药品注册申请号：202038
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA LTD
申请人全名：AUROBINDO PHARMA LTD
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 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE No No AB 2012/09/28 2012/09/28 Prescription
002 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE No No AB 2012/09/28 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
2023/09/26 SUPPL-25（补充） Approval Labeling STANDARD
2022/06/09 SUPPL-23（补充） Approval Labeling STANDARD
2022/06/09 SUPPL-22（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-18（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-15（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-13（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-12（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-10（补充） Approval Labeling STANDARD
2016/04/04 SUPPL-9（补充） Approval Manufacturing (CMC) UNKNOWN
2015/04/08 SUPPL-6（补充） Approval Labeling STANDARD
2015/01/02 SUPPL-4（补充） Approval Labeling STANDARD
2013/06/13 SUPPL-3（补充） Approval Labeling STANDARD
2013/06/13 SUPPL-2（补充） Approval Labeling STANDARD
2012/09/28 ORIG-1（原始申请） Approval Not Applicable
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
无
与本品治疗等效的药品
活性成分:PANTOPRAZOLE SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;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
020987 002 NDA PROTONIX PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription Yes No AB 2001/06/12 WYETH PHARMS
077619 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/19 DR REDDYS LABS LTD
090074 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/19 TORRENT PHARMS
090970 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/19 MYLAN PHARMS INC
091231 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/19 WOCKHARDT BIO AG
078281 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/20 LANNETT CO INC
090797 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/02/07 ACTAVIS TOTOWA
090807 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2012/05/02 RUBICON
202038 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2012/09/28 AUROBINDO PHARMA LTD
203024 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Discontinued No No AB 2014/05/07 L PERRIGO CO
202882 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2014/09/10 HETERO LABS LTD V
202052 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2014/12/02 ORBION PHARMS
205119 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2016/01/26 AMNEAL PHARMS
217282 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2023/12/11 GRANULES
215880 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Discontinued No No AB 2024/04/25 MANKIND PHARMA
活性成分:PANTOPRAZOLE SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;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
020987 001 NDA PROTONIX PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription Yes Yes AB 2000/02/02 WYETH PHARMS
077619 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/19 DR REDDYS LABS LTD
090074 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/19 TORRENT PHARMS
090970 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/19 MYLAN PHARMS INC
091231 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/19 WOCKHARDT BIO AG
078281 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/20 LANNETT CO INC
090797 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/02/07 ACTAVIS TOTOWA
090807 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2012/05/02 RUBICON
202038 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2012/09/28 AUROBINDO PHARMA LTD
202882 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2014/09/10 HETERO LABS LTD V
202052 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2014/12/02 ORBION PHARMS
205119 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2016/01/26 AMNEAL PHARMS
211368 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2019/03/01 INGENUS PHARMS LLC
215880 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2022/07/26 MANKIND PHARMA
217282 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2023/12/11 GRANULES
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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