药品名称CREON
申请号020725产品号004
活性成分PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)市场状态处方药
剂型或给药途径CAPSULE, DELAYED RELEASE;ORAL规格15,000USP UNITS;3,000USP UNITS;9,500USP UNITS
治疗等效代码参比药物
批准日期2011/07/12申请机构ABBVIE INC
化学类型Drug already marketed, but without an approved NDA审评分类Priority 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
91988712030/02/07YU-1787PDF格式
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
M-932019/07/29
历史市场独占权保护信息
NCE2014/04/30
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
020725016APLabel2013/03/15下载
020725014APLetter2011/05/12下载
020725014APLabel2011/06/16下载
020725011APLabel2011/06/14下载
020725011APLetter2011/06/14下载
020725008APLetter2011/07/14下载
020725008APMedication Guide2011/07/14下载
020725008APLabel2011/07/14下载
020725007APLetter2010/08/16下载
020725007APLabel2010/08/19下载
020725006APLabel2010/07/31下载
020725006APLetter2010/08/03下载
020725003APLetter2010/05/06下载
020725003APLabel2010/05/07下载
020725000APLetter2009/05/01下载
020725000APLabel2009/05/13下载
020725000APMedication Guide2009/11/16下载
020725000APReview2010/08/10下载
020725000APSummary Review2010/08/10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
020725023AP2016/06/16Manufacturing Change or Addition
020725022AP2015/04/10Manufacturing Change or Addition
020725021AP2015/01/05Manufacturing Change or Addition
020725021AP2015/01/05Manufacturing Change or Addition
020725020AP2014/11/19Manufacturing Change or Addition
020725018AP2014/11/21Manufacturing Change or Addition
020725017AP2013/02/28Manufacturing Change or Addition
020725016AP2013/03/14Manufacturing Change or Addition
020725015AP2012/11/20Manufacturing Change or Addition
020725014AP2011/05/09Approval
020725011AP2011/06/10Manufacturing Change or Addition
020725009AP2014/03/17Manufacturing Change or Addition
020725008AP2011/07/12Efficacy Supplement with Clinical Data to Support
020725007AP2010/08/12Labeling Revision
020725006AP2010/07/29Efficacy Supplement with Clinical Data to Support
020725003AP2010/04/30Patient Population Altered
020725000AP2009/04/30Approval