药品注册申请号:020757
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
001 AVAPRO IRBESARTAN TABLET;ORAL 75MG Yes No AB 1997/09/30 1997/09/30 Prescription
002 AVAPRO IRBESARTAN TABLET;ORAL 150MG Yes No AB 1997/09/30 Prescription
003 AVAPRO IRBESARTAN TABLET;ORAL 300MG Yes Yes AB 1997/09/30 Prescription
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
2018/07/20 SUPPL 69 Approval Labeling STANDARD
2016/02/05 SUPPL 67 Approval Labeling STANDARD
2016/02/05 SUPPL 59 Approval Labeling UNKNOWN
2015/01/05 SUPPL 65 Approval Manufacturing (CMC) STANDARD
2014/05/28 SUPPL 64 Approval Labeling STANDARD
2013/10/10 SUPPL 63 Approval Manufacturing (CMC) STANDARD
2013/02/28 SUPPL 61 Approval Manufacturing (CMC) STANDARD
2012/09/12 SUPPL 60 Approval Labeling UNKNOWN
2012/01/18 SUPPL 58 Approval Labeling UNKNOWN
2011/12/08 SUPPL 56 Approval Labeling UNKNOWN
2011/08/01 SUPPL 55 Approval Labeling UNKNOWN
2006/04/21 SUPPL 38 Approval Labeling STANDARD
2006/03/16 SUPPL 39 Approval Labeling STANDARD
2005/11/21 SUPPL 37 Approval Labeling STANDARD
2004/10/29 SUPPL 33 Approval Supplement STANDARD
2004/07/21 SUPPL 32 Approval Supplement STANDARD
2004/05/20 SUPPL 31 Approval Supplement STANDARD
2004/01/02 SUPPL 30 Approval Supplement STANDARD
2003/10/09 SUPPL 27 Approval Supplement STANDARD
2003/09/09 SUPPL 28 Approval Supplement STANDARD
2003/05/21 SUPPL 26 Approval Supplement STANDARD
2003/05/01 SUPPL 24 Approval Supplement STANDARD
2003/03/21 SUPPL 25 Approval Supplement STANDARD
2003/03/21 SUPPL 23 Approval Supplement STANDARD
2002/09/17 SUPPL 21 Approval Efficacy PRIORITY
2002/07/19 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2001/09/26 SUPPL 11 Approval Labeling STANDARD
2001/06/07 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2001/05/26 SUPPL 14 Approval Efficacy STANDARD
2001/03/06 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2001/02/02 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2000/09/20 SUPPL 17 Approval Labeling STANDARD
2000/08/23 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2000/08/01 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2000/05/10 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/05/09 SUPPL 15 Approval Labeling STANDARD
2000/04/28 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1999/11/02 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1999/03/16 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1999/03/16 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1998/12/08 SUPPL 6 Approval Labeling STANDARD
1998/09/03 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1998/04/06 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1997/11/10 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/09/30 ORIG 1 Approval Type 1 - New Molecular Entity 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
001 5270317 2011/09/30 PDF格式**本条是由Drugfuture回溯的历史信息**
5270317*PED 2012/03/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247*PED 2015/12/07 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5270317 2011/09/30 PDF格式**本条是由Drugfuture回溯的历史信息**
5270317*PED 2012/03/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247*PED 2015/12/07 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5270317 2011/09/30 PDF格式**本条是由Drugfuture回溯的历史信息**
5270317*PED 2012/03/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
6342247*PED 2015/12/07 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
活性成分:IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:75MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020757 001 NDA AVAPRO IRBESARTAN TABLET;ORAL 75MG Prescription Yes No AB 1997/09/30 SANOFI AVENTIS US
077159 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/03/30 TEVA PHARMS
203161 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 NEOPHARMA
203071 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 PRINSTON INC
077466 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 SANDOZ
203081 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 AUROBINDO PHARMA LTD
202910 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 HETERO LABS LTD V
079213 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/09/27 ZYDUS PHARMS USA INC
202254 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/10/03 MACLEODS PHARMS LTD
090201 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/10/15 WEST-WARD PHARMS INT
201531 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/10/15 LUPIN LTD
091236 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/10/15 ALEMBIC PHARMS LTD
077205 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2012/11/14 CHARTWELL MOLECULAR
203534 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2015/02/23 JUBILANT GENERICS
203020 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2015/12/07 UNICHEM LABS LTD
204774 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2015/12/07 SCIEGEN PHARMS INC
206194 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2016/06/14 HISUN PHARM HANGZHOU
204740 001 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 75MG Prescription No No AB 2018/04/17 AMNEAL PHARMS
活性成分:IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:150MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020757 002 NDA AVAPRO IRBESARTAN TABLET;ORAL 150MG Prescription Yes No AB 1997/09/30 SANOFI AVENTIS US
077159 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/03/30 TEVA PHARMS
202910 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 HETERO LABS LTD V
077466 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 SANDOZ
079213 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 ZYDUS PHARMS USA INC
203071 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 PRINSTON INC
203081 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 AUROBINDO PHARMA LTD
203161 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/09/27 NEOPHARMA
202254 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/10/03 MACLEODS PHARMS LTD
090201 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/10/15 WEST-WARD PHARMS INT
091236 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/10/15 ALEMBIC PHARMS LTD
201531 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/10/15 LUPIN LTD
077205 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2012/11/14 CHARTWELL MOLECULAR
203534 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2015/02/23 JUBILANT GENERICS
204774 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2015/12/07 SCIEGEN PHARMS INC
203020 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2015/12/07 UNICHEM LABS LTD
206194 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2016/06/14 HISUN PHARM HANGZHOU
204740 002 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 150MG Prescription No No AB 2018/04/17 AMNEAL PHARMS
活性成分:IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:300MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020757 003 NDA AVAPRO IRBESARTAN TABLET;ORAL 300MG Prescription Yes Yes AB 1997/09/30 SANOFI AVENTIS US
077159 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/03/30 TEVA PHARMS
202910 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 HETERO LABS LTD V
077466 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 SANDOZ
079213 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 ZYDUS PHARMS USA INC
203071 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 PRINSTON INC
203081 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 AUROBINDO PHARMA LTD
203161 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/09/27 NEOPHARMA
202254 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/10/03 MACLEODS PHARMS LTD
090201 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/10/15 WEST-WARD PHARMS INT
091236 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/10/15 ALEMBIC PHARMS LTD
201531 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/10/15 LUPIN LTD
077205 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2012/11/14 CHARTWELL MOLECULAR
203534 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2015/02/23 JUBILANT GENERICS
204774 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2015/12/07 SCIEGEN PHARMS INC
203020 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2015/12/07 UNICHEM LABS LTD
206194 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2016/06/14 HISUN PHARM HANGZHOU
204740 003 ANDA IRBESARTAN IRBESARTAN TABLET;ORAL 300MG Prescription No No AB 2018/04/17 AMNEAL PHARMS
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