NATIONAL BUREAU OF ECONOMIC RESEARCH
NATIONAL BUREAU OF ECONOMIC RESEARCH

FDA Orange Book

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.

Updates and changes.

All Raw Data Files
Patent
Products
Exclusivity
Ingredient
Raw
Stata
SAS
CSV
Desc
Raw
Stata
SAS
CSV
Desc
Raw
Stata
SAS
CSV
Desc
Raw
Stata
SAS
CSV
Desc
UCM163762.zip
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc
txt
dta
sas7bdat
csv
desc

To report problems or if you have comments or suggestions , e-mail Jean Roth at jroth@nber.org

Last Update Created by Jean Roth February 10, 2014
 
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