Search Orphan Drug Designations and Approvals
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Generic Name: | budesonide |
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Date Designated: | 02/11/2019 |
Orphan Designation: | Treatment of primary biliary cholangitis |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Calliditas Therapeutics AB Kungsbron 1 Stockholm, Stockholms län SE-111 22 Sweden The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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