Application 125557
- Type
- BLA
- Sponsor
- AMGEN
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BLINCYTO | BLINATUMOMAB | INJECTABLE;INJECTION | 35MCG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
| 55513-160 | BLINCYTO | blinatumomab | Amgen Inc | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 83879 | SUPPL | 2025-10-23 |
| 83867 | SUPPL | 2025-10-22 |
| 82136 | SUPPL | 2025-05-05 |
| 82074 | SUPPL | 2025-04-30 |
| 82073 | SUPPL | 2025-04-30 |
| 80615 | SUPPL | 2024-12-18 |
| 80610 | SUPPL | 2024-12-18 |
| 78812 | SUPPL | 2024-06-18 |
| 78804 | SUPPL | 2024-06-14 |
| 77444 | SUPPL | 2024-02-09 |
| 77432 | SUPPL | 2024-02-09 |
| 74571 | SUPPL | 2023-06-21 |
| 74570 | SUPPL | 2023-06-21 |
| 74561 | SUPPL | 2023-06-21 |
| 74560 | SUPPL | 2023-06-21 |
| 72796 | SUPPL | 2022-12-06 |
| 70211 | SUPPL | 2022-02-22 |
| 70196 | SUPPL | 2022-02-22 |
| 70195 | SUPPL | 2022-02-22 |
| 66759 | SUPPL | 2021-03-12 |
| 66754 | SUPPL | 2021-03-12 |
| 62294 | SUPPL | 2020-03-24 |
| 62265 | SUPPL | 2020-03-23 |
| 62221 | SUPPL | 2020-03-23 |
| 59049 | SUPPL | 2019-06-13 |
| 58378 | SUPPL | 2019-04-24 |
| 58377 | SUPPL | 2019-04-24 |
| 58354 | SUPPL | 2019-04-19 |
| 58353 | SUPPL | 2019-04-19 |
| 53757 | SUPPL | 2018-04-20 |
| 53582 | SUPPL | 2018-04-01 |
| 53544 | SUPPL | 2018-03-29 |
| 50570 | SUPPL | 2017-12-01 |
| 50549 | SUPPL | 2017-12-01 |
| 50548 | SUPPL | 2017-12-01 |
| 48987 | SUPPL | 2017-07-14 |
| 48952 | SUPPL | 2017-07-12 |
| 48820 | SUPPL | 2017-06-26 |
| 48289 | SUPPL | 2017-05-09 |
| 48244 | SUPPL | 2017-05-05 |
| 45208 | SUPPL | 2016-08-30 |
| 45207 | SUPPL | 2016-08-30 |
| 45185 | SUPPL | 2016-08-30 |
| 45184 | SUPPL | 2016-08-30 |
| 43339 | ORIG | 2015-01-12 |
| 24093 | ORIG | 2014-12-05 |
| 9787 | ORIG | 2014-12-04 |
| 39995 | ORIG | 2014-12-03 |
| 63253 | ORIG | 1900-01-01 |
| 63252 | ORIG | 1900-01-01 |
| 63251 | ORIG | 1900-01-01 |