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Orange Book

Published by U.S. Food and Drug Administration | U.S. Department of Health & Human Services | Metadata Last Checked: July 14, 2025 | Last Modified: 2014-01-08
The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides consumers timely updates on these products. In addition to these products (fo

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