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Table of Contents
Green Book On-Line
On-Line Database
Subscription Information
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The Generic Animal Drug and Patent
Restoration act requires that each sponsor of an approved
animal drug must submit to the FDA certain information regarding
patents held for the animal drug or its method of use. The
Act requires that this information, as well as a list of
all animal drug products approved for safety and
effectiveness, be made available to the public. This list
must be updated monthly under the provisions of the Act.
The list, known as the "Green Book," was first
published in January 1989. Updates have been added monthly
since then. Each January, the list is published in its entirety.
The book is published on a non-profit basis from information
in a database maintained under a cooperative agreement between
the U.S. Department of Agriculture and the Virginia Polytechnic
Institute and State University, and funded through an interagency
agreement between the FDA and the USDA. The current year
Green Book is available in print form by subscription. The
electronic Green Book is being developed to improve public
access to the information contained in the databases that
support its publication. The Web Site formerly known as
the "FDA Approved Animal Drug Database" was a
derivative of these databases. The initial offering of the
electronic Green Book by the Drug Information Laboratory
includes the "FDA Approved Animal Drug Database"
files, all chapters of the printed Green Book and a searchable
archive of monthly updates dating back to 1989.
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