Orange Book

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. For more information on the Orange Book including its history, see the Orange Book Preface.

Preface to the Orange Book

Food and Drug Administration Preface to the 41st Edition Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations 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 FD&C Act).

www.fda.gov

Source Links

Download

www.fda.gov

www.fda.gov

The compressed (ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde (~) delimited format. Please note the recent changes to the Data Descriptions below.

1. products.txt
2. patent.txt
3. exclusivity.txt

Update Frequency

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.

Licensing

Table Info

Orange Book Data Files

Data Descriptions updated (February 24, 2017)

www.fda.gov

On this page

• Orange Book
• Description
• Source Links
• Download
• Update Frequency
• Licensing
• Table Info