Licensed vaccine
PENBRAYA
FDA-licensed vaccine · Pfizer Ireland Pharmaceuticals · STN 125770
Key facts
| Trade name | PENBRAYA |
|---|---|
| Proper name | Meningococcal Groups A, B, C, W, and Y Vaccine |
| Manufacturer | Pfizer Ireland Pharmaceuticals |
| Submission tracking number (STN) | 125770 |
| Recent FDA documents | November 21, 2024 Approval Letter - PENBRAYA, September 9, 2024 Approval Letter - PENBRAYA, November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA, Demographic Subgroup Information - Meningococcal Groups A, B, C, W, and Y Vaccine (PENBRAYA), Approval History, Letters, Reviews, and Related Documents – PENBRAYA, October 20, 2023 Approval Letter - PENBRAYA, Package Insert - PENBRAYA |
| FDA page updated | Nov 21, 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: