fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea
Products: 3 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 TAFINLAR safely and effectively. See full prescribing information for TAFINLAR. TAFINLAR (dabrafenib) capsules, for oral useTAFINLAR (dabrafenib) tablets for oral suspensionInitial U.S. Approval: 2013

Quick Stats

Total Products3

Labelers2

Label Sections40

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.