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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207533
Company: ALKERMES INC

Medication Guide

Summary Review

Products on NDA 207533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTADA	ARIPIPRAZOLE LAUROXIL	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
ARISTADA	ARIPIPRAZOLE LAUROXIL	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No
ARISTADA	ARIPIPRAZOLE LAUROXIL	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	Yes
ARISTADA	ARIPIPRAZOLE LAUROXIL	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207533Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207533Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207533Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2021	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207533Orig1s021,209830Orig1s009ltr.pdf
08/27/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207533Orig1s017, 209830Orig1s005ltr.pdf
11/30/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207533s013lbl.pdf
01/25/2018	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207533Orig1s009ltr.pdf
02/23/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207533Orig1s006ltr.pdf
06/05/2017	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207533Orig1s004ltr.pdf
08/18/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207533s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207533Orig1s003ltr.pdf
03/24/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207533

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf
11/30/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207533s013lbl.pdf
06/05/2017	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf
02/23/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s006lbl.pdf
08/18/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207533s003lbl.pdf
10/05/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533s000lbl.pdf

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