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Hiberix

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Hiberix

Proper name

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Licence type

351(a)

BLA number

125347

Applicant

GlaxoSmithKline Biologicals

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
10UG/25UG	For Injection	Intramuscular	Single-Dose Vial	Rx	August 19, 2009

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