Authorized Generic Drug [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 314.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 314 Applications for FDA Approval to Market a New Drug; Subpart A General Provisions], Authorized Generic Drug means “a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug.”