药品注册申请号：019123
申请类型：NDA (新药申请)
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 POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Yes No AB2 1986/04/17 1986/04/17 Prescription
002 KLOR-CON POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Yes Yes AB2 1986/04/17 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1986/04/17 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/04/30 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2013/11/29 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
2007/01/02 SUPPL-27（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
2006/04/13 SUPPL-24（补充） Approval Labeling STANDARD
2004/05/24 SUPPL-22（补充） Approval Labeling STANDARD
2003/11/21 SUPPL-21（补充） Approval Labeling STANDARD
1996/07/18 SUPPL-19（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1995/07/18 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/12/16 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1994/04/08 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1993/07/02 SUPPL-15（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1992/06/26 SUPPL-8（补充） Approval Efficacy-Accelerated Approval Confirmatory Study
1991/10/31 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/07/18 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/07/17 SUPPL-13（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1989/09/21 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/09/18 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/24 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/11/07 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1988/06/02 SUPPL-6（补充） Approval Labeling
1987/08/25 SUPPL-4（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/07/31 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/06/26 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1987/04/17 SUPPL-2（补充） Approval Manufacturing (CMC)-Formulation 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
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:8MEQ; 治疗等效代码:AB2<<<
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
019123 001 NDA KLOR-CON POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription Yes No AB2 1986/04/17 UPSHER SMITH LABS
204662 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2014/08/21 PHARMOBEDIENT
205993 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2015/11/05 PADAGIS US
206759 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2016/08/09 NOVEL LABS INC
209314 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2018/06/22 YICHANG HUMANWELL
210733 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2018/08/31 STRIDES PHARMA
210921 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2018/12/19 AUROBINDO PHARMA
211797 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2020/03/04 GRANULES
217412 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2023/12/19 RISING
212987 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2024/09/06 MACLEODS PHARMS LTD
218979 001 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ Prescription No No AB2 2024/10/28 TWI PHARMS
>>>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:AB2<<<
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
019123 002 NDA KLOR-CON POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription Yes Yes AB2 1986/04/17 UPSHER SMITH LABS
204662 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2014/08/21 PHARMOBEDIENT
205993 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2015/11/05 PADAGIS US
206759 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2016/08/09 NOVEL LABS INC
209314 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2018/06/22 YICHANG HUMANWELL
210733 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2018/08/31 STRIDES PHARMA
210921 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2018/12/19 AUROBINDO PHARMA
211797 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2020/03/04 GRANULES
217412 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2023/12/19 RISING
212987 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2024/09/06 MACLEODS PHARMS LTD
218979 002 ANDA POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ Prescription No No AB2 2024/10/28 TWI PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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