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Last Updated: February 4, 2023

Details for New Drug Application (NDA): 208798


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NDA 208798 describes ARMONAIR RESPICLICK, which is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ARMONAIR RESPICLICK profile page.

The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 208798
Tradename:ARMONAIR RESPICLICK
Applicant:Teva Pharm
Ingredient:fluticasone propionate
Patents:25
Formulation / Manufacturing:see details
Pharmacology for NDA: 208798
Suppliers and Packaging for NDA: 208798
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798 NDA Teva Respiratory, LLC 59310-114 59310-114-06 1 POUCH in 1 CARTON (59310-114-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798 NDA Teva Respiratory, LLC 59310-114 59310-114-06 1 POUCH in 1 CARTON (59310-114-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength0.055MG/INH
Approval Date:Jan 27, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 9, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 9, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:See Plans and PricingPatent Expiration:Nov 18, 2031Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 208798

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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. 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.