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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
FLECAINIDE ACETATE | 075442 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2001/07/31 | 2001/07/31 | AMNEAL PHARM | Prescription |
FLECAINIDE ACETATE | 075442 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2001/07/31 | 2001/07/31 | AMNEAL PHARM | Prescription |
FLECAINIDE ACETATE | 075442 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2001/07/31 | 2001/07/31 | AMNEAL PHARM | Prescription |
FLECAINIDE ACETATE | 075882 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Prescription |
FLECAINIDE ACETATE | 075882 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Prescription |
FLECAINIDE ACETATE | 075882 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Prescription |
FLECAINIDE ACETATE | 076030 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Discontinued |
FLECAINIDE ACETATE | 076030 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Discontinued |
FLECAINIDE ACETATE | 076030 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2002/10/28 | 2002/10/28 | ANI PHARMS | Discontinued |
FLECAINIDE ACETATE | 076278 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2003/01/14 | 2003/01/14 | HIKMA | Prescription |
FLECAINIDE ACETATE | 076278 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2003/01/14 | 2003/01/14 | HIKMA | Prescription |
FLECAINIDE ACETATE | 076278 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | Yes | 2003/01/14 | 2003/01/14 | HIKMA | Prescription |
FLECAINIDE ACETATE | 076421 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2003/03/28 | 2003/03/28 | SUN PHARM INDS LTD | Prescription |
FLECAINIDE ACETATE | 076421 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2003/03/28 | 2003/03/28 | SUN PHARM INDS LTD | Prescription |
FLECAINIDE ACETATE | 076421 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2003/03/28 | 2003/03/28 | SUN PHARM INDS LTD | Prescription |
FLECAINIDE ACETATE | 079164 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2009/07/09 | 2009/07/09 | CHARTWELL | Discontinued |
FLECAINIDE ACETATE | 079164 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2009/07/09 | 2009/07/09 | CHARTWELL | Discontinued |
FLECAINIDE ACETATE | 079164 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2009/07/09 | 2009/07/09 | CHARTWELL | Discontinued |
FLECAINIDE ACETATE | 202821 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2017/11/03 | 2017/11/03 | AUROBINDO PHARMA LTD | Prescription |
FLECAINIDE ACETATE | 202821 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2017/11/03 | 2017/11/03 | AUROBINDO PHARMA LTD | Prescription |