Licensed vaccine
Fluzone, Fluzone High-Dose and Fluzone Intradermal
FDA-licensed vaccine · Sanofi Pasteur, Inc · STN BL 103914
Key facts
| Trade name | Fluzone, Fluzone High-Dose and Fluzone Intradermal |
|---|---|
| Proper name | Influenza Virus Vaccine (Trivalent, Types A and B) |
| Manufacturer | Sanofi Pasteur, Inc |
| Submission tracking number (STN) | BL 103914 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | July 1, 2024 Approval Letter- Fluzone and Fluzone High-Dose, Package Insert - Fluzone, Package Insert - Fluzone High-Dose, Clinical Review Memorandum - Fluzone High-Dose Quadrivalent, Toxicology Review - Fluzone High-Dose Quadrivalent, Statistical Review -Fluzone High-Dose, July 2, 2019 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose, January 23, 2019 Approval Letter - Fluzone High-Dose, June 29, 2018 Approval Letter- Fluzone, January 10, 2018 Approval Letter - Fluzone, July 7, 2017 Approval Letter - Fluzone, Supporting Documents older than three years - Fluzone, Fluzone High-Dose and Fluzone Intradermal |
| FDA page updated | Dec 17, 2024 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 10–99 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: