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Monoclate, Monoclate-P

Antihemophilic Factor (Human)

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Monoclate, Monoclate-P
Proper name
Antihemophilic Factor (Human)
Licence type
351(a)
BLA number
103953
Applicant
CSL Behring LLC
Center
CBER
Presentations
4
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 Vial Disc May 14, 2003
1500IU For Injection Intravenous Vial Disc March 4, 2004
250IU For Injection Intravenous Vial Disc May 14, 2003
500IU For Injection Intravenous Vial Disc May 14, 2003

Sources for this page

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