| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TEMOZOLOMIDE | 078879 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 078879 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 078879 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 078879 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 078879 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 078879 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2010/03/01 | 2010/03/01 | HERITAGE | Discontinued |
| TEMOZOLOMIDE | 201742 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 201742 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 201742 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 201742 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 201742 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 201742 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2014/02/12 | 2014/02/12 | SUN PHARM | Prescription |
| TEMOZOLOMIDE | 203691 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203691 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203691 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203691 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203691 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203691 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | Yes | 2015/05/08 | 2015/05/08 | AMNEAL PHARMS | Prescription |
| TEMOZOLOMIDE | 203898 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |
| TEMOZOLOMIDE | 203898 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |