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 Label Grayed out Product Label links indicate that there is no product label available for the product.
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(k) Biosimilar | Udenyca | Rx |
002 | Injection | Subcutaneous | 6MG/0.6ML | Autoinjector | 351(k) Biosimilar | Udenyca | Rx |
003 | Injection | Subcutaneous | 6MG/0.6ML | Pre-Filled Syringe | 351(k) Biosimilar | Udenyca Onbody | Rx |
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