| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZOCOR | 019766 | 001 | NDA | SIMVASTATIN | TABLET;ORAL | 5MG | Yes | No | 1991/12/23 | 1991/12/23 | ORGANON | Prescription |
| ZOCOR | 019766 | 002 | NDA | SIMVASTATIN | TABLET;ORAL | 10MG | Yes | No | 1991/12/23 | 1991/12/23 | ORGANON | Prescription |
| ZOCOR | 019766 | 003 | NDA | SIMVASTATIN | TABLET;ORAL | 20MG | Yes | No | 1991/12/23 | 1991/12/23 | ORGANON | Prescription |
| ZOCOR | 019766 | 004 | NDA | SIMVASTATIN | TABLET;ORAL | 40MG | Yes | No | 1991/12/23 | 1991/12/23 | ORGANON | Prescription |
| ZOCOR | 019766 | 005 | NDA | SIMVASTATIN | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/12/23 | 1998/07/10 | ORGANON | Discontinued |