Product Details for: Gintuit
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Cellular Sheet
Topical
>0.000001UG/ML
Bag
351(a)
Gintuit
Disc
Proper Name
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
BLA Number
125400
125400
Applicant
Organogenesis, Inc.
Organogenesis, Inc.
Original Approval Date
March 9, 2012
March 9, 2012
Date of First Licensure