On this page

Gintuit

Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Gintuit

Proper name

Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

Licence type

351(a)

BLA number

125400

Applicant

Organogenesis, Inc.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
>0.000001UG/ML	Cellular Sheet	Topical	Bag	Disc	March 9, 2012

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