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
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/06/06 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2013/07/31 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2003/06/23 SUPPL 14 Approval Labeling STANDARD
2002/10/25 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1999/01/22 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1997/05/05 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1994/07/11 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1993/12/30 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1992/09/28 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1992/02/10 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1988/06/17 SUPPL 5 Approval Labeling
1987/12/01 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1986/12/04 SUPPL 2 Approval Labeling
1986/12/04 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1986/04/03 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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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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