药品名称TEMOVATE
申请号019322产品号001
活性成分CLOBETASOL PROPIONATE市场状态停止上市
剂型或给药途径CREAM;TOPICAL规格0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1985/12/27申请机构FOUGERA PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
019322018APLabel2003/04/07下载
019322018APLetter2003/04/18下载
019322015APReview2003/08/05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
019322018AP2003/04/02Labeling Revision
019322016AP1997/08/08Manufacturing Change or Addition
019322015AP1996/11/15Manufacturing Change or Addition
019322014AP1994/06/29Control Supplement
019322013AP1994/06/07Manufacturing Change or Addition
019322012AP1993/08/23Control Supplement
019322011AP1993/03/05Control Supplement
019322010AP1995/08/30Labeling Revision
019322009AP1992/04/17Manufacturing Change or Addition
019322007AP1989/09/15Labeling Revision
019322006AP1989/12/07Labeling Revision
019322005AP1989/12/07Labeling Revision
019322004AP1987/03/03Package Change
019322003AP1987/07/10Control Supplement
019322002AP1987/04/09Control Supplement
019322000AP1985/12/27Approval