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Novoseven, Novoseven Rt
Coagulation Factor VIIa (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Novoseven, Novoseven Rt
Proper name
Coagulation Factor VIIa (Recombinant)
Licence type
351(a)
BLA number
103665
Applicant
Novo Nordisk Inc.
Center
CBER
Presentations
7
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | May 9, 2008 |
| 1.2MG | For Injection | Intravenous | Vial | Disc | November 15, 2000 |
| 2.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | May 9, 2008 |
| 2.4MG | For Injection | Intravenous | Single-Dose Vial | Disc | March 25, 1999 |
| 4.8MG | For Injection | Intravenous | Vial | Disc | November 15, 2000 |
| 5.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | May 9, 2008 |
| 8.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | August 6, 2010 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 2, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |