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Fesilty
fibrinogen, humanchmt
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Fesilty
Proper name
fibrinogen, humanchmt
Licence type
351(a)
BLA number
125833
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | December 16, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |