Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202971
Company: OTSUKA PHARM CO LTD
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
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
02/23/2017 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.

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