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Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Prevnar 13

Proper name

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Licence type

351(a)

BLA number

125324

Applicant

Wyeth Pharmaceuticals 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
0.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	February 24, 2010

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