AVSOLA

Amgen Inc🇺🇸 United States

FDA Page

Effective Date: Jul 22, 2026
Approval ID: de34bcb7-b524-45c8-9181-61c6f48d540e
Products: 1 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AVSOLAsafely and effectively. See full prescribing information for AVSOLA. AVSOLA (infliximab-axxq) for injection, for intravenous use Initial U.S. Approval: 2019 AVSOLA (infliximab-axxq) is biosimilar to REMICADE (infliximab).

Quick Stats

Total Products1

Labelers1

Label Sections32

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.