药品名称CYTOTEC
申请号019268产品号001
活性成分MISOPROSTOL市场状态处方药
剂型或给药途径TABLET;ORAL规格0.2MG
治疗等效代码AB参比药物
批准日期1988/12/27申请机构GD SEARLE LLC
化学类型New molecular entity (NME)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
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
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
019268047APLetter2012/11/21下载
019268047APLabel2012/11/26下载
019268041APLabel2009/10/06下载
019268041APLetter2009/11/12下载
019268040APLetter2003/08/14下载
019268039APLetter2003/08/14下载
019268037APLetter2002/04/17下载
019268037APLabel2002/04/17下载
019268000APOther Important Information from FDA2005/07/29下载
019268000APReview2011/12/16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
019268048AP2013/02/08Manufacturing Change or Addition
019268047AP2012/11/19Labeling Revision
019268041AP2009/09/11Labeling Revision
019268040AP2003/08/13Labeling Revision
019268039AP2003/08/13Labeling Revision
019268038AP2002/07/01Control Supplement
019268037AP2002/04/17Labeling Revision
019268036AP2000/10/19Control Supplement
019268035AP2000/10/19Manufacturing Change or Addition
019268033AP2000/01/07Control Supplement
019268032AP1999/08/11Package Change
019268031AP2000/06/22Labeling Revision
019268030AP1998/12/03Expiration Date Change
019268029AP1998/10/15Control Supplement
019268028AP1998/10/15Control Supplement
019268027AP1998/07/14Control Supplement
019268026AP1997/07/30Package Change
019268025AP1997/04/10Control Supplement
019268024AP1996/06/10Manufacturing Change or Addition
019268023AP1997/08/13Labeling Revision
019268022AP1996/06/11Control Supplement
019268018AP1994/05/31Package Change
019268017AP1993/05/10Manufacturing Change or Addition
019268016AP1992/10/28Package Change
019268015AP1991/07/29Labeling Revision
019268014AP1991/04/23Labeling Revision
019268013AP1990/09/06Labeling Revision
019268012AP1990/09/21Formulation Revision
019268010AP1990/04/05Labeling Revision
019268009AP1991/06/21Manufacturing Change or Addition
019268008AP1990/04/05Labeling Revision
019268007AP1990/05/09Control Supplement
019268006AP1990/07/16Package Change
019268004AP1989/06/27Package Change
019268002AP1989/04/18Manufacturing Change or Addition
019268001AP1989/02/08Manufacturing Change or Addition
019268000AP1988/12/27Approval