DRIXORAL(DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE)

药品名称	DRIXORAL
申请号	013483	产品号	003
活性成分	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE	市场状态	停止上市
剂型或给药途径	TABLET, EXTENDED RELEASE;ORAL	规格	6MG;120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	1982/09/13	申请机构	SCHERING PLOUGH HEALTHCARE PRODUCTS 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

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
013483	042	AP	2005/03/10	Formulation Revision
013483	039	AP	2001/06/29	Control Supplement
013483	038	AP	2001/07/11	Control Supplement
013483	037	AP	2001/03/06	Control Supplement
013483	036	AP	2000/10/17	Control Supplement
013483	035	AP	2001/01/24	Control Supplement
013483	034	AP	2000/04/18	Control Supplement
013483	033	AP	1998/10/06	Control Supplement
013483	032	AP	1998/09/22	Manufacturing Change or Addition
013483	031	AP	1998/11/18	Control Supplement
013483	028	AP	1989/01/24	Manufacturing Change or Addition
013483	027	AP	1986/07/08	Control Supplement
013483	024	AP	1984/09/18	Package Change
013483	022	AP	1986/02/22	Control Supplement
013483	021	AP	1984/09/21	Control Supplement
013483	020	AP	1985/03/20	Control Supplement
013483	019	AP	1982/07/01	Control Supplement
013483	017	AP	1982/09/13	Resubmission - Other (MarkIV)
013483	016	AP	1982/09/13	Control Supplement
013483	015	AP	1981/09/11	Labeling Revision
013483	014	AP	1980/07/21	Labeling Revision
013483	013	AP	1980/06/13	Control Supplement
013483	012	AP	1980/05/07	Control Supplement
013483	011	AP	1978/10/02	Expiration Date Change
013483	010	AP	1978/05/15	Control Supplement
013483	009	AP	1978/08/14	Control Supplement
013483	008	AP	1976/08/30	Formulation Revision
013483	000	AP	1963/10/18	Approval