HepaGam B

Kamada Ltd.🇺🇸 United States

FDA Page

Effective Date: Mar 2, 2026
Approval ID: 0146011c-944b-4251-8a5f-e573a3d5f8c0
Products: 2 registered
Version: 4

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use HepaGam B safely and effectively. See full prescribing information for HepaGam B . HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. greater than 312 international units per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006

Quick Stats

Total Products2

Labelers1

Label Sections17

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.