Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211994
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
03/23/2021 SUPPL-11 Labeling-Patient Package Insert, Labeling-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
03/23/2021 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211994s011lbl.pdf
03/23/2021 SUPPL-11 Labeling-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

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