Code of Federal Regulations Title 21. Food and Drugs § 21.316.28 Publication of orphan-drug designations

(a) The name and address of the sponsor;

(b) The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;

(c) The date of the granting of orphan-drug designation;

(d) The designated use in the rare disease or condition;  and

(e) If the drug loses designation after August 12, 2013, the date of it no longer having designation.