Licensed vaccine
AUDENZ
FDA-licensed vaccine · Seqirus, Inc. · STN 125692
Key facts
| Trade name | AUDENZ |
|---|---|
| Proper name | Influenza A (H5N1) Monovalent Vaccine, Adjuvanted |
| Manufacturer | Seqirus, Inc. |
| Submission tracking number (STN) | 125692 |
| Recent FDA documents | April 24, 2024 Approval Letter - AUDENZ, November 17, 2021 Approval Letter - AUDENZ, October 29, 2021 Approval Letter - AUDENZ, Demographic Subgroup Information - AUDENZ, Statistical Review - AUDENZ, Approval History, Letters, Reviews, and Related Documents - AUDENZ, January 31, 2020 Summary Basis for Regulatory Action - AUDENZ, Package Insert - AUDENZ, January 31, 2020 Approval Letter - AUDENZ |
| FDA page updated | Apr 25, 2024 |
| 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: