药品名称HEPARIN SODIUM PRESERVATIVE FREE
申请号017029产品号019
活性成分HEPARIN SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10,000 UNITS/ML
治疗等效代码参比药物
批准日期2010/11/22申请机构FRESENIUS KABI USA LLC
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
017029135APLetter2014/04/07下载
017029131APLabel2011/12/23下载
017029131APLetter2011/12/29下载
017029128APLetter2011/07/05下载
017029120APLetter2010/06/14下载
017029120APLabel2010/06/24下载
017029108APLetter2008/09/26下载
017029108APLabel2008/10/03下载
017029099APLetter2002/03/22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
017029139AP2016/06/09Manufacturing Change or Addition
017029137AP2015/07/21Manufacturing Change or Addition
017029136AP2013/09/24Manufacturing Change or Addition
017029135AP2014/03/21Labeling Revision
017029134AP2015/03/09Manufacturing Change or Addition
017029131AP2011/12/23Labeling Revision
017029129AP2015/12/23Manufacturing Change or Addition
017029128AP2011/06/24Labeling Revision
017029120AP2010/06/11Labeling Revision
017029108AP2008/09/23Labeling Revision
017029099AP2002/03/22Labeling Revision
017029098AP1999/12/13Manufacturing Change or Addition
017029097AP2000/03/08Package Change
017029096AP1997/11/04Control Supplement
017029095AP1997/06/24Control Supplement
017029094AP1998/08/06Manufacturing Change or Addition
017029084AP1995/05/17Manufacturing Change or Addition
017029078AP1994/10/27Manufacturing Change or Addition
017029073AP1996/07/26Control Supplement
017029069AP1993/08/25Labeling Revision
017029063AP1998/08/06Manufacturing Change or Addition
017029062AP1998/08/06Manufacturing Change or Addition
017029061AP1989/06/08Package Change
017029060AP1988/09/22Labeling Revision
017029058AP1988/02/16Control Supplement
017029057AP1989/12/01Package Change
017029056AP1992/06/26Labeling Revision
017029054AP1986/04/28Control Supplement
017029053AP1986/04/07Labeling Revision
017029051AP1987/09/22Package Change
017029050AP1987/09/22Package Change
017029049AP1985/07/29General Efficacy (MarkIV)
017029048AP1984/11/06Package Change
017029047AP1985/12/05Package Change
017029046AP1985/12/05Package Change
017029045AP1985/12/05Package Change
017029044AP1985/12/05Package Change
017029043AP1985/12/05Package Change
017029042AP1985/12/05Package Change
017029041AP1983/11/02Formulation Revision
017029040AP1983/11/02Formulation Revision
017029039AP1983/11/02Formulation Revision
017029038AP1983/11/02Formulation Revision
017029037AP1985/05/16Formulation Revision
017029036AP1983/11/02Formulation Revision
017029034AP1983/11/02Expiration Date Change
017029033AP1983/01/04Expiration Date Change
017029032AP1982/09/21Manufacturing Change or Addition
017029031AP1982/09/21Manufacturing Change or Addition
017029030AP1982/05/06Labeling Revision
017029029AP1982/09/17Control Supplement
017029027AP1981/02/24Labeling Revision
017029026AP1981/03/24Manufacturing Change or Addition
017029025AP1979/10/31Control Supplement
017029024AP1979/10/31Manufacturing Change or Addition
017029023AP1978/11/21Control Supplement
017029022AP1978/11/21Control Supplement
017029021AP1978/05/23Labeling Revision
017029020AP1977/12/14Control Supplement
017029019AP1976/12/03Control Supplement
017029017AP1976/12/03Formulation Revision
017029016AP1977/01/26Formulation Revision
017029015AP1977/12/04Labeling Revision
017029014AP1976/06/16Manufacturing Change or Addition
017029012AP1976/02/09Labeling Revision
017029011AP1976/01/09Control Supplement
017029010AP1976/01/09Formulation Revision
017029009AP1976/03/17Control Supplement
017029008AP1976/02/09Control Supplement
017029007AP1975/08/29Control Supplement
017029000AP1972/02/22Approval