药品名称MONISTAT 3
申请号020827产品号001
活性成分MICONAZOLE NITRATE市场状态非处方药
剂型或给药途径CREAM;VAGINAL规格4%
治疗等效代码参比药物
批准日期1998/03/30申请机构MEDTECH PRODUCTS 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
020827014APLetter2009/11/10下载
020827013APLetter2008/09/09下载
020827006APLetter2002/08/07下载
020827000APReview1998/03/30下载
020827000APLetter1998/03/30下载
020827000APLabel1998/03/30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
020827025AP2014/03/10Manufacturing Change or Addition
020827024AP2014/02/27Manufacturing Change or Addition
020827023AP2014/02/11Manufacturing Change or Addition
020827021AP2013/07/10Manufacturing Change or Addition
020827020AP2013/01/29Manufacturing Change or Addition
020827014AP2009/10/02Manufacturing Change or Addition
020827013AP2008/09/05Manufacturing Change or Addition
020827010AP2002/10/28Control Supplement
020827009AP2002/04/10Package Change
020827008AP2001/11/28Package Change
020827007AP2000/10/17Manufacturing Change or Addition
020827006AP2002/08/07Labeling Revision
020827004AP1999/03/26Manufacturing Change or Addition
020827003AP1998/10/30Manufacturing Change or Addition
020827002AP1998/07/27Control Supplement
020827001AP1998/10/06Package Change
020827000AP1998/03/30Approval