药品名称AZULFIDINE
申请号007073产品号001
活性成分SULFASALAZINE市场状态处方药
剂型或给药途径TABLET;ORAL规格500MG
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PHARMACIA AND UPJOHN CO
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
007073128APLabel2014/03/05下载
007073128APLetter2014/03/06下载
007073126APLetter2013/07/22下载
007073126APLabel2013/07/23下载
007073125APLabel2012/12/13下载
007073125APLetter2012/12/18下载
007073124APLabel2009/10/21下载
007073120APLetter2004/05/27下载
007073115APLetter2004/05/27下载
007073115APLabel2003/05/07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
007073128AP2014/03/04Labeling Revision
007073127AP2015/11/20Manufacturing Change or Addition
007073126AP2013/07/18Labeling Revision
007073125AP2012/12/12Labeling Revision
007073124AP2009/10/19Labeling Revision
007073121AP2002/11/12Manufacturing Change or Addition
007073120AP2002/07/30Labeling Revision
007073118AP2000/09/26Labeling Revision
007073117AP2001/02/05Package Change
007073116AP2000/08/18Labeling Revision
007073115AP2001/08/17Labeling Revision
007073113AP2000/04/18Labeling Revision
007073112AP2000/04/25Labeling Revision
007073110AP1999/08/13Labeling Revision
007073109AP2000/04/24Labeling Revision
007073107AP1997/12/23Manufacturing Change or Addition
007073106AP1995/05/18Manufacturing Change or Addition
007073105AP1996/07/25Manufacturing Change or Addition
007073104AP1996/03/05Control Supplement
007073103AP1996/06/14Package Change
007073102AP1996/10/17Labeling Revision
007073101AP1996/06/14Package Change
007073100AP1995/03/29Manufacturing Change or Addition
007073099AP1996/02/21Formulation Revision
007073098AP1994/12/19Control Supplement
007073097AP1995/09/28Manufacturing Change or Addition
007073096AP1993/11/03Labeling Revision
007073095AP1993/11/02Labeling Revision
007073094AP1993/10/20Manufacturing Change or Addition
007073093AP1994/06/08Manufacturing Change or Addition
007073092AP1994/06/08Formulation Revision
007073091AP1993/04/05Labeling Revision
007073090AP1993/04/05Labeling Revision
007073089AP1993/08/09Control Supplement
007073088AP1993/08/09Control Supplement
007073087AP1994/01/26Control Supplement
007073086AP1993/06/09Control Supplement
007073085AP1994/06/07Control Supplement
007073084AP1993/10/20Manufacturing Change or Addition
007073083AP1992/09/22Control Supplement
007073082AP1990/11/07Labeling Revision
007073081AP1990/11/07Labeling Revision
007073080AP1991/07/10Formulation Revision
007073079AP1991/07/10Formulation Revision
007073077AP1984/05/11Labeling Revision
007073076AP1983/12/12Labeling Revision
007073075AP1983/01/18Package Change
007073074AP1985/07/19Manufacturing Change or Addition
007073073AP1982/07/02Manufacturing Change or Addition
007073072AP1982/07/15Manufacturing Change or Addition
007073071AP1985/02/05Practioner Draft Labeling
007073070AP1985/02/05Practioner Draft Labeling
007073065AP1981/06/30Labeling Revision
007073064AP1981/03/25Labeling Revision
007073061AP1981/03/25Labeling Revision
007073060AP1981/03/25Labeling Revision
007073054AP1981/03/05Control Supplement
007073020AP1983/04/06Labeling Revision
007073018AP1983/04/06Control Supplement
007073017AP1983/04/06Control Supplement
007073000AP1950/06/20Approval