| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ABILIFY MYCITE KIT | 207202 | 005 | NDA | ARIPIPRAZOLE | TABLET;ORAL | 20MG | Yes | No | 2017/11/13 | 2017/11/13 | OTSUKA | Prescription |
| ABILIFY MYCITE KIT | 207202 | 006 | NDA | ARIPIPRAZOLE | TABLET;ORAL | 30MG | Yes | No | 2017/11/13 | 2017/11/13 | OTSUKA | Prescription |
| ABILIFY ASIMTUFII | 217006 | 001 | NDA | ARIPIPRAZOLE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 720MG/2.4ML (300MG/ML) | Yes | No | 2023/04/27 | 2023/04/27 | OTSUKA | Prescription |
| ABILIFY ASIMTUFII | 217006 | 002 | NDA | ARIPIPRAZOLE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 960MG/3.2ML (300MG/ML) | Yes | Yes | 2023/04/27 | 2023/04/27 | OTSUKA | Prescription |