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-two 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:	10,022,510*PED	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 RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,446,627	⤷ Subscribe
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020	8,006,690	⤷ Subscribe
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017	6,446,627	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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