Fluticasone Propionate
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray.FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
Approved
Approval ID
4916301d-bcc8-4cd1-86b4-7bf0aecfbf68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
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 Code68788-9678
Application NumberANDA077538
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateJune 14, 2023
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT