Application Nr Approved Date Route Status External Links
NDA208799 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluticasone Propionate/salmeterol Multidose Dry Powder Inhaler (Fs Mdpi) Is Indicated For The Treatment Of Asthma In Patients Aged 12 Years And Older. Fluticasone Propionate/salmeterol Mdpi Should Be Used For Patients Not Adequately Controlled On A Long Term Asthma Control Medication Such As An Inhaled Corticosteroid Or Whose Disease Warrants Initiation Of Treatment With Both An Inhaled Corticosteroid And Long Acting Beta 2 Adrenergic Agonist (Laba). Limitations Of Use : Fluticasone Propionate/salmeterol Mdpi Is Not Indicated For The Relief Of Acute Bronchospasm. Fluticasone Propionate/salmeterol Multi-Dose Dry Powder Inhaler (Mdpi) Is A Combination Of Fluticasone Propionate, A Corticosteroid, And Salmeterol, A Long-Acting Beta 2 -Adrenergic Agonist (Laba), Indicated For Treatment Of Asthma In Patients Aged 12 Years And Older. Fluticasone Propionate/salmeterol Inhalation Powder Should Be Used For Patients Not Adequately Controlled On A Long Term Asthma Control Medication Such As An Inhaled Corticosteroid Or Whose Disease Warrants Initiation Of Treatment With Both An Inhaled Corticosteroid And Long Acting Beta 2 -Adrenergic Agonist (Laba). ( 1 ) Limitations Of Use : Not Indicated For The Relief Of Acute Bronchospasm. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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