GONAL-F(FOLLITROPIN ALFA/BETA) - 美国FDA药品数据库

药品名称	GONAL-F
申请号	020378	产品号	004
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	1,050 IU/VIAL
治疗等效代码		参比药物	否
批准日期	2001/02/28	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
7563763	2019/08/23		Y		PDF格式
历史专利信息
5767067	2015/06/16	Y			PDF格式
5767251	2015/06/16	Y			PDF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
ODE	2007/05/24

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
020378	029	AP	Letter	2003/07/28	下载
020378	026	AP	Letter	2003/07/28	下载
020378	015	AP	Letter	2004/03/28	下载
020378	015	AP	Label	2004/04/05	下载
020378	006	AP	Review	2004/04/14	下载
020378	006	AP	Letter	2000/05/24	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
020378	069	AP	2015/03/03	Manufacturing Change or Addition
020378	068	AP	2015/02/09	Manufacturing Change or Addition
020378	065	AP	2014/08/11	Manufacturing Change or Addition
020378	064	AP	2013/12/19	Manufacturing Change or Addition
020378	063	AP	2013/12/11	Manufacturing Change or Addition
020378	062	AP	2013/09/20	Manufacturing Change or Addition
020378	061	AP	2014/01/30	Manufacturing Change or Addition
020378	060	AP	2013/04/04	Manufacturing Change or Addition
020378	059	AP	2013/02/26	Manufacturing Change or Addition
020378	058	AP	2016/02/29	Manufacturing Change or Addition
020378	057	AP	2013/02/20	Manufacturing Change or Addition
020378	056	AP	2013/02/19	Manufacturing Change or Addition
020378	055	AP	2013/02/14	Manufacturing Change or Addition
020378	054	AP	2013/02/08	Manufacturing Change or Addition
020378	053	AP	2013/02/15	Manufacturing Change or Addition
020378	052	AP	2013/01/31	Manufacturing Change or Addition
020378	051	AP	2013/01/23	Manufacturing Change or Addition
020378	050	AP	2013/02/06	Manufacturing Change or Addition
020378	047	AP	2013/01/18	Manufacturing Change or Addition
020378	043	AP	2015/11/19	Manufacturing Change or Addition
020378	042	AP	2013/08/13	Manufacturing Change or Addition
020378	029	AP	2003/07/16	Supplement
020378	026	AP	2003/07/16	Labeling Revision
020378	021	AP	2002/10/16	Manufacturing Change or Addition
020378	020	AP	2002/10/08	Control Supplement
020378	019	AP	2002/10/07	Control Supplement
020378	017	AP	2002/07/15	Control Supplement
020378	015	AP	2004/03/25	Formulation Revision
020378	014	AP	2001/07/23	Control Supplement
020378	013	AP	2001/03/26	Manufacturing Change or Addition
020378	012	AP	2000/10/26	Manufacturing Change or Addition
020378	011	AP	2000/11/08	Manufacturing Change or Addition
020378	010	AP	2000/08/31	Manufacturing Change or Addition
020378	009	AP	2001/02/28	Control Supplement
020378	008	AP	2000/01/05	Control Supplement
020378	007	AP	1999/11/22	Control Supplement
020378	006	AP	2000/05/24	New or Modified Indication
020378	005	AP	2000/01/05	Control Supplement
020378	004	AP	1999/06/23	Manufacturing Change or Addition
020378	003	AP	2000/05/25	Control Supplement
020378	002	AP	1998/11/10	Control Supplement
020378	001	AP	1998/09/18	Manufacturing Change or Addition
020378	000	AP	1997/09/29	Approval

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