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Artiss

Fibrin Sealant (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Artiss

Proper name

Fibrin Sealant (Human)

Licence type

351(a)

BLA number

125266

Applicant

Baxter Healthcare Corporation

Center

CBER

Presentations

6

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
10ML	Solution	Topical	Pre-Filled Syringe	Rx	March 19, 2008
10ML	For Solution	Topical	Single-Dose Vial	Disc	March 19, 2008
2ML	Solution	Topical	Pre-Filled Syringe	Rx	March 19, 2008
2ML	For Solution	Topical	Single-Dose Vial	Disc	March 19, 2008
4ML	Solution	Topical	Pre-Filled Syringe	Rx	March 19, 2008
4ML	For Solution	Topical	Single-Dose Vial	Disc	March 19, 2008

Sources for this page

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