药品注册申请号：209281
申请类型：ANDA (仿制药申请)
申请人：ACCORD HLTHCARE
申请人全名：ACCORD HEALTHCARE 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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG No No AB 2019/02/07 2019/02/07 Prescription
002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG No No AB 2019/02/07 Prescription
003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG No No AB 2019/02/07 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
2019/02/07 ORIG-1（原始申请） Approval STANDARD
>>>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
2021/01/21 SUPPL-1（补充） Approval Labeling-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: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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2024/07/11 ALKEM LABS LTD
209199 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2025/07/25 HETERO LABS LTD V
214427 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2025/08/20 HANGZHOU BINJIANG
217398 001 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;20MG Prescription No No AB 2025/09/26 MSN
>>>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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2024/07/11 ALKEM LABS LTD
209199 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2025/07/25 HETERO LABS LTD V
214427 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2025/08/20 HANGZHOU BINJIANG
217398 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2025/09/26 MSN
>>>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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2024/07/11 ALKEM LABS LTD
209199 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2025/07/25 HETERO LABS LTD V
214427 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2025/08/20 HANGZHOU BINJIANG
217398 003 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG Prescription No No AB 2025/09/26 MSN
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