Licensed vaccine
Pentacel
FDA-licensed vaccine · Sanofi Pasteur Limited · STN 125145
Key facts
| Trade name | Pentacel |
|---|---|
| Proper name | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine |
| Manufacturer | Sanofi Pasteur Limited |
| Submission tracking number (STN) | 125145 |
| FDA product areas | Biologics |
| Recent FDA documents | October 21, 2022 Approval Letter - Pentacel, July 21, 2022 Approval Letter - Pentacel, Package Insert – Pentacel - (inactivated poliovirus component grown in Vero cells), February 17, 2021 Approval Letter - Pentacel, December 19, 2019 Approval Letter - Pentacel, June 11, 2019 Approval Letter - Pentacel, Approval History, Letters, Reviews, and Related Documents - Pentacel, March 16, 2017 Approval Letter- PENTACEL, Package Insert – Pentacel - (inactivated poliovirus component grown in MRC-5 cells), Supporting Documents older than three years - Pentacel |
| FDA page updated | Oct 24, 2022 |
| 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: