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 | 202821 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2017/11/03 | 2017/11/03 | AUROBINDO PHARMA LTD | Prescription |
FLECAINIDE ACETATE | 210683 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2020/09/16 | 2020/09/16 | BEXIMCO PHARMS USA | Prescription |
FLECAINIDE ACETATE | 210683 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2020/09/16 | 2020/09/16 | BEXIMCO PHARMS USA | Prescription |
FLECAINIDE ACETATE | 210683 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2020/09/16 | 2020/09/16 | BEXIMCO PHARMS USA | Prescription |
FLECAINIDE ACETATE | 215599 | 001 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No | 2022/09/08 | 2022/09/08 | YICHANG HUMANWELL | Prescription |
FLECAINIDE ACETATE | 215599 | 002 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No | 2022/09/08 | 2022/09/08 | YICHANG HUMANWELL | Prescription |
FLECAINIDE ACETATE | 215599 | 003 | ANDA | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No | 2022/09/08 | 2022/09/08 | YICHANG HUMANWELL | Prescription |