| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No | AB | 2016/04/21 | 2016/04/21 | Prescription |
| 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | No | No | AB | 2016/04/21 | Prescription |
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2024/05/13 | SUPPL-21（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-19（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-17（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-14（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-8（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-6（补充） | Approval | Labeling | STANDARD | ||
| 2024/05/13 | SUPPL-4（补充） | Approval | Labeling | STANDARD | ||
| 2023/11/20 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | UNKNOWN | ||
| 2016/04/21 | ORIG-1（原始申请） | Approval | STANDARD |
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|---|---|---|---|---|---|---|---|---|
| 无 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 021153 | 001 | NDA | NEXIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | Yes | No | AB | 2001/02/20 | ASTRAZENECA |
| 078003 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2015/01/26 | IVAX SUB TEVA PHARMS |
| 078936 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2015/08/02 | MYLAN |
| 202784 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Discontinued | No | No | AB | 2015/09/21 | HETERO LABS LTD III |
| 078279 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2015/09/25 | DR REDDYS |
| 203636 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Discontinued | No | No | AB | 2015/10/19 | TORRENT |
| 205606 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2016/04/21 | AUROBINDO PHARMA LTD |
| 205563 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2017/09/01 | LANNETT CO INC |
| 208333 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2017/10/20 | ALKEM LABS LTD |
| 209735 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2018/04/30 | SUN PHARM |
| 209495 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Discontinued | No | No | AB | 2019/05/10 | GLENMARK SPECLT |
| 206296 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2019/05/22 | ZYDUS PHARMS |
| 211977 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2020/06/02 | HETERO LABS LTD III |
| 213158 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2020/09/22 | CISEN |
| 212949 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2020/10/02 | CSPC OUYI |
| 213859 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2020/11/18 | GUANGZHOU NOVAKEN |
| 210559 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2021/02/26 | INDCHEMIE HEALTH |
| 213486 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2021/03/19 | GRAVITI PHARMS |
| 090841 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2021/03/31 | ETHYPHARM |
| 214920 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2023/03/28 | PRINSTON INC |
| 217427 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2023/10/18 | GRANULES |
| 217022 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2023/12/27 | ZHEJIANG YONGTAI |
| 208511 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Prescription | No | No | AB | 2024/10/23 | MACLEODS PHARMS LTD |
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 021153 | 002 | NDA | NEXIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | Yes | Yes | AB | 2001/02/20 | ASTRAZENECA |
| 078003 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2015/01/26 | IVAX SUB TEVA PHARMS |
| 078936 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2015/08/03 | MYLAN |
| 202784 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Discontinued | No | No | AB | 2015/09/21 | HETERO LABS LTD III |
| 078279 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2015/09/25 | DR REDDYS |
| 203636 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Discontinued | No | No | AB | 2015/10/19 | TORRENT |
| 205606 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2016/04/21 | AUROBINDO PHARMA LTD |
| 205563 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2017/09/01 | LANNETT CO INC |
| 208333 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2017/10/20 | ALKEM LABS LTD |
| 209735 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2018/04/30 | SUN PHARM |
| 209495 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Discontinued | No | No | AB | 2019/05/10 | GLENMARK SPECLT |
| 206296 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2019/05/22 | ZYDUS PHARMS |
| 211977 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2020/06/02 | HETERO LABS LTD III |
| 213158 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2020/09/22 | CISEN |
| 212949 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2020/10/02 | CSPC OUYI |
| 213859 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2020/11/18 | GUANGZHOU NOVAKEN |
| 210559 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2021/02/26 | INDCHEMIE HEALTH |
| 213486 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2021/03/19 | GRAVITI PHARMS |
| 090841 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2021/03/31 | ETHYPHARM |
| 214920 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2023/03/28 | PRINSTON INC |
| 217427 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2023/10/18 | GRANULES |
| 217022 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2023/12/27 | ZHEJIANG YONGTAI |
| 208511 | 002 | ANDA | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Prescription | No | No | AB | 2024/10/23 | MACLEODS PHARMS LTD |