Details for New Drug Application (NDA): 209022

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NDA 209022 describes XHANCE, which is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the XHANCE profile page.

The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for 209022

Tradename:	XHANCE
Applicant:	Optinose Us Inc
Ingredient:	fluticasone propionate
Patents:	15

Pharmacology for NDA: 209022

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 209022

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022	NDA	OptiNose US, Inc.	71143-375	71143-375-01	1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE
XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022	NDA	OptiNose US, Inc.	71143-375	71143-375-98	1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.093MG
Approval Date:	Sep 18, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 15, 2027
Regulatory Exclusivity Use:	TREATMENT OF CHRONIC RHINOSINUSITIS WITHOUT NASAL POLYPS (CRSSNP) IN ADULTS
Patent:	⤷ Sign Up	Patent Expiration:	Oct 20, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 30, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY

Expired US Patents for NDA 209022

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	⤷ Sign Up	⤷ Sign Up
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	⤷ Sign Up	⤷ Sign Up
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	⤷ Sign Up	⤷ Sign Up
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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