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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 44 mcg (fluticasone propionate 44 mcg) Inhalation AerosolFLOVENT HFA 110 mcg (fluticasone propionate 110 mcg) Inhalation Aerosol FLOVENT HFA 220 mcg (fluticasone propionate 220 mcg) Inhalation AerosolFOR ORAL INHALATION ONLYInitial U.S. Approval: 1994

Approved
Approval ID

ac4fc4e3-f9a6-4176-96a9-a2c78fad96e0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 16, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-5362
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 16, 2012
FDA Product Classification

INGREDIENTS (2)

NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 110 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB

fluticasone propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5995
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 16, 2012
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 Code54868-5637
Application NumberNDA021433
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 16, 2012
FDA Product Classification

INGREDIENTS (2)

FLUTICASONE PROPIONATEActive
Quantity: 220 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT

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FLOVENT - FDA Drug Approval Details