药品名称APRESOLINE
申请号008303产品号001
活性成分HYDRALAZINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
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
008303068APLabel2008/01/22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
008303071AP1999/04/28Package Change
008303070AP1997/02/03Control Supplement
008303069AP1996/08/22Manufacturing Change or Addition
008303068AP1996/02/28Labeling Revision
008303067AP1994/07/12Control Supplement
008303066AP1993/12/27Control Supplement
008303065AP1992/01/03Control Supplement
008303064AP1991/08/05Manufacturing Change or Addition
008303063AP1991/06/19Control Supplement
008303062AP1989/03/07Labeling Revision
008303059AP1986/12/22Labeling Revision
008303058AP1985/09/13Labeling Revision
008303057AP1985/03/19Control Supplement
008303055AP1984/09/18Package Change
008303053AP1983/12/15Formulation Revision
008303052AP1983/11/15Formulation Revision
008303050AP1983/07/15Package Change
008303049AP1982/08/23Manufacturing Change or Addition
008303048AP1982/05/05Package Change
008303047AP1985/04/18Practioner Draft Labeling
008303046AP1981/02/27Labeling Revision
008303045AP1980/05/08Labeling Revision
008303044AP1980/01/25Package Change
008303043AP1979/07/31Package Change
008303042AP1979/08/02Package Change
008303041AP1979/05/29Control Supplement
008303040AP1979/04/09Package Change
008303039AP1979/04/09Package Change
008303038AP1979/04/09Package Change
008303037AP1979/10/04Labeling Revision
008303036AP1979/10/04Labeling Revision
008303033AP1977/09/07Control Supplement
008303032AP1977/12/08Package Change
008303031AP1977/04/18Formulation Revision
008303029AP1977/04/18Labeling Revision
008303027AP1977/04/18Formulation Revision
008303025AP1977/07/11Package Change
008303024AP1976/04/19Labeling Revision
008303023AP1977/07/11Labeling Revision
008303021AP1977/07/11Supplement
008303000AP1953/01/15Approval