Home Applications 761108 Application 761108
Type BLA
Sponsor ALEXION PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761108 Ultomiris ravulizumab-cwvz 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ULTOMIRIS RAVULIZUMAB-CWVZ INJECTABLE;INJECTION 300MG/30ML(10MG/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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-022 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-025 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current 25682-028 Ultomiris ravulizumab Alexion Pharmaceuticals Inc. BLA Current