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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202022
Company: JANSSEN PRODS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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