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Purple Book
Database of Licensed Biological Products

Product Details for: Udenyca, Udenyca Onbody
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) BiosimilarUdenycaRx
002Injection Subcutaneous6MG/0.6MLAutoinjector351(k) BiosimilarUdenycaRx
003Injection Subcutaneous6MG/0.6MLPre-Filled Syringe351(k) BiosimilarUdenyca OnbodyRx

Proper Name
pegfilgrastim-cbqv

Reference Product Proper Name

pegfilgrastim

Reference Product Proprietary Name

Neulasta

BLA Number
761039

Applicant
Coherus BioSciences, Inc.

Original Approval Date
November 2, 2018

Date of First Licensure