药品名称ALDOMET
申请号013400产品号002
活性成分METHYLDOPA市场状态停止上市
剂型或给药途径TABLET;ORAL规格500MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MERCK RESEARCH LABORATORIES DIV MERCK CO INC
化学类型New molecular entity (NME)审评分类Priority 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
013400086APLabel2004/09/21下载
013400086APLetter2004/09/21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
013400086AP2004/09/17Labeling Revision
013400085AP1998/11/10Labeling Revision
013400084AP1997/08/05Labeling Revision
013400083AP1997/07/07Control Supplement
013400082AP1997/07/07Control Supplement
013400081AP1997/08/05Labeling Revision
013400080AP1995/11/30Manufacturing Change or Addition
013400079AP1994/09/26Manufacturing Change or Addition
013400078AP1994/12/16Labeling Revision
013400077AP1992/09/03Labeling Revision
013400076AP1990/09/13Labeling Revision
013400075AP1988/11/22Labeling Revision
013400074AP1988/04/26Manufacturing Change or Addition
013400073AP1987/05/11Labeling Revision
013400072AP1985/10/22Labeling Revision
013400071AP1985/02/22Labeling Revision
013400070AP1985/01/17Control Supplement
013400069AP1984/07/13Labeling Revision
013400068AP1984/04/10Package Change
013400067AP1984/03/01Labeling Revision
013400066AP1983/12/23Formulation Revision
013400065AP1983/03/01Package Change
013400064AP1982/04/19Manufacturing Change or Addition
013400063AP1982/09/08Labeling Revision
013400062AP1982/04/07Formulation Revision
013400061AP1987/05/11Practioner Draft Labeling
013400060AP1981/10/14Labeling Revision
013400058AP1981/08/28Formulation Revision
013400057AP1981/06/17Package Change
013400056AP1981/11/17Labeling Revision
013400055AP1981/08/28Control Supplement
013400054AP1981/04/09Control Supplement
013400053AP1981/01/23Control Supplement
013400052AP1980/11/14Package Change
013400051AP1982/04/07Formulation Revision
013400050AP1979/10/10Control Supplement
013400048AP1979/07/25Labeling Revision
013400047AP1979/03/09Control Supplement
013400046AP1978/11/07Control Supplement
013400045AP1978/10/30Control Supplement
013400044AP1978/08/29Control Supplement
013400043AP1977/10/21Manufacturing Change or Addition
013400042AP1979/07/25Labeling Revision
013400041AP1978/06/08Labeling Revision
013400040AP1978/08/24Control Supplement
013400039AP1977/05/06Package Change
013400038AP1977/05/06Labeling Revision
013400037AP1978/02/15Package Change
013400036AP1977/05/02Package Change
013400035AP1977/02/07Labeling Revision
013400034AP1976/11/09Control Supplement
013400033AP1976/08/31Labeling Revision
013400032AP1976/11/09Control Supplement
013400031AP1976/07/22Labeling Revision
013400030AP1975/12/12Control Supplement
013400029AP1976/01/06Labeling Revision
013400028AP1975/06/06Control Supplement
013400000AP1962/12/20Approval