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Ceprotin
Protein C Concentrate (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ceprotin
Proper name
Protein C Concentrate (Human)
Licence type
351(a)
BLA number
125234
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
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 | March 30, 2007 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 30, 2007 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 30, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |