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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Buprenorphine hydrochloride
Date Designated: 06/15/1994
Orphan Designation: Treatment of opiate addiction in opiate users.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/07/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Indivior, Inc.
10710 Midlothian Turnpike
Suite 125
North Chesterfield, Virginia 23235
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.