FDA classifies as therapeutically equivalent those drug products that meet the following general criteria:
(1) they are approved as safe and effective
(2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the identical active drug ingredient in the identical dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity;
(3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard;
(4) they are adequately labeled; and
(5) they are manufactured in compliance with Current Good Manufacturing Practice regulations.
Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with adequate in vivoand/or in vitro evidence supporting bioequivalence. These are designated AB.
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products.