药品注册申请号：050679
申请类型：NDA (新药申请)
申请人：HOSPIRA INC
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 MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1996/01/18 1996/01/18 Discontinued
002 MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1996/01/18 Discontinued
003 MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1996/01/18 Discontinued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
2021/08/11 SUPPL-46（补充） Approval Labeling STANDARD
2017/05/03 SUPPL-42（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.
2016/06/22 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2016/03/04 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
2016/03/01 SUPPL-40（补充） Approval Labeling STANDARD
2014/06/12 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2014/05/01 SUPPL-31（补充） Approval Labeling STANDARD
2013/03/15 SUPPL-34（补充） Approval Labeling UNKNOWN
2012/09/06 SUPPL-36（补充） Approval Labeling STANDARD
2009/09/30 SUPPL-32（补充） Approval Labeling STANDARD
2007/09/14 SUPPL-28（补充） Approval Labeling STANDARD
2007/09/14 SUPPL-24（补充） Approval Labeling STANDARD
2004/06/09 SUPPL-23（补充） Approval Labeling STANDARD
2003/03/17 SUPPL-21（补充） Approval Efficacy STANDARD
2002/08/21 SUPPL-18（补充） Approval Labeling STANDARD
2002/08/21 SUPPL-14（补充） Approval Labeling STANDARD
2002/08/21 SUPPL-9（补充） Approval Labeling STANDARD
2002/03/15 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2001/06/20 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2001/04/02 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2000/09/20 SUPPL-13（补充） Approval Labeling STANDARD
2000/06/26 SUPPL-15（补充） Approval Labeling STANDARD
2000/05/10 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1999/02/08 SUPPL-5（补充） Approval Labeling STANDARD
1999/01/27 SUPPL-7（补充） Approval Labeling STANDARD
1998/11/24 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1998/07/21 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1998/01/30 SUPPL-8（补充） Approval Efficacy UNKNOWN
1997/10/20 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1997/05/16 SUPPL-2（补充） Approval Efficacy STANDARD
1996/12/23 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1996/03/13 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1996/01/18 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
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
无
与本品治疗等效的药品
活性成分:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050679 001 NDA MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1996/01/18 HOSPIRA INC
活性成分:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050679 002 NDA MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1996/01/18 HOSPIRA INC
活性成分:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050679 003 NDA MAXIPIME CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1996/01/18 HOSPIRA INC
更多信息
药品NDC数据与药品包装、标签说明书
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