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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215413
Company: VIIV HLTHCARE

Medication Guide

Products on NDA 215413

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIUMEQ PD	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215413

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2022	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215413Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215413Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2023	SUPPL-2	Efficacy-New Patient Population	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-1	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

Labels for NDA 215413

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2023	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf
10/07/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf
03/30/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf

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