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.
- products.txt
- patent.txt
- exclusivity.txt
Product Number Download
Center for Drug Evaluation and Research Orange Book Data Files
Thank you for your follow-up inquiry. There are Orange Book data text data files containing the content of the Orange Book Query at Orange Book Data Files | FDA: these are tilde delimited text files, product.txt, patent.txt, and exclusivity.txt, that can be downloaded and imported into Excel. File descriptions, including Product Number, are provided on the webpage. The files are updated monthly. Please see the download Instructions on how to download the Orange Book product information into a spreadsheet.
We hope you find this information helpful.
Regards,
Division of Orange Book Publication and Regulatory Assessment, xb/ac
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
- Product Number Download
- Update Frequency
- Licensing
- Table Info