Flunisolide

Overview

Flunisolide (marketed as AeroBid, Nasalide, Nasarel) is a corticosteroid with anti-inflammatory actions. It is often prescribed as treatment for allergic rhinitis and its principle mechanism of action involves activation of glucocorticoid receptors.

Indication

For the maintenance treatment of asthma as a prophylactic therapy.

Associated Conditions

Allergic Rhinitis (AR)
Asthma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Flunisolide HFA in Children With Small Airway Disease	2015/03/31	NCT02404103	Not Applicable	Completed	University of Louisville
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)	2006/06/30	NCT00346775	Phase 3	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Flunisolide	Bausch & Lomb Incorporated	24208-344	NASAL	0.25 mg in 1 mL	2/27/2024
Flunisolide	Ingenus Pharmaceuticals, LLC	50742-317	NASAL	0.25 mg in 1 mL	6/24/2022
Flunisolide	Physicians Total Care, Inc.	54868-4799	NASAL	0.25 mg in 1 mL	9/6/2012
Flunisolide	Oceanside Pharmaceuticals	68682-344	NASAL	0.25 mg in 1 mL	5/2/2025

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
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	2.496g/1000ml	3/7/2023
PHOSPHO-SODA ORAL SOLUTION	Casen Recordati S.L.	SIN12230P	SOLUTION	2.71g/5 ml	3/17/2003
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	2.496g/1000ml	4/23/2018
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	1.872g/1000ml	4/23/2018

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
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
PRECLINT ORAL SOLUTION	N/A	wings pharmaceutical ltd	N/A	N/A	4/30/2025

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
RHINALAR	syntex inc.	00421456	Spray - Nasal	.025 %	12/31/1978
NOVO-FLUNISOLIDE	novopharm limited	02230306	Spray - Nasal	25 MCG / DOSE	6/30/1998
RHINALAR NASAL MIST	ivax laboratories incorporated	02162687	Solution , Spray - Nasal	25 MCG / ACT	12/31/1996
RATIO-FLUNISOLIDE	ratiopharm inc division of teva canada limited	00878790	Spray - Nasal	25 MCG / ACT	12/31/1993
PMS-FLUNISOLIDE	Pharmascience Inc	01927167	Spray - Nasal	0.025 %	12/31/1994
BRONALIDE INHAL 250MCG/AEM	boehringer ingelheim (canada) ltd ltee	00790486	Metered-Dose Aerosol - Inhalation	250 MCG / ACT	12/31/1988
APO-FLUNISOLIDE NASAL SPRAY	Apotex Inc	02239288	Metered-Dose Pump - Nasal	0.25 MG / ML	3/10/2000

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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