Skip to content

On this page

Crosseal, Evicel

Fibrin Sealant (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Crosseal, Evicel

Proper name

Fibrin Sealant (Human)

Licence type

351(a)

BLA number

125010

Applicant

Omrix Biopharmaceuticals Ltd

Center

CBER

Presentations

3

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
1ML	Spray	Topical	Single-Dose Vial	Disc	March 21, 2003
2ML	Spray	Topical	Single-Dose Vial	Disc	March 21, 2003
5ML	Spray	Topical	Single-Dose Vial	Disc	March 21, 2003

Sources for this page

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