Product Details for: Udenyca

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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
Udenyca
Rx
002
Injection
Subcutaneous
6MG/0.6ML
Autoinjector
351(k) Biosimilar
Udenyca
Rx
003
Injection
Subcutaneous
6MG/0.6ML
Pre-Filled Syringe
351(k) Biosimilar
Udenyca Onbody
Rx
Proper Name
pegfilgrastim-cbqv
Reference Product Proper Name
pegfilgrastim
Reference Product Properietary Name
Neulasta
BLA Number
761039
Applicant
Accord BioPharma Inc.
Original Approval Date
November 2, 2018
Date of First Licensure
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