| 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 | 205227 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |
| TEMOZOLOMIDE | 205227 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |
| TEMOZOLOMIDE | 203490 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 203490 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 203490 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 203490 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 203490 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 203490 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/07/13 | 2016/07/13 | ANI PHARMS | Discontinued |
| TEMOZOLOMIDE | 204639 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 204639 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 204639 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 204639 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 204639 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 204639 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/11/23 | 2016/11/23 | CHEMI SPA | Prescription |
| TEMOZOLOMIDE | 201528 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |
| TEMOZOLOMIDE | 201528 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |
| TEMOZOLOMIDE | 201528 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |
| TEMOZOLOMIDE | 201528 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |
| TEMOZOLOMIDE | 201528 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |
| TEMOZOLOMIDE | 201528 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | Yes | 2017/02/27 | 2017/02/27 | ACCORD HLTHCARE | Prescription |