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Comvax

Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Comvax

Proper name

Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine

Licence type

351(a)

BLA number

103623

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 PRP/125UG OMPC/5UG HBsAg	Injection	Intramuscular	Vial	Disc	October 2, 1996

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