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Afstyla

Antihemophilic Factor (Recombinant), Single Chain

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Afstyla
Proper name
Antihemophilic Factor (Recombinant), Single Chain
Licence type
351(a)
BLA number
125591
Applicant
CSL Behring Lengnau AG
Center
CBER
Presentations
7
First licensure
—

Presentations

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 May 25, 2016
1500IU For Injection Intravenous Single-Dose Vial Rx March 31, 2017
2000IU For Injection Intravenous Single-Dose Vial Rx May 25, 2016
2500IU For Injection Intravenous Single-Dose Vial Rx March 31, 2017
250IU For Injection Intravenous Single-Dose Vial Rx May 25, 2016
3000IU For Injection Intravenous Single-Dose Vial Rx May 25, 2016
500IU For Injection Intravenous Single-Dose Vial Rx May 25, 2016

Sources for this page

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