AB Rated Product means a product which has been approved by a Regulatory Agency having an approved application that contains adequate scientific evidence establishing, through in vitro and/or in vivo studies, the bioequivalence of such product to a Licensed Product developed under this Agreement and which product …

What is AB rating in Orange Book?

CodeInterpretationAANo bioequivalence problems in conventional dosage formsABMeets necessary bioequivalence requirementsAB1Meets bioequivalence requirement to AB1 rated reference drugAB2Meets bioequivalence requirement to AB2 rated reference drug

What impact does AB rating have in the pharmacy?

“What an AB rating from the FDA means is that the active ingredient is both bioequivalent and therapeutically equivalent to the brand-name version and that the inactive ingredients used must be proven to be safe for use in humans.