Product Details for: Tachosil
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Patch
Topical
4.8 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN
Tray & Lid
351(a)
Tachosil
Rx
002
Patch
Topical
9.5 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN
Tray & Lid
351(a)
Tachosil
Rx
003
Patch
Topical
3.0 CM X 2.5 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN
Tray & Lid
351(a)
Tachosil
Disc
Proper Name
Fibrin Sealant Patch
Fibrin Sealant Patch
BLA Number
125351
125351
Applicant
Corza Medical GmbH
Corza Medical GmbH
Original Approval Date
April 5, 2010
April 5, 2010
Date of First Licensure