ANDA Forms & Submission Requirements

Model Bioequivalence Data Summary Tables. [Word]  The Division of Bioequivalence has developed new data summary tables so that data can be submitted to the Office of Generic Drugs in a concise format consistent with the Common Technical Document. ANDA applicants should complete these tables and send the completed tables along with the rest of the Bioequivalence submission of their ANDA. There are instructions with the tables explaining how to fill them out. Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs