On this page

Tisseel

Fibrin Sealant (Tisseel)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Tisseel

Proper name

Fibrin Sealant (Tisseel)

Licence type

351(a)

BLA number

103980

Applicant

Baxter Healthcare Corporation

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin	For Solution	Topical	Single-Dose Vial	Rx	May 1, 1998
86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin	Solution	Topical	Pre-Filled Syringe	Rx	July 27, 2006

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