药品注册申请号:018254
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 DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML No No None 1980/01/15 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
1999/10/28 SUPPL 68 Approval Labeling
1999/10/12 SUPPL 65 Approval Labeling
1998/12/01 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL 32 Approval Labeling
1985/11/29 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL 41 Approval Labeling
1985/10/26 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1984/11/09 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 21 Approval Labeling
1984/10/10 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1983/10/25 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1982/06/18 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1982/06/17 SUPPL 10 Approval Labeling
1982/06/09 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1981/07/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1981/06/20 SUPPL 11 Approval Labeling
1981/03/02 SUPPL 8 Approval Labeling
1981/03/02 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1980/09/22 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1980/05/23 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1980/03/20 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1980/03/20 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1980/01/15 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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本品无治疗等效药品
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