药品名称SINGULAIR
申请号020830产品号002
活性成分MONTELUKAST SODIUM市场状态处方药
剂型或给药途径TABLET, CHEWABLE;ORAL规格EQ 4MG BASE
治疗等效代码AB参比药物
批准日期2000/03/03申请机构MERCK AND CO INC
化学类型New dosage form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
55654732012/02/03YYU-228PDF格式
55654732012/02/03YYU-675PDF格式
55654732012/02/03YYU-807PDF格式
5565473*PED2012/08/03U-228PDF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
I-4652008/08/27
I-5302010/04/13
M-492008/11/30
NPP2015/03/26
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
020830070APLetter2014/11/28下载
020830070APLabel2014/12/19下载
020830068APLetter2013/12/31下载
020830068APLabel2013/12/31下载
020830066APLetter2013/03/22下载
020830066APLabel2013/03/26下载
020830064APLabel2012/09/28下载
020830064APLetter2012/10/02下载
020830063APLetter2012/10/22下载
020830063APLabel2012/10/22下载
020830062APLabel2011/12/20下载
020830062APLetter2011/12/21下载
020830061APLabel2012/03/27下载
020830061APLetter2012/03/28下载
020830059APLabel2011/04/29下载
020830059APLetter2011/05/03下载
020830056APLetter2010/08/16下载
020830056APLabel2010/08/19下载
020830055APLetter2011/06/17下载
020830053APLabel2010/04/28下载
020830053APLetter2010/04/29下载
020830052APLabel2009/08/28下载
020830052APLetter2009/11/10下载
020830051APLetter2009/01/30下载
020830051APLabel2009/02/04下载
020830050APLetter2008/04/28下载
020830050APLabel2008/04/29下载
020830049APLabel2008/06/05下载
020830049APLetter2008/04/22下载
020830048APLetter2008/03/11下载
020830048APLabel2008/03/13下载
020830047APLetter2008/01/09下载
020830043APLetter2007/04/20下载
020830041APLabel2006/12/14下载
020830041APLetter2006/12/28下载
020830040APLabel2006/05/22下载
020830040APLetter2006/05/22下载
020830039APLetter2005/06/29下载
020830039APLabel2005/06/29下载
020830038APLetter2007/04/20下载
020830038APLabel2007/04/20下载
020830037APLetter2005/05/27下载
020830037APLabel2005/05/27下载
020830036APLabel2005/12/05下载
020830036APLetter2005/12/06下载
020830035APLabel2005/07/29下载
020830035APLetter2005/07/29下载
020830034APLetter2005/01/11下载
020830034APLabel2005/01/11下载
020830033APLetter2004/11/17下载
020830033APLabel2004/11/17下载
020830029APLetter2003/12/23下载
020830029APLabel2003/12/29下载
020830029APReview2007/07/06下载
020830028APReview2007/07/06下载
020830028APLabel2003/11/13下载
020830028APLetter2003/11/13下载
020830026APLabel2004/06/17下载
020830026APLetter2003/10/09下载
020830026APReview2007/07/09下载
020830020APLetter2002/12/31下载
020830020APLabel2004/06/17下载
020830011APLabel2003/04/24下载
020830011APLetter2001/11/23下载
020830008APLetter2000/03/03下载
020830008APLabel2000/03/03下载
020830008APReview2001/09/07下载
020830001APReview2001/07/05下载
020830000APReview2001/05/24下载
020830000APLetter2005/04/26下载
020830000APOther Important Information from FDA2008/08/12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
020830070AP2014/11/26Labeling Revision
020830068AP2013/12/30Labeling Revision
020830067AP2014/10/29Manufacturing Change or Addition
020830066AP2013/03/21Labeling Revision
020830064AP2012/09/27Labeling Revision
020830063AP2012/10/18Labeling Revision
020830062AP2011/12/16Labeling Revision
020830061AP2012/03/26New or Modified Indication
020830059AP2011/04/27Labeling Revision
020830056AP2010/08/10Labeling Revision
020830055AP2011/06/10Labeling Revision
020830053AP2010/04/26Labeling Revision
020830052AP2009/08/19Labeling Revision
020830051AP2009/01/27Labeling Revision
020830050AP2008/04/23Labeling Revision
020830049AP2008/04/21Labeling Revision
020830048AP2008/03/07Labeling Revision
020830047AP2007/12/07Labeling Revision
020830043AP2007/04/13Labeling Revision
020830041AP2006/12/08Labeling Revision
020830040AP2006/05/19Labeling Revision
020830039AP2005/06/27Labeling Revision
020830038AP2007/04/13New or Modified Indication
020830037AP2005/05/26Labeling Revision
020830036AP2005/11/30Efficacy Supplement with Clinical Data to Support
020830035AP2005/07/27New or Modified Indication
020830034AP2004/12/29Labeling Revision
020830033AP2004/11/15Labeling Revision
020830029AP2003/12/19Labeling Revision
020830028AP2003/11/05Labeling Revision
020830026AP2003/10/02Labeling Revision
020830021AP2002/10/07Package Change
020830020AP2002/12/31New or Modified Indication
020830019AP2002/02/11Manufacturing Change or Addition
020830016AP2001/10/26Labeling Revision
020830015AP2001/05/09Control Supplement
020830014AP2001/08/02Labeling Revision
020830012AP2000/09/05Control Supplement
020830011AP2001/11/23Efficacy Supplement with Clinical Data to Support
020830010AP2000/10/17Labeling Revision
020830008AP2000/03/03New or Modified Indication
020830007AP1999/07/28Control Supplement
020830006AP1998/12/01Labeling Revision
020830005AP1999/01/21Manufacturing Change or Addition
020830004AP1998/09/18Labeling Revision
020830003AP1998/04/30Labeling Revision
020830002AP1998/04/02Labeling Revision
020830001AP1999/02/12Labeling Revision
020830000AP1998/02/20Approval