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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Fluoxetine
Date Designated:  04/14/2004
Orphan Designation:  Treatment of body dysmorphic disorder in children and adolescents
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Hollander, Eric MD
The Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, New York 10029
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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