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. Seventy-six 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

Pharmacology for NDA: 208798

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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	59310-200	59310-200-06	1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798	NDA	Teva Respiratory, LLC	59310-200	59310-200-06	1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INHALATION			Strength	0.055MG/INH
Approval Date:	Jan 27, 2017	TE:		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:	⤷ Sign Up	Patent Expiration:	Nov 18, 2031	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 208798

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020	⤷ Sign Up	⤷ Sign Up
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020	⤷ Sign Up	⤷ Sign Up
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.