药品名称OVIDREL
申请号021149产品号002
活性成分CHORIOGONADOTROPIN ALFA市场状态处方药
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格EQ 0.25MG /0.5ML
治疗等效代码参比药物
批准日期2003/10/06申请机构EMD SERONO 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
67066812021/03/16YPDF格式
历史专利信息
57672512015/06/16YPDF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
021149020APLabel2010/06/07下载
021149020APLetter2010/06/08下载
021149013APLetter2007/07/31下载
021149013APLabel2007/07/31下载
021149006APLetter2003/07/28下载
021149000APReview2004/12/07下载
021149000APLetter2000/09/20下载
021149000APLabel2000/09/20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
021149040AP2015/09/30Manufacturing Change or Addition
021149039AP2014/12/11Manufacturing Change or Addition
021149037AP2013/12/19Manufacturing Change or Addition
021149036AP2013/12/11Manufacturing Change or Addition
021149035AP2013/04/11Manufacturing Change or Addition
021149034AP2013/04/05Manufacturing Change or Addition
021149033AP2013/01/31Manufacturing Change or Addition
021149032AP2013/02/08Manufacturing Change or Addition
021149031AP2013/01/15Manufacturing Change or Addition
021149030AP2013/01/31Manufacturing Change or Addition
021149029AP2013/01/15Manufacturing Change or Addition
021149026AP2012/12/10Manufacturing Change or Addition
021149025AP2012/12/13Manufacturing Change or Addition
021149020AP2010/06/02Labeling Revision
021149017AP2013/07/09Manufacturing Change or Addition
021149013AP2007/07/30Labeling Revision
021149006AP2003/07/14Labeling Revision
021149001AP2002/05/15Control Supplement
021149000AP2000/09/20Approval