| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ISRADIPINE | 077317 | 001 | ANDA | ISRADIPINE | CAPSULE;ORAL | 2.5MG | No | No | 2006/01/05 | 2006/01/05 | WATSON LABS TEVA | Prescription |
| ISRADIPINE | 077317 | 002 | ANDA | ISRADIPINE | CAPSULE;ORAL | 5MG | No | Yes | 2006/01/05 | 2006/01/05 | WATSON LABS TEVA | Prescription |
| ISRADIPINE | 077169 | 001 | ANDA | ISRADIPINE | CAPSULE;ORAL | 2.5MG | No | No | 2006/04/24 | 2006/04/24 | ELITE LABS INC | Prescription |
| ISRADIPINE | 077169 | 002 | ANDA | ISRADIPINE | CAPSULE;ORAL | 5MG | No | No | 2006/04/24 | 2006/04/24 | ELITE LABS INC | Prescription |
| ISRADIPINE | 201067 | 001 | ANDA | ISRADIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No | 2015/11/27 | 2015/11/27 | NORVIUM BIOSCIENCE | Discontinued |
| ISRADIPINE | 201067 | 002 | ANDA | ISRADIPINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No | 2015/11/27 | 2015/11/27 | NORVIUM BIOSCIENCE | Discontinued |