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ArmonAir Digihaler

These highlights do not include all the information needed to use ARMONAIR DIGIHALER safely and effectively. See full prescribing information for ARMONAIR DIGIHALER. ARMONAIR DIGIHALER (fluticasone propionate) inhalation powder, for oral inhalationInitial U.S. Approval: 1994

Approved
Approval ID

5cea205f-e6d4-45e8-bfcc-a12a6907d5bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 27, 2022

Manufacturers
FDA

Teva Respiratory, LLC

DUNS: 176697907

Products 6

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 Code59310-515
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 113 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB

fluticasone propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59310-505
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

FLUTICASONE PROPIONATEActive
Quantity: 55 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Fluticasone Propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59310-200
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 113 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB

fluticasone propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59310-525
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

FLUTICASONE PROPIONATEActive
Quantity: 232 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Fluticasone Propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59310-311
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

FLUTICASONE PROPIONATEActive
Quantity: 232 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Fluticasone Propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59310-114
Application NumberNDA208798
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 27, 2022
FDA Product Classification

INGREDIENTS (2)

FLUTICASONE PROPIONATEActive
Quantity: 55 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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ArmonAir Digihaler - FDA Drug Approval Details