Overview
Long-acting, broad-spectrum, water-soluble, cephalexin derivative.
Indication
For the treatment of the following infections (skin, UTI, ENT) caused by; S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A beta-hemolytic streptococci), E. coli, P. mirabilis, Klebsiella sp, coagulase-negative staphylococci and Streptococcus pyogenes
Associated Conditions
- Bacterial Infections
- Infection and inflammatory reaction due to internal prosthetic device, implant, and graft
- Skin and Subcutaneous Tissue Bacterial Infections
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Urinary Tract Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/01/26 | Phase 3 | UNKNOWN | |||
2020/03/05 | Phase 4 | ENROLLING_BY_INVITATION | |||
2019/09/11 | Phase 1 | Completed | Société des Produits Nestlé (SPN) | ||
2019/01/14 | Phase 1 | Completed | |||
2016/06/28 | Phase 3 | Completed | |||
2015/06/24 | Phase 1 | Completed | Genuine Research Center, Egypt | ||
2015/05/18 | Phase 4 | Completed | |||
2015/03/06 | Phase 2 | Completed | |||
2010/11/19 | Phase 4 | Completed | |||
2009/02/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NorthStar Rx LLC | 16714-389 | ORAL | 250 mg in 5 mL | 2/9/2024 | |
| NuCare Pharmaceuticals, Inc. | 66267-045 | ORAL | 500 mg in 1 1 | 3/10/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-182 | ORAL | 500 mg in 5 mL | 10/31/2023 | |
| DIRECT RX | 72189-103 | ORAL | 500 mg in 1 1 | 6/27/2023 | |
| NorthStar Rx LLC | 16714-388 | ORAL | 500 mg in 1 1 | 1/30/2024 | |
| Direct_Rx | 72189-445 | ORAL | 500 mg in 1 1 | 6/2/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2752 | ORAL | 500 mg in 1 1 | 6/3/2022 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-081 | ORAL | 500 mg in 1 1 | 11/30/2020 | |
| Preferred Pharmaceuticals Inc. | 68788-7484 | ORAL | 500 mg in 1 1 | 3/21/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-4690 | ORAL | 500 mg in 1 1 | 9/19/2023 |
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 |
|---|---|---|---|---|---|
| SOFIDROX CAPSULE 500 mg | SIN11665P | CAPSULE | 500 mg | 9/13/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefadroxil Granules | 国药准字H19991095 | 化学药品 | 颗粒剂 | 12/3/2019 | |
| Cefadroxil Granules | 国药准字H20053632 | 化学药品 | 颗粒剂 | 6/22/2020 | |
| Cefadroxil Granules | 国药准字H20023529 | 化学药品 | 颗粒剂 | 4/27/2020 | |
| Cefadroxil Granules | 国药准字H10970395 | 化学药品 | 颗粒剂 | 7/29/2020 | |
| Cefadroxil Granules | 国药准字H20053155 | 化学药品 | 颗粒剂 | 7/21/2020 | |
| Cefadroxil Granules | 国药准字H10970430 | 化学药品 | 颗粒剂 | 12/6/2019 | |
| Cefadroxil Granules | 国药准字H20023861 | 化学药品 | 颗粒剂 | 12/11/2019 | |
| Cefadroxil Granules | 国药准字H10960160 | 化学药品 | 颗粒剂 | 3/27/2020 | |
| Cefadroxil Granules | 国药准字H20053103 | 化学药品 | 颗粒剂 | 4/29/2020 | |
| Cefadroxil Granules | 国药准字H10970039 | 化学药品 | 颗粒剂 | 7/29/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LIKODIN CAPSULE 500MG | N/A | N/A | N/A | 2/15/2012 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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