| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALEVE | 020204 | 002 | NDA | NAPROXEN SODIUM | TABLET;ORAL | 220MG | Yes | Yes | 1994/01/11 | 1994/01/11 | BAYER | Over-the-counter |
| ALEVE-D SINUS & COLD | 021076 | 001 | NDA | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/11/29 | 1999/11/29 | BAYER | Discontinued |
| ALEVE PM | 205352 | 001 | NDA | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | TABLET;ORAL | 25MG;220MG | Yes | Yes | 2014/01/17 | 2014/01/17 | BAYER HLTHCARE | Over-the-counter |