APPLICATION
BLA761439
TYPE
BLA
ORIGINAL APPROVAL
2025-09-26
LATEST ACTION
2025-10-29
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ENOBYPrescription
DENOSUMAB-QBDE 60MG/ML · SOLUTION · INJECTION
XTRENBOPrescription
DENOSUMAB-QBDE 120MG/1.7ML(70MG/ML) · SOLUTION · INJECTION
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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