药品名称GYNE-LOTRIMIN
申请号018052产品号002
活性成分CLOTRIMAZOLE市场状态非处方药
剂型或给药途径CREAM;VAGINAL规格1%
治疗等效代码参比药物
批准日期1990/11/30申请机构BAYER HEALTHCARE LLC
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
018052032APLetter2010/04/14下载
018052032APLabel2015/01/12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
018052032AP2010/04/12Labeling Revision
018052030AP2002/01/16Control Supplement
018052029AP2001/02/02Control Supplement
018052028AP2000/09/01Control Supplement
018052027AP2000/01/20Manufacturing Change or Addition
018052026AP1998/12/09Package Change
018052025AP1998/08/11Package Change
018052024AP1993/04/26New or Modified Indication
018052023AP1993/04/15Package Change
018052022AP1992/10/08Labeling Revision
018052021AP1993/04/21Package Change
018052020AP1992/05/12Labeling Revision
018052019AP1992/04/14Labeling Revision
018052018AP1993/09/22Manufacturing Change or Addition
018052017AP1992/06/23Control Supplement
018052014AP1990/09/11Control Supplement
018052013AP1988/10/04Control Supplement
018052012AP1990/11/30OTC Labeling
018052011AP1987/06/18Control Supplement
018052010AP1986/09/12Manufacturing Change or Addition
018052009AP1986/05/20Control Supplement
018052007AP1985/07/24Package Change
018052006AP1981/08/17Control Supplement
018052005AP1981/10/09Control Supplement
018052004AP1986/12/04Practioner Draft Labeling
018052003AP1981/03/27Control Supplement
018052002AP1980/01/03Package Change
018052001AP1979/11/27Distributor
018052000AP1978/11/08Approval