Application Nr Approved Date Route Status External Links
NDA021929 None Respiratory (inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Symbicort Is A Combination Product Containing A Corticosteroid And A Long-Acting Beta 2 -Adrenergic Agonist Indicated For: • Treatment Of Asthma In Patients 6 Years Of Age And Older. ( 1.1 ) • Maintenance Treatment Of Airflow Obstruction And Reducing Exacerbations In Patients With Chronic Obstructive Pulmonary Disease (copd) Including Chronic Bronchitis And/or Emphysema. ( 1.2 ) Important Limitations: • Not Indicated For The Relief Of Acute Bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment Of Asthma Symbicort Is Indicated For The Treatment Of Asthma In Patients 6 Years Of Age And Older. Symbicort 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 Inhaled Corticosteroid And Long-Acting Beta2-Adrenergic Agonist (laba). Important Limitations Of Use: • Symbicort Is Not Indicated For The Relief Of Acute Bronchospasm. 1.2 Maintenance Treatment Of Chronic Obstructive Pulmonary Disease Symbicort 160/4.5 Is Indicated For The Maintenance Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (copd) Including Chronic Bronchitis And/or Emphysema. Symbicort 160/4.5 Is Also Indicated To Reduce Exacerbations Of Copd. Symbicort 160/4.5 Is The Only Strength Indicated For The Treatment Of Copd. Important Limitations Of Use: • Symbicort Is Not Indicated For The Relief Of Acute Bronchospasm.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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