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Heplisav-B

Hepatitis B Vaccine (Recombinant), Adjuvanted

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Heplisav-B

Proper name

Hepatitis B Vaccine (Recombinant), Adjuvanted

Licence type

351(a)

BLA number

125428

Applicant

Dynavax Technologies Corporation

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
20UG/.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	November 9, 2017

Purple Book	FDA	Licence type, presentations, reference product, exclusivity