Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202971
Company: OTSUKA PHARM CO LTD
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 | AP | Yes | No |
ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | AP | 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 |
---|---|---|---|---|---|
01/22/2025 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202971s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021436Orig1s046s050;202971Orig1s019;207202Orig1s009;217006Orig1s002ltr.pdf | |
02/05/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf | |
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 |
---|---|---|---|---|---|
01/22/2025 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202971s019lbl.pdf | |
02/05/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf | |
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 |
ABILIFY MAINTENA KIT
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 300MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | Yes | AP | 202971 | OTSUKA PHARM CO LTD |
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 400MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | Yes | AP | 202971 | OTSUKA PHARM CO LTD |