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Prehevbrio
Hepatitis B Vaccine (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Prehevbrio
Proper name
Hepatitis B Vaccine (Recombinant)
Licence type
351(a)
BLA number
125737
Applicant
VBI Vaccines (Delaware), Inc.
Center
CBER
Presentations
1
First licensure
November 30, 2021
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10UG/ML | For Injection | Intramuscular | Single-Dose Vial | Disc | November 30, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |