Hydrocortisone butyrate

Overview

No overview information available.

Indication

For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Also used to treat endocrine (hormonal) disorders (adrenal insufficiency, Addisons disease). It is also used to treat many immune and allergic disorders, such as arthritis, lupus, severe psoriasis, severe asthma, ulcerative colitis, and Crohn's disease.

Associated Conditions

Atopic Dermatitis
Corticosteroid responsive, Inflammatory Dermatosis
Corticosteroid responsive, pruritic Dermatosis
Pruritic, corticosteroid responsive, Inflammatory Dermatosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Vasoconstriction Trial With LEO 90100 Aerosol Foam	2016/11/25	NCT02973776	Phase 1	Completed	LEO Pharma
Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis	2016/11/09	NCT02959580	Phase 4	UNKNOWN	Peking Union Medical College Hospital
Treatment of Atopic Dermatitis With Different Orders of Application of Locoid Lotion and Hylatopic Plus Cream	2014/06/03	NCT02153762	Not Applicable	Completed	Icahn School of Medicine at Mount Sinai

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Locoid Lipocream	Bausch Health US, LLC	16781-384	TOPICAL	1 mg in 1 g	3/31/2021
Hydrocortisone Butyrate	Taro Pharmaceuticals U.S.A., Inc.	51672-4083	TOPICAL	1 mg in 1 g	4/6/2021
Hydrocortisone Butyrate	Teligent Pharma, Inc.	52565-087	TOPICAL	1 mg in 1 mL	9/10/2019
Hydrocortisone Butyrate	Lupin Pharmaceuticals, Inc.	68180-951	TOPICAL	1 mg in 1 mL	12/13/2019
Hydrocortisone Butyrate	Taro Pharmaceuticals U.S.A., Inc.	51672-4061	TOPICAL	1 mg in 1 mL	4/6/2021
HYDROCORTISONE BUTYRATE	Oceanside Pharmaceuticals	68682-392	TOPICAL	1 mg in 1 mL	12/11/2023
Hydrocortisone Butyrate	Taro Pharmaceuticals U.S.A., Inc.	51672-4074	TOPICAL	1 mg in 1 g	4/6/2021
Hydrocortisone Butyrate	Oceanside Pharmaceuticals	68682-384	TOPICAL	1 mg in 1 g	3/31/2021
Hydrocortisone Butyrate	The J. Molner Company LLC	83148-012	TOPICAL	1 mg in 1 mL	11/30/2023
Aquax-H	Pella Pharmaceuticals Co. ltd	82160-127	TOPICAL	30 mg in 30 g	12/26/2023

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

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
No Health Canada approvals found for this drug.

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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