Application 019774
- Type
- BLA
- Sponsor
- FERRING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BIO-TROPIN | SOMATROPIN | INJECTABLE;INJECTION | 4.8MG/VIAL | No | No |
| 002 | ZOMACTON | SOMATROPIN | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 003 | ZOMACTON | SOMATROPIN | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1801 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1901 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1902 | ZOMACTON | somatropin | Ferring Pharmaceuticals Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82802 | SUPPL | 2025-07-11 |
| 82770 | SUPPL | 2025-07-11 |
| 78049 | SUPPL | 2024-04-03 |
| 78039 | SUPPL | 2024-04-03 |
| 66704 | SUPPL | 2021-03-09 |
| 62152 | SUPPL | 2020-03-23 |
| 54937 | SUPPL | 2020-03-23 |
| 54936 | SUPPL | 2020-03-23 |
| 54935 | SUPPL | 2020-03-23 |
| 54934 | SUPPL | 2020-03-23 |
| 54925 | SUPPL | 2020-03-23 |
| 54924 | SUPPL | 2020-03-23 |
| 54923 | SUPPL | 2020-03-23 |
| 54922 | SUPPL | 2020-03-23 |
| 52277 | SUPPL | 2020-03-23 |
| 52276 | SUPPL | 2020-03-23 |
| 52275 | SUPPL | 2020-03-23 |
| 52274 | SUPPL | 2020-03-23 |
| 52271 | SUPPL | 2020-03-23 |
| 52270 | SUPPL | 2020-03-23 |
| 52269 | SUPPL | 2020-03-23 |
| 52268 | SUPPL | 2020-03-23 |
| 46857 | SUPPL | 2020-03-23 |
| 46805 | SUPPL | 2020-03-23 |
| 46186 | SUPPL | 2020-03-23 |
| 46153 | SUPPL | 2020-03-23 |
| 45584 | SUPPL | 2020-03-23 |
| 45471 | SUPPL | 2020-03-23 |
| 41009 | SUPPL | 2020-03-23 |
| 33938 | SUPPL | 2020-03-23 |
| 33937 | SUPPL | 2020-03-23 |
| 33936 | SUPPL | 2020-03-23 |
| 33935 | SUPPL | 2020-03-23 |
| 33934 | SUPPL | 2020-03-23 |
| 19191 | SUPPL | 2020-03-23 |
| 19190 | SUPPL | 2020-03-23 |
| 19189 | SUPPL | 2020-03-23 |
| 19188 | SUPPL | 2020-03-23 |
| 19187 | SUPPL | 2020-03-23 |
| 19186 | SUPPL | 2020-03-23 |
| 11701 | SUPPL | 2020-03-23 |
| 11700 | SUPPL | 2020-03-23 |
| 11699 | SUPPL | 2020-03-23 |
| 1596 | SUPPL | 2020-03-23 |
| 1595 | SUPPL | 2020-03-23 |
| 1594 | SUPPL | 2020-03-23 |
| 66426 | APPL | 2020-03-22 |