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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Mixture of delta 9-tetrahydrocannabinol glycosides
Date Designated: 08/09/2021
Orphan Designation: Treatment of pediatric ulcerative colitis between the ages of 0-18 years
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Vitality Biopharma, Inc.
1901 Avenue of the Stars
2nd Floor
Los Angeles, California 90067
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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