Animal Drugs @ FDA
There are eight sections in the publication. The first lists approved drug products; subsections being sorted by tradename and then by NADA number. The second section lists active ingredients and each approved product containing that active ingredient. The third section lists patent information as provided by the sponsors of approved animal drug products. Section four lists exclusivity periods granted for new uses or claims approved subsequent to enactment of GADPTRA. Section five lists any approved products that are currently the subject of a Notice of Hearing and thus may not be used as a basis of an ANADA. Section six lists animal drug products whose approval has been voluntarily withdrawn by their sponsors since GADPTRA was enacted.Section seven lists the actions on ANADA suitability petitions that have been received by the FDA since the enactment of GADPTRA. Section eight is reserved for monthly updates.