Product Details for: Nivestym

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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/ML
Single-Dose Vial
351(k) Biosimilar
Nivestym
Rx
002
Injection
Intravenous, Subcutaneous
480MCG/1.6ML
Single-Dose Vial
351(k) Biosimilar
Nivestym
Rx
003
Injection
Subcutaneous
300MCG/0.5ML
Pre-Filled Syringe
351(k) Biosimilar
Nivestym
Rx
004
Injection
Subcutaneous
480MCG/0.8ML
Pre-Filled Syringe
351(k) Biosimilar
Nivestym
Rx
Proper Name
filgrastim-aafi
Reference Product Proper Name
filgrastim
Reference Product Properietary Name
Neupogen
BLA Number
761080
Applicant
Hospira Inc., a Pfizer Company
Original Approval Date
July 20, 2018
Date of First Licensure
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