ENGERIX-B

A-S Medication Solutions🇺🇸 United States

FDA Page

Effective Date: May 15, 2025
Approval ID: dcecf9e0-6c28-4964-9ddb-9379705fa26c
Products: 1 registered
Version: 42

Regulatory Information

Labeling Type

VACCINE LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular useInitial U.S. Approval: 1989

Quick Stats

Total Products1

Labelers2

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.