Home Applications 761297 Application 761297
Type BLA
Sponsor CHECKPOINT THERAPEUTICS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761297 Unloxcyt cosibelimab-ipdl 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UNLOXCYT COSIBELIMAB-IPDL INJECTABLE;INJECTION 300MG/5ML(60MG/ML) No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 UNLOXCYT COSIBELIMAB Sun Pharmaceutical Industries, Inc. 06bdadd5-d2db-406f-a3f8-de47f48a52e3 2025-12-08 Warnings, Adverse reactions Exact identifier application number: BLA761297
Documents# Document, Submission type, Date table Document Submission type Date 84294 SUPPL 2025-11-25 84282 SUPPL 2025-11-24 80830 ORIG 2025-01-10 80592 ORIG 2024-12-16 80576 ORIG 2024-12-16