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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205123
Company: JANSSEN PRODS

Summary Review

Products on NDA 205123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLYSIO	SIMEPREVIR SODIUM	EQ 150MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s014ltr.pdf
05/12/2017	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s013ltr.pdf
02/14/2017	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205123Orig1s012ltr.pdf
05/20/2016	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s011ltr.pdf
02/26/2016	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205123Orig1s010ltr.pdf
04/10/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s009ltr.pdf
04/15/2015	SUPPL-8	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205123Orig1s008.pdf
06/19/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/05/2015	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s006ltr.pdf
10/05/2015	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205123Orig1s005ltr.pdf
03/03/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/05/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s003ltr.pdf
11/05/2014	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s002lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205123Orig1s002ltr.pdf
12/05/2013	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205123Orig1s001ltr.pdf

Labels for NDA 205123

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s014lbl.pdf
05/12/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s013lbl.pdf
02/14/2017	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s012lbl.pdf
02/14/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s012lbl.pdf
05/20/2016	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s011lbl.pdf
02/26/2016	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205123s010lbl.pdf
10/05/2015	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s006lbl.pdf
10/05/2015	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s005lbl.pdf
04/15/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s008lbl.pdf
04/15/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s008lbl.pdf
04/10/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205123s009lbl.pdf
11/05/2014	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s002lbledt.pdf
09/05/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf
12/05/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf
12/05/2013	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdf
11/22/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s000lbledt.pdf

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