CREON(PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))

药品名称	CREON
申请号	020725	产品号	004
活性成分	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	市场状态	处方药
剂型或给药途径	CAPSULE, DELAYED RELEASE;ORAL	规格	15,000USP UNITS;3,000USP UNITS;9,500USP UNITS
治疗等效代码		参比药物	否
批准日期	2011/07/12	申请机构	ABBVIE INC
化学类型	Drug already marketed, but without an approved NDA	审评分类	Priority 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
9198871	2030/02/07		Y	U-1787	PDF格式
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
020725	023	AP	2016/06/16	Manufacturing Change or Addition
020725	022	AP	2015/04/10	Manufacturing Change or Addition
020725	021	AP	2015/01/05	Manufacturing Change or Addition
020725	021	AP	2015/01/05	Manufacturing Change or Addition
020725	020	AP	2014/11/19	Manufacturing Change or Addition
020725	018	AP	2014/11/21	Manufacturing Change or Addition
020725	017	AP	2013/02/28	Manufacturing Change or Addition
020725	016	AP	2013/03/14	Manufacturing Change or Addition
020725	015	AP	2012/11/20	Manufacturing Change or Addition
020725	014	AP	2011/05/09	Approval
020725	011	AP	2011/06/10	Manufacturing Change or Addition
020725	009	AP	2014/03/17	Manufacturing Change or Addition
020725	008	AP	2011/07/12	Efficacy Supplement with Clinical Data to Support
020725	007	AP	2010/08/12	Labeling Revision
020725	006	AP	2010/07/29	Efficacy Supplement with Clinical Data to Support
020725	003	AP	2010/04/30	Patient Population Altered
020725	000	AP	2009/04/30	Approval