药品名称MACRODANTIN
申请号016620产品号001
活性成分NITROFURANTOIN, MACROCRYSTALLINE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格50MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALVOGEN MALTA OPERATIONS LTD
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)
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
016620072APLabel2013/09/09下载
016620072APLetter2013/09/10下载
016620070APLetter2011/06/09下载
016620068APLetter2009/03/06下载
016620068APLabel2009/03/17下载
016620067APLabel2007/09/19下载
016620067APLetter2007/09/25下载
016620065APReview2008/07/31下载
016620065APLabel2004/04/05下载
016620065APLetter2004/04/07下载
016620064APLetter2003/02/04下载
016620064APReview2008/08/01下载
016620063APReview2008/08/11下载
016620062APReview2008/08/11下载
016620059APReview2008/02/19下载
016620057APReview2008/02/19下载
016620055APReview2008/02/19下载
016620054APReview2008/02/19下载
016620053APReview2008/02/19下载
016620047APReview2007/02/20下载
016620045APReview2006/05/10下载
016620020APReview2007/07/09下载
016620019APReview2007/07/09下载
016620018APReview2007/07/09下载
016620017APReview2007/07/09下载
016620016APReview2007/07/09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
016620074AP2015/10/15Manufacturing Change or Addition
016620073AP2015/10/02Manufacturing Change or Addition
016620072AP2013/09/06Labeling Revision
016620070AP2011/06/06Labeling Revision
016620068AP2009/03/05Labeling Revision
016620067AP2007/09/14Labeling Revision
016620065AP2004/03/29Labeling Revision
016620064AP2003/02/04Labeling Revision
016620063AP1998/10/21Control Supplement
016620062AP1997/07/16Labeling Revision
016620061AP1997/03/27Labeling Revision
016620060AP1996/07/30Manufacturing Change or Addition
016620059AP1996/03/07Control Supplement
016620058AP1998/02/17Labeling Revision
016620057AP1993/08/09Control Supplement
016620056AP1998/02/17Labeling Revision
016620055AP1992/12/08Control Supplement
016620054AP1992/12/08Formulation Revision
016620053AP1992/12/08Package Change
016620052AP1992/12/08Manufacturing Change or Addition
016620051AP1991/04/10Control Supplement
016620050AP1990/07/09Package Change
016620049AP1990/09/11Manufacturing Change or Addition
016620047AP1989/01/03Manufacturing Change or Addition
016620045AP1988/05/13Labeling Revision
016620039AP1993/05/19Labeling Revision
016620038AP1984/07/09Manufacturing Change or Addition
016620037AP1983/06/02Manufacturing Change or Addition
016620036AP1993/05/18Labeling Revision
016620035AP1982/05/13Package Change
016620032AP1980/12/12Labeling Revision
016620031AP1982/10/15Labeling Revision
016620030AP1980/08/14Formulation Revision
016620028AP1980/05/20Package Change
016620027AP1979/07/16Manufacturing Change or Addition
016620026AP1979/12/18Labeling Revision
016620025AP1979/07/26Package Change
016620023AP1978/07/28Labeling Revision
016620021AP1977/05/13Control Supplement
016620020AP1977/03/21Control Supplement
016620019AP1976/11/22Package Change
016620018AP1976/07/21Package Change
016620017AP1976/07/21Manufacturing Change or Addition
016620016AP1976/07/15Package Change
016620000AP1970/06/05Approval