Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022406
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XARELTO RIVAROXABAN 10MG TABLET;ORAL Prescription None Yes No
XARELTO RIVAROXABAN 15MG TABLET;ORAL Prescription None Yes No
XARELTO RIVAROXABAN 20MG TABLET;ORAL Prescription None Yes Yes
XARELTO RIVAROXABAN 2.5MG TABLET;ORAL Prescription None Yes 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
07/01/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s030s032lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s030s032ltr.pdf
01/15/2019 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s030s032lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s030s032ltr.pdf
11/07/2018 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022406Orig1s029ltr.pdf
07/30/2018 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022406Orig1s028Ltr.pdf
10/27/2017 SUPPL-24 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022406Orig1s024ltr.pdf
06/28/2017 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022406Orig1s023ltr.pdf
02/10/2017 SUPPL-21 Labeling-Container/Carton Labels

Label is not available on this site.

08/25/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf
08/25/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s019,s020ltr.pdf
08/17/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022406Orig1s017ltr.pdf
10/26/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s015ltr.pdf
05/05/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/15/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022406s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022406Orig1s012ltr.pdf
09/15/2014 SUPPL-11 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s011lbl.pdf
02/13/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s010ltr.pdf
03/06/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s009ltr.pdf
01/07/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s007ltr.pdf
01/31/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/01/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022406s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022406Orig1s004ltr.pdf
11/02/2012 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf
11/02/2012 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf
11/02/2012 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022406Orig1s001,s002,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/15/2019 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s030s032lbledt.pdf
01/15/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s030s032lbledt.pdf
11/07/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf
07/30/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s028lbl.pdf
10/27/2017 SUPPL-24 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s024lbl.pdf
06/28/2017 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s023lbl.pdf
06/28/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s023lbl.pdf
08/25/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf
08/25/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf
08/17/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s017lbl.pdf
01/15/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022406s012lbl.pdf
12/19/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s015lbl.pdf
09/15/2014 SUPPL-11 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s011lbl.pdf
03/06/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s009lbl.pdf
02/13/2014 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s010lbl.pdf
02/13/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s010lbl.pdf
01/07/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022406s007lbl.pdf
03/01/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022406s004lbl.pdf
11/02/2012 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf
11/02/2012 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf
11/02/2012 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022406s001s002s003lbl.pdf
07/01/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf

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