Application 761115
- Type
- BLA
- Sponsor
- IMMUNOMEDICS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRODELVY | SACITUZUMAB GOVITECAN-HZIY | INJECTABLE;INJECTION | 180MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Immunomedics, Inc. | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Gilead Sciences | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Gilead Sciences | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Gilead Sciences | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Immunomedics, Inc. | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Gilead Sciences | BLA | Current |
| 55135-132 | TRODELVY | SACITUZUMAB GOVITECAN | Immunomedics, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81767 | SUPPL | 2025-03-28 |
| 81748 | SUPPL | 2025-03-27 |
| 80428 | SUPPL | 2024-11-26 |
| 80356 | SUPPL | 2024-11-25 |
| 73808 | SUPPL | 2023-03-20 |
| 73389 | SUPPL | 2023-02-06 |
| 73378 | SUPPL | 2023-02-03 |
| 72810 | SUPPL | 2022-12-07 |
| 72795 | SUPPL | 2022-12-06 |
| 71254 | SUPPL | 2022-06-08 |
| 71219 | SUPPL | 2022-06-06 |
| 67056 | SUPPL | 2021-04-14 |
| 67050 | SUPPL | 2021-04-14 |
| 67026 | SUPPL | 2021-04-12 |
| 67025 | SUPPL | 2021-04-12 |
| 67013 | SUPPL | 2021-04-09 |
| 67012 | SUPPL | 2021-04-09 |
| 63094 | ORIG | 2020-05-19 |
| 62652 | ORIG | 2020-04-23 |
| 62628 | ORIG | 2020-04-22 |