Licensed vaccine
Pediarix
FDA-licensed vaccine · GlaxoSmithKline · STN BL 103907
Key facts
| Trade name | Pediarix |
|---|---|
| Proper name | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined |
| Manufacturer | GlaxoSmithKline |
| Submission tracking number (STN) | BL 103907 |
| Recent FDA documents | April 26, 2023 Approval Letter - PEDIARIX, November 6, 2019 Approval Letter - PEDIARIX, Package Insert - PEDIARIX, Supporting Documents older than three years - Pediarix |
| FDA page updated | Apr 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: