Licensed vaccine

Flucelvax

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

Key facts

Trade name Flucelvax
Proper name Influenza Virus Vaccine (Trivalent, Types A and B)
Manufacturer Seqirus, Inc.
Submission tracking number (STN) 125408
FDA product areas Biologics
Recent FDA documents July 1, 2024 Approval Letter - FLUCELVAX, Approval History, Letters, Reviews, and Related Documents - Flucelvax, May 2, 2016 Clinical Review Addendum - FLUCELVAX, Statistical Review (STN: 125408/101) - FLUCELVAX, Package Insert - FLUCELVAX, Supporting documents older than 3 years - Flucelvax
FDA page updated Jul 1, 2024
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:

Browse all FDA-licensed vaccines