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Generated: November 16, 2018

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Details for New Drug Application (NDA): 022051

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NDA 022051 describes FLONASE SENSIMIST ALLERGY RELIEF, which is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug. Additional details are available on the FLONASE SENSIMIST ALLERGY RELIEF profile page.

The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 022051
Tradename:FLONASE SENSIMIST ALLERGY RELIEF
Applicant:Glaxosmithkline Cons
Ingredient:fluticasone furoate
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 022051
Suppliers and Packaging for NDA: 022051
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0615 0135-0615-01 1 BOTTLE in 1 CARTON (0135-0615-01) > 30 SPRAY, METERED in 1 BOTTLE
FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0615 0135-0615-02 1 BOTTLE in 1 PACKAGE (0135-0615-02) > 60 SPRAY, METERED in 1 BOTTLE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.0275MG/SPRAY
Approval Date:Aug 2, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))
Patent:➤ Sign UpPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))
Patent:➤ Sign UpPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))

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