药品注册申请号：050558
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
002 ZINACEF CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1983/10/19 1983/10/19 Discontinued
003 ZINACEF CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1983/10/19 Discontinued
004 ZINACEF CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AP 1986/10/23 Discontinued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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1983/10/19 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/05/16 SUPPL-76（补充） Approval Labeling-Package Insert STANDARD
2020/02/11 SUPPL-75（补充） Approval Labeling STANDARD
2015/03/16 SUPPL-73（补充） Approval Manufacturing (CMC) STANDARD
2014/09/25 SUPPL-69（补充） Approval Labeling-Package Insert STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/08/14 SUPPL-72（补充） Approval Manufacturing (CMC) STANDARD
2007/07/30 SUPPL-67（补充） Approval Labeling STANDARD
2004/05/19 SUPPL-57（补充） Approval Labeling STANDARD
2002/10/23 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/11/09 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/10/12 SUPPL-50（补充） Approval Labeling STANDARD
2001/07/12 SUPPL-49（补充） Approval Labeling STANDARD
2001/05/05 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/04/13 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/03 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1996/12/23 SUPPL-47（补充） Approval Labeling STANDARD
1996/12/23 SUPPL-44（补充） Approval Labeling STANDARD
1996/09/11 SUPPL-45（补充） Approval Labeling STANDARD
1995/10/31 SUPPL-46（补充） Approval Manufacturing (CMC) STANDARD
1995/10/23 SUPPL-31（补充） Approval Labeling
1995/09/29 SUPPL-43（补充） Approval Labeling STANDARD
1995/02/06 SUPPL-37（补充） Approval Labeling STANDARD
1994/10/27 SUPPL-41（补充） Approval Labeling STANDARD
1993/06/28 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/02/18 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1992/12/31 SUPPL-40（补充） Approval Labeling
1992/11/04 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/09/23 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/02/13 SUPPL-32（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1992/02/13 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/02/13 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/08/14 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1990/03/22 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1989/06/30 SUPPL-26（补充） Approval Labeling
1989/03/24 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/05/12 SUPPL-20（补充） Approval Labeling
1987/09/25 SUPPL-24（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/08/28 SUPPL-23（补充） Approval Labeling
1987/08/13 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1986/10/23 SUPPL-19（补充） Approval Labeling
1986/05/30 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/04/17 SUPPL-17（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1986/01/23 SUPPL-15（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/11/25 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1984/08/20 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1984/07/27 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/05/11 SUPPL-8（补充） Approval Labeling
1984/04/18 SUPPL-7（补充） Approval Labeling
1984/03/05 SUPPL-6（补充） Approval Labeling
1984/02/17 SUPPL-5（补充） Approval Labeling
1984/02/08 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1983/12/22 SUPPL-2（补充） Approval Labeling
1983/12/07 SUPPL-1（补充） Approval Labeling
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:CEFUROXIME SODIUM; 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 规格:EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<
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
050558 002 NDA ZINACEF CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1983/10/19 PAI HOLDINGS PHARM
>>>活性成分:CEFUROXIME SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 1.5GM 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
050558 003 NDA ZINACEF CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1983/10/19 PAI HOLDINGS PHARM
>>>活性成分:CEFUROXIME SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 7.5GM 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
050558 004 NDA ZINACEF CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AP 1986/10/23 PAI HOLDINGS PHARM
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database