Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022406
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 | 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 | AB | 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 |
|---|---|---|---|---|---|
| 02/08/2023 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022406s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022406Orig1s041;215859Orig1s002ltr.pdf | |
| 03/01/2022 | SUPPL-39 | Labeling-Package Insert |
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 | |
| 08/23/2021 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022406Orig1s037; 202439Orig1s035ltr.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
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 | |
| 03/10/2020 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
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 | |
| 08/23/2019 | SUPPL-34 | Labeling-Package Insert |
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 | |
| 10/11/2019 | SUPPL-33 | Efficacy-New Indication |
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 | |
| 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 | |
| 11/15/2019 | SUPPL-27 | 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 | |
| 10/27/2017 | 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 |
|---|---|---|---|---|---|
| 02/08/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022406s041lbl.pdf | |
| 02/08/2023 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022406s041lbl.pdf | |
| 03/01/2022 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406Orig1s039,202439Orig1s038correctedlbl.pdf | |
| 08/23/2021 | SUPPL-37 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf | |
| 08/23/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf | |
| 01/28/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf | |
| 03/10/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202439s031,022406s035lbl.pdf | |
| 03/10/2020 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202439s031,022406s035lbl.pdf | |
| 11/15/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s027,202439s034lbl.pdf | |
| 10/11/2019 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf | |
| 08/23/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s034,202439s032lbl.pdf | |
| 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 |
XARELTO
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208544 | AUROBINDO PHARMA LTD |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208555 | LUPIN LTD |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208557 | TARO |
| XARELTO | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 022406 | JANSSEN PHARMS |