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Infanrix

Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Infanrix

Proper name

Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

Licence type

351(a)

BLA number

103647

Applicant

GlaxoSmithKline Biologicals

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
25LF/10LF/25UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	January 29, 1997
25LF/10LF/25UG/.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	January 29, 1997

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