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Details for New Drug Application (NDA): 205434

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NDA 205434 describes FLONASE ALLERGY RELIEF, which is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from two suppliers. Additional details are available on the FLONASE ALLERGY RELIEF profile page.

The generic ingredient in FLONASE ALLERGY RELIEF is fluticasone propionate. There are twenty-two drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 205434

Suppliers and Packaging for NDA: 205434

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLONASE ALLERGY RELIEF
fluticasone propionate
SPRAY, METERED;NASAL 205434 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0576 0135-0576-01 1 BOTTLE in 1 CARTON (0135-0576-01) > 30 SPRAY, METERED in 1 BOTTLE
FLONASE ALLERGY RELIEF
fluticasone propionate
SPRAY, METERED;NASAL 205434 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0576 0135-0576-02 1 BOTTLE in 1 PACKAGE (0135-0576-02) > 60 SPRAY, METERED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Jul 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 23, 2017
Regulatory Exclusivity Use:OTC USE FOR TEMPORARY RELIEF OF OCULAR SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES


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