OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Advate

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Advate
Proper name
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Licence type
351(a)
BLA number
125063
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 July 25, 2003
1500IU For Injection Intravenous Single-Dose Vial Rx July 25, 2003
2000IU For Injection Intravenous Single-Dose Vial Rx April 12, 2006
250IU For Injection Intravenous Single-Dose Vial Rx July 25, 2003
3000IU For Injection Intravenous Single-Dose Vial Rx July 3, 2007
4,000IU For Injection Intravenous Single-Dose Vial Rx July 12, 2012
500IU For Injection Intravenous Single-Dose Vial Rx July 25, 2003

Sources for this page

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