Simponi

Janssen Biotech, Inc.🇺🇸 United States

FDA Page

Effective Date: Oct 29, 2025
Approval ID: f86cb4a7-c358-4136-ae57-b32bda9bba00
Products: 2 registered
Version: 34

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SIMPONI safely and effectively. See full prescribing information for SIMPONI. SIMPONI (golimumab) injection, for subcutaneous use Initial U.S. Approval: 2009

Quick Stats

Total Products2

Labelers2

Label Sections47

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.