Hadlima

Organon LLC🇺🇸 United States

FDA Page

Effective Date: Jul 11, 2023
Approval ID: 4774a951-3ce8-43b6-80b1-e6b23752aae6
Products: 5 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)

Quick Stats

Total Products5

Labelers2

Label Sections28

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.