Gammaplex

Bio Products Laboratory Limited🇺🇸 United States

FDA Page

Effective Date: Sep 16, 2025
Approval ID: 6c3ce068-59f0-413b-9f93-85fb597d55e5
Products: 1 registered
Version: 26

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use GAMMAPLEX 5% safely and effectively. See full prescribing information for GAMMAPLEX 5%. GAMMAPLEX 5% Immune Globulin Intravenous (Human), 5% Liquid, for intravenous use Initial U.S. Approval: 2009

Quick Stats

Total Products1

Labelers1

Label Sections41

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.