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Wilate

von Willebrand Factor/Coagulation Factor VIII Complex (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Wilate

Proper name

von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Licence type

351(a)

BLA number

125251

Applicant

Octapharma Pharmazeutika Produktionsges.m.b.H.

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	December 20, 2010
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	December 20, 2010

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 1, 2030

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