药品名称NORDITROPIN FLEXPRO
申请号021148产品号008
活性成分SOMATROPIN RECOMBINANT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5MG/1.5ML
治疗等效代码BX参比药物
批准日期2010/03/01申请机构NOVO NORDISK 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
58497002015/12/15U-1041PDF格式
58497042015/12/15YU-1041PDF格式
76867862026/08/03YPDF格式
89203832026/07/17YPDF格式
91080022026/01/20YPDF格式
88412522017/12/26YPDF格式
94571542027/09/27YPDF格式
91322392032/02/01YPDF格式
86849692025/10/20YPDF格式
86728982022/01/02YPDF格式
68996992022/01/02YPDF格式
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
ODE2014/05/31
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
021148044APLetter2015/07/10下载
021148044APLabel2015/07/23下载
021148043APLetter2015/06/15下载
021148043APLabel2015/06/15下载
021148042APLetter2015/01/26下载
021148042APLabel2015/01/29下载
021148041APLetter2014/09/29下载
021148041APLabel2014/09/30下载
021148039APLetter2013/10/15下载
021148039APLabel2013/10/14下载
021148035APLabel2011/05/25下载
021148035APLetter2011/05/26下载
021148027APLabel2010/03/02下载
021148025APLetter2009/03/16下载
021148025APLabel2009/03/26下载
021148023APLetter2008/11/03下载
021148023APLabel2008/11/07下载
021148018APLabel2007/09/19下载
021148018APLetter2007/09/25下载
021148017APLabel2007/09/26下载
021148017APLetter2007/09/25下载
021148016APLetter2007/06/04下载
021148016APLabel2007/06/04下载
021148015APLabel2007/02/21下载
021148015APLetter2007/02/23下载
021148013APLabel2006/09/01下载
021148013APLetter2006/09/18下载
021148007APLetter2004/11/08下载
021148006APLetter2004/10/05下载
021148004APLetter2005/04/28下载
021148001APLetter2001/04/10下载
021148000APReview2004/06/14下载
021148000APLetter2000/06/20下载
021148000APLabel2000/06/20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
021148046AP2016/06/23Manufacturing Change or Addition
021148045AP2016/01/13Manufacturing Change or Addition
021148044AP2015/07/07Labeling Revision
021148043AP2015/06/12Labeling Revision
021148042AP2015/01/23Labeling Revision
021148041AP2014/09/25Labeling Revision
021148040AP2013/05/15Manufacturing Change or Addition
021148039AP2013/10/14Labeling Revision
021148035AP2011/05/25Labeling Revision
021148028AP2015/06/12Manufacturing Change or Addition
021148027AP2010/03/01Manufacturing Change or Addition
021148025AP2009/03/10Control Supplement
021148023AP2008/10/31New or Modified Indication
021148018AP2007/09/14Control Supplement
021148017AP2007/09/20New or Modified Indication
021148016AP2007/05/31New or Modified Indication
021148015AP2007/02/12Labeling Revision
021148013AP2006/09/01Labeling Revision
021148007AP2004/11/01New or Modified Indication
021148007TA2004/10/13New or Modified Indication
021148006AP2004/10/01Package Change
021148004AP2005/04/25Control Supplement
021148002AP2001/08/16Package Change
021148001AP2001/03/30Package Change
021148000AP2000/06/20Approval