药品名称DALMANE
申请号016721产品号001
活性成分FLURAZEPAM HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格15MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT PHARMACEUTICALS INTERNATIONAL
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
016721077APLetter2009/04/01下载
016721077APLabel2009/04/03下载
016721076APLabel2007/11/07下载
016721076APLetter2007/11/08下载
016721074APLetter2001/06/14下载
016721000APOther Important Information from FDA2007/03/16下载
016721000APMedication Guide2009/11/18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
016721077AP2009/03/27Labeling Revision
016721076AP2007/10/30Labeling Revision
016721075AP2002/08/12Manufacturing Change or Addition
016721074AP2001/06/14Labeling Revision
016721072AP1993/05/25Formulation Revision
016721071AP1992/12/31Control Supplement
016721070AP1990/04/25Control Supplement
016721068AP1990/01/16Manufacturing Change or Addition
016721067AP1989/11/07Package Change
016721066AP1987/11/09Labeling Revision
016721064AP1984/12/11Package Change
016721063AP1982/06/15Formulation Revision
016721062AP1982/01/28Package Change
016721061AP1981/12/22Control Supplement
016721060AP1981/12/22Control Supplement
016721059AP1981/11/05Manufacturing Change or Addition
016721057AP1981/08/04Package Change
016721056AP1981/07/17Package Change
016721055AP1981/03/26Control Supplement
016721054AP1981/05/06Labeling Revision
016721052AP1980/08/20Control Supplement
016721051AP1980/08/20Control Supplement
016721050AP1980/07/11Package Change
016721049AP1980/06/17Formulation Revision
016721048AP1980/06/17Package Change
016721047AP1980/02/04Manufacturing Change or Addition
016721046AP1979/11/09Manufacturing Change or Addition
016721045AP1979/09/17Manufacturing Change or Addition
016721044AP1979/05/01Formulation Revision
016721043AP1979/03/26Formulation Revision
016721042AP1978/07/28Formulation Revision
016721041AP1978/07/12Formulation Revision
016721040AP1978/07/20Labeling Revision
016721039AP1978/07/10Labeling Revision
016721038AP1978/05/02Manufacturing Change or Addition
016721037AP1977/07/12Formulation Revision
016721036AP1977/06/29Control Supplement
016721034AP1977/08/02Distributor
016721032AP1976/12/10Labeling Revision
016721030AP1978/07/10Labeling Revision
016721027AP1975/07/01Control Supplement
016721025AP1975/01/16Control Supplement
016721024AP1974/09/17Control Supplement
016721023AP1974/04/22Final Printed Labeling (MarkIV)
016721000AP1970/04/07Approval