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Riastap
Fibrinogen Concentrate (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Riastap
Proper name
Fibrinogen Concentrate (Human)
Licence type
351(a)
BLA number
125317
Applicant
CSL Behring GmbH
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1800-2600MG | For Injection | Intravenous | Single-Dose Vial | Rx | December 19, 2025 |
| 900-1300MG | For Injection | Intravenous | Single-Dose Vial | Rx | January 16, 2009 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | January 16, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |