Cefadroxil

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
Or v IV Antibiotics for Infection	2021/01/26	NCT04723940	Phase 3	UNKNOWN	Rothman Institute Orthopaedics
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients	2020/03/05	NCT04297592	Phase 4	ENROLLING_BY_INVITATION	Mayo Clinic
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)	2019/09/11	NCT04085666	Phase 1	Completed	Société des Produits Nestlé (SPN)
Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections	2019/01/14	NCT03802552	Phase 1	Completed	University of Colorado, Denver
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA	2016/06/28	NCT02814916	Phase 3	Completed	AbbVie
A Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)	2015/06/24	NCT02479867	Phase 1	Completed	Genuine Research Center, Egypt
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects	2015/05/18	NCT02446496	Phase 4	Completed	GlaxoSmithKline
Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers	2015/03/06	NCT02381470	Phase 2	Completed	National University Hospital, Singapore
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	2010/11/19	NCT01244698	Phase 4	Completed	Stony Brook University
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.	2009/02/03	NCT00835081	Phase 1	Completed	Teva Pharmaceuticals USA

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cefadroxil	NorthStar Rx LLC	16714-389	ORAL	250 mg in 5 mL	2/9/2024
Cefadroxil	NuCare Pharmaceuticals, Inc.	66267-045	ORAL	500 mg in 1 1	3/10/2023
Cefadroxil	Lupin Pharmaceuticals, Inc.	68180-182	ORAL	500 mg in 5 mL	10/31/2023
CEFADROXIL	DIRECT RX	72189-103	ORAL	500 mg in 1 1	6/27/2023
Cefadroxil	NorthStar Rx LLC	16714-388	ORAL	500 mg in 1 1	1/30/2024
Cefadroxil	Direct_Rx	72189-445	ORAL	500 mg in 1 1	6/2/2023
Cefadroxil	NuCare Pharmaceuticals,Inc.	68071-2752	ORAL	500 mg in 1 1	6/3/2022
Cefadroxil	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	70934-081	ORAL	500 mg in 1 1	11/30/2020
Cefadroxil	Preferred Pharmaceuticals Inc.	68788-7484	ORAL	500 mg in 1 1	3/21/2024
Cefadroxil	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	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN11665P	CAPSULE	500 mg	9/13/2001

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LIKODIN CAPSULE 500MG	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CEFADROXIL	Apotex Inc	02240600	Capsule - Oral	500 MG / CAP	N/A
DURICEF	bristol-myers squibb canada	00507245	Capsule - Oral	500 MG	12/31/1981
PRO-CEFADROXIL - 500	PRO DOC LIMITEE	02311062	Capsule - Oral	500 MG	7/4/2008
APO-CEFADROXIL	Apotex Inc	02240774	Capsule - Oral	500 MG	8/31/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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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