药品名称ISMELIN
申请号012329产品号001
活性成分GUANETHIDINE MONOSULFATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 10MG SULFATE
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Priority review drug
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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
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申请号修订号审批结论审批日期审批内容
012329054AP1986/10/22Labeling Revision
012329053AP1986/05/05Labeling Revision
012329052AP1986/05/05Labeling Revision
012329051AP1985/03/19Control Supplement
012329050AP1986/05/05Practioner Draft Labeling
012329049AP1981/02/02Formulation Revision
012329048AP1980/12/12Labeling Revision
012329047AP1980/05/08Labeling Revision
012329046AP1980/01/24Package Change
012329045AP1980/01/17Package Change
012329044AP1979/06/25Package Change
012329043AP1979/06/25Package Change
012329042AP1979/06/25Package Change
012329041AP1979/01/08Labeling Revision
012329040AP1979/01/31Control Supplement
012329039AP1979/02/12Package Change
012329038AP1977/06/29Control Supplement
012329037AP1977/04/12Manufacturing Change or Addition
012329036AP1976/12/02Package Change
012329035AP1976/12/29Control Supplement
012329034AP1976/02/03Manufacturing Change or Addition
012329033AP1976/03/19Control Supplement
012329032AP1975/07/02Control Supplement
012329030AP1975/03/31Control Supplement
012329029AP1975/03/31Package Change
012329028AP1975/03/31Package Change
012329026AP1975/05/15Other Amendment
012329023AP1975/05/15Other Amendment
012329000AP1960/07/05Approval