General MedicationsINJECTIONStandard
UNLOXCYT
COSIBELIMAB-IPDL
Standard Dose
300MG/5ML(60MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview UNLOXCYT is listed in Drugs@FDA under application 761297 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient COSIBELIMAB-IPDL Form and strength INJECTABLE;INJECTION - 300MG/5ML(60MG/ML) Sponsor CHECKPOINT THERAPEUTICS INC Submission history Latest submission status date: 2025-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview UNLOXCYT is listed in Drugs@FDA under application 761297 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient COSIBELIMAB-IPDL Form and strength INJECTABLE;INJECTION - 300MG/5ML(60MG/ML) Sponsor CHECKPOINT THERAPEUTICS INC Submission history Latest submission status date: 2025-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.