اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ABILIFY MYCITE KIT از شرکت OTSUKA
New Drug Application (NDA): 207202
Company: OTSUKA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription |
None |
Yes | Yes |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | 30MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/13/2017 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2020 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf |
||
| 12/19/2020 | SUPPL-3 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf |
|||
| 02/05/2020 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 202971Orig1s013; 207202Orig1s002, s004; 021713Orig1s035, s036; 021729Orig1s027, s028; 021866Orig1s029, s030ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2020 | SUPPL-3 |
Manufacturing (CMC) |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf | |
| 02/05/2020 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf | |
| 02/05/2020 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf | |
| 11/13/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf |
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