药品名称BIAXIN
申请号050662产品号002
活性成分CLARITHROMYCIN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1991/10/31申请机构ABBVIE 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
050662057APLetter2015/10/28下载
050662057APLabel2015/10/29下载
050662056APLetter2015/01/09下载
050662056APLabel2015/01/12下载
050662055APLetter2014/07/28下载
050662055APLabel2014/08/07下载
050662054APLetter2016/05/31下载
050662054APLabel2016/06/01下载
050662053APLabel2013/09/09下载
050662053APLetter2013/09/11下载
050662052APLabel2013/09/09下载
050662052APLetter2013/09/11下载
050662050APLetter2012/05/09下载
050662050APLabel2012/05/07下载
050662048APLetter2012/07/10下载
050662048APLabel2012/07/10下载
050662046APLetter2012/06/05下载
050662045APLabel2011/05/31下载
050662045APLetter2011/05/31下载
050662044APLabel2012/05/07下载
050662044APLetter2012/05/09下载
050662043APLabel2011/05/31下载
050662043APLetter2011/05/31下载
050662042APLabel2009/09/22下载
050662042APLetter2009/11/20下载
050662041APLetter2008/05/29下载
050662040APLabel2007/12/27下载
050662040APLetter2008/01/09下载
050662039APLetter2006/07/13下载
050662038APLabel2005/10/10下载
050662038APLetter2005/10/20下载
050662036APLetter2004/07/21下载
050662031APLetter2002/06/06下载
050662031APReview2004/06/29下载
050662030APReview2004/06/29下载
050662030APLetter2002/06/06下载
050662029APReview2001/11/23下载
050662029APLetter2000/10/20下载
050662029APLabel2000/10/20下载
050662028APReview2004/06/29下载
050662013APReview1999/08/02下载
050662000APOther Important Information from FDA2006/03/03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
050662057AP2015/10/23Labeling Revision
050662056AP2015/01/08Labeling Revision
050662055AP2014/07/25Labeling Revision
050662054AP2016/05/26Labeling Revision
050662053AP2013/09/09Labeling Revision
050662052AP2013/09/09Labeling Revision
050662050AP2012/05/03Labeling Revision
050662049AP2012/11/23Manufacturing Change or Addition
050662048AP2012/07/05Labeling Revision
050662046AP2012/06/01Labeling Revision
050662045AP2011/05/27Labeling Revision
050662044AP2012/05/03Labeling Revision
050662043AP2011/05/27Labeling Revision
050662042AP2009/08/14Labeling Revision
050662041AP2008/05/21Labeling Revision
050662040AP2007/12/18Labeling Revision
050662039AP2006/07/05Labeling Revision
050662038AP2005/10/04Labeling Revision
050662036AP2004/07/19Labeling Revision
050662033AP2002/11/08Control Supplement
050662032AP2002/06/06Control Supplement
050662031AP2002/06/06Labeling Revision
050662030AP2002/06/06Labeling Revision
050662029AP2000/10/20New or Modified Indication
050662028AP2000/03/20Labeling Revision
050662027AP1999/05/04Control Supplement
050662026AP1999/07/29Labeling Revision
050662025AP1999/10/22Formulation Revision
050662024AP1998/11/10Labeling Revision
050662023AP1998/04/27Formulation Revision
050662022AP1998/07/21Labeling Revision
050662021AP1998/01/05Package Change
050662020AP1998/09/16New or Modified Indication
050662019AP1997/09/16New or Modified Indication
050662018AP1997/09/16Labeling Revision
050662017AP1997/04/29Control Supplement
050662016AP1997/01/14Control Supplement
050662015AP1997/01/16New or Modified Indication
050662014AP1996/10/15Package Change
050662013AP1996/12/20Labeling Revision
050662012AP1997/08/26Labeling Revision
050662011AP1995/08/31Manufacturing Change or Addition
050662010AP1996/04/18New or Modified Indication
050662009AP1995/03/13Manufacturing Change or Addition
050662008AP1993/12/23Labeling Revision
050662007AP1993/09/15Manufacturing Change or Addition
050662005AP1993/06/08Manufacturing Change or Addition
050662004AP1995/02/28New or Modified Indication
050662003AP1995/02/28Labeling Revision
050662002AP1993/01/28Control Supplement
050662001AP1992/06/17Control Supplement
050662000AP1991/10/31Approval