Application 020367
- Type
- BLA
- Sponsor
- GENZYME
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEREZYME | IMIGLUCERASE | INJECTABLE;INJECTION | 200 UNITS/VIAL | No | No |
| 002 | CEREZYME | IMIGLUCERASE | INJECTABLE;INJECTION | 400 UNITS/VIAL | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58468-1983 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-1983 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | NDA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | BLA | Current |
| 58468-4663 | Cerezyme | IMIGLUCERASE | Genzyme Corporation | NDA | Current |