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
1999/10/28 SUPPL-68(补充) Approval Labeling
1999/10/12 SUPPL-65(补充) Approval Labeling
1998/12/01 SUPPL-67(补充) Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL-66(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-61(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-60(补充) Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-63(补充) Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-62(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-56(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL-32(补充) Approval Labeling
1985/11/29 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL-41(补充) Approval Labeling
1985/10/26 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1984/11/09 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL-21(补充) Approval Labeling
1984/10/10 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1983/10/25 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1982/06/18 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1982/06/17 SUPPL-10(补充) Approval Labeling
1982/06/09 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1981/07/08 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1981/06/20 SUPPL-11(补充) Approval Labeling
1981/03/02 SUPPL-8(补充) Approval Labeling
1981/03/02 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1980/09/22 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1980/05/23 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1980/03/20 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/03/20 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1980/01/15 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
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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