Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022264
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | No |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022264s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264_invega_sustenna_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000sumr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022264s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022264Orig1s034ltr.pdf | |
| 08/09/2021 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022264Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022264Orig1s033ltr.pdf | |
| 02/12/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021999Orig1s037, 022264Orig1s030, 207946Orig1s009ltr.pdf | |
| 01/25/2019 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022264s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021999Orig1s036,022264Orig1s029,207946Orig1s008Ltr.pdf | |
| 07/27/2018 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022264s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf | |
| 02/23/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf | |
| 06/15/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022264Orig1s023ltr.pdf | |
| 11/16/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2016 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf | |
| 06/09/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022264Orig1s018ltr.pdf | |
| 06/16/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2017 | SUPPL-15 | Efficacy-Accelerated Approval Confirmatory Study |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022264Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022264Orig1s015.pdf | |
| 11/12/2014 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf | |
| 11/12/2014 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf | |
| 08/25/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf | |
| 09/24/2011 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s006ltr.pdf | |
| 08/29/2012 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022264s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022264Orig1s005ltr.pdf | |
| 12/01/2010 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s004ltr.pdf | |
| 06/15/2011 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s002ltr.pdf | |
| 05/13/2010 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022264s034lbl.pdf | |
| 08/09/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022264Orig1s033lbl.pdf | |
| 02/12/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf | |
| 01/25/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022264s029lbl.pdf | |
| 07/27/2018 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022264s027lbl.pdf | |
| 12/20/2017 | SUPPL-15 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s015lbl.pdf | |
| 06/15/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf | |
| 02/23/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s024lbl.pdf | |
| 03/01/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf | |
| 06/09/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf | |
| 11/12/2014 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf | |
| 11/12/2014 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf | |
| 04/29/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf | |
| 08/29/2012 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022264s005lbl.pdf | |
| 09/24/2011 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s006lbl.pdf | |
| 06/15/2011 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s002lbl.pdf | |
| 12/01/2010 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s004lbl.pdf | |
| 05/13/2010 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s001lbl.pdf | |
| 07/31/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf |