STEQEYMA

CELLTRION USA Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 21, 2025
Approval ID: 66085e17-e3f2-4196-8c81-87448e804b0c
Products: 3 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use STEQEYMA safely and effectively. See full prescribing information for STEQEYMA. STEQEYMA (ustekinumab-stba) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 STEQEYMA (ustekinumab-stba) is biosimilar to STELARA (ustekinumab)

Quick Stats

Total Products3

Labelers2

Label Sections22

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.