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Obizur

Antihemophilic Factor (Recombinant), Porcine Sequence

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Obizur

Proper name

Antihemophilic Factor (Recombinant), Porcine Sequence

Licence type

351(a)

BLA number

125512

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

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
500U	For Injection	Intravenous	Single-Dose Vial	Rx	October 23, 2014

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 23, 2021

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