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Tachosil

Fibrin Sealant Patch

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Tachosil
Proper name
Fibrin Sealant Patch
Licence type
351(a)
BLA number
125351
Applicant
Corza Medical GmbH
Center
CBER
Presentations
3
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
3.0 CM X 2.5 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN Patch Topical Tray & Lid Disc April 5, 2010
4.8 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN Patch Topical Tray & Lid Rx April 5, 2010
9.5 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN Patch Topical Tray & Lid Rx April 5, 2010

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity