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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210192
Company: VIIV HLTHCARE

Products on NDA 210192

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JULUCA	DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE	EQ 50MG BASE;EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2017	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210192s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210192Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210192Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210192s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210192Orig1s014ltr.pdf
10/07/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210192s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210192Orig1s013ltr.pdf
03/23/2021	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210192s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210192Orig1s012ltr.pdf
07/09/2021	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210192s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210192Orig1s011ltr.pdf
10/24/2019	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210192s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210192Orig1s008ltr.pdf
07/14/2020	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210192s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210192Orig1s007ltr.pdf
09/06/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf
09/06/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf
01/17/2018	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s001ltr.pdf

Labels for NDA 210192

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210192s014lbl.pdf
10/07/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210192s013lbl.pdf
07/09/2021	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210192s011lbl.pdf
03/23/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210192s012lbl.pdf
03/23/2021	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210192s012lbl.pdf
07/14/2020	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210192s007lbl.pdf
10/24/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210192s008lbl.pdf
10/24/2019	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210192s008lbl.pdf
09/06/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf
09/06/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf
01/17/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf
01/17/2018	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf
11/21/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210192s000lbl.pdf

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