Product Details for: Stimufend Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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 | Stimufend | Rx |
Proper Name
pegfilgrastim-fpgk
Reference Product Proper Name
pegfilgrastim
Reference Product Proprietary Name
Neulasta
BLA Number
761173
Applicant
Fresenius Kabi USA, LLC
Original Approval Date
September 1, 2022
Date of First Licensure