| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ROXICET | 087003 | 001 | ANDA | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1980/02/25 | Approved Prior to Jan 1, 1982 | HIKMA | Discontinued |
| ROXICET | 089351 | 001 | ANDA | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1986/12/03 | 1986/12/03 | HIKMA | Discontinued |
| ROXICET 5/500 | 089775 | 001 | ANDA | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 500MG;5MG | No | No | 1989/01/12 | 1989/01/12 | ROXANE | Discontinued |