Sameness Evaluations in an Abbreviated New Drug Application-Active Ingredients; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sameness Evaluations in an ANDA--Active Ingredients."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).
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