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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
FENOFIBRATE | 090715 | 001 | ANDA | FENOFIBRATE | TABLET;ORAL | 48MG | No | No | 2012/04/05 | 2012/04/05 | VALEANT PHARMS NORTH | Prescription |
FENOFIBRATE | 090715 | 002 | ANDA | FENOFIBRATE | TABLET;ORAL | 145MG | No | No | 2012/04/05 | 2012/04/05 | VALEANT PHARMS NORTH | Prescription |
FENOFIBRATE (MICRONIZED) | 202676 | 001 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 67MG | No | No | 2012/10/23 | 2012/10/23 | RISING | Discontinued |
FENOFIBRATE (MICRONIZED) | 202676 | 002 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 134MG | No | No | 2012/10/23 | 2012/10/23 | RISING | Discontinued |
FENOFIBRATE (MICRONIZED) | 202676 | 003 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 200MG | No | No | 2012/10/23 | 2012/10/23 | RISING | Discontinued |
FENOFIBRATE | 200579 | 001 | ANDA | FENOFIBRATE | CAPSULE; ORAL | 43MG | No | No | 2012/11/29 (TA) | -- | MYLAN PHARMS INC | None (Tentative Approval) |
FENOFIBRATE | 200579 | 002 | ANDA | FENOFIBRATE | CAPSULE; ORAL | 130MG | No | No | 2012/11/29 (TA) | -- | MYLAN PHARMS INC | None (Tentative Approval) |
FENOFIBRATE | 202856 | 001 | ANDA | FENOFIBRATE | TABLET;ORAL | 48MG | No | No | 2012/12/07 | 2012/12/07 | MYLAN PHARMS INC | Prescription |
FENOFIBRATE | 202856 | 002 | ANDA | FENOFIBRATE | TABLET;ORAL | 145MG | No | No | 2012/12/07 | 2012/12/07 | MYLAN PHARMS INC | Prescription |
FENOFIBRATE (MICRONIZED) | 202579 | 001 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 43MG | No | No | 2013/01/10 | 2013/01/10 | MYLAN PHARMS INC | Discontinued |
FENOFIBRATE (MICRONIZED) | 202579 | 002 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 130MG | No | No | 2013/01/10 | 2013/01/10 | MYLAN PHARMS INC | Discontinued |
FENOFIBRATE (MICRONIZED) | 202252 | 001 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 43MG | No | No | 2013/07/26 | 2013/07/26 | APOTEX | Prescription |
FENOFIBRATE (MICRONIZED) | 202252 | 002 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 130MG | No | No | 2013/07/26 | 2013/07/26 | APOTEX | Prescription |
FENOFIBRATE | 201748 | 001 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 43MG | No | No | 2014/10/31 | 2014/10/31 | SUN PHARM INDS LTD | Prescription |
FENOFIBRATE | 201748 | 002 | ANDA | FENOFIBRATE | CAPSULE;ORAL | 130MG | No | No | 2014/10/31 | 2014/10/31 | SUN PHARM INDS LTD | Prescription |
FENOFIBRATE | 204019 | 001 | ANDA | FENOFIBRATE | TABLET;ORAL | 54MG | No | No | 2015/08/17 | 2015/08/17 | LUPIN LTD | Prescription |
FENOFIBRATE | 204019 | 002 | ANDA | FENOFIBRATE | TABLET;ORAL | 160MG | No | No | 2015/08/17 | 2015/08/17 | LUPIN LTD | Prescription |
FENOFIBRATE | 205118 | 001 | ANDA | FENOFIBRATE | TABLET;ORAL | 48MG | No | No | 2016/05/05 | 2016/05/05 | AUROBINDO PHARMA | Prescription |
FENOFIBRATE | 205118 | 002 | ANDA | FENOFIBRATE | TABLET;ORAL | 145MG | No | Yes | 2016/05/05 | 2016/05/05 | AUROBINDO PHARMA | Prescription |
FENOFIBRATE | 204475 | 001 | ANDA | FENOFIBRATE | TABLET;ORAL | 40MG | No | No | 2016/06/23 | 2016/06/23 | MYLAN PHARMS INC | Prescription |