药品名称MODICON 21
申请号017488产品号001
活性成分ETHINYL ESTRADIOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-21规格0.035MG;0.5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ORTHO MCNEIL PHARMACEUTICAL INC
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)
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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
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
017488108AP2002/02/21Manufacturing Change or Addition
017488107AP2001/07/09Control Supplement
017488105AP2000/01/05Package Change
017488104AP1999/08/27Labeling Revision
017488103AP1998/04/28Manufacturing Change or Addition
017488102AP1998/04/13Manufacturing Change or Addition
017488101AP1999/08/27Labeling Revision
017488100AP1997/02/24Control Supplement
017488099AP1997/01/29Control Supplement
017488098AP1996/04/09Control Supplement
017488097AP1996/05/10Control Supplement
017488096AP1995/11/30Manufacturing Change or Addition
017488095AP1995/09/07Control Supplement
017488094AP1995/02/16Control Supplement
017488093AP1994/06/28Labeling Revision
017488092AP1993/11/04Manufacturing Change or Addition
017488091AP1993/05/18Control Supplement
017488090AP1994/03/07Formulation Revision
017488088AP1991/03/18Control Supplement
017488087AP1991/09/16Labeling Revision
017488085AP1989/10/23Labeling Revision
017488084AP1989/07/19Labeling Revision
017488083AP1988/10/28Control Supplement
017488082AP1988/06/08Manufacturing Change or Addition
017488081AP1988/09/09Labeling Revision
017488080AP1987/02/26Labeling Revision
017488079AP1987/11/23Control Supplement
017488077AP1985/10/21Labeling Revision
017488076AP1985/04/05Labeling Revision
017488075AP1984/06/21Labeling Revision
017488074AP1984/01/30Labeling Revision
017488073AP1983/09/29Labeling Revision
017488071AP1983/06/15Labeling Revision
017488070AP1983/06/09Control Supplement
017488069AP1980/11/20Control Supplement
017488068AP1980/11/20Control Supplement
017488066AP1980/08/21Control Supplement
017488065AP1980/03/28Expiration Date Change
017488064AP1980/03/24Manufacturing Change or Addition
017488063AP1979/11/13Labeling Revision
017488062AP1979/08/15Labeling Revision
017488060AP1979/05/07Expiration Date Change
017488059AP1979/08/15Labeling Revision
017488058AP1979/10/19Package Change
017488054AP1978/06/01Labeling Revision
017488045AP1979/06/19Formulation Revision
017488042AP1978/04/17Control Supplement
017488041AP1978/05/25Control Supplement
017488037AP1977/10/20Control Supplement
017488036AP1978/03/29Control Supplement
017488035AP1978/01/18Package Change
017488034AP1978/01/18Package Change
017488033AP1978/01/18Labeling Revision
017488032AP1978/01/18Labeling Revision
017488031AP1978/07/31Control Supplement
017488025AP1977/07/01Labeling Revision
017488024AP1976/12/23Control Supplement
017488022AP1976/05/11Control Supplement
017488021AP1976/05/11Package Change
017488012AP1976/05/18Control Supplement
017488010AP1976/05/18Control Supplement
017488009AP1976/05/18Control Supplement
017488008AP1976/05/18Control Supplement
017488006AP1975/08/07Control Supplement
017488005AP1975/08/07Control Supplement
017488004AP1975/08/07Control Supplement
017488003AP1975/08/07Control Supplement
017488002AP1975/08/07Control Supplement
017488001AP1975/08/07Control Supplement
017488000AP1974/10/15Approval