Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207946
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INVEGA TRINZA PALIPERIDONE PALMITATE 273MG/0.875ML (273MG/0.875ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes No
INVEGA TRINZA PALIPERIDONE PALMITATE 410MG/1.315ML (311.79MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes No
INVEGA TRINZA PALIPERIDONE PALMITATE 546MG/1.75ML (312MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR Prescription None Yes No
INVEGA TRINZA PALIPERIDONE PALMITATE 819MG/2.625ML (312MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 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
05/18/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207946s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207946Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207946s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021999Orig1s036,022264Orig1s029,207946Orig1s008Ltr.pdf
07/27/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207946s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021999Orig1s035,022264Orig1s027,207946Orig1s006ltr.pdf
02/23/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207946s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021999Orig1s032,022264Orig1s024,207946Orig1s003ltr.pdf
03/01/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207946s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207946s008lbl.pdf
07/27/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207946s006lbl.pdf
02/23/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207946s003lbl.pdf
03/01/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207946s001lbl.pdf
05/18/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207946s000lbl.pdf

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