药品注册申请号:018249
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER SODIUM LACTATE INJECTABLE;INJECTION 1.87GM/100ML No No None 1980/07/25 Approved Prior to Jan 1, 1982 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
2009/06/18 SUPPL 58 Approval Labeling
2009/06/18 SUPPL 8 Approval Labeling
2008/05/07 SUPPL 30 Approval Labeling
2008/05/07 SUPPL 20 Approval Labeling
2008/05/07 SUPPL 7 Approval Labeling
2008/05/07 SUPPL 2 Approval Labeling
1998/12/01 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1989/09/13 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1985/12/06 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1985/03/15 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1983/12/07 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1983/10/25 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1982/07/21 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1982/06/29 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1981/03/02 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1981/01/26 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1980/10/20 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1980/09/26 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1980/07/25 ORIG 1 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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