Econazole

Overview

A broad spectrum antimycotic with some action against Gram positive bacteria. It is used topically in dermatomycoses also orally and parenterally.

Indication

For topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Associated Conditions

Allergic Skin Reaction
Balanitis candida
Dermatitis
Fungal infectious disorders of the Beard
Fungal skin infection
Herpes Zoster
Intertrigo
Mycotic Eczema
Pityriasis versicolor
Ringworm
Skin candida
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea pedis of the interdigital
Vulvovaginal mycotic infection
Cutaneous candidiasis
Cutaneous dermatophyte infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis	2017/04/26	NCT03129321	Phase 3	Completed	Mylan Inc.
Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary	2016/03/28	NCT02720783	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream	2016/03/21	NCT02713893	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years	2012/10/01	NCT01696799	Phase 2	Completed	AmDerma
Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis	2011/05/23	NCT01358240	Phase 3	Completed	AmDerma
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis	2011/05/16	NCT01353976	Phase 3	Completed	AmDerma
A Study of Econazole Foam 1% in Athlete's Foot	2008/10/08	NCT00768599	Phase 2	Completed	AmDerma

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Econazole Nitrate	Preferred Pharmaceuticals Inc.	68788-8174	TOPICAL	10 mg in 1 g	5/22/2023
Ecoza	Resilia Pharmaceuticals, Inc.	81811-100	TOPICAL	10 mg in 1 g	12/4/2023
ECONAZOLE NITRATE 1% / NIACINAMIDE 4%	Sincerus Florida, LLC	72934-2073	TOPICAL	1 g in 100 g	5/20/2019
ECOZA	Exeltis USA Dermatology, LLC	23710-100	TOPICAL	10 mg in 1 g	1/1/2022
071023 ECONAZOLE NITRATE 1% / NIACINAMIDE 4%	Sincerus Florida, LLC	72934-2218	TOPICAL	1 g in 100 g	7/2/2020
Econazole Nitrate	Teligent Pharma, Inc.	52565-022	TOPICAL	10 mg in 1 g	2/4/2020
Econazole Nitrate	Physicians Total Care, Inc.	54868-5042	TOPICAL	10 mg in 1 g	8/27/2010
Econazole Nitrate	Rebel Distributors Corp	21695-892	TOPICAL	10 mg in 1 g	1/9/2007
Econazole Nitrate	Bryant Ranch Prepack	63629-8645	TOPICAL	10 mg in 1 g	7/17/2023
Econazole Nitrate	Padagis Israel Pharmaceuticals Ltd	45802-466	TOPICAL	10 mg in 1 g	11/14/2016

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
ECOCORT CREAM	HOE PHARMACEUTICALS SDN BHD	SIN10246P	CREAM	1%w/w	10/9/1998
ECONAZINE CREAM	Y S P INDUSTRIES (M) SDN BHD	SIN06601P	CREAM	10 mg/g	10/1/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Liquor Econazoli Nitratis	上海小方制药股份有限公司	国药准字H31021306	化学药品	搽剂	5/11/2024
Liquor Econazoli Nitratis	福建南少林药业有限公司	国药准字H35020718	化学药品	搽剂	4/14/2020
Econazole Nitrate Suppositories	昆山培力药品有限公司	国药准字H32021475	化学药品	栓剂	8/21/2020
Econazole Nitrate Suppositories	湖北纽兰药业有限公司	国药准字H20084010	化学药品	栓剂	1/31/2023
Econazole Nitrate Suppositories	湖北东信药业有限公司	国药准字H20113220	化学药品	栓剂	4/7/2021
Econazole Nitrate Suppositories	修正药业集团天汉药业有限公司	国药准字H22022783	化学药品	栓剂	3/6/2020
Econazole Nitrate Suppositories	湖北东信药业有限公司	国药准字H20065906	化学药品	栓剂	4/7/2021
Econazole Nitrate Suppositories	哈药集团制药总厂	国药准字H23022394	化学药品	栓剂	6/29/2020
Econazole Nitrate Suppositories	四川恩威制药有限公司	国药准字H51020081	化学药品	栓剂	1/19/2020
Econazole Nitrate Suppositories	广州白云山敬修堂药业股份有限公司	国药准字H44024015	化学药品	栓剂	6/12/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ECONAZINE CREAM	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	10/17/1990
TRIECONA-N CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	6/1/1993
ECONSONE CREAM	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PEVARYL ANTI-FUNGAL CREAM econazole nitrate 1% w/w cream tube	12996	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/14/1991
PEVARYL FOAMING SOLUTION econazole 10mg/g sachet	13042	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/14/1991

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