Skip to contentApplication 021597
- Type
- BLA
- Sponsor
- EMD SERONO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZORBTIVE | SOMATROPIN RECOMBINANT | INJECTABLE;INJECTION | 4MG/VIAL | No | No |
| 002 | ZORBTIVE | SOMATROPIN RECOMBINANT | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 003 | ZORBTIVE | SOMATROPIN RECOMBINANT | INJECTABLE;INJECTION | 6MG/VIAL | No | No |
| 004 | ZORBTIVE | SOMATROPIN RECOMBINANT | INJECTABLE;INJECTION | 8.8MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44087-3388 | Zorbtive | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-3388 | Zorbtive | somatropin | EMD Serono, Inc. | BLA | Current |
| 44087-3388 | Zorbtive | somatropin | EMD Serono, Inc. | NDA | Current |
| 44087-3388 | Zorbtive | somatropin | EMD Serono, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66678 | ORIG | 2021-03-09 |
| 42227 | ORIG | 2020-03-23 |
| 28221 | ORIG | 2020-03-23 |
| 15851 | ORIG | 2020-03-23 |
| 66425 | APPL | 2020-03-22 |