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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Tretinoin
Date Designated: 04/15/1985
Orphan Designation: Treatment of squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hannan Ophthalmic Marketing Services, Inc
34 Sherrill Rd.
Marshfield, Massachusetts 02050
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.