药品名称MYAMBUTOL
申请号016320产品号002
活性成分ETHAMBUTOL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格200MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构STI PHARMA LLC
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
016320066APLabel2013/02/26下载
016320063APLetter2008/11/03下载
016320063APLabel2008/11/07下载
016320060APLetter2004/03/28下载
016320060APLabel2004/04/05下载
016320058APLetter2003/02/06下载
016320058APLabel2003/02/06下载
016320057APLabel2003/02/06下载
016320057APLetter2003/02/06下载
016320056APLabel2003/06/10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
016320066AP2013/02/22Manufacturing Change or Addition
016320063AP2008/10/30Package Change
016320060AP2004/03/24Labeling Revision
016320058AP2003/02/06Labeling Revision
016320057AP2003/02/06Labeling Revision
016320056AP2001/10/10Labeling Revision
016320055AP1998/05/14Control Supplement
016320054AP1998/05/08Package Change
016320053AP1995/06/20Control Supplement
016320052AP1987/11/02Expiration Date Change
016320051AP1987/11/23Control Supplement
016320050AP1987/05/19Formulation Revision
016320049AP1986/01/03Control Supplement
016320047AP1985/09/12Control Supplement
016320046AP1987/06/25Labeling Revision
016320044AP1982/02/24Control Supplement
016320043AP1981/11/03Manufacturing Change or Addition
016320042AP1981/08/18Expiration Date Change
016320041AP1981/08/18Control Supplement
016320040AP1981/07/29Control Supplement
016320039AP1981/01/09Manufacturing Change or Addition
016320038AP1979/04/03Control Supplement
016320037AP1979/04/03Manufacturing Change or Addition
016320036AP1978/12/21Labeling Revision
016320035AP1978/06/26Control Supplement
016320034AP1978/06/27Control Supplement
016320033AP1978/05/03Manufacturing Change or Addition
016320032AP1978/04/07Control Supplement
016320031AP1977/07/05Formulation Revision
016320030AP1977/05/13Control Supplement
016320029AP1976/06/10Control Supplement
016320028AP1976/04/28Control Supplement
016320027AP1975/02/21Control Supplement
016320000AP1967/11/06Approval