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Kcentra
Prothrombin Complex Concentrate (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kcentra
Proper name
Prothrombin Complex Concentrate (Human)
Licence type
351(a)
BLA number
125421
Applicant
CSL Behring GmbH
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | November 26, 2013 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | April 29, 2013 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 13, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |