药品名称LIDEX
申请号016909产品号002
活性成分FLUOCINONIDE市场状态处方药
剂型或给药途径OINTMENT;TOPICAL规格0.05%
治疗等效代码AB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 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
016909053APLabel2016/06/13下载
016909049APLetter2006/01/19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
016909053AP2016/06/08Manufacturing Change or Addition
016909049AP2005/12/16Control Supplement
016909047AP2000/09/26Manufacturing Change or Addition
016909046AP1996/07/22Manufacturing Change or Addition
016909045AP1992/11/16Control Supplement
016909044AP1992/04/24Control Supplement
016909043AP1991/03/12Labeling Revision
016909042AP1990/02/13Control Supplement
016909041AP1989/12/06Control Supplement
016909040AP1989/09/26Formulation Revision
016909039AP1989/02/10Control Supplement
016909038AP1984/08/29Manufacturing Change or Addition
016909037AP1984/05/16Expiration Date Change
016909036AP1983/09/07Manufacturing Change or Addition
016909035AP1983/04/21Practioner Draft Labeling
016909033AP1982/11/19Manufacturing Change or Addition
016909032AP1981/11/20Manufacturing Change or Addition
016909031AP1981/11/10Control Supplement
016909030AP1981/01/19Package Change
016909029AP1981/01/19Package Change
016909028AP1981/01/19Package Change
016909027AP1981/01/19Package Change
016909026AP1980/08/07Package Change
016909025AP1981/03/24Control Supplement
016909024AP1979/10/23Manufacturing Change or Addition
016909023AP1979/08/13Manufacturing Change or Addition
016909022AP1978/11/07Expiration Date Change
016909021AP1978/11/29Control Supplement
016909020AP1979/01/02Labeling Revision
016909019AP1978/11/30Control Supplement
016909018AP1978/07/05Control Supplement
016909017AP1978/04/11Expiration Date Change
016909016AP1977/12/14Control Supplement
016909015AP1977/06/04Manufacturing Change or Addition
016909014AP1977/01/11Labeling Revision
016909000AP1971/09/22Approval