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Purple Book
Database of Licensed Biological Products

Product Details for: Neulasta, Neulasta Onpro
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous6MG/0.6MLPre-Filled Syringe351(a)NeulastaRx
002Injection Subcutaneous6MG/0.6MLPre-Filled Syringe351(a)Neulasta OnproRx

Proper Name
pegfilgrastim

BLA Number
125031

Applicant
Amgen Inc.

Original Approval Date
January 31, 2002

Date of First Licensure

Patent List Provided
Yes