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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213983
Company: VIIV HLTHCARE

Products on NDA 213983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIVICAY PD	DOLUTEGRAVIR SODIUM	EQ 5MG BASE	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2020	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213983Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213983Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-4	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-3	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/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204790Orig1s030,213983Orig1s003ltr.pdf
07/09/2021	SUPPL-2	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
03/23/2021	SUPPL-1	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

Labels for NDA 213983

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204790s031,213983s004lbl.pdf
10/07/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204790s030,213983s003lbl.pdf
07/09/2021	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf
03/23/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf
03/23/2021	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf
06/12/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf

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