Product Details for: Neulasta
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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(a)
Neulasta
Rx
002
Injection
Subcutaneous
6MG/0.6ML
Pre-Filled Syringe
351(a)
Neulasta Onpro
Rx
Proper Name
pegfilgrastim
pegfilgrastim
BLA Number
125031
125031
Applicant
Amgen Inc.
Amgen Inc.
Original Approval Date
January 31, 2002
January 31, 2002
Date of First Licensure