Licensed vaccine

Flucelvax Quadrivalent

FDA-licensed vaccine · Seqirus, Inc. · STN: BL 125408

Key facts

Trade name Flucelvax Quadrivalent
Proper name Influenza Vaccine
Manufacturer Seqirus, Inc.
Submission tracking number (STN) : BL 125408
FDA product areas Biologics
Recent FDA documents June 30, 2023 Approval Letter - Flucelvax Quadrivalent, February 28, 2023 Approval Letter - Flucelvax, July 1, 2022 Approval Letter - Flucelvax Quadrivalent, Clinical Review (125408/351) - Flucelvax Quadrivalent, Statistical Review (125408/351) - Flucelvax Quadrivalent, October 14, 2021 Approval Letter - Flucelvax Quadrivalent, July 2, 2021 Approval Letter - Flucelvax, Statistical Review (STN: 125408/329) - Flucelvax Quadrivalent, Clinical Review (STN: 125408/329) - Flucelvax Quadrivalent, March 3, 2021 Approval Letter - Flucelvax Quadrivalent, July 2, 2020 Approval Letter - Flucelvax, September 18, 2019 Approval Letter - Flucelvax
FDA page updated Jul 6, 2023
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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