药品名称PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
申请号088763产品号001
活性成分CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE市场状态处方药
剂型或给药途径SYRUP;ORAL规格10MG/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
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申请号修订号审批结论审批日期审批内容
088763046AP2001/10/03Control Supplement
088763045AP2001/10/03Package Change
088763044AP2000/10/02Package Change
088763040AP1998/12/01Chemistry
088763039AP1998/12/01Chemistry
088763037AP1997/09/15Chemistry
088763036AP1996/10/21Chemistry
088763035AP1996/06/18Chemistry
088763033AP1996/05/07Labeling
088763032AP1996/05/07Chemistry
088763031AP1996/05/07Chemistry
088763030AP1995/10/23Chemistry
088763029AP1996/05/07Chemistry
088763028AP1996/05/07Chemistry
088763027AP1996/05/30Chemistry
088763026AP1996/05/30Chemistry
088763025AP1994/04/29Chemistry
088763023AP1993/08/03Chemistry
088763022AP1993/04/05Chemistry
088763021AP1990/09/28Chemistry
088763019AP1990/08/24Labeling
088763018AP1989/11/03Labeling in Effect
088763016AP1989/06/21Chemistry
088763015AP1989/06/21Chemistry
088763014AP1989/06/21Chemistry
088763013AP1988/12/15Chemistry
088763012AP1988/12/15Chemistry
088763008AP1987/03/10Chemistry
088763007AP1987/03/10Chemistry
088763005AP1987/02/18Chemistry
088763004AP1987/10/13Chemistry
088763003AP1986/02/18Chemistry
088763002AP1985/08/14Chemistry
088763000AP1984/10/31Approval