药品名称HECTOROL
申请号021027产品号002
活性成分DOXERCALCIFEROL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2MCG/ML (2MCG/ML)
治疗等效代码AP参比药物否
批准日期2000/04/06申请机构GENZYME CORP
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
无
历史专利信息
56021162014/02/11U-321PDF格式
71482112023/09/14YPDF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
无
历史市场独占权保护信息
无
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
021027026APLabel2016/06/02下载
021027026APLetter2016/06/06下载
021027015APLetter2008/12/11下载
021027015APLabel2009/01/02下载
021027015APReview2012/05/09下载
021027013APLabel2006/07/21下载
021027013APLetter2006/07/21下载
021027012APLetter2005/06/23下载
021027012APLabel2005/06/23下载
021027007APLetter2003/12/04下载
021027000APLetter2000/04/06下载
021027000APReview2000/04/06下载
021027000APLabel2000/04/06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
021027032AP2016/08/15Manufacturing Change or Addition
021027031AP2015/12/15Manufacturing Change or Addition
021027030AP2014/09/11Manufacturing Change or Addition
021027029AP2014/07/31Manufacturing Change or Addition
021027028AP2013/12/24Manufacturing Change or Addition
021027027AP2013/09/23Manufacturing Change or Addition
021027026AP2016/06/01Labeling Revision
021027015AP2008/12/05Formulation Revision
021027013AP2006/07/20Labeling Revision
021027012AP2005/06/22Labeling Revision
021027007AP2003/11/26Manufacturing Change or Addition
021027006AP2002/11/19Manufacturing Change or Addition
021027005AP2002/07/24Manufacturing Change or Addition
021027004AP2002/06/03Manufacturing Change or Addition
021027001AP2001/06/26Manufacturing Change or Addition
021027000AP2000/04/06Approval