药品名称ACTONEL
申请号020835产品号005
活性成分RISEDRONATE SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格150MG
治疗等效代码AB参比药物
批准日期2008/04/22申请机构ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
化学类型New molecular entity (NME)审评分类
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
71929382023/05/06U-353PDF格式
77186342023/05/06U-662PDF格式
61655132018/06/10YPDF格式
6165513*PED2018/12/10PDF格式
7192938*PED2023/11/06PDF格式
7718634*PED2023/11/06PDF格式
历史专利信息
55831222013/12/10YYU-353PDF格式
5583122*PED2014/06/10PDF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-522009/01/24
NS2011/04/22
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
020835048APLabel2015/04/10下载
020835048APLetter2015/04/13下载
020835047APLetter2015/03/27下载
020835047APLabel2015/03/27下载
020835045APLetter2013/04/23下载
020835045APLabel2013/04/23下载
020835044APLetter2011/08/24下载
020835043APLabel2011/01/31下载
020835043APLetter2011/02/02下载
020835042APLetter2011/02/02下载
020835042APLabel2011/01/31下载
020835036APLabel2010/01/04下载
020835036APLetter2010/01/06下载
020835035APLabel2009/07/30下载
020835035APLetter2009/07/31下载
020835030APLetter2008/04/25下载
020835029APLetter2008/04/25下载
020835028APLabel2007/07/27下载
020835028APLetter2007/07/27下载
020835025APLetter2007/04/20下载
020835025APLabel2007/04/20下载
020835023APLetter2006/08/21下载
020835023APLabel2006/08/14下载
020835022APLetter2006/08/21下载
020835022APLabel2006/08/14下载
020835020APLetter2005/09/15下载
020835020APLabel2005/09/15下载
020835019APLabel2006/01/25下载
020835019APLetter2006/01/30下载
020835018APLetter2005/05/17下载
020835018APLabel2005/05/17下载
020835014APLetter2004/02/25下载
020835014APLabel2004/04/05下载
020835014APReview2007/07/27下载
020835012APReview2008/02/19下载
020835011APReview2008/02/19下载
020835010APReview2008/02/19下载
020835009APLetter2002/05/17下载
020835008APLetter2002/05/17下载
020835008APLabel2003/05/20下载
020835004APLabel2000/04/14下载
020835004APReview2001/08/17下载
020835004APLetter2000/04/14下载
020835003APLetter2000/04/14下载
020835003APReview2001/08/17下载
020835003APLabel2000/04/14下载
020835002APReview2001/08/17下载
020835002APLabel2000/04/14下载
020835002APLetter2000/04/14下载
020835001APLetter2000/04/14下载
020835001APLabel2000/04/14下载
020835001APReview2001/08/17下载
020835000APLetter1998/03/27下载
020835000APOther Important Information from FDA2003/12/08下载
020835000APReview2004/05/25下载
020835000APMedication Guide2011/02/01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
020835049AP2015/10/22Manufacturing Change or Addition
020835048AP2015/04/08Labeling Revision
020835047AP2015/03/26Labeling Revision
020835046AP2014/12/02Manufacturing Change or Addition
020835045AP2013/04/19Labeling Revision
020835044AP2011/08/22Labeling Revision
020835043AP2011/01/25Labeling Revision
020835042AP2011/01/25Labeling Revision
020835036AP2009/12/31Labeling Revision
020835035AP2009/07/23Efficacy Supplement with Clinical Data to Support
020835030AP2008/04/22New Dosage Regimen
020835029AP2008/04/22Labeling Revision
020835028AP2007/07/24Labeling Revision
020835025AP2007/04/16New Dosage Regimen
020835023AP2006/08/11Labeling Revision
020835022AP2006/08/11New or Modified Indication
020835020AP2005/09/12Labeling Revision
020835019AP2006/01/24Efficacy Supplement with Clinical Data to Support
020835018AP2005/05/06Labeling Revision
020835014AP2004/02/24Labeling Revision
020835012AP2002/12/10Manufacturing Change or Addition
020835011AP2002/11/05Package Change
020835010AP2002/09/26Control Supplement
020835009AP2002/05/17New Dosage Regimen
020835008AP2002/05/17New Dosage Regimen
020835007AP2001/12/21Control Supplement
020835005AP2001/05/02Control Supplement
020835004AP2000/04/14New or Modified Indication
020835003AP2000/04/14New or Modified Indication
020835002AP2000/04/14New or Modified Indication
020835001AP2000/04/14New or Modified Indication
020835000AP1998/03/27Approval