药品注册申请号：050578
申请类型：NDA (新药申请)
申请人：PAI HOLDINGS PHARM
申请人全名：PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES 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 FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1985/07/19 1985/07/19 Discontinued
002 FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1985/07/19 Discontinued
003 FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1985/07/19 Discontinued
004 FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1985/07/19 Discontinued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
2020/02/12 SUPPL-62（补充） Approval Labeling STANDARD
2020/02/11 SUPPL-64（补充） Approval Labeling STANDARD
2017/07/28 SUPPL-61（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.
2015/03/03 SUPPL-60（补充） Approval Manufacturing (CMC) PRIORITY
2014/09/24 SUPPL-55（补充） Approval Labeling STANDARD
2007/07/09 SUPPL-53（补充） Approval Labeling STANDARD
2007/03/14 SUPPL-51（补充） Approval Labeling STANDARD
2004/05/19 SUPPL-46（补充） Approval Labeling STANDARD
2002/10/23 SUPPL-44（补充） Approval Manufacturing (CMC) PRIORITY
2002/03/29 SUPPL-40（补充） Approval Labeling STANDARD
2002/03/22 SUPPL-42（补充） Approval Labeling STANDARD
2002/02/22 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
1998/01/26 SUPPL-32（补充） Approval Labeling STANDARD
1997/11/25 SUPPL-39（补充） Approval Manufacturing (CMC) PRIORITY
1997/04/03 SUPPL-38（补充） Approval Manufacturing (CMC) PRIORITY
1996/12/24 SUPPL-37（补充） Approval Labeling STANDARD
1996/10/04 SUPPL-36（补充） Approval Manufacturing (CMC) PRIORITY
1996/09/11 SUPPL-30（补充） Approval Labeling STANDARD
1996/08/20 SUPPL-31（补充） Approval Labeling STANDARD
1996/06/20 SUPPL-34（补充） Approval Labeling STANDARD
1996/06/20 SUPPL-33（补充） Approval Labeling STANDARD
1995/11/03 SUPPL-35（补充） Approval Manufacturing (CMC) PRIORITY
1994/10/20 SUPPL-27（补充） Approval Labeling
1994/09/07 SUPPL-22（补充） Approval Labeling
1993/04/29 SUPPL-17（补充） Approval Labeling
1993/04/29 SUPPL-15（补充） Approval Labeling
1993/02/18 SUPPL-29（补充） Approval Manufacturing (CMC) PRIORITY
1992/12/31 SUPPL-28（补充） Approval Labeling
1992/02/13 SUPPL-24（补充） Approval Manufacturing (CMC) PRIORITY
1992/02/13 SUPPL-21（补充） Approval Manufacturing (CMC) PRIORITY
1991/08/09 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1990/04/10 SUPPL-18（补充） Approval Manufacturing (CMC) PRIORITY
1990/03/22 SUPPL-20（补充） Approval Manufacturing (CMC) PRIORITY
1985/07/19 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）
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:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/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
050578 001 NDA FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1985/07/19 PAI HOLDINGS PHARM
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/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
050578 002 NDA FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1985/07/19 PAI HOLDINGS PHARM
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/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
050578 003 NDA FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1985/07/19 PAI HOLDINGS PHARM
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:6GM/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
050578 004 NDA FORTAZ CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1985/07/19 PAI HOLDINGS PHARM
更多信息
药品NDC数据与药品包装、标签说明书
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