Issue Date: July 22, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Final
Orange Book Questions and Answers Guidance for Industry: Guidance for Industry
This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). This guidance provides answers to commonly asked questions that we have received from these interested parties regarding the Orange Book.
Download the Guidance Document
