CLARITIN HIVES RELIEF(LORATADINE) - 美国FDA药品数据库

药品名称	CLARITIN HIVES RELIEF
申请号	020641	产品号	003
活性成分	LORATADINE	市场状态	停止上市
剂型或给药途径	SYRUP;ORAL	规格	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	2003/11/19	申请机构	BAYER HEALTHCARE LLC
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
无
历史专利信息
无

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
020641	042	AP	2016/08/09	Labeling Revision
020641	041	AP	2016/02/12	Manufacturing Change or Addition
020641	040	AP	2015/12/30	Labeling Revision
020641	039	AP	2015/12/10	Manufacturing Change or Addition
020641	038	AP	2015/11/05	Labeling Revision
020641	037	AP	2015/10/21	Manufacturing Change or Addition
020641	036	AP	2015/04/16	Manufacturing Change or Addition
020641	035	AP	2014/05/15	Manufacturing Change or Addition
020641	033	AP	2013/04/16	Manufacturing Change or Addition
020641	032	AP	2013/02/28	Manufacturing Change or Addition
020641	030	AP	2012/11/20	Manufacturing Change or Addition
020641	025	AP	2008/07/25	Labeling Revision
020641	024	AP	2008/07/25	Package Change
020641	018	AP	2005/06/14	Formulation Revision
020641	017	AP	2004/10/27	Control Supplement
020641	016	AP	2004/07/15	Package Change
020641	012	AP	2002/12/09	Package Change
020641	011	AP	2003/11/19	OTC Labeling
020641	010	AP	2002/07/23	Expiration Date Change
020641	009	AP	2002/11/27	OTC Labeling
020641	007	AP	2000/12/04	Patient Population Altered
020641	006	AP	1999/01/07	Formulation Revision
020641	003	AP	1998/10/29	Manufacturing Change or Addition
020641	002	AP	1998/03/30	Labeling Revision
020641	001	AP	1998/01/23	Manufacturing Change or Addition
020641	000	AP	1996/10/10	Approval