药品名称COUMADIN
申请号009218产品号013
活性成分WARFARIN SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格2MG
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BRISTOL MYERS SQUIBB PHARMA CO
化学类型New molecular entity (NME)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
009218116APLabel2016/09/09下载
009218116APLetter2016/09/12下载
009218115APLabel2015/10/29下载
009218115APLetter2015/10/30下载
009218108APLabel2010/01/24下载
009218108APLetter2010/01/28下载
009218107APLabel2011/10/05下载
009218107APLetter2011/10/05下载
009218105APLabel2007/08/16下载
009218105APLetter2007/08/17下载
009218102APLetter2006/10/05下载
009218102APLabel2006/10/05下载
009218101APReview2005/09/02下载
009218101APLabel2005/09/07下载
009218101APLetter2005/09/07下载
009218099APLetter2002/05/03下载
009218098APLetter2002/05/03下载
009218097APReview2000/02/17下载
009218091APReview1998/06/01下载
009218090APReview1998/06/01下载
009218086APReview1998/06/01下载
009218000APMedication Guide2007/02/20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
009218116AP2016/09/08Labeling Revision
009218115AP2015/10/28Labeling Revision
009218114AP2014/12/02Manufacturing Change or Addition
009218113AP2013/03/25Manufacturing Change or Addition
009218108AP2010/01/22Labeling Revision
009218107AP2011/10/04Labeling Revision
009218105AP2007/08/16Labeling Revision
009218102AP2006/10/04Labeling Revision
009218101AP2005/09/02Labeling Revision
009218099AP2002/05/03Labeling Revision
009218098AP2002/05/03Labeling Revision
009218097AP2000/02/17Labeling Revision
009218096AP1999/07/09Labeling Revision
009218095AP1999/12/02Manufacturing Change or Addition
009218094AP1999/03/31Manufacturing Change or Addition
009218093AP1998/12/23Manufacturing Change or Addition
009218091AP1998/06/01Labeling Revision
009218090AP1998/06/01Labeling Revision
009218089AP1998/04/16Package Change
009218088AP1997/10/29Control Supplement
009218087AP1998/11/23Package Change
009218086AP1998/06/01Labeling Revision
009218085AP1996/09/05Labeling Revision
009218084AP1996/11/08Manufacturing Change or Addition
009218083AP1996/11/18Formulation Revision
009218080AP1995/09/07Labeling Revision
009218079AP1995/03/08Control Supplement
009218078AP1995/02/07Manufacturing Change or Addition
009218077AP1995/02/07Formulation Revision
009218076AP1995/04/28New or Modified Indication
009218075AP1993/08/06Labeling Revision
009218074AP1994/03/31New or Modified Indication
009218073AP1993/06/08Labeling Revision
009218072AP1993/02/01Labeling Revision
009218071AP1992/08/20Labeling Revision
009218070AP1993/08/24Formulation Revision
009218069AP1993/12/15Manufacturing Change or Addition
009218068AP1991/04/11Labeling Revision
009218067AP1991/04/11Labeling Revision
009218066AP1991/05/10Manufacturing Change or Addition
009218065AP1990/04/25Labeling Revision
009218064AP1990/03/01Labeling Revision
009218063AP1990/03/01Labeling Revision
009218062AP1990/03/01Formulation Revision
009218061AP1988/07/01Formulation Revision
009218060AP1987/07/06Labeling Revision
009218059AP1986/07/08Labeling Revision
009218056AP1985/05/13Labeling Revision
009218054AP1985/02/25Labeling Revision
009218052AP1985/01/17Labeling Revision
009218051AP1987/07/06Practioner Draft Labeling
009218042AP1980/12/29Package Change
009218041AP1980/02/01Control Supplement
009218039AP1980/04/30Package Change
009218037AP1979/07/06Package Change
009218036AP1978/04/14Control Supplement
009218035AP1977/12/05Control Supplement
009218033AP1977/02/11Formulation Revision
009218032AP1976/09/27Labeling Revision
009218031AP1975/08/21Labeling Revision
009218000AP1954/06/08Approval