Pharmaceutical equivalents: Drug products that contain the same active ingredient(s), dosage form, route of administration, and amount of active ingredient while meeting the same standards (i.e., strength, quality, purity, and identity). They may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling. Being pharmaceutical equivalents is a requirement to be therapeutic equivalents (e.g., to be a generic to the reference listed drug).
Therapeutic equivalents: Pharmaceutical equivalents for which bioequivalence has been demonstrated, and they 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 criteria for therapeutically equivalent drug products are: