| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GLEOSTINE | 017588 | 001 | NDA | LOMUSTINE | CAPSULE;ORAL | 10MG | Yes | No | 1976/08/04 | Approved Prior to Jan 1, 1982 | LATINA PHARMA | Prescription |
| GLEOSTINE | 017588 | 002 | NDA | LOMUSTINE | CAPSULE;ORAL | 40MG | Yes | Yes | 1976/08/04 | Approved Prior to Jan 1, 1982 | LATINA PHARMA | Prescription |
| GLEOSTINE | 017588 | 003 | NDA | LOMUSTINE | CAPSULE;ORAL | 100MG | Yes | No | 1976/08/04 | Approved Prior to Jan 1, 1982 | LATINA PHARMA | Prescription |
| GLEOSTINE | 017588 | 004 | NDA | LOMUSTINE | CAPSULE;ORAL | 5MG | Yes | No | 1976/08/04 | 2014/12/19 | LATINA PHARMA | Discontinued |