PROMETHAZINE HYDROCHLORIDE PLAIN(PROMETHAZINE HYDROCHLORIDE)

药品名称	PROMETHAZINE HYDROCHLORIDE PLAIN
申请号	008381	产品号	003
活性成分	PROMETHAZINE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	SYRUP;ORAL	规格	25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	ANI PHARMACEUTICALS INC
化学类型	New active ingredient	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
008381	030	AP	2008/11/10	Labeling Revision
008381	028	AP	2008/04/02	Manufacturing Change or Addition
008381	027	AP	2003/06/27	Labeling Revision
008381	026	AP	2003/06/27	Supplement
008381	024	AP	1998/05/06	Manufacturing Change or Addition
008381	023	AP	1992/03/30	Manufacturing Change or Addition
008381	022	AP	1992/02/06	Control Supplement
008381	021	AP	1989/12/12	Manufacturing Change or Addition
008381	020	AP	1989/12/13	Manufacturing Change or Addition
008381	019	AP	1988/06/30	Control Supplement
008381	018	AP	1988/04/06	Labeling Revision
008381	014	AP	1987/03/02	Labeling Revision
008381	013	AP	1986/09/08	Labeling Revision
008381	012	AP	1985/11/04	Labeling Revision
008381	011	AP	1985/07/27	Control Supplement
008381	010	AP	1986/05/29	Control Supplement
008381	009	AP	1984/04/18	New or Modified Indication
008381	008	AP	1984/04/18	Formulation Revision
008381	007	AP	1984/04/18	Practioner Draft Labeling
008381	000	AP	1952/04/11	Approval