Griseofulvin

Overview

An antifungal antibiotic. Griseofulvin may be given by mouth in the treatment of tinea infections.

Indication

For the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, cradle cap or other conditions caused by Trichophyton or Microsporum fungi.

Associated Conditions

Tinea Capitis
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Unguium
Tinea barbae

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions	2020/03/24	NCT04318535	Phase 1	Completed	GlaxoSmithKline
Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH	2012/01/25	NCT01518166	Phase 1	Completed	Novo Nordisk A/S
A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Non-fasting Conditions	2009/03/18	NCT00863863	Phase 1	Completed	Actavis Inc.
A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Fasting Conditions	2009/03/18	NCT00864071	Phase 1	Completed	Actavis Inc.
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis	2005/07/08	NCT00117767	Phase 3	Completed	Novartis Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ultramicrosize Griseofulvin	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-864	ORAL	250 mg in 1 1	8/9/2023
Ultramicrosize Griseofulvin	Chartwell RX, LLC.	62135-494	ORAL	125 mg in 1 1	10/5/2023
Griseofulvin	Actavis Pharma, Inc.	0472-0013	ORAL	125 mg in 5 mL	10/6/2023
Ultramicrosize Griseofulvin	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-863	ORAL	125 mg in 1 1	8/9/2023
Ultramicrosize Griseofulvin	Sigmapharm Laboratories, LLC	42794-013	ORAL	125 mg in 1 1	1/14/2022
Griseofulviin (microsize)	Rebel Distributors Corp	42254-306	ORAL	125 mg in 5 mL	7/27/2010
Griseofulvin	Sandoz Inc	0781-5515	ORAL	500 mg in 1 1	12/20/2016
Ultramicrosize Griseofulvin	Sigmapharm Laboratories, LLC	42794-014	ORAL	250 mg in 1 1	1/14/2022
Ultramicrosize Griseofulvin	Chartwell RX, LLC.	62135-495	ORAL	250 mg in 1 1	10/5/2023
Griseofulvin	Physicians Total Care, Inc.	54868-5234	ORAL	125 mg in 5 mL	10/25/2010

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
HOVID-GRISEOFULVIN 500 TABLET B.P. 500mg	HOVID Bhd.	SIN07993P	TABLET, FILM COATED	500.00 mg	2/2/1995
HEXENE TABLET 125 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN00896P	TABLET	125 mg	5/9/1988
HEXENE-FORTE TABLET 500 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN00899P	TABLET	500 mg	5/9/1988

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
FUYOU TAB 500MG	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	2/15/1986

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
GRISOVIN griseofulvin 125 mg tablet bottle	12512	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/13/1991
GRISOVIN griseofulvin 500 mg tablet blister pack	157849	Aspen Pharmacare Australia Pty Ltd	Medicine	A	3/19/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FULVICIN UF TAB 500MG	schering-plough canada inc	00028282	Tablet - Oral	500 MG	12/31/1966
GRISOVIN FP TAB 250MG	glaxo canada inc	00012254	Tablet - Oral	250 MG / TAB	12/31/1962
GRISOVIN-FP 125MG TAB	roberts pharmaceutical canada inc.	02100266	Tablet - Oral	125 MG / TAB	12/31/1995
GRISOVIN-FP 250MG TAB	roberts pharmaceutical canada inc.	02100274	Tablet - Oral	250 MG / TAB	7/30/1996
FULVICIN PG TAB 330MG	schering-plough canada inc	00513237	Tablet - Oral	330 MG / TAB	12/31/1982
GRISOVIN FP TAB 125MG	glaxo canada inc	00012246	Tablet - Oral	125 MG / TAB	12/31/1964
FULVICIN U/F TAB 250MG	schering-plough canada inc	00028274	Tablet - Oral	250 MG	12/31/1966
GRISOVIN FP TAB 500MG	glaxo canada inc	00012262	Tablet - Oral	500 MG / TAB	12/31/1967

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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