药品名称TAVIST-1
申请号017661产品号003
活性成分CLEMASTINE FUMARATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格1.34MG
治疗等效代码参比药物
批准日期1992/08/21申请机构NOVARTIS PHARMACEUTICALS CORP
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)
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历史专利信息
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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
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
017661051AP2002/02/11Manufacturing Change or Addition
017661049AP1996/06/06Control Supplement
017661048AP1996/10/31New or Modified Indication
017661047AP1995/10/20Manufacturing Change or Addition
017661046AP1995/10/17Control Supplement
017661045AP1995/11/07Package Change
017661044AP1994/06/08Control Supplement
017661043AP1995/02/03Labeling Revision
017661042AP1994/07/21Control Supplement
017661041AP1993/05/21Package Change
017661040AP1993/04/22Control Supplement
017661038AP1992/08/07Labeling Revision
017661036AP1992/07/22Labeling Revision
017661035AP1991/02/21Control Supplement
017661034AP1992/09/08Control Supplement
017661033AP1992/04/23Control Supplement
017661032AP1991/03/04Control Supplement
017661031AP1992/09/04Package Change
017661030AP1987/12/04Control Supplement
017661028AP1986/04/16Control Supplement
017661026AP1992/08/21OTC Labeling
017661024AP1986/04/15Package Change
017661023AP1983/03/01Control Supplement
017661022AP1981/07/15Control Supplement
017661021AP1981/07/17Manufacturing Change or Addition
017661019AP1980/05/01Control Supplement
017661018AP1980/04/01Control Supplement
017661017AP1980/04/17Control Supplement
017661016AP1979/04/20Labeling Revision
017661015AP1979/04/20Control Supplement
017661014AP1980/10/14Control Supplement
017661013AP1978/08/17Control Supplement
017661012AP1978/08/11Control Supplement
017661011AP1978/08/14Labeling Revision
017661010AP1978/08/14Control Supplement
017661009AP1978/05/30Control Supplement
017661008AP1978/05/30Control Supplement
017661007AP1978/05/24Labeling Revision
017661006AP1979/03/16Labeling Revision
017661005AP1979/03/16General Efficacy (MarkIV)
017661004AP1978/02/16Labeling Revision
017661003AP1978/02/16Formulation Revision
017661002AP1979/03/16Formulation Revision
017661000AP1977/02/25Approval