Licensed vaccine
DENGVAXIA
FDA-licensed vaccine · Sanofi Pasteur, Inc. · STN 125682
Key facts
| Trade name | DENGVAXIA |
|---|---|
| Proper name | Dengue Tetravalent Vaccine, Live |
| Manufacturer | Sanofi Pasteur, Inc. |
| Submission tracking number (STN) | 125682 |
| FDA product areas | Biologics |
| Recent FDA documents | June 30, 2023 Statistical Review Memo - DENGVAXIA, June 30, 2023 Clinical Review Memo - DENGVAXIA, June 30, 2023 Approval Letter - DENGVAXIA, January 25, 2023 Approval Letter - DENGVAXIA, January 22, 2020 Approval Letter - DENGVAXIA, Approval History, Letters, Reviews, and Related Documents - DENGVAXIA, April 30, 2019 Statistical Review - DENGVAXIA, Demographic Subgroup Information – DENGVAXIA (Dengue Tetravalent Vaccine, Live), May 1, 2019 Summary Basis for Regulatory Action - DENGVAXIA, May 1, 2019 Approval Letter - DENGVAXIA, Package Insert - DENGVAXIA |
| FDA page updated | Aug 8, 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: