Application 125476
- Type
- BLA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENTYVIO | VEDOLIZUMAB | INJECTABLE;INJECTION | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
| 64764-300 | Entyvio | vedolizumab | Takeda Pharmaceuticals America, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85184 | SUPPL | 2026-03-02 |
| 85171 | SUPPL | 2026-02-27 |
| 78403 | SUPPL | 2024-05-06 |
| 78402 | SUPPL | 2024-05-06 |
| 78177 | SUPPL | 2024-04-19 |
| 78176 | SUPPL | 2024-04-19 |
| 77845 | SUPPL | 2024-03-15 |
| 77839 | SUPPL | 2024-03-15 |
| 77838 | SUPPL | 2024-03-15 |
| 77627 | SUPPL | 2024-02-26 |
| 77616 | SUPPL | 2024-02-26 |
| 75625 | SUPPL | 2023-09-29 |
| 75614 | SUPPL | 2023-09-29 |
| 71418 | SUPPL | 2022-06-21 |
| 71372 | SUPPL | 2022-06-21 |
| 68415 | SUPPL | 2021-08-19 |
| 68414 | SUPPL | 2021-08-19 |
| 68401 | SUPPL | 2021-08-18 |
| 68400 | SUPPL | 2021-08-18 |
| 62418 | SUPPL | 2020-04-02 |
| 62417 | SUPPL | 2020-04-02 |
| 62404 | SUPPL | 2020-04-01 |
| 62403 | SUPPL | 2020-04-01 |
| 62402 | SUPPL | 2020-04-01 |
| 62401 | SUPPL | 2020-04-01 |
| 58641 | SUPPL | 2019-05-13 |
| 58617 | SUPPL | 2019-05-08 |
| 58616 | SUPPL | 2019-05-08 |
| 52701 | SUPPL | 2018-02-23 |
| 52684 | SUPPL | 2018-02-22 |
| 52683 | SUPPL | 2018-02-22 |
| 24373 | ORIG | 2014-06-19 |
| 22814 | ORIG | 2014-06-19 |
| 39973 | ORIG | 2014-05-20 |
| 9765 | ORIG | 2014-05-20 |