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contributors
FDA Center for Drug Evaluation and Research
description The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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) and related patent and exclusivity information.
last_edit Mon, 19 Jun 2023 16:46:57 GMT
location https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
maintained_by The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to orangebook@fda.hhs.gov. General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information druginfo@fda.hhs.gov.
open_access TRUE
related_projects
parent
orangebook_nber
shortname orangebook_fda
tags
drugs
pharmaceuticals
us
exclusivity
title FDA Orange Book Database
uuid dc9b201c-5f40-4aca-9f40-b7e1dcee5c67
versioning FALSE