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Havrix

Hepatitis A Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Havrix

Proper name

Hepatitis A Vaccine

Licence type

351(a)

BLA number

103475

Applicant

GlaxoSmithKline Biologicals

Center

CBER

Presentations

4

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1440ELISA U/ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	February 22, 1995
1440ELISA U/ML	Injection	Intramuscular	Single-Dose Vial	Rx	February 22, 1995
720ELISA U/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	February 22, 1995
720ELISA U/.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	February 22, 1995

Sources for this page

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