药品名称ACCOLATE
申请号020547产品号001
活性成分ZAFIRLUKAST市场状态处方药
剂型或给药途径TABLET;ORAL规格20MG
治疗等效代码AB参比药物
批准日期1996/09/26申请机构PAR PHARMACEUTICAL INC
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
48596922010/09/26PDF格式
52946362011/12/11PDF格式
53190972011/12/11PDF格式
54829632013/01/09PDF格式
55831522010/09/26PDF格式
56123672014/03/18U-189PDF格式
61437752011/12/11PDF格式
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
020547033APLetter2013/11/18下载
020547033APLabel2013/11/22下载
020547031APLabel2011/08/08下载
020547031APLetter2011/08/10下载
020547030APLetter2010/10/19下载
020547030APLabel2010/10/19下载
020547029APLetter2010/07/15下载
020547029APLabel2010/07/19下载
020547027APLabel2009/08/28下载
020547027APLetter2009/11/19下载
020547025APLetter2008/06/02下载
020547022APLetter2005/06/08下载
020547022APLabel2005/06/08下载
020547019APLabel2004/04/05下载
020547017APLetter2004/05/25下载
020547014APLetter2003/07/29下载
020547011APReview2004/05/25下载
020547008APReview2004/05/25下载
020547007APLetter1999/09/17下载
020547007APReview2004/04/14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
020547034AP2016/03/29Manufacturing Change or Addition
020547033AP2013/11/15Labeling Revision
020547032AP2013/05/15Manufacturing Change or Addition
020547031AP2011/08/08Labeling Revision
020547030AP2010/10/13Labeling Revision
020547029AP2010/07/14Labeling Revision
020547027AP2009/08/21Labeling Revision
020547025AP2008/05/29Labeling Revision
020547022AP2005/06/06Labeling Revision
020547019AP2004/03/26Labeling Revision
020547017AP2003/10/31Labeling Revision
020547016AP2001/01/08Manufacturing Change or Addition
020547015AP2000/09/19Manufacturing Change or Addition
020547014AP2001/04/27New or Modified Indication
020547013AP2000/06/12Labeling Revision
020547012AP1999/11/12Manufacturing Change or Addition
020547011AP2000/02/07Labeling Revision
020547010AP1999/09/09Manufacturing Change or Addition
020547009AP1999/04/30Manufacturing Change or Addition
020547008AP1999/03/17Labeling Revision
020547007AP1999/09/17New or Modified Indication
020547006AP1998/08/17Labeling Revision
020547005AP1998/05/06Manufacturing Change or Addition
020547004AP1998/01/23Labeling Revision
020547003AP1998/05/06Manufacturing Change or Addition
020547002AP1997/07/10Labeling Revision
020547001AP1997/04/28Labeling Revision
020547000AP1996/09/26Approval