药品注册申请号:021073
申请类型:NDA (新药申请)
申请人:TAKEDA PHARMS USA
申请人全名:TAKEDA 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 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Yes No AB 1999/07/15 1999/07/15 Prescription
002 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Yes No AB 1999/07/15 Prescription
003 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Yes Yes AB 1999/07/15 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
2017/12/21 SUPPL-49(补充) Approval Labeling STANDARD
2016/12/12 SUPPL-48(补充) Approval Efficacy STANDARD
2013/11/12 SUPPL-46(补充) Approval Labeling UNKNOWN
2013/06/27 SUPPL-47(补充) Approval Manufacturing (CMC) PRIORITY
2012/05/17 SUPPL-45(补充) Approval REMS N/A
2011/08/04 SUPPL-44(补充) Approval Labeling 901 REQUIRED
2011/08/04 SUPPL-43(补充) Approval REMS N/A
2011/02/03 SUPPL-35(补充) Approval Labeling STANDARD
2010/07/29 SUPPL-40(补充) Approval Labeling STANDARD
2009/09/09 SUPPL-37(补充) Approval Labeling STANDARD
2008/12/11 SUPPL-34(补充) Approval Labeling STANDARD
2008/05/07 SUPPL-33(补充) Approval Labeling STANDARD
2007/09/06 SUPPL-30(补充) Approval Labeling STANDARD
2007/08/14 SUPPL-31(补充) Approval Labeling STANDARD
2007/02/25 SUPPL-26(补充) Approval Efficacy STANDARD
2006/11/04 SUPPL-28(补充) Approval Labeling STANDARD
2006/09/28 SUPPL-29(补充) Approval Labeling STANDARD
2006/08/30 SUPPL-27(补充) Approval Labeling STANDARD
2004/08/03 SUPPL-23(补充) Approval Labeling STANDARD
2004/07/20 SUPPL-24(补充) Approval Labeling STANDARD
2003/11/26 SUPPL-20(补充) Approval Efficacy STANDARD
2003/06/11 SUPPL-21(补充) Approval Labeling STANDARD
2003/01/17 SUPPL-17(补充) Approval Efficacy STANDARD
2002/12/03 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
2002/10/01 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
2002/07/12 SUPPL-10(补充) Approval Efficacy STANDARD
2002/02/28 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2002/01/07 SUPPL-16(补充) Approval Labeling STANDARD
2001/08/03 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/06 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/06 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/02 SUPPL-11(补充) Approval Labeling STANDARD
2001/05/22 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/25 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
2000/11/03 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
2000/10/25 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
2000/07/26 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/11 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/25 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/25 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1999/07/15 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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
001 4687777 2011/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
5965584 2016/06/19 U-753 U-417 PDF格式**本条是由Drugfuture回溯的历史信息**
6150383 2016/06/19 U-418 PDF格式**本条是由Drugfuture回溯的历史信息**
6150384 2016/06/19 U-419 PDF格式**本条是由Drugfuture回溯的历史信息**
6166042 2016/06/19 U-414 PDF格式**本条是由Drugfuture回溯的历史信息**
6166043 2016/06/19 U-415 PDF格式**本条是由Drugfuture回溯的历史信息**
6172090 2016/06/19 U-416 PDF格式**本条是由Drugfuture回溯的历史信息**
6211205 2016/06/19 U-410 PDF格式**本条是由Drugfuture回溯的历史信息**
6271243 2016/06/19 U-411 PDF格式**本条是由Drugfuture回溯的历史信息**
6303640 2016/08/09 U-425 PDF格式**本条是由Drugfuture回溯的历史信息**
6329404 2016/06/19 U-430 U-753 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4687777 2011/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
5965584 2016/06/19 U-417 U-753 PDF格式**本条是由Drugfuture回溯的历史信息**
6150383 2016/06/19 U-418 PDF格式**本条是由Drugfuture回溯的历史信息**
6150384 2016/06/19 U-419 PDF格式**本条是由Drugfuture回溯的历史信息**
6166042 2016/06/19 U-414 PDF格式**本条是由Drugfuture回溯的历史信息**
6166043 2016/06/19 U-415 PDF格式**本条是由Drugfuture回溯的历史信息**
6172090 2016/06/19 U-416 PDF格式**本条是由Drugfuture回溯的历史信息**
6211205 2016/06/19 U-410 PDF格式**本条是由Drugfuture回溯的历史信息**
6271243 2016/06/19 U-411 PDF格式**本条是由Drugfuture回溯的历史信息**
6303640 2016/08/09 U-425 PDF格式**本条是由Drugfuture回溯的历史信息**
6329404 2016/06/19 U-753 U-430 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4687777 2011/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
5965584 2016/06/19 U-753 U-417 PDF格式**本条是由Drugfuture回溯的历史信息**
6150383 2016/06/19 U-418 PDF格式**本条是由Drugfuture回溯的历史信息**
6150384 2016/06/19 U-419 PDF格式**本条是由Drugfuture回溯的历史信息**
6166042 2016/06/19 U-414 PDF格式**本条是由Drugfuture回溯的历史信息**
6166043 2016/06/19 U-415 PDF格式**本条是由Drugfuture回溯的历史信息**
6172090 2016/06/19 U-416 PDF格式**本条是由Drugfuture回溯的历史信息**
6211205 2016/06/19 U-410 PDF格式**本条是由Drugfuture回溯的历史信息**
6271243 2016/06/19 U-411 PDF格式**本条是由Drugfuture回溯的历史信息**
6303640 2016/08/09 U-425 PDF格式**本条是由Drugfuture回溯的历史信息**
6329404 2016/06/19 U-753 U-430 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-35 2006/11/26**本条是由Drugfuture回溯的历史信息**
002 M-35 2006/11/26**本条是由Drugfuture回溯的历史信息**
003 M-35 2006/11/26**本条是由Drugfuture回溯的历史信息**
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 SHUANGCHENG
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 SHUANGCHENG
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 SHUANGCHENG
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