Home Applications 761388 Application 761388
Type BLA
Sponsor GENENTECH INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761388 Piasky crovalimab-akkz 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PIASKY CROVALIMAB-AKKZ INJECTABLE;INTRAVENOUS 340MG/2ML(170MG/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 Piasky CROVALIMAB Genentech, Inc. 2597efc2-a97b-487c-b500-a67fd282a73b 2025-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761388
Documents# Document, Submission type, Date table Document Submission type Date 82308 SUPPL 2025-05-23 79255 ORIG 2024-07-30 78868 ORIG 2024-06-24 78867 ORIG 2024-06-24 78866 ORIG 2024-06-24