Application 761432
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761432 | Enflonsia | clesrovimab-cfor | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENFLONSIA | CLESROVIMAB-CFOR | INJECTION;SOLUTION | 105MG/0.7ML | 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 |
|---|
| 82880 | ORIG | 2025-07-16 |
| 82520 | ORIG | 2025-06-10 |
| 82516 | ORIG | 2025-06-10 |