| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 213330 | 002 | NDA | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | Yes | Yes | 2020/11/09 | 2020/11/09 | HIKMA | Prescription |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 213330 | 003 | NDA | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 200MG/200ML (1MG/ML) | Yes | Yes | 2020/11/09 | 2020/11/09 | HIKMA | Prescription |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 213330 | 004 | NDA | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 300MG/300ML (1MG/ML) | Yes | Yes | 2020/11/09 | 2020/11/09 | HIKMA | Prescription |