| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | 011265 | 002 | NDA | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 15MG/5ML;6.25MG/5ML | Yes | No | 1957/12/03 | 1984/04/02 | ANI PHARMS | Prescription |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | 040027 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 15MG/5ML;6.25MG/5ML | No | No | 1996/07/31 | 1996/07/31 | HIKMA | Discontinued |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | 090575 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 15MG/5ML;6.25MG/5ML | No | No | 2011/02/08 | 2011/02/08 | AMNEAL PHARMS | Prescription |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | 091687 | 001 | ANDA | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 15MG/5ML;6.25MG/5ML | No | No | 2012/06/28 | 2012/06/28 | TRIS PHARMA INC | Prescription |