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Adynovate

Antihemophilic Factor (Recombinant), PEGylated

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Adynovate
Proper name
Antihemophilic Factor (Recombinant), PEGylated
Licence type
351(a)
BLA number
125566
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
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 November 13, 2015
1500IU For Injection Intravenous Single-Dose Vial Rx October 25, 2016
2000IU For Injection Intravenous Single-Dose Vial Rx November 13, 2015
250IU For Injection Intravenous Single-Dose Vial Rx November 13, 2015
3000IU For Injection Intravenous Single-Dose Vial Rx March 13, 2017
500IU For Injection Intravenous Single-Dose Vial Rx November 13, 2015
750IU For Injection Intravenous Single-Dose Vial Rx October 25, 2016

Sources for this page

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