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Cablivi
caplacizumab-yhdp
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Cablivi
Proper name
caplacizumab-yhdp
Licence type
351(a)
BLA number
761112
Applicant
Ablynx NV
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 11MG | For injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | February 6, 2019 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 6, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |