药品名称PRED FORTE
申请号017011产品号001
活性成分PREDNISOLONE ACETATE市场状态处方药
剂型或给药途径SUSPENSION/DROPS;OPHTHALMIC规格1%
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ALLERGAN PHARMACEUTICAL
化学类型New formulation or new manufacturer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
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
017011041AP2002/04/12Control Supplement
017011039AP2001/12/04Manufacturing Change or Addition
017011038AP2001/09/28Manufacturing Change or Addition
017011037AP2001/07/24Manufacturing Change or Addition
017011036AP2001/04/12Manufacturing Change or Addition
017011035AP2000/10/02Manufacturing Change or Addition
017011034AP1998/05/19Control Supplement
017011033AP1997/09/30Control Supplement
017011032AP1996/12/05Control Supplement
017011031AP1995/05/10Control Supplement
017011030AP1995/08/03Control Supplement
017011029AP1989/10/30Manufacturing Change or Addition
017011028AP1989/10/12Manufacturing Change or Addition
017011027AP1988/09/09Control Supplement
017011026AP1988/02/17Labeling Revision
017011025AP1987/11/03Control Supplement
017011024AP1987/04/30Control Supplement
017011023AP1986/06/13Control Supplement
017011022AP1986/06/13Manufacturing Change or Addition
017011021AP1986/04/15Labeling Revision
017011017AP1982/08/13Control Supplement
017011016AP1983/07/11Package Change
017011014AP1982/09/03Manufacturing Change or Addition
017011013AP1982/09/02Manufacturing Change or Addition
017011012AP1980/01/22Manufacturing Change or Addition
017011011AP1979/11/19Control Supplement
017011003AP1975/08/05Labeling Revision
017011001AP1974/11/26Control Supplement
017011000AP1973/05/30Approval