U.S. Food and Drug Administration
U.S. Food and Drug Administration
Electronic Orange Book | FDA
FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity.
Orange Book Data Files | FDA
Mar 8, 2023 · Downloadable Data Files for the Orange Book. The compressed (.ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde (~)...
Orange Book Data File Download Instructions . A step-by-step guide to download the latest Orange Book monthly data to Microsoft Excel on Microsoft Windows*. 1. Go to the Orange Book...
Approved Drug Products with Therapeutic Equivalence Evaluations
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act).
Dec 27, 2024 · For drug manufacturers, the Orange Book’s information on a drug’s patents and regulatory exclusivities can be critical to whether and when generic competition occurs.
The Orange Book - Food and Drug Administration
How to determine what drugs are approved in the United States by the FDA? The FDA's Orange Book identifies approved drug products FDA has draft guidance explaining that certain currently...
Approved Drug Products with Therapeutic Equivalence Evaluations
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). (For more information, see the Orange Book Preface.)"
What are the FDA’s Orange, Purple, and Green Books?
Nov 22, 2022 · The Orange Book is the Grandparent of the FDA color books, celebrating its 40th anniversary in 2020. The products listed in the Orange Book have an application with an approval that has not been withdrawn for safety or efficacy reasons.
FDA Orange Book - PubChem Data Source
Dec 20, 2024 · 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.