药品名称ATROPEN
申请号017106产品号003
活性成分ATROPINE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 0.5MG SULFATE/0.7ML
治疗等效代码参比药物
批准日期2003/06/19申请机构MERIDIAN MEDICAL TECHNOLOGIES INC
化学类型New formulation or new manufacturer审评分类Priority 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
017106032APLabel2004/09/21下载
017106032APLetter2004/09/21下载
017106028APLetter2003/06/25下载
017106028APLabel2003/06/25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
017106051AP2015/08/10Manufacturing Change or Addition
017106049AP2016/05/27Manufacturing Change or Addition
017106045AP2013/11/14Manufacturing Change or Addition
017106032AP2004/09/17Formulation Revision
017106028AP2003/06/19Patient Population Altered
017106027AP2002/06/28Control Supplement
017106026AP2002/01/07Control Supplement
017106025AP2002/03/04Manufacturing Change or Addition
017106024AP2001/06/08Manufacturing Change or Addition
017106023AP2001/02/13Package Change
017106022AP2001/01/31Package Change
017106021AP2000/10/19Control Supplement
017106020AP2000/08/16Manufacturing Change or Addition
017106019AP2000/08/18Manufacturing Change or Addition
017106018AP1999/10/28Manufacturing Change or Addition
017106017AP1999/04/26Control Supplement
017106016AP1999/03/16Manufacturing Change or Addition
017106015AP1998/08/25Manufacturing Change or Addition
017106014AP1998/04/21Labeling Revision
017106013AP1997/03/06Control Supplement
017106012AP1996/12/17Control Supplement
017106011AP1991/03/05Manufacturing Change or Addition
017106010AP1990/08/17Package Change
017106009AP1989/04/04Control Supplement
017106008AP1987/08/19Package Change
017106007AP1986/10/06Package Change
017106006AP1985/01/14Control Supplement
017106005AP1984/06/06Labeling Revision
017106004AP1979/12/27Expiration Date Change
017106003AP1979/05/10Control Supplement
017106001AP1978/07/27Manufacturing Change or Addition
017106000AP1973/05/15Approval