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Raplixa

Fibrin Sealant (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Raplixa

Proper name

Fibrin Sealant (Human)

Licence type

351(a)

BLA number

125523

Applicant

Mallinckrodt Pharma IP Trading DAC

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
0.5G	Powder	Topical	Vial	Disc	April 30, 2015
1G	Powder	Topical	Vial	Disc	April 30, 2015
2G	Powder	Topical	Vial	Disc	April 30, 2015

Sources for this page

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