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ABILIFY MAINTENA KIT از شرکت OTSUKA PHARM CO LTD
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2020 | SUPPL-13 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s004lbl.pdf |
||
| 12/05/2014 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
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) |
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 |
|---|---|---|---|---|---|
| 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 |
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