Home Applications 020744 Application 020744
Type BLA
Sponsor CHIESI USA INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020744 Curosurf poractant alfa 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CUROSURF PORACTANT ALFA SUSPENSION;INTRATRACHEAL 80MG/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 · 1 matching rows.
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 10122-510 Curosurf poractant alfa Chiesi USA, Inc. BLA Current 10122-510 Curosurf poractant alfa Chiesi USA, Inc. NDA Current 10122-510 Curosurf poractant alfa Chiesi USA, Inc. NDA Current 10122-510 Curosurf poractant alfa Chiesi USA, Inc. BLA Current 10122-510 Curosurf poractant alfa Chiesi USA, Inc. NDA Current 10122-510 Curosurf poractant alfa Chiesi USA, Inc. BLA Current