药品名称FOSAMAX
申请号020560产品号004
活性成分ALENDRONATE SODIUM市场状态停止上市
剂型或给药途径TABLET;ORAL规格EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期2000/10/20申请机构MERCK AND CO 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
46210772007/08/06U-114PDF格式
4621077*PED2008/02/06U-114PDF格式
53589412012/12/02PDF格式
5358941*PED2013/06/02PDF格式
56815902012/12/02PDF格式
5681590*PED2013/06/02PDF格式
58497262015/06/06PDF格式
5849726*PED2015/12/16PDF格式
59943292018/07/17PDF格式
5994329*PED2019/01/17PDF格式
60082072015/06/06PDF格式
6008207*PED2015/12/06PDF格式
60158012018/07/17U-353PDF格式
6015801*PED2019/01/17U-353PDF格式
60904102012/12/02PDF格式
6090410*PED2013/06/02PDF格式
62252942018/07/17PDF格式
6225294*PED2019/01/17PDF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
M-512008/12/21
PED2009/06/21
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
020560069APLetter2015/12/01下载
020560069APLabel2015/12/01下载
020560068APLabel2015/04/10下载
020560068APLetter2015/04/13下载
020560066APLabel2013/12/24下载
020560066APLetter2013/12/26下载
020560065APLetter2013/04/23下载
020560065APLabel2013/04/23下载
020560062APLetter2012/06/28下载
020560062APLabel2012/06/28下载
020560062APMedication Guide2012/06/28下载
020560061APLetter2011/07/06下载
020560060APMedication Guide2011/01/26下载
020560060APLabel2011/01/26下载
020560060APLetter2011/01/28下载
020560057APLabel2010/03/02下载
020560057APLetter2010/03/05下载
020560056APLabel2012/02/06下载
020560056APLetter2012/02/08下载
020560055APLabel2010/03/02下载
020560055APLetter2010/03/05下载
020560052APLetter2008/10/09下载
020560052APLabel2008/11/07下载
020560051APLabel2010/03/02下载
020560051APLetter2010/03/05下载
020560048APLetter2007/01/08下载
020560048APLabel2007/01/08下载
020560047APLetter2007/01/08下载
020560047APLabel2007/01/08下载
020560046APLabel2005/11/03下载
020560046APLetter2005/11/08下载
020560044APLabel2004/12/08下载
020560044APLetter2004/12/08下载
020560043APLabel2004/12/08下载
020560043APLetter2004/12/08下载
020560042APLetter2004/03/03下载
020560042APLabel2004/04/05下载
020560042APReview2007/07/06下载
020560041APReview2008/07/31下载
020560041APLetter2004/04/20下载
020560041APLabel2004/05/03下载
020560040APLabel2003/09/25下载
020560040APLetter2003/09/29下载
020560038APLabel2006/01/05下载
020560038APLetter2006/01/06下载
020560037APReview2008/08/01下载
020560037APLetter2003/03/26下载
020560036APLetter2002/08/05下载
020560036APLabel2002/08/05下载
020560036APReview2008/08/01下载
020560033APReview2008/08/01下载
020560033APLetter2002/08/13下载
020560032APReview2008/08/04下载
020560031APReview2008/08/01下载
020560031APLabel2002/07/25下载
020560030APLabel2004/05/04下载
020560030APLetter2004/04/29下载
020560029APReview2007/11/19下载
020560028APReview2008/08/01下载
020560028APLetter2002/09/16下载
020560028APLabel2002/09/16下载
020560025APLetter2001/01/31下载
020560025APLabel2001/01/31下载
020560024APLetter2001/01/31下载
020560024APLabel2001/01/31下载
020560023APLetter2000/09/29下载
020560022APLetter2000/10/20下载
020560022APLabel2000/10/20下载
020560021APLetter2000/10/20下载
020560021APLabel2000/10/20下载
020560020APReview2007/11/19下载
020560019APReview2008/08/08下载
020560018APLetter1999/11/24下载
020560018APReview2003/04/30下载
020560016APReview2007/11/19下载
020560015APReview2003/04/30下载
020560015APLetter1999/11/24下载
020560014APReview2008/08/08下载
020560013APReview1999/06/08下载
020560013APLetter1999/06/08下载
020560013APLabel1999/06/08下载
020560012APLetter1999/06/16下载
020560012APReview1999/06/16下载
020560012APLabel1999/06/16下载
020560006APReview1997/04/25下载
020560003APReview1997/04/25下载
020560000APOther Important Information from FDA2008/01/07下载
020560000APMedication Guide2013/05/09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
020560069AP2015/11/30Labeling Revision
020560068AP2015/04/08Labeling Revision
020560067AP2015/06/19Manufacturing Change or Addition
020560066AP2013/12/23Labeling Revision
020560065AP2013/04/19Labeling Revision
020560062AP2012/06/27Labeling Revision
020560061AP2011/07/01Labeling Revision
020560060AP2011/01/25Labeling Revision
020560057AP2010/03/01Labeling Revision
020560056AP2012/02/06Labeling Revision
020560055AP2010/03/01Labeling Revision
020560052AP2008/10/08Packaging Addition
020560051AP2010/03/01Labeling Revision
020560048AP2006/12/28Labeling Revision
020560047AP2006/12/28Labeling Revision
020560046AP2005/11/02Labeling Revision
020560044AP2004/12/01Labeling Revision
020560043AP2004/12/01Labeling Revision
020560042AP2004/02/20Labeling Revision
020560041AP2004/04/16Efficacy Supplement with Clinical Data to Support
020560040AP2003/09/17Labeling Revision
020560038AP2005/12/21New or Modified Indication
020560037AP2003/03/24Labeling Revision
020560036AP2002/08/05Package Change
020560033AP2002/08/13Package Change
020560032AP2001/11/27Control Supplement
020560031AP2002/07/25Labeling Revision
020560030AP2004/04/27Labeling Revision
020560029AP2001/06/26Manufacturing Change or Addition
020560028AP2002/09/16Labeling Revision
020560025AP2001/01/31New Dosage Regimen
020560024AP2001/01/31Labeling Revision
020560023AP2000/09/29New or Modified Indication
020560022AP2000/10/20New Dosage Regimen
020560021AP2000/10/20New Dosage Regimen
020560020AP1999/10/19Control Supplement
020560019AP1999/05/28Manufacturing Change or Addition
020560018AP1999/11/24Efficacy Supplement with Clinical Data to Support
020560016AP1999/10/19Package Change
020560015AP1999/11/24Efficacy Supplement with Clinical Data to Support
020560014AP1999/03/19Labeling Revision
020560013AP1999/06/08Efficacy Supplement with Clinical Data to Support
020560012AP1999/06/16New or Modified Indication
020560011AP1998/05/12Labeling Revision
020560010AP1998/01/27Package Change
020560007AP1997/03/24Package Change
020560006AP1997/04/25New or Modified Indication
020560005AP1996/11/21Labeling Revision
020560003AP1997/04/25New or Modified Indication
020560002AP1996/12/03Labeling Revision
020560001AP1995/10/16Control Supplement
020560000AP1995/09/29Approval