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Kovaltry
Antihemophilic Factor (Recombinant), Full Length
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kovaltry
Proper name
Antihemophilic Factor (Recombinant), Full Length
Licence type
351(a)
BLA number
125574
Applicant
Bayer HealthCare LLC
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 16, 2016 |
| 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 16, 2016 |
| 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 16, 2016 |
| 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 16, 2016 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 16, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |