药品名称HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
申请号018609产品号001
活性成分HEPARIN SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格200 UNITS/100ML
治疗等效代码AP参比药物
批准日期1982/04/28申请机构BAXTER HEALTHCARE CORP
化学类型New formulation or new manufacturer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
018609044APLetter2010/08/20下载
018609044APLabel2010/08/28下载
018609042APLetter2012/02/29下载
018609035APLabel2003/04/14下载
018609035APReview2008/04/02下载
018609033APLabel2003/04/14下载
018609033APReview2008/04/02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
018609050AP2016/07/25Manufacturing Change or Addition
018609049AP2015/08/18Manufacturing Change or Addition
018609044AP2010/08/13Labeling Revision
018609042AP2012/02/27Labeling Revision
018609037AP2001/08/14Control Supplement
018609036AP1999/11/23Package Change
018609035AP2001/08/21Labeling Revision
018609034AP1999/06/01Manufacturing Change or Addition
018609033AP2001/08/21Labeling Revision
018609032AP1997/05/20Package Change
018609031AP1996/09/17Labeling Revision
018609030AP1994/03/10Control Supplement
018609029AP1994/09/14Manufacturing Change or Addition
018609027AP1993/04/15Manufacturing Change or Addition
018609025AP1991/03/04Control Supplement
018609024AP1990/07/26Control Supplement
018609023AP1991/02/01Package Change
018609022AP1989/08/24Control Supplement
018609021AP1989/11/08Labeling Revision
018609020AP1987/04/29Package Change
018609019AP1986/12/01Control Supplement
018609018AP1986/12/01Control Supplement
018609017AP1985/09/20Control Supplement
018609016AP1985/09/20Package Change
018609015AP1989/11/08Labeling Revision
018609014AP1984/10/16Control Supplement
018609013AP1984/08/03Manufacturing Change or Addition
018609012AP1984/02/28Control Supplement
018609011AP1984/03/06Labeling Revision
018609010AP1989/11/08Practioner Draft Labeling
018609009AP1984/03/06Control Supplement
018609008AP1984/03/06Package Change
018609004AP1984/03/06Package Change
018609003AP1982/08/09Package Change
018609002AP1982/08/09Control Supplement
018609001AP1982/06/29Expiration Date Change
018609000AP1982/04/28Approval