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GUIDANCE DOCUMENT

Sameness Evaluations in an ANDA — Active Ingredients November 2022

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0697
Issued by:
Guidance Issuing Office
Center 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)).

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0697.

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