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Alphanate

Antihemophilic Factor/von Willebrand Factor Complex (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Alphanate

Proper name

Antihemophilic Factor/von Willebrand Factor Complex (Human)

Licence type

351(a)

BLA number

102475

Applicant

Grifols Biologicals LLC

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
1000IU	For Injection	Intravenous	Single-Dose Vial	Rx	August 15, 1978
1500IU	For Injection	Intravenous	Single-Dose Vial	Rx	August 15, 1978
2000IU	For Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2014
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	August 15, 1978
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	August 15, 1978

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 31, 2014

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