Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210655
Company: INDIVIOR
Company: INDIVIOR
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 |
---|---|---|---|---|---|
08/29/2022 | SUPPL-11 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210655s011lbl.pdf | ||
12/15/2022 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210655s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210655Orig1s010ltr.pdf | |
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 |
---|---|---|---|---|---|
12/15/2022 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210655s010lbl.pdf | |
08/29/2022 | SUPPL-11 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210655s011lbl.pdf | |
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 |