| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ROXICODONE | 020932 | 001 | NDA | OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No | 1998/10/26 | 1998/10/26 | ROXANE | Discontinued |
| ROXICODONE | 020932 | 002 | NDA | OXYCODONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No | 1998/10/26 | 1998/10/26 | ROXANE | Discontinued |
| ROXICODONE | 021011 | 001 | NDA | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | Yes | Yes | 2000/08/31 | 2000/08/31 | SPECGX LLC | Prescription |
| ROXICODONE | 021011 | 002 | NDA | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | Yes | No | 2000/08/31 | 2000/08/31 | SPECGX LLC | Prescription |
| ROXICODONE | 021011 | 003 | NDA | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | No | 2000/08/31 | 2009/05/15 | SPECGX LLC | Prescription |