AMJEVITA

Amgen Inc🇺🇸 United States

FDA Page

Effective Date: Sep 17, 2025
Approval ID: 9c44bd5b-4464-40a4-8933-8680950f00f2
Products: 9 registered
Version: 29

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilar to HUMIRA (adalimumab).

Quick Stats

Total Products9

Labelers1

Label Sections57

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.