药品名称EDEX
申请号020649产品号003
活性成分ALPROSTADIL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.02MG/VIAL
治疗等效代码AP参比药物
批准日期1997/06/12申请机构AUXILIUM PHARMACEUTICALS INC
化学类型New dosage form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
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
020649023APLetter2015/03/11下载
020649023APLabel2015/03/26下载
020649015APLetter2006/06/12下载
020649015APLabel2006/06/12下载
020649000APReview2003/08/08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
020649023AP2015/03/09Labeling Revision
020649022AP2014/03/12Manufacturing Change or Addition
020649021AP2014/02/11Manufacturing Change or Addition
020649015AP2006/06/09Labeling Revision
020649013AP2001/12/14Manufacturing Change or Addition
020649012AP2000/06/01Expiration Date Change
020649011AP2000/07/31Control Supplement
020649010AP2000/03/10Control Supplement
020649009AP1999/09/06Labeling Revision
020649008AP1999/10/15Manufacturing Change or Addition
020649007AP1999/10/20Manufacturing Change or Addition
020649006AP1999/11/19Formulation Revision
020649005AP1999/10/20Control Supplement
020649004AP1998/09/22Expiration Date Change
020649003AP1998/04/01Manufacturing Change or Addition
020649002AP1998/07/30Control Supplement
020649001AP1997/11/05Control Supplement
020649000AP1997/06/12Approval