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
>>>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
1975/08/13 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
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)-Control STANDARD
1998/05/12 SUPPL-103（补充） Approval Labeling STANDARD
1998/02/12 SUPPL-105（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/06/11 SUPPL-104（补充） Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-100（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/27 SUPPL-99（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/06 SUPPL-102（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/03/04 SUPPL-101（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/01/28 SUPPL-95（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/09/10 SUPPL-94（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/08/30 SUPPL-96（补充） Approval Manufacturing (CMC)-Packaging 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)-Control STANDARD
1987/07/30 SUPPL-88（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/11/26 SUPPL-87（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/08 SUPPL-86（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/04 SUPPL-85（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1986/01/31 SUPPL-84（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/31 SUPPL-81（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/11/29 SUPPL-69（补充） Approval Labeling
1985/11/29 SUPPL-68（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/29 SUPPL-67（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/10/26 SUPPL-78（补充） Approval Labeling
1985/10/26 SUPPL-76（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/09/26 SUPPL-71（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/06/10 SUPPL-83（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/14 SUPPL-80（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/03 SUPPL-77（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/11/09 SUPPL-75（补充） Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-72（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/17 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/10 SUPPL-58（补充） Approval Labeling
1984/10/10 SUPPL-57（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/04/09 SUPPL-65（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/21 SUPPL-62（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/01 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/01/17 SUPPL-60（补充） Approval Labeling
1984/01/17 SUPPL-59（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1983/12/08 SUPPL-61（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/10/25 SUPPL-64（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1983/02/15 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/08 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/08 SUPPL-46（补充） Approval Labeling
1982/06/18 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/09 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/01 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/01/08 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/10/07 SUPPL-48（补充） Approval Manufacturing (CMC)-Control 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)-Control STANDARD
1981/01/07 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/15 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/11 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/10 SUPPL-40（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/04/08 SUPPL-39（补充） Approval Labeling
1980/01/22 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/12/03 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/12/03 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/11/29 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/11/27 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/10/10 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/08/08 SUPPL-32（补充） Approval Labeling
1979/02/06 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/02/01 SUPPL-30（补充） Approval / STANDARD
1979/01/05 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/12/29 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/11/22 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/11/22 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/10/11 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/15 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/02 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/07/12 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/06/26 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/06/14 SUPPL-14（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1978/06/14 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/04/11 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/03/30 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/03/09 SUPPL-18（补充） Approval Labeling
1978/03/09 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/02/08 SUPPL-19（补充） Approval Labeling
1978/01/23 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/09/28 SUPPL-13（补充） Approval Labeling
1977/05/20 SUPPL-9（补充） Approval Manufacturing (CMC)-Control 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)-Packaging STANDARD
1975/11/20 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/11/03 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/10/21 SUPPL-4（补充） Approval Labeling
1975/10/15 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
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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
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本品无治疗等效药品
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