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Humate-P

Antihemophilic Factor/von Willebrand Factor Complex (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Humate-P

Proper name

Antihemophilic Factor/von Willebrand Factor Complex (Human)

Licence type

351(a)

BLA number

103960

Applicant

CSL Behring GmbH

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1000IU	For Injection	Intravenous	Single-Dose Vial	Rx	April 11, 2000
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	April 11, 2000
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	April 11, 2000

Source: Purple Book

Kind	Expires
Orphan exclusivity	April 1, 2006

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