Product Details for: Prolia

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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(a)
Prolia
Rx
002
Injection
Subcutaneous
60MG/ML
Single-Dose Vial
351(a)
Prolia
Disc
003
Injection
Subcutaneous
120MG/1.7ML (70MG/ML)
Single-Dose Vial
351(a)
Xgeva
Rx
Proper Name
denosumab
BLA Number
125320
Applicant
Amgen Inc.
Original Approval Date
June 1, 2010
Date of First Licensure
Patent List Provided
Yes
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