Skip to contentApplication 019764
- Type
- BLA
- Sponsor
- EMD SERONO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SAIZEN | SOMATROPIN | INJECTABLE;INJECTION | 6MG/VIAL | No | No |
| 002 | SAIZEN | SOMATROPIN | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 003 | SAIZEN | SOMATROPIN | INJECTABLE;INJECTION | 8.8MG/VIAL | No | No |
| 005 | SAIZEN | SOMATROPIN | INJECTABLE;INJECTION | 4MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44087-0016 | saizenprep | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-0016 | saizenprep | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-0016 | saizenprep | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-0016 | saizenprep | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-1005 | Saizen | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-1005 | Saizen | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-1005 | Saizen | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-1005 | Saizen | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-1080 | SAIZEN CLICKEASY | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-1088 | Saizen | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-1088 | Saizen | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-1088 | Saizen | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-1088 | Saizen | somatropin | EMD Serono, Inc. | NDA | Current |