Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202022
Company: JANSSEN PRODS
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 |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202022Orig1s020; s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202022Orig1s020; s022ltr.pdf | |
| 03/15/2024 | SUPPL-20 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202022Orig1s020; s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202022Orig1s020; s022ltr.pdf | |
| 10/19/2022 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202022Orig1s019ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202022Orig1s020; s022lbl.pdf | |
| 03/15/2024 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202022Orig1s020; s022lbl.pdf | |
| 10/19/2022 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202022s019lbl.pdf | |
| 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 |