药品名称METRODIN
申请号019415产品号003
活性成分UROFOLLITROPIN市场状态停止上市
剂型或给药途径INJECTABLE;INTRAMUSCULAR规格150 IU/AMP
治疗等效代码参比药物
批准日期1986/09/18申请机构SERONO LABORATORIES INC
化学类型New active ingredient审评分类Standard review drug
罕用药/孤儿药
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
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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
019415030AP2002/04/15Control Supplement
019415028AP2000/12/28Control Supplement
019415027AP2000/06/19Control Supplement
019415026AP2000/08/31Manufacturing Change or Addition
019415025AP2000/07/18Control Supplement
019415024AP2000/01/21Control Supplement
019415023AP1999/05/20Manufacturing Change or Addition
019415022AP1999/04/01Control Supplement
019415021AP1999/11/24Labeling Revision
019415018AP1998/04/15Manufacturing Change or Addition
019415017AP1998/02/18Control Supplement
019415016AP1996/08/22Manufacturing Change or Addition
019415015AP1996/01/22Manufacturing Change or Addition
019415014AP1995/07/12Labeling Revision
019415013AP1995/08/29New Dosage Regimen
019415012AP1993/12/06Control Supplement
019415011AP1994/01/24Labeling Revision
019415010AP1994/03/28Labeling Revision
019415009AP1996/08/23New Route of Administration
019415008AP1994/05/31Manufacturing Change or Addition
019415006AP1991/01/17Control Supplement
019415004AP1990/03/14Expiration Date Change
019415002AP1988/04/25Labeling Revision
019415001AP1988/03/01New or Modified Indication
019415000AP1986/09/18Approval