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Purple Book
Database of Licensed Biological Products

Product Details for: Ziextenzo
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) BiosimilarZiextenzoRx

Proper Name
pegfilgrastim-bmez

Reference Product Proper Name

pegfilgrastim

Reference Product Proprietary Name

Neulasta

BLA Number
761045

Applicant
Sandoz Inc.

Original Approval Date
November 4, 2019

Date of First Licensure