Product Details for: Fylnetra
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
6MG/0.6ML
Pre-Filled Syringe
351(k) Biosimilar
Fylnetra
Rx
Proper Name
pegfilgrastim-pbbk
pegfilgrastim-pbbk
Reference Product Proper Name
pegfilgrastim
pegfilgrastim
Reference Product Properietary Name
Neulasta
Neulasta
BLA Number
761084
761084
Applicant
Kashiv BioSciences, LLC
Kashiv BioSciences, LLC
Original Approval Date
May 26, 2022
May 26, 2022
Date of First Licensure