GEMZAR(GEMCITABINE HYDROCHLORIDE) - 美国FDA药品数据库

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
无
历史专利信息
4808614	2010/05/15	Y			PDF格式
4808614*PED	2010/11/15				PDF格式
5464826	2012/11/07			U-146	PDF格式
5464826*PED	2013/05/07				PDF格式

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
020509	077	AP	2014/05/08	Labeling Revision
020509	076	AP	2014/08/11	Manufacturing Change or Addition
020509	075	AP	2014/06/10	Labeling Revision
020509	072	AP	2013/05/07	Labeling Revision
020509	069	AP	2011/02/04	Labeling Revision
020509	064	AP	2010/03/19	Labeling Revision
020509	039	AP	2006/07/14	New or Modified Indication
020509	037	AP	2006/04/05	Labeling Revision
020509	033	AP	2005/04/26	Efficacy Supplement with Clinical Data to Support
020509	032	AP	2005/04/20	Labeling Revision
020509	029	AP	2004/05/19	New or Modified Indication
020509	022	AP	2002/11/13	Control Supplement
020509	021	AP	2002/05/01	Control Supplement
020509	020	AP	2001/05/18	Control Supplement
020509	019	AP	2000/11/01	Control Supplement
020509	018	AP	2001/01/04	Control Supplement
020509	017	AP	2000/06/09	Control Supplement
020509	016	AP	2000/06/22	Control Supplement
020509	014	AP	2000/03/03	Control Supplement
020509	013	AP	2003/01/06	Labeling Revision
020509	011	AP	1998/11/23	Manufacturing Change or Addition
020509	010	AP	2000/06/23	Labeling Revision
020509	007	AP	1998/10/16	Control Supplement
020509	006	AP	1998/01/23	Manufacturing Change or Addition
020509	005	AP	1998/08/25	New or Modified Indication
020509	004	AP	1997/09/18	Labeling Revision
020509	003	AP	1997/10/10	Manufacturing Change or Addition
020509	002	AP	1997/04/11	Control Supplement
020509	001	AP	1997/02/05	Manufacturing Change or Addition
020509	000	AP	1996/05/15	Approval