NORDETTE-28(ETHINYL ESTRADIOL; LEVONORGESTREL)

药品名称	NORDETTE-28
申请号	018782	产品号	001
活性成分	ETHINYL ESTRADIOL; LEVONORGESTREL	市场状态	停止上市
剂型或给药途径	TABLET;ORAL-28	规格	0.03MG;0.15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	1982/07/21	申请机构	TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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

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
018782	036	AP	2013/06/03	Approval
018782	027	AP	2002/03/06	Manufacturing Change or Addition
018782	025	AP	1998/12/11	Manufacturing Change or Addition
018782	024	AP	1998/03/11	Manufacturing Change or Addition
018782	023	AP	2000/04/03	Labeling Revision
018782	022	AP	1996/05/17	Manufacturing Change or Addition
018782	021	AP	1995/10/11	Control Supplement
018782	020	AP	1994/04/08	Manufacturing Change or Addition
018782	019	AP	1994/11/29	Labeling Revision
018782	018	AP	1994/01/28	Labeling Revision
018782	017	AP	1992/06/10	Control Supplement
018782	016	AP	1991/05/03	Manufacturing Change or Addition
018782	015	AP	1991/05/20	Manufacturing Change or Addition
018782	014	AP	1989/05/19	Manufacturing Change or Addition
018782	013	AP	1988/04/27	Expiration Date Change
018782	012	AP	1990/08/08	Labeling Revision
018782	010	AP	1986/07/15	Labeling Revision
018782	009	AP	1996/12/27	Control Supplement
018782	008	AP	1985/12/20	Labeling Revision
018782	007	AP	1986/02/19	Control Supplement
018782	006	AP	1985/09/06	Labeling Revision
018782	005	AP	1985/07/29	Control Supplement
018782	004	AP	1984/09/04	Manufacturing Change or Addition
018782	003	AP	1984/07/25	Labeling Revision
018782	002	AP	1985/03/12	Manufacturing Change or Addition
018782	001	AP	1982/12/03	Labeling Revision
018782	000	AP	1982/07/21	Approval