Licensed vaccine
PREHEVBRIO
FDA-licensed vaccine · VBI Vaccines (Delaware) Inc. · STN 125737
Key facts
| Trade name | PREHEVBRIO |
|---|---|
| Proper name | Hepatitis B Vaccine (Recombinant) |
| Manufacturer | VBI Vaccines (Delaware) Inc. |
| Submission tracking number (STN) | 125737 |
| Recent FDA documents | Approval History, Letters, Reviews, and Related Documents - PREHEVBRIO, Demographic Subgroup Information – Hepatitis B Vaccine (Recombinant) - PREHEVBRIO, November 30, 2021 Summary Basis for Regulatory Action - PREHEVBRIO, Package Insert - PREHEVBRIO, November 30, 2021 Approval Letter - PREHEVBRIO |
| FDA page updated | Nov 29, 2024 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- None Supporting documents
- None 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: