Product Details for: Releuko

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
300MCG/ML
Single-Dose Vial
351(k) Biosimilar
Releuko
Rx
002
Injection
Intravenous, Subcutaneous
480MCG/1.6ML
Single-Dose Vial
351(k) Biosimilar
Releuko
Rx
003
Injection
Subcutaneous
300MCG/0.5ML
Pre-Filled Syringe
351(k) Biosimilar
Releuko
Rx
004
Injection
Subcutaneous
480MCG/0.8ML
Pre-Filled Syringe
351(k) Biosimilar
Releuko
Rx
Proper Name
filgrastim-ayow
Reference Product Proper Name
filgrastim
Reference Product Properietary Name
Neupogen
BLA Number
761082
Applicant
Kashiv BioSciences, LLC
Original Approval Date
February 25, 2022
Date of First Licensure
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