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1.15 orange book

orange book codes

QuestionAnswer
AA Products in conventional dosage forms not presenting bioequivalence problems
AB, AB1, AB2, AB3.... Products meeting necessary bioequivalence requirements
AN Solutions and Powders for Aerosolization
AO Injectable Oil Solutions
AP Injectable aqueous solutions and, in certain instances, IV non-aqueous solutions
AT Topical Products
B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence
BC Extended-release dosage form (capsules, injectables, and tablets)
BD Active ingredients and dosage forms w/ documented bioequivalence problems
BE Delayed-release oral dosage forms
BN Products in aerosol-nebulizer drug delivery systems
BR Suppositories or enemas that deliver drugs for systemic absorption
BS Products having drug standard deficiencies
BT Topical products with bioequivalence issues
BX Drug products for which the data are insufficient to determine therapeutic equivalence
Created by: 23704589
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