药品注册申请号:062662
申请类型:ANDA (仿制药申请)
申请人:HOSPIRA
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 TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 500MG/VIAL No No AP 1986/03/06 1986/03/06 Prescription
002 TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL No No AP 1986/03/06 Prescription
003 TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL No No AP 1986/03/06 Prescription
004 TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL No No AP 1986/03/06 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/03/14 SUPPL 27 Approval Labeling STANDARD
2016/03/14 SUPPL 23 Approval Labeling
2005/03/08 SUPPL 20 Approval Labeling
1999/07/13 SUPPL 17 Approval Labeling
1996/01/17 SUPPL 16 Approval Manufacturing (CMC)
1994/12/09 SUPPL 15 Approval Manufacturing (CMC)
1994/04/04 SUPPL 14 Approval Labeling
1992/12/17 SUPPL 12 Approval Labeling
1992/11/09 SUPPL 13 Approval Manufacturing (CMC)
1990/07/18 SUPPL 10 Approval Manufacturing (CMC)
1989/07/07 SUPPL 8 Approval Manufacturing (CMC)
1988/07/25 SUPPL 7 Approval Manufacturing (CMC)
1986/03/06 ORIG 1 Approval
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
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
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/VIAL 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 Prescription Yes Yes AP 1985/07/19 TELIGENT
062662 001 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 1986/03/06 HOSPIRA
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/VIAL 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 Prescription Yes Yes AP 1985/07/19 TELIGENT
062640 002 ANDA CEFTAZIDIME CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 1985/11/20 ACS DOBFAR
062662 002 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 1986/03/06 HOSPIRA
064032 001 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 1993/10/31 HOSPIRA
065196 001 ANDA CEFTAZIDIME CEFTAZIDIME INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2008/10/15 WOCKHARDT
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/VIAL 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 Prescription Yes Yes AP 1985/07/19 TELIGENT
062640 003 ANDA CEFTAZIDIME CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 1985/11/20 ACS DOBFAR
062662 003 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 1986/03/06 HOSPIRA
064032 002 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 1993/10/31 HOSPIRA
活性成分:CEFTAZIDIME 剂型/给药途径:INJECTABLE;INJECTION 规格:6GM/VIAL 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 Prescription Yes Yes AP 1985/07/19 TELIGENT
062662 004 ANDA TAZICEF CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL Prescription No No AP 1986/03/06 HOSPIRA
062640 004 ANDA CEFTAZIDIME CEFTAZIDIME INJECTABLE;INJECTION 6GM/VIAL Prescription No No AP 1992/02/03 ACS DOBFAR
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database