药品名称TESSALON
申请号011210产品号003
活性成分BENZONATATE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1999/06/25申请机构PFIZER INC
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
011210053APLabel2011/01/25下载
011210053APLetter2011/01/25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
011210053AP2011/01/20Labeling Revision
011210041AP2002/07/23Manufacturing Change or Addition
011210040AP2000/11/01Control Supplement
011210039AP2000/06/30Control Supplement
011210037AP1999/06/08Manufacturing Change or Addition
011210035AP1999/06/25Manufacturing Change or Addition
011210032AP1993/12/01Manufacturing Change or Addition
011210031AP1992/09/04Labeling Revision
011210030AP1986/10/08Labeling Revision
011210029AP1985/11/29Practioner Draft Labeling
011210027AP1985/11/05Control Supplement
011210026AP1985/06/13Control Supplement
011210025AP1985/11/29Labeling Revision
011210022AP1981/07/15Manufacturing Change or Addition
011210021AP1980/07/03Control Supplement
011210020AP1979/08/28Manufacturing Change or Addition
011210019AP1979/07/06Expiration Date Change
011210018AP1978/09/29Labeling Revision
011210015AP1978/09/29Control Supplement
011210014AP1978/10/24Control Supplement
011210013AP1975/03/31Control Supplement
011210011AP1974/12/30Supplement
011210002AP1972/04/12Labeling Revision
011210000AP1958/02/10Approval