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.
Background
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/13 | Phase 4 | Recruiting | Brett A Faine | ||
2023/09/28 | Phase 4 | ENROLLING_BY_INVITATION | |||
2023/05/10 | Phase 4 | ENROLLING_BY_INVITATION | |||
2022/12/23 | Phase 2 | Recruiting | |||
2022/03/10 | Phase 4 | UNKNOWN | |||
2021/08/25 | Phase 2 | Recruiting | |||
2021/06/08 | Phase 1 | ENROLLING_BY_INVITATION | |||
2021/05/06 | Phase 4 | Recruiting | |||
2021/04/08 | Phase 4 | Withdrawn | |||
2020/10/08 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-2145 | ORAL | 500 mg in 1 1 | 12/7/2023 | |
| Bryant Ranch Prepack | 72162-1851 | ORAL | 250 mg in 5 mL | 3/8/2024 | |
| ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0005 | ORAL | 500 mg in 1 1 | 1/18/2024 | |
| Aidarex Pharmaceuticals LLC | 33261-485 | ORAL | 250 mg in 5 mL | 10/12/2012 | |
| DIRECT RX | 61919-358 | ORAL | 500 mg in 1 1 | 5/25/2016 | |
| A-S Medication Solutions | 50090-7091 | ORAL | 250 mg in 5 mL | 12/29/2022 | |
| RPK Pharmaceuticals, Inc. | 53002-2181 | ORAL | 500 mg in 1 1 | 12/31/2020 | |
| MedVantx, Inc. | 66116-607 | ORAL | 250 mg in 5 mL | 7/25/2012 | |
| NuCare Pharmaceuticals,Inc. | 68071-4516 | ORAL | 250 mg in 1 1 | 2/7/2022 | |
| A-S Medication Solutions | 50090-0219 | ORAL | 250 mg in 5 mL | 12/31/2020 |
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 |
|---|---|---|---|---|---|
| CEPHANMYCIN CAPSULE 250 mg | SIN07619P | CAPSULE | 250 mg (potency) | 1/21/1994 | |
| FELEXIN 500 CAPSULE 500 mg | SIN00449P | CAPSULE | 500 mg | 4/27/1988 | |
| CEFALEXIN CAPSULE 250 mg | SIN11397P | CAPSULE | 250 mg | 9/14/2000 | |
| CEFALEXIN CAPSULE 500 mg | SIN11396P | CAPSULE | 500 mg | 9/14/2000 | |
| APO-CEPHALEX TABLET 500 mg | SIN08381P | TABLET, FILM COATED | 500 mg | 10/12/1995 | |
| SOFILEX FOR ORAL SUSPENSION 125 mg/5 ml | SIN10419P | POWDER, FOR SUSPENSION | 125 mg/5 ml | 11/16/1998 | |
| AXCEL CEPHALEXIN-250 CAPSULE 250MG | SIN16644P | CAPSULE | 250mg | 11/21/2022 | |
| CEPHALEN-500 CAPSULE 500 mg | SIN09643P | CAPSULE | 500 mg | 2/18/1998 | |
| FELEXIN 250 CAPSULE 250 mg | SIN09477P | CAPSULE | 250 mg | 8/19/1997 | |
| AXCEL CEPHALEXIN-500 CAPSULE 500MG | SIN16585P | CAPSULE | 500 mg | 8/30/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefalexin Sustained-release Tablets | 国药准字H10960287 | 化学药品 | 缓释制剂 | 6/30/2020 | |
| Cefalexin Effervescent Tablets | 国药准字H20053751 | 化学药品 | 片剂（泡腾） | 4/9/2024 | |
| Cefalexin Effervescent Tablets | 国药准字H10950010 | 化学药品 | 片剂（泡腾） | 4/9/2024 | |
| Cefalexin Capsules | 国药准字H42020946 | 化学药品 | 胶囊剂 | 6/29/2020 | |
| Cefalexin Capsules | 国药准字H15020398 | 化学药品 | 胶囊剂 | 4/26/2020 | |
| Cefalexin Capsules | 国药准字H20045699 | 化学药品 | 胶囊剂 | 2/23/2021 | |
| Cefalexin Capsules | 国药准字H50020437 | 化学药品 | 胶囊剂 | 9/28/2020 | |
| Cefalexin Capsules | 国药准字H34020568 | 化学药品 | 胶囊剂 | 2/28/2020 | |
| Cefalexin Capsules | 国药准字H45020872 | 化学药品 | 胶囊剂 | 8/9/2020 | |
| Cefalexin Capsules | 国药准字H32020986 | 化学药品 | 胶囊剂 | 5/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ORA-C GRANULES 250MG/5ML | N/A | N/A | N/A | 6/24/1996 | |
| IKODIN CAPSULE 500MG | N/A | N/A | N/A | 2/15/2012 | |
| IKODIN CAP 250MG | N/A | N/A | N/A | 4/28/1982 | |
| CEFALEXIN 500 CAP 500MG | N/A | N/A | N/A | 12/21/2001 | |
| COLAXIN POWDER FOR ORAL SUSPENSION 125MG/5ML | N/A | N/A | N/A | 5/29/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEPHALEXIN - LUPIN cefalexin monohydrate 500 mg capsules blister pack | 127408 | Medicine | A | 5/7/2007 | |
| CEFALEXIN SANDOZ cefalexin (as monohydrate) 125mg/5mL powder for suspension bottle | 78981 | Medicine | A | 3/11/2002 | |
| CEPHALEXIN GENERICHEALTH cefalexin monohydrate 500 mg capsules blister pack | 154381 | Medicine | A | 6/10/2009 | |
| Keflex cefalexin 500mg capsules blister pack | 73523 | Medicine | A | 4/17/2000 | |
| KEFLEX cefalexin 250mg/5mL powder for oral liquid bottle | 92971 | Medicine | A | 3/26/2003 | |
| APO-CEPHALEXIN cefalexin 500mg capsule blister pack | 133852 | Medicine | A | 2/20/2007 | |
| APO-CEPHALEXIN (as monohydrate) 250mg capsule blister pack | 73870 | Medicine | A | 9/15/2000 | |
| IBILEX 250 cefalexin 250mg capsule blister pack | 73524 | Medicine | A | 4/28/2000 | |
| CEPHALKEM cefalexin (as monohydrate) 500 mg capsules blister pack | 204536 | Medicine | A | 10/2/2013 | |
| IBILEX 500 cefalexin 500mg capsule blister pack | 73525 | Medicine | A | 4/28/2000 |