Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 205422
Company: OTSUKA

Medication Guide

Products on NDA 205422

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REXULTI	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	AB	Yes	No
REXULTI	BREXPIPRAZOLE	0.5MG	TABLET;ORAL	Prescription	AB	Yes	No
REXULTI	BREXPIPRAZOLE	1MG	TABLET;ORAL	Prescription	AB	Yes	No
REXULTI	BREXPIPRAZOLE	2MG	TABLET;ORAL	Prescription	AB	Yes	Yes
REXULTI	BREXPIPRAZOLE	3MG	TABLET;ORAL	Prescription	AB	Yes	No
REXULTI	BREXPIPRAZOLE	4MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2015	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf
07/10/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205422Orig1Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205422s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
05/07/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422s011lblcorrection.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205422Orig1s011ltr.pdf
05/10/2023	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF) Review	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205422s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205422Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205422Orig1s009TOC.cfm
10/06/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205422Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205422Orig1s008ltr.pdf
12/27/2021	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205422s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205422Orig1s007ltr.pdf
06/17/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205422Orig1s005ltr.pdf
02/09/2018	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205422Orig1s003ltr.pdf
02/23/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205422Orig1s002ltr.pdf
09/23/2016	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205422Orig1s001ltr.pdf

Labels for NDA 205422

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
05/07/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422s011lblcorrection.pdf
05/10/2023	SUPPL-9	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205422s009lbl.pdf
10/06/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205422Orig1s008lbl.pdf
12/27/2021	SUPPL-7	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205422s007lbl.pdf
06/17/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf
02/09/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf
02/09/2018	SUPPL-3	Labeling-Medication Guide	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf
02/23/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205422s002lbl.pdf
09/23/2016	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205422s001lbl.pdf
07/10/2015	ORIG-2	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf
07/10/2015	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf

Therapeutic Equivalents for NDA 205422

REXULTI

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	0.5MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	1MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	2MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA

TABLET;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	3MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REXULTI	BREXPIPRAZOLE	4MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA