Application Nr Approved Date Route Status External Links
NDA022518 None Respiratory (inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dulera Is A Combination Product Containing A Corticosteroid And A Long-Acting Beta 2 -Adrenergic Agonist (laba) Indicated For: Treatment Of Asthma In Patients 5 Years Of Age And Older. ( 1.1 ) Important Limitation Of Use: Not Indicated For The Relief Of Acute Bronchospasm. ( 1.1 ) 1.1 Treatment Of Asthma Dulera Is Indicated For The Twice-Daily Treatment Of Asthma In Patients 5 Years Of Age And Older. Dulera Should Be Used For Patients Not Adequately Controlled On A Long-Term Asthma-Control Medication Such As An Inhaled Corticosteroid (ics) Or Whose Disease Warrants Initiation Of Treatment With Both An Ics And Long-Acting Beta 2 -Adrenergic Agonist (laba). Important Limitation Of Use: Dulera Is Not Indicated For The Relief Of Acute Bronchospasm.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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