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Tretten
Coagulation Factor XIII A-Subunit (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tretten
Proper name
Coagulation Factor XIII A-Subunit (Recombinant)
Licence type
351(a)
BLA number
125398
Applicant
Novo Nordisk Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2000 - 3125IU | For Injection | Intravenous | Single-Dose Vial | Rx | December 23, 2013 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 23, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |