药品注册申请号:078385
申请类型:ANDA (仿制药申请)
申请人:ZYDUS PHARMS USA INC
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 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG No No AB 2010/10/06 2010/10/06 Prescription
002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG No No AB 2010/10/06 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
2020/02/24 SUPPL-18(补充) Approval Labeling STANDARD
2019/07/08 SUPPL-17(补充) Approval Labeling STANDARD
2016/07/15 SUPPL-16(补充) Approval Labeling STANDARD
2015/10/06 SUPPL-14(补充) Approval Labeling STANDARD
2014/08/15 SUPPL-11(补充) Approval Labeling STANDARD
2013/11/06 SUPPL-10(补充) Approval Labeling STANDARD
2013/03/08 SUPPL-8(补充) Approval Labeling
2013/02/20 SUPPL-9(补充) Approval Labeling STANDARD
2013/01/28 SUPPL-7(补充) Approval Labeling
2011/09/21 SUPPL-6(补充) Approval Labeling
2010/10/30 SUPPL-1(补充) Approval Labeling
2010/10/06 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; LOSARTAN POTASSIUM 剂型/给药途径:TABLET;ORAL 规格:12.5MG;50MG 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
020387 001 NDA HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription Yes No AB 1995/04/28 ORGANON
077157 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/04/06 TEVA PHARMS
077948 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 SANDOZ
078245 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 LUPIN LTD
078385 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
091629 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
091617 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/02/17 ALEMBIC PHARMS LTD
202289 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/08/09 MACLEODS PHARMS LTD
201845 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
201682 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2013/03/01 IPCA LABS LTD
204832 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2017/07/21 UNICHEM
204901 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2017/11/06 PRINSTON INC
218015 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Discontinued No No AB 2023/09/29 GRANULES
活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 剂型/给药途径:TABLET;ORAL 规格:25MG;100MG 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
020387 002 NDA HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription Yes No AB 1998/11/10 ORGANON
091629 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No Yes AB 2010/01/06 AUROBINDO PHARMA
077157 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/04/06 TEVA PHARMS
077948 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 SANDOZ
078245 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 LUPIN LTD
078385 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
091617 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/02/17 ALEMBIC PHARMS LTD
202289 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/08/09 MACLEODS PHARMS LTD
201845 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
201682 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2013/03/01 IPCA LABS LTD
204832 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2017/07/21 UNICHEM
204901 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2017/11/06 PRINSTON INC
218015 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Discontinued No No AB 2023/09/29 GRANULES
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