药品注册申请号：074726
申请类型：ANDA (仿制药申请)
申请人：UPSHER SMITH LABS
申请人全名：UPSHER SMITH LABORATORIES LLC
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 KLOR-CON M20 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ No Yes AB1 1998/11/20 1998/11/20 Prescription
002 KLOR-CON M10 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ No No AB1 2000/08/09 Prescription
003 KLOR-CON M15 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ No No AB1 2003/06/06 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
2011/03/03 SUPPL-34（补充） Approval Labeling
2008/11/24 SUPPL-32（补充） Approval Labeling
2003/06/06 SUPPL-17（补充） Approval Labeling
2003/06/06 SUPPL-16（补充） Approval Manufacturing (CMC)
2003/06/06 SUPPL-11（补充） Approval Labeling
2002/12/19 SUPPL-18（补充） Approval Manufacturing (CMC)
2002/03/29 SUPPL-14（补充） Approval Manufacturing (CMC)
2002/03/29 SUPPL-13（补充） Approval Manufacturing (CMC)
2002/02/08 SUPPL-12（补充） Approval Manufacturing (CMC)
2001/06/28 SUPPL-8（补充） Approval Labeling
2001/06/28 SUPPL-7（补充） Approval Manufacturing (CMC)
2001/06/28 SUPPL-6（补充） Approval Manufacturing (CMC)
2001/06/28 SUPPL-5（补充） Approval Manufacturing (CMC)
2001/01/05 SUPPL-4（补充） Approval Manufacturing (CMC)
2000/10/10 SUPPL-3（补充） Approval Manufacturing (CMC)
2000/08/09 SUPPL-2（补充） Approval Labeling
2000/08/09 SUPPL-1（补充） Approval Manufacturing (CMC)
1998/11/20 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:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:20MEQ 治疗等效代码:AB1
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
074726 001 ANDA KLOR-CON M20 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No Yes AB1 1998/11/20 UPSHER SMITH LABS
075604 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2002/04/10 ACTAVIS LABS FL INC
076368 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2004/08/18 ADARE PHARMS INC
206347 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2016/01/21 NOVEL LABS INC
203562 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2016/07/26 GLENMARK PHARMS LTD
209922 003 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2019/04/30 PRINSTON INC
212861 003 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2020/05/08 AMNEAL
210395 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2020/09/17 ZYDUS PHARMS
214452 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2020/10/21 GRANULES
214422 003 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2020/12/29 ASCENT PHARMS INC
214395 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2021/01/28 GUANGZHOU NOVAKEN
216321 003 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2023/06/16 RUBICON
216269 003 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ Prescription No No AB1 2024/05/09 MACLEODS PHARMS LTD
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:10MEQ 治疗等效代码:AB1
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
074726 002 ANDA KLOR-CON M10 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2000/08/09 UPSHER SMITH LABS
075604 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2002/04/10 ACTAVIS LABS FL INC
206347 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2016/01/21 NOVEL LABS INC
203562 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2016/07/26 GLENMARK PHARMS LTD
209922 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2019/04/30 PRINSTON INC
076368 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2019/06/05 ADARE PHARMS INC
212861 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2020/05/08 AMNEAL
210395 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2020/09/17 ZYDUS PHARMS
214452 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2020/10/21 GRANULES
214422 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2020/12/29 ASCENT PHARMS INC
214395 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2021/01/28 GUANGZHOU NOVAKEN
216321 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2023/06/16 RUBICON
216269 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB1 2024/05/09 MACLEODS PHARMS LTD
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:15MEQ 治疗等效代码:AB1
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
074726 003 ANDA KLOR-CON M15 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB1 2003/06/06 UPSHER SMITH LABS
209922 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB1 2019/04/30 PRINSTON INC
214422 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB1 2020/12/29 ASCENT PHARMS INC
216321 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB1 2023/06/16 RUBICON
216269 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MEQ Prescription No No AB1 2024/05/09 MACLEODS PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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