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Prolia

denosumab

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Prolia
Proper name
denosumab
Licence type
351(a)
BLA number
125320
Applicant
Amgen Inc.
Center
CDER
Presentations
2
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
60MG/ML Injection Subcutaneous Pre-Filled Syringe Rx June 1, 2010
60MG/ML Injection Subcutaneous Single-Dose Vial Disc June 1, 2010

Sources for this page

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