Product Details for: Artiss
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Solution
Topical
4ML
Pre-Filled Syringe
351(a)
Artiss
Rx
002
Solution
Topical
10ML
Pre-Filled Syringe
351(a)
Artiss
Rx
003
Solution
Topical
2ML
Pre-Filled Syringe
351(a)
Artiss
Rx
004
For Solution
Topical
4ML
Single-Dose Vial
351(a)
Artiss
Disc
005
For Solution
Topical
10ML
Single-Dose Vial
351(a)
Artiss
Disc
006
For Solution
Topical
2ML
Single-Dose Vial
351(a)
Artiss
Disc
Proper Name
Fibrin Sealant (Human)
Fibrin Sealant (Human)
BLA Number
125266
125266
Applicant
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Original Approval Date
March 19, 2008
March 19, 2008
Date of First Licensure