Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202439
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XARELTO | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | None | No | No |
| XARELTO | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | None | No | No |
| XARELTO | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | None | No | No |
| XARELTO | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|
| 03/01/2022 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406Orig1s039,202439Orig1s038correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022406Orig1s039, 202439Orig1s038correctedltr.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022406Orig1s036,202439Orig1s036ltr.pdf | |
| 08/23/2021 | SUPPL-35 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022406Orig1s037;%20202439Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/202439Orig1s035.pdf | |
| 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-Package Insert, Labeling-Medication Guide |
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 | |
| 03/10/2020 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202439s031,022406s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202439Orig1s031,022406Orig1s035ltr.pdf | |
| 02/01/2019 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
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 |
|---|---|---|---|---|---|
| 03/01/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406Orig1s039,202439Orig1s038correctedlbl.pdf | |
| 03/01/2022 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406Orig1s039,202439Orig1s038correctedlbl.pdf | |
| 08/23/2021 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf | |
| 03/10/2020 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202439s031,022406s035lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf | |
| 10/11/2019 | SUPPL-33 | Labeling-Medication Guide | 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202439s029lbl.pdf | |
| 02/01/2019 | SUPPL-29 | Labeling-Medication Guide | 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 |