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