药品名称PROMETH W/ DEXTROMETHORPHAN
申请号088762产品号001
活性成分DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE市场状态处方药
剂型或给药途径SYRUP;ORAL规格15MG/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G AND W LABORATORIES INC
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
088762051AP2001/10/03Control Supplement
088762050AP2001/10/03Package Change
088762049AP2000/10/02Package Change
088762046AP2000/08/01Expiration Date Change
088762045AP2000/08/01Supplier Addition
088762044AP1998/12/01Chemistry
088762043AP1998/12/01Chemistry
088762041AP1997/09/22Chemistry
088762040AP1996/10/18Labeling
088762039AP1996/06/18Chemistry
088762037AP1996/05/07Labeling
088762036AP1996/05/07Chemistry
088762035AP1996/05/07Chemistry
088762034AP1995/10/23Chemistry
088762033AP1996/05/07Chemistry
088762032AP1996/05/07Chemistry
088762031AP1996/05/30Chemistry
088762030AP1996/05/30Chemistry
088762029AP1994/02/02Chemistry
088762028AP1993/06/04Chemistry
088762027AP1992/04/14Chemistry
088762026AP1991/04/23Chemistry in Effect
088762025AP1991/01/23Chemistry
088762024AP1991/01/23Chemistry in Effect
088762022AP1990/09/28Chemistry
088762021AP1991/02/22Labeling
088762020AP1990/03/26Labeling
088762019AP1990/10/03Chemistry
088762018AP1990/10/03Chemistry
088762016AP1990/10/03Chemistry
088762015AP1990/10/03Chemistry
088762014AP1989/12/19Labeling
088762011AP1989/05/31Chemistry
088762010AP1989/05/31Chemistry
088762009AP1988/12/15Chemistry
088762008AP1988/12/15Chemistry
088762007AP1988/08/02Labeling
088762003AP1987/03/17Chemistry
088762002AP1987/10/09Chemistry
088762001AP1986/02/05Chemistry
088762000AP1984/10/31Approval