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Symbicort Approval History

  • FDA approved: Yes (First approved July 21st, 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 History and FDA Approval Process for Symbicort

DateArticle
Feb 27, 2009Approval FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)
Jul 22, 2006Approval AstraZeneca’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

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