药品名称BENADRYL PRESERVATIVE FREE
申请号009486产品号001
活性成分DIPHENHYDRAMINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
批准日期Approved Prior to Jan 1, 1982申请机构MCNEIL CONSUMER HEALTHCARE
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
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
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
009486028APLetter2003/11/05下载
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
009486028AP2003/10/24Labeling Revision
009486027AP2001/12/14Control Supplement
009486026AP2000/03/30Control Supplement
009486024AP1997/07/01Package Change
009486023AP1997/06/06Control Supplement
009486022AP1997/11/18Labeling Revision
009486021AP1997/03/31Labeling Revision
009486020AP1997/04/04Package Change
009486019AP1996/05/13Labeling Revision
009486018AP1992/08/20Labeling Revision
009486017AP1986/07/16Control Supplement
009486015AP1986/07/16Practioner Draft Labeling
009486000AP1957/12/30Approval