| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NEORAL | 050715 | 001 | NDA | CYCLOSPORINE | CAPSULE;ORAL | 25MG | Yes | No | 1995/07/14 | 1995/07/14 | NOVARTIS | Prescription |
| NEORAL | 050715 | 002 | NDA | CYCLOSPORINE | CAPSULE;ORAL | 100MG | Yes | Yes | 1995/07/14 | 1995/07/14 | NOVARTIS | Prescription |
| NEORAL | 050715 | 003 | NDA | CYCLOSPORINE | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/07/14 | 1995/07/14 | NOVARTIS | Discontinued |
| NEORAL | 050716 | 001 | NDA | CYCLOSPORINE | SOLUTION;ORAL | 100MG/ML | Yes | Yes | 1995/07/14 | 1995/07/14 | NOVARTIS | Prescription |
| NEORAL | 050735 | 001 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 25MG | No | No | 1997/05/22 | -- | NOVARTIS | Prescription |
| NEORAL | 050735 | 002 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 100MG | No | No | 1997/05/22 | -- | NOVARTIS | Prescription |
| NEORAL | 050736 | 001 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 25MG | No | No | 1997/05/22 | -- | NOVARTIS | Prescription |
| NEORAL | 050736 | 002 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 100MG | No | No | 1997/05/22 | -- | NOVARTIS | Prescription |
| NEORAL | 050737 | 001 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 25MG | No | No | 1997/06/19 | -- | NOVARTIS | Prescription |
| NEORAL | 050737 | 002 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 100MG | No | No | 1997/06/19 | -- | NOVARTIS | Prescription |
| NEORAL | 050738 | 001 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 25MG | No | No | 1997/06/19 | -- | NOVARTIS | Prescription |
| NEORAL | 050738 | 002 | NDA | CYCLOSPORINE | CAPSULE; ORAL | 100MG | No | No | 1997/06/19 | -- | NOVARTIS | Prescription |