Licensed vaccine
Quadracel
FDA-licensed vaccine
Key facts
| Trade name | Quadracel |
|---|---|
| Proper name | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine |
| FDA product areas | Biologics |
| Recent FDA documents | July 21, 2022 Approval Letter - Quadracel, Package Insert – Quadracel (inactivated poliovirus component grown in Vero cells), February 17, 2021 Approval Letter - Quadracel, December 19, 2019 Approval Letter - Quadracel, June 11, 2019 Approval Letter - Quadracel, Approval History, Letters, Reviews, and Related Documents - Quadracel, Clinical Statistical Review - Quadracel, Package Insert - Quadracel (inactivated poliovirus component grown in MRC-5 cells), Clinical Serology and Bioassay Review, and Approval Memo, March 1, 2015 - Quadracel, Supporting Documents older than three years - Quadracel |
| FDA page updated | Jul 22, 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: