药品注册申请号:050585
申请类型:NDA (新药申请)
申请人:HOFFMANN LA ROCHE
申请人全名:HOFFMANN LA ROCHE 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 ROCEPHIN CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/21 1984/12/21 Discontinued
002 ROCEPHIN CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/21 Discontinued
003 ROCEPHIN CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/21 Discontinued
004 ROCEPHIN CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/21 Discontinued
005 ROCEPHIN CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/21 Discontinued
006 ROCEPHIN KIT CEFTRIAXONE SODIUM; LIDOCAINE INJECTABLE;INJECTION EQ 1GM BASE/VIAL,N/A;N/A,1% No No None 1996/05/08 Discontinued
007 ROCEPHIN KIT CEFTRIAXONE SODIUM; LIDOCAINE INJECTABLE;INJECTION EQ 500MG BASE/VIAL,N/A;N/A,1% No No None 1996/05/08 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
2018/07/12 SUPPL-68(补充) Approval Labeling STANDARD
2015/06/30 SUPPL-67(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.
2015/03/20 SUPPL-66(补充) Approval Labeling STANDARD
2013/04/12 SUPPL-65(补充) Approval Labeling STANDARD
2010/11/12 SUPPL-62(补充) Approval Labeling STANDARD
2010/02/25 SUPPL-64(补充) Approval Labeling UNKNOWN
2009/06/07 SUPPL-63(补充) Approval Labeling STANDARD
2009/03/11 SUPPL-61(补充) Approval Labeling STANDARD
2008/08/18 SUPPL-60(补充) Approval Labeling STANDARD
2008/08/18 SUPPL-50(补充) Approval Labeling STANDARD
2007/07/17 SUPPL-58(补充) Approval Labeling STANDARD
2007/05/11 SUPPL-59(补充) Approval Labeling STANDARD
2004/09/14 SUPPL-57(补充) Approval Labeling STANDARD
2004/09/02 SUPPL-56(补充) Approval Labeling STANDARD
2004/03/29 SUPPL-54(补充) Approval Labeling STANDARD
2000/08/25 SUPPL-47(补充) Approval Labeling STANDARD
1999/10/18 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
1998/04/28 SUPPL-48(补充) Approval Manufacturing (CMC) PRIORITY
1997/12/23 SUPPL-46(补充) Approval Efficacy STANDARD
1996/05/08 SUPPL-44(补充) Approval Efficacy STANDARD
1996/03/14 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1995/09/14 SUPPL-45(补充) Approval Labeling STANDARD
1994/08/18 SUPPL-43(补充) Approval Labeling STANDARD
1994/04/26 SUPPL-39(补充) Approval Labeling
1994/02/04 SUPPL-42(补充) Approval Manufacturing (CMC) PRIORITY
1993/10/07 SUPPL-33(补充) Approval Labeling
1993/05/28 SUPPL-34(补充) Approval Efficacy
1993/02/08 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
1992/09/23 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1992/06/17 SUPPL-35(补充) Approval Efficacy
1992/02/11 SUPPL-23(补充) Approval Efficacy
1992/02/04 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1992/01/31 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1991/11/22 SUPPL-9(补充) Approval Efficacy
1991/09/12 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/11 SUPPL-26(补充) Approval Labeling
1991/03/11 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/11 SUPPL-18(补充) Approval Labeling
1990/12/31 SUPPL-27(补充) Approval Efficacy
1989/09/25 SUPPL-15(补充) Approval Labeling
1989/06/29 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1989/02/07 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/26 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1986/10/07 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1986/10/07 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1985/05/10 SUPPL-4(补充) Approval Labeling
1984/12/21 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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