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Eloctate
Antihemophilic Factor (Recombinant), Fc Fusion protein
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Eloctate
Proper name
Antihemophilic Factor (Recombinant), Fc Fusion protein
Licence type
351(a)
BLA number
125487
Applicant
Bioverativ Therapeutics, Inc.
Center
CBER
Presentations
10
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 27, 2017 |
| 5000IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 27, 2017 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
| 6000IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 27, 2017 |
| 750IU | For Injection | Intravenous | Single-Dose Vial | Rx | June 6, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 6, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |