药品名称AQUAMEPHYTON
申请号012223产品号002
活性成分PHYTONADIONE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构TELIGENT PHARMA 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
012223039APLetter2003/06/08下载
012223039APLabel2015/09/03下载
012223038APLetter2003/03/10下载
012223036APLetter2001/05/18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
012223039AP2003/06/04Labeling Revision
012223038AP2003/02/27Labeling Revision
012223037AP2001/08/16Control Supplement
012223036AP2001/05/18Labeling Revision
012223035AP1998/07/14Control Supplement
012223034AP1998/05/28Control Supplement
012223033AP1997/01/14Control Supplement
012223032AP1996/12/06Control Supplement
012223031AP1996/12/06Control Supplement
012223030AP1996/06/25Manufacturing Change or Addition
012223029AP1995/12/05Manufacturing Change or Addition
012223028AP1995/06/08Package Change
012223027AP1995/04/24Labeling Revision
012223026AP1991/06/28Labeling Revision
012223025AP1990/04/26Labeling Revision
012223024AP1985/08/27Package Change
012223023AP1984/10/11Package Change
012223022AP1982/08/18Labeling Revision
012223021AP1986/08/19Practioner Draft Labeling
012223020AP1981/07/14Package Change
012223019AP1981/11/03Manufacturing Change or Addition
012223018AP1980/11/28Control Supplement
012223017AP1979/09/18Control Supplement
012223016AP1976/09/01Control Supplement
012223000AP1960/06/28Approval