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The “Orange Book” is the FDA’s official publication titled the Approved Drug Products with Therapeutic Equivalence Evaluations. It lists approved drug products and includes information used to determine therapeutic equivalence (such as whether generic versions can be substituted for a brand-name drug). [1] Sources: [1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process
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