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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Orphan Designation Status:  Designated/Withdrawn
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.
 
Generic Name:  Buprenorphine hydrochloride
Date Designated:  06/15/1994
Orphan Designation:  Treatment of opiate addiction in opiate users.
Orphan Designation Status:  Designated/Withdrawn
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 Jan. 1, 2013, to the present.
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