| 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 | 086034 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 1988/01/06 | 1988/01/06 | WATSON LABS | Discontinued |
| ISOSORBIDE DINITRATE | 086032 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 1988/01/07 | 1988/01/07 | ANI PHARMS | Discontinued |
| ISOSORBIDE DINITRATE | 086221 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 1988/01/07 | 1988/01/07 | SANDOZ | Prescription |
| ISOSORBIDE DINITRATE | 086223 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 1988/01/07 | 1988/01/07 | SANDOZ | Prescription |
| ISOSORBIDE DINITRATE | 086222 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG | No | No | 1988/02/19 | 1988/02/19 | SANDOZ | Discontinued |
| ISOSORBIDE DINITRATE | 086225 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG | No | No | 1988/02/19 | 1988/02/19 | SANDOZ | Discontinued |
| ISOSORBIDE DINITRATE | 086033 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1988/02/26 | 1988/02/26 | WATSON LABS | Discontinued |
| ISOSORBIDE DINITRATE | 089367 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | 1988/04/07 | 1988/04/07 | SANDOZ | Prescription |
| ISOSORBIDE DINITRATE | 040009 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | No | 1998/12/30 | 1998/12/30 | SUN PHARM INDS INC | Discontinued |
| ISOSORBIDE DINITRATE | 040591 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG | No | No | 2007/01/10 | 2007/01/10 | HIKMA INTL PHARMS | Discontinued |
| ISOSORBIDE DINITRATE | 040723 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | No | 2008/03/17 | 2008/03/17 | IMPAX LABS INC | Discontinued |
| ISOSORBIDE DINITRATE | 213057 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 2019/11/20 | 2019/11/20 | ZYDUS | Prescription |
| ISOSORBIDE DINITRATE | 213057 | 002 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 2019/11/20 | 2019/11/20 | ZYDUS | Prescription |
| ISOSORBIDE DINITRATE | 213057 | 003 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 20MG | No | No | 2019/11/20 | 2019/11/20 | ZYDUS | Prescription |
| ISOSORBIDE DINITRATE | 213057 | 004 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 30MG | No | No | 2019/11/20 | 2019/11/20 | ZYDUS | Prescription |
| ISOSORBIDE DINITRATE | 213057 | 005 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 40MG | No | No | 2019/11/20 | 2019/11/20 | ZYDUS | Prescription |
| ISOSORBIDE DINITRATE | 211290 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 40MG | No | No | 2021/11/23 | 2021/11/23 | ENDO OPERATIONS | Prescription |
| ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | 215586 | 001 | ANDA | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | TABLET;ORAL | 37.5MG;20MG | No | No | 2022/04/06 | 2022/04/06 | RICONPHARMA LLC | Prescription |
| ISOSORBIDE DINITRATE | 215723 | 001 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 5MG | No | No | 2022/07/08 | 2022/07/08 | RUBICON | Prescription |
| ISOSORBIDE DINITRATE | 215723 | 002 | ANDA | ISOSORBIDE DINITRATE | TABLET;ORAL | 10MG | No | No | 2022/07/08 | 2022/07/08 | RUBICON | Prescription |