Application 125472
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACTEMRA | TOCILIZUMAB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 162MG/0.9ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-138 | Actemra | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
| 50242-143 | Actemra ACTPen | tocilizumab | Genentech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84391 | SUPPL | 2025-12-12 |
| 84386 | SUPPL | 2025-12-11 |
| 83090 | SUPPL | 2025-08-12 |
| 83074 | SUPPL | 2025-08-11 |
| 83073 | SUPPL | 2025-08-11 |
| 80561 | SUPPL | 2024-12-13 |
| 80554 | SUPPL | 2024-12-11 |
| 79714 | SUPPL | 2024-09-24 |
| 79699 | SUPPL | 2024-09-23 |
| 79678 | SUPPL | 2024-09-23 |
| 79672 | SUPPL | 2024-09-20 |
| 72995 | SUPPL | 2022-12-22 |
| 72989 | SUPPL | 2022-12-22 |
| 72988 | SUPPL | 2022-12-22 |
| 71537 | SUPPL | 2022-07-12 |
| 70337 | SUPPL | 2022-03-01 |
| 70336 | SUPPL | 2022-03-01 |
| 70309 | SUPPL | 2022-03-01 |
| 69084 | SUPPL | 2021-10-25 |
| 66684 | SUPPL | 2021-03-09 |
| 66681 | SUPPL | 2021-03-09 |
| 66569 | SUPPL | 2021-03-08 |
| 63357 | SUPPL | 2020-06-01 |
| 63344 | SUPPL | 2020-05-29 |
| 63343 | SUPPL | 2020-05-29 |
| 61000 | SUPPL | 2019-11-20 |
| 59037 | SUPPL | 2019-06-12 |
| 59036 | SUPPL | 2019-06-12 |
| 59028 | SUPPL | 2019-06-12 |
| 58332 | SUPPL | 2019-04-15 |
| 58301 | SUPPL | 2019-04-12 |
| 56991 | SUPPL | 2018-12-21 |
| 56963 | SUPPL | 2018-12-21 |
| 56518 | SUPPL | 2018-11-20 |
| 56515 | SUPPL | 2018-11-20 |
| 55484 | SUPPL | 2018-09-14 |
| 55464 | SUPPL | 2018-09-13 |
| 54269 | SUPPL | 2018-05-21 |
| 54262 | SUPPL | 2018-05-21 |
| 54199 | SUPPL | 2018-05-16 |
| 54173 | SUPPL | 2018-05-14 |
| 53483 | SUPPL | 2018-03-28 |
| 53097 | SUPPL | 2018-03-22 |
| 48513 | SUPPL | 2017-05-24 |
| 48509 | SUPPL | 2017-05-24 |
| 47823 | SUPPL | 2017-04-03 |
| 47802 | SUPPL | 2017-03-31 |
| 45390 | SUPPL | 2016-09-27 |
| 45401 | SUPPL | 2016-09-26 |
| 9764 | SUPPL | 2015-08-21 |
| 24372 | ORIG | 2014-07-17 |
| 22813 | ORIG | 2014-07-17 |
| 18918 | ORIG | 2013-10-25 |
| 9763 | ORIG | 2013-10-24 |