Fluticasone Propionate
Approved
Approval ID
f9edc9b3-12e7-4917-a27c-8dbf6ac654ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5545
Application NumberANDA076504
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 22, 2009
FDA Product Classification
INGREDIENTS (7)
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
PHENETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT