药品注册申请号:204221
申请类型:ANDA (仿制药申请)
申请人:ZYDUS PHARMS
申请人全名:ZYDUS 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 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG No No AB 2017/08/15 2017/08/15 Prescription
002 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG No No AB 2017/08/15 Prescription
003 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG No No AB 2017/08/15 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
2021/12/10 SUPPL-2(补充) Approval Labeling STANDARD
2019/11/06 SUPPL-1(补充) Approval Labeling STANDARD
2017/08/15 ORIG-1(原始申请) Approval
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
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
与本品治疗等效的药品
活性成分:HYDROCHLOROTHIAZIDE; TELMISARTAN 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
021162 001 NDA MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription Yes No AB 2000/11/17 BOEHRINGER INGELHEIM
203010 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2014/02/25 ALEMBIC
091351 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2014/08/07 LUPIN LTD
208727 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2016/12/15 AUROBINDO PHARMA
204221 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/08/15 ZYDUS PHARMS
209028 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2017/11/06 PRINSTON INC
202544 001 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;40MG Prescription No No AB 2019/03/04 GLENMARK PHARMS LTD
活性成分:HYDROCHLOROTHIAZIDE; TELMISARTAN 剂型/给药途径:TABLET;ORAL 规格:12.5MG;80MG 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
021162 002 NDA MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription Yes No AB 2000/11/17 BOEHRINGER INGELHEIM
203010 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2014/02/25 ALEMBIC
091351 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2014/08/07 LUPIN LTD
208727 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2016/12/15 AUROBINDO PHARMA
204221 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2017/08/15 ZYDUS PHARMS
209028 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2017/11/06 PRINSTON INC
202544 002 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 12.5MG;80MG Prescription No No AB 2019/03/04 GLENMARK PHARMS LTD
活性成分:HYDROCHLOROTHIAZIDE; TELMISARTAN 剂型/给药途径:TABLET;ORAL 规格:25MG;80MG 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
021162 003 NDA MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription Yes Yes AB 2004/04/19 BOEHRINGER INGELHEIM
203010 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2014/02/25 ALEMBIC
091351 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2014/08/07 LUPIN LTD
208727 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2016/12/15 AUROBINDO PHARMA
204221 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2017/08/15 ZYDUS PHARMS
209028 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2017/11/06 PRINSTON INC
202544 003 ANDA TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL 25MG;80MG Prescription No No AB 2019/03/04 GLENMARK PHARMS LTD
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