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Benefix
Coagulation Factor IX (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Benefix
Proper name
Coagulation Factor IX (Recombinant)
Licence type
351(a)
BLA number
103677
Applicant
Wyeth Pharmaceuticals LLC
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | February 11, 1997 |
| 2000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | March 21, 2007 |
| 250IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | February 11, 1997 |
| 3000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | November 23, 2011 |
| 500IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | February 11, 1997 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 11, 2004 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |