Product Details for: Nyvepria 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 | Nyvepria | Rx |
Proper Name
pegfilgrastim-apgf
Reference Product Proper Name
pegfilgrastim
Reference Product Proprietary Name
Neulasta
BLA Number
761111
Applicant
Hospira Inc., a Pfizer Company
Original Approval Date
June 10, 2020
Date of First Licensure