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Vaxelis

Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vaxelis

Proper name

Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine

Licence type

351(a)

BLA number

125563

Applicant

MSP Vaccine Company

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	Single-Dose Vial	Rx	December 21, 2018
0.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	September 25, 2020

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