Codes For Orange Book Flashcards
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
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
B codes
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
BE
Delayed-release oral dosage forms
BN
Products in aerosol-nebulizer drug delivery systems
BR
Suppositories or enemas that deliver drugs for systemic absorption
BT
Topical products with bioequivalence issues
BX
Drug products for which the data are insufficient to determine therapeutic equivalence
What is a class 1 BCS drug?
High solubility
High Permeability
What are class 2 drugs of BCS
Low Solubility
High Permeability
Dissolution limited
What are class 3 drugs of BCS system
High solubility
Low Permeability
Permeability limited
