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Vistaseal
Fibrin Sealant (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vistaseal
Proper name
Fibrin Sealant (Human)
Licence type
351(a)
BLA number
125640
Applicant
Instituto Grifols, S.A.
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10ML | Frozen | Topical | Pre-Filled Syringe | Rx | November 1, 2017 |
| 2ML | Frozen | Topical | Pre-Filled Syringe | Rx | November 1, 2017 |
| 4ML | Frozen | Topical | Pre-Filled Syringe | Rx | November 1, 2017 |
| 6ML | Frozen | Topical | Pre-Filled Syringe | Rx | November 1, 2017 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |