Skip to contentApplication 020378
- Type
- BLA
- Sponsor
- EMD SERONO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GONAL-F | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 75 IU/VIAL | No | No |
| 002 | GONAL-F | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 150 IU/VIAL | No | No |
| 003 | GONAL-F | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 37.5 IU/VIAL | No | No |
| 004 | GONAL-F | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 1,050 IU/VIAL | No | No |
| 005 | GONAL-F | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 450 IU/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |
| 44087-9030 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | BLA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |
| 44087-9070 | Gonal-f | follitropin alfa | EMD Serono, Inc. | NDA | Current |