Licensed vaccine
Fluarix Quadrivalent
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN BL 125127
Key facts
| Trade name | Fluarix Quadrivalent |
|---|---|
| Proper name | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | BL 125127 |
| FDA product areas | Biologics |
| Recent FDA documents | July 12, 2023 Approval Letter - FLUARIX QUADRIVALENT, March 1, 2023 Approval Letter - Fluarix Quadrivalent, July 1, 2022 Approval Letter - Fluarix Quadrivalent, July 2, 2021 Approval Letter - Fluarix, July 2, 2020 Approval Letter - Fluarix Quadrivalent, March 20, 2020 Approval Letter - Fluarix Quadrivalent, July 2, 2019 - Approval Letter - Fluarix Quadrivalent, June 29, 2018 Approval Letter - Fluarix Quadrivalent, March 16, 2018 Approval Letter - Fluarix Quadrivalent, Statistical Review (STN: 125127/834) - Fluarix Quadrivalent, Clinical Review (STN: 125127/834) - Fluarix Quadrivalent, January 11, 2018 SBRA Fluarix Quadrivalent |
| FDA page updated | Jul 13, 2023 |
| FDA product page | fda.gov |
At a glance
- 10–99 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: