药品名称IMODIUM A-D
申请号019487产品号001
活性成分LOPERAMIDE HYDROCHLORIDE市场状态非处方药
剂型或给药途径SOLUTION;ORAL规格1MG/5ML
治疗等效代码参比药物是
批准日期1988/03/01申请机构JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
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
无
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
无
历史市场独占权保护信息
无
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
019487028APLetter2016/04/07下载
019487028APLabel2016/04/11下载
019487027APLetter2015/03/19下载
019487027APLabel2015/03/24下载
019487023APReview2008/07/30下载
019487023APLetter2005/06/09下载
019487022APLetter2004/07/14下载
019487022APReview2008/07/31下载
019487021APLetter2004/06/16下载
019487021APReview2008/04/04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
019487029AP2016/05/17Manufacturing Change or Addition
019487028AP2016/04/05Labeling Revision
019487027AP2015/03/18Labeling Revision
019487023AP2005/06/08Package Change
019487022AP2004/07/08Formulation Revision
019487021AP2004/06/16Labeling Revision
019487018AP1999/12/03Manufacturing Change or Addition
019487016AP1998/09/04Package Change
019487015AP1996/10/28Labeling Revision
019487014AP1996/03/22Labeling Revision
019487013AP1996/02/12Package Change
019487012AP1994/08/15Labeling Revision
019487011AP1992/07/16Package Change
019487009AP1991/05/17Package Change
019487008AP1993/05/13Formulation Revision
019487007AP1992/11/23New or Modified Indication
019487006AP1990/02/09Manufacturing Change or Addition
019487005AP1990/01/29Manufacturing Change or Addition
019487004AP1989/01/05Manufacturing Change or Addition
019487001AP1988/12/06Package Change
019487000AP1988/03/01Approval