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Vonvendi

von Willebrand factor (Recombinant)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vonvendi

Proper name

von Willebrand factor (Recombinant)

Licence type

351(a)

BLA number

125577

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
1300IU	For Injection	Intravenous	Single-Dose Vial	Rx	December 8, 2015
650IU	For Injection	Intravenous	Single-Dose Vial	Rx	December 8, 2015

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 5, 1932

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