| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EFUDEX | 016831 | 001 | NDA | FLUOROURACIL | SOLUTION;TOPICAL | 2% | Yes | Yes | 1970/07/29 | Approved Prior to Jan 1, 1982 | EXTROVIS | Prescription |
| EFUDEX | 016831 | 002 | NDA | FLUOROURACIL | SOLUTION;TOPICAL | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1970/07/29 | Approved Prior to Jan 1, 1982 | EXTROVIS | Discontinued |
| EFUDEX | 016831 | 003 | NDA | FLUOROURACIL | CREAM;TOPICAL | 5% | Yes | Yes | 1970/07/29 | Approved Prior to Jan 1, 1982 | EXTROVIS | Prescription |