Home Applications 761027 Application 761027
Type BLA
Sponsor ACCORD BIOPHARMA INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761027 Filkri filgrastim-laha 351(k) Biosimilar Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FILKRI FILGRASTIM-LAHA INJECTABLE;INJECTION 300MCG/0.5ML No No 002 FILKRI FILGRASTIM-LAHA INJECTABLE;INJECTION 480MCG/0.8ML 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FILKRI FILGRASTIM-LAHA Accord BioPharma Inc., 9c2f9573-08fd-43be-a489-8a5e5d8ab2ff 2026-07-10 Warnings, Adverse reactions Exact identifier application number: BLA761027
Documents# Document, Submission type, Date table Document Submission type Date 84806 ORIG 2026-01-21 84779 ORIG 2026-01-20