Approved Animal Drug Products (Green Book)

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 with the list published in its entirety each January. As of June 8, 2017, all Green Book reports are updated in their entirety on a monthly basis and are located on the Animal Drugs @ FDA website: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

Additional Information

• Animal Drugs @ FDA
• Recent Animal Drug Approvals
• Approved Animal Drug Products (Green Book) Corrections
• New Animal Drug Applications
• User Fees
• Electronic Submissions

Reporting Problems

• How to Report Animal Drug Side Effects and Product Problems
• Veterinary Adverse Event Reporting for Manufacturers