Product Details for: Bildyos

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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
Single-Dose Vial
351(k) Interchangeable
Bildyos
Rx
002
Injection
Subcutaneous
60MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Bildyos
Rx
003
Injection
Subcutaneous
120MG/1.7ML (70MG/ML)
Single-Dose Vial
351(k) Interchangeable
Bilprevda
Rx
Proper Name
denosumab-nxxp
Reference Product Proper Name
denosumab
Reference Product Properietary Name
Prolia
BLA Number
761444
Applicant
Shanghai Henlius Biotech, Inc.
Original Approval Date
August 29, 2025
Date of First Licensure
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