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Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

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Proper name

Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Licence type

351(a)

BLA number

103905

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/VIAL	Injection	Intramuscular	Pre-Filled Syringe	Rx	February 17, 2000

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