FLEXERIL(CYCLOBENZAPRINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	FLEXERIL
申请号	017821	产品号	001
活性成分	CYCLOBENZAPRINE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	Approved Prior to Jan 1, 1982	申请机构	JANSSEN RESEARCH AND DEVELOPMENT LLC
化学类型	New molecular entity (NME)	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
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
017821	051	AP	2013/04/11	Labeling Revision
017821	047	AP	2002/11/05	Manufacturing Change or Addition
017821	046	AP	2002/10/03	Manufacturing Change or Addition
017821	045	AP	2003/02/03	Efficacy Supplement with Clinical Data to Support
017821	041	AP	1998/09/15	Control Supplement
017821	040	AP	1996/11/29	Control Supplement
017821	039	AP	1996/03/01	Manufacturing Change or Addition
017821	037	AP	1994/08/18	Control Supplement
017821	033	AP	1990/01/10	Manufacturing Change or Addition
017821	032	AP	1994/06/09	Manufacturing Change or Addition
017821	031	AP	1988/04/08	Package Change
017821	029	AP	1986/05/30	Labeling Revision
017821	026	AP	1986/01/16	Labeling Revision
017821	025	AP	1984/02/24	Manufacturing Change or Addition
017821	024	AP	1997/06/21	Labeling Revision
017821	023	AP	1983/01/04	Package Change
017821	021	AP	1982/05/13	Control Supplement
017821	020	AP	1982/04/01	Manufacturing Change or Addition
017821	019	AP	1983/06/21	Package Change
017821	018	AP	1981/05/26	Package Change
017821	017	AP	1981/05/26	Manufacturing Change or Addition
017821	016	AP	1982/06/03	Labeling Revision
017821	015	AP	1980/12/02	Package Change
017821	014	AP	1980/10/10	Formulation Revision
017821	013	AP	1980/10/10	Manufacturing Change or Addition
017821	012	AP	1980/10/10	Labeling Revision
017821	011	AP	1980/08/21	Control Supplement
017821	008	AP	1979/05/31	Labeling Revision
017821	007	AP	1979/05/03	Manufacturing Change or Addition
017821	004	AP	1978/03/02	Labeling Revision
017821	002	AP	1978/03/14	Labeling Revision
017821	000	AP	1977/08/26	Approval