Licensed vaccine
Prevnar 13
FDA-licensed vaccine · Wyeth Pharmaceuticals, Inc · STN 125324
Key facts
| Trade name | Prevnar 13 |
|---|---|
| Proper name | Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein) |
| Manufacturer | Wyeth Pharmaceuticals, Inc |
| Submission tracking number (STN) | 125324 |
| FDA product areas | Biologics |
| Recent FDA documents | Package Insert - Prevnar 13, Approval History, Letters, Reviews, and Related Documents - Prevnar 13, August 22, 2017 Approval Letter - Prevnar 13, March 24, 2017 Summary Basis for Regulatory Action - Prevnar 13, March 24, 2017 Approval Letter - Prevnar 13, Supporting Documents older than three years - Prevnar 13 |
| FDA page updated | Dec 11, 2019 |
| 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: