Product NDC: | 42606-004 |
Proprietary Name: | GINTUIT |
Non Proprietary Name: | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
Active Ingredient(s): | /; /; / & nbsp; Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
Administration Route(s): | TOPICAL |
Dosage Form(s): | CELLULAR SHEET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42606-004 |
Labeler Name: | Organogenesis, Inc |
Product Type: | CELLULAR THERAPY |
FDA Application Number: | BLA125400 |
Marketing Category: | BLA |
Start Marketing Date: | 20120315 |
Package NDC: | 42606-004-01 |
Package Description: | 44.2 cm2 in 1 TRAY (42606-004-01) |
NDC Code | 42606-004-01 |
Proprietary Name | GINTUIT |
Package Description | 44.2 cm2 in 1 TRAY (42606-004-01) |
Product NDC | 42606-004 |
Product Type Name | CELLULAR THERAPY |
Non Proprietary Name | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen |
Dosage Form Name | CELLULAR SHEET |
Route Name | TOPICAL |
Start Marketing Date | 20120315 |
Marketing Category Name | BLA |
Labeler Name | Organogenesis, Inc |
Substance Name | BOVINE TYPE I COLLAGEN; FORESKIN FIBROBLAST (NEONATAL); FORESKIN KERATINOCYTE (NEONATAL) |
Strength Number | |
Strength Unit | /; /; / |
Pharmaceutical Classes | Allogeneic Cultured Cell Scaffold [EPC],Collagen [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Fibroblasts [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Keratinocytes [Chemical/Ingredient] |