药品名称PREGNYL
申请号017692产品号001
活性成分GONADOTROPIN, CHORIONIC市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10,000 UNITS/VIAL
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ORGANON USA 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
017692021APLabel2011/04/18下载
017692021APLetter2011/04/19下载
017692020APLetter2008/01/09下载
017692018APLetter2007/02/12下载
017692018APLabel2007/02/21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
017692027AP2015/10/02Manufacturing Change or Addition
017692025AP2015/01/12Manufacturing Change or Addition
017692024AP2014/02/28Manufacturing Change or Addition
017692023AP2013/02/26Manufacturing Change or Addition
017692021AP2011/04/15Labeling Revision
017692020AP2007/12/03Labeling Revision
017692018AP2007/02/07Labeling Revision
017692013AP1999/04/02Manufacturing Change or Addition
017692012AP1999/11/23Labeling Revision
017692011AP1997/02/21Manufacturing Change or Addition
017692010AP1994/02/18Manufacturing Change or Addition
017692009AP1992/06/30Control Supplement
017692008AP1991/01/02Manufacturing Change or Addition
017692007AP1988/11/03Manufacturing Change or Addition
017692006AP1988/04/19Control Supplement
017692005AP1987/02/17Control Supplement
017692004AP1986/12/24Control Supplement
017692003AP1984/11/09Manufacturing Change or Addition
017692002AP1982/04/05Manufacturing Change or Addition
017692001AP1981/06/03Control Supplement
017692000AP1976/10/20Approval