Product Details for: Fulphila
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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
Fulphila
Rx
Proper Name
pegfilgrastim-jmdb
pegfilgrastim-jmdb
Reference Product Proper Name
pegfilgrastim
pegfilgrastim
Reference Product Properietary Name
Neulasta
Neulasta
BLA Number
761075
761075
Applicant
Biocon Biologics Inc.
Biocon Biologics Inc.
Original Approval Date
June 4, 2018
June 4, 2018
Date of First Licensure