Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021999
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| INVEGA | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| INVEGA | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| INVEGA | PALIPERIDONE | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| INVEGA | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021999s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021999s000_TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2022 | SUPPL-39 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021999Orig1s039lbl.pdf | ||
| 02/12/2021 | SUPPL-37 | 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-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021999s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021999Orig1s036,022264Orig1s029,207946Orig1s008Ltr.pdf | |
| 07/27/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021999s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf | |
| 08/11/2017 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s034ltr.pdf | |
| 02/23/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf | |
| 03/01/2016 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf | |
| 04/29/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf | |
| 06/17/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/2011 | SUPPL-24 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf | |
| 12/01/2010 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s023ltr.pdf | |
| 04/06/2011 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf | |
| 03/03/2010 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s018ltr.pdf | |
| 02/16/2011 | SUPPL-17 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s017ltr.pdf | |
| 07/19/2009 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s015ltr.pdf | |
| 07/31/2009 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf | |
| 07/31/2009 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf | |
| 10/30/2009 | SUPPL-11 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf | |
| 08/14/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s010ltr.pdf | |
| 08/26/2008 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf | |
| 05/16/2008 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s007ltr.pdf |
| 09/04/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s006ltr.pdf | |
| 08/26/2008 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf | |
| 12/22/2009 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021999Orig1s004.pdf |
| 04/27/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/21/2007 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf |
| 12/21/2007 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2022 | SUPPL-39 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021999Orig1s039lbl.pdf | |
| 02/12/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf | |
| 01/25/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021999s036lbl.pdf | |
| 07/27/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021999s035lbl.pdf | |
| 08/11/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s034lbl.pdf | |
| 02/23/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf | |
| 03/01/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf | |
| 04/29/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf | |
| 04/06/2011 | SUPPL-24 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf | |
| 04/06/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf | |
| 02/16/2011 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf | |
| 12/01/2010 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf | |
| 03/03/2010 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf | |
| 10/30/2009 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf | |
| 07/31/2009 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf | |
| 07/31/2009 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf | |
| 07/19/2009 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf | |
| 09/04/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf | |
| 08/26/2008 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf |
| 08/26/2008 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf | |
| 08/26/2008 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf | |
| 08/14/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf | |
| 12/21/2007 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf | |
| 12/19/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf |
INVEGA
TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 6MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |