药品名称DYNACIRC
申请号019546产品号002
活性成分ISRADIPINE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格5MG
治疗等效代码参比药物
批准日期1990/12/20申请机构SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
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
019546031APLetter2005/05/20下载
019546000APReview2002/09/10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
019546031AP2005/05/18Labeling Revision
019546026AP2002/06/14Manufacturing Change or Addition
019546025AP2002/04/29Manufacturing Change or Addition
019546024AP2001/05/30Control Supplement
019546023AP1999/12/14Control Supplement
019546022AP1999/05/07Manufacturing Change or Addition
019546021AP1999/04/28Package Change
019546020AP1997/01/14Manufacturing Change or Addition
019546017AP1995/11/27Control Supplement
019546016AP1995/11/02Manufacturing Change or Addition
019546015AP1995/04/04Control Supplement
019546013AP1995/05/04Labeling Revision
019546012AP1993/11/03Labeling Revision
019546011AP1993/03/23Package Change
019546010AP1993/02/08Control Supplement
019546009AP1992/08/17Package Change
019546008AP1991/11/06Control Supplement
019546007AP1991/11/06Control Supplement
019546006AP1991/08/05Package Change
019546005AP1991/06/13Labeling Revision
019546004AP1991/06/12Formulation Revision
019546002AP1991/06/13Labeling Revision
019546001AP1991/04/30Package Change
019546000AP1990/12/20Approval