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Fluticasone propionate

Generic Name
Fluticasone propionate
Brand Names
Advair, Airduo, Airduo Respiclick, Aller-flo, Armonair, Beser, Cutivate, Dymista, Flonase, Flovent, Fluticare, Ticanase, Wixela, Xhance, Seffalair Spiromax, BroPair Spiromax
Drug Type
Small Molecule
Chemical Formula
C25H31F3O5S
CAS Number
80474-14-2
Unique Ingredient Identifier
O2GMZ0LF5W

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
2021/07/08
Phase 4
UNKNOWN
Xijing Hospital
2021/05/13
Phase 3
Completed
Susanna Naggie, MD
2021/02/11
Phase 4
Completed
2020/12/21
Phase 4
Completed
2020/12/19
Phase 2
Completed
2020/12/17
Phase 4
Withdrawn
2020/12/14
Phase 3
Completed
2020/10/23
Phase 4
Withdrawn
2020/09/25
Phase 1
Completed
2020/09/11
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
0168-0332
TOPICAL
0.5 mg in 1 g
1/23/2019
Physicians Total Care, Inc.
54868-5995
RESPIRATORY (INHALATION)
44 ug in 1 1
1/16/2012
GlaxoSmithKline LLC
0173-0720
RESPIRATORY (INHALATION)
220 ug in 1 1
1/7/2019
Teva Respiratory, LLC
59310-505
RESPIRATORY (INHALATION)
55 ug in 1 1
9/27/2022
Teva Pharmaceuticals USA, Inc.
0093-7516
RESPIRATORY (INHALATION)
500 ug in 1 1
9/28/2022
Proficient Rx LP
63187-638
NASAL
50 ug in 1 1
6/1/2022
Physicians Total Care, Inc.
54868-5337
TOPICAL
0.5 mg in 1 g
9/6/2011
Prasco Laboratories
66993-088
RESPIRATORY (INHALATION)
230 ug in 1 1
8/1/2022
A-S Medication Solutions
50090-3387
RESPIRATORY (INHALATION)
232 ug in 1 1
9/28/2022
NuCare Pharmaceuticals,Inc.
68071-4156
NASAL
50 ug in 0.1 g
2/15/2021

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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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
FLIXOTIDE JUNIOR ACCUHALER fluticasone propionate 100 micrograms powder for inhalation blister pack
58439
Medicine
A
1/8/1997
FLIXOTIDE ACCUHALER fluticasone propionate 250 micrograms powder for inhalation blister pack
58438
Medicine
A
1/8/1997
FLUTICASONE SALMETEROL CIP HALER 250/50 fluticasone propionate/salmeterol 250/50 mcg/dose inhalation powder pre-dispensed BP plastic inhaler
331741
Medicine
A
8/12/2021
SALFLUMIX EASYHALER 500/50 fluticasone propionate/salmeterol (as xinafoate) 500ug/50ug Powder for inhalation Dry powder Inhaler
338158
Medicine
A
10/28/2022
FLUAIR INHALER fluticasone propionate 250 microgram/actuation inhalation pressurised aerosol can metered dose
270512
Medicine
A
2/21/2017
AZELASTINE/FLUTICASONE 125/50 APOTEX azelastine (as hydrochloride)/fluticasone propionate 125 microgram/50 microgram nasal spray bottle
277526
Medicine
A
8/22/2017
FLIXOTIDE NEBULES fluticasone propionate 0.5mg/2mL inhalation ampoule
69004
Medicine
A
5/21/1999
FLUTIFORM
177869
Medicine
A
6/14/2013
FLUTIFORM
177873
Medicine
A
6/14/2013
EVOCAIR ACCUHALER 250/50 fluticasone propionate 250 microgram/salmeterol (as xinafoate) 50 microgram powder for inhalation blister pack
208195
Medicine
A
5/7/2014

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-FLUTICASONE
02503174
Powder - Inhalation
500 MCG / ACT
N/A
ARBESDA RESPICLICK
teva canada limited
02474611
Powder (Metered Dose) - Inhalation
55 MCG / ACT
N/A
ALLERGY RELIEF NASAL SPRAY
02460475
Spray, Metered Dose - Nasal
50 MCG / ACT
N/A
FLOVENT HFA
02244292
Metered-Dose Aerosol - Inhalation ,  Oral
125 MCG / ACT
12/20/2001
CUTIVATE
02089912
Cream - Topical
0.05 %
11/8/2004
FLOVENT HFA
02244291
Metered-Dose Aerosol - Oral ,  Inhalation
50 MCG / ACT
12/20/2001
AERMONY RESPICLICK
teva canada limited
02467895
Powder (Metered Dose) - Inhalation
55 MCG / ACT
9/30/2020
WIXELA INHUB
Mylan Pharmaceuticals ULC
02495619
Powder - Inhalation
500 MCG / ACT
2/13/2020
WIXELA INHUB
Mylan Pharmaceuticals ULC
02495597
Powder - Inhalation
100 MCG / ACT
2/13/2020
APO-FLUTICASONE HFA
02528428
Aerosol, Metered Dose - Inhalation ,  Oral
50 MCG / ACT
2/27/2025

CIMA AEMPS Drug Approvals

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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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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approval Date
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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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