Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204447
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/30/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204447s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/ 204447Orig1s027ltr.pdf | |
| 08/23/2023 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204447Orig1s026ltr.pdf | |
| 09/20/2021 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s024ltr.pdf | |
| 01/22/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s021, s022ltr.pdf | |
| 01/22/2021 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s021, s022ltr.pdf | |
| 11/13/2020 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204447s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204447Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/204447Orig1s020.pdf | |
| 07/23/2019 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204447s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204447Orig1s018ltr.pdf | |
| 10/19/2018 | SUPPL-17 | Efficacy-Accelerated Approval Confirmatory Study |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204447Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204447Orig1s017.pdf | |
| 04/11/2017 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447Orig1s013ltr.pdf | |
| 10/17/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s012ltr.pdf | |
| 08/30/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s011ltr.pdf | |
| 03/10/2017 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204447Orig1s009.pdf | |
| 04/03/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447ORig1s008ltr.pdf | |
| 05/02/2016 | SUPPL-7 | Labeling-Proprietary Name Change |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204447Orig1s007ltr.pdf | |
| 05/02/2018 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204447Orig1s006ltr.pdf | |
| 07/17/2014 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204447Orig1s005ltr.pdf | |
| 09/08/2014 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s004lbl.pdf | |
| 09/30/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/23/2023 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s026lbl.pdf | |
| 08/18/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s027lbl.pdf | |
| 09/20/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf | |
| 01/22/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf | |
| 01/22/2021 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf | |
| 11/13/2020 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204447s020lbl.pdf | |
| 07/23/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204447s018lbl.pdf | |
| 10/19/2018 | SUPPL-17 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s017lbl.pdf | |
| 05/02/2018 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s006lbl.pdf | |
| 04/11/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s013lbl.pdf | |
| 04/03/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s008lbl.pdf | |
| 03/10/2017 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s009lbl.pdf | |
| 10/17/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s012lbl.pdf | |
| 08/30/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s011lbl.pdf | |
| 05/02/2016 | SUPPL-7 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204447s007lbl.pdf | |
| 09/08/2014 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s004lbl.pdf |
| 07/17/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s005lbl.pdf | |
| 09/30/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204447s000lbl.pdf |