Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204447
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 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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204447s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204447Orig1s009ltr.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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English