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Alphanine, Alphanine Hp, Alphanine Sd
Coagulation Factor IX (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Alphanine, Alphanine Hp, Alphanine Sd
Proper name
Coagulation Factor IX (Human)
Licence type
351(a)
BLA number
103249
Applicant
Grifols Biologicals LLC
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | Injection | Intravenous | Single-Dose Vial | Rx | December 31, 1990 |
| 1500IU | Injection | Intravenous | Single-Dose Vial | Rx | December 31, 1990 |
| 250IU | Injection | Intravenous | Single-Dose Vial | Disc | December 31, 1990 |
| 500IU | Injection | Intravenous | Single-Dose Vial | Rx | December 31, 1990 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 31, 1997 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |