Issue Date: August 24, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan
Status: Final
Evaluation of Therapeutic Equivalence
This final guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what TE codes indicate for multisource prescription drug products listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). This guidance finalizes the draft guidance of the same title issued in July 2022, with revisions including an additional process for 505(b)(2) applicants to request TE codes and other clarifying changes.
Download the Guidance Document
