药品名称GONAL-F RFF
申请号021765产品号002
活性成分FOLLITROPIN ALFA/BETA市场状态处方药
剂型或给药途径INJECTABLE;SUBCUTANEOUS规格75 IU/VIAL
治疗等效代码参比药物
批准日期2004/03/25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
57670672015/06/16YPDF格式
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
NP2007/03/25
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
021765007APLabel2007/07/06下载
021765007APLetter2007/07/10下载
021765004APLabel2006/01/06下载
021765004APLetter2006/01/19下载
021765000APReview2007/04/20下载
021765000APLetter2004/03/28下载
021765000APLabel2004/04/05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
021765040AP2016/02/10Manufacturing Change or Addition
021765039AP2015/04/29Manufacturing Change or Addition
021765035AP2014/08/11Manufacturing Change or Addition
021765034AP2013/12/19Manufacturing Change or Addition
021765032AP2013/12/11Manufacturing Change or Addition
021765029AP2013/04/04Manufacturing Change or Addition
021765026AP2013/02/19Manufacturing Change or Addition
021765025AP2013/02/14Manufacturing Change or Addition
021765024AP2013/02/08Manufacturing Change or Addition
021765022AP2013/01/31Manufacturing Change or Addition
021765021AP2013/01/23Manufacturing Change or Addition
021765020AP2013/02/06Manufacturing Change or Addition
021765019AP2013/01/17Manufacturing Change or Addition
021765018AP2013/01/17Manufacturing Change or Addition
021765011AP2015/11/17Manufacturing Change or Addition
021765007AP2007/07/05Labeling Revision
021765004AP2005/12/20Control Supplement
021765000AP2004/03/25Approval