Fluticasone propionate

Overview

Fluticasone propionate is a synthetic glucocorticoid. These drugs are available as inhalers, nasal, sprays, and topical treatments for various inflammatory indications. Fluticasone propionate was first approved in 1990.

Indication

Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxisas well as inflammatory and pruritic dermatoses. Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis.

Associated Conditions

Allergic Rhinitis (AR)
Allergy to Animal Dander
Allergy to Mold
Allergy to Tree Pollen
Asthma
Bacterial Sinusitis
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Sinusitis
Dermatitis
Emphysema
Eosinophilic Esophagitis
House Dust Mite Allergy
House dust allergy
Itching of the nose
Nasal Congestion
Non-Allergic Rhinitis
Rhinitis
Rhinitis Perennial
Rhinorrhoea
Seasonal Allergic Rhinitis
Sneezing
Moderate, severe Perennial Allergic Rhinitis (PAR)
Moderate, severe Seasonal Allergic Rhinitis

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus	2017/08/07	NCT03240575	Phase 4	Completed	Boehringer Ingelheim
Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)	2017/07/18	NCT03219866	Phase 4	Terminated	Wake Forest University Health Sciences
Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma	2017/07/02	NCT03207243	Phase 2	Completed	GlaxoSmithKline
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing	2017/06/27	NCT03199976	Phase 4	Completed	Helsinki University Central Hospital
Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)	2017/06/19	NCT03191864	Phase 2	Completed	Adare Pharmaceuticals, Inc.
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps	2017/06/02	NCT03174483	Not Applicable	UNKNOWN	Assiut University
INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation With Tiotropium and Olodaterol	2017/05/12	NCT03152149	Phase 4	Completed	University of Dundee
Study of REGN3500 and Dupilumab in Patients With Asthma	2017/04/13	NCT03112577	Phase 1	Completed	Regeneron Pharmaceuticals
Cardiovascular Function in COPD Patients	2017/02/16	NCT03055988	Phase 4	Completed	Boehringer Ingelheim
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children	2017/02/02	NCT03040596	Phase 1	Terminated	Joseph Dohar, MD

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FLUTICASONE	RPK Pharmaceuticals, Inc.	53002-7693	NASAL	50 ug in 1 1	1/25/2019
ADVAIR DISKUS	Rebel Distributors Corp	21695-361	RESPIRATORY (INHALATION)	100 ug in 1 1	9/2/2009
Fluticasone Propionate	Asclemed USA, Inc.	76420-329	NASAL	50 ug in 1 1	4/19/2025
Fluticasone Propionate	Cosette Pharmaceuticals, Inc.	0713-0631	TOPICAL	0.5 mg in 1 g	5/5/2022
FLOVENT HFA	A-S Medication Solutions	50090-0910	RESPIRATORY (INHALATION)	110 ug in 1 1	10/17/2023
Fluticasone Propionate	Proficient Rx LP	63187-806	NASAL	50 ug in 1 1	6/1/2022
Fluticasone Propionate and Salmeterol DISKUS	Prasco Laboratories	66993-585	RESPIRATORY (INHALATION)	250 ug in 1 1	1/7/2019
FLOVENT HFA	GlaxoSmithKline LLC	0173-0719	RESPIRATORY (INHALATION)	110 ug in 1 1	1/7/2019
Fluticasone Propionate	Physicians Total Care, Inc.	54868-5545	NASAL	50 ug in 1 1	12/22/2009
exchange select allergy relief	Army & Air Force Exchange Service	55301-506	NASAL	50 ug in 1 1	5/22/2025

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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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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