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Xyntha, Xyntha Solofuse
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Xyntha, Xyntha Solofuse
Proper name
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Licence type
351(a)
BLA number
125264
Applicant
Wyeth Pharmaceuticals LLC
Center
CBER
Presentations
9
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | February 21, 2008 |
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 21, 2008 |
| 2000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | February 21, 2008 |
| 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 21, 2008 |
| 250IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | February 21, 2008 |
| 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 21, 2008 |
| 3000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | August 6, 2010 |
| 500IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | February 21, 2008 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | February 21, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |