药品名称PROTONIX
申请号020987产品号002
活性成分PANTOPRAZOLE SODIUM市场状态处方药
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格EQ 20MG BASE
治疗等效代码AB参比药物
批准日期2001/06/12申请机构WYETH PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
59979032016/12/07PDF格式
5997903*PED2017/06/07PDF格式
历史专利信息
47585792010/07/19PDF格式
4758579*PED2011/01/19PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020987050APLetter2016/10/26下载
020987050APLabel2016/10/31下载
020987049APLetter2014/12/24下载
020987049APLabel2014/12/29下载
020987048APLabel2013/12/11下载
020987048APLetter2013/12/13下载
020987045APLabel2012/05/15下载
020987043APLetter2012/10/11下载
020987043APLabel2012/10/15下载
020987041APLetter2011/05/25下载
020987041APLabel2011/05/25下载
020987039APLetter2011/10/31下载
020987039APLabel2011/11/01下载
020987038APLetter2010/09/08下载
020987038APLabel2010/09/10下载
020987037APLabel2009/11/16下载
020987037APLetter2009/11/25下载
020987036APLabel2009/11/16下载
020987036APLetter2009/11/25下载
020987035APLetter2008/01/09下载
020987032APLetter2006/07/27下载
020987026APLetter2004/12/02下载
020987023APLetter2004/03/16下载
020987023APLabel2004/04/05下载
020987022APLetter2004/01/14下载
020987022APLabel2004/01/15下载
020987021APLetter2004/01/14下载
020987020APLabel2004/05/07下载
020987020APLetter2004/05/07下载
020987017APLabel2004/04/05下载
020987017APLetter2004/03/10下载
020987013APLetter2002/10/28下载
020987007APLetter2002/04/19下载
020987007APLabel2002/04/19下载
020987007APReview2002/04/19下载
020987005APLabel2003/04/25下载
020987002APLetter2001/06/12下载
020987001APLetter2001/06/12下载
020987001APLabel2003/04/09下载
020987000APReview2000/02/02下载
020987000APLetter2000/02/02下载
020987000APLabel2000/02/02下载
020987000APOther Important Information from FDA2011/12/20下载
020987000APMedication Guide2012/10/16下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020987050AP2016/10/24Labeling Revision
020987049AP2014/12/19Labeling Revision
020987048AP2013/12/10Labeling Revision
020987046AP2013/01/25Manufacturing Change or Addition
020987045AP2012/05/11Labeling Revision
020987043AP2012/10/09Labeling Revision
020987041AP2011/05/20Labeling Revision
020987039AP2011/10/31Labeling Revision
020987038AP2010/09/03Labeling Revision
020987037AP2009/11/12Labeling Revision
020987036AP2009/11/12Patient Population Altered
020987035AP2007/12/20Labeling Revision
020987032AP2006/07/25Labeling Revision
020987026AP2004/11/18Labeling Revision
020987023AP2004/03/12Labeling Revision
020987022AP2004/01/09Labeling Revision
020987021AP2003/12/30Labeling Revision
020987020AP2004/05/05Labeling Revision
020987017AP2004/03/05Labeling Revision
020987016AP2002/12/04Control Supplement
020987015AP2002/12/03Control Supplement
020987014AP2002/12/06Manufacturing Change or Addition
020987013AP2002/10/28Labeling Revision
020987012AP2002/07/22Manufacturing Change or Addition
020987011AP2002/09/05Control Supplement
020987010AP2002/05/14Manufacturing Change or Addition
020987009AP2002/07/02Control Supplement
020987008AP2002/03/12Manufacturing Change or Addition
020987007AP2002/04/19New or Modified Indication
020987006AP2002/06/12Manufacturing Change or Addition
020987005AP2001/07/20Labeling Revision
020987004AP2001/05/21Labeling Revision
020987003AP2000/10/19Manufacturing Change or Addition
020987002AP2001/06/12Formulation Revision
020987001AP2001/06/12New or Modified Indication
020987000AP2000/02/02Approval