Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202439
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XARELTO RIVAROXABAN 10MG TABLET;ORAL Prescription None TBD No
XARELTO RIVAROXABAN 15MG TABLET;ORAL Prescription None TBD No
XARELTO RIVAROXABAN 20MG TABLET;ORAL Prescription None TBD No
XARELTO RIVAROXABAN 2.5MG TABLET;ORAL Prescription None TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/04/2011 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s027,202439s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s027, 202439Orig1s034ltr.pdf
10/11/2019 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s033, 202439Orig1s033ltr.pdf
08/23/2019 SUPPL-32 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s034,202439s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s034, 202439Orig1s032ltr.pdf
02/01/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202439s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202439Orig1s029ltr.pdf
06/27/2018 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s027ltr.pdf
10/11/2018 SUPPL-25 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf
02/08/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s024ltr.pdf
07/27/2018 SUPPL-23 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s023Ltr.pdf
03/29/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202439s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202439Orig1s021ltr.pdf
10/05/2016 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s020ltr.pdf
09/06/2016 SUPPL-19 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s019ltr.pdf
05/06/2016 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s017ltr.pdf
09/10/2015 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202439s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202439Orig1s015ltr.pdf
02/16/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf
05/15/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/07/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202439Orig1s008ltr.pdf
11/05/2012 SUPPL-7 REMS-Modified

Label is not available on this site.

07/12/2012 SUPPL-5 REMS-Modified

Label is not available on this site.

04/03/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/05/2011 SUPPL-1 Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s027,202439s034lbl.pdf
10/11/2019 SUPPL-33 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf
10/11/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf
08/23/2019 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s034,202439s032lbl.pdf
08/23/2019 SUPPL-32 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s034,202439s032lbl.pdf
02/01/2019 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202439s029lbl.pdf
02/01/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202439s029lbl.pdf
10/11/2018 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf
06/27/2018 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf
02/08/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s024lbl.pdf
03/29/2017 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202439s021lbl.pdf
10/05/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s020lbl.pdf
10/05/2016 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s020lbl.pdf
05/06/2016 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s017lbl.pdf
09/10/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202439s015lbl.pdf
08/07/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf
11/04/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf

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