Approved Drug Products with Therapeutic Equivalence Evaluations

FDA Orange Book Data

Source FDA

The FDA produces "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly referred to as the Orange Book. 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.)"

The FDA offers an Orange Book searchable database.

The Orange Book consists of the Patents, Products, and Exclusivity data files.

The documentation describes the data fields in each file. The Orange Book Preface has additional information as well.

The Product data file contains an ingredient variable which has multiple ingredients separated by a semicolon.

The Ingredients data file contains the multiple ingredients ingredient variable plus the single ingredients in a long shape.

The FDA Orange Book data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

Some historic files are available in the CCYY/CCYYMMDD folders where CCYY is the year and CCYYMMDD is the day.

Updates and changes.

All Source Data Files

Patent

Products

Exclusivity