Overview
An antibiotic similar to flucloxacillin used in resistant staphylococci infections.
Indication
Used in the treatment of resistant staphylococci infections.
Associated Conditions
- Catheter Related Infections
- Community Acquired Pneumonia (CAP)
- Infections caused by penicillinase-producing staphylococci
- Necrotizing Soft Tissue Infections
- Surgical Site Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/01 | Phase 2 | Completed | |||
2016/06/28 | Phase 3 | Completed | |||
2007/01/30 | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | ||
2002/05/15 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sagent Pharmaceuticals | 25021-162 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 9/10/2018 | |
| Baxter Healthcare Corporation | 0338-1013 | INTRAVENOUS | 1 g in 50 mL | 2/24/2017 | |
| Sagent Pharmaceuticals | 25021-163 | INTRAVENOUS | 10 g in 100 mL | 5/5/2020 | |
| Sagent Pharmaceuticals | 25021-163 | INTRAVENOUS | 10 g in 100 mL | 9/10/2018 | |
| Sagent Pharmaceuticals | 25021-162 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 3/20/2018 | |
| Wockhardt USA LLC. | 64679-698 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 20 mL | 11/22/2023 | |
| Fresenius Kabi USA, LLC | 63323-813 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 20 mL | 7/29/2020 | |
| Wockhardt USA LLC. | 64679-700 | INTRAVENOUS | 10 g in 100 mL | 11/21/2023 | |
| Fresenius Kabi USA, LLC | 63323-812 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 20 mL | 7/29/2020 | |
| Eugia US LLC | 55150-129 | INTRAVENOUS | 10 g in 100 mL | 2/2/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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