Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204790
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIVICAY | DOLUTEGRAVIR SODIUM | EQ 50MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
| TIVICAY | DOLUTEGRAVIR SODIUM | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| TIVICAY | DOLUTEGRAVIR SODIUM | EQ 25MG BASE | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/12/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204790Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1S000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/18/2024 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204790s031,213983s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204790Orig1s031; 213983Orig1s004ltr.pdf | |
| 10/07/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204790s030,213983s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204790Orig1s030,213983Orig1s003ltr.pdf | |
| 03/23/2021 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s029,213983Orig1s001ltr.pdf | |
| 07/09/2021 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s028; 213983Orig1s002ltr.pdf | |
| 06/12/2020 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204790s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204790Orig1s025ltr.pdf | |
| 10/24/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204790s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204790Orig1s024ltr.pdf | |
| 03/24/2020 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204790s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204790orig1s023ltr.pdf | |
| 09/06/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204790Orig1s016s018Ltr.pdf | |
| 09/06/2018 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204790Orig1s016s018Ltr.pdf | |
| 11/21/2017 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204790Orig1s014ltr.pdf | |
| 03/27/2017 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204790Orig1s013ltr.pdf | |
| 12/20/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/2016 | SUPPL-8 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s008ltr.pdf | |
| 04/22/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s007ltr.pdf | |
| 11/05/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2015 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204790Orig1s005ltr.pdf | |
| 07/30/2015 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 08/29/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s002ltr.pdf | |
| 05/12/2014 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/18/2024 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204790s031,213983s004lbl.pdf | |
| 10/07/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204790s030,213983s003lbl.pdf | |
| 07/09/2021 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf | |
| 03/23/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf | |
| 03/23/2021 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf | |
| 06/12/2020 | SUPPL-25 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204790s025lbl.pdf | |
| 03/24/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204790s023lbl.pdf | |
| 03/24/2020 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204790s023lbl.pdf | |
| 10/24/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204790s024lbl.pdf | |
| 10/24/2019 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204790s024lbl.pdf | |
| 09/06/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf | |
| 09/06/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204790s016s018lbl.pdf | |
| 11/21/2017 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s014lbl.pdf | |
| 03/27/2017 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s013lbl.pdf | |
| 06/09/2016 | SUPPL-8 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf | |
| 04/22/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790s007lbl.pdf | |
| 08/05/2015 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf | |
| 08/05/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf | |
| 12/19/2014 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf | |
| 05/12/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf | |
| 05/12/2014 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf | |
| 08/12/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf |