Application 103979
- Type
- BLA
- Sponsor
- GENZYME
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FABRAZYME | AGALSIDASE BETA | VIAL; INTRAVENOUS | 5MG/VIAL | No | No |
| 002 | FABRAZYME | AGALSIDASE BETA | VIAL; INTRAVENOUS | 35MG/VIAL | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58468-0040 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0040 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0040 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0040 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0040 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0041 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0041 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0041 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0041 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |
| 58468-0041 | Fabrazyme | AGALSIDASE BETA | Genzyme Corporation | BLA | Current |