USTEKINUMAB-AAUZ

Fresenius Kabi USA, LLC🇺🇸 United States

FDA Page

Effective Date: Feb 26, 2026
Approval ID: a6d75316-c9a7-49cf-83be-b7b6c6cecf7a
Products: 2 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 USTEKINUMAB-AAUZ safely and effectively. See full prescribing information for USTEKINUMAB-AAUZ. USTEKINUMAB-AAUZ injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024This product is OTULFI (ustekinumab-aauz). Ustekinumab-aauz is biosimilar to STELARA ® (ustekinumab).

Quick Stats

Total Products2

Labelers1

Label Sections20

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.