Licensed vaccine

Infanrix

FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN BL 103647

Key facts

Trade name Infanrix
Proper name Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Manufacturer GlaxoSmithKline Biologicals
Submission tracking number (STN) BL 103647
FDA product areas Biologics, Vaccines
Recent FDA documents October 27, 2023 Approval Letter - INFANRIX, July 20, 2023 Approval Letter - INFANRIX, November 23, 2022 Approval Letter - INFANRIX, November 6, 2019 Approval Letter - INFANRIX, Package Insert - INFANRIX, Supporting Documents older than three years - INFANRIX
FDA page updated Oct 27, 2023
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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