Home Applications 761075 Application 761075
Type BLA
Sponsor MYLAN GMBH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761075 Fulphila pegfilgrastim-jmdb 351(k) Biosimilar Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FULPHILA PEGFILGRASTIM-JMDB INJECTABLE;INJECTION 6MG/0.6ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fulphila PEGFILGRASTIM-JMDB Biocon Biologics Inc. 9bfc4d3e-6120-7fec-f1d6-0b3743752034 2026-01-30 Warnings, Adverse reactions Exact identifier application number: BLA761075
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current 67457-833 Fulphila pegfilgrastim Mylan Institutional LLC BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 75842 SUPPL 2023-10-19 75778 SUPPL 2023-10-16 66848 SUPPL 2021-03-24 66811 SUPPL 2021-03-19 58932 SUPPL 2019-06-04 58894 SUPPL 2019-05-30 58071 SUPPL 2019-03-25 58061 SUPPL 2019-03-22 56169 ORIG 2018-10-30 54435 ORIG 2018-06-04 54434 ORIG 2018-06-04