药品名称MONISTAT 3 COMBINATION PACK
申请号020670产品号002
活性成分MICONAZOLE NITRATE市场状态非处方药
剂型或给药途径CREAM, SUPPOSITORY;TOPICAL, VAGINAL规格2%,200MG
治疗等效代码参比药物
批准日期1996/04/16申请机构MEDTECH PRODUCTS INC
化学类型OTC (over-the-counter) switch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
020670014APLabel2007/03/23下载
020670014APLetter2007/03/23下载
020670014APReview2012/11/09下载
020670011APLetter2003/01/09下载
020670009APReview2014/07/02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
020670029AP2016/01/21Manufacturing Change or Addition
020670028AP2015/11/20Manufacturing Change or Addition
020670024AP2014/02/11Manufacturing Change or Addition
020670022AP2013/07/10Manufacturing Change or Addition
020670021AP2013/02/06Manufacturing Change or Addition
020670014AP2007/03/16Formulation Revision
020670011AP2003/01/09Labeling Revision
020670010AP2002/10/28Control Supplement
020670009AP2002/04/10Package Change
020670007AP2000/01/20Package Change
020670005AP1999/10/04Manufacturing Change or Addition
020670004AP1999/03/26Manufacturing Change or Addition
020670003AP1998/03/17Manufacturing Change or Addition
020670002AP1997/03/21Formulation Revision
020670001AP1996/08/15Package Change
020670000AP1996/04/16Approval