药品注册申请号:020987
申请类型:NDA (新药申请)
申请人:WYETH PHARMS
申请人全名:WYETH PHARMACEUTICALS LLC
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 PROTONIX PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Yes Yes AB 2000/02/02 2000/02/02 Prescription
002 PROTONIX PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Yes No AB 2001/06/12 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/04/25 SUPPL 55 Approval Labeling STANDARD
2018/06/07 SUPPL 54 Approval Labeling STANDARD
2017/12/20 SUPPL 51 Approval Labeling STANDARD
2017/12/06 SUPPL 52 Approval Labeling STANDARD
2017/07/06 SUPPL 53 Approval Labeling STANDARD
2016/10/24 SUPPL 50 Approval Labeling STANDARD
2014/12/19 SUPPL 49 Approval Labeling 901 REQUIRED
2013/12/10 SUPPL 48 Approval Labeling STANDARD
2013/01/25 SUPPL 46 Approval Manufacturing (CMC) STANDARD
2012/10/09 SUPPL 43 Approval Labeling STANDARD
2012/05/11 SUPPL 45 Approval Labeling STANDARD
2011/10/31 SUPPL 39 Approval Labeling UNKNOWN
2011/05/20 SUPPL 41 Approval Labeling UNKNOWN
2010/09/03 SUPPL 38 Approval Labeling 901 REQUIRED
2009/11/12 SUPPL 37 Approval Labeling STANDARD
2009/11/12 SUPPL 36 Approval Efficacy STANDARD
2007/12/20 SUPPL 35 Approval Labeling STANDARD
2006/07/25 SUPPL 32 Approval Labeling STANDARD
2004/11/18 SUPPL 26 Approval Labeling STANDARD
2004/05/05 SUPPL 20 Approval Labeling STANDARD
2004/03/12 SUPPL 23 Approval Labeling STANDARD
2004/03/05 SUPPL 17 Approval Labeling STANDARD
2004/01/09 SUPPL 22 Approval Labeling STANDARD
2003/12/30 SUPPL 21 Approval Labeling STANDARD
2002/12/06 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2002/12/04 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2002/12/03 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2002/10/28 SUPPL 13 Approval Labeling STANDARD
2002/09/05 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2002/07/22 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2002/07/02 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2002/06/12 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2002/05/14 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2002/04/19 SUPPL 7 Approval Efficacy STANDARD
2002/03/12 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2001/07/20 SUPPL 5 Approval Labeling STANDARD
2001/06/12 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/06/12 SUPPL 1 Approval Efficacy STANDARD
2001/05/21 SUPPL 4 Approval Labeling STANDARD
2000/10/19 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2000/02/02 ORIG 1 Approval Type 1 - New Molecular Entity 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
001 4758579 2010/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
4758579*PED 2011/01/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5997903 2016/12/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5997903*PED 2017/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4758579 2010/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
4758579*PED 2011/01/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5997903 2016/12/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5997903*PED 2017/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
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: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
077056 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2007/08/02 TEVA
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
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
090074 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/01/19 TORRENT PHARMS
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
090901 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2011/08/30 JUBILANT GENERICS
200821 002 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 40MG BASE Prescription No No AB 2012/02/16 MACLEODS PHARMS LTD
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 ORCHID HLTHCARE
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
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
077056 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2007/08/02 TEVA
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
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
090074 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/01/19 TORRENT PHARMS
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
090901 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2011/08/30 JUBILANT GENERICS
200821 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2012/02/16 MACLEODS PHARMS LTD
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 Prescription 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 ORCHID HLTHCARE
205119 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE;ORAL EQ 20MG BASE Prescription No No AB 2016/01/26 AMNEAL PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database