Product Details for: Conexxence

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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
Conexxence
Rx
002
Injection
Subcutaneous
120MG/1.7ML (70MG/ML)
Single-Dose Vial
351(k) Interchangeable
Bomyntra
Rx
003
Injection
Subcutaneous
120MG/1.7ML (70MG/ML)
Pre-Filled Syringe
351(k) Interchangeable
Bomyntra
Rx
Proper Name
denosumab-bnht
Reference Product Proper Name
denosumab
Reference Product Properietary Name
Prolia
BLA Number
761398
Applicant
Fresenius Kabi USA, LLC
Original Approval Date
March 25, 2025
Date of First Licensure
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