| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DRIXORAL | 013483 | 003 | NDA | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1963/10/18 | 1982/09/13 | SCHERING PLOUGH | Discontinued |
| DRIXORAL PLUS | 019453 | 001 | NDA | ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 500MG;3MG;60MG | No | No | 1987/05/22 | 1987/05/22 | SCHERING PLOUGH | Discontinued |