| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DANTROLENE SODIUM | 076856 | 001 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 25MG | No | No | 2005/03/01 | 2005/03/01 | IMPAX LABS | Prescription |
| DANTROLENE SODIUM | 076856 | 002 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 50MG | No | No | 2005/03/01 | 2005/03/01 | IMPAX LABS | Prescription |
| DANTROLENE SODIUM | 076856 | 003 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 100MG | No | No | 2005/03/01 | 2005/03/01 | IMPAX LABS | Prescription |
| DANTROLENE SODIUM | 076686 | 001 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 25MG | No | No | 2005/10/24 | 2005/10/24 | ELITE LABS INC | Prescription |
| DANTROLENE SODIUM | 076686 | 002 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 50MG | No | No | 2005/10/24 | 2005/10/24 | ELITE LABS INC | Prescription |
| DANTROLENE SODIUM | 076686 | 003 | ANDA | DANTROLENE SODIUM | CAPSULE;ORAL | 100MG | No | No | 2005/10/24 | 2005/10/24 | ELITE LABS INC | Prescription |
| DANTROLENE SODIUM | 205239 | 001 | ANDA | DANTROLENE SODIUM | INJECTABLE;INJECTION | 20MG/VIAL | No | No | 2016/02/18 | 2016/02/18 | EUGIA PHARMA SPECLTS | Discontinued |
| DANTROLENE SODIUM | 204762 | 001 | ANDA | DANTROLENE SODIUM | INJECTABLE;INJECTION | 20MG/VIAL | No | No | 2017/06/19 | 2017/06/19 | HIKMA | Prescription |