Budesonide

Budesonide is a glucocorticoid steroid and is available as an inhaler, pill, nasal spray, and rectal forms. The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD). The nasal spray is used for non-infectious rhinitis (including hay fever and other allergies) and for treatment and prevention of nasal polyposis. In addition,
the pills in a delayed release form and rectal forms may be used for inflammatory bowel disease including Crohn’s disease, ulcerative colitis and microscopic colitis.

Sterling holds Certificate of Suitability n. R0-CEP 2009-057-Rev 00 issued by Quality of Medicines & HealthCare (EDQM) on 20/10/2010.

US DMF was submitted to FDA on 19/03/2009 and the following number was assigned n. 22641.