U.S. flag

An official website of the United States government

Purple Book
Database of Licensed Biological Products

Product Details for: Fulphila
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous6MG/0.6MLPre-Filled Syringe351(k) BiosimilarFulphilaRx

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