药品注册申请号:016692
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
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 1971/03/22 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
2015/01/12 SUPPL 99 Approval Manufacturing (CMC) STANDARD
2013/04/26 SUPPL 98 Approval Manufacturing (CMC) STANDARD
2011/10/19 SUPPL 95 Approval Labeling UNKNOWN
2001/08/14 SUPPL 88 Approval Manufacturing (CMC) STANDARD
2000/11/29 SUPPL 85 Approval Labeling STANDARD
2000/11/02 SUPPL 87 Approval Labeling STANDARD
1999/11/24 SUPPL 86 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1991/04/26 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 77 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 75 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1985/04/17 SUPPL 68 Approval Labeling
1985/04/15 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL 57 Approval Labeling
1982/06/03 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1982/02/16 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 52 Approval Labeling
1981/06/29 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1978/10/20 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1978/08/07 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1978/08/02 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1978/06/20 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1978/04/25 SUPPL 33 Approval Labeling
1978/03/24 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1978/03/22 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1977/06/06 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1977/02/07 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1976/10/18 SUPPL 18 Approval Labeling
1976/07/13 SUPPL 24 Approval Labeling
1976/07/01 SUPPL 21 Approval Labeling
1976/06/17 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1976/05/11 SUPPL 16 Approval Labeling
1976/01/05 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1975/09/25 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1975/09/23 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1975/09/17 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1975/07/10 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1971/03/22 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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