药品注册申请号:017385
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 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;32MG/100ML;128MG/100ML;234MG/100ML No No None 1979/02/01 Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2018/07/11 SUPPL-64(补充) Approval STANDARD
2016/03/18 SUPPL-62(补充) Approval Labeling STANDARD
2014/12/22 SUPPL-60(补充) Approval Labeling STANDARD
2013/09/11 SUPPL-59(补充) Approval Labeling STANDARD
2001/08/14 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
2001/02/01 SUPPL-51(补充) Approval Labeling STANDARD
2000/11/29 SUPPL-49(补充) Approval Labeling STANDARD
1999/11/24 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1991/01/10 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1985/04/18 SUPPL-34(补充) Approval Labeling
1985/04/15 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL-23(补充) Approval Labeling
1982/06/03 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1982/02/16 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL-18(补充) Approval Labeling
1981/06/29 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1979/08/10 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1979/02/01 ORIG-1(原始申请) 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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