药品注册申请号：207848
申请类型：ANDA (仿制药申请)
申请人：PROVEPHARM SAS
申请人全名：PROVEPHARM SAS
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 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL No No AP;AP 2017/01/13 2018/05/11 Prescription
002 PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL No No AP;AP 2017/01/13 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
2024/05/01 SUPPL-15（补充） Approval Labeling STANDARD
2021/03/04 SUPPL-8（补充） Approval Labeling STANDARD
2021/03/04 SUPPL-7（补充） Approval Labeling STANDARD
2018/05/11 ORIG-2（原始申请） Approval STANDARD
2017/01/13 ORIG-1（原始申请） Approval 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:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 12GM BASE/VIAL;EQ 1.5GM 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
203557 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Prescription No Yes AP 2014/10/29 SANDOZ
206204 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Discontinued No No AP 2018/05/11 FRESENIUS KABI USA
207848 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Prescription No No AP 2018/05/11 PROVEPHARM SAS
217409 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Discontinued No No AP 2023/10/12 EUGIA PHARMA
活性成分:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 12GM BASE/VIAL;EQ 1.5GM 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
203557 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Prescription No Yes AP 2014/10/29 SANDOZ
206204 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Discontinued No No AP 2018/05/11 FRESENIUS KABI USA
207848 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Prescription No No AP 2018/05/11 PROVEPHARM SAS
217409 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL Discontinued No No AP 2023/10/12 EUGIA PHARMA
活性成分:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 36GM BASE/VIAL;EQ 4.5GM 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
090498 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2011/05/31 ISTITUTO BIO ITA SPA
207848 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2017/01/13 PROVEPHARM SAS
207146 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No Yes AP 2017/03/17 WOCKHARDT BIO AG
203720 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2018/05/11 FRESENIUS KABI
208675 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2021/02/16 SAGENT PHARMS INC
203557 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2021/07/08 SANDOZ
217243 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2023/04/14 SHANDONG
217409 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Discontinued No No AP 2023/10/12 EUGIA PHARMA
活性成分:PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 36GM BASE/VIAL;EQ 4.5GM 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
090498 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2011/05/31 ISTITUTO BIO ITA SPA
207848 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2017/01/13 PROVEPHARM SAS
207146 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No Yes AP 2017/03/17 WOCKHARDT BIO AG
203720 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2018/05/11 FRESENIUS KABI
208675 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2021/02/16 SAGENT PHARMS INC
203557 002 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2021/07/08 SANDOZ
217243 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Prescription No No AP 2023/04/14 SHANDONG
217409 001 ANDA PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Discontinued No No AP 2023/10/12 EUGIA PHARMA
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database