药品名称PROMETH VC W/ CODEINE
申请号088764产品号001
活性成分CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE市场状态处方药
剂型或给药途径SYRUP;ORAL规格10MG/5ML;5MG/5ML;6.25MG/5ML
治疗等效代码AA参比药物
批准日期1984/10/31申请机构ACTAVIS MID ATLANTIC LLC
化学类型审评分类
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
088764084APLabel2013/09/04下载
088764084APLetter2013/09/04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
088764084AP2013/05/10Labeling Revision
088764048AP2002/07/15Control Supplement
088764047AP2001/10/03Control Supplement
088764046AP2001/10/03Package Change
088764045AP2000/10/02Package Change
088764042AP1998/12/01Chemistry
088764041AP1998/11/05Chemistry
088764040AP1998/11/05Chemistry
088764039AP1998/11/05Chemistry
088764037AP1997/09/02Chemistry
088764036AP1997/04/07Chemistry
088764035AP1996/06/18Chemistry
088764034AP1996/05/07Labeling
088764033AP1996/05/07Chemistry
088764032AP1996/05/07Chemistry
088764031AP1995/10/23Chemistry
088764030AP1996/05/07Chemistry
088764029AP1996/05/07Chemistry
088764028AP1996/05/30Chemistry
088764027AP1996/05/30Chemistry
088764026AP1994/02/02Chemistry
088764025AP1992/06/12Labeling
088764023AP1991/01/23Chemistry in Effect
088764022AP1990/09/28Chemistry
088764021AP1991/02/08Labeling
088764020AP1990/03/29Labeling
088764019AP1990/02/07Labeling
088764018AP1989/11/06Labeling
088764017AP1990/10/03Chemistry
088764016AP1990/10/03Chemistry
088764015AP1990/10/03Chemistry
088764014AP1988/12/15Chemistry
088764013AP1988/12/09Chemistry
088764009AP1987/03/17Chemistry
088764007AP1986/06/19Chemistry
088764005AP1987/04/28Chemistry
088764004AP1987/04/28Chemistry
088764003AP1986/02/18Chemistry
088764002AP1985/08/14Chemistry
088764000AP1984/10/31Approval