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FLUTICARE

Fluticasone Propionate Nasal Spray USP, 50 mcg per spray

Approved
Approval ID

fed545ab-6a85-4ce3-8651-370e279db49e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 3, 2025

Manufacturers
FDA

INNOVUS PHARMACEUTICALS, INC.

DUNS: 962507187

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluticasone propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57483-180
Application NumberANDA217088
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 3, 2025
FDA Product Classification

INGREDIENTS (8)

FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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FLUTICARE - FDA Drug Approval Details