FLOVENT
These highlights do not include all the information needed to use FLOVENT HFA safely and effectively. See full prescribing information for FLOVENT HFA. FLOVENT HFA (fluticasone propionate inhalation aerosol), for oral inhalation useInitial U.S. Approval: 1994
Approved
Approval ID
b49ed7c1-123e-4b1d-fea6-0c6839fd9d6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 3
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 Code0173-0718
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 7, 2019
FDA Product Classification
INGREDIENTS (2)
FLUTICASONE PROPIONATEActive
Quantity: 44 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
fluticasone propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0719
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 7, 2019
FDA Product Classification
INGREDIENTS (2)
FLUTICASONE PROPIONATEActive
Quantity: 110 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
fluticasone propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0720
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 7, 2019
FDA Product Classification
INGREDIENTS (2)
FLUTICASONE PROPIONATEActive
Quantity: 220 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT