Licensed vaccine
Boostrix
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN BL 125106
Key facts
| Trade name | Boostrix |
|---|---|
| Proper name | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | BL 125106 |
| FDA product areas | Biologics |
| Recent FDA documents | October 27, 2023 Approval Letter - BOOSTRIX, June 14, 2023 Approval Letter - BOOSTRIX, November 23, 2022 Approval Letter - BOOSTRIX, Statistical Review - BOOSTRIX, October 7, 2022 Clinical Review Memo - BOOSTRIX, October 7, 2022 Approval Letter - BOOSTRIX, September 10, 2020 Approval Letter - BOOSTRIX, Package Insert - BOOSTRIX, April 25, 2019 Approval Letter BOOSTRIX, Supporting Documents older than three years - Boostrix |
| 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: