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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: retinol palmitate (vitamin A palmitate)
Date Designated: 06/28/2017
Orphan Designation: Prevention of retinopathy of prematurity (ROP)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
orphanix GmbH
41 Peter-Rosegger-Straße
Ried im Innkreis, Oberösterreich

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.