Overview
Cefprozil is a cephalosporin antibiotic that is commonly employed to treat a variety of bacterial infections, including those of the ear and skin, bronchitis, and others.
Background
Cefprozil is a cephalosporin antibiotic that is commonly employed to treat a variety of bacterial infections, including those of the ear and skin, bronchitis, and others.
Indication
For the treatment of the following infections (respiratory, skin, soft tissue, UTI, ENT) caused by; S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A beta-hemolytic streptococci), E. coli, P. mirabilis, Klebsiella sp, coagulase-negative staph
Associated Conditions
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
- Bacterial Infections
- Community Acquired Pneumonia (CAP)
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Urinary Tract Infection
- Bacterial otitis media
- Uncomplicated skin and subcutaneous tissue bacterial infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/10 | Phase 4 | Recruiting | |||
2020/06/04 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/02/10 | Phase 1 | Completed | |||
2009/02/10 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RedPharm Drug Inc. | 67296-0590 | ORAL | 500 mg in 1 1 | 7/7/2011 | |
| A-S Medication Solutions | 50090-1188 | ORAL | 500 mg in 1 1 | 8/9/2018 | |
| Rising Health, LLC | 57237-034 | ORAL | 125 mg in 5 mL | 10/26/2022 | |
| Physicians Total Care, Inc. | 54868-5757 | ORAL | 250 mg in 5 mL | 12/8/2010 | |
| Teva Pharmaceuticals USA, Inc. | 0093-1077 | ORAL | 250 mg in 1 1 | 8/31/2018 | |
| Aurobindo Pharma Limited | 65862-099 | ORAL | 125 mg in 5 mL | 12/31/2021 | |
| Aurobindo Pharma Limited | 65862-068 | ORAL | 250 mg in 1 1 | 12/23/2021 | |
| Rising Health, LLC | 57237-035 | ORAL | 250 mg in 5 mL | 10/26/2022 | |
| Wockhardt USA LLC. | 64679-713 | ORAL | 500 mg in 1 1 | 11/26/2019 | |
| A-S Medication Solutions | 50090-1739 | ORAL | 500 mg in 1 1 | 9/24/2019 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefprozil Dispersible Tablets | 国药准字H20184003 | 化学药品 | 片剂 | 4/12/2023 | |
| Cefprozil Dispersible Tablets | 国药准字H20083387 | 化学药品 | 片剂 | 1/29/2023 | |
| Cefprozil Dispersible Tablets | 国药准字H20052514 | 化学药品 | 片剂 | 6/11/2020 | |
| Cefprozil Chewable Tablets | 国药准字H20060575 | 化学药品 | 片剂 | 6/12/2020 | |
| Cefprozil Granules | 国药准字H20080301 | 化学药品 | 颗粒剂 | 10/12/2021 | |
| Cefprozil Granules | 国药准字H20080792 | 化学药品 | 颗粒剂 | 11/15/2022 | |
| Cefprozil Granules | 国药准字H20060186 | 化学药品 | 颗粒剂 | 11/17/2020 | |
| Cefprozil Granules | 国药准字H20052697 | 化学药品 | 颗粒剂 | 5/25/2021 | |
| Cefprozil Granules | 国药准字H20140048 | 化学药品 | 颗粒剂 | 12/5/2022 | |
| Cefprozil for Suspension | 国药准字H20243606 | 化学药品 | 口服混悬剂 | 7/23/2024 |
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. | |||||