Licensed vaccine

Pneumovax 23

FDA-licensed vaccine · Merck Sharp & Dohme Corp. · STN BLA 101094

Key facts

Trade name Pneumovax 23
Proper name Pneumococcal Vaccine, Polyvalent
Manufacturer Merck Sharp & Dohme Corp.
Submission tracking number (STN) BLA 101094
Recent FDA documents October 27, 2021 Approval Letter - PNEUMOVAX 23, September 25, 2020 Approval Letter - PNEUMOVAX 23, November 26, 2019 Approval Letter - PNEUMOVAX 23, Patient Information - PNEUMOVAX 23, Package Insert - PNEUMOVAX 23, Supporting Documents older than three years - PNEUMOVAX 23
FDA page updated Oct 28, 2021
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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