Orange Book-Questions and Answers; Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Orange Book--Questions and Answers." This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance finalizes the draft guidance of the same title issued on June 1, 2020.
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