Product Details for: Ponlimsi

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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
Ponlimsi
Rx
Proper Name
denosumab-adet
Reference Product Proper Name
denosumab
Reference Product Properietary Name
Prolia
BLA Number
761385
Applicant
Teva Pharmaceuticals, Inc.
Original Approval Date
March 27, 2026
Date of First Licensure
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