药品名称GONAL-F RFF REDI-JECT
申请号021684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450 IU/0.75ML
治疗等效代码参比药物
批准日期2004/05/25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
74460902019/08/23YPDF格式
77412682024/04/02YPDF格式
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
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
021684036APLabel2013/10/18下载
021684008APLetter2008/01/09下载
021684007APLabel2007/12/27下载
021684007APLetter2008/01/09下载
021684000APLetter2004/06/01下载
021684000APLabel2004/06/01下载
021684000APReview2006/03/21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
021684039AP2016/09/13Manufacturing Change or Addition
021684036AP2013/10/16Manufacturing Change or Addition
021684033AP2013/04/04Manufacturing Change or Addition
021684029AP2013/02/19Manufacturing Change or Addition
021684028AP2013/02/14Manufacturing Change or Addition
021684027AP2013/02/08Manufacturing Change or Addition
021684025AP2013/01/31Manufacturing Change or Addition
021684024AP2013/01/23Manufacturing Change or Addition
021684023AP2013/02/06Manufacturing Change or Addition
021684019AP2013/01/11Manufacturing Change or Addition
021684008AP2007/12/06Manufacturing Change or Addition
021684007AP2007/12/18Labeling Revision
021684000AP2004/05/25Approval