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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Testosterone sublingual
Date Designated: 01/16/1991
Orphan Designation: Treatment of constitutional delay of growth and puberty in boys.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bio-Technology General Corp.
70 Wood Avenue, South
Iselin, New Jersey 08830
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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