药品名称SYNALAR
申请号012787产品号004
活性成分FLUOCINOLONE ACETONIDE市场状态处方药
剂型或给药途径CREAM;TOPICAL规格0.01%
治疗等效代码AT参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MEDIMETRIKS PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority 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
012787071APLabel2013/04/01下载
012787071APLabel2013/04/09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
012787071AP2013/03/28Manufacturing Change or Addition
012787071AP2013/04/05Manufacturing Change or Addition
012787066AP2000/09/26Manufacturing Change or Addition
012787065AP1996/07/22Manufacturing Change or Addition
012787064AP1995/03/01Labeling Revision
012787063AP1992/11/13Control Supplement
012787062AP1992/04/24Control Supplement
012787061AP1995/03/06Labeling Revision
012787060AP1995/03/06Labeling Revision
012787059AP1990/02/13Control Supplement
012787058AP1989/04/04Control Supplement
012787057AP1989/02/10Control Supplement
012787056AP1989/04/12Control Supplement
012787055AP1984/12/20Formulation Revision
012787054AP1984/08/29Manufacturing Change or Addition
012787053AP1983/09/07Manufacturing Change or Addition
012787052AP1983/04/08Practioner Draft Labeling
012787050AP1982/11/19Manufacturing Change or Addition
012787049AP1981/11/20Manufacturing Change or Addition
012787048AP1981/11/12Control Supplement
012787047AP1981/01/19Package Change
012787046AP1981/01/19Package Change
012787045AP1981/01/19Package Change
012787044AP1981/01/19Package Change
012787043AP1981/06/26Manufacturing Change or Addition
012787042AP1980/07/30Package Change
012787040AP1980/02/19Labeling Revision
012787039AP1980/02/19Labeling Revision
012787038AP1979/10/23Manufacturing Change or Addition
012787037AP1979/08/13Manufacturing Change or Addition
012787036AP1979/07/25Control Supplement
012787034AP1979/04/13Control Supplement
012787033AP1978/11/28Control Supplement
012787032AP1978/09/12Labeling Revision
012787031AP1979/01/10Labeling Revision
012787030AP1977/06/04Manufacturing Change or Addition
012787029AP1977/01/04Labeling Revision
012787028AP1976/07/08Labeling Revision
012787027AP1975/12/12Labeling Revision
012787026AP1975/06/26Final Printed Labeling - MarkIV
012787000AP1963/02/15Approval