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Helixate Fs, Kogenate, Kogenate Fs

Antihemophilic Factor (Recombinant)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Helixate Fs, Kogenate, Kogenate Fs

Proper name

Antihemophilic Factor (Recombinant)

Licence type

351(a)

BLA number

103332

Applicant

Bayer HealthCare 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	Disc	August 20, 2002
2000IU	For Injection	Intravenous	Single-Dose Vial	Disc	June 7, 2007
250IU	For Injection	Intravenous	Single-Dose Vial	Disc	August 20, 2002
3000IU	For Injection	Intravenous	Single-Dose Vial	Disc	July 31, 2009
500IU	For Injection	Intravenous	Single-Dose Vial	Disc	August 20, 2002

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 25, 2000

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