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 2026-08-01
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# 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 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