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U.S. Department of Health and Human Services

Drugs

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Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book),  identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).  Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax®  Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication.

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