药品名称CARDENE
申请号019734产品号001
活性成分NICARDIPINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格25MG/10ML (2.5MG/ML)
治疗等效代码AP参比药物
批准日期1992/01/30申请机构CHIESI USA INC
化学类型New dosage form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
48808232006/11/14PDF格式
51644052009/11/17PDF格式
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
019734027APLetter2016/08/29下载
019734027APLabel2016/08/29下载
019734023APLabel2014/07/24下载
019734023APLetter2014/07/24下载
019734017APLabel2011/02/07下载
019734017APLetter2011/02/09下载
019734015APLetter2010/01/15下载
019734015APLabel2010/01/20下载
019734014APLetter2008/11/13下载
019734013APLetter2008/08/05下载
019734009APLetter2007/07/05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
019734027AP2016/08/26Labeling Revision
019734026AP2015/12/21Manufacturing Change or Addition
019734025AP2015/05/21Manufacturing Change or Addition
019734024AP2014/12/02Manufacturing Change or Addition
019734023AP2014/07/23Labeling Revision
019734022AP2014/04/30Manufacturing Change or Addition
019734021AP2013/09/27Manufacturing Change or Addition
019734020AP2013/05/02Manufacturing Change or Addition
019734017AP2011/02/07Labeling Revision
019734015AP2010/01/13Labeling Revision
019734014AP2008/11/07Formulation Revision
019734013AP2008/07/31Formulation Revision
019734009AP2007/06/22Labeling Revision
019734005AP2002/10/24Control Supplement
019734004AP1997/04/29Manufacturing Change or Addition
019734003AP1995/04/10Control Supplement
019734002AP1995/05/12Manufacturing Change or Addition
019734001AP1992/11/20Control Supplement
019734000AP1992/01/30Approval