药品注册申请号:019438
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 AMINOSYN II 3.5% AMINO ACIDS INJECTABLE;INJECTION 3.5% (3.5GM/100ML) No No None 1986/04/03 1986/04/03 Discontinued
002 AMINOSYN II 5% AMINO ACIDS INJECTABLE;INJECTION 5% (5GM/100ML) No No None 1986/04/03 Discontinued
003 AMINOSYN II 7% AMINO ACIDS INJECTABLE;INJECTION 7% (7GM/100ML) No No None 1986/04/03 Discontinued
004 AMINOSYN II 8.5% AMINO ACIDS INJECTABLE;INJECTION 8.5% (8.5GM/100ML) No No None 1986/04/03 Discontinued
005 AMINOSYN II 10% AMINO ACIDS INJECTABLE;INJECTION 10% (10GM/100ML) No No None 1986/04/03 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
2003/06/06 SUPPL 13 Approval Labeling STANDARD
2002/10/25 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1999/01/22 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1997/05/05 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1994/07/11 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1993/12/30 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1992/09/28 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1992/02/10 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1988/12/30 SUPPL 5 Approval Labeling
1987/12/01 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1987/06/29 SUPPL 3 Approval Labeling
1986/04/03 ORIG 1 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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