| 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 | 075242 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 1999/09/30 | 1999/09/30 | HOSPIRA | Discontinued |
| LABETALOL HYDROCHLORIDE | 075239 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | Yes | 1999/11/29 | 1999/11/29 | HOSPIRA | Prescription |
| LABETALOL HYDROCHLORIDE | 075240 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | Yes | 1999/11/29 | 1999/11/29 | HOSPIRA | Prescription |
| LABETALOL HYDROCHLORIDE | 075431 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 1999/11/29 | 1999/11/29 | RISING | Prescription |
| LABETALOL HYDROCHLORIDE | 075524 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 1999/11/29 | 1999/11/29 | RISING | Discontinued |
| LABETALOL HYDROCHLORIDE | 076051 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 2002/07/05 | 2002/07/05 | BAXTER HLTHCARE CORP | Prescription |
| LABETALOL HYDROCHLORIDE | 079134 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 2010/02/03 | 2010/02/03 | STERISCIENCE SPECLTS | Discontinued |
| LABETALOL HYDROCHLORIDE | 090699 | 001 | ANDA | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No | 2012/04/03 | 2012/04/03 | GLAND PHARMA LTD | Prescription |
| LABETALOL HYDROCHLORIDE | 200908 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2012/07/10 | 2012/07/10 | ENDO OPERATIONS | Prescription |
| LABETALOL HYDROCHLORIDE | 200908 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | Yes | 2012/07/10 | 2012/07/10 | ENDO OPERATIONS | Prescription |
| LABETALOL HYDROCHLORIDE | 200908 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2012/07/10 | 2012/07/10 | ENDO OPERATIONS | Prescription |
| LABETALOL HYDROCHLORIDE | 207743 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2017/09/19 | 2017/09/19 | ZYDUS PHARMS | Prescription |
| LABETALOL HYDROCHLORIDE | 207743 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2017/09/19 | 2017/09/19 | ZYDUS PHARMS | Prescription |
| LABETALOL HYDROCHLORIDE | 207743 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2017/09/19 | 2017/09/19 | ZYDUS PHARMS | Prescription |
| LABETALOL HYDROCHLORIDE | 209603 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2018/06/20 | 2018/06/20 | APPCO | Prescription |
| LABETALOL HYDROCHLORIDE | 209603 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2018/06/20 | 2018/06/20 | APPCO | Prescription |
| LABETALOL HYDROCHLORIDE | 209603 | 003 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2018/06/20 | 2018/06/20 | APPCO | Prescription |
| LABETALOL HYDROCHLORIDE | 209603 | 004 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2018/06/20 | 2024/10/18 | APPCO | Prescription |
| LABETALOL HYDROCHLORIDE | 207863 | 001 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2019/02/04 | 2019/02/04 | HIBROW HLTHCARE | Prescription |
| LABETALOL HYDROCHLORIDE | 207863 | 002 | ANDA | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2019/02/04 | 2019/02/04 | HIBROW HLTHCARE | Prescription |