USTEKINUMAB-TTWE

Quallent Pharmaceuticals Health LLC🇺🇸 United States

FDA Page

Effective Date: Jan 12, 2026
Approval ID: 2b34392a-ecf6-41bd-8706-d4e9f0b25da8
Products: 4 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 USTEKINUMAB-TTWE safely and effectively. See full prescribing information for USTEKINUMAB-TTWE. USTEKINUMAB-TTWE injection, for subcutaneous or intravenous useInitial U.S. Approval: 2024 Ustekinumab-ttwe is biosimilar to STELARA (ustekinumab)

Quick Stats

Total Products4

Labelers1

Label Sections21

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.