| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | 021346 | 001 | NDA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 25MG/VIAL | Yes | Yes | 2003/10/29 | 2003/10/29 | JANSSEN PHARMS | Prescription |
| RISPERDAL CONSTA | 021346 | 002 | NDA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 37.5MG/VIAL | Yes | No | 2003/10/29 | 2003/10/29 | JANSSEN PHARMS | Prescription |
| RISPERDAL CONSTA | 021346 | 003 | NDA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 50MG/VIAL | Yes | No | 2003/10/29 | 2003/10/29 | JANSSEN PHARMS | Prescription |
| RISPERDAL CONSTA | 021346 | 004 | NDA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 12.5MG/VIAL | Yes | No | 2003/10/29 | 2007/04/12 | JANSSEN PHARMS | Prescription |