| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZOFRAN ODT | 020781 | 001 | NDA | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/01/27 | 1999/01/27 | SANDOZ | Discontinued |
| ZOFRAN ODT | 020781 | 002 | NDA | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/01/27 | 1999/01/27 | SANDOZ | Discontinued |