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Evarrest
Fibrin Sealant Patch
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Evarrest
Proper name
Fibrin Sealant Patch
Licence type
351(a)
BLA number
125392
Applicant
Ethicon, Inc.
Center
CBER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 50.3MG FIBRINOGEN&203.2IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | December 5, 2012 |
| 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 2x4 IN | Patch | Topical | Pouch | Rx | May 27, 2014 |
| 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | May 16, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |