| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZADITOR | 021066 | 002 | NDA | KETOTIFEN FUMARATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/07/02 | 2006/10/19 | ALCON PHARMA | Discontinued |
| ZADITOR | 077200 | 001 | ANDA | KETOTIFEN FUMARATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE | No | Yes | 2008/09/02 | 2008/09/02 | ALCON PHARMS LTD | Over-the-counter |