ABSTRACT
This document contains data that, when submitted to FDA’s Center for Drug
New Drug
Evaluation and Research (CDER), Office of Generic Drugs, provide for the
Application
review and ultimate approval of a generic drug product. This document does
(ANDA)
not contain preclinical or clinical data but must demonstrate that the drug in question is a bioequivalent to the currently licensed drug, which is also referred to as the innovator drug. See https://www.fda.gov/cder/drugsatfda/glossary.htm.
