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 use Initial U.S. Approval: 2000
Approved
Approval ID
ce347bf4-4cc1-46dc-b5f1-6f8ff48da84b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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
NDC Product Code0093-7517
Application NumberANDA213948
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
Generic Namefluticasone propionate and salmeterol
INGREDIENTS (2)
FLUTICASONE PROPIONATEActive
Quantity: 100 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
fluticasone propionate and salmeterol
PRODUCT DETAILS
NDC Product Code0093-7516
Application NumberANDA213948
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
Generic Namefluticasone propionate and salmeterol
INGREDIENTS (2)
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
FLUTICASONE PROPIONATEActive
Quantity: 500 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
fluticasone propionate and salmeterol
PRODUCT DETAILS
NDC Product Code0093-7518
Application NumberANDA213948
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 28, 2022
Generic Namefluticasone propionate and salmeterol
INGREDIENTS (2)
FLUTICASONE PROPIONATEActive
Quantity: 250 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM