Cefaclor

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
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis	2022/06/01	NCT05398679	Phase 4	Recruiting	Fundacion Clinic per a la Recerca Biomédica

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cefaclor	Teva Pharmaceuticals USA, Inc.	0093-1087	ORAL	500 mg in 1 1	7/31/2019
Cefaclor	Carlsbad Technology, Inc.	61442-176	ORAL	375 mg in 5 mL	9/9/2015
Cefaclor	Physicians Total Care, Inc.	54868-3511	ORAL	500 mg in 1 1	12/8/2010
Cefaclor	Carlsbad Technology, Inc.	61442-172	ORAL	500 mg in 1 1	9/9/2015
Cefaclor	Azorian Pharma, LLC	81948-6250	ORAL	250 mg in 5 mL	11/7/2022
Cefaclor	Carlsbad Technology, Inc.	61442-173	ORAL	125 mg in 5 mL	9/9/2015
Cefaclor	Physicians Total Care, Inc.	54868-3478	ORAL	250 mg in 1 1	12/8/2010
Cefaclor	A-S Medication Solutions	50090-1602	ORAL	500 mg in 1 1	9/9/2015
Cefaclor	Carlsbad Technology, Inc.	61442-171	ORAL	250 mg in 1 1	9/9/2015
Cefaclor	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	SHIN POONG PHARMACEUTICAL CO LTD	SIN09294P	CAPSULE	250 mg	4/10/1997
SOFICLOR FOR ORAL SUSPENSION 125 mg/5 ml	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
AXCEL CEFACLOR-250 CAPSULES 250MG	N/A	KOTRA PHARMA (HONG KONG) COMPANY	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	Sun Pharma ANZ Pty Ltd	Medicine	A	9/2/2014
OZCEF cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle	169127	Sun Pharma ANZ Pty Ltd	Medicine	A	4/9/2010
CEFACLOR SUN cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle	226401	Sun Pharma ANZ Pty Ltd	Medicine	A	9/2/2014
CECLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle	347593	Viatris Pty Ltd	Medicine	A	2/17/2021
KEFLOR cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle	58651	Alphapharm Pty Ltd	Medicine	A	2/19/1997
CECLOR cefaclor 125mg/5mL (as monohydrate) powder for oral liquid	347594	Viatris Pty Ltd	Medicine	A	2/17/2021
KEFLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle	58653	Alphapharm Pty Ltd	Medicine	A	2/19/1997
OZCEF cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle	169128	Sun Pharma ANZ Pty Ltd	Medicine	A	4/9/2010
CECLOR CD cefaclor 375 mg (as monohydrate) modified release tablet blister pack	58264	Viatris Pty Ltd	Medicine	A	3/14/1997
CEFACLOR RBX	182058	Sun Pharma ANZ Pty Ltd	Medicine	A	8/9/2011

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CEFACLOR-375	PRO DOC LIMITEE	02238204	Powder - Oral	375 MG / 5 ML	11/24/1998
CEFACLOR-250	PRO DOC LIMITEE	02238203	Powder - Oral	250 MG / 5 ML	11/24/1998
CEFACLOR CAPSULES	ivax pharmaceuticals incorporated	02237730	Capsule - Oral	500 MG	7/14/1998
APO-CEFACLOR	Apotex Inc	02237502	Powder - Oral	375 MG / 5 ML	3/6/1998
APO-CEFACLOR	Apotex Inc	02237501	Powder - Oral	250 MG / 5 ML	3/6/1998
APO-CEFACLOR	Apotex Inc	02230264	Capsule - Oral	500 MG	1/20/1997
CEFACLOR	mm therapeutics inc	02237381	Capsule - Oral	500 MG	6/4/1998
CECLOR	pendopharm division of pharmascience inc	00465216	Powder For Suspension - Oral	250 MG / 5 ML	12/31/1980
CEFACLOR-250	PRO DOC LIMITEE	02238200	Capsule - Oral	250 MG	11/23/1998
APO-CEFACLOR	Apotex Inc	02237500	Powder - Oral	125 MG / 5 ML	3/6/1998

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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