Product Details for: Evarrest
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Patch
Topical
50.3MG FIBRINOGEN&203.2IU THROMBIN/IN^2; 4x4 IN
Pouch
351(a)
Evarrest
Disc
002
Patch
Topical
55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 4x4 IN
Pouch
351(a)
Evarrest
Disc
003
Patch
Topical
55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 2x4 IN
Pouch
351(a)
Evarrest
Rx
Proper Name
Fibrin Sealant Patch
Fibrin Sealant Patch
BLA Number
125392
125392
Applicant
Ethicon, Inc.
Ethicon, Inc.
Original Approval Date
December 5, 2012
December 5, 2012
Date of First Licensure