药品注册申请号：202467
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 PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE No No AB 2013/02/06 2013/02/06 Prescription
002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE No No AB 2013/02/06 Prescription
003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE No No AB 2013/02/06 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
2023/06/07 SUPPL-23（补充） Approval Labeling STANDARD
2018/12/17 SUPPL-12（补充） Approval Labeling STANDARD
2018/12/17 SUPPL-9（补充） Approval Labeling STANDARD
2016/01/26 SUPPL-4（补充） Approval Labeling STANDARD
2013/02/06 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
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:PIOGLITAZONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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
021073 001 NDA ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription Yes No AB 1999/07/15 TAKEDA PHARMS USA
076798 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2012/10/26 CHARTWELL RX
202467 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2013/02/06 MACLEODS PHARMS LTD
078670 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2013/02/13 SANDOZ
200044 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2013/02/13 ACCORD HLTHCARE
200268 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2013/02/13 AUROBINDO PHARMA LTD
202456 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2013/02/13 ZYDUS PHARMS USA INC
077210 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2014/01/10 TEVA PHARMS USA
204133 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2014/04/07 ANNORA PHARMA
206738 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2017/10/06 PURACAP PHARM LLC
207806 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2018/04/17 PRINSTON INC
210165 001 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Prescription No No AB 2021/01/22 COREPHARMA
活性成分:PIOGLITAZONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 30MG 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
021073 002 NDA ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription Yes No AB 1999/07/15 TAKEDA PHARMS USA
076798 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2012/10/26 CHARTWELL RX
202467 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2013/02/06 MACLEODS PHARMS LTD
078670 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2013/02/13 SANDOZ
200044 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2013/02/13 ACCORD HLTHCARE
200268 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2013/02/13 AUROBINDO PHARMA LTD
202456 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2013/02/13 ZYDUS PHARMS USA INC
077210 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2014/01/10 TEVA PHARMS USA
204133 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2014/04/07 ANNORA PHARMA
206738 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2017/10/06 PURACAP PHARM LLC
207806 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/04/17 PRINSTON INC
210165 002 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2021/01/22 COREPHARMA
活性成分:PIOGLITAZONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 45MG 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
021073 003 NDA ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription Yes Yes AB 1999/07/15 TAKEDA PHARMS USA
076798 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2012/10/26 CHARTWELL RX
202467 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2013/02/06 MACLEODS PHARMS LTD
078670 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2013/02/13 SANDOZ
200044 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2013/02/13 ACCORD HLTHCARE
200268 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2013/02/13 AUROBINDO PHARMA LTD
202456 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2013/02/13 ZYDUS PHARMS USA INC
077210 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2014/01/10 TEVA PHARMS USA
204133 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2014/04/07 ANNORA PHARMA
206738 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2017/10/06 PURACAP PHARM LLC
207806 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2018/04/17 PRINSTON INC
210165 003 ANDA PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Prescription No No AB 2021/01/22 COREPHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database