Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022264
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022264Orig1s015ltr.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
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

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