药品名称ACIPHEX
申请号020973产品号002
活性成分RABEPRAZOLE SODIUM市场状态处方药
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格20MG
治疗等效代码AB参比药物
批准日期1999/08/19申请机构EISAI 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
历史专利信息
50358992009/04/04U-385PDF格式
50455522013/05/08U-385PDF格式
5045552*PED2013/11/08PDF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
NPP2011/06/30
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
020973037APLetter2016/10/26下载
020973037APLabel2016/10/28下载
020973035APLetter2014/12/24下载
020973035APLabel2014/12/29下载
020973034APLabel2014/10/16下载
020973034APLetter2014/10/21下载
020973033APLabel2016/04/05下载
020973033APLetter2016/04/06下载
020973033APMedication Guide2016/04/27下载
020973032APLetter2013/04/23下载
020973032APLabel2013/04/23下载
020973030APLetter2012/05/10下载
020973030APLabel2012/05/10下载
020973029APLabel2012/10/09下载
020973029APMedication Guide2012/10/09下载
020973029APLetter2012/10/10下载
020973028APLetter2011/05/25下载
020973028APLabel2011/05/26下载
020973025APLetter2010/09/08下载
020973025APLabel2010/09/10下载
020973022APLabel2008/06/30下载
020973022APLetter2008/07/02下载
020973022APSummary Review2008/08/12下载
020973020APLetter2005/06/07下载
020973020APLabel2005/06/07下载
020973016APLetter2003/08/15下载
020973015APLetter2002/09/30下载
020973014APLetter2002/09/23下载
020973013APLetter2002/11/08下载
020973013APLabel2002/11/08下载
020973013APReview2003/04/25下载
020973012APLetter2002/05/29下载
020973009APLetter2002/02/12下载
020973009APLabel2002/02/12下载
020973009APReview2012/03/02下载
020973008APLabel2003/04/25下载
020973008APReview2007/07/06下载
020973000APLetter1999/08/19下载
020973000APReview1999/08/19下载
020973000APLabel1999/08/19下载
020973000APOther Important Information from FDA2011/12/20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
020973037AP2016/10/24Labeling Revision
020973036AP2016/09/21Manufacturing Change or Addition
020973035AP2014/12/19Labeling Revision
020973034AP2014/10/15Labeling Revision
020973033AP2016/04/04Labeling Revision
020973032AP2013/04/19Labeling Revision
020973030AP2012/05/08Labeling Revision
020973029AP2012/10/05Labeling Revision
020973028AP2011/05/20Labeling Revision
020973025AP2010/09/03Labeling Revision
020973022AP2008/06/30Patient Population Altered
020973020AP2005/06/03Labeling Revision
020973016AP2003/08/01Labeling Revision
020973015AP2002/09/30Formulation Revision
020973014AP2002/09/23Labeling Revision
020973013AP2002/11/08Efficacy Supplement with Clinical Data to Support
020973012AP2002/05/29Formulation Revision
020973011AP2001/10/02Package Change
020973010AP2001/10/02Control Supplement
020973009AP2002/02/12New or Modified Indication
020973008AP2001/08/15Labeling Revision
020973007AP2000/12/15Manufacturing Change or Addition
020973006AP2000/09/20Package Change
020973005AP2000/02/28Control Supplement
020973004AP2000/05/08Manufacturing Change or Addition
020973003AP2000/02/16Manufacturing Change or Addition
020973002AP2000/02/16Manufacturing Change or Addition
020973001AP1999/10/21Control Supplement
020973000AP1999/08/19Approval