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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
REPAGLINIDE | 077571 | 001 | ANDA | REPAGLINIDE | TABLET; ORAL | 0.5MG | No | No | 2013/07/11 | -- | SUN PHARM INDS INC | None (Tentative Approval) |
REPAGLINIDE | 077571 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2013/07/11 | 2013/07/11 | SUN PHARM INDS INC | Prescription |
REPAGLINIDE | 077571 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2013/07/11 | 2013/07/11 | SUN PHARM INDS INC | Prescription |
REPAGLINIDE | 201189 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2013/07/17 | 2013/07/17 | PADAGIS US | Prescription |
REPAGLINIDE | 201189 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2013/07/17 | 2014/01/22 | PADAGIS US | Prescription |
REPAGLINIDE | 201189 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2013/07/17 | 2014/01/22 | PADAGIS US | Prescription |
REPAGLINIDE | 090252 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2013/08/23 | 2013/08/23 | MYLAN | Discontinued |
REPAGLINIDE | 090252 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2013/08/23 | 2014/01/22 | MYLAN | Discontinued |
REPAGLINIDE | 090252 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2013/08/23 | 2014/01/22 | MYLAN | Discontinued |
REPAGLINIDE | 078555 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2013/11/22 | 2013/11/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 078555 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2013/11/22 | 2014/01/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 078555 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2013/11/22 | 2014/01/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 078555 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2014/01/22 | 2013/11/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 078555 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2014/01/22 | 2014/01/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 078555 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2014/01/22 | 2014/01/22 | CHARTWELL RX | Prescription |
REPAGLINIDE | 090008 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2014/01/22 | 2014/01/22 | ACTAVIS TOTOWA | Discontinued |
REPAGLINIDE | 090008 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2014/01/22 | 2014/01/22 | ACTAVIS TOTOWA | Discontinued |
REPAGLINIDE | 090008 | 003 | ANDA | REPAGLINIDE | TABLET;ORAL | 2MG | No | No | 2014/01/22 | 2014/01/22 | ACTAVIS TOTOWA | Discontinued |
REPAGLINIDE | 090252 | 001 | ANDA | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No | 2014/01/22 | 2013/08/23 | MYLAN | Discontinued |
REPAGLINIDE | 090252 | 002 | ANDA | REPAGLINIDE | TABLET;ORAL | 1MG | No | No | 2014/01/22 | 2014/01/22 | MYLAN | Discontinued |