Adalimumab

Mylan Specialty L.P.🇺🇸 United States

FDA Page

Effective Date: Aug 15, 2023
Approval ID: e94548f8-6a95-4159-9db8-6e734febbea0
Products: 3 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2020 This product is HULIO (Adalimumab-fkjp). HULIO is biosimilar* to HUMIRA (adalimumab)

Quick Stats

Total Products3

Labelers2

Label Sections45

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.