TEE Ratings
(Therapeutic Equivalence Ratings)
"A" CODES
Drug products the FDA considers therapeutically equivalent to other pharmaceutically equivalent products. 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 | Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading |
| AB2 | Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading |
| AB3 | 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 |
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The following codes are applied to specific products where appropriate: | |
| n/a (1) | No rating |
| n/a (2) | Therapeutic equivalent, manufactured and distributed under originator's NDA |
| n/a (3) | Same therapeutic effect as the reference listed drug |
| n/a (4) | New Drug Application (NDA); no rating |
