药品注册申请号:019437
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
004 AMINOSYN II 10% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE INJECTABLE;INJECTION 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML No No None 1986/04/03 1986/04/03 Discontinued
005 AMINOSYN II 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE INJECTABLE;INJECTION 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML No No None 1986/04/03 Discontinued
006 AMINOSYN II 7% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE INJECTABLE;INJECTION 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML No No None 1986/04/03 Discontinued
007 AMINOSYN II 3.5% M AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INJECTABLE;INJECTION 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML No No None 1986/04/03 Discontinued
008 AMINOSYN II 8.5% W/ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC INJECTABLE;INJECTION 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML No No None 2002/10/25 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
2016/06/06 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2013/07/31 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2003/06/23 SUPPL-14(补充) Approval Labeling STANDARD
2002/10/25 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1999/01/22 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1997/05/05 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1994/07/11 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1993/12/30 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1992/09/28 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1992/02/10 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1988/06/17 SUPPL-5(补充) Approval Labeling
1987/12/01 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1986/12/04 SUPPL-2(补充) Approval Labeling
1986/12/04 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1986/04/03 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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