药品名称KLONOPIN
申请号017533产品号001
活性成分CLONAZEPAM市场状态处方药
剂型或给药途径TABLET;ORAL规格0.5MG
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HOFFMANN LA ROCHE INC
化学类型New molecular entity (NME)审评分类Priority 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
017533055APLabel2016/03/29下载
017533055APLetter2016/03/29下载
017533053APLabel2013/11/01下载
017533053APLetter2013/11/06下载
017533052APLetter2011/12/14下载
017533048APMedication Guide2010/09/07下载
017533048APLabel2010/09/07下载
017533048APLetter2010/09/21下载
017533046APMedication Guide2012/06/04下载
017533046APLabel2012/06/04下载
017533046APLetter2012/06/04下载
017533045APLetter2009/05/01下载
017533045APLabel2009/05/12下载
017533037APLetter2002/01/29下载
017533037APReview2007/04/09下载
017533031APLetter2001/01/22下载
017533031APReview2007/04/09下载
017533000APMedication Guide2013/11/08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
017533056AP2016/06/13Manufacturing Change or Addition
017533055AP2016/03/25Labeling Revision
017533054AP2015/02/03Manufacturing Change or Addition
017533053AP2013/10/31Labeling Revision
017533052AP2011/11/29Labeling Revision
017533048AP2010/09/01Labeling Revision
017533046AP2010/09/01Labeling Revision
017533045AP2009/04/23Labeling Revision
017533039AP2002/03/15Expiration Date Change
017533038AP2002/03/11Expiration Date Change
017533037AP2002/01/29Labeling Revision
017533036AP2001/11/07Package Change
017533035AP2001/09/10Control Supplement
017533034AP2001/01/22Manufacturing Change or Addition
017533033AP2000/03/28Control Supplement
017533032AP1999/10/18Manufacturing Change or Addition
017533031AP2001/04/11Labeling Revision
017533030AP1997/12/30Package Change
017533029AP1997/09/19Package Change
017533028AP1997/03/07Expiration Date Change
017533027AP1996/11/20Manufacturing Change or Addition
017533026AP1996/10/17Manufacturing Change or Addition
017533025AP1996/08/30Manufacturing Change or Addition
017533024AP1996/06/18Control Supplement
017533023AP1997/04/09New or Modified Indication
017533022AP1994/07/01Control Supplement
017533021AP1993/06/03Control Supplement
017533020AP1993/06/03Control Supplement
017533019AP1993/04/30Labeling Revision
017533018AP1993/05/28Manufacturing Change or Addition
017533017AP1993/04/30Labeling Revision
017533016AP1990/07/19Labeling Revision
017533015AP1990/07/19Expiration Date Change
017533014AP1987/05/01Control Supplement
017533013AP1985/12/13Labeling Revision
017533012AP1984/12/11Control Supplement
017533010AP1983/12/19Package Change
017533009AP1981/01/13Control Supplement
017533007AP1980/06/13Package Change
017533006AP1981/02/24Manufacturing Change or Addition
017533005AP1979/09/19Control Supplement
017533004AP1979/03/23Package Change
017533003AP1978/08/30Labeling Revision
017533002AP1975/06/30Labeling Revision
017533001AP1975/09/26Control Supplement
017533000AP1975/06/04Approval