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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207946
Company: JANSSEN PHARMS

Summary Review

Products on NDA 207946

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207946

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
08/09/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)	Label for INVEGA TRINZA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207946Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207946Orig1s011ltr.pdf
08/30/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)	Label for INVEGA HAFYERA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207946Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207946Orig1s010ltr.pdf
02/12/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021999Orig1s037, 022264Orig1s030, 207946Orig1s009ltr.pdf
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

Labels for NDA 207946

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)	Label for INVEGA HAFYERA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207946Orig1s010lbl.pdf
08/09/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)	Label for INVEGA TRINZA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207946Orig1s011lbl.pdf
02/12/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf
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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