药品注册申请号:205563
申请类型:ANDA (仿制药申请)
申请人:LANNETT CO INC
申请人全名:LANNETT CO INC
产品信息
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 2017/09/01 2017/09/01 Prescription
002 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 40MG BASE No No AB 2017/09/01 Prescription
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
2017/09/01 ORIG-1(原始申请) Approval STANDARD
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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RLDRSTE 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
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