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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211994
Company: VIIV HLTHCARE

Products on NDA 211994

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211994

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

Labels for NDA 211994

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

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