药品名称PERGONAL
申请号017646产品号001
活性成分MENOTROPINS (FSH;LH)市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格75 IU/AMP
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SERONO LABORATORIES INC
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
017646049APLetter2002/07/30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
017646051AP2001/12/20Control Supplement
017646049AP2002/07/30Labeling Revision
017646048AP2000/08/31Manufacturing Change or Addition
017646047AP2000/10/12Control Supplement
017646046AP1999/05/20Manufacturing Change or Addition
017646044AP1998/02/17Control Supplement
017646043AP1998/02/18Control Supplement
017646042AP1996/08/22Manufacturing Change or Addition
017646040AP1996/01/22Manufacturing Change or Addition
017646039AP1995/04/05Labeling Revision
017646038AP1994/10/31Labeling Revision
017646037AP1993/12/06Control Supplement
017646036AP1994/10/21Labeling Revision
017646033AP1993/06/09Control Supplement
017646032AP1994/05/31Manufacturing Change or Addition
017646031AP1991/01/17Manufacturing Change or Addition
017646029AP1990/02/28Manufacturing Change or Addition
017646028AP1988/04/18Labeling Revision
017646027AP1987/12/04Control Supplement
017646026AP1986/03/18Control Supplement
017646025AP1985/08/23Control Supplement
017646024AP1985/05/20Formulation Revision
017646023AP1985/07/29Manufacturing Change or Addition
017646022AP1985/05/20Manufacturing Change or Addition
017646021AP1989/08/23New or Modified Indication
017646020AP1986/09/15Labeling Revision
017646018AP1983/07/18Control Supplement
017646016AP1983/07/11Control Supplement
017646014AP1983/07/18Labeling Revision
017646013AP1982/02/11Labeling Revision
017646011AP1981/10/22Control Supplement
017646010AP1980/10/28Control Supplement
017646005AP1979/10/26Manufacturing Change or Addition
017646001AP1982/01/20Labeling Revision
017646000AP1975/08/22Approval