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Purple Book
Database of Licensed Biological Products

Product Details for: Fylnetra
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(k) BiosimilarFylnetraRx

Proper Name
pegfilgrastim-pbbk

Reference Product Proper Name

pegfilgrastim

Reference Product Proprietary Name

Neulasta

BLA Number
761084

Applicant
Kashiv BioSciences, LLC

Original Approval Date
May 26, 2022

Date of First Licensure