| 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 | 207863 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2019/02/04 | 2019/02/04 | HIBROW HLTHCARE | Prescription |
| LABETALOL HYDROCHLORIDE | 211325 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2019/05/13 | 2019/05/13 | CADILA PHARMS LTD | Prescription |
| LABETALOL HYDROCHLORIDE | 211325 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2019/05/13 | 2019/05/13 | CADILA PHARMS LTD | Prescription |
| LABETALOL HYDROCHLORIDE | 211325 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2019/05/13 | 2019/05/13 | CADILA PHARMS LTD | Prescription |
| LABETALOL HYDROCHLORIDE | 212990 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2020/09/30 | 2020/09/30 | EPIC PHARMA LLC | Prescription |
| LABETALOL HYDROCHLORIDE | 212990 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2020/09/30 | 2020/09/30 | EPIC PHARMA LLC | Prescription |
| LABETALOL HYDROCHLORIDE | 212990 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2020/09/30 | 2020/09/30 | EPIC PHARMA LLC | Prescription |
| LABETALOL HYDROCHLORIDE IN DEXTROSE | 213330 | 001 | 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 | 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 |
| LABETALOL HYDROCHLORIDE | 213330 | 005 | NDA | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/2ML (5MG/ML) | Yes | No | 2020/11/09 | 2022/03/18 | HIKMA | Discontinued |
| LABETALOL HYDROCHLORIDE | 213330 | 006 | NDA | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 20MG/4ML (5MG/ML) | Yes | Yes | 2020/11/09 | 2024/08/19 | HIKMA | Prescription |
| LABETALOL HYDROCHLORIDE | 211953 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2021/08/18 | 2021/08/18 | RUBICON | Prescription |
| LABETALOL HYDROCHLORIDE | 211953 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2021/08/18 | 2021/08/18 | RUBICON | Prescription |
| LABETALOL HYDROCHLORIDE | 211953 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2021/08/18 | 2021/08/18 | RUBICON | Prescription |
| LABETALOL HYDROCHLORIDE | 214533 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 2021/09/07 | 2021/09/07 | CAPLIN | Prescription |
| LABETALOL HYDROCHLORIDE | 212719 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2022/08/08 | 2022/08/08 | UNICHEM | Discontinued |
| LABETALOL HYDROCHLORIDE | 212719 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2022/08/08 | 2022/08/08 | UNICHEM | Discontinued |
| LABETALOL HYDROCHLORIDE | 212719 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2022/08/08 | 2022/08/08 | UNICHEM | Discontinued |