Overview
Cephalexin is the first of the first generation cephalosporins. This antibiotic contains a beta lactam and a dihydrothiazide. Cephalexin is used to treat a number of susceptible bacterial infections through inhibition of cell wall synthesis. Cephalexin was approved by the FDA on 4 January 1971.
Indication
Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria. These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections.
Associated Conditions
- Bone Infection
- Genitourinary tract infection
- Otitis Media (OM)
- Respiratory Tract Infections (RTI)
- Skin and skin structure infections
- Acute Prostatitis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/10/08 | Phase 3 | UNKNOWN | |||
2020/09/17 | Phase 3 | Recruiting | |||
2020/09/03 | Phase 4 | Recruiting | |||
2020/07/15 | Phase 4 | Completed | |||
2020/03/05 | Phase 4 | ENROLLING_BY_INVITATION | |||
2019/01/14 | Phase 1 | Completed | |||
2018/11/09 | Not Applicable | UNKNOWN | |||
2017/11/29 | Not Applicable | Withdrawn | |||
2017/06/14 | Phase 1 | Completed | |||
2017/05/11 | Phase 4 | UNKNOWN | Kaplan Medical Center |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-4175 | ORAL | 125 mg in 5 mL | 12/31/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-5016 | ORAL | 250 mg in 5 mL | 2/19/2021 | |
| Bryant Ranch Prepack | 63629-8856 | ORAL | 500 mg in 1 1 | 11/30/2021 | |
| Bryant Ranch Prepack | 63629-7742 | ORAL | 500 mg in 1 1 | 11/30/2021 | |
| A-S Medication Solutions | 50090-2749 | ORAL | 500 mg in 1 1 | 10/4/2022 | |
| Aurobindo Pharma Limited | 65862-019 | ORAL | 500 mg in 1 1 | 12/27/2023 | |
| Asclemed USA, Inc. | 76420-287 | ORAL | 250 mg in 1 1 | 9/21/2022 | |
| Bryant Ranch Prepack | 63629-8857 | ORAL | 250 mg in 5 mL | 11/26/2021 | |
| Blenheim Pharmacal, Inc. | 10544-082 | ORAL | 500 mg in 1 1 | 4/9/2015 | |
| Teva Pharmaceuticals USA, Inc. | 0093-4177 | ORAL | 250 mg in 5 mL | 12/31/2020 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FELEXIN 250 FOR ORAL SUSPENSION 250 mg/5 ml | SIN09472P | POWDER, FOR SUSPENSION | 5300mg/ 100ml | 8/18/1997 | |
| UPHALEXIN CAPSULE 250 MG | SIN16584P | CAPSULE | 250 mg | 8/29/2022 | |
| CEPHALEN CAPSULE 250 mg | SIN09644P | CAPSULE | 250 mg | 2/18/1998 | |
| APO-CEPHALEX TABLET 250 mg | SIN08382P | TABLET, FILM COATED | 250 mg | 10/12/1995 | |
| SOFILEX CAPSULE 250 mg | SIN10378P | CAPSULE | 250 mg | 11/4/1998 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEPHA RBX | 176788 | Medicine | A | 1/31/2011 | |
| IBILEX 250 cefalexin 250mg/5mL powder for oral liquid bottle | 92973 | Medicine | A | 3/26/2003 | |
| CEPHALEXIN RBX | 176786 | Medicine | A | 1/31/2011 | |
| CEPHALEXIN-WGR cefalexin 250mg capsule blister pack | 432151 | Medicine | A | 5/29/2024 | |
| CEPHALEX cefalexin (as monohydrate) 500 mg capsules blister pack | 204534 | Medicine | A | 10/2/2013 | |
| CEPHALEXIN-WGR cefalexin 500mg capsule blister pack | 432150 | Medicine | A | 5/29/2024 | |
| CEPHALEX cefalexin (as monohydrate) 250 mg capsules blister pack | 204535 | Medicine | A | 10/2/2013 | |
| CEPHA RBX | 176787 | Medicine | A | 1/31/2011 | |
| KEFLEX cefalexin 250mg capsule blister pack | 73522 | Medicine | A | 4/17/2000 | |
| CEFALEXIN SANDOZ cefalexin (as monohydrate) 250mg/5mL powder for suspension bottle | 78982 | Medicine | A | 3/11/2002 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| STCC-CEPHALEXIN -TAB 500MG | stcc inc. | 02180766 | Tablet - Oral | 500 MG | 12/31/1995 |
| NU-CEPHALEX TAB 500MG | nu-pharm inc | 00865885 | Tablet - Oral | 500 MG | 12/31/1990 |
| DOM-CEPHALEXIN 125 - SUS 125MG/5ML | dominion pharmacal | 02177862 | Suspension - Oral | 125 MG / 5 ML | 12/31/1995 |
| STCC-CEPHALEXIN 250 - SUS ORL 250MG/5ML | stcc inc. | 02180782 | Suspension - Oral | 250 MG / 5 ML | 12/31/1995 |
| STCC-CEPHALEXIN 125 - ORL SUS 125MG/5ML | stcc inc. | 02180774 | Suspension - Oral | 125 MG / 5 ML | 12/31/1995 |
| DOM-CEPHALEXIN - TAB 250MG | dominion pharmacal | 02177846 | Tablet - Oral | 250 MG | 12/31/1995 |
| PMS-CEPHALEXIN - TAB 500MG | 02177803 | Tablet - Oral | 500 MG | 12/31/1995 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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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