Orange Book: Approved Drug Products with Therapeutic Equivalence
Publisher: U.S. Department of Health and Human Services 2011
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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