Orange Book: Approved Drug Products with Therapeutic Equivalence

Small book cover: Orange Book: Approved Drug Products with Therapeutic Equivalence

Orange Book: Approved Drug Products with Therapeutic Equivalence

Publisher: U.S. Department of Health and Human Services
Number of pages: 1252

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).

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