药品名称ORTHO-NOVUM 10/11-28
申请号018354产品号002
活性成分ETHINYL ESTRADIOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-28规格0.035MG;0.5MG;1MG
治疗等效代码参比药物
批准日期1982/01/11申请机构ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
化学类型New dosage form审评分类Standard review drug
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申请号修订号审批结论审批日期审批内容
018354043AP2002/06/03Control Supplement
018354042AP2002/02/21Manufacturing Change or Addition
018354041AP2001/07/09Control Supplement
018354039AP2000/01/05Package Change
018354038AP2000/01/21Labeling Revision
018354037AP1999/08/27Labeling Revision
018354036AP1998/04/28Manufacturing Change or Addition
018354035AP1998/04/13Manufacturing Change or Addition
018354034AP1999/08/27Labeling Revision
018354033AP1997/01/29Manufacturing Change or Addition
018354032AP1997/02/24Control Supplement
018354031AP1996/04/09Control Supplement
018354030AP1996/05/10Control Supplement
018354029AP1995/11/30Manufacturing Change or Addition
018354028AP1995/09/07Control Supplement
018354027AP1995/02/16Control Supplement
018354026AP1994/07/06Labeling Revision
018354025AP1993/11/04Manufacturing Change or Addition
018354024AP1993/05/18Control Supplement
018354023AP1994/03/07Formulation Revision
018354021AP1991/03/18Control Supplement
018354020AP1991/09/16Labeling Revision
018354019AP1990/01/18Control Supplement
018354017AP1989/10/23Labeling Revision
018354016AP1989/07/19Labeling Revision
018354015AP1988/10/28Control Supplement
018354014AP1988/06/08Manufacturing Change or Addition
018354013AP1988/09/09Labeling Revision
018354012AP1987/02/26Labeling Revision
018354011AP1987/11/23Control Supplement
018354009AP1985/10/21Labeling Revision
018354008AP1985/04/05Labeling Revision
018354007AP1984/06/21Labeling Revision
018354006AP1984/01/30Labeling Revision
018354005AP1983/09/29Labeling Revision
018354003AP1983/06/15Labeling Revision
018354002AP1983/06/09Control Supplement
018354000AP1982/01/11Approval