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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021999
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INVEGA PALIPERIDONE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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 Prescription AB Yes No
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-Package Insert Label (PDF) 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
08/14/2008 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
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