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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: oral testosterone
Date Designated: 06/02/2016
Orphan Designation: Treatment of constitutional delay of growth and puberty in adolescent boys 14 to 17 years of age.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TesoRx Pharma, LLC
3670 West Temple Avenue
Suite 270
Pomona, California 91768
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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