XELJANZ

U.S. Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Jul 13, 2026
Approval ID: 68e3d6b2-7838-4d2d-a417-09d919b43e13
Products: 4 registered
Version: 18

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ (tofacitinib) tablets, for oral use XELJANZ (tofacitinib) oral solution XELJANZ XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012

Quick Stats

Total Products4

Labelers2

Label Sections24

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.