Product Details for: Nypozi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
300MCG/0.5ML
Pre-Filled Syringe
351(k) Biosimilar
Nypozi
Rx
002
Injection
Intravenous, Subcutaneous
480MCG/0.8ML
Pre-Filled Syringe
351(k) Biosimilar
Nypozi
Rx
Proper Name
filgrastim-txid
Reference Product Proper Name
filgrastim
Reference Product Properietary Name
Neupogen
BLA Number
761126
Applicant
Tanvex BioPharma USA, Inc.
Original Approval Date
June 28, 2024
Date of First Licensure
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