药品注册申请号：065498
申请类型：ANDA (仿制药申请)
申请人：EUGIA PHARMA SPECLTS
申请人全名：EUGIA PHARMA SPECIALITIES LTD
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 PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL No No AP 2011/05/23 2011/05/23 Prescription
002 PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL No No AP 2011/05/23 Prescription
003 PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL No No AP 2011/05/23 Prescription
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
2024/12/03 SUPPL-31（补充） Approval Labeling STANDARD
2024/05/01 SUPPL-26（补充） Approval Labeling STANDARD
2023/10/13 SUPPL-22（补充） Approval Manufacturing (CMC) UNKNOWN
2022/01/31 SUPPL-19（补充） Approval Labeling STANDARD
2021/03/16 SUPPL-18（补充） Approval Labeling STANDARD
2019/08/29 SUPPL-14（补充） Approval Labeling STANDARD
2019/08/29 SUPPL-9（补充） Approval Labeling STANDARD
2016/05/23 SUPPL-6（补充） Approval Labeling STANDARD
2016/05/23 SUPPL-4（补充） Approval Labeling STANDARD
2016/05/23 SUPPL-3（补充） Approval Labeling
2011/05/23 ORIG-1（原始申请） 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
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:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM BASE/VIAL;EQ 250MG BASE/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
065362 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065363 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065498 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2011/05/23 EUGIA PHARMA SPECLTS
065523 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2011/05/31 ISTITUTO BIO ITA SPA
065458 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2014/08/15 STERISCIENCE SPECLTS
207847 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2017/01/13 PROVEPHARM SAS
206996 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No Yes AP 2017/03/22 WOCKHARDT BIO AG
203719 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2018/05/18 FRESENIUS KABI
204959 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2018/08/10 SHANDONG
212287 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Discontinued No No AP 2019/07/29 ASTRAL
208674 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Prescription No No AP 2021/02/16 SAGENT PHARMS INC
活性成分:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 3GM BASE/VIAL;EQ 375MG BASE/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
065362 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065363 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065498 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2011/05/23 EUGIA PHARMA SPECLTS
065523 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2011/05/31 ISTITUTO BIO ITA SPA
065458 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2014/08/15 STERISCIENCE SPECLTS
207847 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2017/01/13 PROVEPHARM SAS
206996 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No Yes AP 2017/03/22 WOCKHARDT BIO AG
203719 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2018/05/18 FRESENIUS KABI
204959 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2018/08/10 SHANDONG
212287 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Discontinued No No AP 2019/07/29 ASTRAL
208674 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Prescription No No AP 2021/02/16 SAGENT PHARMS INC
活性成分:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 4GM BASE/VIAL;EQ 500MG BASE/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
065362 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065363 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2010/10/21 SANDOZ
065498 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2011/05/23 EUGIA PHARMA SPECLTS
065523 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2011/05/31 ISTITUTO BIO ITA SPA
065458 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2014/08/15 STERISCIENCE SPECLTS
207847 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2017/01/13 PROVEPHARM SAS
206996 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No Yes AP 2017/03/22 WOCKHARDT BIO AG
203719 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2018/05/18 FRESENIUS KABI
204959 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2018/08/10 SHANDONG
212287 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Discontinued No No AP 2019/07/29 ASTRAL
208674 003 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2021/02/16 SAGENT PHARMS INC
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药品NDC数据与药品包装、标签说明书
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