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.
Approved Animal Drug Products Online (Green Book)
Sections have been updated for January 2016
Introduction (Green Book)(PDF - 28KB) Section 1 - NADA Number,Tradenames and Sponsors arranged by: Tradename(PDF - 448KB) Section 1 - NADA Number,Tradenames and Sponsors arranged by: NADA Number(PDF - 669KB) Section 2 - Active Ingredients(PDF - 1.5MB) Section 3 - Patent Information(PDF - 175KB) Section 4 - Exclusivity Periods(PDF - 167KB) Section 5 - Products Subject to Notice of Hearing(PDF - 96KB) Section 6 - Voluntary Withdrawals(PDF - 294KB) Section 7 - Suitability Petition Actions(PDF - 4.7MB) Approved Animal Drug Products (Green Book) Monthly Updates Approved Animal Drug Products (Green Book) Corrections