Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211994
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOVATO | DOLUTEGRAVIR SODIUM; LAMIVUDINE | 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 |
---|---|---|---|---|---|---|---|
04/08/2019 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211994Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211994Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2022 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s015ltr.pdf | |
01/25/2023 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211994s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211994Orig1s014ltr.pdf | |
01/20/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s012,s013ltr.pdf | |
01/20/2022 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211994Orig1s012,s013ltr.pdf | |
03/23/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211994Orig1s011ltr.pdf | |
03/01/2021 | SUPPL-10 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211994Orig1s010ltr.pdf | |
08/06/2020 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s006,s007ltr.pdf | |
08/06/2020 | SUPPL-6 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s006,s007ltr.pdf | |
10/24/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211994Orig1s005ltr.pdf | |
03/24/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211994Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/25/2023 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211994s014lbl.pdf | |
10/07/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s015lbl.pdf | |
01/20/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf | |
01/20/2022 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211994s012s013lbl.pdf | |
03/23/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s011lbl.pdf | |
03/23/2021 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s011lbl.pdf | |
03/01/2021 | SUPPL-10 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s010lbl.pdf | |
08/06/2020 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf | |
08/06/2020 | SUPPL-6 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s006s007lbl.pdf | |
03/24/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s004lbl.pdf | |
03/24/2020 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211994s004lbl.pdf | |
10/24/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s005lbl.pdf | |
10/24/2019 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s005lbl.pdf | |
04/08/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211994s000lbl.pdf |