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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | 086166 | 002 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | -- | 1986/09/19 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 086167 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | -- | 1986/09/19 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 086168 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG | No | No | -- | 1986/09/18 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 086169 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | -- | 1986/09/19 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 087545 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 10MG | No | No | -- | 1986/09/18 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 087564 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG | No | No | -- | 1986/09/18 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 084204 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG | No | No | 1978/12/01 | 1986/09/18 | SUN PHARM INDUSTRIES | Discontinued |
ISOSORBIDE DINITRATE | 089190 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 1987/02/17 | 1987/02/17 | SUPERPHARM | Discontinued |
ISOSORBIDE DINITRATE | 089191 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 1987/02/17 | 1987/02/17 | SUPERPHARM | Discontinued |
ISOSORBIDE DINITRATE | 089192 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | 1987/02/17 | 1987/02/17 | SUPERPHARM | Discontinued |
ISOSORBIDE DINITRATE | 086923 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 1987/03/12 | 1987/03/12 | ENDO OPERATIONS | Prescription |
ISOSORBIDE DINITRATE | 086925 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 1987/03/12 | 1987/03/12 | ENDO OPERATIONS | Prescription |
ISOSORBIDE DINITRATE | 087946 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG | No | Yes | 1987/03/12 | 1988/01/12 | ENDO OPERATIONS | Prescription |
ISOSORBIDE DINITRATE | 086031 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1987/09/29 | 1987/09/29 | WATSON LABS TEVA | Discontinued |
ISOSORBIDE DINITRATE | 087537 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | 1987/10/02 | 1987/10/02 | ENDO OPERATIONS | Prescription |
ISOSORBIDE DINITRATE | 086066 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 1987/10/26 | 1987/10/29 | HIKMA INTL PHARMS | Prescription |
ISOSORBIDE DINITRATE | 086067 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 1987/10/26 | 1987/10/29 | HIKMA INTL PHARMS | Prescription |
ISOSORBIDE DINITRATE | 086054 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG | No | No | 1987/10/29 | 1987/10/29 | HIKMA INTL PHARMS | Discontinued |
ISOSORBIDE DINITRATE | 086055 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG | No | No | 1987/11/02 | 1987/11/02 | HIKMA INTL PHARMS | Discontinued |
ISOSORBIDE DINITRATE | 088088 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | 1987/11/02 | 1987/11/02 | HIKMA INTL PHARMS | Prescription |