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 | 203898 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |
TEMOZOLOMIDE | 203898 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |
TEMOZOLOMIDE | 203898 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |
TEMOZOLOMIDE | 203898 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/02/10 | 2016/02/10 | CHARTWELL MOLECULAR | Discontinued |
TEMOZOLOMIDE | 206413 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206413 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206413 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206413 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206413 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206413 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/04/12 | 2016/04/12 | CHARTWELL | Prescription |
TEMOZOLOMIDE | 206309 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 206309 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 206309 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 206309 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 206309 | 005 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 206309 | 006 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No | 2016/04/27 | 2016/04/27 | RISING | Prescription |
TEMOZOLOMIDE | 205227 | 001 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |
TEMOZOLOMIDE | 205227 | 002 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |
TEMOZOLOMIDE | 205227 | 003 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |
TEMOZOLOMIDE | 205227 | 004 | ANDA | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No | 2016/06/29 | 2016/06/29 | MYLAN | Discontinued |