Issue Date: November 8, 2022
Issued by: Center for Drug Evaluation and Research,Office of Generic Drugs
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Draft
Sameness Evaluations in an ANDA — Active Ingredients
This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD) as required under section 505(j)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(2)(A)(ii)) and FDA’s regulations in § 314.94(a)(5) (21 CFR 314.94(a)(5)).
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