Product Details for: Boncresa
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
60MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Boncresa
Rx
Proper Name
denosumab-mobz
denosumab-mobz
Reference Product Proper Name
denosumab
denosumab
Reference Product Properietary Name
Prolia
Prolia
BLA Number
761456
761456
Applicant
Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC
Original Approval Date
December 19, 2025
December 19, 2025
Date of First Licensure