Application 205434

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATESPRAY, METERED;NASAL0.05MG/SPRAYYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0576FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0576FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0576FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0576FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0576FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0582CHILDRENS FLONASEfluticasone propionateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
50090-1978FLONASEfluticasone propionateA-S Medication SolutionsNDACurrent
50090-1978FLONASEfluticasone propionateA-S Medication SolutionsNDACurrent
70518-1223FLONASEfluticasone propionateREMEDYREPACK INC.NDACurrent
70518-1223FLONASEfluticasone propionateREMEDYREPACK INC.NDACurrent
70518-1223FLONASEfluticasone propionateREMEDYREPACK INC.NDACurrent
70518-1223FLONASEfluticasone propionateREMEDYREPACK INC.NDACurrent
70518-1223FLONASEfluticasone propionateREMEDYREPACK INC.NDACurrent

Documents

DocumentSubmission typeDate
84547SUPPL 2025-12-23
84510SUPPL 2025-12-23
80838SUPPL 2025-01-13
80837SUPPL 2025-01-13
80019SUPPL 2024-10-28
80018SUPPL 2024-10-28
76588SUPPL 2023-11-16
76580SUPPL 2023-11-16
49655SUPPL2017-09-01
49654SUPPL2017-09-01
22988ORIG2016-03-18
19646SUPPL2015-12-09
32674SUPPL2015-11-27
19645SUPPL2015-10-15
32673SUPPL2015-10-02
40467ORIG2014-07-25
10447ORIG2014-07-25