药品名称IMODIUM
申请号017694产品号001
活性成分LOPERAMIDE HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格2MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
化学类型New molecular entity (NME)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
017694050APLabel2005/10/25下载
017694050APLetter2005/10/25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
017694050AP2005/10/21Labeling Revision
017694048AP1999/10/13Package Change
017694047AP1999/03/01Labeling Revision
017694045AP1998/06/30Manufacturing Change or Addition
017694044AP1998/06/02Control Supplement
017694043AP1998/09/01Manufacturing Change or Addition
017694042AP1995/10/05Manufacturing Change or Addition
017694041AP1993/06/01Labeling Revision
017694040AP1993/08/24Manufacturing Change or Addition
017694039AP1999/06/17Control Supplement
017694038AP1992/10/02Control Supplement
017694037AP1988/04/15Labeling Revision
017694036AP1988/05/26Control Supplement
017694035AP1987/06/16Labeling Revision
017694034AP1986/09/16Control Supplement
017694033AP1985/09/20Manufacturing Change or Addition
017694032AP1985/10/29Labeling Revision
017694031AP1984/08/02Control Supplement
017694030AP1984/08/02Package Change
017694029AP1983/11/22Manufacturing Change or Addition
017694028AP1983/07/15Control Supplement
017694027AP1983/02/15Labeling Revision
017694026AP1982/12/15Control Supplement
017694025AP1982/11/03Package Change
017694024AP1982/11/03Package Change
017694022AP1983/04/27Labeling Revision
017694021AP1982/05/19Control Supplement
017694020AP1982/08/10Manufacturing Change or Addition
017694019AP1984/07/31Practioner Draft Labeling
017694018AP1981/05/14Control Supplement
017694017AP1981/05/11Labeling Revision
017694016AP1980/06/13Manufacturing Change or Addition
017694015AP1980/03/26Manufacturing Change or Addition
017694014AP1979/11/05Labeling Revision
017694013AP1979/10/03Control Supplement
017694012AP1979/05/23Labeling Revision
017694011AP1979/06/25Labeling Revision
017694010AP1979/04/05Package Change
017694009AP1979/04/05Labeling Revision
017694008AP1979/03/14Package Change
017694007AP1978/10/30Formulation Revision
017694006AP1978/10/30Control Supplement
017694005AP1978/07/05Labeling Revision
017694003AP1978/04/24Control Supplement
017694001AP1978/09/14Labeling Revision
017694000AP1976/12/28Approval