Difluocortolone

Overview

Difluocortolone is a potent topical corticosteroid. It is commonly used in dermatology for the reduction of inflammation and itching. It was submitted to the FDA in July 1984 by the pharmaceutical company Schering AG.

Indication

Difluocortolone is used as a topical treatment of the symptoms of inflammatory skin disorders like eczema, seborrheic eczema, lichen planus and psoriasis. All these disorders present as a common characteristic the occurrence of symptoms as itching, swelling, redness and scaling.

Associated Conditions

Aphthous Stomatitis
Dermatitis
Gingivitis
Infectious Periodontal Diseases
Periodontitis
Stomatitis
Corticosteroid-responsive dermatoses
Eczematous rash
Oral lesions

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis	2018/12/28	NCT03788863	N/A	Completed	LEO Pharma
An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids	2015/12/11	NCT02627989	N/A	Completed	LEO Pharma

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
TRAVOCORT CREAM	LEO Pharma Manufacturing Italy S.r.I	SIN04564P	CREAM	1 mg/g	5/31/1990

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
MYCOCIN A CREAM	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	6/5/1996

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
NERISONE OINTMENT	GlaxoSmithKline Inc	00587834	Ointment - Topical	0.1 %	12/31/1983
NERISONE OILY CREAM	GlaxoSmithKline Inc	00587818	Cream - Topical	0.1 %	12/31/1983
NERISONE CREAM	GlaxoSmithKline Inc	00587826	Cream - Topical	0.1 %	12/31/1983
NERISALIC OILY CREAM	GlaxoSmithKline Inc	02028719	Cream - Topical	0.1 % / W/W	12/31/1995

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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