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Acthib,Omnihib

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Acthib,Omnihib

Proper name

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Licence type

351(a)

BLA number

103935

Applicant

Sanofi Winthrop Industrie

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
24UG	For Injection	Intramuscular	Single-Dose Vial	Rx	February 4, 2000

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