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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202971
Company: OTSUKA PHARM CO LTD

Medication Guide

Summary Review

Products on NDA 202971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	Yes
ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202971Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf
02/23/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021436Orig1s042,021713Orig2s033,021729Orig1s025,021866Orig1s027,202971Orig1s011ltr.pdf
07/27/2017	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202971Orig1s010ltr.pdf
08/18/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf
01/15/2016	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf
03/24/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/29/2015	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202971s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202971Orig1s006ltr.pdf
01/05/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/29/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s004lbl.pdf
12/05/2014	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202971Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202971Orig1s003TOC.cfm
05/30/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s002lbl.pdf
08/15/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202971

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf
07/27/2017	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf
02/23/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s011lbl.pdf
08/18/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s009lbl.pdf
01/15/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s008lbl.pdf
07/29/2015	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202971s006lbl.pdf
12/05/2014	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s003lbl.pdf
09/29/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s004lbl.pdf
05/30/2014	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s002lbl.pdf
02/28/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf

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