Licensed vaccine
TRUMENBA
FDA-licensed vaccine · Wyeth Pharmaceuticals, LLC, a subsidiary of Pfizer Inc. · STN 125549
Key facts
| Trade name | TRUMENBA |
|---|---|
| Proper name | Meningococcal Group B Vaccine |
| Manufacturer | Wyeth Pharmaceuticals, LLC, a subsidiary of Pfizer Inc. |
| Submission tracking number (STN) | 125549 |
| FDA product areas | Biologics |
| Recent FDA documents | June 18, 2024 Approval Letter - TRUMENBA, November 19, 2021 Approval Letter - Trumenba, March 14, 2018 Approval Letter - Trumenba, January 10, 2018 Approval Letter - Trumenba, September 26, 2017 Approval Letter - Trumenba, Approval History, Letters, Reviews, and Related Documents - TRUMENBA, March 13, 2017 Approval Letter - Trumenba, March 13, 2017 Summary Basis for Regulatory Action - Trumenba, Clinical Review of 125549/17 - TRUMENBA, Addendum to Statistical Review of STN 125549/17, Statistical Review of STN 125549/17 - TRUMENBA, Statistical Review - TRUMENBA |
| FDA page updated | Jun 20, 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: