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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 and is included in one NDA. It is available from four 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-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

Summary for NDA: 022051

Tradename:
FLONASE SENSIMIST ALLERGY RELIEF
Applicant:
Glaxosmithkline
Ingredient:
fluticasone furoate
Patents:8
Therapeutic Class:Respiratory Tract Agents
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 LLC 0173-0753 0173-0753-00 1 BOTTLE, PUMP in 1 CARTON (0173-0753-00) > 120 SPRAY, METERED in 1 BOTTLE, PUMP
FLONASE SENSIMIST ALLERGY RELIEF
fluticasone furoate
SPRAY, METERED;NASAL 022051 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-474 35356-474-10 120 SPRAY, METERED in 1 BOTTLE, PUMP (35356-474-10)

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.0275MG/SPRAY
Approval Date:Aug 2, 2016TE:RLD:Yes
Patent:6,858,596Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,101,866Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,541,350Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?


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