Licensed vaccine

Recombivax HB

FDA-licensed vaccine · Merck & Co, Inc · STN BL 101066

Key facts

Trade name Recombivax HB
Proper name Hepatitis B Vaccine (Recombinant)
Manufacturer Merck & Co, Inc
Submission tracking number (STN) BL 101066
FDA product areas Biologics
Recent FDA documents December 21, 2018 Approval Letter - Recombivax HB, Package Insert - Recombivax HB, Supporting Documents older than three years - Recombivax HB
FDA page updated Apr 24, 2019
FDA product page fda.gov

At a glance

  • 1–9 FDA approval letters
  • 1–9 Supporting documents
  • 1–9 Product information documents
  • Yes Document full text searchable in Orca1

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-licensed vaccines

The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.

Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date:

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