HABITROL(NICOTINE) - 美国FDA药品数据库

药品名称	HABITROL
申请号	020076	产品号	004
活性成分	NICOTINE	市场状态	非处方药
剂型或给药途径	FILM, EXTENDED RELEASE;TRANSDERMAL	规格	7MG/24HR
治疗等效代码		参比药物	否
批准日期	1999/11/12	申请机构	DR REDDYS LABORATORIES 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
无
历史专利信息
5016652	2008/05/21				PDF格式
5834011	2007/05/01			U-355	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
020076	044	AP	2016/09/22	Manufacturing Change or Addition
020076	043	AP	2016/07/05	Labeling Revision
020076	042	AP	2016/07/06	Labeling Revision
020076	041	AP	2016/05/10	Labeling Revision
020076	040	AP	2016/05/09	Manufacturing Change or Addition
020076	039	AP	2016/04/04	Manufacturing Change or Addition
020076	038	AP	2016/01/19	Manufacturing Change or Addition
020076	037	AP	2015/11/17	Manufacturing Change or Addition
020076	036	AP	2014/07/25	Labeling Revision
020076	035	AP	2013/05/16	Manufacturing Change or Addition
020076	029	AP	2006/05/05	Labeling Revision
020076	028	AP	2005/11/22	Labeling Revision
020076	027	AP	2004/10/21	Package Change
020076	025	AP	2004/01/21	Labeling Revision
020076	024	AP	2004/02/06	Labeling Revision
020076	021	AP	2002/07/15	Labeling Revision
020076	020	AP	2002/07/12	Labeling Revision
020076	018	AP	2000/11/07	Formulation Revision
020076	017	AP	2000/01/31	Manufacturing Change or Addition
020076	015	AP	1999/12/03	Manufacturing Change or Addition
020076	014	AP	1998/10/29	Manufacturing Change or Addition
020076	013	AP	1999/01/07	Comparative Efficacy Claim
020076	011	AP	1999/11/12	OTC Labeling
020076	010	AP	1995/10/06	Package Change
020076	009	AP	1996/07/24	Manufacturing Change or Addition
020076	007	AP	1996/02/08	Manufacturing Change or Addition
020076	006	AP	1994/10/06	Manufacturing Change or Addition
020076	004	AP	1992/07/21	Manufacturing Change or Addition
020076	003	AP	1992/07/21	Manufacturing Change or Addition
020076	001	AP	1992/01/06	Package Change
020076	000	AP	1991/11/27	Approval