批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
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 |
2015/09/21 |
ORIG-1(原始申请) |
Approval |
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|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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 |
与本品治疗等效的药品
活性成分:ESOMEPRAZOLE MAGNESIUM 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:EQ 20MG BASE 治疗等效代码:AB
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 |
Prescription |
No |
No |
AB |
2019/05/10
|
GLENMARK PHARMS |
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 |
活性成分:ESOMEPRAZOLE MAGNESIUM 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:EQ 40MG BASE 治疗等效代码:AB
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 |
Prescription |
No |
No |
AB |
2019/05/10
|
GLENMARK PHARMS |
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 |