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Fibryga
Fibrinogen (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Fibryga
Proper name
Fibrinogen (Human)
Licence type
351(a)
BLA number
125612
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1G | For Injection | Intravenous | Single-Use Bottle | Rx | June 7, 2017 |
| 2G | For Injection | Intravenous | Single-Use Bottle | Rx | June 23, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |