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 | 2026-09-01 |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |