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Pedvaxhib

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Pedvaxhib

Proper name

Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

Licence type

351(a)

BLA number

103237

Applicant

Merck Sharp & Dohme LLC

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
7.5UG/.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	December 20, 1989

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