Home Applications 761411 Application 761411
Type BLA
Sponsor INCYTE CORP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761411 Niktimvo axatilimab-csfr 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIKTIMVO axatilimab-csfr INJECTABLE;INTRAVENOUS 50 MG/ML 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 NIKTIMVO AXATILIMAB-CSFR Incyte Corporation bb6dba23-e7a6-4765-a1e6-b9e277ce0381 2026-06-24 Warnings, Adverse reactions Exact identifier application number: BLA761411
Documents# Document, Submission type, Date table Document Submission type Date 79627 ORIG 2024-09-16 79412 ORIG 2024-08-16 79398 ORIG 2024-08-14