Product Details for: Zarxio

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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/0.5ML
Pre-Filled Syringe
351(k) Biosimilar
Zarxio
Rx
002
Injection
Intravenous, Subcutaneous
480MCG/0.8ML
Pre-Filled Syringe
351(k) Biosimilar
Zarxio
Rx
003
Injection
Intravenous, Subcutaneous
300MCG/ML
Single-Dose Vial
351(k) Biosimilar
Zarxio
Disc
004
Injection
Intravenous, Subcutaneous
480MCG/1.6ML (300MCG/ML)
Single-Dose Vial
351(k) Biosimilar
Zarxio
Disc
Proper Name
filgrastim-sndz
Reference Product Proper Name
filgrastim
Reference Product Properietary Name
Neupogen
BLA Number
125553
Applicant
Sandoz Inc.
Original Approval Date
March 6, 2015
Date of First Licensure
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