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Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd

Factor IX Complex

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd
Proper name
Factor IX Complex
Licence type
351(a)
BLA number
102476
Applicant
Grifols Biologicals LLC
Center
CBER
Presentations
3
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 20, 1981
1500IU For Injection Intravenous Single-Dose Vial Rx July 20, 1981
500IU For Injection Intravenous Single-Dose Vial Rx July 20, 1981

Sources for this page

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