Flashcards in Codes For Orange Book Deck (16)
Solutions and powders for aerosolization
Injectable Oil solutions
Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
AB, AB1, AB3,....
These codes a re assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading
What are A codes?
Products for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or vitro evidence supporting bioquivalence
Products, for which actual or potential bioquivalence problems have not been resolved by adequate evidence of bioequivalnce, often have problem with specific dosage forms rather than with the active ingredients
Delayed-release oral dosage forms
Products in aerosol-nebulizer drug delivery systems
Suppositories or enemas that deliver drugs for systemic absorption
Topical products with bioequivalence issues
Drug products for which the data are insufficient to determine therapeutic equivalence
What is a class 1 BCS drug?
What are class 2 drugs of BCS
What are class 3 drugs of BCS system