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Xgeva
denosumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Xgeva
Proper name
denosumab
Licence type
351(a)
BLA number
125320
Applicant
Amgen Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | November 18, 2010 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 5, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |