21 CFR 316.28 - Publication of orphan-drug designations.
Each month FDA will update a publically available list of drugs designated as orphan drugs. A cumulative, updated list of all designated drugs will be provided annually. These will be placed on file at the FDA Division of Dockets Management, and will contain the following information:
(b) The generic name and trade name, if any, of the drug and the date of the granting of orphan-drug designation;
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.