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Symbicort FDA Approval History

FDA Approved: Yes (First approved July 21, 2006)
Brand name: Symbicort
Generic name: budesonide and formoterol
Dosage form: Inhaler
Company: AstraZeneca
Treatment for: Asthma, Maintenance, COPD, Maintenance

Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma and the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Development Timeline for Symbicort

Jan 26, 2017ApprovalSymbicort Approved for the Treatment of Asthma in Patients 6 to 12 Years of Age
Feb 27, 2009ApprovalFDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)
Jul 22, 2006ApprovalAstraZeneca’s Symbicort (budesonide/formoterol) Treatment For Asthma Approved By The FDA
Sep 23, 2005AstraZeneca Submits New Drug Application (NDA) to FDA for Symbicort Maintenance Treatment of Asthma

Further information

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