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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202022
Company: JANSSEN PRODS

Summary Review

Products on NDA 202022

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202022

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202022s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/19/2022	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202022Orig1s019ltr.pdf
03/29/2022	SUPPL-18	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202022Orig1s017,s018ltr.pdf
03/29/2022	SUPPL-17	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202022Orig1s017,s018ltr.pdf
01/31/2022	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202022Orig1s016ltr.pdf
01/21/2021	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202022s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202022Orig1s014ltr.pdf
05/14/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202022s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202022Orig1s013ltr.pdf
02/01/2018	SUPPL-11	Efficacy-New Patient Population, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202022s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202022Orig1s011ltr.pdf
09/15/2017	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202022s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202022Orig1s010ltr.pdf
05/05/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s009ltr.pdf
08/26/2015	SUPPL-8	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202022Orig1s008ltr.pdf
05/01/2014	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202022s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202022Orig1s007ltr.pdf
07/23/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/21/2013	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202022s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202022Orig1s005ltr.pdf
04/26/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/10/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s003ltr.pdf
12/07/2012	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202022Orig1s002ltr.pdf

Labels for NDA 202022

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/19/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s019lbl.pdf
03/29/2022	SUPPL-18	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s017s018lbl.pdf
03/29/2022	SUPPL-17	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s017s018lbl.pdf
01/31/2022	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s016lbl.pdf
01/21/2021	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202022s014lbl.pdf
05/14/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202022s013lbl.pdf
02/01/2018	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202022s011lbl.pdf
02/01/2018	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202022s011lbl.pdf
09/15/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202022s010lbl.pdf
08/26/2015	SUPPL-8	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s008lbledt.pdf
05/05/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202022s009lbl.pdf
05/01/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202022s007lbl.pdf
05/01/2014	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202022s007lbl.pdf
06/21/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202022s005lbl.pdf
06/21/2013	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202022s005lbl.pdf
12/07/2012	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s002lbl.pdf
08/10/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202022s003lbl.pdf
05/20/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf

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