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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210655
Company: INDIVIOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERSERIS KIT RISPERIDONE 90MG FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS Prescription None Yes No
PERSERIS KIT RISPERIDONE 120MG FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 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
07/27/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210655s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210655Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210655Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2020 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210655s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210655Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2020 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210655s004lbl.pdf
07/27/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210655s000lbl.pdf
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