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-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/04/12 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/04/12 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/04/05 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/03/16 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/14 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/14 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/14 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/14 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/17 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/09 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
2014/09/09 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2011/05/31 |
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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 |