FDA.report

Application 022051

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
002FLONASE SENSIMIST ALLERGY RELIEFFLUTICASONE FUROATESPRAY, METERED;NASAL0.0275MG/SPRAYYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0615FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0615FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0615FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0616FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0616FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0616FLONASE SENSIMISTfluticasone furoateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0173-0753VERAMYSTfluticasone furoateGlaxoSmithKline LLCNDACurrent
50090-5967FLONASE SENSIMISTfluticasone furoateA-S Medication SolutionsNDACurrent
50090-6075FLONASE SENSIMISTfluticasone furoateA-S Medication SolutionsNDACurrent

Documents

DocumentSubmission typeDate
84546SUPPL 2025-12-23
84508SUPPL 2025-12-23
83356SUPPL 2025-09-16
83355SUPPL 2025-09-16
80841SUPPL 2025-01-13
80835SUPPL 2025-01-13
80020SUPPL 2024-10-28
80017SUPPL 2024-10-28
76587SUPPL 2023-11-16
76579SUPPL 2023-11-16
54300SUPPL2018-05-22
52689ORIG2018-02-23
49578SUPPL2017-08-29
47956SUPPL2017-04-12
47939SUPPL2017-04-12
45883SUPPL2016-11-10