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Generated: November 12, 2018

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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 nine patents protecting this drug. Additional details are available on the XHANCE profile page.

The generic ingredient in XHANCE is fluticasone propionate. There are twenty-eight drug master file entries for this compound. Eighty-four 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:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 209022
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 71143-375-99 1 BOTTLE in 1 CARTON (71143-375-99) > 120 SPRAY, METERED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.093MG
Approval Date:Sep 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 18, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Mar 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 29, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY

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