Application 761139
- Type
- BLA
- Sponsor
- DAIICHI SANKYO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENHERTU | FAM-TRASTUZUMAB DERUXTECAN-NXKI | INJECTABLE;INJECTION | 100MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo, Inc. | BLA | Current |
| 65597-406 | Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Sankyo Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 86001 | SUPPL | 2026-05-21 |
| 86000 | SUPPL | 2026-05-21 |
| 85978 | SUPPL | 2026-05-19 |
| 85977 | SUPPL | 2026-05-19 |
| 85966 | SUPPL | 2026-05-19 |
| 85965 | SUPPL | 2026-05-19 |
| 85794 | SUPPL | 2026-05-01 |
| 85793 | SUPPL | 2026-05-01 |
| 84496 | SUPPL | 2025-12-22 |
| 84494 | SUPPL | 2025-12-22 |
| 84460 | SUPPL | 2025-12-18 |
| 84459 | SUPPL | 2025-12-18 |
| 81168 | SUPPL | 2025-02-07 |
| 81166 | SUPPL | 2025-02-07 |
| 80923 | SUPPL | 2025-02-05 |
| 80922 | SUPPL | 2025-02-05 |
| 80852 | SUPPL | 2025-01-15 |
| 78079 | SUPPL | 2024-04-08 |
| 78077 | SUPPL | 2024-04-05 |
| 77526 | SUPPL | 2024-02-16 |
| 77510 | SUPPL | 2024-02-16 |
| 76574 | SUPPL | 2023-11-15 |
| 72576 | SUPPL | 2022-11-07 |
| 72568 | SUPPL | 2022-11-07 |
| 71794 | SUPPL | 2022-08-12 |
| 71779 | SUPPL | 2022-08-11 |
| 71778 | SUPPL | 2022-08-11 |
| 71776 | SUPPL | 2022-08-11 |
| 71741 | SUPPL | 2022-08-08 |
| 71005 | SUPPL | 2022-05-06 |
| 71004 | SUPPL | 2022-05-06 |
| 70998 | SUPPL | 2022-05-04 |
| 70996 | SUPPL | 2022-05-04 |
| 70995 | SUPPL | 2022-05-04 |
| 67009 | SUPPL | 2021-04-09 |
| 65917 | SUPPL | 2021-01-15 |
| 65916 | SUPPL | 2021-01-15 |
| 61604 | ORIG | 2020-01-17 |
| 61515 | ORIG | 2020-01-15 |
| 61369 | ORIG | 2019-12-20 |