Licensed vaccine
Gardasil 9
FDA-licensed vaccine
Key facts
| Trade name | Gardasil 9 |
|---|---|
| Proper name | Human Papillomavirus 9-valent Vaccine, Recombinant |
| FDA product areas | Biologics |
| Recent FDA documents | March 14, 2024 Approval Letter - GARDASIL 9, April 28, 2023 Approval Letter - GARDASIL 9, August 20, 2020 Approval Letter - GARDASIL 9, June 9, 2020 Clinical Review - GARDASIL 9, June 12, 2020 Approval Letter - GARDASIL 9, February 20, 2020 Approval Letter - GARDASIL 9, October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9, October 5, 2018 Approval Letter - GARDASIL 9, February 9, 2018 Approval Letter - GARDASIL 9, Approval History, Letters, Reviews, and Related Documents - GARDASIL 9, Statistical Review - GARDASIL 9, Clinical Review - GARDASIL 9 |
| FDA page updated | Mar 15, 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: