药品注册申请号：021532
申请类型：NDA (新药申请)
申请人：COSETTE
申请人全名：COSETTE PHARMACEUTICALS 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
2020/08/20 SUPPL-37（补充） Approval Labeling STANDARD
2016/05/13 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2016/02/11 SUPPL-15（补充） Approval Labeling STANDARD
2014/09/23 SUPPL-26（补充） Approval Labeling STANDARD
2014/06/27 SUPPL-25（补充） Approval Labeling STANDARD
2014/06/13 SUPPL-24（补充） Approval Labeling STANDARD
2014/05/07 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2013/07/03 SUPPL-22（补充） Approval Labeling STANDARD
2013/02/01 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2012/12/11 SUPPL-21（补充） Approval Labeling STANDARD
2012/09/18 SUPPL-20（补充） Approval Labeling UNKNOWN
2012/01/18 SUPPL-16（补充） Approval Labeling UNKNOWN
2011/05/03 SUPPL-14（补充） Approval Labeling UNKNOWN
2011/05/03 SUPPL-13（补充） Approval Labeling UNKNOWN
2007/11/16 SUPPL-8（补充） Approval Labeling STANDARD
2005/07/13 SUPPL-4（补充） Approval Labeling STANDARD
2004/11/12 SUPPL-1（补充） Approval Labeling STANDARD
2003/06/05 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
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 2021/11/19 U-3 Y 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 2021/11/19 U-3 Y 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 2021/11/19 U-3 Y 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 COSETTE
204233 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/04/24 ALEMBIC
205391 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA
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 Discontinued No No AB 2017/05/03 TORRENT
209281 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2019/02/07 ACCORD HLTHCARE
208847 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2019/09/17 UMEDICA
206377 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Discontinued No No AB 2023/02/24 ZYDUS PHARMS
204801 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2023/06/01 MACLEODS PHARMS LTD
207037 001 ANDA HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2024/07/11 ALKEM LABS 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 COSETTE
200532 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Discontinued 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
205391 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA
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 Discontinued No No AB 2017/05/03 TORRENT
209281 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2019/02/07 ACCORD HLTHCARE
208847 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2019/09/17 UMEDICA
206377 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Discontinued No No AB 2023/02/24 ZYDUS PHARMS
204801 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2023/06/01 MACLEODS PHARMS LTD
207037 002 ANDA HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2024/07/11 ALKEM LABS 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 COSETTE
204233 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/04/24 ALEMBIC
205391 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA
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 Discontinued No No AB 2017/05/03 TORRENT
209281 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2019/02/07 ACCORD HLTHCARE
208847 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2019/09/17 UMEDICA
206377 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Discontinued No No AB 2023/02/24 ZYDUS PHARMS
204801 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2023/06/01 MACLEODS PHARMS LTD
207037 003 ANDA HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2024/07/11 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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