Licensed vaccine
ERVEBO
FDA-licensed vaccine · Merck Sharp & Dohme LLC · STN 125690
Key facts
| Trade name | ERVEBO |
|---|---|
| Proper name | Ebola Zaire Vaccine, Live |
| Manufacturer | Merck Sharp & Dohme LLC |
| Submission tracking number (STN) | 125690 |
| Recent FDA documents | July 27, 2023 Clinical Review Memo - ERVEBO, Statistical Review and Evaluation - ERVEBO, July 27, 2023 Approval Letter - ERVEBO, September 16, 2022 Approval Letter - ERVEBO, Approval History, Letters, Reviews, and Related Documents - ERVEBO, Statistical Review - ERVEBO, Demographic Subgroup Information – ERVEBO (Ebola Zaire Vaccine, Live), December 19, 2019 Summary Basis for Regulatory Action - ERVEBO, Patient Information - ERVEBO, December 19, 2019 Approval Letter - ERVEBO, Package Insert - ERVEBO |
| FDA page updated | Aug 9, 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: