Fluticasone Propionate
Fluticasone Propionate Nasal Spray, USP, 50 MCG
Approved
Approval ID
e709c834-61a5-4797-a8ef-0d5aa990d136
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2011
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-9992
Application NumberANDA077570
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateAugust 26, 2009
FDA Product Classification
INGREDIENTS (8)
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 0.1 g
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT