Product Details for: Fylnetra 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 | Fylnetra | Rx |
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