Product NDC: | 58468-1025 |
Proprietary Name: | Carticel |
Non Proprietary Name: | autologous cultured chondrocytes |
Active Ingredient(s): | 12000000 1/1 & nbsp; autologous cultured chondrocytes |
Administration Route(s): | INTRA-ARTICULAR |
Dosage Form(s): | IMPLANT |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58468-1025 |
Labeler Name: | Genzyme Corporation |
Product Type: | CELLULAR THERAPY |
FDA Application Number: | BLA103661 |
Marketing Category: | BLA |
Start Marketing Date: | 19970822 |
Package NDC: | 58468-1025-1 |
Package Description: | 1 IMPLANT in 1 VIAL, GLASS (58468-1025-1) |
NDC Code | 58468-1025-1 |
Proprietary Name | Carticel |
Package Description | 1 IMPLANT in 1 VIAL, GLASS (58468-1025-1) |
Product NDC | 58468-1025 |
Product Type Name | CELLULAR THERAPY |
Non Proprietary Name | autologous cultured chondrocytes |
Dosage Form Name | IMPLANT |
Route Name | INTRA-ARTICULAR |
Start Marketing Date | 19970822 |
Marketing Category Name | BLA |
Labeler Name | Genzyme Corporation |
Substance Name | AUTOLOGOUS CULTURED CHONDROCYTES |
Strength Number | 12000000 |
Strength Unit | 1/1 |
Pharmaceutical Classes | Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Chondrocytes [Chemical/Ingredient] |