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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SEVELAMER HYDROCHLORIDE | 204724 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2019/02/08 | 2019/02/08 | GLENMARK PHARMS LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 204724 | 002 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2019/02/08 | 2019/02/08 | GLENMARK PHARMS LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 201068 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2020/12/15 | 2020/12/14 | RISING | Discontinued |
SEVELAMER HYDROCHLORIDE | 201068 | 002 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2020/12/15 | 2020/12/14 | RISING | Discontinued |
SEVELAMER HYDROCHLORIDE | 213145 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2021/06/16 | 2021/06/16 | LUPIN LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 213145 | 002 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2021/06/16 | 2021/06/16 | LUPIN LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 206883 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2023/05/26 | 2023/05/26 | MACLEODS PHARMS LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 206883 | 002 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2023/05/26 | 2023/05/26 | MACLEODS PHARMS LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 212599 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2023/07/11 | 2023/07/11 | AUROBINDO PHARMA LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 212599 | 002 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2023/07/11 | 2023/07/11 | AUROBINDO PHARMA LTD | Prescription |
SEVELAMER HYDROCHLORIDE | 218966 | 001 | ANDA | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No | 2025/02/03 | 2025/02/03 | NAVINTA LLC | Prescription |