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Koate, Koate-Dvi
Antihemophilic Factor (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Koate, Koate-Dvi
Proper name
Antihemophilic Factor (Human)
Licence type
351(a)
BLA number
101130
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 24, 1974 |
| 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 24, 1974 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | January 24, 1974 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |