药品注册申请号:017586
申请类型:NDA (新药申请)
申请人:ICU MEDICAL INC
申请人全名:ICU MEDICAL 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 NORMOSOL-R IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML No No None 1975/08/13 Approved Prior to Jan 1, 1982 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
2016/03/22 SUPPL-129(补充) Approval Manufacturing (CMC) STANDARD
2013/09/05 SUPPL-127(补充) Approval Manufacturing (CMC) STANDARD
2000/06/15 SUPPL-107(补充) Approval Labeling STANDARD
1998/10/29 SUPPL-106(补充) Approval Manufacturing (CMC) STANDARD
1998/05/12 SUPPL-103(补充) Approval Labeling STANDARD
1998/02/12 SUPPL-105(补充) Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL-104(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-100(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-99(补充) Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-102(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-101(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-95(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-94(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-96(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-91(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-92(补充) Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-66(补充) Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL-88(补充) Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-87(补充) Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-86(补充) Approval Manufacturing (CMC) STANDARD
1986/08/04 SUPPL-85(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-84(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-81(补充) Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL-69(补充) Approval Labeling
1985/11/29 SUPPL-68(补充) Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-67(补充) Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL-78(补充) Approval Labeling
1985/10/26 SUPPL-76(补充) Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL-71(补充) Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL-83(补充) Approval Manufacturing (CMC) STANDARD
1985/05/14 SUPPL-80(补充) Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL-77(补充) Approval Manufacturing (CMC) STANDARD
1984/11/09 SUPPL-75(补充) Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-72(补充) Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL-63(补充) Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL-58(补充) Approval Labeling
1984/10/10 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL-65(补充) Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL-62(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1984/01/17 SUPPL-60(补充) Approval Labeling
1984/01/17 SUPPL-59(补充) Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL-61(补充) Approval Manufacturing (CMC) STANDARD
1983/10/25 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-56(补充) Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL-46(补充) Approval Labeling
1982/06/18 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1981/03/02 SUPPL-47(补充) Approval Labeling
1981/03/02 SUPPL-45(补充) Approval Labeling
1981/03/02 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1980/09/11 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1980/06/10 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1980/04/08 SUPPL-39(补充) Approval Labeling
1980/01/22 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1979/11/29 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1979/11/27 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1979/10/10 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1979/08/08 SUPPL-32(补充) Approval Labeling
1979/02/06 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1979/02/01 SUPPL-30(补充) Approval Supplement STANDARD
1979/01/05 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1978/12/29 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1978/11/22 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1978/11/22 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1978/10/11 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1978/08/15 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1978/08/02 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1978/07/12 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1978/06/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1978/06/14 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1978/06/14 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1978/04/11 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1978/03/30 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1978/03/09 SUPPL-18(补充) Approval Labeling
1978/03/09 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1978/02/08 SUPPL-19(补充) Approval Labeling
1978/01/23 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1977/09/28 SUPPL-13(补充) Approval Labeling
1977/05/20 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1977/04/29 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1977/01/28 SUPPL-8(补充) Approval Labeling
1976/11/08 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1975/11/20 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1975/11/03 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1975/10/21 SUPPL-4(补充) Approval Labeling
1975/10/15 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1975/08/13 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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