药品注册申请号：200532
申请类型：ANDA (仿制药申请)
申请人：TEVA PHARMS USA
申请人全名：TEVA PHARMACEUTICALS USA 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 None 2017/04/24 2017/04/24 Discontinued
002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG No No AB 2017/04/24 Discontinued
003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 25MG;40MG No No None 2017/04/24 Discontinued
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
2017/04/24 ORIG-1（原始申请） Approval Not Applicable
>>>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
无
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;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
208465 002 ANDA OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL 12.5MG;40MG Prescription No No AB 2026/03/31 SCIEGEN PHARMS
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药品NDC数据与药品包装、标签说明书
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