Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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