TEE Ratings
(Therapeutic Equivalence Evaluations Codes)
Therapeutic Equivalence Evaluations Code is the FDA's coding system to identify if the product is therapeutically equivalent to the brand. These codes are published in FDA's Orange Book:
AA |
Products in conventional dosage forms not presenting bioequivalence problems |
AB |
Products meeting necessary bioequivalence requirements |
AB1 - AB4 |
Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading |
AN |
Solutions and powders for aerosolization |
AO |
Injectable oil solutions |
AP |
Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions |
AT |
Topical products |
BD |
Products containing active ingredients with known bioequivalence problems and for which adequate studies have not been submitted to FDA demonstrating bioequivalence |