Home Applications 761309 Application 761309
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 761309 Columvi glofitamab-gxbm 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COLUMVI GLOFITAMAB-GXBM INJECTABLE;INJECTION 2.5MG/2.5ML(1MG/ML) No No 002 COLUMVI GLOFITAMAB-GXBM INJECTABLE;INJECTION 10MG/10ML(1MG/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 Columvi GLOFITAMAB Genentech, Inc. 3516e753-f064-4d30-9bd5-e3f2e143f75d 2026-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761309
Documents# Document, Submission type, Date table Document Submission type Date 83961 SUPPL 2025-10-28 83940 SUPPL 2025-10-28 82530 SUPPL 2025-06-10 82529 SUPPL 2025-06-10 75002 ORIG 2023-07-18 74773 ORIG 2023-07-18 74501 ORIG 2023-06-16