Home Applications 761112 Application 761112
Type BLA
Sponsor ABLYNX NV Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761112 Cablivi caplacizumab-yhdp 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CABLIVI CAPLACIZUMAB-YHDP INJECTABLE;INJECTION 11MG/VIAL 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current 58468-0225 Cablivi caplacizumab Genzyme Corporation BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 84622 SUPPL 2025-12-31 84593 SUPPL 2025-12-29 80060 SUPPL 2024-11-01 80057 SUPPL 2024-10-31 78128 SUPPL 2024-04-12 78127 SUPPL 2024-04-12 78120 SUPPL 2024-04-12 70257 SUPPL 2022-02-25 65687 SUPPL 2020-12-22 65645 SUPPL 2020-12-21 58009 ORIG 2019-03-15 57590 ORIG 2019-02-13 57450 ORIG 2019-02-06