ORTHO-NOVUM 1/35-21(ETHINYL ESTRADIOL; NORETHINDRONE)

药品名称	ORTHO-NOVUM 1/35-21
申请号	017489	产品号	002
活性成分	ETHINYL ESTRADIOL; NORETHINDRONE	市场状态	停止上市
剂型或给药途径	TABLET;ORAL-21	规格	0.035MG;1MG
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	ORTHO MCNEIL PHARMACEUTICAL 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
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
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
017489	091	AP	2002/02/21	Manufacturing Change or Addition
017489	090	AP	2001/07/09	Control Supplement
017489	088	AP	2000/01/05	Package Change
017489	087	AP	1999/08/27	Labeling Revision
017489	086	AP	1998/04/28	Manufacturing Change or Addition
017489	085	AP	1998/04/13	Manufacturing Change or Addition
017489	084	AP	1999/08/27	Labeling Revision
017489	083	AP	1997/02/24	Control Supplement
017489	082	AP	1997/01/29	Control Supplement
017489	081	AP	1996/04/09	Control Supplement
017489	080	AP	1996/05/10	Control Supplement
017489	079	AP	1995/11/30	Manufacturing Change or Addition
017489	078	AP	1995/09/07	Control Supplement
017489	077	AP	1995/02/16	Control Supplement
017489	076	AP	1994/06/28	Labeling Revision
017489	075	AP	1993/11/04	Manufacturing Change or Addition
017489	074	AP	1993/05/18	Control Supplement
017489	073	AP	1994/03/07	Formulation Revision
017489	071	AP	1991/03/18	Control Supplement
017489	070	AP	1991/09/16	Labeling Revision
017489	068	AP	1989/10/23	Labeling Revision
017489	067	AP	1989/07/19	Labeling Revision
017489	066	AP	1988/10/28	Control Supplement
017489	065	AP	1988/06/08	Manufacturing Change or Addition
017489	064	AP	1988/09/08	Labeling Revision
017489	063	AP	1987/02/26	Labeling Revision
017489	062	AP	1987/11/23	Control Supplement
017489	060	AP	1985/10/21	Labeling Revision
017489	059	AP	1985/04/05	Labeling Revision
017489	058	AP	1984/06/21	Labeling Revision
017489	057	AP	1984/01/30	Labeling Revision
017489	056	AP	1983/09/29	Labeling Revision
017489	054	AP	1983/06/15	Labeling Revision
017489	053	AP	1983/06/09	Control Supplement
017489	049	AP	1980/11/20	Control Supplement
017489	048	AP	1980/11/20	Control Supplement
017489	046	AP	1980/08/21	Manufacturing Change or Addition
017489	045	AP	1980/03/24	Manufacturing Change or Addition
017489	044	AP	1979/12/05	Labeling Revision
017489	043	AP	1979/12/05	Labeling Revision
017489	042	AP	1979/11/08	Control Supplement
017489	040	AP	1979/06/19	Control Supplement
017489	039	AP	1979/10/19	Package Change
017489	035	AP	1980/03/24	Control Supplement
017489	030	AP	1978/04/17	Control Supplement
017489	029	AP	1978/05/25	Control Supplement
017489	027	AP	1977/10/20	Control Supplement
017489	025	AP	1978/03/29	Control Supplement
017489	024	AP	1978/07/31	Control Supplement
017489	022	AP	1977/07/12	Package Change
017489	021	AP	1977/07/12	Package Change
017489	019	AP	1977/01/06	Manufacturing Change or Addition
017489	012	AP	1976/05/18	Control Supplement
017489	010	AP	1976/05/18	Control Supplement
017489	009	AP	1976/05/18	Control Supplement
017489	008	AP	1976/05/18	Control Supplement
017489	006	AP	1975/08/07	Control Supplement
017489	005	AP	1975/08/07	Control Supplement
017489	004	AP	1975/08/07	Control Supplement
017489	003	AP	1975/08/07	Control Supplement
017489	002	AP	1975/08/07	Control Supplement
017489	001	AP	1975/08/07	Control Supplement
017489	000	AP	1974/10/15	Approval

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