fda-orange-book

is a Data Source.

The FDA Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, identifies drug products approved on the basis of safety and effectiveness by FDA and provides therapeutic equivalence, patent, and exclusivity information.

Compare

Repository

Unknown

External IDs

RRID: RRID:SCR_013727

Product Summary

Contacts

U.S. Food and Drug Administration

Email: druginfo@fda.hhs.gov

URL: https://www.fda.gov/

Products

From this Resource

ID	Name	URL	Category	Format	Description
fda-orange-book.search	FDA Orange Book Search	approved-drug-products-therapeutic-equivalence-evaluations-orange-book	Graphical Interface	http	FDA searchable Orange Book database f...
fda-orange-book.data-files ⚠	FDA Orange Book Data Files	orange-book-data-files	Product	mixed	FDA Orange Book data files and append...
fda-orange-book.preface ⚠	FDA Orange Book Preface	orange-book-preface	Documentation	http	FDA Orange Book preface describing pu...

From other Resources

ID	Name	URL	Category	Format	Relation	Description
medi.orangebook	MeDI Orange Book Extract	orangebook.xlsx (902.6 KB)	Product	xlsx	was derived from	FDA Orange Book regulatory source ext...
openfda.apis	openFDA APIs	apis	Programming Interface	http	had primary source	JSON REST APIs (Elasticsearch query s...
openfda.downloads	openFDA Bulk Downloads	downloads	Product	json	had primary source	Bulk downloads of every openFDA endpo...

Details

FDA Orange Book

The FDA Orange Book is the authoritative FDA publication for approved drug products with therapeutic equivalence evaluations. It provides search and data file access to product approval, therapeutic equivalence, patent, and exclusivity information used by downstream regulatory and drug indication resources.