Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205551
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIUMEQ | ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE | EQ 600MG BASE;EQ 50MG BASE;300MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/22/2014 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205551Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205551Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215413Orig1s002;205551Orig1s031ltr.pdf | |
| 10/07/2022 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205551Orig1s029,215413Orig1s001ltr.pdf | |
| 03/30/2022 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205551Orig1s028ltr.pdf | |
| 03/23/2021 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205551s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205551Orig1s026ltr.pdf | |
| 03/01/2021 | SUPPL-25 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205551s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205551Orig1s025ltr.pdf | |
| 10/24/2019 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205551Orig1s022ltr.pdf | |
| 03/24/2020 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205551s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205551Orig1s021ltr.pdf | |
| 05/03/2019 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205551Orig1s016ltr.pdf | |
| 09/06/2018 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf | |
| 09/06/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf | |
| 05/11/2018 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s013ltr.pdf | |
| 11/21/2017 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s011ltr.pdf | |
| 03/27/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s010ltr.pdf | |
| 04/01/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205551Orig1s005ltr.pdf | |
| 09/28/2015 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s004ltr.pdf | |
| 08/05/2015 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s002ltr.pdf | |
| 06/15/2015 | 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 |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf | |
| 10/07/2022 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf | |
| 03/30/2022 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551Orig1s028lbl.pdf | |
| 03/23/2021 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205551s026lbl.pdf | |
| 03/23/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205551s026lbl.pdf | |
| 03/01/2021 | SUPPL-25 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205551s025lbl.pdf | |
| 03/24/2020 | SUPPL-21 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205551s021lbl.pdf | |
| 03/24/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205551s021lbl.pdf | |
| 10/24/2019 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf | |
| 10/24/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf | |
| 05/03/2019 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf | |
| 05/03/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf | |
| 09/06/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf | |
| 09/06/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf | |
| 05/11/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf | |
| 05/11/2018 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf | |
| 11/21/2017 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s011lbl.pdf | |
| 03/27/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf | |
| 04/21/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf | |
| 09/28/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf | |
| 09/28/2015 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf | |
| 09/28/2015 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf | |
| 08/05/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf | |
| 08/05/2015 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf | |
| 08/22/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf |