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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  estradiol Gel
Date Designated:  10/31/2006
Orphan Designation:  Estrogen replacement therapy in females with Turner syndrome
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Ascend Therapeutics US, LLC
15 Mount Kemble Avenue
Morristown, New Jersey 07960
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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