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Fluticasone Propionate and Salmeterol

These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation useInitial U.S. Approval: 2000

Approved
Approval ID

77269609-fb89-47c7-97cc-22e0183e91ae

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 8, 2024

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluticasone Propionate and Salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3271
Application NumberNDA208799
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fluticasone Propionate and Salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
FDA Product Classification

INGREDIENTS (3)

FLUTICASONE PROPIONATEActive
Quantity: 113 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 14 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Fluticasone Propionate and Salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3387
Application NumberNDA208799
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fluticasone Propionate and Salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
FDA Product Classification

INGREDIENTS (3)

FLUTICASONE PROPIONATEActive
Quantity: 232 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 14 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Fluticasone Propionate and Salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3272
Application NumberNDA208799
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fluticasone Propionate and Salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
FDA Product Classification

INGREDIENTS (3)

FLUTICASONE PROPIONATEActive
Quantity: 55 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SALMETEROL XINAFOATEActive
Quantity: 14 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM

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Fluticasone Propionate and Salmeterol - FDA Drug Approval Details