| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | 022402 | 001 | NDA | CODEINE SULFATE | TABLET;ORAL | 15MG | Yes | No | 2009/07/16 | 2009/07/16 | HIKMA | Prescription |
| CODEINE SULFATE | 022402 | 002 | NDA | CODEINE SULFATE | TABLET;ORAL | 30MG | Yes | No | 2009/07/16 | 2009/07/16 | HIKMA | Prescription |
| CODEINE SULFATE | 022402 | 003 | NDA | CODEINE SULFATE | TABLET;ORAL | 60MG | Yes | Yes | 2009/07/16 | 2009/07/16 | HIKMA | Prescription |
| CODEINE SULFATE | 202245 | 001 | NDA | CODEINE SULFATE | SOLUTION;ORAL | 30MG/5ML | No | No | 2011/06/30 | 2011/06/30 | HIKMA | Discontinued |
| CODEINE SULFATE | 203046 | 001 | ANDA | CODEINE SULFATE | TABLET;ORAL | 15MG | No | No | 2014/06/13 | 2014/06/13 | LANNETT CO INC | Prescription |
| CODEINE SULFATE | 203046 | 002 | ANDA | CODEINE SULFATE | TABLET;ORAL | 30MG | No | No | 2014/06/13 | 2014/06/13 | LANNETT CO INC | Prescription |
| CODEINE SULFATE | 203046 | 003 | ANDA | CODEINE SULFATE | TABLET;ORAL | 60MG | No | No | 2014/06/13 | 2014/06/13 | LANNETT CO INC | Prescription |