GUIDANCE DOCUMENT
Sameness Evaluations in an ANDA — Active Ingredients November 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-0697
- Docket Number:
- FDA-2022-D-0697
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Generic Drugs
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)).