药品注册申请号:020786
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
002 ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 60MG;120MG Yes Yes None 1997/12/24 2011/01/24 Over-the-counter
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/10/31 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2016/10/31 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2016/06/02 SUPPL 35 Approval Labeling STANDARD
2015/07/09 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2015/06/08 SUPPL 33 Approval Efficacy STANDARD
2014/05/14 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2012/12/05 SUPPL 31 Approval Labeling STANDARD
2012/08/23 SUPPL 29 Approval Labeling STANDARD
2012/02/03 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2011/01/24 SUPPL 27 Approval Efficacy STANDARD
2010/04/14 SUPPL 26 Approval Labeling UNKNOWN
2004/12/06 SUPPL 17 Approval Labeling STANDARD
2003/05/12 SUPPL 14 Approval Efficacy PRIORITY
2002/11/01 SUPPL 12 Approval Labeling STANDARD
2002/10/29 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2001/10/31 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2001/01/19 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2000/09/26 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2000/01/21 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2000/01/06 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1999/12/21 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1999/12/01 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1998/12/22 SUPPL 3 Approval Labeling STANDARD
1998/07/06 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/12/24 ORIG 1 Approval Type 4 - New Combination STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
002 5578610 2013/11/26 Y Y U-1159 PDF格式**本条是由Drugfuture回溯的历史信息**
5578610*PED 2014/05/26 PDF格式**本条是由Drugfuture回溯的历史信息**
5855912 2015/02/28 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5855912*PED 2015/08/28 PDF格式**本条是由Drugfuture回溯的历史信息**
6037353 2017/03/14 U-1159 PDF格式**本条是由Drugfuture回溯的历史信息**
6037353*PED 2017/09/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6039974 2018/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6113942 2015/02/28 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6113942*PED 2015/08/28 PDF格式**本条是由Drugfuture回溯的历史信息**
7135571 2014/05/18 Y U-1159 PDF格式**本条是由Drugfuture回溯的历史信息**
7135571*PED 2014/11/18 PDF格式**本条是由Drugfuture回溯的历史信息**
7138524 2014/05/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7138524*PED 2014/11/18 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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