药品注册申请号:204802
申请类型:ANDA (仿制药申请)
申请人:MACLEODS PHARMS LTD
申请人全名:MACLEODS PHARMACEUTICALS LTD
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 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE No No AB 2015/11/05 2015/11/05 Prescription
002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE No No AB 2015/11/05 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
2023/06/07 SUPPL-24(补充) Approval Labeling STANDARD
2019/03/06 SUPPL-8(补充) Approval Labeling STANDARD
2019/03/06 SUPPL-5(补充) Approval Labeling STANDARD
2016/12/14 SUPPL-4(补充) Approval Manufacturing (CMC) UNKNOWN
2015/11/05 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:METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:500MG;EQ 15MG BASE 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
200823 001 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE Prescription No No AB 2013/02/13 AUROBINDO PHARMA LTD
091155 001 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE Prescription No No AB 2014/03/10 TEVA PHARMS USA
204802 001 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE Prescription No No AB 2015/11/05 MACLEODS PHARMS LTD
活性成分:METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:850MG;EQ 15MG BASE 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
021842 002 NDA ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Prescription Yes Yes AB 2005/08/29 TAKEDA PHARMS USA
200823 002 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Prescription No No AB 2013/02/13 AUROBINDO PHARMA LTD
091155 002 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Prescription No No AB 2014/03/10 TEVA PHARMS USA
204802 002 ANDA PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Prescription No No AB 2015/11/05 MACLEODS PHARMS LTD
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