Licensed vaccine
VAXNEUVANCE
FDA-licensed vaccine · Merck Sharp & Dohme LLC · STN 125741
Key facts
| Trade name | VAXNEUVANCE |
|---|---|
| Proper name | Pneumococcal 15-valent Conjugate Vaccine |
| Manufacturer | Merck Sharp & Dohme LLC |
| Submission tracking number (STN) | 125741 |
| Recent FDA documents | May 25, 2023 Approval Letter - VAXNEUVANCE, Statistical Review (STN 125741/6) - VAXNEUVANCE, June 17, 2022 Clinical Review (STN 125741/6) - VAXNEUVANCE, June 17, 2022 Approval Letter - VAXNEUVANCE, July 16, 2021 Summary Basis for Regulatory Action - VAXNEUVANCE, Approval History, Letters, Reviews, and Related Documents - VAXNEUVANCE, Demographic Subgroup Information – Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), July 16, 2021 Approval Letter - VAXNEUVANCE, Package Insert - VAXNEUVANCE, Patient Information - VAXNEUVANCE |
| FDA page updated | Jul 22, 2022 |
| 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: