药品注册申请号:019681
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA WORLDWIDE, 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% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 3.5%;25GM/100ML No No None 1988/11/01 1988/11/01 Discontinued
002 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 3.5%;5GM/100ML No No None 1988/11/01 Discontinued
003 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;25GM/100ML No No None 1988/11/01 Discontinued
004 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;10GM/100ML No No None 1988/11/01 Discontinued
005 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;20GM/100ML No No None 1988/11/01 Discontinued
006 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;25GM/100ML No No None 1988/11/01 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
2003/02/19 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2002/11/08 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2002/08/21 SUPPL 18 Approval Labeling STANDARD
2002/08/21 SUPPL 15 Approval Labeling STANDARD
1998/12/29 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1998/10/29 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1997/05/05 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1997/03/04 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1994/07/11 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1993/12/30 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1992/09/28 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1988/11/01 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
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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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