| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NUVIGIL | 021875 | 001 | NDA | ARMODAFINIL | TABLET;ORAL | 50MG | Yes | No | 2007/06/15 | 2007/06/15 | CEPHALON | Prescription |
| NUVIGIL | 021875 | 002 | NDA | ARMODAFINIL | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/06/15 | 2009/03/26 | CEPHALON | Discontinued |
| NUVIGIL | 021875 | 003 | NDA | ARMODAFINIL | TABLET;ORAL | 150MG | Yes | No | 2007/06/15 | 2007/06/15 | CEPHALON | Prescription |
| NUVIGIL | 021875 | 004 | NDA | ARMODAFINIL | TABLET;ORAL | 250MG | Yes | Yes | 2007/06/15 | 2007/06/15 | CEPHALON | Prescription |
| NUVIGIL | 021875 | 005 | NDA | ARMODAFINIL | TABLET;ORAL | 200MG | Yes | No | 2007/06/15 | 2009/03/26 | CEPHALON | Prescription |