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Application 761112
- Type
- BLA
- Sponsor
- ABLYNX NV
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CABLIVI | CAPLACIZUMAB-YHDP | INJECTABLE;INJECTION | 11MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
| 58468-0225 | Cablivi | caplacizumab | Genzyme Corporation | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84622 | SUPPL | 2025-12-31 |
| 84593 | SUPPL | 2025-12-29 |
| 80060 | SUPPL | 2024-11-01 |
| 80057 | SUPPL | 2024-10-31 |
| 78128 | SUPPL | 2024-04-12 |
| 78127 | SUPPL | 2024-04-12 |
| 78120 | SUPPL | 2024-04-12 |
| 70257 | SUPPL | 2022-02-25 |
| 65687 | SUPPL | 2020-12-22 |
| 65645 | SUPPL | 2020-12-21 |
| 58009 | ORIG | 2019-03-15 |
| 57590 | ORIG | 2019-02-13 |
| 57450 | ORIG | 2019-02-06 |