药品名称LIDEX-E
申请号016908产品号003
活性成分FLUOCINONIDE市场状态停止上市
剂型或给药途径CREAM;TOPICAL规格0.05%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构COUNTY LINE PHARMACEUTICALS LLC
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
016908058APLetter2006/01/19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
016908058AP2005/12/16Control Supplement
016908055AP2000/09/26Manufacturing Change or Addition
016908054AP1999/01/27Control Supplement
016908053AP1996/07/22Manufacturing Change or Addition
016908052AP1995/03/01Labeling Revision
016908051AP1992/11/13Control Supplement
016908050AP1992/04/24Control Supplement
016908049AP1995/03/03Labeling Revision
016908048AP1990/02/13Control Supplement
016908047AP1989/12/06Control Supplement
016908046AP1989/02/10Control Supplement
016908045AP1984/08/29Manufacturing Change or Addition
016908044AP1983/09/07Manufacturing Change or Addition
016908043AP1983/04/08Practioner Draft Labeling
016908041AP1982/11/19Manufacturing Change or Addition
016908040AP1982/05/19Expiration Date Change
016908039AP1981/11/20Manufacturing Change or Addition
016908038AP1981/11/16Manufacturing Change or Addition
016908037AP1981/01/19Package Change
016908036AP1981/01/19Package Change
016908035AP1981/01/19Package Change
016908034AP1981/01/19Package Change
016908033AP1981/06/26Package Change
016908030AP1979/12/18Control Supplement
016908029AP1979/10/23Manufacturing Change or Addition
016908028AP1979/08/13Manufacturing Change or Addition
016908027AP1981/10/23Labeling Revision
016908026AP1978/11/29Control Supplement
016908025AP1978/11/01Labeling Revision
016908024AP1978/10/12Labeling Revision
016908023AP1978/09/12Labeling Revision
016908022AP1978/07/05Control Supplement
016908021AP1978/04/11Control Supplement
016908020AP1977/12/14Control Supplement
016908019AP1977/06/04Control Supplement
016908018AP1977/09/19Formulation Revision
016908017AP1977/01/04Labeling Revision
016908016AP1976/05/06Control Supplement
016908015AP1976/02/24Supplement
016908000AP1971/06/30Approval