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Bioclate (Armour), Recombinate

Antihemophilic Factor (Recombinant)

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Bioclate (Armour), Recombinate
Proper name
Antihemophilic Factor (Recombinant)
Licence type
351(a)
BLA number
103375
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
5
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 December 10, 1992
1500IU For Injection Intravenous Single-Dose Vial Rx March 10, 2010
2000IU For Injection Intravenous Single-Dose Vial Rx March 10, 2010
250IU For Injection Intravenous Single-Dose Vial Rx December 10, 1992
500IU For Injection Intravenous Single-Dose Vial Rx December 10, 1992

Sources for this page

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