药品注册申请号：202491
申请类型：ANDA (仿制药申请)
申请人：TEVA PHARMS USA
申请人全名：TEVA PHARMACEUTICALS USA
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 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG No No AB 2016/11/03 2016/11/03 Prescription
002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG No No AB 2016/11/03 Prescription
003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG No No AB 2016/11/03 Prescription
004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG No No AB 2016/11/03 Prescription
005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG No No AB 2016/11/03 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2016/11/03 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/03/01 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2019/12/10 SUPPL-1（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert 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
无
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
无
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
207437 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB -- MICRO LABS
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 Discontinued 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 PH HEALTH
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
210718 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2025/05/14 PIRAMAL
207088 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2025/07/18 MACLEODS PHARMS LTD
209242 001 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;20MG Prescription No No AB 2025/10/06 HETERO LABS LTD V
>>>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
207437 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB -- MICRO LABS
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 PH HEALTH
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
210718 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2025/05/14 PIRAMAL
207088 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2025/07/18 MACLEODS PHARMS LTD
209242 002 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;12.5MG;40MG Prescription No No AB 2025/10/06 HETERO LABS LTD V
>>>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
207437 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB -- MICRO LABS
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 PH HEALTH
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
210718 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2025/05/14 PIRAMAL
207088 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2025/07/18 MACLEODS PHARMS LTD
209242 003 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;25MG;40MG Prescription No No AB 2025/10/06 HETERO LABS LTD V
>>>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
207437 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB -- MICRO LABS
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 Discontinued 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 PH HEALTH
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
210718 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2025/05/14 PIRAMAL
207088 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2025/07/18 MACLEODS PHARMS LTD
209242 004 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;12.5MG;40MG Prescription No No AB 2025/10/06 HETERO LABS LTD V
>>>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
207437 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB -- MICRO LABS
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 Discontinued 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 PH HEALTH
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
210718 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2025/05/14 PIRAMAL
207088 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2025/07/18 MACLEODS PHARMS LTD
209242 005 ANDA OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;25MG;40MG Prescription No No AB 2025/10/06 HETERO LABS LTD V
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