Overview
Semisynthetic, broad-spectrum antibiotic derivative of cephalexin.
Indication
For the treatment of certain infections caused by bacteria such as pneumonia and ear, lung, skin, throat, and urinary tract infections.
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae
- Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenza
- Acute Exacerbations of Chronic Bronchitis caused by Moraxella catarrhalis
- Bacterial Infections
- Bacterial Urinary Tract Infections
- Lower respiratory tract infection bacterial
- Staphylococcal Skin Infections
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Bacterial otitis media
- Streptococcus pyogenes skin infection
- Susceptible Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/01 | Phase 4 | Recruiting | Fundacion Clinic per a la Recerca Biomédica |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-1087 | ORAL | 500 mg in 1 1 | 7/31/2019 | |
| Carlsbad Technology, Inc. | 61442-176 | ORAL | 375 mg in 5 mL | 9/9/2015 | |
| Physicians Total Care, Inc. | 54868-3511 | ORAL | 500 mg in 1 1 | 12/8/2010 | |
| Carlsbad Technology, Inc. | 61442-172 | ORAL | 500 mg in 1 1 | 9/9/2015 | |
| Azorian Pharma, LLC | 81948-6250 | ORAL | 250 mg in 5 mL | 11/7/2022 | |
| Carlsbad Technology, Inc. | 61442-173 | ORAL | 125 mg in 5 mL | 9/9/2015 | |
| Physicians Total Care, Inc. | 54868-3478 | ORAL | 250 mg in 1 1 | 12/8/2010 | |
| A-S Medication Solutions | 50090-1602 | ORAL | 500 mg in 1 1 | 9/9/2015 | |
| Carlsbad Technology, Inc. | 61442-171 | ORAL | 250 mg in 1 1 | 9/9/2015 | |
| Carlsbad Technology, Inc. | 61442-175 | ORAL | 250 mg in 5 mL | 9/9/2015 |
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 |
|---|---|---|---|---|---|
| CLEANCEF CAPSULE 250 mg | SIN09294P | CAPSULE | 250 mg | 4/10/1997 | |
| SOFICLOR FOR ORAL SUSPENSION 125 mg/5 ml | SIN11733P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 11/27/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefaclor Effervescent Tablets | 国药准字H20020226 | 化学药品 | 片剂 | 5/8/2020 | |
| Cefaclor Effervescent Tablets | 国药准字H20020225 | 化学药品 | 片剂(泡腾) | 5/29/2020 | |
| Cefaclor Chewable Tablets | 国药准字H20040146 | 化学药品 | 片剂 | 1/8/2020 | |
| Cefaclor Sustained-Release Tablets | 国药准字H20010733 | 化学药品 | 片剂 | 7/20/2020 | |
| Cefaclor Sustained-Release Tablets | 国药准字H20010732 | 化学药品 | 片剂 | 7/20/2020 | |
| Cefaclor Sustained-Release Tablets | 国药准字H20020456 | 化学药品 | 片剂 | 7/12/2024 | |
| Cefaclor Sustained-Release Tablets | 国药准字H20040402 | 化学药品 | 缓释片剂 | 5/7/2020 | |
| Cefaclor Sustained-Release Tablets | 国药准字H20041606 | 化学药品 | 片剂(缓释片) | 7/24/2020 | |
| Cefaclor Sustained Release Capsules | 国药准字H20000695 | 化学药品 | 胶囊剂 | 5/22/2020 | |
| Cefaclor Sustained Release Capsules | 国药准字H20020240 | 化学药品 | 胶囊剂(缓释) | 7/6/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AXCEL CEFACLOR-250 CAPSULES 250MG | N/A | N/A | N/A | 11/6/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEFACLOR SUN cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle | 226400 | Medicine | A | 9/2/2014 | |
| OZCEF cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle | 169127 | Medicine | A | 4/9/2010 | |
| CEFACLOR SUN cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle | 226401 | Medicine | A | 9/2/2014 | |
| CECLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle | 347593 | Medicine | A | 2/17/2021 | |
| KEFLOR cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle | 58651 | Medicine | A | 2/19/1997 | |
| CECLOR cefaclor 125mg/5mL (as monohydrate) powder for oral liquid | 347594 | Medicine | A | 2/17/2021 | |
| KEFLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle | 58653 | Medicine | A | 2/19/1997 | |
| OZCEF cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle | 169128 | Medicine | A | 4/9/2010 | |
| CECLOR CD cefaclor 375 mg (as monohydrate) modified release tablet blister pack | 58264 | Medicine | A | 3/14/1997 | |
| CEFACLOR RBX | 182058 | Medicine | A | 8/9/2011 |
Help Us Improve
Your feedback helps us provide better drug information and insights.