药品注册申请号：200175
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
001 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Yes No AB 2010/07/23 2010/07/23 Prescription
002 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Yes No AB 2010/07/23 Prescription
003 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Yes No AB 2010/07/23 Prescription
004 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Yes No AB 2010/07/23 Prescription
005 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Yes Yes AB 2010/07/23 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
2020/10/02 SUPPL-33（补充） Approval Labeling STANDARD
2020/08/20 SUPPL-37（补充） Approval Labeling STANDARD
2017/01/05 SUPPL-26（补充） Approval Labeling STANDARD
2016/11/01 SUPPL-25（补充） Approval Labeling STANDARD
2015/09/16 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2014/09/23 SUPPL-20（补充） Approval Labeling STANDARD
2014/06/27 SUPPL-19（补充） Approval Labeling STANDARD
2014/06/20 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2014/06/13 SUPPL-18（补充） Approval Labeling STANDARD
2013/07/03 SUPPL-15（补充） Approval Labeling STANDARD
2013/07/03 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
2013/05/06 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2013/02/01 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
2012/12/10 SUPPL-12（补充） Approval Labeling STANDARD
2012/09/28 SUPPL-11（补充） Approval Labeling UNKNOWN
2012/01/19 SUPPL-8（补充） Approval Labeling UNKNOWN
2011/11/01 SUPPL-7（补充） Approval Labeling UNKNOWN
2011/06/21 SUPPL-3（补充） Approval Labeling UNKNOWN
2011/03/25 SUPPL-1（补充） Approval Labeling UNKNOWN
2010/07/23 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 5616599 2016/04/25 Y Y U-3 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**
002 5616599 2016/04/25 Y Y U-3 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**
003 5616599 2016/04/25 Y Y U-3 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**
004 5616599 2016/04/25 Y Y U-3 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**
005 5616599 2016/04/25 Y Y U-3 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**
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 NC 2013/07/23**本条是由Drugfuture回溯的历史信息**
002 NC 2013/07/23**本条是由Drugfuture回溯的历史信息**
003 NC 2013/07/23**本条是由Drugfuture回溯的历史信息**
004 NC 2013/07/23**本条是由Drugfuture回溯的历史信息**
005 NC 2013/07/23**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:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;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
200175 001 NDA TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription Yes No AB 2010/07/23 COSETTE
203580 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2016/10/26 TORRENT
206137 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2016/10/26 ENDO OPERATIONS
202491 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2016/11/03 TEVA PHARMS USA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;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
200175 002 NDA TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription Yes No AB 2010/07/23 COSETTE
203580 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2016/10/26 TORRENT
206137 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2016/10/26 ENDO OPERATIONS
202491 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2016/11/03 TEVA PHARMS USA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG BASE;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
200175 003 NDA TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription Yes No AB 2010/07/23 COSETTE
203580 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2016/10/26 TORRENT
206137 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2016/10/26 ENDO OPERATIONS
202491 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2016/11/03 TEVA PHARMS USA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;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
200175 004 NDA TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription Yes No AB 2010/07/23 COSETTE
203580 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2016/10/26 TORRENT
206137 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2016/10/26 ENDO OPERATIONS
202491 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2016/11/03 TEVA PHARMS USA
活性成分:AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE;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
200175 005 NDA TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription Yes Yes AB 2010/07/23 COSETTE
203580 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2016/10/26 TORRENT
206137 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2016/10/26 ENDO OPERATIONS
202491 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2016/11/03 TEVA PHARMS USA
更多信息
药品NDC数据与药品包装、标签说明书
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