MODICON 28(ETHINYL ESTRADIOL; NORETHINDRONE)

药品名称	MODICON 28
申请号	017735	产品号	001
活性成分	ETHINYL ESTRADIOL; NORETHINDRONE	市场状态	处方药
剂型或给药途径	TABLET;ORAL-28	规格	0.035MG;0.5MG
治疗等效代码	AB	参比药物	是
批准日期	Approved Prior to Jan 1, 1982	申请机构	JANSSEN PHARMACEUTICALS INC
化学类型	New formulation or new manufacturer	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

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
无

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
017735	117	AP	Letter	2015/11/04	下载
017735	117	AP	Label	2015/11/04	下载
017735	114	AP	Letter	2013/10/04	下载
017735	110	AP	Letter	2013/10/04	下载
017735	108	AP	Letter	2013/10/04	下载
017735	107	AP	Letter	2012/06/20	下载
017735	107	AP	Label	2012/07/13	下载
017735	104	AP	Label	2013/10/04	下载
017735	104	AP	Letter	2013/10/04	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
017735	117	AP	2015/10/29	Labeling Revision
017735	116	AP	2014/09/11	Manufacturing Change or Addition
017735	114	AP	2013/10/02	Labeling Revision
017735	110	AP	2013/10/02	Labeling Revision
017735	108	AP	2013/10/02	Labeling Revision
017735	107	AP	2012/06/18	Labeling Revision
017735	104	AP	2013/10/02	Labeling Revision
017735	093	AP	2002/06/03	Control Supplement
017735	092	AP	2002/02/21	Manufacturing Change or Addition
017735	091	AP	2001/07/09	Control Supplement
017735	089	AP	2000/06/06	Labeling Revision
017735	088	AP	2000/01/05	Package Change
017735	087	AP	1999/08/27	Labeling Revision
017735	086	AP	1998/04/28	Manufacturing Change or Addition
017735	085	AP	1998/04/13	Manufacturing Change or Addition
017735	084	AP	1999/01/06	Labeling Revision
017735	083	AP	1999/08/27	Labeling Revision
017735	082	AP	1997/02/24	Control Supplement
017735	081	AP	1997/01/29	Control Supplement
017735	080	AP	1996/04/09	Control Supplement
017735	079	AP	1996/05/10	Control Supplement
017735	078	AP	1995/11/30	Manufacturing Change or Addition
017735	077	AP	1995/09/07	Control Supplement
017735	076	AP	1995/02/16	Control Supplement
017735	075	AP	1993/11/04	Manufacturing Change or Addition
017735	074	AP	1994/01/04	Labeling Revision
017735	073	AP	1993/05/18	Control Supplement
017735	072	AP	1994/03/07	Formulation Revision
017735	070	AP	1991/03/18	Control Supplement
017735	069	AP	1991/09/16	Labeling Revision
017735	068	AP	1990/01/18	Control Supplement
017735	066	AP	1989/10/23	Labeling Revision
017735	065	AP	1989/07/19	Labeling Revision
017735	064	AP	1988/10/28	Control Supplement
017735	063	AP	1988/06/08	Manufacturing Change or Addition
017735	062	AP	1988/09/08	Labeling Revision
017735	061	AP	1987/02/26	Labeling Revision
017735	060	AP	1987/11/23	Control Supplement
017735	058	AP	1985/10/21	Labeling Revision
017735	057	AP	1985/04/05	Labeling Revision
017735	056	AP	1984/06/21	Labeling Revision
017735	055	AP	1984/01/30	Labeling Revision
017735	054	AP	1983/09/29	Labeling Revision
017735	052	AP	1983/06/15	Labeling Revision
017735	051	AP	1983/06/09	Control Supplement
017735	049	AP	1982/09/29	Labeling Revision
017735	046	AP	1980/11/20	Control Supplement
017735	045	AP	1980/11/20	Control Supplement
017735	043	AP	1980/08/21	Manufacturing Change or Addition
017735	042	AP	1980/03/28	Expiration Date Change
017735	041	AP	1980/03/24	Manufacturing Change or Addition
017735	040	AP	1979/11/13	Labeling Revision
017735	039	AP	1979/11/08	Control Supplement
017735	038	AP	1979/05/07	Expiration Date Change
017735	037	AP	1979/08/15	Labeling Revision
017735	036	AP	1979/10/19	Package Change
017735	033	AP	1980/03/24	Control Supplement
017735	032	AP	1978/06/07	Labeling Revision
017735	023	AP	1979/06/19	Formulation Revision
017735	019	AP	1978/02/28	Control Supplement
017735	018	AP	1978/02/28	Control Supplement
017735	017	AP	1978/02/28	Control Supplement
017735	016	AP	1978/04/17	Control Supplement
017735	014	AP	1978/05/25	Control Supplement
017735	009	AP	1977/10/20	Control Supplement
017735	008	AP	1978/03/29	Control Supplement
017735	005	AP	1978/07/31	Control Supplement
017735	003	AP	1977/07/01	Labeling Revision
017735	002	AP	1977/07/15	Manufacturing Change or Addition
017735	001	AP	1976/12/30	Control Supplement
017735	000	AP	1976/05/14	Approval

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