药品名称GONAL-F
申请号020378产品号003
活性成分FOLLITROPIN ALFA/BETA市场状态停止上市
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格37.5 IU/VIAL
治疗等效代码参比药物
批准日期2000/05/25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
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
ODE2007/05/24
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
020378029APLetter2003/07/28下载
020378026APLetter2003/07/28下载
020378015APLetter2004/03/28下载
020378015APLabel2004/04/05下载
020378006APReview2004/04/14下载
020378006APLetter2000/05/24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
020378069AP2015/03/03Manufacturing Change or Addition
020378068AP2015/02/09Manufacturing Change or Addition
020378065AP2014/08/11Manufacturing Change or Addition
020378064AP2013/12/19Manufacturing Change or Addition
020378063AP2013/12/11Manufacturing Change or Addition
020378062AP2013/09/20Manufacturing Change or Addition
020378061AP2014/01/30Manufacturing Change or Addition
020378060AP2013/04/04Manufacturing Change or Addition
020378059AP2013/02/26Manufacturing Change or Addition
020378058AP2016/02/29Manufacturing Change or Addition
020378057AP2013/02/20Manufacturing Change or Addition
020378056AP2013/02/19Manufacturing Change or Addition
020378055AP2013/02/14Manufacturing Change or Addition
020378054AP2013/02/08Manufacturing Change or Addition
020378053AP2013/02/15Manufacturing Change or Addition
020378052AP2013/01/31Manufacturing Change or Addition
020378051AP2013/01/23Manufacturing Change or Addition
020378050AP2013/02/06Manufacturing Change or Addition
020378047AP2013/01/18Manufacturing Change or Addition
020378043AP2015/11/19Manufacturing Change or Addition
020378042AP2013/08/13Manufacturing Change or Addition
020378029AP2003/07/16Supplement
020378026AP2003/07/16Labeling Revision
020378021AP2002/10/16Manufacturing Change or Addition
020378020AP2002/10/08Control Supplement
020378019AP2002/10/07Control Supplement
020378017AP2002/07/15Control Supplement
020378015AP2004/03/25Formulation Revision
020378014AP2001/07/23Control Supplement
020378013AP2001/03/26Manufacturing Change or Addition
020378012AP2000/10/26Manufacturing Change or Addition
020378011AP2000/11/08Manufacturing Change or Addition
020378010AP2000/08/31Manufacturing Change or Addition
020378009AP2001/02/28Control Supplement
020378008AP2000/01/05Control Supplement
020378007AP1999/11/22Control Supplement
020378006AP2000/05/24New or Modified Indication
020378005AP2000/01/05Control Supplement
020378004AP1999/06/23Manufacturing Change or Addition
020378003AP2000/05/25Control Supplement
020378002AP1998/11/10Control Supplement
020378001AP1998/09/18Manufacturing Change or Addition
020378000AP1997/09/29Approval