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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Phenylbutyrate
Date Designated: 01/19/2000
Orphan Designation: Treatment of acute promyelocytic leukemia.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Elan Drug Delivery, Inc.
1300 Gould Dr.
Gainesville, Georgia 30504
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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