药品注册申请号:021532
申请类型:NDA (新药申请)
申请人:DAIICHI SANKYO
申请人全名:DAIICHI SANKYO INC
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 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Yes No AB 2003/06/05 2003/06/05 Prescription
003 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Yes No AB 2003/06/05 Prescription
005 BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Yes Yes AB 2003/06/05 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
2016/05/13 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2016/02/11 SUPPL 15 Approval Labeling STANDARD
2014/09/23 SUPPL 26 Approval Labeling STANDARD
2014/06/27 SUPPL 25 Approval Labeling STANDARD
2014/06/13 SUPPL 24 Approval Labeling STANDARD
2014/05/07 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2013/07/03 SUPPL 22 Approval Labeling STANDARD
2013/02/01 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2012/12/11 SUPPL 21 Approval Labeling STANDARD
2012/09/18 SUPPL 20 Approval Labeling UNKNOWN
2012/01/18 SUPPL 16 Approval Labeling UNKNOWN
2011/05/03 SUPPL 14 Approval Labeling UNKNOWN
2011/05/03 SUPPL 13 Approval Labeling UNKNOWN
2007/11/16 SUPPL 8 Approval Labeling STANDARD
2005/07/13 SUPPL 4 Approval Labeling STANDARD
2004/11/12 SUPPL 1 Approval Labeling STANDARD
2003/06/05 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 5616599 2016/04/25 Y Y U-500 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5616599 2016/04/25 Y Y U-500 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5616599 2016/04/25 Y Y U-500 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 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
002 NCE 2007/04/25**本条是由Drugfuture回溯的历史信息**
003 NCE 2007/04/25**本条是由Drugfuture回溯的历史信息**
005 NCE 2007/04/25**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; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;20MG 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
021532 002 NDA BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription Yes No AB 2003/06/05 DAIICHI SANKYO
204233 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
205391 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
207804 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/04/24 PRINSTON INC
206515 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/05/03 TORRENT
208847 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2019/09/17 UMEDICA LABS PVT LTD
活性成分:HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;40MG 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
021532 003 NDA BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription Yes No AB 2003/06/05 DAIICHI SANKYO
200532 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/04/24 TEVA PHARMS USA
204233 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
205391 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
207804 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/04/24 PRINSTON INC
206515 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/05/03 TORRENT
208847 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2019/09/17 UMEDICA LABS PVT LTD
活性成分:HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:25MG;40MG 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
021532 005 NDA BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription Yes Yes AB 2003/06/05 DAIICHI SANKYO
204233 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
205391 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
207804 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/04/24 PRINSTON INC
206515 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/05/03 TORRENT
208847 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2019/09/17 UMEDICA LABS PVT LTD
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