APPLICATION
BLA761392
TYPE
BLA
ORIGINAL APPROVAL
2025-02-13
LATEST ACTION
2025-10-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DENOSUMAB-DSSBPrescription
DENOSUMAB-DSSB 60MG/ML · INJECTABLE · SUBCUTANEOUS
OSPOMYVPrescription
DENOSUMAB-DSSB 60MG/ML · INJECTABLE · SUBCUTANEOUS
DENOSUMAB-DSSBPrescription
DENOSUMAB-DSSB 70MG/ML · INJECTABLE · SUBCUTANEOUS
XBRYKPrescription
DENOSUMAB-DSSB 70MG/ML · INJECTABLE · SUBCUTANEOUS
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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