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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208436


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NDA 208436 describes AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, which is a drug marketed by Apotex, Padagis Israel, and Teva Pharms Usa Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 208436
Tradename:AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Applicant:Teva Pharms Usa Inc
Ingredient:azelastine hydrochloride; fluticasone propionate
Patents:0
Pharmacology for NDA: 208436
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 208436
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 208436 ANDA Teva Pharmaceuticals, Inc. 0480-2157 0480-2157-57 1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.137MG/SPRAY;0.05MG/SPRAY
Approval Date:Apr 8, 2025TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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