Licensed vaccine

Fluzone Quadrivalent

FDA-licensed vaccine · Sanofi Pasteur Inc. · STN 103914

Key facts

Trade name Fluzone Quadrivalent
Proper name Influenza Virus Vaccine (Quadrivalent, Types A and Types B)
Manufacturer Sanofi Pasteur Inc.
Submission tracking number (STN) 103914
FDA product areas Biologics, Vaccines
Recent FDA documents September 26, 2024 Approval Letter - Fluzone High-Dose Quadrivalent Southern Hemisphere, July 1, 2024 Approval Letter- Fluzone and Fluzone High-Dose, February 14, 2024 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent Southern Hemisphere, November 29, 2023 Approval Letter - Fluzone, July 12, 2023 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose, Package Insert - Fluzone, February 22, 2023 Approval Letter - Fluzone High Dose Quadrivalent, February 13, 2023 Approval Letter - Fluzone Quadrivalent Southern Hemisphere and Fluzone High-Dose Quadrivalent Southern Hemisphere, Package Insert and Patient Information - Fluzone High-Dose Quadrivalent Southern Hemisphere, November 2, 2022 Approval Letter - Fluzone Quadrivalent and Fluzone Quadrivalent Southern Hemisphere, July 1, 2022 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent, February 14, 2022 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
FDA page updated Sep 27, 2024
FDA product page fda.gov

At a glance

  • 10–99 FDA approval letters
  • 10–99 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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