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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210655
Company: INDIVIOR

Products on NDA 210655

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210655

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

Labels for NDA 210655

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

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