药品注册申请号:214426
申请类型:ANDA (仿制药申请)
申请人:EYWA
申请人全名:EYWA PHARMA 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 POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ No No AB 2021/02/19 2021/02/19 Prescription
002 POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ No No AB 2021/02/19 Prescription
003 POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ No No AB 2021/02/19 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
2022/03/31 SUPPL-4(补充) Approval Labeling STANDARD
2021/02/19 ORIG-1(原始申请) Approval STANDARD
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:POTASSIUM CITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:5MEQ 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
019071 001 NDA UROCIT-K POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription Yes No AB 1985/08/30 MISSION PHARMA
077440 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2006/06/09 RISING
203546 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2014/08/06 ZYDUS PHARMS
206813 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2017/09/11 STRIDES PHARMA
209758 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2018/03/05 TEVA PHARMS USA INC
214420 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2021/02/05 ASCENT PHARMS INC
214426 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Prescription No No AB 2021/02/19 EYWA
213986 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 5MEQ Discontinued No No AB 2024/02/06 TORRENT
活性成分:POTASSIUM CITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:10MEQ 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
019071 002 NDA UROCIT-K POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription Yes No AB 1992/08/31 MISSION PHARMA
077440 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2006/06/09 RISING
203546 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2014/08/06 ZYDUS PHARMS
206813 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2017/09/11 STRIDES PHARMA
209758 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2018/03/05 TEVA PHARMS USA INC
212779 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2020/01/14 ANI PHARMS
212799 001 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2020/06/29 BIONPHARMA
214420 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2021/02/05 ASCENT PHARMS INC
214426 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB 2021/02/19 EYWA
213986 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 10MEQ Discontinued No No AB 2024/02/06 TORRENT
活性成分:POTASSIUM CITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:15MEQ 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
019071 003 NDA UROCIT-K POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription Yes Yes AB 2009/12/30 MISSION PHARMA
203546 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2014/08/06 ZYDUS PHARMS
206813 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2017/09/11 STRIDES PHARMA
209758 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2018/03/05 TEVA PHARMS USA INC
212779 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2020/01/14 ANI PHARMS
212799 002 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2020/06/29 BIONPHARMA
214420 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2021/02/05 ASCENT PHARMS INC
214426 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB 2021/02/19 EYWA
213986 003 ANDA POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL 15MEQ Discontinued No No AB 2024/02/06 TORRENT
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