| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACTONEL | 020835 | 001 | NDA | RISEDRONATE SODIUM | TABLET;ORAL | 30MG | Yes | No | 1998/03/27 | 1998/03/27 | APIL | Discontinued |
| ACTONEL | 020835 | 002 | NDA | RISEDRONATE SODIUM | TABLET;ORAL | 5MG | Yes | No | 1998/03/27 | 2000/04/14 | APIL | Discontinued |
| ACTONEL | 020835 | 003 | NDA | RISEDRONATE SODIUM | TABLET;ORAL | 35MG | Yes | Yes | 1998/03/27 | 2002/05/25 | APIL | Prescription |
| ACTONEL | 020835 | 004 | NDA | RISEDRONATE SODIUM | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/03/27 | 2007/04/16 | APIL | Discontinued |
| ACTONEL | 020835 | 005 | NDA | RISEDRONATE SODIUM | TABLET;ORAL | 150MG | Yes | Yes | 1998/03/27 | 2008/04/22 | APIL | Prescription |
| ACTONEL WITH CALCIUM (COPACKAGED) | 021823 | 001 | NDA | CALCIUM CARBONATE; RISEDRONATE SODIUM | TABLET;ORAL | EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2005/08/12 | 2005/08/12 | WARNER CHILCOTT | Discontinued |