| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FLUVASTATIN SODIUM | 078872 | 001 | ANDA | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE; ORAL | 80MG | No | No | 2009/09/15 (TA) | -- | PAR PHARM | None (Tentative Approval) |
| FLUVASTATIN SODIUM | 090595 | 001 | ANDA | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 20MG BASE | No | No | 2012/04/11 | 2012/04/11 | MYLAN PHARMS INC | Prescription |
| FLUVASTATIN SODIUM | 090595 | 002 | ANDA | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 40MG BASE | No | Yes | 2012/04/11 | 2012/04/11 | MYLAN PHARMS INC | Prescription |
| FLUVASTATIN SODIUM | 078407 | 001 | ANDA | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 20MG BASE | No | No | 2012/06/12 | 2012/06/12 | TEVA PHARMS | Prescription |
| FLUVASTATIN SODIUM | 078407 | 002 | ANDA | FLUVASTATIN SODIUM | CAPSULE;ORAL | EQ 40MG BASE | No | No | 2012/06/12 | 2012/06/12 | TEVA PHARMS | Prescription |
| FLUVASTATIN SODIUM | 202458 | 001 | ANDA | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No | 2015/09/11 | 2015/09/11 | NORVIUM BIOSCIENCE | Discontinued |
| FLUVASTATIN SODIUM | 079011 | 001 | ANDA | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No | 2016/01/27 | 2016/01/27 | TEVA PHARMS USA | Prescription |
| FLUVASTATIN SODIUM | 209397 | 001 | ANDA | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No | 2021/04/26 | 2021/04/26 | BEIJING | Prescription |