APPLICATION
BLA761436
TYPE
BLA
ORIGINAL APPROVAL
2025-09-16
LATEST ACTION
2025-10-29
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AUKELSOPrescription
DENOSUMAB-KYQQ 120MG/1.7ML(70MG/ML) · INJECTABLE · INJECTION
BOSAYAPrescription
DENOSUMAB-KYQQ 60MG/ML · INJECTABLE · 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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