药品注册申请号:018279
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE 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 K-TAB POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB3 1980/06/09 Approved Prior to Jan 1, 1982 Discontinued
002 K-TAB POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/08/01 Discontinued
003 K-TAB POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB3 2013/11/25 Discontinued
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
2018/04/30 SUPPL-37(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
2014/06/26 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2014/06/03 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
2013/11/25 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
2013/08/01 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
2012/02/15 SUPPL-29(补充) Approval Labeling UNKNOWN
2004/12/14 SUPPL-27(补充) Approval Labeling STANDARD
2002/12/24 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2002/10/02 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1998/04/16 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1997/10/29 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1996/11/21 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1993/01/27 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1990/03/26 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1989/11/02 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1988/08/01 SUPPL-16(补充) Approval Labeling
1988/08/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1987/06/12 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1986/10/07 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1986/06/17 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1986/01/14 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1985/03/25 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1984/08/13 SUPPL-8(补充) Approval Labeling
1984/08/01 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1982/11/10 SUPPL-5(补充) Approval Labeling
1982/07/02 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1981/04/29 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1981/02/04 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/02/03 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1981/01/16 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/06/09 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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 CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB3
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
018279 001 NDA K-TAB POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB3 Approved Prior to Jan 1, 1982 ABBVIE
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB3
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
018279 003 NDA K-TAB POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB3 2013/11/25 ABBVIE
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药品NDC数据与药品包装、标签说明书
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