药品注册申请号:018876
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 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;74.5MG/100ML;300MG/100ML No No None 1986/01/17 1986/01/17 Discontinued
002 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;300MG/100ML No No None 1986/01/17 Discontinued
003 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;300MG/100ML No No None 1986/01/17 Discontinued
004 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;298MG/100ML;300MG/100ML No No None 1988/03/28 Discontinued
005 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;74.5MG/100ML;300MG/100ML No No None 1988/03/28 Discontinued
006 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;300MG/100ML No No None 1988/03/28 Discontinued
007 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;300MG/100ML No No None 1988/03/28 Discontinued
008 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;298MG/100ML;300MG/100ML No No None 1988/03/28 Discontinued
009 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;300MG/100ML No No None 1988/03/28 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
2013/09/05 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
2001/08/24 SUPPL-24(补充) Approval Labeling STANDARD
1998/10/29 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL-20(补充) Approval Labeling STANDARD
1997/06/11 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1988/03/28 SUPPL-6(补充) Approval Labeling
1988/03/28 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1987/08/31 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1986/10/09 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1986/08/11 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1986/01/17 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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