|A||Drug products that the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, that is, drugs for which:|
|B||Drug products that the FDA at this time considers not to be therapeutically equivalent to the other pharmaceutically equivalent products for which 1 of the following is true: |
The subcodes consist of BC (extended-release capsules, injectables, tablets); BD (active ingredients and dosage forms with documented bioequivalence problems); BE (delayed release oral dosage forms); BN (aerosol-nebulizer drug delivery); BP (active ingredients and dosage forms with potential bioequivalence problems); BR (suppositories and enemas); BS (products having drug standard deficiencies); BT (topical products); BX (drug products with insufficient data); or B†.
FDA indicates U.S. Food and Drug Administration.
Table content adapted from U.S. Food and Drug Administration (1).
↵⁎ A number is added to the end of the code (e.g., AB1, AB2), which indicates that >1 reference drug of the same strength has been designated under the same heading. Two or more reference medications are identified only when there are at least 2 potential reference drug products that are not bioequivalent to each other.
↵† Code B represents drugs that may have been previously assigned an A or B code before new information raising significant questions about therapeutic equivalence was received by the FDA. The therapeutic equivalence of the product may be redetermined after the FDA completes its investigation and review.