| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | 021083 | 001 | NDA | SIROLIMUS | SOLUTION;ORAL | 1MG/ML | Yes | Yes | 1999/09/15 | 1999/09/15 | PF PRISM CV | Prescription |
| RAPAMUNE | 021110 | 001 | NDA | SIROLIMUS | TABLET;ORAL | 1MG | Yes | No | 2000/08/25 | 2000/08/25 | PF PRISM CV | Prescription |
| RAPAMUNE | 021110 | 002 | NDA | SIROLIMUS | TABLET;ORAL | 2MG | Yes | Yes | 2000/08/25 | 2002/08/22 | PF PRISM CV | Prescription |
| RAPAMUNE | 021110 | 003 | NDA | SIROLIMUS | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2000/08/25 | 2004/02/23 | PF PRISM CV | Discontinued |
| RAPAMUNE | 021110 | 004 | NDA | SIROLIMUS | TABLET;ORAL | 0.5MG | Yes | No | 2000/08/25 | 2010/01/25 | PF PRISM CV | Prescription |