Application 125427
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | VIAL; SINGLE-USE | 100MG | No | No |
| 002 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | VIAL; SINGLE-USE | 160MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-087 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
| 50242-088 | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | Genentech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85588 | SUPPL | 2026-03-30 |
| 85562 | SUPPL | 2026-03-30 |
| 82301 | SUPPL | 2025-05-23 |
| 82241 | SUPPL | 2025-05-14 |
| 70070 | SUPPL | 2022-02-04 |
| 70064 | SUPPL | 2022-02-03 |
| 64748 | SUPPL | 2020-09-29 |
| 64734 | SUPPL | 2020-09-29 |
| 58578 | SUPPL | 2019-05-06 |
| 58560 | SUPPL | 2019-05-03 |
| 56925 | SUPPL | 2018-12-21 |
| 56905 | SUPPL | 2018-12-20 |
| 56004 | SUPPL | 2018-10-17 |
| 55732 | SUPPL | 2018-10-01 |
| 39964 | SUPPL | 2016-07-27 |
| 31969 | SUPPL | 2016-07-26 |
| 9750 | SUPPL | 2016-05-02 |
| 39963 | SUPPL | 2016-04-29 |
| 39962 | SUPPL | 2015-06-04 |
| 9749 | SUPPL | 2015-06-02 |
| 39961 | SUPPL | 2014-07-15 |
| 31968 | SUPPL | 2014-07-15 |
| 23953 | ORIG | 2014-02-07 |
| 9748 | SUPPL | 2013-09-03 |
| 18914 | SUPPL | 2013-08-30 |
| 9747 | SUPPL | 2013-08-22 |
| 39960 | SUPPL | 2013-08-21 |
| 22809 | ORIG | 2013-02-28 |
| 31967 | ORIG | 2013-02-22 |
| 24370 | ORIG | 2013-02-22 |
| 18913 | ORIG | 2013-02-22 |