药品注册申请号:020758
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 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/30 1997/09/30 Discontinued
002 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Yes Yes AB 1997/09/30 Prescription
003 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Yes Yes AB 1998/08/31 Prescription
004 AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2005/03/15 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2021/09/10 SUPPL-80(补充) Approval Labeling STANDARD
2021/05/11 SUPPL-81(补充) Approval Labeling STANDARD
2020/12/15 SUPPL-76(补充) Approval Labeling STANDARD
2020/08/20 SUPPL-79(补充) Approval Labeling STANDARD
2018/07/20 SUPPL-73(补充) Approval Labeling STANDARD
2017/07/10 SUPPL-72(补充) Approval Labeling STANDARD
2016/02/05 SUPPL-70(补充) Approval Labeling STANDARD
2014/05/28 SUPPL-67(补充) Approval Labeling STANDARD
2012/10/26 SUPPL-64(补充) Approval Labeling UNKNOWN
2012/02/09 SUPPL-60(补充) Approval Labeling UNKNOWN
2012/01/18 SUPPL-62(补充) Approval Labeling UNKNOWN
2011/06/06 SUPPL-59(补充) Approval Labeling UNKNOWN
2011/06/06 SUPPL-58(补充) Approval Labeling UNKNOWN
2010/09/07 SUPPL-50(补充) Approval Labeling STANDARD
2007/11/16 SUPPL-37(补充) Approval Efficacy UNKNOWN
2006/04/21 SUPPL-36(补充) Approval Labeling STANDARD
2005/11/21 SUPPL-35(补充) Approval Labeling STANDARD
2005/03/15 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
2004/10/29 SUPPL-31(补充) Approval Supplement STANDARD
2004/07/21 SUPPL-30(补充) Approval Supplement STANDARD
2004/01/02 SUPPL-29(补充) Approval Supplement STANDARD
2003/10/10 SUPPL-28(补充) Approval Supplement STANDARD
2003/05/01 SUPPL-23(补充) Approval Supplement STANDARD
2001/09/26 SUPPL-13(补充) Approval Labeling STANDARD
2001/06/07 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2001/03/06 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2001/02/21 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2000/09/20 SUPPL-18(补充) Approval Labeling STANDARD
2000/08/23 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2000/08/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2000/05/10 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2000/05/09 SUPPL-16(补充) Approval Labeling STANDARD
2000/04/28 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1999/04/20 SUPPL-11(补充) Approval Labeling STANDARD
1999/03/16 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1999/03/16 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1999/01/21 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1998/09/03 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1998/08/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1998/07/15 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1998/07/14 SUPPL-7(补充) Approval Labeling STANDARD
1998/04/06 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1997/09/30 ORIG-1(原始申请) 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
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**
5994348 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5994348*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**
5994348 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5994348*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**
5994348 2015/06/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5994348*PED 2015/12/07 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5270317 2011/09/30 Y Y 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**
5994348 2015/06/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5994348*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
001 I-549 2010/11/16**本条是由Drugfuture回溯的历史信息**
002 I-549 2010/11/16**本条是由Drugfuture回溯的历史信息**
003 I-549 2010/11/16**本条是由Drugfuture回溯的历史信息**
004 I-549 2010/11/16**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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
020758 002 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription Yes Yes AB 1997/09/30 SANOFI AVENTIS US
077369 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/03/30 TEVA
077446 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 SANDOZ
202414 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 HIKMA
091370 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2012/10/15 ALEMBIC
203630 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2013/02/27 LUPIN LTD
203072 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 001 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG Discontinued No No AB 2017/09/19 UNICHEM
活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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
020758 003 NDA AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription Yes Yes AB 1998/08/31 SANOFI AVENTIS US
077369 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/03/30 TEVA
077446 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 SANDOZ
202414 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 MACLEODS PHARMS LTD
203500 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/09/27 DR REDDYS LABS LTD
090351 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 HIKMA
091370 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2012/10/15 ALEMBIC
203630 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2013/02/22 AUROBINDO PHARMA LTD
201524 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2013/02/27 LUPIN LTD
203072 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2014/05/09 PRINSTON INC
207896 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Prescription No No AB 2016/10/14 HISUN PHARM HANGZHOU
207018 002 ANDA IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG Discontinued No No AB 2017/09/19 UNICHEM
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