Overview
Semisynthetic, broad-spectrum, ampicillin derived ureidopenicillin antibiotic proposed for pseudomonas infections. It is also used in combination with other antibiotics.
Background
Semisynthetic, broad-spectrum, ampicillin derived ureidopenicillin antibiotic proposed for pseudomonas infections. It is also used in combination with other antibiotics.
Indication
For the treatment of polymicrobial infections.
Associated Conditions
- Animal bite
- Bacterial Infections
- Bone and Joint Infections
- Community Acquired Pneumonia (CAP)
- Gynecological Infection
- Infection, Mixed
- Intraabdominal Infections
- Lower Respiratory Tract Infection (LRTI)
- Nosocomial Pneumonia
- Pelvic Infections
- Septicemia
- Skin and skin structure infections
- Urinary Tract Infection
- Uncomplicated Urethritis gonococcal caused by Neisseria Gonorrhoeae
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/10 | N/A | Recruiting | Shandong University | ||
2022/05/02 | Phase 4 | Suspended | |||
2021/09/29 | Phase 2 | UNKNOWN | |||
2021/07/02 | Phase 4 | Recruiting | |||
2019/04/30 | N/A | Recruiting | Shandong University | ||
2018/12/05 | Not Applicable | Completed | |||
2018/09/26 | Phase 1 | Completed | Allecra | ||
2016/06/29 | Phase 1 | Terminated | |||
2015/07/09 | Phase 3 | Completed | |||
2015/06/16 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eugia US LLC | 55150-120 | INTRAVENOUS | 3 g in 1 1 | 1/25/2024 | |
| Fresenius Kabi USA, LLC | 65219-259 | INTRAVENOUS | 4 g in 20 mL | 5/19/2021 | |
| Eugia US LLC | 55150-121 | INTRAVENOUS | 4 g in 1 1 | 1/25/2024 | |
| BluePoint Laboratories | 68001-508 | INTRAVENOUS | 4 g in 20 mL | 2/28/2024 | |
| Fresenius Kabi USA, LLC | 63323-982 | INTRAVENOUS | 4 g in 20 mL | 1/23/2020 | |
| Fresenius Kabi USA, LLC | 63323-300 | INTRAVENOUS | 3 g in 15 mL | 12/31/2019 | |
| Steriscience Specialties Private Limited | 82449-501 | INTRAVENOUS | 3 g in 15 mL | 7/5/2023 | |
| Xellia Pharmaceuticals USA LLC | 70594-080 | INTRAVENOUS | 4 g in 150 mL | 8/26/2022 | |
| Fresenius Kabi USA, LLC | 65219-434 | INTRAVENOUS | 2 g in 10 mL | 11/30/2023 | |
| Fresenius Kabi USA, LLC | 63323-309 | INTRAVENOUS | 2 g in 10 mL | 12/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials | SIN13985P | POWDER, FOR SOLUTION | 4000mg | 7/7/2011 | |
| Piperacillin-Tazobactam Stragen For Injection 4.5g/vial | SIN13978P | INJECTION, POWDER, FOR SOLUTION | 4000 mg | 6/20/2011 | |
| SALATAZ POWDER FOR SOLUTION FOR INJECTION/INFUSION 4.5G/VIAL | SIN15299P | INJECTION, POWDER, FOR SOLUTION | 4g | 7/14/2017 | |
| TAZOCIN FOR INJECTION 4.5 g/vial | SIN08362P | INJECTION, POWDER, FOR SOLUTION | 4000 mg/vial | 10/3/1995 | |
| PIPTAZ-AFT POWDER FOR SOLUTION FOR INJECTION 4.5G/VIAL | SIN15482P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 4g | 5/11/2018 | |
| PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G | SIN15308P | INJECTION, POWDER, FOR SOLUTION | 4.0 g | 7/31/2017 | |
| TAZPEN FOR INJECTION 4.5g/VIAL | SIN13758P | INJECTION, POWDER, FOR SOLUTION | 4.0g | 1/26/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Piperacillin Sodium for Injection | 国药准字H43022227 | 化学药品 | 注射剂 | 12/18/2020 | |
| Piperacillin Sodium for Injection | 国药准字H20234549 | 化学药品 | 注射剂 | 11/28/2023 | |
| Piperacillin Sodium for Injection | 国药准字H20234548 | 化学药品 | 注射剂 | 11/28/2023 | |
| Piperacillin Sodium for Injection | 国药准字H35020353 | 化学药品 | 注射剂 | 8/14/2019 | |
| Piperacillin Sodium for Injection | 国药准字H21022896 | 化学药品 | 注射剂 | 7/29/2020 | |
| Piperacillin Sodium for Injection | 国药准字H20023386 | 化学药品 | 注射剂 | 12/21/2020 | |
| Piperacillin Sodium for Injection | 国药准字H20058776 | 化学药品 | 注射剂 | 4/15/2020 | |
| Piperacillin Sodium for Injection | 国药准字H19983032 | 化学药品 | 注射剂 | 7/31/2020 | |
| Piperacillin Sodium for Injection | 国药准字H37020553 | 化学药品 | 注射剂(无菌分装粉针剂) | 3/20/2020 | |
| Piperacillin Sodium for Injection | 国药准字H44025071 | 化学药品 | 注射剂 | 9/28/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||