Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209830
Company: ALKERMES INC

• Medication Guide

Products on NDA 209830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTADA INITIO KIT	ARIPIPRAZOLE LAUROXIL	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209830

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209830Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2021	SUPPL-9	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-5	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,%20209830Orig1s005ltr.pdf

Labels for NDA 209830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf
06/29/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf