药品名称DIFLUCAN
申请号019949产品号003
活性成分FLUCONAZOLE市场状态处方药
剂型或给药途径TABLET;ORAL规格200MG
治疗等效代码AB参比药物
批准日期1990/01/29申请机构PFIZER CENTRAL RESEARCH
化学类型New molecular entity (NME)审评分类
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
019949060APLetter2014/10/31下载
019949060APLabel2014/11/04下载
019949058APLabel2014/03/25下载
019949058APLetter2014/03/25下载
019949057APLabel2013/09/17下载
019949057APLetter2013/09/17下载
019949055APLetter2011/11/21下载
019949055APLabel2011/11/21下载
019949052APLetter2011/04/29下载
019949052APLabel2011/04/29下载
019949051APLabel2011/06/06下载
019949051APLetter2011/06/08下载
019949048APLetter2010/08/10下载
019949048APLabel2010/08/10下载
019949041APLetter2008/04/04下载
019949041APLabel2008/04/16下载
019949037APLetter2004/03/28下载
019949037APLabel2004/04/05下载
019949035APLetter2004/10/08下载
019949035APLabel2004/10/08下载
019949033APLabel2002/08/07下载
019949033APLetter2002/08/07下载
019949032APLetter2004/10/08下载
019949032APLabel2004/10/08下载
019949030APLabel2004/10/08下载
019949030APLetter2004/10/08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
019949063AP2016/06/06Manufacturing Change or Addition
019949062AP2016/05/02Manufacturing Change or Addition
019949061AP2015/05/29Manufacturing Change or Addition
019949060AP2014/10/30Labeling Revision
019949059AP2014/07/28Manufacturing Change or Addition
019949058AP2014/03/24Labeling Revision
019949057AP2013/09/13Labeling Revision
019949055AP2011/11/16Labeling Revision
019949052AP2011/04/26Labeling Revision
019949051AP2011/06/06Labeling Revision
019949048AP2010/08/05Labeling Revision
019949041AP2008/03/31Labeling Revision
019949037AP2004/03/24Labeling Revision
019949035AP2004/10/07Labeling Revision
019949033AP2002/08/07Labeling Revision
019949032AP2004/10/07Labeling Revision
019949031AP2001/03/05Control Supplement
019949030AP2004/10/07Labeling Revision
019949029AP2000/03/01Package Change
019949028AP1999/09/27Manufacturing Change or Addition
019949027AP1999/02/22Labeling Revision
019949026AP1998/02/18Control Supplement
019949025AP1997/08/05Labeling Revision
019949024AP1997/02/19Labeling Revision
019949023AP1997/05/02Package Change
019949022AP1996/08/06Labeling Revision
019949019AP1996/07/23Labeling Revision
019949018AP1995/09/11Manufacturing Change or Addition
019949017AP1995/09/11Manufacturing Change or Addition
019949016AP1995/12/22Control Supplement
019949015AP1994/06/30Labeling Revision
019949014AP1995/05/24Formulation Revision
019949012AP1994/11/23Patient Population Altered
019949008AP1993/10/13Labeling Revision
019949007AP1993/06/14Control Supplement
019949006AP1993/10/13Labeling Revision
019949003AP1993/12/30New or Modified Indication
019949002AP1993/10/13Labeling Revision
019949001AP1992/08/20Manufacturing Change or Addition
019949000AP1990/01/29Approval