药品名称PERSANTINE
申请号012836产品号005
活性成分DIPYRIDAMOLE市场状态处方药
剂型或给药途径TABLET;ORAL规格75MG
治疗等效代码AB参比药物
批准日期1987/02/06申请机构BOEHRINGER INGELHEIM PHARMACEUTICALS 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
012836057APLetter2005/08/03下载
012836057APLabel2005/08/03下载
012836054APLetter2004/08/06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
012836060AP2015/07/29Manufacturing Change or Addition
012836059AP2014/05/08Manufacturing Change or Addition
012836057AP2005/08/01Labeling Revision
012836056AP2002/06/20Control Supplement
012836055AP2002/02/08Manufacturing Change or Addition
012836054AP2004/08/05Labeling Revision
012836053AP2001/05/24Manufacturing Change or Addition
012836052AP2000/02/08Manufacturing Change or Addition
012836051AP1997/07/03Labeling Revision
012836050AP1994/05/18Formulation Revision
012836049AP1994/02/18Labeling Revision
012836047AP1991/03/26Labeling Revision
012836046AP1995/02/21Manufacturing Change or Addition
012836045AP1988/11/08Labeling Revision
012836044AP1989/08/30Formulation Revision
012836042AP1988/12/12Manufacturing Change or Addition
012836041AP1988/02/24Labeling Revision
012836040AP1987/02/06Control Supplement
012836038AP1986/12/22Labeling Revision
012836032AP1982/10/08Manufacturing Change or Addition
012836014AP1986/12/22New or Modified Indication
012836000AP1961/12/06Approval