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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: budesonide
Date Designated: 05/06/2013
Orphan Designation: Treat of ulcerative colitis in pediatric patients aged 0 through 16 years.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Santarus, Inc.
3611 Valley Centre Drive, Suite 400
San Diego, California 92130
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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