Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The Orange Book data files are current through April 2009. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files. However, if you detect an error or discrepancy in drug data, please send a brief description of the data problem to the following e-mail address: DRUGPRODUCTS@CDER.FDA.GOV.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Drug Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information Staff at:

Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500
The CDER Freedom of Information Office Electronic Reading Room provides background information about the FOI process.

abrir aquí para acceder al documento FDA y poder bajar el ORANGE BOOK:
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)