Otulfi

Fresenius Kabi USA, LLC🇺🇸 United States

FDA Page

Effective Date: Feb 16, 2026
Approval ID: 853130e5-7406-4fd6-8138-ff2179195927
Products: 4 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

Quick Stats

Total Products4

Labelers1

Label Sections48

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.