Who publishes Orange Book?

Center for Drug Evaluation and Research, part of U.S. Department of Health & Human Services, publishes this dataset on Data.gov.

How do I download it?

Use the official source link above to view or request the data.

Checked Oct 30, 2026

Federal dataHealth

Orange Book

Name: Orange Book
Creator: U.S. Department of Health & Human Services
License: https://www.usa.gov/government-works

Published by Center for Drug Evaluation and Research

Official source

Last updated: Not listed
Update frequency: Not listed
Formats: Web only
Coverage: Nationwide; Federal data

About this dataset

Lists 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), therapeutic equivalence evaluations, marketing statuses, and related applicable patent and exclusivity information.

Health

Files and access

Links open the official government source

Orange Bookfda.gov

Links open outside websites we do not control.

Frequently asked questions

Who publishes Orange Book?: Center for Drug Evaluation and Research, part of U.S. Department of Health & Human Services, publishes this dataset on Data.gov.
How do I download it?: Use the official source link above to view or request the data.

Where this catalog comes from

Data.gov CatalogU.S. General Services Administration
State and local open data portalsSocrata Discovery API
State and city CKAN portalsCalifornia, Virginia, Boston, Houston and more
Government ArcGIS Hub sitesCity and county GIS data

Catalog checked 10/24/2026

We list dataset descriptions only. Downloads and APIs link straight to the official government source, which holds the current version and its terms of use.

Source: Data.gov · Last updated 10/24/2026 · Listing only; the data stays with the publisher