Product Details for: Tisseel
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Solution
Topical
86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin
Single-Dose Vial
351(a)
Tisseel
Rx
002
Solution
Topical
86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin
Pre-Filled Syringe
351(a)
Tisseel
Rx
Proper Name
Fibrin Sealant (Tisseel)
Fibrin Sealant (Tisseel)
BLA Number
103980
103980
Applicant
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Original Approval Date
May 1, 1998
May 1, 1998
Date of First Licensure