This guidance explains 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 FDA has determined 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.


FDA’s therapeutic equivalence evaluations are listed for multisource2 23 prescription drug products  approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 25 U.S.C. 355) in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book)3. As FDA explained when it first proposed  to make available a list of all approved drug products, together with therapeutic evaluations of  listed products that are available from more than one manufacturer, therapeutic equivalence  evaluations have been prepared to serve as public information and advice to state health  agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.