Licensed vaccine
Prevnar 20
FDA-licensed vaccine · Wyeth Pharmaceuticals LLC · STN 125731
Key facts
| Trade name | Prevnar 20 |
|---|---|
| Proper name | Pneumococcal 20-valent Conjugate Vaccine |
| Manufacturer | Wyeth Pharmaceuticals LLC |
| Submission tracking number (STN) | 125731 |
| FDA product areas | Biologics |
| Recent FDA documents | April 27, 2023 Statistical Review - Prevnar20, April 27, 2023 Clinical Review - Prevnar20, April 27, 2023 Approval Letter - PREVNAR 20, September 30, 2022 Approval Letter - PREVNAR 20, Approval History, Letters, Reviews and Related Documents - PREVNAR 20, Demographic Subgroup Information - PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine), June 8, 2021 Summary Basis for Regulatory Action - PREVNAR 20, June 10, 2021 Approval Letter - PREVNAR 20, Package Insert - PREVNAR 20 |
| FDA page updated | Jun 2, 2023 |
| 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: