| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | 202993 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE | CAPSULE;ORAL | 20MG;10MG | No | No | 2015/12/23 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | 202934 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | CAPSULE;ORAL | 20MG;10MG | No | No | 2017/10/10 | 2017/10/10 | ACTAVIS ELIZABETH | Prescription |
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | 218426 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | CAPSULE;ORAL | 20MG;10MG | No | No | 2024/08/28 | 2024/08/28 | HETERO LABS LTD III | Prescription |