药品注册申请号:050517
申请类型:NDA (新药申请)
申请人:NORVIUM BIOSCIENCE
申请人全名:NORVIUM BIOSCIENCE LLC
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 MEFOXIN CEFOXITIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1978/10/18 Approved Prior to Jan 1, 1982 Discontinued
002 MEFOXIN CEFOXITIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 MEFOXIN CEFOXITIN SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2017/03/09 SUPPL-53(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.
2013/05/10 SUPPL-51(补充) Approval Labeling STANDARD
2011/02/04 SUPPL-50(补充) Approval Labeling UNKNOWN
2007/09/17 SUPPL-47(补充) Approval Labeling STANDARD
2004/06/28 SUPPL-45(补充) Approval Labeling STANDARD
2004/06/28 SUPPL-42(补充) Approval Labeling STANDARD
2004/06/02 SUPPL-46(补充) Approval Labeling STANDARD
2002/06/06 SUPPL-44(补充) Approval Manufacturing (CMC) PRIORITY
2002/05/07 SUPPL-43(补充) Approval Manufacturing (CMC) PRIORITY
2001/10/19 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/14 SUPPL-38(补充) Approval Labeling STANDARD
1999/10/12 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1997/04/24 SUPPL-39(补充) Approval Labeling STANDARD
1997/02/27 SUPPL-31(补充) Approval Labeling
1996/10/11 SUPPL-37(补充) Approval Labeling STANDARD
1996/07/30 SUPPL-28(补充) Approval Efficacy
1996/05/20 SUPPL-35(补充) Approval Labeling STANDARD
1996/05/20 SUPPL-32(补充) Approval Labeling
1995/02/28 SUPPL-29(补充) Approval Efficacy
1994/11/30 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1994/10/27 SUPPL-33(补充) Approval Labeling STANDARD
1978/10/18 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
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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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