📆 August 2026
This guidance provides information regarding FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TE codes).
As defined in 21 CFR 314.3(b), therapeutic equivalents are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.