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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207202
Company: OTSUKA

Medication Guide

Products on NDA 207202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABILIFY MYCITE KIT	ARIPIPRAZOLE	2MG	TABLET;ORAL	Prescription	None	Yes	No
ABILIFY MYCITE KIT	ARIPIPRAZOLE	5MG	TABLET;ORAL	Prescription	None	Yes	Yes
ABILIFY MYCITE KIT	ARIPIPRAZOLE	10MG	TABLET;ORAL	Prescription	None	Yes	No
ABILIFY MYCITE KIT	ARIPIPRAZOLE	15MG	TABLET;ORAL	Prescription	None	Yes	No
ABILIFY MYCITE KIT	ARIPIPRAZOLE	20MG	TABLET;ORAL	Prescription	None	Yes	No
ABILIFY MYCITE KIT	ARIPIPRAZOLE	30MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2017	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207202Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207202Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207202s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021436Orig1s048;207202Orig1s006ltr.pdf
02/05/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf
12/19/2020	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf
02/05/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf

Labels for NDA 207202

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207202s006lbl.pdf
12/19/2020	SUPPL-3	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf
02/05/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf
02/05/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf
11/13/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf

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