Overview
Dirithromycin is a macrolide glycopeptide antibiotic used to treat many different types of bacterial infections, such as bronchitis, pneumonia, tonsillitis, and even skin infections.
Background
Dirithromycin is a macrolide glycopeptide antibiotic used to treat many different types of bacterial infections, such as bronchitis, pneumonia, tonsillitis, and even skin infections.
Indication
For the treatment of the following mild-to-moderate infections caused by susceptible strains of microorganisms: acute bacterial exacerbations of chronic bronchitis, secondary bacterial infection of acute bronchitis, community-acquired pneumonia, pharyngitis/tonsilitis, and uncomplicated skin and skin structure infections.
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis (AECB)
- Community Acquired Pneumonia (CAP)
- Lower Respiratory Tract Infection (LRTI)
- Pharyngitis
- Secondary Infection
- Skin and Soft Tissue Infections (SSTIs)
- Tonsillitis
- Upper Respiratory Tract Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/09/11 | Phase 1 | Completed | |||
2014/09/11 | Phase 1 | Completed | |||
2014/07/10 | Phase 1 | Completed | |||
2014/07/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Dirithromycin Enteric-coated Capsules | 国药准字H20050497 | 化学药品 | 胶囊剂(肠溶胶囊) | 10/19/2020 | |
| Dirithromycin Enteric-coated Capsules | 国药准字H20061219 | 化学药品 | 胶囊剂 | 4/10/2024 | |
| Dirithromycin Enteric-coated Capsules | 国药准字H20052134 | 化学药品 | 胶囊剂 | 8/4/2020 | |
| Dirithromycin Enteric-coated Capsules | 国药准字H20051614 | 化学药品 | 胶囊剂 | 4/10/2024 | |
| Dirithromycin Enteric-coated Capsules | 国药准字H20060858 | 化学药品 | 胶囊剂 | 8/18/2022 | |
| Dirithromycin Enteric-coated Capsules | 国药准字H20030577 | 化学药品 | 胶囊剂 | 5/7/2020 | |
| Dirithromycin Enteric-coated Tablets | 国药准字H20050600 | 化学药品 | 片剂 | 12/5/2019 | |
| Dirithromycin Enteric-coated Tablets | 国药准字H20051415 | 化学药品 | 片剂 | 8/6/2024 | |
| Dirithromycin Enteric-coated Tablets | 国药准字H20143028 | 化学药品 | 片剂 | 8/14/2024 | |
| Dirithromycin Enteric-coated Tablets | 国药准字H20140001 | 化学药品 | 片剂 | 10/14/2020 |
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. | |||||