药品名称SYNALAR
申请号013960产品号001
活性成分FLUOCINOLONE ACETONIDE市场状态处方药
剂型或给药途径OINTMENT;TOPICAL规格0.025%
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 dosage form审评分类Standard review drug
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历史专利信息
与本品相关的市场独占权保护信息
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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
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
013960052AP2000/09/26Manufacturing Change or Addition
013960051AP1995/03/02Labeling Revision
013960050AP1992/11/13Control Supplement
013960049AP1992/04/24Control Supplement
013960048AP1995/03/02Labeling Revision
013960047AP1990/02/13Control Supplement
013960046AP1989/02/10Control Supplement
013960045AP1985/07/24Control Supplement
013960044AP1984/08/29Manufacturing Change or Addition
013960043AP1984/05/25Manufacturing Change or Addition
013960042AP1983/04/08Practioner Draft Labeling
013960040AP1982/11/19Manufacturing Change or Addition
013960039AP1981/11/20Manufacturing Change or Addition
013960038AP1981/11/16Control Supplement
013960037AP1982/01/08Labeling Revision
013960036AP1981/01/19Package Change
013960035AP1981/01/19Package Change
013960034AP1981/01/19Package Change
013960033AP1981/01/19Package Change
013960032AP1981/09/15Package Change
013960031AP1980/08/07Package Change
013960030AP1980/02/19Labeling Revision
013960029AP1979/10/23Manufacturing Change or Addition
013960028AP1979/08/13Manufacturing Change or Addition
013960027AP1978/11/28Control Supplement
013960026AP1979/01/02Labeling Revision
013960025AP1978/10/12Labeling Revision
013960024AP1978/06/30Control Supplement
013960023AP1978/01/09Control Supplement
013960022AP1977/05/11Control Supplement
013960021AP1977/05/11Control Supplement
013960020AP1977/06/04Manufacturing Change or Addition
013960019AP1977/01/04Labeling Revision
013960018AP1976/07/15Labeling Revision
013960017AP1975/07/16Labeling Revision
013960000AP1963/06/19Approval