HEPLISAV-B

Bamboo US BidCo LLC🇺🇸 United States

FDA Page

Effective Date: Jun 10, 2026
Approval ID: 1a8b8271-208d-ecde-e063-6294a90a54c6
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

VACCINE LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HEPLISAV-B safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] Solution for Intramuscular Injection Initial U.S. Approval: 2017

Quick Stats

Total Products1

Labelers1

Label Sections1

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.