药品注册申请号:050547
申请类型:NDA (新药申请)
申请人:STERIMAX
申请人全名:STERIMAX 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 CLAFORAN CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1981/03/11 Approved Prior to Jan 1, 1982 Discontinued
002 CLAFORAN CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 CLAFORAN CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 CLAFORAN CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1983/12/29 Discontinued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
2015/03/23 SUPPL-71(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2014/02/21 SUPPL-70(补充) Approval Labeling STANDARD
2011/09/09 SUPPL-68(补充) Approval Labeling STANDARD
2009/05/27 SUPPL-67(补充) Approval Labeling STANDARD
2008/02/21 SUPPL-66(补充) Approval Labeling STANDARD
2004/09/02 SUPPL-61(补充) Approval Labeling STANDARD
2004/06/23 SUPPL-60(补充) Approval Labeling STANDARD
2002/02/22 SUPPL-57(补充) Approval Manufacturing (CMC) PRIORITY
2002/01/18 SUPPL-47(补充) Approval Labeling STANDARD
2001/09/06 SUPPL-56(补充) Approval Manufacturing (CMC) PRIORITY
2001/07/27 SUPPL-55(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/12 SUPPL-54(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/10 SUPPL-53(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/18 SUPPL-52(补充) Approval Manufacturing (CMC) PRIORITY
1998/06/26 SUPPL-50(补充) Approval Manufacturing (CMC) PRIORITY
1998/06/16 SUPPL-51(补充) Approval Manufacturing (CMC) PRIORITY
1998/03/16 SUPPL-48(补充) Approval Manufacturing (CMC) PRIORITY
1997/10/28 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
1997/04/24 SUPPL-45(补充) Approval Labeling STANDARD
1996/12/23 SUPPL-44(补充) Approval Labeling STANDARD
1996/09/27 SUPPL-42(补充) Approval Efficacy STANDARD
1996/09/24 SUPPL-15(补充) Approval Labeling
1996/04/30 SUPPL-38(补充) Approval Labeling STANDARD
1995/08/25 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/17 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1994/11/22 SUPPL-21(补充) Approval Labeling STANDARD
1994/09/14 SUPPL-24(补充) Approval Labeling STANDARD
1994/09/02 SUPPL-25(补充) Approval Labeling STANDARD
1994/05/19 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1993/11/12 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1993/10/20 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1993/01/19 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1992/06/30 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1989/08/07 SUPPL-14(补充) Approval Labeling
1988/06/20 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1987/07/14 SUPPL-11(补充) Approval Labeling
1985/10/25 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1985/09/16 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1985/06/24 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1984/12/14 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1984/02/29 SUPPL-5(补充) Approval Labeling
1983/12/29 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1983/08/23 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1983/01/14 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1982/07/26 SUPPL-34(补充) Approval Labeling
1982/06/29 SUPPL-35(补充) Approval Labeling
1982/02/23 SUPPL-33(补充) Approval Labeling
1982/02/05 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1981/10/19 SUPPL-30(补充) Approval Labeling
1981/10/05 SUPPL-29(补充) Approval Labeling
1981/08/13 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1981/07/22 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1981/03/11 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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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