| 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 MAINTENA KIT | 202971 | 001 | NDA | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 300MG/VIAL | Yes | No | 2013/02/28 | 2013/02/28 | OTSUKA PHARM CO LTD | Prescription |
| ABILIFY MAINTENA KIT | 202971 | 002 | NDA | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG/VIAL | Yes | Yes | 2013/02/28 | 2013/02/28 | OTSUKA PHARM CO LTD | Prescription |
| ABILIFY MAINTENA KIT | 202971 | 003 | NDA | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 300MG | Yes | No | 2013/02/28 | 2014/09/29 | OTSUKA PHARM CO LTD | Prescription |
| ABILIFY MAINTENA KIT | 202971 | 004 | NDA | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG | Yes | No | 2013/02/28 | 2014/09/29 | OTSUKA PHARM CO LTD | Prescription |