Drugs@FDA: FDA Approved Drug Products

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLYSIO SIMEPREVIR SODIUM EQ 150MG BASE CAPSULE;ORAL Prescription None Yes Yes

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 Submission Classification Letters, Reviews, Labels,
Patient Package Insert 		Note Url
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-Package Insert, Labeling-Patient 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

Action Date Submission Submission Classification or
Approval
Type		 Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205123s012lbl.pdf
02/14/2017 SUPPL-12 Labeling-Patient 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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