药品名称PHENERGAN
申请号010926产品号002
活性成分PROMETHAZINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径SUPPOSITORY;RECTAL规格12.5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构DELCOR ASSET CORP
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
010926030APLetter2004/11/15下载
010926030APLabel2004/11/15下载
010926022APLetter2002/12/26下载
010926021APLetter2002/12/26下载
010926020APLetter2002/12/26下载
010926017APLetter2002/12/26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
010926031AP2015/08/04Manufacturing Change or Addition
010926030AP2004/11/08Labeling Revision
010926027AP2001/09/12Control Supplement
010926022AP2002/12/26Labeling Revision
010926021AP2002/12/26Labeling Revision
010926020AP2002/12/26Labeling Revision
010926019AP2001/07/27Manufacturing Change or Addition
010926018AP2001/06/22Manufacturing Change or Addition
010926017AP2002/12/26Labeling Revision
010926016AP1994/07/01Control Supplement
010926015AP1992/03/30Manufacturing Change or Addition
010926014AP1993/04/28Manufacturing Change or Addition
010926011AP1988/06/30Control Supplement
010926010AP1988/01/22Labeling Revision
010926007AP1986/05/29Control Supplement
010926000AP1958/05/05Approval