Product Details for: Vistaseal
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Frozen
Topical
10ML
Pre-Filled Syringe
351(a)
Vistaseal
Rx
002
Frozen
Topical
2ML
Pre-Filled Syringe
351(a)
Vistaseal
Rx
003
Frozen
Topical
4ML
Pre-Filled Syringe
351(a)
Vistaseal
Rx
004
Frozen
Topical
6ML
Pre-Filled Syringe
351(a)
Vistaseal
Rx
Proper Name
Fibrin Sealant (Human)
Fibrin Sealant (Human)
BLA Number
125640
125640
Applicant
Instituto Grifols, S.A.
Instituto Grifols, S.A.
Original Approval Date
November 1, 2017
November 1, 2017
Date of First Licensure