Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125476
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENTYVIO | VEDOLIZUMAB | 300MG | INJECTABLE;INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/20/2014 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125476Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/25/2026 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125476s66lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125476Orig1s066,761133Orig1s014ltr.pdf | |
| 04/18/2024 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf | |
| 04/18/2024 | SUPPL-60 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf | |
| 03/14/2024 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s058, 761133Orig1s004ltr.pdf | |
| 09/28/2023 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125476Orig1s057ltr.pdf | |
| 02/23/2024 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s054; 761133Orig1s003ltr.pdf | |
| 01/25/2023 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125476Orig1s046ltr.pdf | |
| 08/17/2021 | SUPPL-39 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125476Orig1s038, s039ltr.pdf | |
| 08/17/2021 | SUPPL-38 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125476Orig1s038, s039ltr.pdf |
| 03/31/2020 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125476Orig1s025, s030ltr.pdf | |
| 05/06/2019 | SUPPL-27 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125476Orig1s027ltr.pdf |
| 03/31/2020 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125476Orig1s025, s030ltr.pdf | |
| 05/07/2019 | SUPPL-24 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf | |
| 02/16/2018 | SUPPL-22 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125476Orig1s022ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2026 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125476s66lbl.pdf | |
| 02/25/2026 | SUPPL-66 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125476s66lbl.pdf | |
| 04/18/2024 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf | |
| 04/18/2024 | SUPPL-61 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf | |
| 04/18/2024 | SUPPL-60 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf | |
| 04/18/2024 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf | |
| 03/14/2024 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf | |
| 02/23/2024 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf | |
| 09/28/2023 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf | |
| 09/28/2023 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf | |
| 06/17/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf | |
| 06/17/2022 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf | |
| 06/17/2022 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf | |
| 08/17/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf | |
| 03/31/2020 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf | |
| 03/31/2020 | SUPPL-30 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf | |
| 03/31/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf | |
| 05/07/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf | |
| 02/16/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf | |
| 05/20/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf |