Home Applications 761128 Application 761128
Type BLA
Sponsor NOVARTIS PHARMS CORP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761128 Adakveo crizanlizumab-tmca 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADAKVEO CRIZANLIZUMAB-TMCA INJECTABLE; INJECTION 100MG/10ML 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ADAKVEO CRIZANLIZUMAB Novartis Pharmaceuticals Corporation b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6 2026-06-04 Warnings, Adverse reactions Exact identifier application number: BLA761128 ndc (product): 0078-0883
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0883 ADAKVEO crizanlizumab Novartis Pharmaceuticals Corporation BLA Current 0078-0883 ADAKVEO crizanlizumab Novartis Pharmaceuticals Corporation BLA Current 0078-0883 ADAKVEO crizanlizumab Novartis Pharmaceuticals Corporation BLA Current 0078-0883 ADAKVEO crizanlizumab Novartis Pharmaceuticals Corporation BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 78972 SUPPL 2024-07-02 78909 SUPPL 2024-06-28 72058 SUPPL 2022-09-10 72054 SUPPL 2022-09-09 68086 SUPPL 2021-07-14 68079 SUPPL 2021-07-14 61294 ORIG 2019-12-17 60957 ORIG 2019-11-19 60858 ORIG 2019-11-15