Licensed vaccine
CAPVAXIVE
FDA-licensed vaccine · Merck Sharp & Dohme LLC · STN 125814
Key facts
| Trade name | CAPVAXIVE |
|---|---|
| Proper name | Pneumococcal 21-valent Conjugate Vaccine |
| Manufacturer | Merck Sharp & Dohme LLC |
| Submission tracking number (STN) | 125814 |
| Recent FDA documents | Approval History, Letters, Reviews, and Related Documents - CAPVAXIVE, June 17, 2024 Summary Basis for Regulatory Action - CAPVAXIVE, Patient Information - CAPVAXIVE, June 17, 2024 Approval Letter - CAPVAXIVE, Package Insert - CAPVAXIVE |
| FDA page updated | Jul 17, 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: