药品注册申请号:017850
申请类型:NDA (新药申请)
申请人:APOTHECON
申请人全名:APOTHECON INC DIV BRISTOL MYERS SQUIBB
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 KLOTRIX POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MEQ No No None 1980/05/22 Approved Prior to Jan 1, 1982 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
1995/10/03 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1990/10/03 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1989/09/19 SUPPL-26(补充) Approval Labeling STANDARD
1988/08/26 SUPPL-23(补充) Approval Labeling STANDARD
1988/06/15 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1988/06/07 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1987/10/01 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1987/05/15 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1987/03/11 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1987/02/13 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1985/10/24 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1985/10/24 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1985/07/30 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1985/06/14 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1985/05/24 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1985/05/15 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1984/08/13 SUPPL-4(补充) Approval Labeling STANDARD
1983/06/09 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1983/06/09 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1983/05/04 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1983/05/04 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1983/05/04 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1983/01/04 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1982/02/04 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1981/10/01 SUPPL-5(补充) Approval Labeling STANDARD
1981/03/17 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/08/14 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/08/14 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1980/05/22 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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