药品名称CORDRAN
申请号012806产品号004
活性成分FLURANDRENOLIDE市场状态停止上市
剂型或给药途径OINTMENT;TOPICAL规格0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构AQUA PHARMACEUTICALS
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
012806037APLabel2013/07/30下载
012806036APLetter2013/06/14下载
012806028APLetter2002/07/17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
012806037AP2013/07/23Manufacturing Change or Addition
012806036AP2013/06/12Manufacturing Change or Addition
012806035AP2012/12/14Manufacturing Change or Addition
012806028AP2002/07/17Manufacturing Change or Addition
012806027AP1998/11/06Manufacturing Change or Addition
012806026AP1991/08/30Package Change
012806025AP1990/10/02Package Change
012806024AP1987/12/18Control Supplement
012806023AP1987/06/03Manufacturing Change or Addition
012806022AP1986/11/14Labeling Revision
012806021AP1982/10/08Practioner Draft Labeling
012806020AP1980/08/12Labeling Revision
012806019AP1979/11/26Control Supplement
012806017AP1978/06/30Labeling Revision
012806016AP1978/07/24Labeling Revision
012806015AP1977/12/14Expiration Date Change
012806014AP1977/02/23Labeling Revision
012806013AP1977/11/11Control Supplement
012806000AP1965/10/18Approval