Licensed vaccine
Adacel
FDA-licensed vaccine · Sanofi Pasteur Limited · STN BL 125111
Key facts
| Trade name | Adacel |
|---|---|
| Proper name | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
| Manufacturer | Sanofi Pasteur Limited |
| Submission tracking number (STN) | BL 125111 |
| FDA product areas | Biologics |
| Recent FDA documents | May 11, 2023 Approval Letter - Adacel, BLA Clinical Review Memorandum (125111/904) - ADACEL, January 9, 2023 Statistical Review - ADACEL, January 9, 2023 Approval Letter - Adacel, December 28, 2020 Approval Letter - Adacel, January 11, 2019 Summary Basis for Regulatory Action - Adacel, January 11, 2019 Approval Letter - Adacel, Package Insert - Adacel, September 29, 2017 Approval Letter - Adacel, Patient Prescribing Information (PPI) Sheet - Adacel, Supporting Documents older than three years - Adacel |
| FDA page updated | May 12, 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: